Textbook of Female Urology and Urogynecology, Volume 2: Surgical Perspectives [5 ed.] 2022025452, 2022025453, 0367700166, 9780367700164, 9780367700171, 9781003144243, 9780367700140, 9780367700157, 9781003144236

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Textbook of Female Urology and Urogynecology Featuring contributions by an international team of the world’s experts in urology and urogynecology, this fifth edition reinforces its status as the classic comprehensive resource on female urology and urogynecology and an essential clinical reference in the field, with new chapters throughout.

Volume 1 (Clinical Perspectives) – available separately or as part of the set – covers background issues; role of patient-reported outcome measures and health economics; structure and function of the lower urinary tract and anorectal tract in women; diagnostic evaluation of incontinence and urogenital prolapse; conservative and minimally invasive therapies; and associated disorders.

Volume 2 (Surgical Perspectives) – available separately or as part of the set – covers surgery for urinary incontinence; surgery for urogenital prolapse; laparoscopy and robotics; complex problems; and appendix on standardized terminology for incontinence and pelvic floor dysfunction.

Volume Two

Textbook of Female Urology and Urogynecology Surgical Perspectives Fifth Edition Edited by

Linda Cardozo O.B.E., M.D., F.R.C.O.G

Professor of Urogynaecology, King’s College Hospital, London, UK

David Staskin M.D.

Director, Male and Female Pelvic Surgery, Division of Urology, Steward Health - St. Elizabeth’s Medical Center and Associate Professor of Urology, Boston University School of Medicine, Boston, Massachusetts, USA Section Editors

Lori A. Birder Ph.D. Rufus Cartwright M.D., M.R.C.O.G. Nikki Cotterill Ph.D. Roger R. Dmochowski M.D., M.M.H.C., F.A.C.S. Ian Milsom M.D., Ph.D. Victor W. Nitti M.D. Christian Phillips M.D. Dudley Robinson M.B.B.S., M.D., F.R.C.O.G. Eric S. Rovner M.D. Peter K. Sand M.D. Philip Toozs-Hobson M.B.B.S., A.S.M., F.R.C.O.G, M.D.

Fifth edition published 2023 by CRC Press 4 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN and by CRC Press 6000 Broken Sound Parkway NW, Suite 300, Boca Raton, FL 33487-2742 CRC Press is an imprint of Taylor & Francis Group, LLC © 2023 selection and editorial matter, Linda Cardozo and David Staskin individual chapters, the contributors First edition published by CRC Press 2001 Fifth edition published by CRC Press 2023 The right of Linda Cardozo and David Staskin to be identified as the authors of the editorial material, and of the authors for their individual chapters, has been asserted in accordance with sections 77 and 78 of the Copyright, Designs and Patents Act 1988. This book contains information obtained from authentic and highly regarded sources. While all reasonable efforts have been made to publish reliable data and information, neither the author[s] nor the publisher can accept any legal responsibility or liability for any errors or omissions that may be made. The publishers wish to make clear that any views or opinions expressed in this book by individual editors, authors or contributors are personal to them and do not necessarily reflect the views/opinions of the publishers. The information or guidance contained in this book is intended for use by medical, scientific or health-care professionals and is provided strictly as a supplement to the medical or other professional’s own judgement, their knowledge of the patient’s medical history, relevant manufacturer’s instructions and the appropriate best practice guidelines. Because of the rapid advances in medical science, any information or advice on dosages, procedures or diagnoses should be independently verified. The reader is strongly urged to consult the relevant national drug formulary and the drug companies’ and device or material manufacturers’ printed instructions, and their websites, before administering or utilizing any of the drugs, devices or materials mentioned in this book. This book does not indicate whether a particular treatment is appropriate or suitable for a particular individual. Ultimately it is the sole responsibility of the medical professional to make his or her own professional judgements, so as to advise and treat patients appropriately. The authors and publishers have also attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, access www.copyright.com or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. For works that are not available on CCC please contact [email protected] Trademark notice: Product or corporate names may be trademarks or registered trademarks and are used only for identification and explanation without intent to infringe. Library of Congress Cataloging‑in‑Publication Data Names: Cardozo, Linda, editor. | Staskin, David, editor. Title: Textbook of female urology and urogynecology. Surgical perspectives / edited by Linda Cardozo, David Staskin. Other titles: Surgical perspectives | Textbook of female urology and urogynecology. Description: Fifth edition. | Boca Raton : CRC Press, 2022. | Replacement in part of Textbook of female urology and urogynecology / editors in chief, Linda Cardozo and David R. Staskin. Fourth edition. 2017. | Includes bibliographical references and index. Identifiers: LCCN 2022025452 (print) | LCCN 2022025453 (ebook) | ISBN 9780367700164 (v. 2 ; hardback) | ISBN 9780367700171 (v. 2 ; paperback) | ISBN 9781003144243 (v. 2 ; ebook) Subjects: MESH: Urinary Incontinence--surgery | Pelvic Organ Prolapse--surgery | Urogenital Abnormalities--surgery | Urogenital Surgical Procedures--methods | Laparoscopy--methods | Robotic Surgical Procedures--methods Classification: LCC RG484 (print) | LCC RG484 (ebook) | NLM WJ 146 | DDC 618.1--dc23/eng/20220811 LC record available at https://lccn.loc.gov/2022025452 LC ebook record available at https://lccn.loc.gov/2022025453 ISBN: 9780367700140 (hbk1) ISBN: 9780367700157 (pbk1) ISBN: 9781003144236 (ebk1) ISBN: 9780367700164 (hbk2) ISBN: 9780367700171 (pbk2) ISBN: 9781003144243 (ebk2) DOI: 10.1201/9781003144243 Typeset in Warnock Pro by KnowledgeWorks Global Ltd. Access the companion website: https://resourcecentre.routledge.com/books/9780367700164

CONTENTS Preface.................................................................................................................................................................................................................................. viii Editors-in-Chief....................................................................................................................................................................................................................ix Section Editors....................................................................................................................................................................................................................... x Current Contributors..........................................................................................................................................................................................................xi

VOLUME TWO: SURGICAL PERSPECTIVES SECTION VII: SURGERY FOR URINARY INCONTINENCE

Section Editor: Roger Dmochowski

68 How and Why Incontinence Surgery Works..................................................................................................................................................... 736 Joshua Kent Calvert, Elizabeth Rourke, Mauricio Plata, Nicolas Fernandez, David James Osborn, and Roger Dmochowski 69 Peri- and Postoperative Care..................................................................................................................................................................................743 George Araklitis, Sushma Srikrishna, and Linda Cardozo 70 Traditional Surgery and Other Historical Procedures for Stress Incontinence.........................................................................................757 Elisabeth Sebesta, Malcolm Lucas, Elizabeth Timbrook Brown, and Roger Dmochowski 71 Retropubic Urethropexy..........................................................................................................................................................................................776 Dudley Robinson and Linda Cardozo 72 Fascial Slings..............................................................................................................................................................................................................787 Elizabeth A. Rourke, W. Stuart Reynolds, Aaron Brothers, David James Osborn, Roger R. Dmochowski, and Melissa R. Kaufman 73 Retropubic Mid-Urethral Sling Procedure for the Treatment of Female Urinary Stress Incontinence...............................................795 Steven E. Schraffordt Koops and Femke van Zanten 74 Transobturator Tape for Surgical Treatment of Stress Urinary Incontinence: Outside-In Technique............................................... 807 Emmanuel Delorme 75 Single-Incision Mini-Slings....................................................................................................................................................................................817 Mickey Karram and Ahmed Abdelaziz 76 Readjustable Slings: SAFYRE and REMEEX......................................................................................................................................................822 Paulo Palma, Cassio Riccetto, and Carlos Errando Smet 77 Artificial Urinary Sphincter for Treatment of Stress Urinary Incontinence in Women..........................................................................837 Elizabeth A. Rourke, David Castro-Diaz, David Staskin, and Roger R. Dmochoski 78 Diagnosis and Treatment of Obstruction Following Incontinence Surgery: Urethrolysis and Other Techniques........................... 847 Elisabeth M. Sebesta, Melissa R. Kaufman, W. Stuart Reynolds, Stephen Mock, and Roger R. Dmochowski 79 Complications of Stress Urinary Incontinence Surgery................................................................................................................................. 860 Véronique Phé and Emmanuel Chartier-Kastler 80 Mesh Complications and Their Management................................................................................................................................................... 868 Antonin Prouza and Hashim Hashim

SECTION VIII: SURGERY FOR UROGENITAL PROLAPSE

Section Editor: Peter Sand

81 Classification and Epidemiology of Pelvic Organ Prolapse............................................................................................................................ 880 Steven E. Swift and Joel D. Winer 82 Anterior Vaginal Wall Prolapse............................................................................................................................................................................ 889 Whitney K. Hendrickson and Matthew D. Barber 83 Enterocele.................................................................................................................................................................................................................. 902 Kaven Baessler 84 Rectocele: Anatomic and Functional Repair......................................................................................................................................................912 Olivia H. Chang, James H. Ross, and Marie Fidela R. Paraiso v

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Contents

85 Vaginal Approach to Apical Suspension............................................................................................................................................................ 925 Debjyoti Karmakar and Peter L. Dwyer 86 Open Abdominal Approach to Supporting the Vaginal Apex.......................................................................................................................935 Russell Stanley, T. Clark Powell, and Holly E. Richter 87 Uterine Preservation and Hysteropexy............................................................................................................................................................... 945 Roger P. Goldberg and Nani P. Moss 88 Surgery for Urogenital Prolapse: Colpocleisis................................................................................................................................................... 958 Emilly Santos and G. Willy Davila 89 Biological and Synthetic Grafts in Reconstructive Pelvic Surgery............................................................................................................... 965 Katrina M. Knight, Brittany R. Egnot, William R. Barone, and Pamela A. Moalli 90 Complications of Synthetic Mesh Used to Repair Pelvic Organ Prolapse and Stress Urinary Incontinence.............................................................................................................................................................................................. 990 Rubin Raju, Ahmed Abdelaziz, Mickey Karram, and John B. Gebhart 91 Management of the Perineum, Episiotomy, and Perineal Reconstruction............................................................................................... 1000 J. Oliver Daly 92 Primary Repair of Obstetric Anal Sphincter Injuries....................................................................................................................................1013 Ruwan Fernando and Abdul H. Sultan 93 Surgery for Fecal Incontinence........................................................................................................................................................................... 1025 Emanuela Silva-Alvarenga, Yasmin Zerhouni, and Steven D. Wexner 94 Rectal Prolapse and Other Causes of Defecatory Dysfunction................................................................................................................... 1038 Megan R. Routzong, Steven Abramowitch, and Ghazaleh Rostaminia

SECTION IX: LAPAROSCOPY AND ROBOTICS

Section Editor: Christian Phillips

95 The Role of Laparoscopic Surgery in Urogynecology: An Introduction................................................................................................... 1048 Christian Phillips 96 Abdominal and Pelvic Anatomy Through the Laparoscope........................................................................................................................ 1049 Fiona Reid 97 Training and Accreditation in Laparoscopic and Robotic Pelvic Floor Surgery..................................................................................... 1054 Shannon L. Wallace, Karl Jallad, Alfred Cutner, and Marie Fidela R. Paraiso 98 Laparoscopic Colposuspension...........................................................................................................................................................................1061 Matthew Izett-Kay and Arvind Vashisht 99 Laparoscopic Sacrocolpopexy............................................................................................................................................................................. 1077 Mugdha Kulkarni, Anna Rosamilia, and Marcus Carey 100 Laparoscopic Sacrohysteropexy......................................................................................................................................................................... 1088 Matthew Izett-Kay and Natalia Price 101 Prevention, Recognition and Treatment of Complications in Laparoscopic Pelvic Floor Surgery..................................................... 1098 Ellen Yeung and Christopher Maher 102 The Role of Robotic Surgery.................................................................................................................................................................................1109 D. Galvin, O.E. O’Sullivan, and B.A. O’Reilly 103 Cost-Effectiveness in Laparoscopic and Robotic Surgery in Urogynecology............................................................................................1117 Karen Ward 104 New Techniques in Laparoscopic Pelvic Floor Surgery................................................................................................................................ 1124 Stephen T. Jeffery and Khumbo T. Jere

SECTION X: COMPLEX PROBLEMS

Section Editor: Victor Nitti

105 Diagnosis of Urogenital Fistula.......................................................................................................................................................................... 1134 Caroline A. Brandon, Ekene A. Enemchukwu, and Benjamin M. Brucker

Contents

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106 Transvaginal Repair of VVF.................................................................................................................................................................................1146 Lori Jones and Nirit Rosenblum 107 Transabdominal Vesicovaginal and Vesicouterine Fistula Repair..............................................................................................................1152 Christopher F. Tenggardjaja and Howard B. Goldman 108 Management of Obstetric Urogenital Fistula...................................................................................................................................................1160 Andrew Browning 109 Management of Iatrogenic Ureteral Injury and Ureterovaginal Fistula.....................................................................................................1175 Elizabeth R. Mueller 110 Management of Urethrovaginal Fistula.............................................................................................................................................................1185 Pansy Uberoi and Kathleen C. Kobashi 111 Urethral Diverticulum...........................................................................................................................................................................................1189 Yu Zheng and Eric S. Rovner 112 Diagnosis and Management of Female Urethral Stricture Disease........................................................................................................... 1201 Dmitry Volkin and Victor W. Nitti 113 Bladder Reconstruction and Urinary Diversion..............................................................................................................................................1210 Daniela Kaefer and Ja-Hong Kim 114 Gynaecological Developmental Abnormalities...............................................................................................................................................1219 Cara E. Williams 115 Pediatric Urogynecology...................................................................................................................................................................................... 1227 Jennifer S. Singer, Angela M. Arlen, Tamara Grisales, and Andrew J. Kirsch 116 Female Cosmetic Genital Surgery...................................................................................................................................................................... 1249 Ö. Ferit Saraçoğlu 117 Gender-Affirming Surgery, Care, and Common Complications................................................................................................................ 1270 Christi Butler, Daniel Dugi, and Geolani W. Dy Index........................................................................................................................................................................................................................................I1

PREFACE … we would like to thank our patients, who place their trust in us each and every day. We hope that this textbook contributes to the quality of their care and to the ability of those who will care for them in the future. (from the Preface of the first edition, 2001) The success of the first four editions of the Textbook of Female Urology and Urogynecology (2001, 2006, 2010, 2017) and our desire to continue to provide a timely and relevant reference textbook in an evolving field, stimulated us to produce another contribution, this fifth edition. We hope, as we did with all previous editions, that we have continued to fulfil our mission to present a book that serves as a foundation for established ideas, a review of the current state of the art and a platform for introducing the dynamic concepts of the future. Over 20 years the textbook has evolved from a single volume of seven sections and approximately 1000 pages – to a two volume, ten section, 1500-page version. We are grateful to those who have served as section editors – introduced in the second edition. These section editors are an invaluable part of the process. We specifically selected the section editors and authors to represent

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an international approach to the numerous female urogenital health disorders to produce a good balance of knowledge, and expertise, despite the polarization of ideas that can occur as a natural product of geography, training, and interests. We recognize that there is a significant overlap between Female Urology and Urogynecology. However, there are also important differences, and we hope that these are reflected by having a balance between the healthcare professionals who have edited and authored the chapters. Please allow us to take pride in the fact that many of the authors who contributed as co-authors in the early editions are now distinguished clinicians, department chairs, or editors of their own textbooks. We are humbled by their efforts. Similarly, we are indebted to the publishers, who have expertly facilitated the organization and production of all five editions. Thank you for choosing this textbook for your education and reference, and for your practice and library. Linda Cardozo David Staskin

EDITORS-IN-CHIEF Linda Cardozo O.B.E., M.D., F.R.C.O.G., is Professor of Urogynaecology, King’s College Hospital, London, U.K.

David Staskin M.D., is Director of the Male and Female Pelvic Surgery, Division of Urology, Steward Health – St. Elizabeth’s Medical Center, and Associate Professor of Urology, Tufts University School of Medicine, Boston, Massachusetts, U.S.A.

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SECTION EDITORS Lori A. Birder Ph.D. is with Departments of Medicine and Pharmacology and Chemical Biology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, U.S.A. Rufus Cartwright M.D., M.R.C.O.G., is with the Faculty of Medicine, School of Public Health, Imperial College London, London, U.K. Nikki Cotterill Ph.D., is with the Faculty of Health and Applied Sciences, University of the West of England, Bristol, U.K. Roger R. Dmochowski M.D., M.M.H.C., F.A.C.S., is with the Departments of Urology and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee, U.S.A. Ian Milsom M.D., Ph.D., is with the Department of Obstetrics and Gynecology, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden. Victor W. Nitti M.D., is with the Division of Female Pelvic Medicine and Reconstructive Surgery, Departments of Urology and Obstetrics and Gynecology, David Geffen School of Medicine at UCLA, Los Angeles, California, U.S.A.

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Christian Phillips M.D., is with the Department of Obstetrics and Gynaecology, Hampshire Hospitals NHS Foundation Trust, Basingstoke, and Health and Wellbeing Research Group, University of Winchester, Winchester, U.K. Dudley Robinson M.B.B.S., M.D., F.R.C.O.G., is with the Department of Urogynaecology, King’s College Hospital, London, U.K. Eric S. Rovner M.D., is with the Department of Urology, Medical University of South Carolina, Charleston, South Carolina, U.S.A. Peter K. Sand M.D., is with the Obstetrics and Gynecology, Pritzker School of Medicine, University of Chicago, and Evanston Continence Center, NorthShore University Health System, Chicago, Illinois, U.S.A. Philip Toozs-Hobson M.B.B.S., A.S.M., F.R.C.O.G, M.D., is with the Urogynaecology and Pelvic Floor Medicine, Birmingham Women’s N.H.S. Foundation Trust, University of Birmingham, Birmingham, U.K.

CURRENT CONTRIBUTORS Ahmed Abdelaziz Urogynecology, Obstetrics, and Gynecology The Christ Hospital University of Cincinnati School of Medicine Cincinnati, Ohio, U.S.A. Steven Abramowitch Bioengineering Swanson School of Engineering University of Pittsburgh Pittsburgh, Pennsylvania, U.S.A. George Araklitis Urogynaecology King’s College Hospital London, U.K. Angela M. Arlen Urology Yale School of Medicine New Haven, Connecticut, U.S.A. Kaven Baessler Pelvic Floor Centre Charité – Universitätsmedizin Berlin Berlin, Germany Matthew D. Barber Urogynecology, Obstetrics and Gynecology Duke University Medical Center Durham, North Carolina, U.S.A. William R. Barone Bayer Pharmaceuticals Radiology R&D Indianola, Pennsylvania, U.S.A. Caroline A. Brandon Obstetrics and Gynecology New York University New York, New York, U.S.A. Aaron Brothers Urology Dwight D. Eisenhower Army Medical Center Augusta, Georgia, U.S.A. and Tufts University School of Medicine Boston, Massachusetts, U.S.A. Elizabeth Timbrook Brown Urology Vanderbilt University Medical Center Nashville, Tennessee, U.S.A.

Andrew Browning Maternity Africa Arusha, Tanzania Benjamin M. Brucker Urology and Obstetrics and Gynecology New York University Langone Medical Center New York, New York, U.S.A. Christi Butler Urology & Transgender Health Program Oregon Health & Science University Portland, Oregon, U.S.A. Joshua Kent Calvert Urology Vanderbilt University Medical Center Nashville, Tennessee, U.S.A. Marcus Carey Pelvic Floor Centre of Excellence Epworth Richmond, Australia and University of Melbourne Medical School Victoria, Australia David Castro-Diaz Urology University Hospital of the Canary Islands University of La Laguna Santa Cruz de Tenerife, Spain Olivia H. Chang Female Pelvic Medicine and Reconstructive Surgery Cleveland Clinic Foundation Cleveland, Ohio, U.S.A. Alfred Cutner Institute of Women’s Health University College London London, U.K. J. Oliver Daly Urogynaecology and Obstetrics Western Health and Monash University Clayton, Victoria, Australia G. Willy Davila Urogynecology and Pelvic Health Dorothy Mangurian Comprehensive Women’s Center Fort Lauderdale, Florida, U.S.A. Emmanuel Delorme Urology Private Hospital Sainte Marie Chalon-sur-Saône, France

Daniel Dugi Urology & Transgender Health Program Oregon Health & Science University Portland, Oregon, U.S.A. Peter L. Dwyer Urogynaecology Mercy Health Melbourne, Victoria, Australia Geolani W. Dy Urology & Transgender Health Program Oregon Health & Science University Portland, Oregon, U.S.A. Brittany R. Egnot Department of Bioengineering University of Pittsburgh Pennsylvania, U.S.A. Ekene A. Enemchukwu Urology Stanford University School of Medicine Stanford, California, U.S.A. Nicolas Fernandez Pediatric Urology Seattle Children’s Hospital Seattle, Washington, U.S.A. Ruwan Fernando Urogynaecology Imperial College Healthcare NHS Trust and St Mary’s Hospital London, U.K. Daniel Galvin Urogynaecology Cork University Maternity Hospital Cork, Ireland John B. Gebhart Obstetrics and Gynecology Mayo Clinic College of Medicine Rochester, Minnesota, U.S.A. Roger P. Goldberg Division of Urogynecology NorthShore University Healthsystem, and Obstetrics and Gynecology Pritzker School of Medicine The University of Chicago Skokie, Illinois, U.S.A. xi

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Current Contributors

xii Howard B. Goldman Center for Female Pelvic Medicine and Reconstructive Surgery Glickman Urologic and Kidney Institute Cleveland Clinic Cleveland, Ohio, U.S.A. Tamara Grisales Obstetrics and Gynecology UCLA Los Angeles, California, U.S.A. Hashim Hashim Bristol Urological Institute Southmead Hospital Bristol, U.K. Whitney K. Hendrickson Urogynecology, Obstetrics, and Gynecology Duke University Medical Center Durham, North Carolina, U.S.A. Matthew Izett-Kay Urogynaecology The John Radcliffe Hospital Oxford University Hospitals Oxford, U.K. Karl Jallad La Clinique Beirut, Lebanon Stephen T. Jeffery Urology University of Cape Town Cape Town, South Africa Khumbo T. Jere Urogynaecology University of Cape Town Cape Town, South Africa Lori Jones Urology St. Elizabeth’s Medical Center Boston, Massachusetts, U.S.A. Daniela Kaefer Surgery UCLA Los Angeles, California, U.S.A. Debjyoti Karmakar Urogynaecology Mercy Health Melbourne, Victoria, Australia

Mickey Karram Obstetrics and Gynecology and Urogynecology and Reconstructive Surgery The Christ Hospital University of Cincinnati School of Medicine Cincinnati, Ohio, U.S.A. Melissa R. Kaufman Urology Vanderbilt University Medical Center Nashville, Tennessee, U.S.A. Ja-Hong Kim Urology UCLA Los Angeles, California, U.S.A. Andrew J. Kirsch Pediatric Urology Emory University School of Medicine and Children’s Healthcare of Atlanta Atlanta, Georgia, U.S.A. Katrina M. Knight Bioengineering and Obstetrics Gynecology & Reproductive Sciences School of Medicine University of Pittsburgh Pittsburgh, Pennsylvania, U.S.A. Kathleen C. Kobashi Urology and Renal Transplantation Virginia Mason Medical Center Seattle, Washington, U.S.A. Mugdha Kulkarni Leeds Fertility Leeds, U.K. Malcolm Lucas Urology Vanderbilt University Medical Center Nashville, Tennessee, U.S.A. Christopher Maher Urogynaecology and Reconstructive Gynaecology Surgery University of Queensland Brisbane, Queensland, Australia Pamela A. Moalli Obstetrics, Gynecology & Reproductive Sciences School of Medicine University of Pittsburgh Pittsburgh, Pennsylvania, U.S.A. and Urogynecology & Pelvic Reconstructive Surgery UPMC Magee-Womens Hospital Pittsburgh, Pennsylvania, U.S.A.

Stephen Mock Urology Vanderbilt University Medical Center Nashville, Tennessee, U.S.A. Nani P. Moss Division of Urogynecology NorthShore University Healthsystem Skokie, Illinois, U.S.A. Elizabeth R. Mueller Urology and Obstetrics/Gynecology Loyola University Chicago, Illinois, U.S.A. and Loyola University Medical Center Maywood, Illinois, U.S.A. Barry A. O’Reilly Urogynaecology Cork University Maternity Hospital Cork, Ireland Orfhlaith E. O’Sullivan Urogynaecology Cork University Maternity Hospital Cork, Ireland David James Osborn Urology Germantown, Maryland, U.S.A. and Urologic Surgery Vanderbilt University School of Medicine Nashville, Tennessee, U.S.A. Paulo Palma Female Urology University of Campinas – UNICAMP Sao Paulo, Brazil Marie Fidela R. Paraiso Center for Urogynaecology and Reconstructive Pelvic Surgery Cleveland Clinic Cleveland, Ohio, U.S.A. Mauricio Plata Urology Hospital Universitario Fundación Santa Fe de Bogota and Continence Clinic Pelvic Floor and Urodynamics Division Universidad de los Andes School of Medicine Bogota, Colombia T. Clark Powell Urogynecology and Pelvic Reconstructive Surgery University of Alabama at Birmingham Birmingham, Alabama, U.S.A.

Current Contributors

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Natalia Price Urogynaecology Worcestershire Acute Hospitals NHS Trust Worcester, U.K.

James H. Ross Female Pelvic Medicine and Reconstructive Surgery Cleveland Clinic Foundation Cleveland, Ohio, U.S.A.

Russell Stanley Urogynecology and Pelvic Reconstructive Surgery University of Alabama at Birmingham Birmingham, Alabama, U.S.A.

Antonin Prouza Bristol Urological Institute Southmead Hospital Bristol, U.K.

Ghazaleh Rostaminia Urogynecology University of Chicago Pritzker School of Medicine Northshore University HealthSystem Skokie, Illinois, U.S.A.

Abdul H. Sultan Obstetrics and Urogynaecology Croydon University Hospital and St George’s University London, U.K.

Rubin Raju Obstetrics and Gynecology Mayo Clinic Rochester, Minnesota, U.S.A. Fiona Reid Urogynaecology St. Mary’s Hospital Central Manchester University Hospitals NHS Foundation Trust Manchester Academic Health Science Centre Manchester, U.K. W. Stuart Reynolds Urology Vanderbilt University Medical Center Nashville, Tennessee, U.S.A. Cassio Riccetto Female Urology University of Campinas – UNICAMP Sao Paulo, Brazil Holly E. Richter Obstetrics and Gynecology, Gerontology, and Geriatric Medicine Center for Aging and Genitourinary Disorders Center University of Alabama at Birmingham Birmingham, Alabama, U.S.A. Anna Rosamilia Urogynaecology Pelvic Floor Unit Monash Health Clayton, Victoria, Australia and Monash University Clayton, Victoria, Australia Nirit Rosenblum Urology New York University Langone Medical Center New York, New York, U.S.A.

Elizabeth Rourke Internal Medicine Brigham and Women’s Primary Care Associates of Brookline Brookline, Massachusetts, U.S.A. Megan R. Routzong Bioengineering Swanson School of Engineering University of Pittsburgh Pittsburgh, Pennsylvania, U.S.A. Emilly Santos Advanced Gynecologic Surgery The Woman’s Institute at Itaigara Memorial Day Hospital Salvador, Bahia, Brazil Ö. Ferit Saraçoğlu Obstetrics and Gynecology Femcare Women’s Clinic Ankara, Turkey Elisabeth Sebesta Urology Vanderbilt University Medical Center Nashville, Tennessee, U.S.A. Emanuela Silva-Alvarenga Colorectal Surgery Cleveland Clinic Florida Weston Hospital Weston, Florida, U.S.A.

Steven E. Swift Urogynecology, Obstetrics and Gynecology Medical University of South Carolina Charleston, South Carolina, U.S.A. Christopher F. Tenggardjaja Urology Kaiser Permanente Los Angeles Medical Center Los Angeles, California, U.S.A. Pansy Uberoi Female Pelvic Medicine and Reconstructive Surgery Virginia Mason Medical Center Seattle, Washington, U.S.A. Arvind Vashisht Gynaecology University College Hospital London, U.K. Dmitry Volkin Urological Associates Bridgeport Trumbull, Connecticut, U.S.A. Shannon L. Wallace Women’s Health Cleveland Clinic Cleveland, Ohio, U.S.A.

Carlos Errando Smet Female and Functional Urology Puigvert Foundation Barcelona, Spain

Karen Ward The Warrell Unit St. Mary’s Hospital Central Manchester University Hospitals NHS Foundation Trust Manchester, U.K. and Manchester Academic Health Science Centre Manchester, U.K.

Sushma Srikrishna Urogynaecology King’s College Hospital London, U.K.

Steven D. Wexner Colorectal Surgery Cleveland Clinic Florida Weston, Florida, U.S.A.

Jennifer S. Singer Urology UCLA Los Angeles, California, U.S.A.

Current Contributors

xiv Cara E. Williams Liverpool Women’s Hospital and Alder Hey Children’s Hospital Liverpool, U.K. Joel D. Winer Obstetrics and Gynecology Yale New Haven Hospital New Haven, Connecticut, U.S.A.

Ellen Yeung Mater Urogynaecology Unit Brisbane, Queensland, Australia Yasmin Zerhouni Colon and Rectal Surgery Johns Hopkins Medicine Howard County General Hospital Columbia, Maryland, U.S.A.

Yu Zheng Urology Medical University of South Carolina Charleston, South Carolina, U.S.A.

VOLUME TWO: SURGICAL PERSPECTIVES Section VII Surgery for Urinary Incontinence Section Editor: Roger Dmochowski

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HOW AND WHY INCONTINENCE SURGERY WORKS Joshua Kent Calvert, Elizabeth Rourke, Mauricio Plata, Nicolas Fernandez, David James Osborn, and Roger Dmochowski

Introduction Stress urinary incontinence (SUI), as defined by the International Continence Society (ICS), is the involuntary leakage of urine on effort or exertion or on sneezing or coughing (1). Surgical procedures are considered the most durable treatment for the majority of women with moderate and severe SUI. The procedures have evolved over time due to changes in our understanding of the anatomic and physiologic basis for continence. This chapter will review the history of urinary incontinence theories and its relation to the development of surgery. In order to explain this fully, we will review the anatomic basis of continence, the history of theories of incontinence, and the proposed mechanism behind the procedures performed for SUI. Historically, surgical procedures have failed in achieving universal success in urinary continence outcomes. Approximately 30% of the surgical procedures done for SUI are done on patients with recurrent SUI (2). These failure rates vary depending on the way continence is measured or defined; however, the failure rates are reflective, in part, of the shortcomings in understanding of the pathophysiology of SUI.

Mechanism of continence The physiology of continence depends on central and peripheral mechanisms. There are multiple central input centers including the cerebral cortex, midbrain, and spinal cord. There are also peripheral control mechanisms that involve not only neuromuscular elements but also myofascial support structures. The coordination of these mechanisms contributes to overall continence status (3). Urinary continence during stress maneuvers is the result of a combination of passive anatomical coaptation and active muscle tone. It depends on the intrinsic properties of the urethra and sphincter, as well as the anatomic support of surrounding tissues. The urethra itself is composed of three layers: an inner mucosa, a middle spongy vascular submucosa, and an outer muscular layer (3, 4). Coaptation of the mucosa and compression of the lumen both contribute to the closure of the urethra. Furthermore, the mucosa has many folds in it and it is thought that mucosal secretions increase surface tension, which makes coaptation even more effective. The vascular submucosa exerts some compressive effect on the mucosa, and lack of estrogen may contribute to SUI through the decreased vascularity of this area (5). The outer muscle layer of the urethra is a complex mechanism comprising of an internal smooth muscle sphincter, and an outer striated external sphincter. The internal sphincter is not a true sphincter from an anatomic viewpoint, as there are no clearly defined circular muscle layers. This layer also has longitudinal fibers that emanate from the ureters and trigone and end in the urethra. The external sphincter is composed of striated circular 736

muscle fibers which are thickest in the middle part of the urethra (6). It is thought that the striated muscles provide two kinds of sphincteric function. First, slow-twitch muscle fibers provide a continuous, modulated tone that keeps the urethra closed. Second, fast-twitch fibers respond to voluntary and reflex stimuli that suddenly increase contraction in time of increased abdominal pressure or in voluntary attempts to prevent leakage. The anatomic support of the urethra, bladder, and other pelvic organs is provided by the muscles of the pelvic floor and the fascia associated with them. The pelvic diaphragm itself is composed of the levator ani and coccygeus muscles. The levators consist of the pubovisceral portion, which has a U-shaped configuration around the rectum and connects the pubic bones anteriorly, and the pubococcygeus muscle, which runs from the pubis to the coccyx and provides most of the support for the pelvic organs. These muscles have constant tone, which keeps the levator hiatus (through which the urethra and vagina travel) closed (7, 8). The endopelvic fascia and arcus tendineus play a critical role in continence and pelvic floor support (Figs. 68.1 and 68.2) These structures, although commonly referred to as fascia, are not fascia in the strict definition of the word, but, rather, comprised mostly of connective tissue and muscle loosely termed as the endopelvic fascia. The endopelvic fascia can be divided into three zones which support the bladder above the cervix, the trigone, and the bladder neck, respectively (7). The urethra itself is also supported by endoplevic fascia (9), and is also supported by the pubourethral ligaments anteriorly which are analogous to the puboprostatic ligaments in the male. The arcus tendineus, a thick white band extending from the pubis to the ischial spine, plays a critical role in continence and pelvic floor support as the endopelvic fascia attaches to this structure. The primary principle of any surgical procedure for SUI is to provide urinary continence without disrupting micturition and with an acceptable rate of complication.

Theories of incontinence and its relation to surgical correction Since the beginning of the 20th century, theories describing the pathophysiology of SUI have evolved and changed with our changing understanding of the anatomy and disease process.

Anatomic and urethral mobility theories The earliest theories centered on the alteration in urethral position and lack of physical compression. In 1913, Howard Kelly, a gynecologist at Johns Hopkins, was one of the first authors to describe urethral lumen dysfunction, observed during cystoscopy, as the cause for SUI. This resulted in the Kelly’s plication, a procedure to implicate the urethra and bladder neck to reestablish continence (10).

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How and Why Incontinence Surgery Works

737 Burch colposuspension, and later modifications described by Tanagho (15–17). The concept of urethral hypermobility was further expounded in 1962 when Green demonstrated that SUI was associated with loss of the posterior urethrovesical angle (PUV). Green divided incontinence into two types according to the angle configuration. Type I shows “complete or near complete loss of the PUV angle, but with the angle of inclination to the vertical or the urethral axis either normal or at least 45° and often even completely reversed.” In Green’s study the MMK procedure worked for them both (18).

Intrinsic dysfunction theories FIGURE 68.1  Normal bladder position. 10 years later, Bonney described the concept of loss of paraurethral support that resulted in descent of the urethra, and that this sudden and abnormal displacement of the urethra and urethrovesical junction immediately inferior to the pubic symphysis would contribute to incontinence. As such he described a procedure with the underlying rationale of restoring the urethrovesical junction to a more supported and elevated position above the urogenital diaphragm and providing a restored backboard against which the urethra could be compressed during increases in abdominal pressure (11). This theory was later elaborated on by Enhorning, who postulated, in 1961, that urinary incontinence arose from deficiency of paraurethral support and unequal transmission of abdominal pressures to the urethra and the bladder (12). Kennedy demonstrated the contributing importance of the levator ani muscle fibers posterior to the symphysis pubis as supportive elements (13). These advances led Aldridge, in 1946, to describe the associated incontinence after childbirth secondary to pelvic floor injury, and its associated laxity of the urethra (14). Repositioning of the urethrovesical junction and proximal urethra into an abdominal position with the aim of equilibrating the transmission of abdominal pressure to the bladder and the urethra became the cornerstone concept for all retropubic procedures such as the Marshall–Marchetti–Krantz (MMK),

Intrinsic Sphincter Deficiency (ISD) is associated with an inability to maintain mucosal coaptation either at rest or in the presence of physical stress. Some authors have noted that during urethral pressure profilometry, the maximum urethral closure pressure is low and values of 65 y); omit if GFR < 60 Acetaminophen 1000 mg PO (omit if hepatic dysfunction) Morphine sulphate ER 30 mg PO (15 mg if age > 65 y) Postoperative nausea and vomiting prevention: Perphenazine 8 mg PO Anaesthesia can add scopolamine patch if age < 65 y Antibiotic prophylaxis Cefotetan 2 g IV within 60 minutes of incision No routine fluid administration No IV opioid premedication Induction: Propofol (1–2 mg/kg or titrate to amnesia and anaesthesia) Ketamine 20 mg Lidocaine 100–200 mg bolus Muscle relaxant (no opioids) Dexamethasone 4–5 mg IV (avoid if diabetes) Maintenance: Ketamine 10 mg q 1 hour (avoid in final hour) Lidocaine boluses q 1 hour (1 mg/kg) Avoid opioids intraoperatively unless patient c/o pain at emergence Avoid routine use of nasogastric tube Fluid management: Goal is euvolemia Laparoscopic and vaginal cases: 2 mL/kg per hour Boluses for MAP < 60 mm Hg or 20% of baseline Emergence: Propofol titration Ondansetron 4 mg IV No IV ketorolac (unless celecoxib not given preoperatively) No IV acetaminophen (unless not given preoperatively) Transition from IV to PO opioids for rescue pain management Avoid patient controlled anaesthesia Ketorolac and acetaminophen scheduled Start ice chips/sips of clear liquids as tolerated IV fluids at 40 mL/h until tolerating oral fluids

(Continued)

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TABLE 69.3 (Continued): ERAS Protocol for Urogynaecology Surgical Patients Discharge checklist

Postoperative Follow-up Assessment postoperative day 1 Source:

Tolerating oral fluids without nausea and emesis Pain controlled (pain score < 5) Voiding trial complete Independent ambulation No signs of delirium (oriented to person, place, time, and current events) Phone call from office nurses Home health if required (urinary retention, DVT prophylaxis)

From Ref. (66) with permission.

per cent of women rated their surgical experience as excellent or very good, 87% had excellent or very good pain control, 90% did not suffer from postoperative nausea, and 90% felt prepared for their surgery. In 2020, the IUGA advertised for authors on their website to form a writing group for an IUGA opinion paper on ERAS in urogynaecology.

Follow-up

It is our routine practice to arrange follow-up appointments for all patients at 6 weeks postoperatively as well as to arrange postoperative urodynamic assessment at the 6 months postoperative visit for all patients who have undergone continence surgery. The National Institute for Health and Care Excellence in the UK recommends that those who have had continence surgery should be seen within 6 months. (65) If a mid-urethral sling is used, then a vaginal examination is essential to exclude mesh exposure. Those who had prolapse surgery need a follow-up appointment at 6 months. Patients who have had a urinary diversion or augmentation cystoplasty need lifelong follow-up.

COVID-19 considerations Since the pandemic, hospitals have had to change the preoperative, perioperative, and postoperative journey. Hospitals need to guarantee patients and staff safety through an appropriate COVID-19 testing policy and adequate provision of personal protective equipment. There needs to be implementation of social distancing policies for staff, patient, and patient visitors following local and national recommendations. (66) With the resumption of elective work and increasing waiting lists, there needs to be prioritisation of theatre cases, whilst maintaining patient safety. The NHS has set the following prioritisation guidance: level 1 – emergency surgery, level 2 – defer up to 4 weeks, level 3 – defer up to 3 months, and level 4 – defer beyond 3 months. (67) Urogynaecology surgery will fall into level 3 or 4. Pre-assessment of the patient over the phone or virtually is increasing during the pandemic. This reduces the footfall in hospital waiting rooms and maintains social distancing. The negative side is the fear that important details or investigations may be missed. As the world gets used to this new way of medicine, the use of virtual medicine will certainly improve. Telemedicine can also be used for postoperative follow-up, but this does not allow examination. A randomised control trial compared an eHealth follow-up with usual postoperative care. (68) The intervention group had a reduced time to work and improved quality-of-life score. Patients should self-isolate prior to their surgical date for a time period stipulated by hospital protocol.

Conclusion Adequate preparation for surgery has an important role in ensuring an optimal outcome and reducing morbidity. The elective nature of most urogynaecologic surgery allows time to ensure that all women are well prepared, both psychologically and physically, before undergoing the chosen operation.

References







1. Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997;104:1374–1379. 2. Digesu GA, Chaliha C, Salvatore S, Hutchings A, Khullar V. The relationship of vaginal prolapse severity to symptoms and quality of life. BJOG. 2005 Jul;112(7):971–976. 3. Robinson D, Anders K, Cardozo L, Bidmead J, Dixon A, Balmfoth J, Rufford J. What do women want? Interpretation of the concept of cure. J Pelvic Med Surg. 2003;9(6): 273–277. 4. Robinson D, Anders K, Cardozo L, Bidmead J. Outcome measures in urogynaecology: the clinician’s perspective. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18:273–279. 5. Lowenstein L, Fitzgerald MP, Kenton K, Dooley Y, Templehof M, Mueller ER, Brubaker L. Patient-selected goals: the fourth dimension in assessment of pelvic floor disorders. Int Urogynaecol J Pelvic Floor Dysfunct. 2008;19:81–84. 6. Srikrishna S, Robinson D, Cardozo L, Cartwright R. Experiences and expectations of women with urogenital prolapse: a quantitative and qualitative exploration. BJOG. 2008 Oct;115(11):1362–1368. 7. Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010 May;21(5):523–528. doi: 10.1007/s00192-009-1069-5. 8. Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98–101. 9. National Collaborating Centre for Women’s and Children’s Health. Urinary incontinence: the management of urinary incontinence in women. NICE clinical guideline 171;2013. London: Royal College of Obstetricians and Gynaecologists. 10. Hay-Smith EJ, Dumoulin C. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005654. 11. Bø K. Can pelvic floor muscle training prevent and treat pelvic organ prolapse? Acta Obstet Gynecol Scand. 2006;85(3):263–268. 12. Hagen S, Stark D. Conservative prevention and management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2011;(12):CD003882. DOI: 10.1002/14651858.CD003882. 13. Hagen S, Stark D, Glazener C, Dickson S, Barry S, Elders A, Frawley H, Galea MP, Logan J, McDonald A, McPherson G, Moore KH, Norrie J, Walker A, Wilson D, POPPY Trial Collaborators. Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial. Lancet. 2014 Mar 1;383(9919):796–806. doi: 10.1016/S0140-6736(13)61977-7. Epub 2013 Nov 28. 14. Basu M, Duckett J. The treatment of urinary incontinence with Duloxetine. J Obstet Gynaecol. 2008 Feb;28(2):166–169. 15. Li J, Yang L, Pu C, Tang Y, Yun H, Han P. The role of duloxetine in stress urinary incontinence: a systematic review and meta-analysis. Int Urol Nephrol. 2013 Jun;45(3):679–686. doi: 10.1007/s11255-013-0410-6.

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16. Mariappan P, Alhasso A, Ballantyne Z, Grant A, N’Dow J. Duloxetine, a serotonin and noradrenaline reuptake inhibitor (SNRI) for the treatment of stress urinary incontinence: a systematic review. Eur Urol. 2007 Jan;51(1):67–74. 17. Collings LH, Pike LC, Binder AI, McClymont ME, Knight ST. Value of written information in a general practice setting. Br J Gen Pract. 1991;41:466–467. 18. Kuduvalli M, Grayson AD, Oo AY, Fabri BM, Rashid A. Risk of morbidity and in-hospital mortality in obese patients undergoing coronary artery bypass surgery. Eur J Cardiothorac Surg. 2002;22:787–793. 19. Fetrow CW, Avita JR. The Complete Guide to Herbal Medicine. New York, NY, USA: Simon & Schuster; 2000. Understanding and using herbal medicine; pp. 1–3. 20. Baker K. Impact of herbal medicine and supplements on clinical dentistry. Outlines of Lecture Presented at Lehigh Valley Hospital, Allentown, PA, USA, 2004. 21. Ang-Lee MK, Moss J, Yuan C-S. Herbal medicines and perioperative care. JAMA. 2001;286(2):208–216. 22. Lu WI, Lu DP. Impact of Chinese herbal medicine on American society and health care system: perspective and concern. Evid Based Complement Alternat Med. 2014;2014:251891. Epub 2014 Feb 27. 23. Chalhoub V, Edelman P, Staiti G, Benhamou D. Oral contraception and hormone replacement therapy: management of their thromboembolic risk in the perioperative period. Ann Fr Anesth Reanim. 2008 May;27(5):405–415. 24. Rahn DD, Good MM, Roshanravan SM, Shi H, Schaffer JI, Singh RJ, Word RA. Effects of preoperative local estrogen in postmenopausal women with prolapse: a randomized trial. J Clin Endocrinol Metab. 2014 Oct 1;99(10):3728–3736. 25. Verghese TS, Middleton L, Cheed V, Leighton L, Daniels J, Latthe PM, LOTUS Trial Collaborative Group. Randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS): a pilot study to assess feasibility of a large multicentre trial. BMJ Open. 2020 Sep 1;10(9):e025141. 26. Sun Z, Zhu L, Xu T, Shi X, Lang J. Effects of preoperative vaginal estrogen therapy for the incidence of mesh complication after pelvic organ prolapse surgery in postmenopausal women: is it helpful or a myth? A 1-year randomized controlled trial. Menopause. 2016 Jul 1;23(7):740–748. 27. Cadish LA, West EH, Sisto J, Longoria T, Bebchuk JD, Whitcomb EL. Preoperative vaginal estrogen and midurethral sling exposure: a retrospective cohort study. Int Urogynecol J. 2016 Mar 1;27(3):413–417. 28. Thachil J, Gatt A, Martlew V. Management of surgical patients receiving anticoagulation and antiplatelet agents. Br J Surg. 2008 Dec;95(12):1437–1448. 29. Riva N1, Donadini MP, Bozzato S, Ageno W. Novel oral anticoagulants for the prevention of venous thromboembolism in surgical patients. Thromb Res. 2013 Jan;131 Suppl 1:S67–S70. doi: 10.1016/S0049-3848(13)70026-4. 30. Bergmark B, Giugliano RP. Perioperative management of target-specific oral anticoagulants. Hosp Pract (1995). 2014 Feb;42(1):38–45. 31. Giebl A, Gürtler K. [New oral anticoagulants in perioperative medicine]. Anaesthesist. 2014 Apr;63(4):347–362. 32. Koumpan Y, Vandenkerkhof E, van Vlymen J. An observational cohort study to assess glycosylated hemoglobin screening for elective surgical patients. Can J Anaesth. 2014 May;61(5):407–416. 33. Kwon S, Thompson R, Dellinger P, Yanez D, Farrohki E, Flum D. Importance of perioperative glycemic control in general surgery: a report from the Surgical Care and Outcomes Assessment Program. Ann Surg. 2013 Jan;257(1):8–14. 34. Kao LS, Meeks D, Moyer VA, Lally KP. Peri-operative glycaemic control regimens for preventing surgical site infections in adults. Cochrane Database Syst Rev. 2009;(3):CD006806. DOI: 10.1002/14651858.CD006806.pub2. 35. Srikrishna S, Robinson D, Cardozo L, Yazbek J, Jurkovic D. Is transvaginal ultrasound a worthwhile investigation for women undergoing vaginal hysterectomy? J Obstet Gynaecol. 2008 May;28(4):418–420. 36. Qaseem A, Snow V, Fitterman N, Hornbake ER, Lawrence VA, Smetana GW, Weiss K, Owens DK, Aronson M, Barry P, Casey DE Jr, Cross JT Jr, Sherif KD, Weiss KB, Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Risk assessment for and strategies to reduce perioperative pulmonary complications for patients undergoing noncardiothoracic surgery: a guideline from the American College of Physicians. Ann Intern Med. 2006;144(8):575–580. 37. Hamoui N, Kim K, Anthone G, Crookes PF. The significance of elevated levels of parathyroid hormone in patients with morbid obesity before and after bariatric surgery. Arch Surg. 2003;138:891–897.

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38. Muzii L, Cutillo G, Romanini ME, Zullo MA, Casalino B, Manci N, Pietroluongo F, Croce C, Bellati F, Benedetti Panici P. Bowel preparation before laparoscopy. J Am Assoc Gynecol Laparoscopists. 2001;8:S45–S46. 39. Department of Health Report of the National Confidential Enquiry into Perioperative Deaths. London: HMSO, 1993. 40. Bergquist D. Postoperative Thromboembolism. London: Springer-Verlag, 1983, 106–107. 41. Royal College of Obstetricians and Gynaecologists. Report of RCOG Working party on prophylaxis against thromboembolism in gynaecology and obstetrics. London: RCOG, 1995. 42. Hemsell DL, Heard, Nobles BJ, Bawdon RE, Hemsell PG. Single-dose prophylaxis for vaginal and abdominal hysterectomy. Am J Obstet Gynecol. 1987;157:498–501. 43. Rudnicki M, Jakobsson U, Teleman P. Impact of per-operative antibiotics on the urinary tract infection rate following mid-urethral sling surgery for urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2020;31(8):1545–1550. 44. Giugale LE, Baranski LA, Meyn LA, Schott NJ, Emerick TD, Moalli PA. Preoperative Pelvic Floor Injections With Bupivacaine and Dexamethasone for Pain Control After Vaginal Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):21–31. 45. Athanasiou S, Hadzillia S, Pitsouni E, Kastanias S, Douskos A, Valsamidis D, Loutradis D, Grigoriadis T. Intraoperative local infiltration with ropivacaine 0.5% in women undergoing vaginal hysterectomy and pelvic floor repair: Randomized double-blind placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2019 May 1;236:154–159. 46. Athanasiou S, Zacharakis D, Grigoriadis T, Papalios T, Pitsouni E, Valsamidis D, Hadzillia S. Vaginal hysterectomy with anterior and posterior repair for pelvic organ prolapse under local anesthesia: results of a pilot study. Int Urogynecol J. 2020 Oct;31(10):2109–2116. 47. Thiagamoorthy G, Dua A, Araklitis G, Bansal J, Karim F, Davis C, Khullar V, Khunda A, Srikrishna S, Robinson D, Cardozo L. Post-operative pain after pelvic organ prolapse surgery (POPPOP). Double blind randomised multicentre study to assess the effect of local anaesthesia during vaginal hysterectomy (abstract). IUGA. 2020. 48. Weissman C. The metabolic response to stress: an overview and update. Anesthesiology.1990;73:308–327. 49. Kehlet H. Surgical stress: the role of pain and analgesia. Br J Anaesth. 1989;63:189–195. 50. Kehlet H, Dahl JB. The value of “multimodal” or “balanced analgesia” in postoperative pain treatment. Anesth Analg. 1993;77:1048–1056. 51. Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003;362:1921–1928. 52. Elit LM, Thomas H, Trim K, Mazurka J, Moens F. Evaluation of postoperative pain control for women undergoing surgery for gynaecologic malignancies. J Obstet Gynaecol Can. 2004 Dec;26(12):1051–1058. 53. Thiagamoorthy G, Khalil A, Cardozo L, Srikrishna S, Leslie G, Robinson D. The value of vaginal packing in pelvic floor surgery: a randomised doubleblind study. Int Urogynecol J. 2014 May;25(5):585–591. 54. Osborne JL. Urodynamics and the Gynaecologist. Alec Bourne Lecture. London: RCOG Press, 1981. 55. Phipps S, Lim YN, McClinton S, Barry C, Rane A, N’Dow J. Short term urinary catheter policies following urogenital surgery in adults. Cochrane Database Syst Rev. 2006;(2):CD004374. DOI: 10.1002/14651858.CD004374. pub2. 56. Tammela T, Konturri M, Lukkarien O. Postoperative urinary retention. I. Incidence and predisposing factors. Scand J Urol Nephrol. 1986;20:197–201. 57. Smith NGK, Morrant JD. Postoperative urinary retention in women: management by intermittent catheterization. Age Ageing. 1990;19:337–340. 58. Bray R, Cartwright R, Digesu A, Fernando R, Khullar V. A randomised controlled trial comparing immediate versus delayed catheter removal following vaginal prolapse surgery. Eur J Obstet Gynecol Reprod Biol. 2017 Mar 1;210:314–318. 59. Niël-Weise BS1, van den Broek PJ. Antibiotic policies for short-term catheter bladder drainage in adults. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD005428. 60. Shatkin-Margolis A, Yook E, Hill AM, Crisp CC, Yeung J, Kleeman S, Pauls RN. Self-removal of a urinary catheter after urogynecologic surgery: a randomized controlled trial. Obstet Gynecol. 2019 Nov 1;134(5):1027–1036. 61. Spilsbury K, Hammond I, Bulsara M, Semmensa JB. Morbidity outcomes of 78,577 hysterectomies for benign reasons over 23 years. BJOG. 2008 Nov;115(12):1473–1483. 62. Forsgren C, Zetterström J, Lopez A, Nordenstam J, Anzen B, Altman D. Effects of hysterectomy on bowel function: a three-year, prospective cohort study. Dis Colon Rectum. 2007 Aug;50(8):1139–1145.

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63. Greer IA. Epidemiology, risk factors and prophylaxis of venous thromboembolism in obstetrics and gynaecology. Baillieres Clin Obstet Gynaecol. 1997 Sep;11(3):403–430. 64. Carter-Brooks CM, Du AL, Ruppert KM, Romanova AL, Zyczynski HM. Implementation of a urogynecology-specific enhanced recovery after surgery (ERAS) pathway. Am J Obstet Gynecol. 2018 Nov 1;219(5):495. e1–495.e10. 65. Gannon RH. Current strategies for preventing or ameliorating postoperative ileus: a multimodal approach. Am J Health Syst Pharm. 2007 Oct 15;64(20 Suppl 13):S8–S12. 66. Urinary incontinence and pelvic organ prolapse in women: management NICE guideline. 2019.





67. Moletta L, Pierobon ES, Capovilla G, Costantini M, Salvador R, Merigliano S, Valmasoni M. International guidelines and recommendations for surgery during Covid-19 pandemic: a systematic review. Int J Surg. 2020 Jul;79:180–188. 68. Vonk Noordegraaf A, Anema JR, van Mechelen W, Knol DL, van Baal WM, van Kesteren PJM, Brölmann HAM, Huirne JAF. A personalised eHealth programme reduces the duration until return to work after gynaecological surgery: results of a multicentre randomised trial. BJOG. 2014;121:1127–1135.

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TRADITIONAL SURGERY AND OTHER HISTORICAL PROCEDURES FOR STRESS INCONTINENCE Elisabeth Sebesta, Malcolm Lucas, Elizabeth Timbrook Brown, and Roger Dmochowski

Introduction The surgical management of stress urinary incontinence (SUI) is based on basic principles with slight modifications accompanied by occasional advancements which lead to dramatic changes in practice. Our concept of what is historical or obsolete can change rapidly. In part, this reflects new and compelling clinical or economic evidence (1, 2), but there is no doubt that fashion also plays its part. Surgeons are easily seduced by new technology, and a patient’s perception of whether a procedure is newer or older has been shown to affect the choice he or she makes (3). The powerful influence of new technologies and the emphasis on minimal invasiveness, decreasing morbidity, and decreasing hospital stay means once popular operations such as retropubic suspensions, biological grafts, needle suspensions, and anterior colporrhaphy, find themselves relegated to the historical section of this book. According to all the major guidelines for the management options of SUI, the contemporary surgical management options include retropubic colposuspension (Burch), slings, either autologous fascial pubovaginal or synthetic mid-urethral, and bulking agent injection (4–6). However, a careful review of historical techniques remains a valid study, partly as it provides a backdrop and illustration of the changing thought processes that have emerged over the years, but also as a yardstick against which newer techniques can be compared.

Aim of surgery The aim of any operation for SUI is to achieve balance between continence and voiding as simply and as durably as possible without serious operative complications such as the creation of obstruction or urgency. It has always been understood that by simply obstructing the urethra, one could render a woman continent. Early slings addressed the problem in this way with an acceptance that obstruction could result in urinary retention. A long-held belief about the etiology of SUI declared that it was necessary to lift the urethrovesical junction, and hence proximal urethra, into an intra-abdominal position, such that during times of increased intra-abdominal pressure, that pressure could be equally conveyed to the bladder and urethra with no resultant leakage. This was the basis of retropubic suspensions such as the Marshall–Marchetti–Krantz (MMK) and the Burch colposuspension as well as the subsequent needle suspensions. Blaivas popularized a classification of SUI in which the cause was seen as either anatomical, due to hypermobility of the urethrovesical angle (type 1) or rotational descent of the bladder base (type 2), or alternatively due to intrinsic sphincter deficiency (ISD) (type 3) (7). Diagnosis along these lines made urodynamics— even videourodynamics—essential. It followed then that when

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hypermobility was identified, procedures to elevate the bladder neck were used, and where ISD was identified, an obstructing procedure would be chosen. The current prevalent view—based on DeLancey’s theories (8)—holds that there is a passive component of compression against a “backboard” created by the normal supporting structures of the urethra and bladder base, together with an active sphincteric component, which provide continence. However, since midurethral slings (MUS) have proved effective in SUI of either type, this distinction has become of less clinical importance, at least at the time of primary surgery.

Individual choices The need to treat each patient individually is obvious. There are many factors that have an impact on surgery and its outcomes. The subject has been extensively reviewed as part of the work of the International Consultation on Incontinence (ICI) working group on surgery for women with incontinence (9). Age, parity, estrogenization, prior surgical interventions, and body mass index (BMI) are all factors that might alter tissue quality and laxity. Previous surgery may have produced scarring with resultant tethering, interfered with normal sensory innervation, and altered sphincter function. The coexistence of varying degrees of hypermobility and descent of the vagina, the bladder base, and its fascial supports, and how much this bothers the patient, will influence the choice of surgery. The psychological profile, expectations, and motivation of women will differ greatly, and this may significantly alter perceptions of outcome, even when the degree of urinary control experienced by two individuals is the same. All of these factors are taken into account when deciding when and what type of anti-incontinence surgery a patient should undergo.

Interpreting the literature The randomized controlled trial (RCT) in surgery remains something of a rarity. Two reviews in the 1990s found that the total number of women in the world who had ever been recruited into an RCT for SUI surgery was less than 600 across only seven studies (10, 11). By 2006, there were 53 RCTs and over 5000 women had been treated in this context (2). However, the quality of that evidence remained quite poor. Even in recent years, few RCTs have been devoted to these procedures, many of which are now considered obsolete. There are other problems with the literature. The lack of consistency of outcome measures makes comparison of evidence dangerous. Many authors refer to subjective and objective cure rates, but these terms are rarely defined. There are degrees of objectivity, and it is debatable whether a quality-of-life (QoL) questionnaire is truly objective unless the context in which it is 757

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758 applied is both independent and carefully controlled (12). Some papers report complications and others do not. In some cases, outcomes have been recorded by “chart review” and in others by independent assessors using validated tools. Most innovators are constantly changing their surgical practice in search of refinements to make procedures easier, quicker, cheaper, less morbid, or more effective. Thus, it is rare for the original technique described to remain constant over the years that the surgeon performs it; therefore one must question the extent to which, when operations are lumped together into a series, the procedure was truly the same for every woman. Surgeons remain reluctant to report poor outcomes, and publication bias always favors the positive message. One critical issue is how nonattenders and dropouts are reported. Most studies ignore them and offer their results as a proportion of patients who were available for follow-up. However, this makes unsafe assumptions about nonattenders, which may not be justified. The United Kingdom tension-free vaginal tape (TVT) versus Burch colposuspension trial (1) illustrated this point very clearly—in the same study, success could vary from less than 30% to over 90% depending on the outcome definition and which population was analyzed. We have observed the same phenomenon in the trial of two lengths of autologous fascial sling (13). An interesting debate is emerging about the relative value of RCTs on the one hand and large national or international registries on the other. The RCT asserts a rigor to the collection and reporting of data, but sanitizes recruitment and disallows the kind of individual decision making and modification of approach that occurs with patients in normal practice. This results in poor external validity. The large-scale registry, on the other hand, can include all women and all surgeons (14). For the purpose of this review, evidence has been presented as the original author intended. In most cases, this is a “per protocol” analysis in which dropouts are disregarded. A few studies report outcomes as “intention to treat,” and this is often what accounts for apparently poorer results. What matters most to women who are about to undergo surgery is what happens in the hands of their surgeon, and for this reason, surgeons should audit their own outcomes rigorously and compare their performance with others by participating in larger registries.

Anterior colporrhaphy Anterior urethral plication (Kelly plication) was first described in 1913 as a method of cystourethrocele repair as a treatment for SUI by placating tissues at the vesical neck (15). In the initial description, it was reported this resulted in an 80% short-term cure rate in 20 patients. Subsequent iterations of anterior vaginal plication for SUI, the anterior colporrhaphy (AC), includes the midline plication of the endopelvic fascial layers overlying the bladder as opposed to just the urethra and bladder neck (16). Anterior colporrhaphy aims to restore a normal anatomical position of the anterior vaginal wall by means of plication sutures to the endopelvic fascial layers between the bladder base and vaginal skin. These structures, under normal conditions, provide support to the bladder base, urethra, and entire sphincter mechanism. The theory behind AC for treatment of SUI was to restore the urethrovesical junction to an elevated position above the urogenital diaphragm and to provide a restored backboard against which the urethra could be compressed during coughing, straining, etc. The obvious flaw in

this proposal is that success will depend on the integrity of intrinsically weak and damaged tissues. Ultimate failure, therefore seems inevitable unless the scar tissue, which replaces the weakened fascia, offers greater strength than normal fascia. Many authors have added a sling to colporrhaphy to support the urethra—this makes the evidence for SUI from these studies difficult to interpret (17). Ultimately, the use of AC for SUI decreased after it was found the outcomes were quite poor, and the AUA guidelines on surgical management of SUI from 1997 published a long-term failure rate of nearly 40% (11). The operation begins with infiltration of the anterior vaginal wall to perform hydrodissection of the vesicovaginal plane. A longitudinal incision is made from the urethral meatus to the vaginal apex and held apart using Allis forceps. Dissection of this avascular plane continues laterally to expose the hernial defect in the endopelvic fascia, and, in women with significant prolapse, this may be extended as far laterally as the pubic ramus to fully expose the bladder base and urethra. The next step is to place “buttressing sutures” to the fascia on either side of the urethrovesical angle or bladder neck and one or two additional similar sutures to the paraurethral tissues. These sutures are tied in the midline, creating a shelf or hammock upon which the bladder neck and urethra will then be supported. Any additional prolapsing of the bladder base, or cystocele, is then reduced by means of additional plicating sutures—or alternatively by means of a purse-string suture. The judgment in this procedure is in providing enough support to the previously prolapsed structures while avoiding overtightening and consequent vaginal narrowing. Excess vaginal epithelium may then be trimmed. In execution, if not in intent, this procedure is, in effect, a hernia repair. While this made some sense if the underlying defect constituted a central defect of the paravaginal fascia, many anterior wall defects result not so much from central attenuation of this layer but from loss of attachment laterally to the arcus tendineus fascia pelvis (ATFP). In these patients, it is possible for the central layer of vesicovaginal fascia to remain intact. The failure to make this distinction may lie behind some of the poor reported results for AC. There is still a role for AC for the treatment of anterior wall prolapse, and can be used in conjunction with another anti-incontinence procedure to control the cystocele element when both prolapse and SUI coexist. A great deal of the literature on AC relates to its use in the repair of prolapse, and relatively few studies address the question of how it performs for SUI alone. This review focuses only on the latter (Table 70.1). A recent Cochrane Database Review on AC for SUI from 2017 identified ten RCTs including a total of 1012 women (18). There are five published trials comparing AC to open retropubic colposuspension for SUI alone (19–23), which included Burch in all but one which also used MMK (23). In summary, AC was found to be less effective in the Cochrane Review than retropubic suspensions within the first year of surgery, with 29% versus 14% of women after AC and retropubic suspension respectively still being incontinent (18). In the few trials that also published long-term five-year outcome data, AC continued to perform inferiorly to retropubic suspension, with 38% versus 21% of women being incontinent at five years (18, 21, 24). There are three trials comparing AC to needle suspensions (19, 20, 25), including the Pereyra procedure (19, 20) and a four-corner Raz suspension (25). The results with regards to these procedures at one year appeared quite comparable, with subjective incontinence of 35% and 32% for AC and needle suspension respectively.

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TABLE 70.1: Evidence Table for AC and PVdR Outcome Measures

Author

Study Year type

Intervention Comparatora

2000 RCT

AC

No. (n)

Mean FU (mo.)

Obj. Obj. cure improved (%) (%)

Subj. cure (%)

Subj. improved (%)

De novo DO or OAB (%)

CIC/ retention (%)

Prolapse (n)

AC Colombo et al. (21) Kammerer-Doak et al. (22) Bergman et al. (19, 24)

Bergman et al. (20)

1999 RCT 1989 RCT

1989 RCT

33

167

42

52

Burch

35

167

74

86

16

12

31

19

Burch

19

12

89

95

35

12

63

3

Burch

38

12

89

1

Pereyra

34

12

65

2

99

12

69

101

12

87

12

70

AC AC

AC Burch Pereyra

Liapis et al. (23)

1996 RCT

AC

50 Burch MMK

60

56

60

89

60

67

52

>9

73.1

28

>9

85.7

107

60

61

60

21

Di Palumbo (25)

2003 RCT

AC

Tamussino et al. (26)

1999 Cohort

AC

Cosiski Marana et al. (27)

1996 Cohort

AC

57

Van Geelen et al. (28)

1988 Cohort

AC

56

>60

Luna et al. (29)

1999 Cohort

AC

77

135.6

Demirci et al. (30)

2002 Cohort

AC

67

120

Park et al. (31)

1988 Cohort

AC

336

>60

Riggs et al. (32)

1986 Cohort

Pereyra + AC

252

12

43

Scotti et al. (33)

1998 CS

PVdR

40

39

94

84

20 37

Abbreviations: DO, detrusor overactivity; OAB, overactive bladder; CIC, clean intermittent catheterization; AC, anterior colporrhaphy; PVdR, paravaginal repair; RCT, randomized controlled trial; CS, case series; mo., months. Note:  a Italics refer to comparator procedures only.

Seven separate cohort studies with follow-up in excess of 5 years were found, which reported comparisons with Burch (26–28) and MMK (29–32). In these studies, the subjective cures for AC ranged from just 21% to 50%. It does seem that the longterm outcomes for AC as a treatment for SUI are poor, by any standards.

Paravaginal defect repair In women in whom there is anterior wall descent but maintenance of normal rugosity of the vaginal epithelium, there is usually an underlying defect of the paravaginal fascia. The normal attachment of the endopelvic fascia to the ATFP has become disrupted, and very often in these women, the layer of the fascia in between the bladder base and vaginal epithelium remains intact. It is logical in such women to attempt paravaginal defect repair (PVdR). The operation can be performed either transvaginally, retropubically, or laparoscopically. The latter surgical approaches will be described in other sections of this book. Paravaginal defect repair is more commonly reported

for management of prolapse in association with other techniques such as sling or Burch for SUI, so it is difficult to establish how much effect this procedure independently has on the control SUI. When repaired through a vaginal approach, the operation commences as an AC, but the dissection of the vesicovaginal plane continues laterally to the pubic rami and into the space behind the pubic ramus. In a normal woman, the thick layer of the endopelvic fascia will prevent further progress at this point, but when this layer has failed, dissection will continue into the retropubic space without difficulty. Laterally, along the surface of obturator internus muscle runs the ATFP from the pubic symphysis anteriorly to the ischial spine laterally and can usually be easily palpated. A series of plicating sutures are then applied, which incorporate three bites each—the lateral structure of ATFP or obturator fascia, the medial structure of endopelvic fascia as it lies under the bladder base or paraurethral tissues, and thirdly the vaginal muscularis itself. A row of sutures is placed on each side and then carefully tied so that tissue apposition is achieved without distorting the positions

Textbook of Female Urology and Urogynecology

760 of the bladder neck or vaginal vault. As the sutures are tied, the anterior wall descent should be seen to reduce itself back toward a normal anatomical position. When performed from a retropubic approach, the same three layers of tissue are exposed and approximated using sutures placed from above. Exposure is usually much easier through the retropubic or laparoscopic approach as opposed to vaginally. The PVdR would be a rare procedure to correct isolated SUI. Once again, PVdR has been reported more commonly in association with other suspensory procedures for SUI, and it is nearly impossible from these studies to ascertain what contribution to cure has been made by the PVdR alone. Scotti et al. (33) did a cadaver study in which he identified the strongest attachment points for this procedure—namely, the ischial periosteum and the obturator membrane—using these fixation points as the basis for plication of the more medial structures. This series of 36 women with SUI achieved a 94% subjective cure rate at a median follow-up of 39 months. Only one RCT exists for PVdR as an anti-incontinence procedure as compared to Burch (34). In this study, PVdR was performed via a retropubic approach. The length of follow-up for cure was not reported, and “objective cure” was said to be 61% compared to 100% for Burch; thus care must be taken in the amount of confidence placed in this study. In three contemporary case series, the subjective cure rate of SUI at a minimum of 12 months ranges from 43% to 94% (33, 35, 36). In one case series on vaginal PVdR in 35 patients with anterior vaginal wall prolapse, it was found that of the 21 patients with concomitant SUI, 12 (57%) had persistent SUI after surgery (36). With regards to abdominal PVdR, early reports suggested SUI cure rates of 88–97% (37, 38). However, more contemporary results, suggested the cure rates for SUI were similar to that of the vaginal approach. In a retrospective cohort of 52 patients, half of the patients underwent abdominal PVdR alone and half underwent abdominal PVdR with pubovaginal sling (35). After a mean follow-up of 17 months, the overall cure rate for SUI was 72% in the PVdR alone group, which was inferior to those who also underwent concomitant sling procedures. There is some data comparing the outcomes vaginal versus abdominal approaches for PVdR, although these studies do not primarily focus on outcomes for SUI. In a retrospective comparision of 52 women who underwent abdominal PVdR to 59 women who underwent vaginal PVdR, authors reported that 82.7% of those who had an abdominal repair “remained or were rendered dry” after surgery as compared to 69.5% of those who had a vaginal repair (39). However, the study does not report on how many of these patients had SUI preoperatively, and therefore the results are difficult to interpret. In conclusion, there is insufficient evidence to support the widespread use of PVdR alone for SUI, and there is some limited evidence to suggest it is less effective than retropubic suspension. Its role in pelvic organ prolapse will be discussed elsewhere in this book.

Needle suspensions In the late 1950s, the most common operations performed for SUI were the MMK and AC. In 1959 Armand Pereyra introduced an alternative operative management for SUI, which relied on the idea that failure was less likely to occur if the suspensory sutures could be supported by the abdominal fascia rather than the periosteum of the pubic bone (40). In this way, Pereyra believed that

FIGURE 70.1  Pereyra operation. Illustration showing the angled trocar and needle used by Pereyra to load a stainless steel suture with a measured thickness of paraurethral tissue in between to facilitate elevation. contraction of the rectus muscle would provide dynamic support of the bladder neck. He designed a special angulated trocar and cannula through which stainless steel wires could be inserted from a suprapubic stab incision to emerge lateral to the bladder neck about an inch apart (Fig. 70.1). These wires in turn were tied over the rectus sheath to provide elevation of the bladder neck. A series of diathermy burns made with a pointed diathermy probe pushed through the vaginal skin lateral to the urethra were meant to induce paraurethral scarring so that the wires could elevate fibrous tissue rather than cutting through. In his first 31 cases, there were apparently just three failures. As is usual with all innovative procedures, other surgeons (including Pereyra himself) immediately adapted and modified the ideas. However, it was not until the late 1970s and early 1980s that needle suspensions became popular. The essence of Pereyra’s procedure—placement of nonabsorbable sutures through the retropubic space by means of a long needle/suture carrier, fixation at one end to paraurethral tissues, and at the other end fixation to the rectus fascia (RF)—was the basis of every subsequent modification of the technique.

Stamey

In 1973, Tom Stamey described the use of cystoscopy to standardize the procedure (41). The cystoscope was used both to check suture placement and also to adjust the tension so that appropriate closure of the bladder neck could be achieved. Stamey’s operation is performed in the lithotomy position using a weighted vaginal speculum. Having emptied the bladder with catheter placement and identified, by palpation, the position of the bladder neck, a T incision is made on the anterior vaginal wall to expose the urethrovesical angle. Many other surgeons, of course, adapted this, and incisions of all shapes have been used to expose the area (Fig. 70.2).

Traditional Surgery and Other Historical Procedures

(a)

(b)

(c)

(e)

761

(d)

(f )

(g)

FIGURE 70.2  Stamey operation: (a) longitudinal vaginal incision, (b) exposure of the bladder neck and paraurethral fascia from below, indicating the points at which the Stamey needles should perforate the paraurethral fascia, (c) the needle can be passed downward to the vaginal incision or applied to the index finger from vagina to rectus sheath. This facilitates passage of the nylon suspensory sutures, (d) needle being passed downward onto the tip of surgeon’s finger lying alongside bladder neck, (e) positioning of the Dacron cuff, which will support the paraurethral tissues, (f) the bladder neck is checked endoscopically to ensure that sutures do not pass through the bladder and the effect of suture tension on bladder neck closure can be checked, (g) final positioning of the bladder neck after elevation of sutures.

Textbook of Female Urology and Urogynecology

762 With minimal dissection of the vaginal wall away from the pubocervical fascia, a small pocket is created in the paraurethral tissues adjacent to and approximately 1 cm lateral to the bladder neck. Through two small suprapubic stab incisions, a single pronged needle (Stamey needle; either straight or bent at 30°) is introduced, puncturing the rectus sheath and then moving downward through the retropubic space to emerge onto the tip of the surgeon’s finger in the previously created pocket. The needle is threaded with a nonabsorbable suture and withdrawn. A 1 cm length of Dacron arterial graft is threaded onto the suture. A second needle passage is then made, about 1 cm from the first toward the same pocket and the remaining end of the suture pulled cephalad to emerge through the stab incision. On pulling up the sutures, the Dacron cuff settles into the pocket and pulls up the bladder neck on that side. This procedure is repeated on the other side. At this point, cystoscopy is performed, and by pulling upward on the sutures, the surgeon can confirm that they are positioned correctly at the level of the bladder neck, and that sutures are not passing through the bladder. The correct amount of tension for tying the suture over the rectus sheath can be selected by observing the point at which the proximal urethral mucosa begins to oppose. Initial voiding difficulty was the norm, so the routine was to place a suprapubic catheter postoperatively and undertake an initial trial of voiding after about 48 hours. This operation was devised at a time when the prevailing thinking was still that one should achieve elevation of the bladder neck, and this implied that tension need be applied. Stamey’s original series reported a cure rate of 91% in 203 patients (42). Some modifications to the procedure over time include the use of silicone tubing rather than Dacron to reduce the infection risk (43), inflammatory changes, and stones forming around the nylon threads. Others advocated for the passage of needles from below as a means to reduce risk of bladder injury (44, 45) and Golomb et al. (46) designed the double pronged ligature carrier to separate the passage of the two needles (Table 70.2).

Raz

In 1981, Shlomo Raz described his personal take on the Pereyra operation, which was slightly different to Stamey (47). His underlying principle was to use the nonabsorbable suture to grasp and bind together the component layers of the endopelvic fascia and to use this to provide support. In essence, his operation was a PVdR because it reconstituted the same disrupted fascial layers (Fig. 70.3). After preparing the patient in a similar way to a Stamey or Pereyra procedure, an inverted U incision is made over the urethra to expose the underlying urethrovesical angle or bladder neck. Dissection then continues—more extensively than with the Stamey—to open the endopelvic fascia on either side of the bladder neck. This is achieved by passing the tips of scissors behind the pubic bone, about 2 cm lateral to the urethra, and while keeping the tips in close proximity to the back of the bone, passing them in the direction of the ipsilateral shoulder and then rotating more caudally to pass through the retropubic space to emerge onto the back of the rectus sheath, which is then penetrated. A finger can then be inserted into the defect, though some surgeons prefer to do this using a long handled instrument to minimize tissue disruption. The long handled needle is again used from above—passing downward through the retropubic space to reach the examining

finger in the paraurethral defect and to pick up a nonabsorbable suture, which is pulled through to the suprapubic stab incision. However, before the second end is pulled through, three helical bites are taken with an attached needle to include three structures: the detached urethropelvic ligament/endopelvic fascia medially, the pubocervical fascia, and the subdermal layers of the vaginal wall. Once this suture is pulled together, the defect in the endopelvic fascia automatically closes and the tissues become elevated alongside the bladder neck. Endoscopy was not described by Raz, but of course, many who subsequently performed this operation adopted Stamey’s recommendation of cystoscopy along with Raz technique of tissue plication rather than graft insertion. In his first description of the new technique, he reported 96 of 100 patients cured of SUI (47).

Gittes

Whether the Gittes operation (48) represents a significant modification of these two highly popular operations is unclear—certainly, it never achieved the same degree of popularity. Gittes essentially dispensed with the need for any vaginal dissection by applying the same technique as Raz in terms of needle passage, but with passage of the helical sutures directly through the vaginal wall. His hypothesis was that the paraurethral dissection suggested by Raz was unnecessary—indeed it created a defect that may or may not have already been present only to immediately repair it again. By placing the sutures directly into the vaginal skin, he was securing the same layers, but they would cut through the vaginal skin and become buried in the paraurethral tissues where they would provide support. It is not clear whether the lack of dissection offered an advantage or disadvantage in providing tissue of adequate strength to hold the sutures in place (Fig. 70.4).

Outcomes

The outcomes from reviewed studies on needle suspensions are shown in Table 70.2. Eight RCTs were identified for needle suspensions, making comparisons with the Burch colposuspension (19, 20, 24, 45, 49, 50), AC (19, 20, 24), MMK (51), porcine dermis PVS (52), and vagina/obturator shelf (VOS) repair (53). The evidence suggests that outcomes are inferior to retropubic suspensions (except for one study with poor methodology (51) in which there were more failures for MMK at 12 months) and equivalent to the results of the AC. The most recent Cochrane Database Review on needle suspensions drew this conclusion after commenting that the quality of the studies was poor (54). After the first year, 29% of needle suspensions failed versus 16% of retropubic suspensions. Ten case series or cohort studies for the Stamey procedure are reviewed with follow-up ranging from 12 to 90 months (43, 55–62). Outcomes are reported with widely differing measures, some objective and others subjective, ranging from 20% objective cure at 2 years to 90% subjective cure at a mean of 38 months. For the studies reporting the Raz operation, the range is from 89% subjective cure at 12 months to 47% objective cure at 25 months (63–65). The subjective cure rates from both the original and modified Pereyra (66–68) and the Gittes operation (69) are quite low. The general conclusion about needle suspensions is that the long-term results are disappointing. Those studies that presented outcomes at later time points (24, 65) appear to show a greater progressive deterioration with time than for the Burch, but this difference does not reach statistical significance. However, if one

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763

TABLE 70.2: Needle Suspension Evidence Table Outcome Measures

Author

Study Year Type

Intervention

1983 RCT

Stamey

Comparatora

No. (n)

Mean Obj. Obj. FU Cure Improved (mo.) (%) (%)

Subj. Cure (%)

Subj. Improved (%)

De novo DO or OAB (%)

CIC/ Retention Prolapse (%) (n)

RCTs Mundy et al. (45) Palma et al. (51) Hilton (52) Bergman et al. (19, 24)

Bergman et al. (20)

1988 RCT 1989 RCT 1989 RCT

1989 RCT

25

>12

76

Burch

26

>12

88

40

>12

96

10

5

MMK

30

>12

86

0

0

20

24

80

70

10

Porcine dermis PVS

20

24

90

90

20

34

60

50

2

Burch

38

60

16

1

AC

35

60

54

3

98

12

70

101

12

87

99

12

69

26

24

58

VOS

24

24

71

24

>8

71

83

Burch

27

>8

74

89

46

36

80.4

84.8

6.8

56

36

89.3

92.9

6.8

Stamey Stamey Pereyra

Pereyra Burch AC

German et al. (53)

1994 RCT

Athanassopoulos et al. (49) 1996 RCT Gilja et al. (50)

1998 RCT

Stamey Stamey Raz Burch

12.5 7

Cohort studies Spencer et al. (55)

1987 Cohort Stamey

41

68

Wang (58)

1996 Cohort Stamey

209

>24

44

Christensen et al. (56)

1997 Cohort Stamey

83

84

32

39

20

16

10

10 12

4 2

Case series Kelly et al. (66)

1991 CS

Pereyra

114

42

51

76

Trockman et al. (67)

1995 CS

Pereyra

125

ll8

20

71

Masson et al. (68)

2000 CS

Pereyra

135

50

14

79

Raz et al. (63)

1992 CS

Raz

206

83

90

Korman et al. (64)

1994 CS

Raz

106

25

47

72

89

Gilja (65)

2000 CS

Raz

71

>60

69

Dmochowski et al. (70)

1997 CS

Raz 4 corner

47

37

53

83

Mustafa et al. (71)

2006 CS

Raz “in situ”

14

>11

86

Huland et al. (57)

1984 CS

Stamey

66

48

71

Hilton et al. (43)

1991 CS

Stamey

100

27

60

O’Sulllivan et al. (59)

1995 CS

Stamey

66

43

34

Gofrit et al. (60)

1998 CS

Stamey

63

90

70

Kuczyk et al. (61)

1998 CS

Stamey

85

61

34

Takahashi et al. (62)

2002 CS

Stamey

86

38

90

Elkabir et al. (69)

1998 CS

Gittes

52

53

23

30

26

16

14

5

2.4

5

17

22

4

8

14

85

5

8

0

6

62

7 13

52 50

3 10

9

2

17

17

10

Abbreviations: DO, detrusor overactivity; OAB, overactive bladder; CIC, clean intermittent catheterization; RCT, randomized controlled trial; CS, case series; MMK, Marshall–Marchetti–Krantz; mo., months; TVT, transvaginal tape; TVM, transvaginal mesh; PVS, pubovaginal sling; VOS, vagina/obturator shelf Note: Excluding case series with 30

16

>30

87

17

>12

100

66

17

>12

15

7

93

11

7

100

9

81

>60

29

62

7

2

84

>60

44

57

2

2

94 13

326

>24

66

3

14

329

>24

49

3

2

5

11

Case series and Cohort studies Flynn et al. (105)

2002 Cohort RF

71

>24

77

13

Rodrigues et al. (106)

2004 Cohort RF

128

70

73

13

Howden et al. (107)

2006 Cohort RF

153

85

Giri et al. (108)

2006 Cohort RF

46

>36

Jeon et al. (109)

2008 Cohort RF

87

36

Onur et al. (110)

2008 Cohort RF

25

18

Muller et al. (95)

1993 CS

RF

108

60

67

Zaragoza (96)

1996 CS

RF

60

25

95

4

1

72 57

80 83

16

68

92

Chaikin et al.(97)

1998 CS

RF

251

37.2

73

Cross et al. (98)

1998 CS

RF

134

22

93

Hassouna et al. (99)

1999 CS

RF

78

41

81

Morgan et al. (100)

2000 CS

RF

235

52

88

73

92

5

3

0.4

2

19

0.7

4

86

21

25

92

30

Groutz et al. (101)

2001 CS

RF

67

34

67

97

10

2002 CS

RF

198

72

41

72

29

Chou et al. (103)

2003 CS

RF

98

36

93

Reichelt et al. (104)

2004 CS

RF

86

39

Wright et al. (112)

1998 Cohort FL

33

16

94

Brown et al. (113)

2000 Cohort FL

46

44

73

27

Almeida et al. (114)

2004 Cohort FL

30

33

70

20

61

8 2

12

Hawkins et al. (102)

26

18 8

0 2

11

2

9 1

65

FL 11

7

Abbreviations: DO, detrusor overactivity; OAB, overactive bladder; CIC, clean intermittent catheterization; RF, rectus fascia; FL, fascia lata; RCT, randomized controlled trial; CS, case series; mo., months; VW, vaginal wall sling. Note: a Italics refer to comparator procedures only.

fascia will become rapidly infiltrated by neovascularization and fibroblasts. Whether the grafted tissue remains intact or is completely replaced by new fibrosis however is not clear. Woodruff et al. biopsied 24 explanted grafts to compare different materials and found that host tissue infiltration was greatest with polypropylene meshes while autologous fascia had minimal inflammation or foreign body reaction and were consistently intact with minimal degradation (115). Lemer studied the mechanical properties of a variety of implantable materials and showed that solvent-dried FL and dermal allografts were as strong as autologous fascia but that freeze-dried FL was substantially weaker (116). Unfortunately, no material has been found to perform as well as autologous fascia with an acceptable complication profile.

Allografts

Allograft (cadaveric) fascial material can be implanted into humans once all cellular and antigenic material has been removed. This is achieved by freeze-drying, by fresh freezing, or by solvent dehydration techniques. All of these have been used in women with SUI. The risk of disease transmission (e.g., hepatitis B and C, HIV, and Creutzfeldt-Jakob diease) has always been a fear, but manufacturers offer strong reassurances that this is theoretically impossible. Selection of donors for allograft material involves rigorous screening for disease (117), and there have been no reported cases as yet after urologic surgeries. Human DNA, however, has been found in allograft materials, but the actual clinical significance of such a finding remains unclear (118). Current allografts are either cadaveric fascia lata (CFL) or acellular human dermis. Once implanted, allograft material goes

770 through a similar process of fibroblast invasion and neovascularization to autologous tissue, but the timing of these steps is unpredictable—hence, there may be a period of relative weakness when grafts can fail. One RCT was found which compared CFL to intravaginal slingplasty (119). The data are limited to short-term followup, and no conclusions can be drawn about relative efficacy (Table 70.4). A further 13 case series (120–132) and six cohort studies (105, 107, 110, 112–114) including over 1000 women who received CFL PVS are reviewed. Cohort studies found comparable short-term cure rates as autologous PVS, but a high SUI recurrence rate of up to 40% in long-term outcomes for CFL PVS (105, 107, 110, 112–114). Subjective cure ranged from 40% to 98% and objective cure from 17% to 68%. However, the range of follow-up and outcome measures, as usual, varies so much that it is impossible to draw conclusions about the relative merits of freeze-dried versus solvent-dried preparations or how this procedure compared to other autologous or synthetic grafts. One study (129), which used bone anchors, showed progressive deterioration of CFL over time, but it is not clear whether the failure is related to the material or the method of anchoring used. Several studies note early failure rate of CFL slings, for both freeze-dried and solvent-dried grafts. The other main allograft material that has been used is lyophilized human dura mater. There are data from a case series (133) and one RCT comparing dura mater to Burch (134). The limited medium-term results suggest a higher efficacy than Burch but with more urgency and voiding problems.

Xenografts

Xenograft (animal) tissues have also been used and are prepared using similar techniques. After going through a step-wise process of cellular destruction and sterilization, these materials essentially provide a framework of collagen, which lends itself to invasion with fibroblasts and new blood vessels. Whether the tissues become completely replaced by host fibrous tissue or remain intact remains unclear. Of the available xenograft materials, the most has been written about porcine dermis. Zenoderm (Zenith Technology Co., New Zealand), a dried preparation requiring preliminary soaking before implantation, was the first xenograft used in sling surgery, while Pelvicol (Bard, Murray Hill, NJ) is a prewetted dermal graft that handles much like a piece of autologous fascia. Two case series (135, 136) and one RCT (52) reported the use of Zenoderm. The material was awkward to handle and was withdrawn from the market by the manufacturers in the mid-1990s. One early RCT with 12-month follow-up promised excellent outcomes from Pelvicol when compared to TVT, with 89% objective cure rate versus 85% in TVT (137). A subsequent RCT of Pelvicol versus TVT versus RF PVS showed lower objective cure rates at one year with Pelvicol (22%) as compared to the other procedures (138) and the Pelvicol arm was terminated early. There are five case series (139–143) and two cohort studies (108, 144) on the use of Pelvicol. Overall, longer-term cure rates appear to be lower, with a high failure rate of 90% reported in one study (108). Porcine small intestinal submucosa (SIS) has also been used for urethral support as well as for many other uses. There are no data from RCTs, but two case series focus exclusively on women with SUI (145, 146). Although one trial reported comparable outcomes to autologous PVS, interestingly of the 7% failures in the SIS group, many occurred within 3 months and at reoperation there was no evidence of the implanted SIS material found (145). There

Textbook of Female Urology and Urogynecology have been conflicting reports on the extent of inflammatory tissue reaction related to the use of this tissue (147, 148). Acellular bovine dermis has been used for PVS, and in a recent cohort study comparing to autologous PVS (149), outcomes were not different, with an 84% cure rate at 19.5 months and a 80.5% cure rate at 36 months (150).

Synthetics

While the autologous fascial sling remains the gold standard for treatment of SUI, synthetic materials pose an attractive option, and were first used in the 1950s. However, the use of synthetic mesh in urology and urogynecology has become one of the most controversial topics in recent times. Mesh kits for anterior and posterior pelvic organ prolapse repair were removed from the market in 2011 by the FDA after severe complications. The most recent iteration of synthetic slings includes the modern day polypropylene monofilament large pore mesh used in current MUS kits. This FDA warning does not apply to MUS, which will be discussed in depth in another chapter. In regards to PVS, there is less data on the use of mesh slings, although numerous materials have been tried over the years. One popular synthetic material was expanded polytetrafluoroethylene (ePTFE), a microporous mesh, and some initial shortterm results seemed quite promising. In 1995 Weinberger and Ostergard reported longer-term outcomes on the use of ePTFE for PVS (151). Of 108 women in the trial, 40% developed various wound complications, leading to a 21% removal rate. Not to mention the cure rate decreased from 86% to 61% over time. Other similar reports led to this material being taken off the market. Other synthetic materials for PVS have faired similarly, including Marlex mesh, a permanent monofilament microporous mesh. One study reporting on long term results on anchoring Marlex mesh to Cooper’s ligament, found long term success rates around 80% (152). But again complications including retention, urethral erosions, and chronic infections led to this falling out of favor. As such, synthetic materials are not recommended for placement at the bladder neck.

Bulking agents Coaptation of the urethral mucosa is thought to be an important contributory mechanism in maintaining continence, the effect being apparently conferred through submucosal vascular cushions. Attempts to improve this coaptation effect through minimally invasive injection techniques have challenged clinicians for over 50 years. The mechanics of urethral bulking seem to be that by increasing the passive resistance of the urethra, leakage is diminished. The ideal injection material should be nonimmunogenic, thus causing no localized inflammatory reaction; stable chemically; nondegradable so that its bulking effect remains; and easy to inject to minimize the difficulties of surgery. Since most of these agents consist of particles suspended in a carrier gel or fluid, it is also important that the particles are large enough not to be absorbed and risk migration, and for as little carrier gel as possible to be absorbed, which results in reduction in efficacy. The first injection techniques to be tried and reported were by Murless in 1938 (153). He used a sclerosing agent, sodium morrhuate, in 20 women and achieved continence in 17 of them, presumably through the effect of scarring and contracture of

Traditional Surgery and Other Historical Procedures

771

TABLE 70.4: Evidence Table for Donor Materials

Author

Study Year Type

Intervention

2008 RCT

CFL

Comparatora

No. (n)

Mean FU (mo.)

Obj. Obj Cure Improved (%) (%)

Subj. Cure (%)

novo Subj. DO Improved or (%) OAB

Pain (n)

CIC/ Retention (%)

Prolapse (n)

Allograft fascia lata Basok et al. (119)

IVS

67

12

52

79

22

12

72

12

47

70

6.9

11

Wright et al. (112)

1998 Cohort FL

59

9.6

98

Brown et al. (113)

2000 Cohort FL

104

12

74

19

Flynn et al. (105)

2002 Cohort FL

63

>24

71

13

Almeida et al. (114)

2004 Cohort FL

30

33

40

28

Howden et al.(107)

2006 Cohort FD FL

150

42

57

Onur et al. (110)

2008 Cohort FD FL

24

13

Amundsen et al. (120)

2000 CS

FD FL

91

19

Fitzgerald et al. (121)

2004 CS

FD FL

27

12

Huang et al. (122)

2001 CS

SD FL

18

9.6

Onur et al. (123)

2005 CS

SD FL

25

12

Elliott et al. (124)

2000 CS

SD FL

26

15

Richter et al. (125)

2003 CS

FL

102

35

Soergel et al. (126)

2001 CS

FL

12

6

1

75

12 63

84

15

2

4 72 80

83

76 77

12 92

33

28

8

75 17

29 1

59 68

2 1.5

28

91

Walsh et al. (127)

2002 CS

FL

31

13.5

94

85

3

Owens et al. (128)

2004 CS

Duraderm

25

6

68

92

12

Nazemi et al. (129)

2008 CS

FL bone anchored

238

>24

Carbone et al. (130)

2001 CS

FD FL bone anchored

154

10.6

62

O’Reilly et al. (131)

2002 CS

FF FL

121

6.5

86

Carey et al. (132)

2004 CS

SD FL

265

12

60

1989 RCT

Z

71 3.2

0

Porcine dermis Hilton (52) Arunkalaivanan et al. (137)

2003 RCT

Guerrero et al. (138)

2010 RCT

20

24

90

90

20

Stamey

20

24

80

70

10

74

>12

89

7

TVT

68

>12

85

3

50

12

22

61

TVT

72

12

55

93

RF

48

90

P P

79

12

Jarvis et al. (135)

1985 CS

Z

50

21

Kinn et al. (136)

1994 CS

Z

47

20

78 68

Giri et al. (108)

2006 Cohort P

48

>36

31

Morgan et al. (144)

2007 Cohort P

30

>12

8

Giri et al. (139)

2005 CS

40

6

75

P

Iosif et al. (140)

1987 CS

P

53

>18

Barrington et al. (141)

2002 CS

P

40

12

85

Broussard et al. (142)

2013 CS

P

70

62.1

43

Khan et al. (143)

2015 CS

P

38

120 (median)

4

2

4.2

2.1

54 30 90

5

13

10

5

89

0

>90

10 2.9

15.7

58

2.6

Acellular bovine dermis Wilson et al. (149)

2008 Cohort BD

37

19.5

84

95

Lyophilized human dura mater Enzelsberger et al. (134)

1996 RCT

Rottenberg et al. (133)

1985 CS

LD Burch LD

36

37

92

13

13

36

37

86

5

3

36

6

89

Porcine intestinal submucosa Jones et al. (146)

2005 CS

SIS

34

24

Rutner et al. (145)

2003 CS

SIS

152

28

79

88

3

93

2

Abbreviations: BD, bovine dermis; DO, detrusor overactivity; OAB, overactive bladder; CISC, clean intermittent self-catheterization; RCT, randomized controlled trial; CS, case series; FL, fascia lata; FD, freeze dried; IVS, intravaginal slingplasty; SD, solvent dehydrated; P, Pelvicol; Z, Xenoderm; LD, lyophilized dura mater; SIS, subintestinal submucosa; RF, rectus fascia; TVT, tension-free vaginal tape; mos, months; FF, fresh frozen Note:

a

Italics refer to comparator procedures only.

Textbook of Female Urology and Urogynecology

772 the vaginal wall. Quackels in 1955 used paraffin to achieve the same effect, but reports of pulmonary embolism stopped the technique (154). In 1964, Politano and Harper (155) began using polytetrafluoroethylene (PTFE, Teflon, Polytef) paste for injection into the vesicoureteric junction, and numerous reports followed over the next 30 years of its use in the paraurethral tissues (156–158). The speed of this procedure and its apparent efficacy, even if this was lower than conventional surgery, appeared to offer a truly minimally invasive alternative to surgery for women who wanted to avoid the risk and morbidity. However, reports of serious complications began to emerge including periurethral abscess (159, 160), pulmonary granulomata (161, 162), and obstructive uropathy (163), and long-term outcomes were observed to deteriorate from 80% initial response to 27% at 3 years (164) and 33% at 5 years (165). As a consequence of these reports, PTFE paste lost its licensing for use as a bulking agent from the FDA. In 1989 the use of an alternative bulking agent that utilized autologous fat cells obtained by micro-liposuction that could be reinjected into the periurethral tissues was reported (166). This had major advantages including being autologous tissue with no immunogenicity problems, inexpensize, and easy to use. However, the initial results were disappointing with only 23% of women improved at 12 months (167). The only RCT carried out in this area, before the advent of newer injectable materials, was in 2001 (168). Of the 68 women enrolled, 35 received fat and 33 received saline injections of whom 22% and 20%, respectively, were improved at three months. The lack of convincing efficacy together with further reports of pulmonary embolism leading to death, have resulted in the use of autologous fat being officially discouraged. Much further research and clinical development has continued into the modern era using a variety of injectable materials. Modern bulking agents and their use is discussed in detail in another chapter.

Conclusions This chapter has described some obsolete operations and others that marked a turning point in surgical practice. Nevertheless, understanding these procedures is paramount as our current surgical treatment options are based on these fundamental surgical principles. The continued use of what some would regard as archaic may be defensible in experienced hands, where the outcomes are well monitored and known to surgeon and patient alike. Historically, objective data in SUI surgery are sparse, but as new advances emerge, researchers understand the importance of RCTs. Thus, scrutiny of surgical technique and materials is becoming commonplace, ultimately providing better patient care, which is the ultimate goal.

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78. Reid SV, Parys B. Long-term 5-year followup of the results of the vesica procedure. The Journal of Urology. 2005;173(4):1234–6. 79. Kato K, Hirata T, Suzuki K, Yoshida K, Murase T. Sling removal after the Vesica sling and tension-free vaginal tape (TVT) procedures. Nihon Hinyokika Gakkai Zasshi The Japanese Journal of Urology. 2004;95(1):17–24. 80. Haab F, Cortesse A, Rode P et al. Treatment of stress urinary incontinence with percutaneous colposuspension: unsatisfactory technique. Progres en Urologie: Journal de L’association Francaise D’urologie et de la Societe Francaise D’urologie. 2001;11(2):336–9. 81. Raz S, Klutke CG, Golomb J. Four-corner bladder and urethral suspension for moderate cystocele. The Journal of Urology. 1989;142(3):712–5. 82. Raz S, Stothers L, Young GP et al. Vaginal wall sling for anatomical incontinence and intrinsic sphincter dysfunction: efficacy and outcome analysis. The Journal of Urology. 1996;156(1):166–70. 83. Kuprasertkul A, Christie AL, Alhalabi F, Zimmern P. Very long-term follow-up of the anterior vaginal wall suspension procedure for incontinence and/or prolapse repair. World Journal of Urology. 2020:1–10. 84. Aldridge AH. Transplantation of fascia for relief of urinary stress incontinence. American Journal of Obstetrics and Gynecology. 1942;44(3):398–411. 85. Goebell R. Zur Operativen Behandlung Der Incontinenz Mannlichen Harnrohre. Verb Dtsch Gee Chir. 1910;2:187. 86. Stoeckel W. Über die Verwendung der Musculi pyramidales bei der operativen Behandlung der Incontinentia urinae. Zentralbl Gynak. 1917;41:11–9. 87. McGuire E., Lytton B. Pubovaginal sling procedures for stress incontinence The Journal of Urology. 1978;119:82. 88. Karram MM, Bhatia NN. Patch procedure: modified transvaginal fascia lata sling for recurrent or severe stress urinary incontinence. Obstetrics and Gynecology. 1990;75(3 Pt 1):461–3. 89. Beck R, McCormick S, Nordstrom L. The fascia lata sling procedure for treating recurrent genuine stress incontinence of urine. Obstetrics and Gynecology. 1988;72(5):699–703. 90. Kaplan SA, Santarosa RP, Te AE. Comparison of fascial and vaginal wall slings in the management of intrinsic sphincter deficiency. Urology. 1996;47(6):885–9. 91. Barbalias G, Liatsikos E, Athanasopoulos A. Gore-Tex sling urethral suspension in type III female urinary incontinence: clinical results and urodynamic changes. International Urogynecology Journal. 1997;8(6):344–50. 92. Demirci F, Yucel O. Comparison of pubovaginal sling and burch colposuspension procedures in type I/II genuine stress incontinence. Archives of Gynecology and Obstetrics. 2001;265(4):190–4. 93. Viseshsindh W, Kochakarn W, Waikakul W, Roongruangsilp U, Siripornpinyo N, Viseshsindh V. A randomized controlled trial of pubovaginal sling versus vaginal wall sling for stress urinary incontinence. Journal of the Medical Association of Thailand= Chotmaihet thangphaet. 2003;86(4):308–15. 94. Albo ME, Richter HE, Brubaker L et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. New England Journal of Medicine. 2007;356(21):2143–55. 95. Müller S, Steinbach F, Maurer F, Melchior S, Stein R, Hohenfellner R. Long-term results of fascial sling procedure. International Urogynecology Journal. 1993;4(4):199–203. 96. Zaragoza MR. Expanded indications for the pubovaginal sling: treatment of type 2 or 3 stress incontinence. The Journal of Urology. 1996;156(5):1620–2. 97. Chaikin DC, Rosenthal J, Blaivas JG. Pubovaginal fascial sling for all types of stress urinary incontinence: long-term analysis. The Journal of Urology. 1998;160(4):1312–6. 98. Cross CA, Cespedes RD, McGuire EJ. Our experience with pubovaginal slings in patients with stress urinary incontinence. The Journal of Urology. 1998;159(4):1195–8. 99. Hassouna ME, Ghoniem GM. Long-term outcome and quality of life after modified pubovaginal sling for intrinsic sphincteric deficiency. Urology. 1999;53(2):287–91. 100. Morgan TO, Westney OL, McGuire EJ. Pubovaginal sling: 4-year outcome analysis and quality of life assessment. The Journal of Urology. 2000;163(6):1845–8. 101. Groutz A, Blaivas JG, Hyman MJ, Chaikin DC. Pubovaginal sling surgery for simple stress urinary incontinence: analysis by an outcome score. The Journal of Urology. 2001;165(5):1597–600. 102. Hawkins E, Taylor D, Hughes-Nurse J. Long term follow up of the cruciate fascial sling for women with genuine stress incontinence. BJOG: An International Journal of Obstetrics and Gynaecology. 2002;109(3):327–38. 103. Chou EC-L, Flisser AJ, Panagopoulos G, Blaivas JG. Effective treatment for mixed urinary incontinence with a pubovaginal sling. The Journal of Urology. 2003;170(2):494–7.

Textbook of Female Urology and Urogynecology 104. Reichelt O, Weirich T, Wunderlich H, Schubert J. Pubovaginal cutaneous fascial sling procedure for stress urinary incontinence: 10 years’ experience. Urologia Internationalis. 2004;72(4):318–24. 105. Flynn BJ, Yap WT. Pubovaginal sling using allograft fascia lata versus autograft fascia for all types of stress urinary incontinence: 2-year minimum followup. The Journal of Urology. 2002;167(2 Part 1):608–12. 106. Rodrigues P, Hering F, Meler A, Campagnari JC, D’Império M. Pubo-fascial versus vaginal sling operation for the treatment of stress urinary incontinence: a prospective study. Neurourology and Urodynamics: Official Journal of the International Continence Society. 2004;23(7):627–31. 107. Howden NS, Zyczynski HM, Moalli PA, Sagan ER, Meyn LA, Weber AM. Comparison of autologous rectus fascia and cadaveric fascia in pubovaginal sling continence outcomes. American Journal of Obstetrics and Gynecology. 2006;194(5):1444–9. 108. Giri SK, Hickey JP, Sil D et al. The long-term results of pubovaginal sling surgery using acellular cross-linked porcine dermis in the treatment of urodynamic stress incontinence. The Journal of Urology. 2006;175(5):1788–93. 109. Jeon M-J, Jung H-J, Chung S-M, Kim S-K, Bai S-W. Comparison of the treatment outcome of pubovaginal sling, tension-free vaginal tape, and transobturator tape for stress urinary incontinence with intrinsic sphincter deficiency. American Journal of Obstetrics and Gynecology. 2008;199(1):76. e1–e4. 110. Onur R, Singla A, Kobashi KC. Comparison of solvent-dehydrated allograft dermis and autograft rectus fascia for pubovaginal sling: questionnairebased analysis. International Urology and Nephrology. 2008;40(1):45–9. 111. Saraswat L, Rehman H, Omar MI, Cody JD, Aluko P, Glazener CM. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database of Systematic Reviews. 2020;1:CD001754. 112. Wright EJ, Iselin CE, Carr LK, Webster GD. Pubovaginal sling using cadaveric allograft fascia for the treatment of intrinsic sphincter deficiency. The Journal of Urology. 1998;160(3 Part 1):759–62. 113. Brown SL, Govier FE. Cadaveric versus autologous fascia lata for the pubovaginal sling: surgical outcome and patient satisfaction. The Journal of Urology. 2000;164(5):1633–7. 114. Almeida S, Gregorio E, Grando J, Rodrigues M, Fraga F, Moreira H, editors. Pubovaginal sling using cadaveric allograft fascia for the treatment of female urinary incontinence. Transplantation Proceedings. 2004. Elsevier. 115. Woodruff AJ, Cole EE, Dmochowski RR, Scarpero HM, Beckman EN, Winters JC. Histologic comparison of pubovaginal sling graft materials: a comparative study. Urology. 2008;72(1):85–9. 116. Lemer ML, Chaikin DC, Blaivas JG. Tissue strength analysis of autologous and cadaveric allografts for the pubovaginal sling. Neurourology and Urodynamics. 1999;18(5):497–503. 117. Buck B, Malinin TI. Human bone and tissue allografts. Preparation and safety. Clinical Orthopaedics and Related Research. 1994(303):8–17. 118. Choe JM, Bell T. Genetic material is present in cadaveric dermis and cadaveric fascia lata. The Journal of Urology. 2001;166(1):122–4. 119. Basok EK, Yildirim A, Atsu N, Basaran A, Tokuc R. Cadaveric fascia lata versus intravaginal slingplasty for the pubovaginal sling: surgical outcome, overall success and patient satisfaction rates. Urologia Internationalis. 2008;80(1):46–51. 120. Amundsen C, Visco A, Ruiz H, Webster G. Outcome in 104 pubovaginal slings using freeze-dried allograft fascia lata from a single tissue bank. Urology. 2000;56(6):2–8. 121. FitzGerald MP, Edwards SR, Fenner D. Medium-term follow-up on use of freeze-dried, irradiated donor fascia for sacrocolpopexy and sling procedures. International Urogynecology Journal. 2004;15(4):238–42. 122. Huang Y-H, Lin AT, Chen K-K, Pan C-C, Chang LS. High failure rate using allograft fascia lata in pubovaginal sling surgery for female stress urinary incontinence. Urology. 2001;58(6):943–6. 123. Onur R, Singla A. Solvent-dehydrated cadaveric dermis: a new allograft for pubovaginal sling surgery. International Journal of Urology. 2005;12(9):801–5. 124. Elliott DS, Boone TB. Is fascia lata allograft material trustworthy for pubovaginal sling repair? Urology. 2000;56(5):772–5. 125. Richter HE, Burgio KL, Holley RL et al. Cadaveric fascia lata sling for stress urinary incontinence: a prospective quality-of-life analysis. American Journal of Obstetrics and Gynecology. 2003;189(6):1590–5. 126. Soergel T, Shott S, Heit M. Poor surgical outcomes after fascia lata allograft slings. International Urogynecology Journal. 2001;12(4):247–53. 127. Walsh I, Nambirajan T, Donellan S, Mahendra V, Stone AR. Cadaveric fascia lata pubovaginal slings: early results on safety, efficacy and patient satisfaction. BJU International. 2002;90(4):415–9.

Traditional Surgery and Other Historical Procedures 128. Owens DC, Winters JC. Pubovaginal sling using Duraderm™ graft: Intermediate follow-up and patient satisfaction. Neurourology and Urodynamics: Official Journal of the International Continence Society. 2004;23(2):115–8. 129. Nazemi TM, Rapp DE, Govier FE, Kobashi KC. Cadaveric fascial sling with bone anchors: minimum of 24 months of follow-up. Urology. 2008;71(5):834–8. 130. Carbone JM, Kavaler E, Hu JC, Raz S. Pubovaginal sling using cadaveric fascia and bone anchors: disappointing early results. The Journal of Urology. 2001;165(5):1605–11. 131. O’Reilly KJ, Govier FE. Intermediate term failure of pubovaginal slings using cadaveric fascia lata: a case series. The Journal of Urology. 2002;167(3):1356–8. 132. Carey JM, Leach GE. Transvaginal surgery in the octogenarian using cadaveric fascia for pelvic prolapse and stress incontinence: minimal one-year results compared to younger patients. Urology. 2004;63(4):665–70. 133. Rottenberg RD, Weil A, Brioschi P, Bischof P, Krauer F. Urodynamic and clinical assessment of the Lyodura sling operation for urinary stress incontinence. BJOG: An International Journal of Obstetrics & Gynaecology. 1985;92(8):829–34. 134. Enzelsberger H, Helmer H, Schatten C. Comparison of Burch and lyodura sling procedures for repair of unsuccessful incontinence surgery. Obstetrics & Gynecology. 1996;88(2):251–6. 135. Jarvis G, Fowlie A. Clinical and urodynamic assessment of the porcine dermis bladder sling in the treatment of genuine stress incontinence. BJOG: An International Journal of Obstetrics & Gynaecology. 1985;92(11):1189–91. 136. Kinn A-C, Larson B, Hammarström M. Urethropexy with porcine dermal sling in complicated stress incontinence. International Urogynecology Journal. 1994;5(1):31–4. 137. Arunkalaivanan A, Barrington J. Randomized trial of porcine dermal sling (Pelvicol™ implant) vs. tension-free vaginal tape (TVT) in the surgical treatment of stress incontinence: a questionnaire-based study. International Urogynecology Journal. 2003;14(1):17–23. 138. Guerrero K, Emery S, Wareham K, Ismail S, Watkins A, Lucas M. A randomised controlled trial comparing TVTTM, PelvicolTM and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG: An International Journal of Obstetrics & Gynaecology. 2010;117(12):1493–503. 139. Giri SK, Drumm J, Saunders JA, McDonald J, Flood HD. Day-case sling surgery for stress urinary incontinence: feasibility and safety. BJU International. 2005;95(6):827–32. 140. Iosif C. Porcine corium sling in the treatment of urinary stress incontinence. Archives of Gynecology. 1987;240(3):131–6. 141. Barrington J, Edwards G, Arunkalaivanan A, Swart M. The use of porcine dermal implant in a minimally invasive pubovaginal sling procedure for genuine stress incontinence. BJU International. 2002;90(3):224–7. 142. Broussard AP, Reddy TG, Frilot CF, Kubricht WS, Gomelsky A. Longterm follow-up of porcine dermis pubovaginal slings. International Urogynecology Journal. 2013;24(4):583–7. 143. Khan ZA, Nambiar A, Morley R, Chapple CR, Emery SJ, Lucas MG. Longterm follow-up of a multicentre randomised controlled trial comparing tension-free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women. BJU International. 2015;115(6):968–77. 144. Morgan DM, Dunn RL, Fenner DE et al. Comparative analysis of urinary incontinence severity after autologous fascia pubovaginal sling, pubovaginal sling and tension-free vaginal tape. The Journal of Urology. 2007;177(2):604–9. 145. Rutner AB, Levine SR, Schmaelzle JF. Processed porcine small intestine submucosa as a graft material for pubovaginal slings: durability and results. Urology. 2003;62(5):805–9.

775 146. Jones JS, Rackley RR, Berglund R, Abdelmalak JB, Deorco G, Vasavada SP. Porcine small intestinal submucosa as a percutaneous mid-urethral sling: 2-year results. BJU International. 2005;96(1):103–6. 147. Wiedemann A, Otto M. Small intestinal submucosa for pubourethral sling suspension for the treatment of stress incontinence: first histopathological results in humans. The Journal of Urology. 2004;172(1):215–8. 148. John TT, Aggarwal N, Singla AK, Santucci RA. Intense inflammatory reaction with porcine small intestine submucosa pubovaginal sling or tape for stress urinary incontinence. Urology. 2008;72(5):1036–9. 149. Wilson CM, Williams BJ, Bilello S, Gomelsky A. Bovine dermis: a novel biologic substitute for autologous tissue in sling surgery. International Urogynecology Journal. 2008;19(12):1671–6. 150. Holstead JP, Williams BJ, Gomelsky A. Long term follow up of bovine dermis pubovaginal slings. Canadian Journal of Urology. 2013;20(2):6721–5. 151. Weinberger MW, Ostergard DR. Long-term clinical and urodynamic evaluation of the polytetrafluoroethylene suburethral sling for treatment of genuine stress incontinence. Obstetrics & Gynecology. 1995;86(1):92–6. 152. Morgan JE, Farrow GA, Stewart FE. The Marlex sling operation for the treatment of recurrent stress urinary incontinence: a 16-year review. American Journal of Obstetrics and Gynecology. 1985;151(2):224–6. 153. Murless BC. The injection treatment of stress incontinence. BJOG: An International Journal of Obstetrics & Gynaecology. 1938;45(1):67–73. 154. Quackels R. Deux incontinences après adenomectomie gueries par injection de paraffine dans le perinee. Acta Urologica Belgica. 1955;23:259–62. 155. Politano VA, Harper JM. Experiences and results with conservative management of vesicoureteral reflux. The Journal of Urology. 1964;92(5):445–7. 156. Politano VA, Small MP, Harper JM, Lynne CM. Periurethral Teflon injection for urinary incontinence. The Journal of Urology. 1974;111(2):180–3. 157. Politano V. Incontinence treated with Teflon. British Journal of Urology. 1995;75(2):261-. 158. Lopez AE, Padron OF, Patsias G, Politano VA. Transurethral polytetrafluoroethylene injection in female patients with urinary continence. The Journal of Urology. 1993;150(3):856–8. 159. Kiilholma P, Mäkinen J. Disappointing effect of endoscopic Teflon injection for female stress incontinence. European Urology. 1991;20:197–9. 160. Kiilholma PJ, Chancellor MB, Makinen J, Hirsch IH, Klemi PJ. Complications of Teflon injection for stress urinary incontinence. Neurourology and Urodynamics. 1993;12(2):131–7. 161. Mittleman RE. Pulmo-nary teflon granulomas following periurethral teflon injection for urinary incontinece. Archives of Pathology & Laboratory Medicine. 1983;107:611–2. 162. Claes DS, Van Meerbeek J, Verbeken E, Knockaert D, Baert L. Pulmonary migration following periurethral polytetrafluoroethylene injection for urinary incontinence. The Journal of Urology. 1989;142(3):821–2. 163. Martinez-Pineiro L, Jimenez de Leon J, Cozar J, Navarro J, MartínezPiñeiro J. Obstructive uropathy secondary to the periurethral injection of teflon paste. Archivos Espanoles de Urologia. 1989;42(6):571–3. 164. Beckingham I, Wemyss-Holden G, Lawrence W. Long-term follow-up of women treated with perurethral Teflon injections for stress incontinence. British Journal of Urology. 1992;69(6):580–3. 165. Harrison S, Brown C, O’Boyle P. Periurethral Teflon for stress urinary incontinence: medium-term results. British Journal of Urology. 1993;71(1):25–7. 166. JM CJ, Robles S, JL SB. Endoscopic injection of autologous adipose tissue in the treatment of female incontinence. Archivos Espanoles de Urologia. 1989;42(2):143–6. 167. Gonzalez de Garibay A, JM CJ, Perez V, MJ VL, JL SB. Treatment of urinary stress incontinence using paraurethral injection of autologous fat. Archivos Espanoles de Urologia. 1991;44(5):595–600. 168. Lee PE, Kung RC, Drutz HP. Periurethral autologous fat injection as treatment for female stress urinary incontinence: a randomized double-blind controlled trial. The Journal of Urology. 2001;165(1):153–8.

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RETROPUBIC URETHROPEXY Dudley Robinson and Linda Cardozo

Introduction The term stress urinary incontinence may be used to describe the symptom or sign of urinary leakage on coughing or exertion but should not be regarded as a diagnosis. A diagnosis of Urodynamic Stress Incontinence (USI) can only be made after urodynamic investigation and this is defined as the involuntary leakage of urine during increased abdominal pressure in the absence of a detrusor contraction.1 Stress incontinence is the most commonly reported type of urinary incontinence in women. In a large epidemiological study of 27,936 women from Norway2 overall 25% of women reported urinary incontinence of whom 7% considered it to be significant, and the prevalence of incontinence increased with age. When considering the type of incontinence 50% of women complained of stress, 11% urge and 36% mixed incontinence. The prevalence of urinary incontinence among nulliparous women ranged from 8% to 32% and increased with age. In general, parity was associated with incontinence and the first delivery was the most significant. In the 20–34 years age group, the relative risk of stress incontinence was 2.7 (95% CI: 2.0–3.5) for primiparous women and 4.0 (95% CI: 2.5–6.4) for multiparous women. There was a similar association for mixed incontinence although not for urge incontinence. 3

Pathophysiology There are various different underlying causes which result in weakness of one or more of the components of the urethral sphincter mechanism (Table 71.1). The bladder neck and proximal urethra are normally situated in an intra-abdominal position above the pelvic floor and are supported by the pubourethral ligaments. Damage to either the pelvic floor musculature (levator ani) or pubourethral ligaments may result in descent of the proximal urethra such that it is no longer an intra-abdominal organ and this results in leakage of urine per urethram during stress. This theory has given rise to the concept of the ‘hammock hypothesis’ which suggests that the posterior position of the vagina provides a backboard against which increasing intraabdominal forces compress the urethra.4 This is supported by the fact that continent women experience an increase in intraurethral closure pressure during coughing. 5 This pressure rise is lost in women with stress incontinence although may be restored following successful continence surgery.6 In addition to pelvic floor damage there is also evidence to suggest that stress incontinence may be caused by primary urethral sphincter weakness or intrinsic sphincter deficiency (ISD). In order to distinguish this type of stress incontinence from that caused by descent and rotation of the bladder neck during straining the Blaivis Classification has been described based on a videocystourethrographic observations.7 This proposes that 776

Type I and Type II stress incontinence are caused principally by urethral hypermobility whereas Type III, or ISD, is caused by a primary weakness in the urethral sphincter. Factors associated with intrinsic sphincter deficiency are pudendal innervation, 8 integrity of the striated urethral sphincter,9 urethral smooth muscle, the urethral mucosa and submucosal urethral cushions. Subsequently the ‘mid-urethral theory’ or ‘integral theory’ has been described by Petros and Ulmsten.10 This concept is based on earlier studies suggesting that the distal and mid-urethra play an important role in the continence mechanism11 and that the maximal urethral closure pressure is at the mid-urethral point.12 This theory proposes that damage to the pubourethral ligaments supporting the urethra, impaired support of the anterior vaginal wall to the mid urethra, and weakened function of part of the pubococcygeal muscles which insert adjacent to the urethra are responsible for causing stress incontinence.

Retropubic urethropexy History

In 1923, Victor Bonney observed that ‘incontinence depends in some way upon a sudden and abnormal displacement of the urethra and urethrovesical junction immediately behind the symphysis’.13 This association of urethral hypermobility and stress urinary incontinence was also noted by Watson in 192414 although it was not until 1949 that the first retropubic procedure for stress incontinence was described by Marshall, Marchetti and Krantz.15 This early example of cooperation between two urologists and a gynaecologist described ‘the correction of stress incontinence by simple vesicourethral suspension’ in a series of 50 patients including 12 men with post prostatectomy stress incontinence. They reported an initial 82% success and 7% improvement rate and the procedure became popular in the management of women with stress urinary incontinence. In 1961, John Burch described his modification of the MarshallMarchetti-Krantz procedure when he encountered difficulty in suture placement. Rather than placing the sutures in the periostium of the pubic symphysis he described the attachment of the anterolaterolateral vagina to the pectineal ligament using three sutures on each side.16 He initially reported a series of 53 patients with 100% success rate and subsequently published a 9 year series of results in 1968 with a 93% success rate and an 8% incidence of enterocele.17 Over the last 50 years the Burch colposuspension has remained an efficacious and durable procedure in the surgical management of stress urinary incontinence and has undergone several modifications. In 1976, Tanagho recommended avoiding dissection of the midline neurovascular supply to the urethra to reduce the risk of causing intrinsic sphincter deficiency18 and also observed that over correction at the level of the bladder neck did not improve success rates but led to a higher incidence of voiding difficulties.19

DOI: 10.1201/9781003144243-78

Retropubic Urethropexy

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TABLE 71.1: Causes of Urodynamic Stress Incontinence Urethral hypermobility • Urogenital prolapse Pelvic floor damage or denervation • Parturition • Pelvic surgery • Menopause Urethral scarring • Vaginal (urethral) surgery • Incontinence surgery • Urethral dilatation or urethrotomy • Recurrent urinary tract infections • Radiotherapy Raised intra-abdominal pressure • Pregnancy • Chronic cough (bronchitis) • Abdominal/pelvic mass • Fecal impaction Ascites • Obesity

This observation led to the widely adopted technique of providing support to the bladder neck without over-elevation. With the increasing trend to minimal access techniques the laparoscopic coloposuspension was first reported in 1991.20 Although many authors have reported excellent short-term subjective results from laparoscopic colposuspension,21 early studies showed inferior results to the open procedure.22,23 More recently the description of the ‘integral theory’ has revolutionised the concept behind the traditional approach to retropubic surgery and has led to the introduction of the mid-urethral tapes using a retropubic24,25 and transobturator approach.26 Whilst these procedures have largely replaced retropubic urethropexies in clinical practice the colposuspension still has an important role in the management of women with stress urinary incontinence.

Marshall-Marchetti-Krantz Operative technique

The patient is placed in the modified lithotomy position and a foley catheter inserted. A low transverse suprapubic incision is made and the retropubic space entered. The bladder neck and proximal urethra are then mobilised from the vagina with the assistance of the index and middle fingers of the surgeons left hand placed within the vagina. Between one and three sutures are inserted on each side. Each suture should include the paraurethral tissue, lateral wall of the urethra and the vaginal wall. The sutures are then fixed to the periostium of the superior pubic ramus or the perichondium of the symphysis pubis. Further sutures may then be placed between the anterior surface of the bladder and rectus abdominis to provide additional elevation and support (Fig. 71.1). At the end of the procedure a redivac drain should be placed in the retropubic space and a suprapubic catheter used for post-operative urinary drainage. When the urinary residuals are less than 100 ml, then the catheter may be removed.

Results

Overall there have been 58 published papers between 1951 and 1998 which have included 3238 patients although many of these studies were retrospective case series. Overall cure rates were

FIGURE 71.1 The Marshall-Marchetti-Krantz procedure (From Ref. (15) with permission). approximately 88% with results of 92% and 84% in primary surgery and redo surgery respectively.27 Whilst there has been no formal Cochrane review of the procedure there has been a review of comparative trials with colposuspension.28–30 Although the early results of MMK are not significantly different to colposuspension both subjective and objective cure were found to be significantly better following colposuspension than after MMK at 1–5 years (RR 0.44; 95% CI: 0.25–0.77). 31 In addition two further studies comparing MMK with colposuspension were identified by the National Collaborating Centre for Women’s and Children’s Health in the UK. Whilst one study showed significantly better objective outcome based on negative stress test in the MMK group (93% vs. 53%; p = 0.02)32 the other showed significantly better subjective outcomes in the colposuspension group at 2-year follow-up (59% vs. 49%; p = 0.02). 33 More recently a case series comparing MMK with Tension Free Vaginal Tape (TVT) has been published in 228 women with a 10-year follow up. The short term success in the MMK was 89% although this fell to 68.2% at 5 years and only 32% at 10 years. Conversely the cure rate for TVT was 90.0% initially and 84.3% at 5 years. 34 Data regarding long-term success of MMK are more limited although six studies have been reported with a mean cure rate of 58% reported between 4 and 15 years.35–40 Two of these long-term studies have shown the efficacy rates to reduce over time with reported success rates being 90% and 77% at 1 year, 86% and 57% at 5 years and 72% and 28% at 10 years.34,36 The recommendation from the 6th International Consultation on Incontinence41 is that the MMK procedure is currently not recommended for the treatment of stress urinary incontinence (Grade A recommendation).

Complications The major complication associated with the MMK procedure is osteitis pubis which has been reported to occur in 2.5–7% of cases.42,43 Patients present with a history of severe suprapubic pain radiating into the groins and perineum and a bone scan shows increased uptake in the suprapubic region. Long-term antibiotic treatment over several months is generally required and occasionally a retropubic abscess may require drainage.

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Colposuspension Operative technique

The patient is positioned on the operating table in the modified lithotomy position using Lloyd-Davies stirrups. The abdomen and vagina are then prepared as a sterile operating field in order to allow manipulation of the vaginal fornices and bladder neck by the surgeon. An indwelling foley catheter is then inserted and the balloon inflated with 6 ml of water to allow identification of the bladder neck. A low transverse supra-pubic incision approximately 1 cm above the pubic symphysis is made and the rectus fascia incised

FIGURE 71.2  (a)–(f) Operative technique.

taking care not to open the peritoneal cavity unless a concomitant intra-abdominal procedure is being performed. A Turner-Warwick self-retaining retractor may then be inserted (Fig. 71.2(a)) and the retropubic space (Cave of Retzius) is opened using both sharp and blunt dissection (Fig. 71.2(b)) until the white paravaginal tissue lateral to the bladder neck and urethra is identified (Fig. 71.2(c)). Vaginal manipulation is also used to further assist in the elevation of the lateral vaginal fornices whilst the bladder is swept medially. Two to four delayed absorbable sutures are inserted into the paravaginal fascia on each side and each tied down onto the vaginal tissue ensuring haemostasis. The

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FIGURE 71.2 (Continued)  (g)–(i) Operative technique. first suture is at the level of the bladder neck and 1 cm lateral (Fig. 71.2(d)). The suture is then passed vertically through the ipsilateral iliopectineal ligament, taking care not to pull the bladder neck open, and left untied. Each subsequent suture is then placed 1 cm lateral and 1 cm cephalad (Fig. 71.2(e)€) and all left untied before the sutures are placed on the opposite side (Fig. 71.2(f)). Once all the sutures are positioned correctly each lateral fornix is elevated by an assistant allowing the sutures to be tied easily without tension (Fig. 71.2(g)). After checking for adequate haemostasis the retropubic space is drained with a redivac suction drain and the abdomen closed (Fig. 71.2(h) and (i)). The bladder is left on free drainage using a supra-pubic catheter for 48 hours prior to starting a clamping regimen. When the urinary residuals are less than 100 ml the supra-pubic catheter may be removed.

Results

The 4th International Consultation on Incontinence27 noted 33 published randomised trials of colposuspension in addition to: • Seven trials comparing colposuspension with anterior colporrhaphy • Four trials comparing colposuspension with MarshallMarchetti-Krantz

• Nine trials comparing colposuspension with needle suspension • One trial comparing colposuspension with abdominal paravaginal repair • Seven trials comparing colposuspension with traditional sling procedures • Five trials comparing colposuspension with tension free vaginal tape (TVT) • One trial comparing colposuspension with transobturator tape (TOT) • Seven trials comparing open colposuspension with laparoscopic colposuspension In total these studies included 4161 women of whom 1900 were randomised to colposuspension. Additionally there has been a recent meta-analysis performed by the Cochrane group.44 Since the 4th report from the International Consultation on Incontinence a further two additional studies have been published comparing retropubic mid-urethral slings to open colposuspension in the updated 5th International Consultation on Incontinence.45 The 6th International Consultation has reported one further trial comparing colposuspension with TOT.41

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780 When considering all studies of colposuspension objective cure rates varied between 59% and 100% (median 80%) and subjective cure rates between 71% and 100% (median 88%). Based on these results, colposuspension would appear to have comparable objective and subjective outcomes to traditional sling procedures and to both retropubic and transobturator mid-urethral tapes. The evidence would also appear to suggest that outcomes with colposuspension are significantly better than those achieved with anterior colporrhaphy, needle suspension procedures, paravaginal repair and the Marshall-Marchetti-Krantz procedure.

Outcome: Colposuspension

Historically there have been many prospective case series and cohort studies assessing the efficacy of colposuspension with some studies providing long-term follow up data up to 20 years (Table 71.2). In addition there have also been a number of reported metaanalyses. The first of these was reported in Jarvis in 1994 42 who reviewed 1726 women with follow up of at least 1 year and a mean objective success rate of 84.3%. Very similar results were reported from a meta-analysis of 2196 women reported by the American Urological Association in 1997. Overall mean objective cure rates were 84% at 48 months (CI: 79–88%) with follow up to at least 4 years.46 More recently the Cochrane group has published a meta-analysis of 55 trials involving a total of 5417 women with overall cure rates of 68.9–88%.44 Evidence for six trials revealed a lower incontinence rate after colposuspension as compared to anterior colporrhaphy and this was maintained over time (RR 0.46; 95% CI 0.30–0.72 in the first year, RR 0.37; 95% CI 0.27–0.51 at 1–5 years and RR 0.49; 95% CI 0.32–0.75 beyond 5 years). Evidence from 22 trials compared open colposuspension with suburethral slings and found no significant difference in subjective incontinence rates at all time points; (RR 0.90; 95% CI 0.69– 1.18 in the first year, RR 1.18; 95% CI 1.01–1.39 at 1–5 years and RR 1.11; 95% CI 0.97–1.27 beyond 5 years). The objective incontinence rates were also not significantly different; (RR 1.24; 95% CI 0.93–1.67 in the first year, RR 1.12; 95% CI 0.82–1.54 at 1–5 years and RR 0.70; 95% CI 0.3–1.64 beyond 5 years). However, in a sub-group analysis comparing traditional slings and open colposuspension the former were associated with greater effectiveness in the medium to longer term; (RR 1.35; 95% CI 1.11–1.64 at 1–5 years and RR 1.19; 95% CI 1.03–1.37 beyond 5 years). TABLE 71.2: Subjective and Objective Outcome of Colposuspension – Case Series and Cohort Studies Study

No

Objective Outcome (%)

Burch 196116 Burch 196817 Stanton 197647 Milani 198548 Cardozo 199249 Herbertsson 199350 Feyereisl 199451 Alcalay 199552 Langer 200153

53 143 32 44 100 72 87 109 127

– – 80 79 80 90 82 90 94

Subjective Follow-Up Outcome (%) (Months) 100 93 – – – – – – –

Unstated 10–60 6–30 >12 6–12 84–144 60–120 120–240 120–180

TABLE 71.3: Objective Outcome of Redo Colposuspension – Case Series Study

Objective Cure (%)

Follow-Up (Months)

65 63 77 83 61 78 81 86 65

60 54 12 >12 120–240 9 9 12 60–180

Stanton 1984 Galloway 198755 Stanton 197956 Jarvis 199442 Alcalay 199552 Cardozo 199957 Maher 199958 Bidmead 200160 Thakar 200261 54

In addition open colposuspension was found to be more effective that needle suspension procedures; (RR 0.66; 95% CI 0.42– 1.03 in the first year, RR 0.56; 95% CI 0.39–0.81 at 1–5 years and RR 0.32; 95% CI 0.15–0.71 beyond 5 years) and MMK (RR 0.38; 95% CI 0.18–0.76).

Outcome: Redo colposuspension

There have been several case series reporting the outcome of colposuspension following failed previous surgery (Table 71.3). Whilst success rates tend to be slightly lower following failed previous continence surgery continence rates of between 65% and 86% are generally reported indicating the efficacy of colposuspension as a secondary procedure.

Outcome: Colposuspension vs. anterior colporrhaphy

There have been seven trials comparing colposuspension with anterior colporrhaphy [Table 71.4] and one meta-analysis. In general success rates tend to be lower in the group of patients having anterior colporrhaphy as compared to colposuspension. Consequently the 4th International Consultation on Incontinence27 recommended that anterior colporrhaphy should not be used alone in the management of stress urinary incontinence.

Outcome: Colposuspension vs. Marshall-Marchetti-Krantz

There have been four trials comparing colposuspension with the Marshall-Marchetti-Krantz procedure (Table 71.5). Whilst some studies indicate comparable success rates in the short TABLE 71.4: Comparative Studies: Colposuspension (Colpo) vs. Anterior Colporrhaphy (AC)

Study

Type of Study

Success Rate (Objective/ Subjective) Colpo vs. AC (%)

Bergman 1989a61 Bergman 1989b62 Bergman 199563 Black 199664 Liapis 1996a65 Liapis 1996b66 Kammerer-Doak 199967 Colombo 200068

RCT RCT RCT Meta-analysis RCT RCT RCT

89 vs. 63 87 vs. 69 82 vs. 37 85 vs. 50–70 88 vs. 57 89 vs. 56 89 vs. 31

12 12 60 12 36 60 12

74 vs. 42

>96

RCT

Follow-Up (Months)

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TABLE 71.5: Comparative Studies: Colposuspension (Colpo) vs. Marshall-Marchetti-Krantz (MMK)

Study

Type of Study

Colombo 199869 Liapis 1996b66 Quadri 199932 McCrery 200533

RCT RCT RCT RCT

Success Rate (Objective/Subjective) Follow-Up Colpo vs. MMK (%) (Months) 80 vs. 65 89 vs. 67 93 vs. 53 59 vs. 49

12–84 60 12 6–60

term the longer-term studies would suggest that efficacy is less good when compared to colposuspension. Consequently the 6th International Consultation on Incontinence concluded that there is no evidence to support the use of the Marshall-MarchettiKrantz procedure over colposuspension.41

Outcome: Colposuspension vs. needle suspension procedures

There have been nine trials comparing colposuspension with needle suspension procedures (Table 71.6). The majority of reported studies suggest that needle suspension operations are less effective than colposuspension both in the long and short term and the 6th International Consultation on Incontinence has concluded that their use should not be recommended.41

Outcome: Colposuspension vs. paravaginal repair

There has been only one randomised controlled trial comparing colposuspension with paravaginal repair in 72 women with follow up at 24 months.70 There was a significantly higher success rate in the colposuspension arm compared to the paravaginal repair arm (100% vs. 61%; p = 0.004) and consequently the trial was discontinued early for ethical reasons. The 6th International Consultation on Incontinence has concluded that the evidence would suggest that abdominal paravaginal repair is less effective than colposuspension.41

Outcome: Colposuspension vs. traditional sling procedures

Seven trials have compared colposuspension with traditional sling procedures (Table 71.7). The evidence suggests that traditional sling procedures have similar efficacy to TABLE 71.6: Comparative Studies: Colposuspension (Colpo) vs. Needle Bladder Neck Suspension Procedures (NBNS)

Study

Type of Study

Mundy 1983 Bergman 198961 Bergman 199563 Klutke 199972 German 199473 Black 199664 Athanassopoulos 199674 Leach 199746 Gilja 199875 71

Success Rate (Objective/Subjective) Follow-Up Colpo vs. NBNS (%) (Months)

Quasi RCT RCT RCT RCT RCT Meta-analysis Quasi RCT

88 vs. 76 89 vs. 65 82 vs. 43 87 vs. 70 86 vs. 53 85 vs. 50–70 74 vs. 71

12 12 60 12 12–44 12 8–27

Meta-analysis RCT

84 vs. 67 89 vs. 80

≥ 48 18

TABLE 71.7: Comparative Studies: Colposuspension (Colpo) vs. Traditional Sling Procedures

Study Black 199664 Enzelsberger 199676 Leach 199746 Sand 200077 Culligan 200378 Demirci 200179 Bai 200580 Albo 200781

Type of Sling

Type of Study

Success Rate (Obj/Subj) Colpo vs. Sling (%)

– Dura

Meta-analysis RCT

83 vs. 74 86 vs. 92

12 32–48

– Gore-tex Gore-tex Fascia Fascia Fascia

Meta-analysis RCT RCT Quasi RCT RCT RCT

84 vs. 67 90 vs. 100 85 vs. 100 88 vs. 94 88 vs. 93 49 vs. 66

≥ 48 3 33–116 12 12 24

Follow-Up (Months)

colposuspension although may be associated with a higher incidence of voiding difficulties. 27 Whilst there is considerable evidence to support the use of autologous fascial slings adverse events may be more common following the use of synthetic sling materials.

Outcome: Colposuspension vs. tension free vaginal tape

There have been seven reported trials comparing colposuspension with the tension-free vaginal tape (TVT) (Table 71.8). Whilst efficacy rates are similar for both procedures, operation time, hospital stay and time to resume normal activities were significantly shorter with the TVT.82–84 However the number of bladder injuries was found to be higher in those women having a TVT when compared to colposuspension.81,82 Conversely, significantly more patients were found to have voiding difficulties following colposuspension82 and subsequently were taught self-catheterisation. In addition, significantly more women required surgery for urogenital prolapse following colposuspension.83 The 4th International Consultation on Incontinence has suggested, based on the available evidence that TVT is more effective than colposuspension and equally effective as the more traditional sling procedures.27 These findings are also supported by the more recently published 5th45 and 6th reports.41 TABLE 71.8: Comparative Studies: Colposuspension (Colpo) vs. Tension-Free Vaginal Tape (TVT)

Study

Type of Study

Success Rate (Obj/Subj) Colpo vs. TVT (%)

Ward 200282 Ward 200483 Ward 200884 Liapis 200285 Wang 200386 El-Barky 2005 87 Bai 200580 McCracken 200788 Tellez Martinez Fornes 200989 Wu 201034

RCT RCT RCT Quasi RCT RCT RCT RCT Retrospective RCT

57 vs. 66 81 vs. 80 81 vs. 90 84 vs. 86 82 vs. 76 72 vs. 72 88 vs. 87 40 vs. 45 24 vs. 25

6 24 60 24 12–36 3–6 12 60 36

Case Series

105 vs. 81

120

Follow-Up (Months)

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782 Outcome: Colposuspension vs. transobturator tape

To date there has been only two randomised controlled trial comparing colposuspension to a transobturator tape procedure. In one, 100 women were followed up at 12 and 24 months. Success rates at 12 months were 80% and 86% in the colposuspension and TOT respectively and were no different at 24 months (84% and 88%, respectively).90 A more recent prospective randomised trial in 62 women has reported cure rates in the TOT arm of 90.3% at 22 months and 74.2% in the colposuspension arm at 28 months.91

Outcome: Colposuspension vs. Laparoscopic Colposuspension

TABLE 71.9: Comparative Studies: Colposuspension (Open) vs. Laparoscopic Colposuspension (Lap) Type of Study

Su 199798 Fatthy 200199 Cheon 2003100 Ankardal 2005101 Ustun 2005102 Kitchener 2006103 Carey 2006105

RCT RCT RCT RCT RCT RCT RCT

Success Rate (Obj/ Subj) Open vs. Lap (%) 96 vs. 80 85 vs. 88 86 vs. 85 92 vs. 90 81 vs. 81 70 vs. 80 80 vs. 69

Complications Perioperative complications

There have been seven reported studies comparing open and laparoscopic colposuspension (Table 71.9). In addition to the published studies the Cochrane group has also reported a metaanalysis of 26 studies including 2271 women.92 Thirteen trials compared laparoscopic colposuspension to open colposuspension and nine trials to mid-urethral sling procedures. One trial compared laparoscopic colposuspension using one suture to two sutures and three trials compared sutures to mesh or staples. There was no significant difference in subjective cure between laparoscopic colposuspension using sutures when compared to open colposuspension (RR 1.04; 95% CI: 0.99–1.08) although the results using mesh or staples are less clear (RR 0.75; 95% CI: 0.61– 0.93). Laparoscopic colposuspension is associated with a lower risk of complications (RR 0.67; 95% CI: 0.47–0.94) although there is a higher risk of bladder injury (RR 1.72; 95% CI: 0.90–3.29). There were no differences in de novo detrusor overactivity (RR 1.29; 95% CI: 0.72–2.30) and voiding dysfunction (RR 0.81; 95% CI: 0.50–1.31). There were no differences in subjective cure between laparoscopic colposuspension using sutures when compared to TVT (RR 1.01; 95% CI: 0.88–1.16) although there is only one trial comparing the use of mesh or staples with TVT (RR 0.71; 95% CI: 0.55–0.91). The rates of redo continence surgery however would appear to be lower with laparoscopic colposuspension (RR 0.40; 95% CI: 0.04–3.62) although this was only based on one small trial. Perioperative complication rates have been shown to be similar (RR 0.99; 95% CI: 0.60–1.64). The Cochrane meta-analysis concluded that there is no difference in terms of subjective cure within 18 months between laparoscopic colposuspension and open colposuspension or between laparoscopic colposuspension and mid-urethral sling procedures although much of the evidence is of relatively low quality and larger, long-term studies are required. There are only two small trials providing long term data at 5 years comparing laparoscopic and open colposuspension, one favouring the open procedure93 and the other the laparoscopic.94

Study

In light of the available evidence the 6th International Consultation on Incontinence concluded that laparoscopic colposuspension has comparable subjective and objective outcomes when compared with open colposuspension in the short to medium term although longer term outcomes are unknown. Laparoscopic colposuspension has similar subjective outcome to TVT although the objective outcome is less good.41

Follow Up (Months) 6 18 12 12 3–24 24 24

Common perioperative complications encountered during colposuspension include haemorrhage and lower urinary tract injury. Whilst major haemorrhage is rare57 one series of 151 patients reported blood loss of over 1000 ml in 2% of cases95 and transfusion rates have been reported to be approximately 5% (CI: 3–8%).45 Bladder and urethral trauma may occur during dissection in the retropubic space and the reported incidence of bladder injury is 1.296 –2.0%.57 In addition the ureters may be injured or kinked at the level of the most cephalad suture with one series of 60 cases reporting an incidence of 6.7%.97

Post-operative complications Overactive bladder

‘De novo’ urgency and urge incontinence may be reported although whether this really represents new pathology or simply symptoms which were not adequately diagnosed preoperatively remains open to debate. Whilst the exact cause may be multifactorial and partially explained by increased outflow resistance post operatively there is some evidence to suggest damage to the autonomic innervation may occur following dissection and mobilisation of the bladder neck.105 Overall the incidence of ‘de novo’ symptoms suggestive of Overactive Bladder (OAB) has been reported as 11% (CI 8–16).45 These findings support the findings of earlier studies which reported an incidence of detrusor overactivity of between 12% and 18.5%.50,102,106,107 Unfortunately there are no reliable predictors of outcome with regard to OAB although there is some evidence to suggest that increased bladder wall thickness may be associated with a higher risk of ‘de novo’ detrusor overactivity post operatively.108 Conversely there is also evidence from some series to suggest that OAB symptoms may improve in 2050 –60%57 of women following colposuspension.

Voiding difficulties

Voiding difficulty may occur early or late in the post-operative period. Whilst the former may be caused by over elevation of the bladder neck at the time of the procedure109 the latter may be related to gradual detrusor muscle compensation secondary to prolonged outflow obstruction. In addition many women also notice that their urinary stream is slower and may need to change position to empty their bladder completely. Overall the incidence of voiding difficulties lasting over 1 month is reported as 5% (CI: 3–5)45 although other series have reported rates as high as 21%.81

Urogenital prolapse

Whilst elevation of the anterior vaginal wall during colposuspension is effective in correcting a mild to moderate cystocele it also results in alteration of the vaginal angle and hence a change in pressure transmission down the vaginal axis. This may exacerbate posterior vaginal wall defects and leads to an increased incidence

Retropubic Urethropexy of posterior vaginal compartment prolapse. In addition, although colposuspension offers effective support of the bladder neck prolapse of the upper third of the anterior vaginal wall may result in a ‘high’ cystocele. To date several large retrospective studies have been performed examining the outcome of colposuspension, which, as well as giving valuable outcome data in terms of cure, also provides information regarding complications. In a retrospective study of 131 women undergoing colposuspension between 1977 and 1986, 35 women (26.7%) required a total of 40 procedures to correct urogenital prolapse.110 There was no association between age, weight, parity, menopausal status and prior pelvic surgery although a large cystocele preoperatively was a significant risk factor. These findings are supported by a further follow-up study of 186 women in Finland, 1 year following colposuspension in which 12% of women were found to have a rectocele or enterocele requiring surgical repair.111 In a similar 6-month follow-up study of 74 women following colposuspension in Mexico the site of urogenital prolapse was assessed.112 The prevalence of urethrocele was 2.7%, cystocele 50.6%, uterine prolapse 21.3%, vault prolapse 9.3% and enterocele 41.9%. The authors concluded that whilst posterior vaginal repair was effective in posterior compartment defects a Moschowitz procedure was not. A 10–15 year follow-up study of 127 women undergoing Burch colposuspension has been reported.52 The mean length of follow up was 12.4 years and objective cure rate was 93.7%. Whilst 18.7% of women complained of anatomical defects the majority of these were not detected until more than 5 years following surgery implying that long-term follow-up should be mandatory. A further study of 220 women with a mean follow-up of 18 months again gives similar results, 18 (8.2%) women complained of cystocele, 32 (14.5%) rectocele and 35 (15.9%) enterocele.113 From these studies it is clear that the incidence of urogenital prolapse, and in particular posterior compartment defects, increases following colposuspension. In view of these findings it is important to counsel women regarding outcome not only in terms of cure but also in respect to the need for further pelvic floor surgery.

Sexual dysfunction

By elevating the bladder neck and anterior vaginal wall a colposuspension may lead to the posterior vaginal being pulled forwards and upwards leading to a change in the vaginal angle causing dyspareunia.114 Post-operative sexual dysfunction has been described in 2–8% of women following continence surgery although there were no significant differences between procedures.45

Economic analysis Two studies have been reported comparing a cost analysis of colposuspension in comparison to both Tension Free Vaginal Tape (TVT) and laparoscopic colposuspension. As part of the UK colposuspension study a cost utility analysis was also performed. At 6 months follow up tension-free vaginal tape resulted in a mean cost saving of £243 when compared to colposuspension. Differential mean Quality Adjusted Life Years (QALYs) per patient (TVT – Colposuspension) was 0.01 (95% CI: -0.01–0.03). The probability of TVT being less costly than colposuspension was 100% whilst the probability of TVT being more cost effective was 94.6% if the willingness to pay threshold was £30 000 per additional QALY gain.115 A cost analysis comparing laparoscopic to open colposuspension was also performed alongside the UK laparoscopic

783 colposuspension study.116 Whilst laparoscopic surgery produced QALY gain there was an additional cost when compared to open colposuspension. Healthcare resource use over the first 6 month follow-up period translated into costs of £1805 for the laparoscopic group versus £1433 for the open group. At 6 months QALYs were slightly higher in the laparoscopic group relative to the open group. Therefore the cost of each extra QALY (incremental cost effectiveness ratio – ICER) was £74 000 at 6 months. At 24 months the laparoscopic arm also had a higher mean QALY score compared to the open group. Consequently the ICER was effectively reduced to £9 300 at 24 months.

Conclusions Retropubic Urethropexy remains a durable and efficacious surgical treatment for stress urinary incontinence in women. The description of Burch colposuspension in 1961 revolutionised the surgical approach to stress incontinence and rapidly replaced the Marshall-Marchetti-Krantz procedure. Almost 60 years later the available evidence demonstrates that open retropubic suspension is an effective treatment for the treatment of stress incontinence in both long and short term trials. Comparative studies have demonstrated that colposuspension is superior to anterior colporrhaphy and needle suspension procedures and is comparable to traditional sling procedures and laparoscopic colposuspension. The evidence from individual trials suggests that colposuspension is as effective as both retropubic and transobturator mid-urethral tape procedures although a recent meta-analysis has shown that overall cure rates (OR 0.61; 95% CI: 0.46–0.82; p = 0.00009) and objective cure rates (OR 0.38; 95% CI: 0.25–0.57; p < 0.0001) are lower for colposuspension when compared to mid urethral tapes.117 These findings are also supported by a recent Cochrane analysis of 34 trials including 3244 women which has also shown a higher cure rate with traditional midurethral slings when compared to colposuspension (OR 1.70; 95% CI: 1.22–2.37). In addition women were less likely to require redo surgery following a traditional sling procedure (RR 0.15; 95% CI: 0.05–0.42) and there were no significant differences in perioperative complications (RR1.24; 95% CI: 0.83–1.86).118 Colposuspension has also been shown to be a durable and long lasting procedure. A recent long-term study has reported outcome in 155 458 women over 10 years following surgery for stress urinary incontinence. The 9-year cumulative incidence of repeat surgery after all procedures was 14.5% (95% CI: 13.4–15.5), after sling procedures 13.0% (95% CI: 11.7–14.3) and colposuspension 10.8% (95% CI: 9.3–12.3). Overall the rate of repeat surgery was 28% higher for sling procedures when compared to colposuspension (adjusted HR 1.28; 95% CI: 1.19–1.37).119 In the 6th report of the International Consultation on Incontinence colposuspension continues to be recommended as an effective treatment for primary stress incontinence and, whilst superseded by the less invasive mid-urethral tapes it should still be considered for those women who are having a concomitant abdominal procedure.43 Consequently colposuspension still has a role in women having concomitant surgery such as abdominal hysterectomy, oophorectomy and open abdominal sacrocolpopexy. In addition colposuspension may offer an alternative to a mid-urethral tape procedure following urethral diverticulectomy or repair of a urethra-vaginal fistula where it may be preferable to avoid the interposition of a synthetic mesh.

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References







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28. Colombo M, Scalambrino S, Maggioni A, Milani R. Burch colposuspension versus modified Marshall – Marchetti – Krantz Urethropexy for primary genuine stress urinary incontinence: a prospective randomised trial. Am J Obstet Gynaecol 1994; 171: 1573–1579. 29. Liapis A, Pyrgiotis E, Kontorvadis A, Louridas C, Zourlas PA. Genuine stress incontinence: prospective randomised comparison of two operative methods. European J Obstetrics, Gynaecology and Reproductive Biology 1996; 64: 69–72. 30. Liapis AE, Asimiadis V, Loghis CD, Pyrgiotis E, Zourlas PA. A randomised prospective study of three operative methods for genuine stress incontinence. Journal of Gynaecologic Surgery 1996; 12: 7–14. 31. Lapitan MC, Cody DJ, Grant AM. Open retropubic colposuspension for urinary incontinence in women. Cochrane Database of Systematic Reviews 2005, Issue 3, Art. No. CD002912. DOI: 10.1002/14651858. 32. Quadri G, Magatti F, Belloni C, Barisani D, Natale N. Marshall-MarchettiKrantz Urethropexy and Burch colposuspension for stress urinary incontinence in women with low pressure and hypermobility of the urethra: early results of a prospective randomised clinical trial. Am J Obstet Gynaecol 1999; 181: 12–18. 33. McCrery RJ, Thompson PK. Outcomes of Urethropexy added to paravaginal defect repair: a randomised trial of Burch versus Marshall-MarchettiKrantz. Journal of Pelvic Medicine and Surgery 2005; 11: 137–143. 34. Wu JY, He HC, Chen SW, Jin XD, Zhou YX. Surgical therapies of female stress urinary incontinence: experience in 228 cases. Int Urogynaecol J 2010; 21: 645–649. 35. McDuffie RW, Litin RB, Blundon KE. Urethrovesival suspension (MarshallMarchetti-Krantz). Experience with 204 cases. Am J Surgery 1981; 141: 297–298. 36. Colombo M, Vitobello D, Proietti F, Arreghini A, Pasta F. Results and complications of the modified Marshall-Marchetti-Krantz procedure. Italian Journal of Obstetrics and Gynaecology 1998; 10: 91–96. 37. Czaplicki M, Dobronski P, Torz C, Borkowski A. Longterm subjective results of the Marshall-Marchetti-Krantz procedure. European Urology 1998; 34; 118–123. 38. Luna MT, Hirakawa T, Kamura T, Yahata H, Ogawa S, Sonoda T, Nakano H. Comparison of the anterior colporrhaphy procedure and the MarshallMarchetti-Krantz operation in the treatment of stress urinary incontinence among women. J Obstet Gynaecol Res 1999; 25: 255–260. 39. Heagarty PK, Power PC, O’Brien MF, Bredin HC. Longevity of the MarshallMarchetti-Krantz procedure. Annales Chirurgiae et Gynaecologiae 2001; 90:286–289. 40. Demirci F, Yildrim U, Demirci E, Ayas S, Arioglu P, Kuyumcuoglu U. Ten year results of Marshall-Marchetti-Krantz and anterior colporrhaphy procedures. Australian and New Zealand Journal of Obstetrics and Gynaecology 2002; 42: 513–514. 41. Rovner E, Athanasiou S, Choo MS, Cosson M, Dmochowski R, Gomelsky A, Gomes C, Monga A, Nager C, Ng R, Sand P, Tomoe H. Surgery for urinary incontinence in women. In Abrams P, Cardozo L, Wagg A, Wein A (eds.). Incontinence: WHO-ICUD International Consultation on Incontinence – 6th edition. 2017. ICS Publications 1741–854. 42. Jarvis GJ. Surgery for stress incontinence. Br J Obstet Gynaecol 1994; 101: 371–374. 43. Lentz SS. Osteitis pubis: a review. Obstet Gynaecol Surv 1995; 50: 310–315. 44. Lapitan MC, Cody JD, Mashayekhi A. Open retropubic colposuspension for urinary incontinence in women. Cochrane Database Syst Rev 2017; CD002912. 45. Dmochowski R, Athanasiou S, Reid FM, Kraus S, Nitti V, Gomelsky A, Robinson D, Smith ARB. Surgery for urinary incontinence in women. In Abrams P, Cardozo L, Khoury S, Wein A (eds.). Incontinence: WHO-ICUD International Consultation on Incontinence, 5th edition. 2013. Editions 21. Paris, France. 1307–1375. 46. Leach GE, Dmochowski RR, Appell RA et al. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol 1997; 158: 875–880. 47. Stanton SL, Williams JE, Ritchie B. The colposuspension operation for urinary incontinence. Br J Obstet Gynaecol 1976; 83: 890–895. 48. Milani R, Scalambrino S, Quadri G, Algeri M, Marchesin R. MarshallMarchetti-Krantz procedure and Burch colposuspension in the surgical treatment of female urinary incontinence. Br J Obstet Gynaecol 1985; 92:1050–1053. 49. Cardozo L, Cutner A. Surgical management of incontinence. Contemp Rev Obstet Gynaecol 1992; 4: 36–41. 50. Herbetsson G, Iosif CS. Surgical results and urodynamic studies 10 years after retropubic colpourethrocystopexy. Acta Obstet Gynaecol Scand 1993; 72:298–301.

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51. Feyereisl J, Dreher E, Haenggi W et al. Long term results after Burch colposuspension. Am J Obstet Gynaecol 1994; 171:647–652. 52. Alcalay M, Monga A, Stanton SL. Burch colposuspension: a 10–20 year follow up. Br J Obstet Gynaecol 1995; 102: 178–186. 53. Langer R, Lipshitz Y, Halperin R et al. Longterm (10–15 years) follow up after Burch colposuspension for urinary stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2001; 12: 323–326. 54. Stanton SL. Urethral sphincter incompetence. In Stanton SL (ed.). Clinical Gynaecologic Urology, St Louis, USA: C.V Moseby, 1984. p.169–192. 55. Galloway NTM, Davies N, Stephenson TP. The complications of colposuspension. Br J Urol 1987; 60: 122–124. 56. Stanton SL, Cardozo L. A comparison of vaginal and suprapubic surgery in the correction of incontinence due to urethral sphincter incompetence. Br J Urol 1979; 51: 497–499. 57. Cardozo L, Hextall A, Bailey J, Boos K. Colposuspension after previous failed continence surgery: a prospective observational study. Br J Obstet Gynaecol 1999; 106: 340–344. 58. Maher C, Dwyer P, Carey M et al. The Burch colposuspension for recurrent urinary stress incontinence following retropubic continence surgery. Br J Obstet Gynaecol 1999; 106: 719–724. 59. Bidmead J, Cardozo L, McLellan A, Khullar V, Kelleher C. A comparison of the objective and subjective outcomes of colposuspension for stress incontinence in women. Br J Obstet Gynaecol 2001; 108: 408–413. 60. Thakar R, Stanton S, Prodigalidad L, Den Boon J. Secondary colposuspension: results of a prospective study from a tertiary referral centre. Br J Obstet Gynaecol 2002; 109: 1115–1120. 61. Bergman A, Ballard CA, Koonings PP. Comparison of three different surgical procedures for genuine stress incontinence; prospective randomised study. Am J Obstet Gynaecol 1989; 160: 1102–1106. 62. Bergman A, Koonings PP, Ballard CA. Primary stress urinary incontinence and pelvic relaxation: Prospective randomised comparison of three different operations. Am J Obstet Gynaecol 1989; 161: 97–101. 63. Bergman A, Elia G. Three surgical procedures for genuine stress incontinence: five year follow up of a prospective randomised study. Am J Obstet Gynaecol 1995; 173: 66–71. 64. Black NA, Downs SH. The effectiveness of surgery for stress incontinence in women: a systematic review. Br J Urol 1996; 78: 497–510. 65. Liapis A, Pyrgiotis E, Kontorvadis A, Louridas C, Zourlas PA. Genuine stress incontinence: prospective randomised comparison of two operative methods. European J Obstet Gynaecol Repro Bio 1996; 64: 69–72. 66. Liapis AE, Asimaidis V, Loghis CD, Pyrgiotis E, Zourlas PA. A randomised prospective study of three operative methods for genuine stress incontinence. J Gynaecologic Surgery 1996; 12: 7–14. 67. Kammerer-Doak DN, Dorin MH, Rogers RG et al. A randomised trial of Burch retropubic Urethropexy and anterior colporrhaphy for stress urinary incontinence. Obstet Gyanecol 1999; 93: 75–78. 68. Colombo M, Vitobello D, Proietti F et al. Randomised comparison of Burch colposuspension versus anterior colporrhaphy in women with stress urinary incontinence and anterior vaginal wall prolapse. Br J Obstet Gyancol 2000; 107: 544–551. 69. Colombo M, Vitobello D, Proietti F, Arreghini A, Pasta F. Results and complications of the modified Marshall-Marchetti-Krantz procedure. Ital J Gynaecol Obstet 1998; 10: 91–96. 70. Colombo M, Milani R, Vitobello D, Maggioni A. A randomised comparison of Burch Colposuspension and abdominal paravaginal defect repair for female stress urinary incontinence. Am J Obstet Gynaecol 1996; 175: 78–84. 71. Mundy AR. A trial comparing the Stamey bladder neck suspension procedure with colposuspension for the treatment of stress incontinence. Br J Urol 1983; 55: 687–690. 72. Klute JJ, Klute CG, Bergman J, Elia G. Bladder neck suspension for stress urinary incontinence: how does it work? Neuro Urol Urodyn 1999; 18: 623–627. 73. German KA, Kynaston H, Weight S, Stephenson TP. A prospective randomised trial comparing a modified needle suspension procedure with the vaginal/obturator shelf procedure for genuine stress incontinence. Br J Urol 1994; 74: 188–190. 74. Athanassopoulos A, Barbalias G. Burch colposuspension versus Stamey endoscopic bladder neck suspension: a urodynamic appraisal. Urol Int; 1996: 56: 23–27. 75. Gilja I, Pushkar D, Mazuran B, Radej M. Comparative analysis of bladder neck suspension using Raz, Burch and transvaginal Burch procedures. A 3-year randomised prospective study. Eur Urol 1998; 33: 298–302. 76. Enzelsberger H, Helmer H, Schatten C. Comparison of Burch and lyodura sling procedures for repair of unsuccessful incontinence surgery. Obstet Gynaecol 1996; 88: 251–256.

785 77. Sand PK, Winkler H, Blackhurst DW, Culligan PJ. A prospective randomised study comparing modified Burch retropubic Urethropexy and suburethral sling for treatment of genuine stress incontinence with low pressure urethra. Am J Obstet Gynaecol 2000; 182: 30–34. 78. Culligan PJ, Goldberg RP, Sand PK. A randomised controlled trial comparing a modified Burch procedure and a suburethral sling: long term follow up. Int Urogynaecol J Pelvic Floor Dysfunct 2003; 14: 229–223. 79. Demirci F, Yucel O. Comparison of Pubovaginal sling and burch colposuspension procedures in type I/II genuine stress incontinence. Arch Gynaecol Obstet 2001; 265: 190–194. 80. Bai SW, Sohn WH, Chung DJ, Park JH, Kim SK. Comparison of the efficacy of Burch colposuspension, Pubovaginal sling and tension free vaginal tape for stress urinary incontinence. Int J Gyanecol Obstet 2005; 91: 246–251. 81. Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007;356(21):2143–2155. 82. Ward KL, Hilton P. On behalf of the UK and Ireland TVT Trial Group. Prospective multicentre randomised trial of tension free vaginal tape and colposuspension as a primary treatment for stress incontinence. Br Med J 2002; 325: 67–70. 83. Ward KL, Hilton P. On behalf of the UK and Ireland TVT Trial Group. A prospective multicentre randomised trial of tension free vaginal tape and colposuspension for primary urodynamic stress incontinence: two year follow up. Am J Obstet Gynaecol 2004; 190: 324–331. 84. Ward KL, Hilton P. On behalf of the UK and Ireland TVT Trial Group. Tension free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5 year follow up. BJOG 2008; 115: 226–233. 85. Liapis A, Bakas P, Creatsas G. Burch colposuspension and tension free vaginal tape in the management of stress urinary incontinence in women. European Urology 2002; 41:469–473. 86. Wang AC, Chen MC. Comparison of tension free vaginal taping versus modified Burch colposuspension on urethral obstruction: a randomised controlled trial. Neurourol Urodynam 2003; 22: 185–190. 87. El-Barky E, El-Shazly A, El-Wahab OA, Kehinde EO, Al-Hunayan A, Al-Awadi KA. Tension free vaginal tape versus Burch colposuspension for treatment of female stress urinary incontinence. Int Urology and Nephrology 2005; 37: 277–281. 88. McCracken GR, Henderson NA, Ashe RG. Five year follow up comparing tension free vaginal tape and colposuspension. Ulster Med J 2007; 76: 146–149. 89. Tellez Martinez-Fornes M, Fernandez Perez C, Fouz Lopez C, Fernandez Lucas C, Borrego Herando J. A three year follow up of a prospective open randomised trial to compare tension free vaginal tape with Burch Colposuspension for treatment of female stress urinary incontinence. Actas Urol Esp 2009; 33: 1088–1096. 90. Sivaslioglu AA, Caliskan E, Dolen I, Haberal A. A randomised comparison of transobturator tape and Burch colposuspension in the treatment of female stress urinary incontinence. Int Urogynaecol J Pelvic Floor Dysfunct 2007; 18: 1015–1019. 91. Bandarian M, Ghanbari Z, Asgari A. Comparison of transobturator tape (TOT) vs Burch method in treatment of stress urinary incontinence. J Obstet Gynaecol 2011; 518–520. 92. Freites J, Stewart F, Omar M, Mashayekhi A, Agur W. Laparoscopic colposuspension for urinary incontinence in women. Cochrane Database Syst Rev 2019; 12(12) CD002239. DOI: 10.1002/14651858. CD002239.pub4 93. Burton G. A five year prospective randomised urodynamic study comparing open and laparoscopic colposuspension. Neurourol Urodynam 1999; 18: 295–296. 94. Morris A, Reilly E, Hassan A, Ramsay I, Hawthorn R. 5-7 year followup of a randomised trial comparing laparoscopic colposuspension and open colposuspension in the treatment of genuine stress incontinence. Int Urogynaecol J Pelvic Floor Dysfunct 2001; 12: s6. 95. Kenton K, Oldham L, Brubaker L. Open Burch Urethropexy has a low rate of perioperative complications. Am J Obstet Gynaecol 2002; 187: 107–110. 96. Cosson M, Boukerrou M, Narducci F et al. Long term results of the Burch procedure combined with abdominal sacrocolpopexy for treatment of vault prolapse. Int Urogynecol J Pelvic Floor Dysfunct 2003; 14: 104–107. 97. Harris RL, Cundiff GW, Theofrastous JP. The value of intraoperative cystoscopy in urogynaecologic and reconstructive pelvic surgery. Am J Obstet Gynaecol 1997; 177: 1367–1371.

786 98. Su TH, Wang KG. Hsu CY, Wei HJ, Hong BK. Prospective comparison of laparoscopic and traditional colposuspensions in the treatment of genuine stress incontinence. Acta Obstet Gynaecol Scand 1997; 76: 576–582. 99. Fatthy H, El Hao M, Samaha I, Abdallah K. Modified Burch colposuspension: laparoscopy versus laparotomy. J Am Assoc Gynaecol Laparosc 2001; 8: 99–106. 100. Cheon WC, Mak JH, Liu JY, Mak JHL, Liu JYS. Prospective randomised controlled trial comparing laparoscopic and open ccolposuspension. Hong Kong Med J 2003; 9: 10–14. 101. Ankardal M, Milsom I, Stjerndahl JH, Engh ME. A three-armed randomised trial comparing open Burch colposuspension using sutures with laparoscopic using sutures and laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence. Acta Obstet Gynaecol Scand 2005; 84: 773–779. 102. Usten Y, Engin-Ustin Y, Gungor M, Tezcan S. Randomised comparison of Burch urethropexy procedures concomitant with gynaecologic operations. Gynecologic and Obstetric Investigation 2005; 59: 19–23. 103. Kitchener HC, Dunn G, Lawton V, Reid F, Nelson L, Smith ARB on behalf of the COLPO study group. Laparoscopic versus open colposuspensionresults of a prospective randomised controlled trial. BJOG 2006; 113: 1007–1013. 104. Carey MP, Goh JT, Rosamilia A, Cornish A, Gordon I, Hawthorne G, Maher CF, Dwyer PL, Moran P, Gilmour DT. Laparoscopic versus open Burch colposuspension: a randomised controlled trial. BJOG 2006; 113: 999–1006. 105. Cardozo L, Stanton SL, Williams JE. Detrusor instability following surgery for genuine stress incontinence. Br J Urology 1979; 58: 138–142. 106. Weil A, Reyes H, Bischoff P, Rottenburg RD, Krauer F. Modifications of urethral rest and stress profiles after three different types of surgery for urinary stress incontinence. Br J Obstet Gynaecol 1984; 91: 46–55. 107. McGuire EJ, Lytton B, Kohorn GI, Pepe V. The value of urodynamic testing in stress urinary incontinence. J Urol 1979; 124: 256–258. 108. Robinson D, Khullar V, Cardozo L. Assessing Surgical Outcome: Urethral Function Revisited. Neurourol Urodyn 2005; 24: 512–514.

Textbook of Female Urology and Urogynecology 109. Dundas D, Hilton P, Williams JE, Stanton SL. Aetiology of voiding difficulty following colposuspension. Proceedings of the 12th Meeting of the International Continence Society, Leiden, Netherlands. 1982. p.132 110. Wiskind AK, Creighton SM, Stanton SL. Am J Obstet Gynaecol 1992; 167(2): 399–404. 111. Kiilholma P, Makinen J, Chancellor MB, Pitkanen Y, Hirvonen T. Modified Burch colposuspension for stress urinary incontinence in females. Surg Gynaecol Obstet 1993; 176 (2): 111–115. 112. Flores Rosas S, Flores Carreras O, Cabrera Jacome R. Posterior genital prolapse following the Burch method of colpsuspension. Ginecol Obstet Mex 1999; 67: 497–502. 113. Demirci F, Yucel O, Eren S, Alkan A, Demirci E, Yildirium U. Long-term results of Burch colposuspension. Gynaecol Obstet Invest 2001; 51(4): 243–247. 114. Poad D, Arnold EP. Sexual function after pelvic surgery in women. Aust N Z J Obstet Gynaecol 1994; 34: 471–474. 115. Manca A, Sculpher MJ, Ward K, Hilton P. A cost utility analysis of tension free vaginal tape versus colposuspension for primary urodynamic stress incontinence. BJOG 2003; 110: 255–262. 116. Dumville JC, Manca A, Kitchener HC, Smith ARB, Nelson L, Torgerson DJ, on behalf of the COLPO study group. Cost effectiveness analysis of open colposuspension versus laparoscopic colposuspension in the treatment of urodynamic stress incontinence. BJOG 2006; 113: 1014–1022. 117. Novara G, Artibani W, Barber MD, Chapple CR, Constantini E, Ficarra V, Hilton P, Nilsson CG, Waltregny D. Updated systematic review and metaanalysis of the comparative data on colposuspensions, pubovaginal slings, and mid-urethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol 2010; 58: 218–238. 118. Saraswat L, Rehman H, Omar MCody JD, Aluko P, Glazener C. Traditional sling operations for urinary incontinence in women. Cochrane Database Syst Rev 2020. Doi: 10.1002/14651858.CD001754.pub5. 119. Jonsson Funk M, Siddiqui NY, Kawasaki A, Wu JM. Long-term outcomes after stress urinary incontinenc surgery. Obstet Gynaecol 2012; 120:83–90.

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FASCIAL SLINGS Elizabeth A. Rourke, W. Stuart Reynolds, Aaron Brothers, David James Osborn, Roger R. Dmochowski, and Melissa R. Kaufman

Introduction Early after inception, pubovaginal bladder neck slings (PVSs) were primarily reserved for the treatment of refractory stress urinary incontinence (SUI). However, owing to an improved understanding of SUI pathophysiology and the introduction of several technological advancements, the PVS has become the surgical gold standard for women who suffer from both uncomplicated and complicated SUI. The ideal material for construction of a pubovaginal sling is sterile, biocompatible, noncarcinogenic, and consistent in quality. In the literature, several allograft, xenograft, and synthetic materials meeting these criteria have been studied. Allograft and xenograft materials are no longer commonly employed for pubovaginal slings because of questions regarding durability and cost. Most synthetic materials are composed of polypropylene mesh. While synthetic meshes are certainly durable, they do carry the potential drawbacks of higher rates of graft infection, urinary tract perforation, and vaginal exposure. Outcomes data have shown that synthetic pubovaginal slings are 15 times more likely to perforate into the urethra (0.02%) and are exposed 14 times more often in the vagina (0.007%) compared to autologous slings [1, 2]. For these reasons and others, autologous fascial slings remain the material of choice and their use and outcomes will be the focus of this chapter.

Pathophysiology of stress urinary incontinence Female continence depends on complex interactions between urethral and bladder neck support, intrinsic urethral properties, the urethral sphincter mechanism, and pelvic floor musculature. In 1990, Petros and Ulmsten proposed a unifying concept termed the integral theory [3]. The integral theory stated that the most important factors for preserving continence were adequate function of the pubourethral ligaments, the suburethral vaginal hammock, and the pubococcygeus muscle. The authors postulated that injury to any of these three components from surgery, parturition, aging, or hormonal deprivation could lead to impaired midurethral function and subsequently urinary incontinence. Dynamic ultrasound studies have shown that stress maneuvers can cause the posterior wall of the urethra to slide away from the anterior urethral wall and allow for opening of the bladder neck and proximal urethra (funneling), resulting in the loss of urine [4]. The goal of a PVS is to provide adequate urethral coaptation (without causing obstruction, ischemia, and erosion from unnecessary tension) and to increase urethral responsiveness to abdominal pressure such that leakage is avoided during stress maneuvers.

DOI: 10.1201/9781003144243-79

Pubovaginal sling operative procedure Preoperative considerations

A comprehensive history and a physical examination including a focused neurourologic exam and pelvic exam should be performed on all patients to properly characterize the nature of their incontinence and to identify all aspects of pelvic support. While not all elements of vaginal prolapse require repair, consideration must be given to addressing prolapse at or distal to the hymenal ring, or symptomatic prolapse of a lesser degree. Doing so may allow counseling regarding the possibility of postoperative SUI, urinary retention, or worsening future prolapse. An in-office cough stress test, either supine or standing, should also be performed on all patients to confirm the diagnosis. According to the AUA Guideline for the Surgical Management of SUI, additional testing should also include a postvoid residual (PVR) measurement and a urinalysis [5]. Some clinicians may also find quantitative measurement of urethral hypermobility and a voiding diary helpful. A cystoscopy or upper tract imaging for women is not routinely recommended for assessment of uncomplicated SUI. In addition, urodynamics are not required for the evaluation of primary SUI; however, they may be helpful in cases of mixed urinary incontinence, concomitant pelvic prolapse, incomplete emptying, neurogenic dysfunction, prior surgical failures, and when the diagnosis of SUI is in doubt. A preoperative bowel preparation is not needed unless a concomitant hysterectomy, vaginal vault suspension, or posterior compartment surgery is planned. Preemptive perioperative clean intermittent catheterization (CIC) training for patients deemed at an elevated risk of postoperative retention may decrease emergency department visits and postoperative indwelling catheters. As with any surgical intervention, a thorough discussion of the risks, benefits, and alternative therapies should be undertaken. Intraoperative risks include bleeding (with potential for transfusion); injury to the bladder, urethra, or bowel; with subsequent symptomatic hematoma formation, need for prolonged catheterization, or need for further surgical interventions. Postoperative risks include transient or permanent voiding dysfunction (possibly requiring urethrolysis or sling incision), worsening or de novo storage or obstructive symptoms, urinary tract infections (UTIs), or in the case of synthetic materials, vaginal sling exposure or erosion. For autologous slings, harvest site complications include seroma formation, wound infection, hematoma, and incisional hernia formation. Fascial slings may be harvested from the rectus fascia or fascia lata and therefore certain patient features including preexisting issues with ambulation, prior abdominal incisions, or previous abdominal mesh should be considered in harvest site selection. As with all surgical procedures, preoperative discussion should also include mention the rare but serious risks of cardiovascular, pulmonary, and thromboembolic events. In the authors’ opinion, sequential compression devices should 787

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788 be placed on the bilateral lower extremities prior to the induction of anesthesia. According to the AUA Best Practice Policy Statement for the Prevention of Deep Venous Thrombosis in Patients Undergoing Urologic Surgery, consideration for the use of low-dose unfractionated heparin or low-molecular-weight heparin should be based on individual patient and procedural risk factors [6].

(FL) may be used. After draping, a weighted speculum is placed in the vagina. At this juncture we advocate performing cystoscopy to set a baseline for any potential urethral or bladder issues which may impact evaluation after trocar passage. Following baseline cystoscopy, an 16-18 F balloon catheter is inserted into the urethra and placed to continuous gravity drainage.

Patient positioning and preparation

Fascial harvest

PVS surgery can be performed under spinal or general anesthesia. Prior to the start of the procedure, patients should receive a single dose of one of the following: a first- or second-generation cephalosporin, aztreonam (in cases of renal insufficiency), an aminoglycoside plus metronidazole, or clindamycin [7]. The patient is then positioned in a slightly exaggerated dorsal lithotomy position. The abdomen just above the umbilicus is prepped with a chlorhexidine gluconate solution and the vagina is prepped with povidoneiodine. The thigh is also widely prepped if autologous fascia lata

A Pfannenstiel incision is created approximately 2 cm above the pubic symphysis, providing excellent exposure and cosmesis. In women with a history of prior surgery, the preexisting skin incision can also be used. Electrocautery is used to carry the incision down to the rectus fascia (RF). A strip of RF measuring approximately 2 cm by 7 cm is then excised at least 2 cm from the pubic symphysis to help ensure a tension-free fascial closure. This is illustrated in Figure 72.1. A No. 1 polydioxanone (PDS) or 1–0 polypropylene suture is secured to each end of the graft and

 

  FIGURE 72.1  (a) Site of incision. (b), (c) The rectus fascia graft is harvested and (d) attached to 2–0 polypropylene sutures. The defect in the rectus fascia is closed while the skin and Scarpa’s fascia are left open. (1(a), 1(c), reproduced from Blaivas JG and Chaikin D, Pubovaginal fascial sling for the treatment of all types of stress urinary incontinence: surgical treatment and long-term outcome, in Cardozo L and Staskin D, eds., Textbook of Female Urology and Urogynecology, 2nd ed., Informa, London, U.K., 2006. With permission.)

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left long to be used during passage of the sling. The fascial edges are scored with cut cautery and elevated off the rectus muscle. The graft is then soaked in a 0.9% normal saline solution and the overlying fat and perifascial tissue is cleaned off. The fascial defect is closed with continuous or interrupted #1 PDS. The skin and Scarpa’s layer are left open for passage of sling sutures later in the procedure. In cases where FL is being harvested with a Crawford fascial stripper, an initial 3 cm longitudinal incision is made above the patella over the iliotibial band. This dissection is carried down to the level of the FL, where two parallel, longitudinal incisions are made, approximately 2 cm apart. The graft is then bluntly separated from the underlying muscle and transected as far distally as possible. This free end is then secured with a No. 1 PDS suture as described for the RF graft. This distal FL is then completely freed from any adipose tissue and muscle fibers before a Crawford fascial stripper is used to extend the fascial incision proximally up to 20 cm. The proximal flap is transected and another No. 1 PDS is secured to the free end. If a Crawford fascial stripper is not available or not preferred, the FL may be harvested through an approximately 7 cm incision on the lateral aspect of the thigh overlying the IT band. Dissection is carried down through skin and Scarpas until the fascial is encountered. A 7cm × 2cm graft is marked and elevated off the muscle on cut cautery. The free ends are secured with No. 1 PDS suture as described above. The flap is then stored in 0.9% normal saline until needed. Immediate compression should be applied to the thigh to constrict perforating vessels. Once hemostasis is ensured, the thigh wound is closed in three layers without closing the FL. A compressive wrap is then placed for 8 hours postoperatively and early ambulation is encouraged [8].

Vaginal dissection

If no concomitant anterior prolapse surgery is planned, an inverted U-shaped incision is made in the vaginal epithelium after injection of 0.9% sterile normal saline for hydrodissection with the apex of the U based at the mid-urethra and the widely spaced legs of the U extending just proximal to the bladder neck. Alternatively, a vertical midline incision can be made if concomitant anterior or apical compartment surgery is planned. The vaginal mucosa is then dissected sharply off the underlying surface of the pubocervical and periurethral fascia, with lateral dissection proceeding up to the inferior edge of the pubic symphysis. The vaginal flaps are retracted with help of a vaginal ring retractor. To prevent inadvertent bladder injury, bladder drainage is ensured prior to perforation of the endopelvic fascia with Metzenbaum scissors. The space of Retzius is then entered. The scissors should be aimed at the ipsilateral shoulder and remain just inferior to the ischiopubic ramus. This is illustrated in Figure 72.2. Once the endopelvic fascia is perforated, periurethral adhesions in the retropubic space are released manually (Fig. 72.3). With this dissection, the infrapubic and retropubic dissection planes are now connected. During this step, it is important to ensure that the retropubic space is fully opened. The posterior surface of the pubic symphysis should be easily palpable with very little intervening tissue.

Sling placement and fixation

If not already done, bladder drainage is again ensured. A finger in the retropubic space is then used to carefully guide suture passage needles from the abdominal incision into the vaginal

FIGURE 72.2  (a) A midline or inverted-U incision is made and vaginal flap developed. (b) After incising the vaginal mucosa in a midline or inverted-U incision, the endopelvic fascia is perforated with Metzenbaum scissors aimed at the ipsilateral shoulder. (c) The retropubic space is entered. (2b, Reproduced from Blaivas JG and Chaikin D, Pubovaginal fascial sling for the treatment of all types of stress urinary incontinence: surgical treatment and long-term outcome, in Cardozo L and Staskin D, eds., Textbook of Female Urology and Urogynecology, Informa, London, U.K., 2006. With permission.)

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Index finger between clamp, urethra, and bladder at all times

FIGURE 72.3  Once the endopelvic fascia is perforated sharply, manual dissection with the index finger is performed to release any adhesions and develop the retropubic space. (Reproduced from Blaivas JG and Chaikin D, Pubovaginal fascial sling for the treatment of all types of stress urinary incontinence: surgical treatment and long-term outcome, in Cardozo L and Staskin D, eds., Textbook of Female Urology and Urogynecology, Informa, London, U.K., 2006. With permission.)

incision on either side of the urethra (Fig. 72.4). The needles should pass directly behind the pubic symphysis approximately 2 cm from midline on each side to avoid bladder perforation. Cystoscopy with both a 30° and a 70° lens is then performed to diagnose inadvertent bladder perforation. Indigo carmine or fluorescein is given intravenously to document ureteral integrity via efflux bilaterally. If bladder perforation is identified, the needle can be repositioned to the appropriate space and the surgery can proceed. The graft sutures are then passed into the needle eyelets and brought out through the abdominal incision and tagged with clamps. The midportion of the sling is positioned over the bladder neck and the distal aspect is sutured to the periurethral tissue with two simple 4-0 polyglactin sutures. The vaginal incision is then closed with running 2-0 polyglactin sutures prior to tensioning of sling Alternatively, the vaginal incision may be closed following tensioning in order to observe the bladder neck and prevent hypersuspension by the sling [9].

Adjusting sling tension and abdominal wound closure

Sling tension is then set from the abdominal incision. The weighted speculum should be removed prior to sling tensioning. The sling PDS sutures are tied above the RF to their contralateral partner while cystoscopy with a 30° lens is performed to visualize adequate coaptation of the proximal urethra. Typically, the sling is tensioned very loosely over the RF with a two-fingerbreadth

FIGURE 72.4  A tonsil-tip clamp or double-headed needle is passed from the abdominal incision, through the rectus fascia, and into the vaginal incision on either side of the urethra. Care is taken to stay just behind the posterior aspect of the pubic symphysis. The index finger of the nonpassing hand guides the clamp from below. (Reproduced from Blaivas JG and Chaikin D, Pubovaginal fascial sling for the treatment of all types of stress urinary incontinence: surgical treatment and long-term outcome, in Cardozo L and Staskin D, eds., Textbook of Female Urology and Urogynecology, Informa, London, U.K., 2006. With permission.)

width distance between the RF and the PDS knot (Fig. 72.5). Before tying a 3rd knot, a cystoscope sheath is passed into the bladder to ensure that there is no obstruction. Appropriate tension of sling may be demonstrated by an indentation in the floor of the bladder neck/proxima urethra however currently there is no standard method of tensioning and the procedure remains subjective [10]. If significant resistance is encountered, the two knots can be undone and the tension adjusted until the sheath passes without obstruction. Preece et al. has suggested a sling height of 40–60 mm above the RF as the ideal range to maintain continence while preventing postoperative urinary retention [9]. Once the sling is correctly tensioned, Scarpa’s fascia is reapproximated with an interrupted 3-0 absorbable suture. The skin is closed with a subcuticular 4-0 absorbable suture and the vagina is carefully packed with gauze impregnated with conjugated estrogen cream (or saline or povidone-iodine-soaked gauze in premenopausal women). The urethral catheter is left to gravity drainage.

Postoperative care

Patients are generally admitted for overnight observation. The vaginal packing is removed on postoperative day 1 (POD#1) and the urethral catheter is removed when the patient is out of bed

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791 Tie loosely with no tension

FIGURE 72.5  After the vaginal incision is closed, sling sutures are tied across the rectus fascia without tension. Typically, an assistant places two fingers between the suture knot and the rectus fascia to ensure tension-free placement. (Reproduced from Blaivas JG and Chaikin D, Pubovaginal fascial sling for the treatment of all types of stress urinary incontinence: surgical treatment and long-term outcome, in Cardozo L and Staskin D, eds., Textbook of Female Urology and Urogynecology, Informa, London, U.K., 2006. With permission.)

and ambulating (usually POD#1). The patient is typically discharged home without a catheter unless she is unable to void or has elevated PVR>150 mL. In this case, she will return to clinic in approximately 5 days for a repeat voiding trial. Alternatively, patients can perform CIC until voiding improves and PVRs are reduced. Some authors recommend leaving a catheter to drainage for at least 48 hours if the bladder was perforated during needle passage. All patients are instructed not to lift objects heavier than 3 kg for 6 weeks. Vaginal intercourse is also avoided for at least 6 weeks and not resumed before follow-up physical examination by the surgeon. Frequent ambulation is encouraged, but again strenuous activity is to be avoided for 6 weeks. Follow-up visits are typically at 2 weeks, 6 weeks, 6 months, and annually thereafter.

Outcomes of autologous PVS surgery Outcomes data for the use of autologous RF and FL as PVS slings are robust. In the earliest modern-day study from 1978, McGuire reported an overall success rate of 80% [11]. Since then, several retrospective studies with long-term follow-up (>48 months) have documented cure rates of 72.9–94% [12–14]. In 1997, Cross et al. published a retrospective analysis of 150 patients who underwent PVS for urinary incontinence [15]. In their study, 98% of patients had predominantly SUI and 93% of all patients were cured of their incontinence based on the results of in-office questionnaires and telephone interviews. In one study with 7.1 years

of mean follow-up of 153 patients, 71.7% were continent and only 3.3% required reoperation for SUI [16]. When comparing synthetic mid-urethral slings (SMUS) to autologous fascial PVS (AFPVS), meta-analyses have demonstrated equivalent improvement in SUI [17, 18]. Additionally a meta-analysis by Blaivas et al suggested superior results for AFPVS as compared to SMUS reporting higher rates of erosion, pelvic pain and de novo overactive bladder in those undergoing SMUS. These studies have demonstrated higher risk of wound infection with AFPVS [19, 20]. Studies comparing RF verses FL for use in PVSs have found comparable success rates between the two techniques. Beck et al. noted a 92.4% cure rate measured by absence of leakage on a postoperative cough test in 170 patients who underwent an FL PVS [21]. Similarly, Latini et al. reported that 83% of respondents who had undergone an FL PVS indicated that the procedure had a positive effect on their life, 82% would recommend the surgery to a friend, and 83% would undergo the procedure again [22]. They also noted that 20% of patients who had undergone an FL PVS reported localized numbness, 7% had pain, and 5% had tendonitis at the harvest site 1-week postoperatively. While the results of these and numerous other studies that document the effectiveness of PVS surgery are encouraging, it is important to note that comparing cure rates between various studies is challenging due to variations in the definition of success, outcome criteria, length of follow-up, inclusion and exclusion criteria, incidence of concomitant surgery, and reporting of perioperative complications. The PVS has also been shown to be an effective treatment for recurrent SUI after a failed corrective surgery. In a retrospective study from 2001, Richter et al. found that rates of postoperative voiding dysfunction were similar in patients getting their first anti-incontinence surgery and in patients who had undergone a previous retropubic suspension (46%) or needle suspension (24%) [23]. Interestingly, 88% of patients in that study felt that the sling improved their quality of life and 82% stated that they would undergo the surgery again; however, 11.8% of patients did require long-term CIC for persistent retention. In another study, Athanasopoulos et al. described outcomes in patients who had failed treatment with a midurethral sling. In this study, 29.9% of the 264 patients had a previously placed midurethral sling that was partially removed at the time of PVS surgery [24]. The overall success rate in terms of markedly improved or cured incontinence in the study was 84.7%. Lastly, in a more recent report by Lee et al., the authors found no difference in outcomes between 36 patients undergoing a primary PVS and 48 patients undergoing a secondary (history of previous major incontinence surgery) PVS procedure [25]. They reported a 76% success rate after a primary PVS procedure and a 69% success rate after a secondary PVS procedure. In summary, PVS surgery demonstrated high success rates in a variety of different types of patients. Autologous pubovaginal slings also serve an important role during urethral reconstruction surgeries and are the preferred option in such situations according to AUA Guidelines. An autologous PVS provides excellent support to the urethra and decreases persistent or de novo SUI after urethral diverticulectomy surgery. Multiple studies that have shown excellent results pertaining to continence and diverticula recurrence after concomitant autologous PVS and urethral diverticulectomy [26–28]. Other authors have published excellent results in terms of continence and spontaneous voiding after using an autologous PVS in conjunction with repair of even more complex urethral damage

792 from etiologies such as protracted obstetrical deliveries, failed anti-incontinence surgeries, aggressive transurethral resections of the bladder neck, long-term indwelling urethral catheters, pelvic trauma, tumors, and radiation [29, 30].

Complications of autologous PVS surgery Typically, complications after PVS surgery may be effectively grouped by their temporal relationship to the procedure itself. Acute major global perioperative complications such as myocardial infarction, pulmonary embolism, deep vein thrombosis, and death are exceedingly rare [12, 21, 31–33]. Wound complications such as hematoma, seroma, and hernia formation have been observed in up to 15% of women undergoing an RF sling [34, 35]. Thigh wound complications such as hematoma (14%), seroma (4%), and persistent leg pain (3%) have also been reported in patients after fascia lata harvest [21, 34, 36]. Peng et al demonstrated a higher risk of wound complications (29.4% of postop complications for RF) with RF as compared to FL while achieving the same functional outcomes in regard to postoperative improvement in SUI [37]. Incisional hernias occur at a rate of 0.8–1% [12, 38]. While several cases of urethral erosion have been reported after autologous PVS surgery, these are most likely a result of overly aggressive periurethral dissection or placement of the sling under excessive tension [39–43]. The most common non-urologic complications from PVS surgery are pulmonary, cardiovascular, neurologic, and gastrointestinal (bowel injury). In 2007, Anger et al. analyzed Medicare claims data for short-term complications after sling (all types) surgery among female beneficiaries aged 65 and older [44]. A total of 1365 sling procedures were included in the analysis. The authors found that 12.5% of women developed surgical or urologic complications in the 3 months after the procedure and 33.6% had a diagnosed UTI. Within the 1-year follow-up period, 6.6% of claims were for bowel injury or obstruction, 9.1% cardiac, 2.6% thromboembolic, 15.3% pulmonary, and 22.1% others. An overall death rate of approximately 3 per 10,000 procedures has been estimated for all SUI procedures (retropubic suspension, transvaginal suspensions, anterior repairs, and PVS) [5]. Voiding dysfunction secondary to bladder outlet obstruction after PVS surgery is often related to detrusor overactivity and impaired detrusor contractility and is often the most concerning complication following PVS. However, iatrogenic obstruction is also a common cause of postoperative voiding dysfunction and is usually the result of overtightening of the sling that results in hypersuspension of the urethrovesical angle. Transient urinary retention is common after PVS surgery and most patients return to spontaneous voiding with the first 10 days postoperatively [45, 46]. The reported incidence of voiding dysfunction after PVS ranges from 2.5% to 35% [47–50]. Kochakarn and Leenanupunth noted that 39% of their patients performed CIC for a mean of 8.9 weeks [51], while Govier et al. noted that women in their study performed CIC for a mean of 3.3 weeks after PVS surgery [52]. In their study, Beck et al. observed postoperative voiding dysfunction for a mean of 2 months after surgery [21]. Additionally, Karram and Bhatia noted that the mean time to spontaneous voiding for women in their study was 20 days [53]. A meta-analysis by the AUA Stress Urinary Incontinence Clinical Guidelines Panel in 1997 reported that the incidence of urinary retention more than 4 weeks after pubovaginal sling placement was 8% and the risk of permanent retention usually does not exceed 5% [2]. Blaivas et al performed 4 large series of APVS outcomes over

Textbook of Female Urology and Urogynecology 15 years and found that less than 1% of patients required surgery or catheterization for urethral obstruction [54]. Preoperative voiding dysfunction has been shown to affect a patient’s ability to empty after anti-incontinence surgery, and therefore it is important to identify this problem during the initial history and physical examination. Preoperative urodynamic studies may be helpful in identifying patients who mount a low detrusor pressure and rely on valsalva for voiding. Such patients are not strictly excluded from having anti-incontinence surgery but should be counseled on the higher risk of postoperative obstruction and the possible need for long-term CIC. Mitsui et al. found that patients with a PVR greater than 100 mL (p = 0.05) or Qmax of less than or equal to 20 mL/s (p = 0.09) during preoperative urodynamics were more likely to require prolonged CIC (28% of patients required CIC for 4–40 months) [55]. Furthermore, the AUA clinical guidelines on stress urinary incontinence reported persistence of preoperative urge urinary incontinence in onethird of patient’s undergoing PVS [56]. Postoperatively, patients with voiding dysfunction can present with frank urinary retention, subtle irritative symptoms, or urgency incontinence. Recurrent UTIs may also be indicative of obstruction in the otherwise asymptomatic patients. Although no clear cutoff values for obstruction exist, the PVR volume is very important in the evaluation of voiding dysfunction and should be measured in spontaneously voiding patients prior to their discharge from the hospital [57]. Persistent urinary retention that is not addressed in the postoperative period can potentiate long-term bladder dysfunction. Because postoperative obstruction following autologous PVS usually improves or resolves with time, it is appropriate and effective to initially treat persistent voiding dysfunction conservatively (CIC, indwelling catheter, timed voiding, double voiding, biofeedback, pelvic floor muscle training, and anticholinergic therapy). Most physicians advocate waiting 3 months prior to considering repeat surgical intervention for persistent obstructive symptoms.

Surgical management of voiding dysfunction after PVS surgery Surgical management of bladder outlet obstruction following a PVS traditionally involves a complete urethrolysis by a retropubic, transvaginal, or suprameatal approach. Early in the postoperative course, usually within 6 weeks of surgery, the authors of this chapter have had success with loosening of the sling via caudal pressure applied to the urethra with a cystoscope under anesthesia; however, worsening of the urethral rigidity secondary to periurethral fibrosis is a possible complication of this maneuver [21]. Other early interventions, such as transurethral resection or incision of the bladder neck, have been shown to be an ineffective means of managing postoperative obstruction [58]. Patients with persistent symptomatic obstruction after 6 weeks that requires intervention should undergo either an urethrolysis or a sling incision. Success rates for these procedures for all sling types (autologous, cadaveric, synthetic) range from 65% to 93% [46–48, 59, 60]. Specifically concerning urethrolysis, Foster and McGuire reported that transvaginal urethrolysis was successful in only 50% of PVS obstructions and thus concluded that transvaginal lateral dissection is insufficient in relieving the direct suburethral compressive force of the sling. To better approach the lateral wings of the sling, the authors

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recommended a suprameatal approach. Petrou et al. reported on a series of 12 patients who underwent such a procedure, 8 of whom had successful results [60]. Likewise, Carr and Webster noted a complete or significant resolution of symptoms in 86% of patients after retropubic urethrolysis [47]. Even in cases of failed urethrolysis, a repeat transvaginal, retropubic, or combined urethrolysis should be able to achieve excellent cure rates of up to 92% as long as the urethra is circumferentially mobilized away from the pubic bone [61]. Some authors have reported that single-sling incision has comparable success rates (84–100%) and shorter operative time and less morbidity than a formal urethrolysis [62–64]. In 2005, Thiel et al. reported a 100% success rate in 11 women following lateral sling incision, with a 54% rate of recurrent stress incontinence [65]. Goldman also performed simple-sling incision in 14 women with iatrogenic urethral obstruction [66]. This included 3 patients with a midurethral polypropylene mesh sling. In this study, 13 of 14 (93%) patient had complete or significant improvement of voiding dysfunction and 1 (7%) required subsequent urethrolysis. Three patients (21%) developed recurrent SUI, one of which required treatment. In the authors’ opinion, the most important factor to consider when deciding on sling incision or formal urethrolysis is the length of time from surgery. Within the first 3–6 months after surgery, a singlesling incision will likely be adequate.

Conclusions The PVS surgery has evolved over the past 100 years. With the introduction of novel graft materials and less invasive methods of placement, women undergoing PVS surgery today may enjoy shorter convalescence periods than ever before. However, because synthetic, allograft, and xenograft materials have unpredictable biocompatibility profiles in vivo, these technological advancements bring unique risks. Autologous RF and FL slings induce minimal inflammatory response and are considered the “biocompatibility gold standard” against which all other sling materials are measured. Autologous PVS surgery affords patients excellent cure rates. Serious complications are rare and voiding dysfunction after surgery is often transient and can usually be managed conservatively. It is however important to avoid excessive sling tension during placement and this aspect of the procedure remains highly variable among surgeons. Sling tensioning lacks a standard technique to date and is a key element in future research to optimize PVS placement. As with all surgical procedures, a discussion of the specific risks, benefits, and alternatives to sling surgery is quintessential to obtaining informed consent preoperatively and to ensuring patient satisfaction postoperatively.

References



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49. Chaliha C, Stanton SL. Complications of surgery for genuine stress incontinence. Br J Obstet Gynaecol 1999;106:1238–1245. 50. Foster HE, McGuire EJ. Management of urethral obstruction with transvaginal urethrolysis. J Urol 1993;150:1448–1451. 51. Kochakarn W, Leenanupunth C. Pubovaginal sling for the treatment of female stress urinary incontinence: experience of 100 cases at Ramathibodi Hospital. J Med Assoc Thai 2001;84(10):1412–1415. 52. Govier FE, Gibbons RP, Correa RJ et al. Pubovaginal slings using fascia lata for the treatment of intrinsic sphincter deficiency. J Urol 1997;157:117–121. 53. Karram MM, Bhatia NN. Patch procedure: modified transvaginal fascia lata sling for recurrent or severe stress urinary incontinence. Obstet Gynecol 1990;75:461–463. 54. Blaivas JG, Simma-Chiang V, Gul Z, Dayan L, Kalkan S, Daniel M. Surgery for stress urinary incontinence. Urol Clin North Am 2019;46(1):41–52. 55. Mitsui T, Tanaka H, Moriya K et al. Clinical and urodynamic outcomes of pubovaginal sling procedure with autologous rectus fascia for stress urinary incontinence. Int J Urol 2007;14:1076–1079. 56. Dmochowski RR, Blaivas JM, Gormley EA et al. Update of AUA Guideline on the surgical management of female stress urinary incontinence. J Urol 2010;183(5):1906–1914. 57. Siddighi S, Karram MM. Surgical and nonsurgical approaches to treat voiding dysfunction following antiincontinence surgery. Curr Opin Obstet Gynecol 2007;19:490–495. 58. Ghoniem GM, Elgamasy AN. Simplified surgical approach to bladder outlet obstruction following pubovaginal sling. J Urol 1995;154:181–183. 59. Goldman HB, Rackley RR, Appell RA. The efficacy of urethrolysis without re-suspension for iatrogenic urethral obstruction. J Urol 1999;161:196–198; discussion 198–199. 60. Petrou SP, Brown JA, Blaivas JG. Suprameatal transvaginal urethrolysis. J Urol 1999;161:1268–1271. 61. Scarpero HM, Dmochowski RR, Nitti VW. Repeat urethrolysis after failed urethrolysis for iatrogenic obstruction. J Urol 2003;169:1013–1016. 62. McLennan MT, Bent AE. Sling incision with associated vaginal wall interposition for obstructed voiding secondary to suburethral sling procedure. Int Urogynecol J Pelvic Floor Dysfunct 1997;8:168–172. 63. Kusuda L. Simple release of pubovaginal sling. Urology 2001;57:358–359. 64. Nitti VW, Carlson KV, Blaivas JG et al. Early results of pubovaginal sling lysis by midline sling incision. Urology 2002;59:47–51. 65. Thiel DD, Pettit P, McClellan WT et al. Long-term urinary continence rates after simple sling incision for relief of urinary retention following fascia lata pubovaginal slings. J Urol November 2005;174(5):1878–1881. 66. Goldman HB. Simple sling incision for the treatment of iatrogenic urethral obstruction. Urology 2003;62:714–718.

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RETROPUBIC MID-URETHRAL SLING PROCEDURE FOR THE TREATMENT OF FEMALE URINARY STRESS INCONTINENCE Steven E. Schraffordt Koops and Femke van Zanten

Introduction For more than a century, sling operations have been developed and performed with different degrees of success in terms of achieved urinary continence. The classical sling operations as described by Goebbel [1], Frangenheim [2], Stoeckel [3] and Aldridge [4] are all major invasive surgical procedures, with the inevitable high risk of complications, post-operative morbidity and voiding difficulties. Slings of many different materials: allografts, xenografts and synthetics have been used. Classical slings are placed at the bladder neck in order to correct hypermobility and to enhance pressure transmission of intra-abdominal pressure provoked by straining. Until 1995, the gold standard of Stress Urinary Incontinence (SUI) surgery was the Burch colposuspension [5]. This bladder neck suspension, with the use of permanent non-resorbable sutures, is performed by Pfannenstiel abdominal incision but can also be performed laparoscopically [6] and robotically [7]. This procedure is also known for its perioperative and post-operative complication rates. The Tension-Free Vaginal Tape (TVT) has been the first choice for surgical treatment for urinary stress incontinence in women in the beginning of this century because of its high cure rate, minimal invasiveness and low complication rate. The TVT is the name the manufacturers and the ‘inventors’ of this retropubic Mid-Urethral Sling (MUS) used for their product. TVT is nowadays often used as a synonym for a retropubic MUS; in this chapter, we will use both. The later introduced transobturator tape (TOT) from the same manufacturer, the TVT-O, which will not be discussed in detail in this chapter. The original procedure was introduced by Ulmsten and Petros in 1995 [8, 9]. The TVT procedure is based on one of the concepts of the Integral Theory for female incontinence: improving mid-urethral support instead of bladder neck suspension, which was a radically different approach than before [10]. According to this theory, damage to the pubo-urethral ligaments supporting the urethra, impaired support of the anterior vaginal wall to the mid-urethra and weakened function of the part of the pubococcygeal muscles, which insert adjacent to the urethra, are responsible for causing urinary stress incontinence. Connective tissue is an important element of the involved structures. The quality of the connective tissue has an influence on continence [11]. In 2001, Delorme presented a novel mid-urethral technique, a TVT-like tape that is passed through the obturator fossa [12]. This procedure is a little less invasive and also has good success rates. Many of these TOT’s came on the market. In total, 41 different MUS were introduced until 2012 [13]. Many of these options are or were on the market in several different sorts of mesh, like Gore-Tex, Mersilene, polytetrafluoroethylene mesh (PTFE), silicone-coated polyethylene or polyester and polypropylene (PP) nonknitted or non-woven mesh. Of all these different types of mesh and options/usage, many have been taken from the market because of complication rates found in clinical research [13].

DOI: 10.1201/9781003144243-80

Recently, mid-urethral tapes were heavily scrutinized because the majority are made of PP, the same material that was used for vaginal Pelvic Organ Prolapse (POP) surgery, which caused many severe complications. After the US Food and Drug Administration (FDA) warnings in 2011, a cascade of actions followed [14]. The most recent milestone was on 16 April 2019, when the FDA ordered manufacturers of surgical mesh, intended for transvaginal repair of POP, to stop selling and distributing these products [15]. In the USA, the use of synthetic MUS is not prohibited by the FDA. In the UK, several reviews were published: the Scottish, Welsh and the National Health Service reviews. After these reviews, all uses of mesh (also for POP and SUI) were paused in the UK [16]. The situation in the UK is aberrant as the National Institute for Health and Care Excellence (NICE) based its 2019 advice on scientific evidence. NICE does recommend the use of PP MUS procedures [17]. The NICE guidelines describe patients to be offered a choice of colposuspension (open or laparoscopic, robotic is not mentioned), an autologous fascial sling or a MUS procedure. When choosing this last option, the patient needs to be informed on the permanency of the implant and that complete removal might not be possible. Also, written information about the implant must be provided. This national guideline further describes that the material of the tape must be type 1 macroporous PP mesh and preferably coloured for high visibility. Notably, in this NICE guideline are the remarks on top-down retropubic, single-incision, sub-urethral short mesh slings and transobturator MUS. These options need to be avoided according to NICE. In Australia and New Zealand, the authorities issued a complete ban on mesh used for transvaginal POP surgery and the mini-sling for urinary stress incontinence [18, 19]. In November 2019, three women won a class action at the Federal Court of Australia. The court ruled that the company (J&J) had misled consumers about the risks involved with its mesh products for POP and SUI. The ruling was based on the Australian negligence law. The final ruling implied that all women feeling injured can now seek financial compensation. The judge stated that the ‘long term effects are currently not reliably known’. The judge has based her ruling on a review article from Cody et al. dating from 2003 on MUS [20]. Since then, multiple articles and Cochrane reviews have been published stating the satisfactory long-term outcome and a ‘good safety profile’. The Medicines and Healthcare products and Regulatory Agency (MHRA) in Europe concluded, after reviewing all information available in 2014, that the use of mesh implants used for SUI are safe and that the overall benefits outweigh the relative low rate of complications [21]. The European Commission has published the ‘final opinion on surgical meshes’ of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR), a document supporting the routine use of mesh for MUS. The commission states that ‘synthetic sling surgery is an accepted procedure with proven 795

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Technique The original TVT device consists of an 11 mm wide and 40 cm long tape of PP, which at both ends is attached to stainless steel, specially curved, 5 mm in diameter insertion trocars. The tape is covered by plastic sheets to protect the tape from contamination and facilitate its passage through the tissues. A reusable handle fits to the trocars and is used to insert the trocars. A rigid catheter guide is placed into an 18 French Foley catheter and helps to deflect the bladder away from the path of the trocar insertion. In 2010, a modernization of the original TVT device was launched. The technique used for this TVT exact is the same as described for the original TVT procedure. The differences between the two devices are the thickness of the trocar, the original consisting of a diameter of 5 mm and the TVT exact having a diameter of 3 mm. Both trocars have the same curvature and tip radius. The PP tape has not changed but is now coloured blue. The narrower trocar reduces the penetration force needed. The TVT exact handle and trocar are combined into one disposable piece. The patient is placed in a lithotomy position avoiding more than a 70° flexion of the thighs. After premedication with, for example, 0.5 mg midazolam, local anaesthetic is injected. The operation requires three small incisions: two 1 cm wide suprapubic skin incisions at the upper rim of the pubic bone, each 2–2.5 cm lateral to the midline, and a vaginal midline incision not more than 1.5 cm wide, starting 0.5 cm from the external meatus of the urethra. Five millilitres of local anaesthetic is injected under the skin at the site of the planned skin incisions. Another 20 ml is placed on each side retropubically, following closely the posterior surface of the pubic bone down to the urogenital diaphragm. Vaginal infiltration of the local anaesthetic includes 10 ml on each side paraurethral up to the urogenital diaphragm and another 5 ml under the vaginal mucosa at the site of the mid-urethra. The skin incisions are made to facilitate the passing of the trocars through the skin. After the vaginal incision is made, careful, minimal blunt dissection, using Metzenbaum scissors, should be undertaken para-urethral between the vaginal mucosa and the pubocervical fascia, not more than 2 cm deep. The TVT trocar is placed in its starting position within the dissected para-urethral tunnel, with the trocar tip between the index finger of the surgeon’s hand in the vagina and the lower rim of the pubic ramus. With slow controlled pressure, the trocar is brought through the urogenital diaphragm, the space of Retzius and the rectus muscle fascia, using the skin incision as a directional target. Attention must be paid constantly to keep the trocar in close contact with the dorsal surface of the pubic bone in order to avoid bladder perforation or entrance into the abdominal cavity. The same procedure is repeated on the other side. After passing each trocar to the extent that the trocar tip is visible at the skin incision, cystoscopy using a 70° optic is performed to assure bladder integrity. If bladder perforation is noted, the trocar is withdrawn and passed once more, paying more careful attention of staying close to the pubic bone and within the safe sector. Once bladder integrity is confirmed, each trocar is brought through, and the final adjustment of the tape can take place. The plastic sheets are taken off. At this point, it is important to control that no further tightening of the tape occurs by placing Metzenbaum scissors or another

instrument between the urethra and the tape when removing the plastic sheets. No fixation of the tape is needed.

Retropubic top to bottom retropubic approach

Since the introduction of the original ‘bottom to top’ TVT, many different types and methods of retropubic placement of mesh have been introduced. One of these is the ‘top to bottom’ insertion. The Cochrane publication of 2017 detected five trials comparing ‘top to bottom’ with ‘bottom to top’ procedure. TVT was found to be more effective and showed to result in fewer complications, including less vaginal mesh exposure [23].

Cough test The original recommendation for placement of a TVT also described filling the bladder with 300 ml of saline and to perform a cough test. The patient is asked to cough vigorously while the tape is adjusted to a point when leakage is only a drop of saline at the urethral meatus. The cough test has been advocated to determine the correct tension of the tape, although it has been very difficult to judge the differences in cough efforts between patients. The theory behind the cough test was to adjust the tension on the tape sufficiently to stop leakage and to avoid creating post-operative voiding difficulty by tightening the tape too much. The cough test was abandoned for several reasons. Firstly, some patients required the use of general anaesthesia or spinal analgesia, mostly because of pain issues during the procedure or when requiring concomitant prolapse surgery. Secondly, the generated cough pressure under spinal analgesia was found to be lower than under local analgesia [24]. Thirdly, conflicting studies were published on cough test’s efficacy. Murphy et al. [25] demonstrated that the use of the cough test was associated with greater improvements in stress incontinence. Lavy et al. [26] compared a group of women undergoing a TVT procedure who had a cough test intra-operatively with a group who did not. This study demonstrated no difference in success rate between these two groups. In the study reported by Adamiak et al. [24], patients in the general anaesthesia group did not use the cough test and patients in the epidural anaesthesia group underwent the cough test during the TVT procedure. No significant difference in efficacy was noted between the two groups. Since these studies, several other studies showed no difference in post-operative voiding dysfunction, nor in efficacy in the treatment of stress incontinence [27, 28], and the cough test is no longer often used.

Clinical outcomes The success of the TVT surgery was investigated in a multicentre prospective trial in 1998, which examined surgical results of 131 carefully selected primary cases with genuine stress incontinence. After 1 year, the objective cure rate was 91% and only 2% were regarded as failures [29]. Empirical support for this surgery increased, and in a prospective clinical trial, 161 consecutive TVT operations were observed, which included 28% with prior failed incontinence surgery, 37% with mixed incontinence, and 11% with intrinsic sphincter deficiency (ISD). The trial’s overall objective cure rate at 16 months of follow-up was 87%, 7% were significantly improved and 5% were classified as failures [30]. In addition, only 3.7% of the women exhibited bladder perforation and 4.3% of the women experienced short-term voiding difficulties.

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Since these early studies, many studies followed, and these favourable results have been confirmed through several metaanalysis and systematic reviews. In 2017, the Cochrane review of Ford et al. [23] described 55 trials with data on 8,652 women on the retropubic route and the transobturator route. Subjective cure rates were similar in the 1 year follow-up, ranging from 71% to 97% in the TVT group and from 62% to 98% in the TVT-O group (RR 0.98, 95% CI 0.96–1.00). Objective cure was also similar, 85% after TVT-O and 87% after TVT (RR 0.98, 95% CI 0.96–1.00). Few trials reported cure rates of more than 1 year. Overall, studies indicate that the occurrence of adverse events was low. The systematic review of Fusco et al. [31] included 15,855 patients across 28 RCTs. They found that patients undergoing MUS had significantly higher overall and objective cure rates than women receiving Burch colposuspension (OR 0.59 and 0.51, respectively). Comparing the retropubic route with the obturator route, the former showed a slightly higher subjective and objective continence rate. This difference was also observed when evaluating studies with at least 5 year follow-up. However, the retropubic route (compared to the obturator route) was associated with a higher risk of some perioperative complications and impaired voiding symptoms.

Long-term results Table 73.1 shows the long-term efficacy and safety results after TVT [32–44]. Two major problems generally faced when evaluating long-term results of incontinence surgeries are: 1) the increasing number of patients lost to follow-up over time and 2) the fact that new illnesses often appear that might affect bladder function, especially in elderly patients, which complicate estimation of the long-term effectiveness and safety of anti-incontinence surgical interventions. The rate of patients who are lost to follow-up when follow-ups span over 10 years ranges between 8% and 28% (Table 73.1). This is a relatively low loss considering the long follow-up duration, and these studies are able to provide a reliable picture of the actual performance of the TVT operation over time. The cure rates even 17 years after surgery are in the same order as those reported in the initial early trials, suggesting a minimal decline in effectiveness over the years [38]. Maggiore et al. [45] performed a systematic review including 11 RCTs and

5 controlled prospective and retrospective studies with data of ≥ 5 years follow-up. Objective and subjective cumulative cure rates for TVT were 61.6% (95% CI 58.5–64.8) and 76.5% (95% CI 73.8–79.2). Compared to TVT-O, both the subjective and objective cure and post-operative complication rates were similar. There is one outlier in Table 73.1 reporting a subjective cure of 32% [40]. This study used a strict definition for subjective continence. The objective cure described was in line with all other studies. One nationwide cohort study reporting on a large cohort of women described the reoperation rate within 5 years after surgical interventions for SUI and reported that the cumulative incidence of re-intervention after any surgical treatment was 10%. This was 6% after TVT, 6% after Burch procedure, 6% after pubovaginal slings and 9% after TVT-O [46].

Recurrent urinary incontinence Tables 73.2 and 73.3 show the objective and/or subjective cure rates found in patients with prior failed traditional incontinence surgery like a Burch colposuspension and prior failed MUS surgery [47–63]. From the results, it can be concluded that the performance of a retropubic procedure is as good as in primary cases when the primary operation had been a traditional method, mostly colposuspension or a pubovaginal sling [47–54]. When the primary failed operation had been an MUS procedure, the repeat MUS, in this context the retropubic MUS procedure, shows favourable cure rates. These cure rates for secondary procedures seem to be slightly lower though than in primary cases and in which a tendency of decline in cure rate is seen after approximately 4 years [55, 56, 58, 61]. The decline is partly explained by the fact that many women over time develop urgency symptoms not necessarily related to the surgery but affecting their subjective perception of cure of urinary symptoms. A question is often raised: Which approach for a repeat MUS is preferred, the retropubic or the transobturator? One hoped that the Cochrane review ‘Intervention for treating SUI after failed minimal invasive synthetic midurethral tape surgery in women’ might give at least a partial answer to that question. But, from the initial 58 articles, only one article was included, and this study compared only redo surgery comparing ‘inside out’ vs. outside in [64]. There is no robust data, but some studies indicate that a retropubic

TABLE 73.1: Ten or More Years of Follow-Up of the Tension-Free Vaginal Tape Procedure Authors Groutz et al. [32] Serati et al. [33] Heinonen et al. [34] Svenningsen et al. [35] Nilsson et al. [36] Olsson et al. [37] Nilsson et al. [38] Han et al. [39] Khan et al. [40] Manach et al. [41] Serati et al. [42]a Braga et al. [43] Holdø et al. [44]

No. of Subjects

Follow-Up (years)

Lost to Follow-Up (%)

Cure Rate

10 10 10 10 11 11 17 12 10 10 13 17 10

13 8 28 20 23 16 22 22 13 NR 13 12 NR

65% sc 93% oc and 90% sc 90% oc and 78% sc 90% oc and 76% sc 90% oc and 77% sc 84% oc and 77% sc 91% oc and 87% sc 78% sc 32% oc and 73% sc 93% oc and 78% sc 91% oc and 86% sc 91% oc and 89% sc 74% sc

60 63 191 603 90 147 90 113 72 58 63 52 390

Abbreviations:  NR, not reported; oc, objective cure; sc, subjective cure. a Similar baseline cohort as in the 10 year follow-up study [33].

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TABLE 73.2: Objective Cure Rate and Time of Follow-Up after Tension-Free Vaginal Tape Surgery for Recurrent or Persistent Stress Incontinence after Traditional Incontinence Surgery Authors Rezapour et al. [47] Azam et al. [48] Lo et al. [49] Kuuva et al. [50] Liapis et al. [51] Ala-Nissilä et al. [52] Sivaslioglu et al. [53] Shao et al. [54]

No. of Subjects

Follow-Up (Months)

Cure Rate (%)

34 67 41 51 33 60 23 24

48 12 12 25 20 96 12 57

82 81 83 90 70 86 62 71

repeat procedure might perform better than a transobturator procedure [55, 58, 65]. The explanation probably lies in the shape of the retropubic tape. This is a more ‘U’ form underneath the mid-urethra than the TOTs. The tension vectors run more vertical in the retropubic tapes than horizontal in the TOT tapes. As in primary cases, this might introduce more post-operative voiding difficulty in these secondary cases, and it might give a higher success rate. Two meta-analyses found different conclusions; the retropubic approach is more effective than the transobturator in correcting primary failed MUS surgery [66], and the other analyses found no difference between both approaches [67]. Another option described is the shortening of the primarily placed tape. Lo et al. described a cure rate of 70% when shortening the original placed TVT [68].

TVT in case of intrinsic sphincter deficiency Intrinsic sphincter deficiency (ISD) can be defined in many ways, for example, as a low-pressure urethra ( 35 kg/m2) patients. The follow-up was short at 6 months. No objective and subjective differences in cure rates were seen between the TOT and TVT groups. Also, this research group did not find any difference between the obese classes. The short follow-up may play a major role in these findings. The Cochrane analyses from 2017 [23] described nine trials reporting on the need for repeat incontinence surgery for all women, both obese and non-obese. In the short term (< 1 year), no differences were seen, but in the medium term (1–5 years) and long term (>5 years), the necessity for repeat surgery for the TOT group was found to be significantly higher.

TVT in mixed urinary incontinence Mixed urinary incontinence (MUI) is a condition in which a patient suffers both stress and urge incontinence simultaneously. Mixed incontinence can be divided into cases with either predominantly stress or predominantly urge incontinence as assessed by subjective parameters or into urodynamically proven mixed incontinence with signs of leakage at stress and detrusor activity. Surgery for mixed incontinence is mostly recommended for cases with predominantly stress incontinence with or without urodynamically proven detrusor overactivity. Study reports on the outcome of TVT surgery in cases of mixed incontinence are difficult to compare and interpret, as the definition of mixed incontinence varies greatly, and cure rates are expressed as overall cure, cure of the stress component or cure of the urgency component. Table 73.6 gives the overall cure rates after TVT in subjects with mixed incontinence from the reports from which these parameters could be extracted [44, 88–94]. A meta-analysis looking at the cure rate after MUS surgery indicates that there is a persistent and good cure of the stress component, while the cure rate of the urge component is variable and less than the stress component. Cure rates of the urge component are quoted at between 30% and 85% at follow-up from a few months up to 5 years [95]. From the studies with longer follow-up, it seems as if cure rates decline with time [90, 92]. This decline is not necessarily caused by the failure of the TVT procedure as the stress component does not tend to recur. It is mostly the symptoms of urge incontinence that increase, which might be the consequence of concomitant

TABLE 73.5: Cure Rates after Tension-Free Vaginal Tape Surgery in Obese and Normal-Weight Women Author Rafii et al. [82] Skriapas et al. [83] Hellberg et al. [84] Rechberger et al. [85] Killingsworth et al. [87] Abbreviation:  ns, not significant.

No. of Controls/Obese 80/32 52/31 239/61 41/80 68/62

BMI >30 >40 >35 >30 >30

Follow-Up (Months) 27 18.5 67 18 12

Cure Rate

p-Value

93%/82% 87%/92% 81%/52% 81%/68% 81%/82%

ns 0.103 0.0005 0.1 Ns

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TABLE 73.6: Cure Rates after Tension-Free Vaginal Tape in Women with Mixed Incontinence Author

No. of Subjects

Segal et al. [88] Abdel-Hady et al. [89] Holmgren et al. [90] Paik et al. [91] Kulseng-Hanssen et al. [92] Palva and Nilsson [93] Athanasiou et al. [94] Holdø et al. [44]

65 128 112 72 258 89 44 206

obstruction, elderly age and/or illnesses evolving during followup. Data on which surgical procedure, TOT or TVT, is best for mixed incontinence are scarce. The study of Athanasiou et al. compared 44 TVT patients with 41 TVT-O (transobturator), all suffering from urodynamically proven mixed incontinence [94]. At 12 months, the cure rates in both groups were found to be the same at 82% and no difference in complaints could be found. However, there was a significant difference in the absence of detrusor activity between the TVT and the TVT-O patients (48.5% vs. 22.7%, p = 0.0014). The numbers are unfortunately too low to draw a conclusion. One could argue that the procedure producing most post-operative urgency symptoms as a complication would be not the procedure of choice for those who suffer from mixed incontinence. However, the study of Laurikainen et al. showed that from a group of 136 TVTs and 132 TVT-Os all diagnosed with MUI pre-operatively, 94% of patients were relieved of their urgency symptoms at follow-up of 60 months [96].

Pregnancy and delivery after TVT Usually, women are advised to postpone surgical intervention for stress incontinence when there is a desire for fertility. The reason for this advice is mostly due to fear of complications during the pregnancy or delivery and of the postnatal recurrence of urinary incontinence. When a pregnancy does occur in patients having had an MUS, an elective caesarean section is usually advised. No specific guidelines are known, and this advice is not based on any solid scientific evidence. Most evidence is found in case reports, but recently, a few larger studies on this subject were published. Tulokas et al. found 94 cases in their register-based study who underwent an MUS and gave birth afterwards [97]. Sixty-five patients with a retropubic MUS and 33 with a transobturator MUS were compared with 330 controls. After a mean follow-up of 11 years, there was a re-procedure rate for SUI of 3.3% after an MUS compared to 5.2% of the controls. The same analysis showed a low complication rate during pregnancy and showed no benefit from a caesarean section as the mode of delivery after an MUS. Dyrkorn et al., from the Norwegian register, published 72 deliveries after an MUS compared to 156 controls with a 10 year follow-up [98]. Telephone interviews using validated questionnaires were used to establish the outcome of recurrent SUI. Subjective cure rates were 82% for the cases and 75% for the controls. Additionally, the study showed that more than one delivery did increase the failure rate, but the impact was thought to be small. Bergman et al. published from the Swedish national care register [99]; 163 patients were identified having a delivery after an

Follow-Up Not stated 6 months 48 months 11 months 38 months 36 months 12 months ≥ 60 months

Cure Rate (%) 64 89 60 82 80 72 82 75

MUS. No differentiation between retropubic and transobturator was made, and no pre-delivery incontinence measurement was performed. The control group of 374 had an MUS but not followed by a delivery. SUI was diagnosed in 22% of the study group and 17% in the controls. Many young women suffer from SUI which can be a significant burden for them. These recent studies show that the surgical MUS treatment for such women, even before possible pregnancy and childbirth, is not contraindicated. The mode of delivery does not alter the SUI recurrence rate significantly after delivery.

Sexual function after TVT Contradictory results of the effect of TVT on sexual function have been described. Dyspareunia after surgery occurs, but also, other negative effects have been described such as decreased genital sensation, discomfort, diminished arousal and vaginal lubrication. These symptoms can inhibit orgasm. Several options for treatment are possible such as oestrogen usage, lubricants, pain medication or, if these are not successful, removal of the mesh is an option. Several articles explain this morbidity by diminished innervation of vaginal anterior wall, clitoris and G-spot after placement of TVT. Removal was shown to reduce pain and to have a positive effect on desire, arousal, lubrication and satisfaction [100]. However, almost every article published on sexual function described an improvement in function. This positive effect of the TVT results from significant relief of penetration incontinence, coital incontinence and reduced negative emotions during sex [101]. A large review article by Alwaal et al. reported that including TVTs and TOTs described an overall improvement in sexual function [102]. Although a small percentage of women developed de novo dyspareunia, the trade-off was less coital incontinence, a reduction in anxiety and avoidance of sex and improved selfimage and body image. De novo dyspareunia is often found after an incorrect placement or other complications such as erosion or abnormal scar formation. Itkonen Freitas et al. recently published an RCT on para-urethral bulking agent, polyacrylamide hydrogel (Bulkamid®) vs. TVT. This well-set-up study described success rates and later, in secondary analyses, the quality of life and sexual function. It showed that both treatments improved the quality of life, but the TVT group showed better objective cure rate. This was also reflected in the benefits in physical activity and sexual function [103, 104]. The Cochrane analysis from 2017 on MUS operations for SUI in women found in total 13 trials addressing sexual

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function. The studies used direct questioning and a variety of validated questionnaires like the Prolapse/Incontinence Symptoms Questionnaire 12, Bristol Female Lower Urinary Tract Symptoms questionnaire, International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms quality-of-life questionnaire and Visual Analogue Scale. After follow-up between 6 and 24 months, all studies showed an overall improvement in sexual function. The rates of dyspareunia found were low [23].

Complications Quality of life is an important concept when discussing the outcome of incontinence surgery. The quality of life of the incontinent woman is not solely due to the absence of urinary leakage but as much by the absence of voiding difficulties, urinary tract infections (UTIs) and other adverse symptoms possibly caused by surgical complications. Minimal invasiveness and standardization of a surgical intervention is a means of reducing complication rates. Severe complications with a low incidence such as injuries to bowel, major vessels, nerves or an abscess, large pelvic hematoma and necrotizing fasciitis are unlikely to be picked up by small RCTs [105]. However, voluntary national patient-reported databases for complications, such as the FDA manufacturer and user facility device experience, register low-incidence complications. These kinds of registers exist in several countries. The problem with all patient-/manufacturer-reported databases is the lack of information, such as which type of implant was used, which surgical procedure was performed and also what the complication incidence was for a specific type and surgical method. To avoid alternative facts, one also needs the denominator, i.e., how many patients underwent a specific surgical procedure and with which specific mesh. Systematic prospective registration of complications is essential in order to obtain an accurate assessment of the risk and the rate of specific complications. Fortunately, a few such registers have been established and published [106–111]. The studies from Finland and the Netherlands are unique, as they consist of every single TVT procedure performed in the country as it was introduced to clinics (in the Netherlands in 25 hospitals) within a systematic hands-on training program. The studies from the

Netherlands and Finland also include the learning curve of all the surgeons involved [106, 112]. A French retrospective survey of complications associated with the TVT procedure was obtained by asking 92 urologists and gynaecologists about the frequency of complications. Altogether, the survey included 12,280 TVT procedures [109] and is the largest survey on complications. The Norwegian register included 4,281 TVT procedures. This was a prospective follow-up study of complications associated with the TVT [108]. Another registry from Austria included 2,795 cases but does not involve all the clinics of the country [107]. A few other more comprehensive studies also focusing on the complication rates have been published [113–118]. The rates of the most common complications associated with incontinence surgery of these studies, and the registries are shown in Table 73.7 [30, 106– 111, 113–116, 118]. It is interesting to note that the rate of bladder injury is rather consistent in these reports at a mean of 4.6%. The definition of voiding difficulties varies between the reports but mostly refers to the need for short-time intermittent catheterization within the first 2 post-operative days. The mean reported post-operative voiding difficulty rate was 6.5% (range 1.6–19.7%) indicating heterogeneity in the definitions used for voiding difficulty. In the report by Abouassaly et al., with the highest rate of voiding difficulties, only 1 patient out of 241 patients needed an indwelling catheter for more than 48 hours [115]. The risk of post-operative UTI also varies somewhat, with the highest rate reported from the Austrian national registry. This might be caused by a policy of routinely using an indwelling catheter postoperatively (63% of the cases). The mean rate of UTI was 5.8%. Occurrence of de novo urge symptoms varies between 0.2% and 15% (Table 73.7). Seventeen years of follow-up suggests that there is no risk of an increasing number of cases with de novo urge problems over time, the rate of these symptoms being 6% at 7 years post-operatively [38]. The problem with long-term followup studies and symptoms of urge incontinence is that these can increase over time and might be the consequence of elderly age and/or illnesses evolving during follow-up. Although the TVT operation is partly a blind procedure, the risk of excessive (>200 mL) intra-operative bleeding and retropubic hematoma formation is rare. Excessive bleeding occurs on average in 1.5% of the cases (Table 73.7) and is mostly managed by manual compression and tamponade. In a systematic evaluation

TABLE 73.7: Rate of Complications (%) after Tension-Free Vaginal Tape Surgery Author Agostini et al. [109] Dyrkorn et al. [108] Tamussino et al. [107] Kuuva and Nilsson [106] Kristensen et al. [117] Karram et al. [113] Levin et al. [114] Debodinance et al. [116] Abouassaly et al. [115] Pushkar et al. [118] Nilsson and Kuuva [30] Schraffordt Koops et al. [110] Tincello et al. [111] Abbreviation:  —, not reported.

n

Bladder Injury

Hematoma

Bleeding

12,280 4,281 2,795 1,455 778 350 313 256 241 187 161 809 208

7.3 3.5 2.7 3.8 6.6 4.9 5.1 5.5 5.8 5.4 3.7 3.5 2.1

— 1.2 — 2.4 0.8 1.7 — 0.4 1.9 9.1 1.2 3.4 0.4

— — 2.3 1.9 — 0.9 — — 2.5 — 1.8 1.2 0.2

Voiding Difficulty 6.6 1.6 — 7.6 16.6 4.9 2.5 5.1 19.7 5.9 4.3 1.6 2.1

UTI

Infection

— — 17 4.1 3.1 10 — 3.1 — — 6.2 0.7 1.9

— 0.7 — 0.8 0.0 — — — 0.4 — 1.8 0.1 0.6

Urgency Symptom — — — 0.2 — 12 8.3 12 15 10.1 3.1 — 3.0

Extrusion 0.2 — — 0.7 — 0.9 1.3 — 0.4 — — 0.2 1.5

Textbook of Female Urology and Urogynecology

802 of the occurrence of post-operative retropubic hematoma formation, Flock et al. reported a rate of 4.1% among 249 consecutive cases, with only four cases (1.6%) exceeding 300 ml and requiring surgical intervention [119].

Long-term post-operative complications Erosion/exposure/extrusion/perforation

The term erosion is usually used to describe a variety of different clinical scenarios, such as exposure, extrusion and perforation. The International Urogynecological Association and International Continence Society jointly published a system of terminology and classification [120]. The different clinical diagnoses are as follows: • Exposition: a condition of displaying, revealing, exhibiting or making accessible • Perforation: abnormal opening into a hollow organ or viscus • Extrusion: passage gradually out of a body structure or tissue (e.g., a loop of tape protruding into the vaginal cavity) MacCraith et al. in a recent review of 283,000 women with an MUS (retropubic and transobturator implants) reported a 1.9% erosion or exposure after a mean of 261 days post-implant [121]. An important finding of the study with the longest follow-up (17 years) is the absence of signs of rejection or adverse tissue reaction of the PP tape material. Neither any erosion of the tape into the urethra nor the bladder was seen [38]. Gurol-Urganci and colleagues retrospectively analysed data of nearly 100,000 women who underwent surgery with a primary MUS for SUI [122]. Of this group, 60,194 women underwent a retropubic MUS. All the procedures were carried out in NHS hospitals in England between 2006 and 2015. The focus of this study was on complications, especially the need for removal of the tape and reoperation. The 9 year removal rate for retropubic MUS was 3.6%. The reasons for removal were not discussed in this article, but one of the reasons must be exposure.

Autoimmune disease

On a cellular level, no firm studies exist. Only one human study has shown that PP MUSs induce a minimal inflammatory reaction without any significant change in collagen solubility, in comparison to multifilament slings (Mersilene) [123]. Up to 2021, it was not possible to confirm whether observed changes in the types of cells were linked to an immunologic reaction or to the exposure to PP itself. Authors have come to the conclusion that PP degradation may play a role in generating a continuous local inflammatory response, resulting in mesh hardening and late deformations. However, these concepts remain very controversial and speculative based on limited evidence. The non-medical society suggestions are that synthetic materials used for MUS can be a trigger for autoimmune inflammatory disease. These suggestions follow a case study that was performed in an autoimmune clinic [124]. In this study, 714 patients were selected. In 40 of these patients, mesh implants were present, 18 patients after a hernia repair, 22 after vaginal mesh implant, 4 after TVTs and 4 after mesh implants for POP, not further described; 39/40 patients presented with fatigue, 38/40 with myalgia/muscle weakness, 36/40 with arthralgias/arthritis, 31/40 had cognitive symptoms like memory loss, 32/40 pyrexia, 34/40 dry eyes/mouth and 7/40 had stroke-like symptoms. All these

symptoms were, in this article, related to the PP mesh implants. The study of Chughtai et al. is of better quality [125]. The set-up is better as there was no selection bias as in the autoimmune clinic. This matched control study involved 2,102 patients with vaginal mesh implants for POP and control groups without implants. This study showed no relation between autoimmune disease and the use of PP implants.

De novo malignancy

A Swedish study assessed the association between the implantation of PP tapes for the treatment of SUI and carcinogenesis in 20,905 exposed women in the general population. There were no significant differences in risk between exposed and unexposed women for pelvic organ cancers including ovarian, endometrial, cervical, bladder and urethral malignancies [126].

Pain

Persisting post-operative pain is one of the most feared complications by patients and doctors. Lack of recognition, and therefore also poor treatment for patients especially after vaginal use of mesh for POP, has led to public opinion being against the use of mesh. The main reason for a pause on mesh surgery in the report of the Independent Medicines and Medical Devices Safety Review in the UK was chronic pain [111]. This and many other reports are mainly based on reviews of patients. The problems with this kind of report have been discussed previously in this paragraph. Forty-one different types of MUS were introduced up until 2012 [13]. Several different options and types of mesh are or were on the market. Many of these different types of MUS and sorts of mesh have been taken off the market because of high complication rates found in clinical research. With retrospective studies, pre-operative pain is not recorded. Whether the pain already existed pre-operatively rather than arising post-operatively remains unclear. Noncyclical pain lasting longer than 6 months is a very common problem for many women. According to the WHO review, 5.7– 26.6% of women are affected [127]. This makes the pre-operative pain status of major importance when reviewing post-operative pain. In a large recent review study, 292,606 patients for POP surgery and 283,529 MUS patients from 26 studies were included to compare the rates of erosion and chronic pain after POP vs. SUI surgery with mesh [121]. The incidence of chronic pain was significantly higher in the POP group at 6.7% vs. 0.6% in the urinary incontinence surgery group. The study of Barber et al. described an RCT for combined POP and SUI [128]. This comparative study comparing two transvaginal native tissue POP repairs, both performed together with a TVT, showed improvement in the functional activity and pain levels in comparison with pre-operative pain. Given that in normal practice, much urogynaecology surgery consists of combined prolapse and surgery for SUI, this is a reassuring finding for both patients and doctors [129].

Dyspareunia

In a recent large review article, Alwaal et al. described an overall improvement in the sexual function [102]. Although a small percentage of women developed de novo dyspareunia, the trade-off was less coital incontinence, a reduction in anxiety and avoidance of sex and improved self-image and body image. De novo dyspareunia is often found to be due to incorrect placement or due to other complications like erosion or abnormal scar formation.

Retropubic Mid-Urethral Sling Procedure

Removal/cutting TVT Although overall minor and major complication rates are low, sometimes removal of the mesh is necessary. Perforations of the tape through the bladder or urethra usually are revealed during intra-operative cystoscopic evaluation with 30° and 70° lenses or during urethroscopy with a 0° scope. Occasionally, these perforations are missed. Mesh in the bladder can cause stone formation, haematuria, recurrent UTIs, dysuria, urgency or urge incontinence. The widespread use of the retropubic tapes has resulted in increased total numbers of tape removal for complications such as erosion/extrusion. Removal of mesh through the urethra often needs a vaginal approach, but the removal of the mesh by laparotomy, when the mesh has been eroded into the bladder, has been described [128, 130]. Removal from the bladder has also been described by cystoscopy [114, 131] or by combined transurethral and transabdominal laparoscopic approach [132]. The NICE commission in the UK amended its 2013 report in 2019. The committee recommended the retropubic, rather than the transobturator, route because the scientific evidence showed that retropubic mesh slings are more likely to cure incontinence in the short term and less likely to cause complications in the short to medium term. In addition, the committee agreed that the retropubic mesh slings are easier to remove if complications do occur. Endoscopic/cystoscopic removal of mesh can be performed with the use of scissors or a rectoscope. Recently, the usage of a holmium YAG laser has become more popular [133, 134]. The recent review article from Karim et al. showed that this minimally invasive technique has a minimal morbidity and is effective in the removal of the eroded part of the mesh from the bladder and urethra [135]. Laparoscopic/robotic total removal of an MUS has some advantages over open removal and partial cystoscopic removal. The advantages are good direct vision for identification of the anatomy and mesh and the opportunity for complete removal of the entire sling. This is one of the major advantages as possible recurrence will not then be possible anymore. The advantage over laparotomy is obvious: reduced morbidity, shorter post-operative recovery time and better cosmetic results. Pikaart et al. described five removals of TVT by laparoscopy in detail [136]. The removal was performed for three patients with a tape erosion into the bladder and two patients with persistent pain and discomfort. One of the patients with pain had a hysterectomy at the time of the TVT placement, and the other also suffered from erosion in the vagina and obstructive voiding, for which the tape was cut in the midline before removal. Both patients had improved pain symptoms but were not cured. One of these patients was later treated for interstitial cystitis and the other patient for endometriosis. The advice of the authors was to pre-operatively counsel the patients on the possibility of persistent pain after removal. Few other papers describe total or partial laparoscopic removal of TVTs [137–140]. Minimally invasive removal has obvious advantages and is safe and technically feasible in the hands of a trained laparoscopic surgeon. Rouprêt et al. described their findings on the removal of 17 TVTs for pain that the anatomical position of the TVT was often (88%) through the levator ani muscle, too laterally placed from the urethra [137]. Carter et al. described the laparoscopic removal of retropubic MUS [139]. The authors suggest that in case of mesh erosion into or in close proximity to

803 the urethra to perform the surgery in two stages to prevent fistula formation. In conclusion, complete laparoscopic removal of a retropubic MUS is feasible with good results and quick recovery times.

Summary Available data obtained from published clinical reports show that the TVT surgery is effective in the treatment of stress incontinence. In prospective trials, where strict criteria for cure and significant improvement were used, approximately 95% of women having a TVT operation are found to be cured or to have a significant improvement in their stress incontinence. Furthermore, the TVT procedure seems to perform well in all categories of patients for whom incontinence surgery is traditionally recommended, that is, in primary cases of stress incontinence, in cases of prior failed incontinence surgery, in cases with mixed incontinence, in those with ISD and in overweight and obese women. The risk of intra-operative and short-term post-operative complications is low if proper training is provided, and the operation is performed in its standardized way. Recently, mid-urethral tapes were heavily scrutinized because the majority are made of PP, the same material that was used for POP surgery which caused many severe complications. In several countries, strict rules were adopted for the use of PP, and also for MUS, although the complication rates are far lower than for the use of PP with POP surgery. Most governmental institutions, like the FDA, NICE, MHRA and European commission, recommend the use of mid-urethral synthetic slings for the treatment of SUI. The use of PP as synthetic material for TVT incontinence surgery has low complication rates such as erosion/exposure/extrusion/perforation, autoimmune disease, de novo malignancy, pain and dyspareunia and results in a good quality of life post-operatively.

References



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35. Svenningsen R, Staff AC, Schøtz HA, Western K, Kulseng-Hanssen S. Longterm follow-up of the retropubic tension-free vaginal tape procedure. Int Urogynecol J 2013;24:1271–1278. 36. Nilsson CG, Palva K, Rezapour M, Falconer C. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2008:19:1043–1047. 37. Olsson I, Abrahamsson AK, Kroon UB. Long-term efficacy of the tension-free vaginal tape procedure for treatment of urinary incontinence: a retrospective follow-up 11.5 years post-operatively. Int Urogynecol J 2010:21:679–683. 38. Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C. Seventeen years follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J 2013;24:1265–1269. 39. Han JY, Park J, Choo MS. Long-term durability, functional outcomes, and factors associated with surgical failure of tension-free vaginal tape procedure. Int Urol Nephrol 2014;46:1921–1297. 40. Khan ZA, Nambiar A, Morley R, Chapple CR, Emery SJ, Lucas MG. Long-term follow-up of a multicentre randomised controlled trial comparing tension-free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women. BJU Int 2015;115:968–977. 41. Manach Q, Bouquot M, Rouprêt M, et al. Résultats fonctionnels à long terme de la bandelette sous-urétrale rétropubienne TVT (tension-free vaginal tape) pour le traitement de l’incontinence urinaire d’effort féminine: étude monocentrique prospective [Placement of tension-free vaginal tape in women with stress urinary incontinence: long-term functional outcomes in a prospective series]. Prog Urol 2017;27:640–646. 42. Serati M, Sorice P, Bogani G, et al. TVT for the treatment of urodynamic stress incontinence: efficacy and adverse effects at 13-year follow-up. Neurourol Urodyn 2017;36:192–197. 43. Braga A, Caccia G, Sorice P, et al. Tension-free vaginal tape for treatment of pure urodynamic stress urinary incontinence: efficacy and adverse effects at 17-year follow-up. BJU Int 2018;122:113–117. 44. Holdø B, Verelst M, Svenningsen R, Milsom I, Skjeldestad FE. The retropubic tension-free vaginal tape procedure—Efficacy, risk factors for recurrence and long-term safety. Acta Obstet Gynecol Scand 2019;98:722–728. 45. Maggiore ULR, Agrò EF, Soligo M, Marzi VL, Digesu A, Serati M. Longterm outcomes of TOT and TVT procedures for the treatment of female stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J 2017;28:1119–1130. 46. Hansen MF, Lose G, Kesmodel US, Gradel KO. Reoperation for urinary incontinence: a nationwide cohort study, 1998-2007. Am J Obstet Gynecol 2016;214:263.e1–263.e8. 47. Rezapour M, Ulmsten U. Tension-free vaginal tape (TVT) procedure in women with recurrent stress urinary incontinence—a long-term follow up. Int Urogynecol J Pelvic Floor Dysfunct 2001;12:S9–S11. 48. Azam U, Frazer MI, Kozman EL, Ward K, Hilton P, Rane A. The tension-free vaginal tape procedure in women with previous failed stress incontinence surgery. J Urol 2001;166:554–556. 49. Lo TS, Horng SG, Chang CL, Huang HJ, Tseng LH, Liang CC. Tensionfree vaginal tape procedure after previous failure in incontinence surgery. Urology 2002;60:57–61. 50. Kuuva N, Nilsson CG. Tension-free vaginal tape procedure: An effective minimally invasive operation for treatment of recurrent stress urinary incontinence. Gynecol Obstet Invest 2003;56:93–98. 51. Liapis A, Bakas P, Lazaris D, Creatsas G. Tension-free vaginal tape in the management of recurrent stress incontinence. Arch Gynecol Obstet 2004;269:205–207. 52. Ala-Nissilä S, Haarala M, Mäkinen J. Tension-free vaginal tape a suitable procedure for patients with recurrent stress incontinence. Acta Obstet Gynecol Scand 2010;89:210–216. 53. Sivaslioglu AA, Unlubilgin E, Keskin HL, Gelisen O, Dolen I. The management of recurrent cases after the Burch colposuspension: 7 years experience. Arch Gynecol Obstet 2011;283:787–790. 54. Shao Y, He H-C, Shen Z-J, Zhou W-L. Tension-free vaginal tape retropubic sling for recurrent stress urinary incontinence after Burch colposuspension failure. Int J Urol 2011;18:452–457. 55. Lee K-S, Doo CK, Han DH, Jung BJ, Han J-Y, Choo M-S. Outcomes following repeat mid urethral synthetic sling after failure of the initial sling procedure: rediscovery of the tension-free vaginal tape procedure. J Urol 2007;178:1370–1374. 56. Palva K, Nilsson CG. Effectiveness of the TVT procedure as a repeat midurethra operation for treatment of stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2009;20:769–774.

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57. Liapis A, Bakas P, Creatsas G. Tension-free vaginal tape in the management of recurrent urodynamic stress incontinence after previous failed midurethral tape. Eur Urol 2009;55:1450–1455. 58. Stav K, Dwyer PL, Rosamilia A, et al. Repeat synthetic mid urethral sling procedure for women with recurrent stress urinary incontinence. J Urol 2010;183:241–246. 59. Sabadell J, Poza JL, Esgueva A, Morales JC, Sánchez-Iglesias JL, Xercavins J. Usefulness of retropubic tape for recurrent stress incontinence after transobturator tape failure. Int Urogynecol J 2011;22:1543–1547. 60. Hassonah S, Medel S, Lovatsis D, Drutz HP, Alarab M. Outcome of the laparoscopic two-team sling procedure tension-free vaginal tape insertion, and transobturator tape insertion in women with recurrent stress urinary incontinence. J Obstet Gynaecol Can 2013;35:1004–1009. 61. Verbrugghe A, De Ridder D, Van der Aa F. A repeat mid-urethral sling as valuable treatment for persistent or recurrent stress urinary incontinence. Int Urogynecol J 2013;24:999–1004. 62. Meyer F, Hermieu JF, Boyd A, et al: Repeat midurethral sling for recurrent female stress urinary incontinence. Int Urogynecol J 2013;24:817–822. 63. Kim TH, You HW, Ryu DS, Lee KS. Surgical outcome of a repeat midurethral sling procedure after failure of a first procedure. Int Urogynecol J 2015;26:1759–1766. 64. Bakali E, Johnson E, Buckley BS, Hilton P, Walker B, Tincello DG. Interventions for treating recurrent stress urinary incontinence after failed minimally invasive synthetic midurethral tape surgery in women (review). Cochrane Database Syst Rev 2019;9(9):CD009407. 65. Xylinas E, Descazeaud A. [Repeat mid-urethral sling for female stress incontinence after failure of the initial sling]. Prog Urol 2009;19:590–594. 66. Pranhan A, Jain P, Latthe PM. Effectiveness of midurethral slings in recurrent stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J 2012;23:831–841. 67. Agur W, Riad M, Secco S, et al. Surgical treatment of recurrent stress urinary incontinence in women: a systematic review and meta-analysis of randomized controlled trials. Eur Urol 2013;64:323–336. 68. Lo T-S, Wang AC, Liang C-C, Long C-Y, Lee S-J. Treatment for unsuccessful tension-free vaginal tape operation by shortening pre-implanted tape. J Urol 2006;175:2196–2199. 69. Rezapour M, Falconer C, Ulmsten U. Tension-Free vaginal tape (TVT) in stress incontinent women with intrinsic sphincter deficiency (ISD)—a longterm follow-up. Int Urogynecol J Pelvic Floor Dysfunct 2001;12:S12–S14. 70. Kim HG, Park HK, Paick SH, Choi WS. Comparison of effectiveness between tension-free vaginal tape (TVT) and trans-obturator tape (TOT) in patients with stress urinary incontinence and intrinsic sphincter deficiency. PLoS One 2016;11:e0156306. 71. Choo G-Y, Kim DH, Park KH, Paik S-H, Lho Y-S, Kim H-G. Long-term outcome of tension-free vaginal tape procedure for treatment of female stress urinary incontinence with intrinsic sphincter deficiency. Int Neurourol J 2012;16:47–50. 72. Liapis A, Bakas P, Salamalekis E, Botsis D, Creatsas G. Tension-free vaginal tape (TVT) in women with low urethral closure pressure. Eur J Obstet Gynecol Reprod Biol 2004;116:67–70. 73. Meschia M, Pifarott P, Buonaguidi A, Gattei U, Spennaccio M. Tensionfree vaginal tape (TVT) for treatment of stress urinary incontinence in women with low-pressure urethra. Eur J Obstet Gynecol Reprod Biol 2005;122:118–121. 74. Segal JL, Vasallo BJ, Kleeman SD, Hungler M, Karam MM. The efficacy of the tension-free vaginal tape in the treatment of five subtypes of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2006;17:120–124. 75. Jeon M-J, Jung H-J, Chung S-M, Kim S-K, Bai S-W. Comparison of treatment of pubovaginal sling, tension-free vaginal tape and transobturator tape for stress urinary incontinence with intrinsic sphincter deficiency. Am J Obstet Gynecol 2008;199:76.e1–76.e4. 76. Güngördük K, Celebi I, Ark C, Gelikkol O, Yldirim G. Which type of midurethral sling should be chosen for treatment of stress urinary incontinence with intrinsic sphincter deficiency? Tension-free vaginal tape or transobturator tape. Acta Obstet Gynecol Scand 2009;88:920–926. 77. Schierlitz L, Dwyer PL, Rosamilia A, et al. Three-year follow-up of tensionfree vaginal tape compared with transobturator tape in women with stress urinary incontinence and intrinsic sphincter deficiency. Obstet Gynecol 2012;119:321–327. 78. Fischer A, Fink T, Zachmann S, Eickenbusch U. Comparison of retropubic and outside-in transoburator sling systems for the cure of female genuine stress urinary incontinence. Eur Urol 2005;48:799–804. 79. Miller JJ, Botros SM, Akl MN, et al. Is transobturator tape as effective as tension-free vaginal tape in patients with borderline maximum urethral closure pressure? Am J Obstet Gynecol 2006;195:1799–1804.

805 80. Rapp DE, Govier FE, Kobashi KC. Outcomes following mid-urethral sling placement in patients with intrinsic sphincteric deficiency: comparison of Sparc and Monarc slings. Int Braz J Urol 2009;35:68–75. 81. Wlaźlak E, Viereck V, Kociszewski J, et al. Role of intrinsic sphincter deficiency with and without urethral hypomobility on the outcome of tape insertion. Neurourol Urodyn 2017;36:1910–1916. 82. Rafii A, Darai E, Haab F, Samain E, Levardon M, Deval B. Body mass index and outcome of tension-free vaginal tape. Eur Urol 2003;43:288–292. 83. Skriapas K, Poulakis V, Dillenburg W, et al. Tension-free vaginal tape (TVT) in morbidly obese patients with severe urodynamic stress incontinence as a last option treatment. Eur Urol 2006;49:544–550. 84. Hellberg D, Holmgren C, Lanner L, Nilsson S. The very obese women and the very old women: Tension-free vaginal tape for treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2007;18:423–429. 85. Rechberger T, Futyma K, Jankiewicz K, Adamiak A, Bogusiewicz M, Skorupski P. Body mass index does not influence the outcome of anti-incontinence surgery among women whereas menopausal status and ageing do: A randomized trial. Int Urogynecol 2010;21:801–806. 86. Kokanali MK, Cavkaytar S, Kokanali D, Aksakal O, Doganay M. A comperative study for short-term surgical outcomes of midurethral sling procedures in obese and non-obese women with stress urinary incontinence. J Obstet Gynaecol 2016;36:1080–1085. 87. Killingsworth LB, Wheeler TL 2nd, Burgio KL, Martirosian TE, Redden DT, Richter HE. One-year outcomes of tension-free vaginal tape (TVT) mid-urethral slings in overweight and obese women. Int Urogynecol J Pelvic Floor Dysfunct 2009;20:1103–1108. 88. Segal JL, Vassallo B, Kleeman S, Silva WA, Karram MM. Prevalence of persistent de novo overactive bladder symptoms after the tension-free vaginal tape. Obstet Gynecol 2004;104:1263–1269. 89. Abdel-Hady E-S, Constantine G. Outcome of the use of tension-free vaginal tape in women with mixed urinary incontinence, previous failed surgery or low valsalva pressure. J Obstet Gynaecol Res 2005;31:38–42. 90. Holmgren C, Nilsson S, Lanner L, Hellberd D. Long-term results with tension-free vaginal tape on mixed and stress urinary incontinence. Obstet Gynecol 2005;106:38–43. 91. Paik J-S, Oh S-J, Kim SW, Ku JH. Tension-free vaginal tape, suprapubic arc sling and transobturator tape in the treatment of mixed urinary incontinence in women. Int Urogynecol J Pelvic Floor Dysfunct 2008;19:123–129. 92. Kulseng-Hanssen S, Husby H, Schiøtz HA. Follow-up of TVT in 1113 women with mixed urinary incontinence at 7 and 38 months. Int Urogynecol J Pelvic Floor Dysfunct 2008;19:391–396. 93. Palva K, Nilsson CG. Prevalence of urinary urgency symptoms decreases by mid-urethral sling procedures for treatment of stress incontinence. Int Urogynecol J 2011;22:1241–1247. 94. Athanasiou S, Grigoriadis T, Giannoulis G, Protopapas A, Antsaklis A. Midurethral slings for women with urodynamic mixed incontinence: what to expect? Int Urogynecol J 2013;24:393–399. 95. Jain P, Jirschele K, Botros SM, Latthe PM. Effectiveness of midurethral slings in mixed urinary incontinence: A systematic review and meta-analysis. Int Urogynecol J 2011;22:923–932. 96. Laurikainen E, Valpasb A, Aukeec P, et al. Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. Eur Urol 2014;65:1109–1114. 97. Tulokas SA, Rahkola-Soisalo P, Gissler M, Mikkola TS, Mentula MJ. Pregnancy and delivery after mid-urethral sling operation. Int Urogynecol J 2021;32:179–186. 98. Dyrkorn OA, Staff AC, Kulseng-Hanssen S, Schiøtz HA, Svenningsen R. Childbirth after mid-urethral sling surgery: effects on long-term success and complications. Int Urogynecol J 2020 Mar;31:485–492. 99. Bergman I, Söderberg MW, Lundqvist A, Ek M. Associations between childbirth and urinary incontinence after mid-urethral sling surgery. Obstet Gynecol 2018;131:297–303. 100. Kuhn A, Eggeman C, Burkhard F, Mueller MD. Correction of erosion after sub-urethral sling insertion for stress incontinence: results and related sexual function. Eur Urol 2009;56:371–376. 101. Jha S, Ammenbal M, Metwally M. Impact of incontinence surgery on sexual function: a systematic review and meta-analysis. J Sex Med 2012;9:34–43. 102. Alwaal A, Tian X, Huang Y, et al. Female sexual function following midurethral slings for the treatment of stress urinary incontinence. Int J Impot Res 2016;28:121–126. 103. Itkonen Freitas AM, Mikkola TS, Rahkola-Soisalo P, Tulokas S, Mentula M. Quality of life and sexual function after TVT surgery versus Bulkamid injection for primary stress urinary incontinence: 1 year results from a randomized clinical trial. Int Urogynecol J 2021;32:595–601.

806 104. Itkonen Freitas AM, Mentula M, Rahkola-Soisalo P, Tulokas S, Mikkola TS. Tension-free vaginal tape surgery versus polyacrylamide hydrogel injection for primary stress urinary incontinence: a randomized clinical trial. J Urol 2020;203:372–378. 105. Tamussino K, Falconer C, Schraffordt Koops S.E, Nilsson CG. Comment on the editorial by Roovers: “Registries: what level of evidence do they provide?” Int Urogynecol J Pelvic Floor Dysfunct 2008;19:1585. 106. Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand 2002;81:72–77. 107. Tamussino KF, Hanzal E, Kölle D, Ralph G, Riss PA, Austrian Urogynecology Working Group. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol 2001;98:732–736. 108. Dyrkorn OA, Kulsen-Hanssen S, Sandvik L. TVT compared with TVT-O and TOT: results from the Norwegian National Incontinence Registry. Int Urogynecol J 2010;21:1321–1326. 109. Agostini A, Bretelle F, Franchi F, Roger V, Cravello L, Blanc B. Immediate complications of tension-free vaginal tape (TVT): results of a French survey. Eur J Obstet Gynecol Reprod Biol 2006;124:237–239. 110. Schraffordt Koops SE, Bisseling TM, Heintz APM, Vervest HAM. Prospective analysis of complications of tension-free vaginal tape from The Netherlands Tension-free Vaginal Tape study. Am J Obstet Gynecol 2005;193:45–52. 111. Tincello DG, Botha T, Grier D, et al. The TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women. J Urol 2011;186;2310–2315. 112. Schraffordt Koops SE, Bisseling TM, van Brummen HJ, Heintz APM, Vervest HAM. What determines a successful tension-free vaginal tape? A prospective multicenter cohort study: results from The Netherlands TVT database. Am J Obstet Gynecol 2006;194:65–74. 113. Karram M, Segal JL, Vassallo BJ, Kleeman SD. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol 2003;101:929–932. 114. Levin I, Groutz A, Gold R, Pauzner D, Lessing JB, Gordon D. Surgical complications and medium-term outcome results of tension-free vaginal tape: a prospective study of 313 consecutive patients. Neurourol Urodyn 2004;23:7–9. 115. Abouassaly R, Steinberg JR, Lemieux M, et al. Complications of tension-free vaginal tape surgery: a multi-institutional review. BJU Int 2004;94:110–113. 116. Debodinance P, Delporte P, Engrand JP, Boulogne M. Tension-free vaginal tape (TVT) in the treatment of urinary stress incontinence: 3 year experience involving 256 operations. Eur J Obstet Gynecol Reprod Biol 2002;105:49–58. 117. Kristensen I, Eldoma M, Williamson T, Wood S, Mainprize T, Ross S. Complications of tension-free vaginal tape procedure for stress urinary incontinence. Int Urogynecol J 2010;21:1353–1357. 118. Pushkar DY, Godunov BN, Gvozdev M, Kasyan GR. Complications of midurethral slings for treatment of stress urinary incontinence. Int J Gynaecol Obstet 2011;113:54–57. 119. Flock F, Reich A, Muche R, Kreienberg R, Reister F. Hemorrhagic complications associated with tension-free vaginal tape procedure. Obstet Gynecol 2004;104:989–994. 120. Haylen, BT, Freeman RM, Swift SE, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Int Urogynecol J 2011;22:3–15. 121. MacCraith E, Cunnane EM, Joyce M, Forde JC, O’Brien FJ, Davis NF. Comparison of synthetic mesh erosion and chronic pain rates after surgery for pelvic organ prolapse and stress urinary incontinence: a systematic review. Int Urogynecol J 2021;32:573–580.

Textbook of Female Urology and Urogynecology 122. Gurol-Urganci I, Geary RS, Mamza JB, et al. Long-term rate of mesh sling removal following midurethral mesh sling insertion among women with stress urinary incontinence. JAMA 2018;320(16):1659–1669. 123. Rovner E, De Tayrac R, Kirschner-Hermanns R, Veit-Rubin N, Anding R. Is polypropylene mesh material fundamentally safe for use as a reconstructive material in vaginal surgery: ICI-RS 2019? Neurourol Urodyn 2020;39:S132–S139. 124. Cohen Tervaert JW. Autoinflammatory/autoimmunity syndrome induced by adjuvants (Shoenfeld’s syndrome) in patients after a polypropylene mesh implantation. Best Pract Res Clin Rhuematol 2018;32: 511–520. 125. Chughtai B, Sedrakyan A, Mao J, Eilber KS, Anger JT, Clemens JQ. Is vaginal mesh a stimulus of autoimmune disease? Am J Obstet Gynecol 2017;216:495. e1–495.e7. 126. Altman D, Rogers RG, Yin L, Tamussino K, Ye W, Iglesia CB. Cancer risk after midurethral sling surgery using polypropylene mesh. Obstet Gynecol 2018;131:469–474. 127. Latthe P, Latthe M, Say L, Gülmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health 2006;6:177. 128. Barber MD, Brubaker L, Burgio K, et al. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA 2014;311:1023–1034. 129. Volkmer BG, Nesslauer T, Rinnab L, Schradin T, Hautmann RE, Gottfried HW. Surgical intervention for complications of the tension-free vaginal tape procedure. J Urol 2003;169:570–574. 130. Tsui KP, Ng SC, Tee YT, Yeh GP, Chen GD. Complications of synthetic graft materials used in suburethral sling procedures. Int Urogynecol J Pelvic Floor Dysfunct 2005;16:165–167. 131. Irer B, Aslan G, Cimen S, Bozkurt O, Celebi I. Development of vesical calculi following tension-free vaginal tape procedure. Int Urogynecol J Pelvic Floor Dysfunct. 2005;16:245–246. 132. Cornel EB, Vervest HAM. Removal of a missed polypropylene tape by a combined transurethral and transabdominal endoscopic approach. Int Urogynecol J Pelvic Floor Dysfunct 2005;16:247–249. 133. Wang C, Zimmern P, Lemack G. Long-term results of transurethral endoscopic excision using the holmium laser for urethral perforation of synthetic slings. Low Urin Tract Symptoms 2019;11:O103–O110. 134. Shrotri KN, Shervington JP, Shrotri NC. Laser excision of encrusted intra-vesical tension-free vaginal tape (TVT). Int Urogynecol J 2010;21:375–357. 135. Karim SS, Pietropaolo A, Skolarikos A, et al. Role of endoscopic management in synthetic sling/mesh erosion following previous incontinence surgery: a systematic review from European Association of Urologists Young Academic Urologists (YAU) and Uro-technology (ESUT) groups. Int Urogynecol J 2020;31:45–53. 136. Pikaart DP, Miklos JR, Moore RD. Laparoscopic removal of pubovaginal polypropylene tension-free tape slings. JSLS 2006;10:220–225. 137. Rouprêt M, Misraï V, Vaessen C, Cour F, Haertig A, Chartier-Kastler E. Laparoscopic surgical complete sling resection for tension-free vaginal tape-related complications refractory to first-line conservative management: a single-centre experience. Eur Urol 2010;58:270–274. 138. Rigaud J, Pothin P, Labat J-J, et al. Functional results after tape removal for chronic pelvic pain following tension-free vaginal tape or transobturator tape. J Urol 2010;184:610–615. 139. Carter EC, Cartwright R, Goodall E, Jackson S, Price N. A laparoscopic technique for excision of retropubic midurethral sling arms eroding into the bladder. Int Urogynecol J 2019;30:1013–1015. 140. Maher C, Feiner B. Laparoscopic removal of intravesical mesh following pelvic organ prolapse mesh surgery. Int Urogynecol J 2011;22:1593–1595.

74

TRANSOBTURATOR TAPE FOR SURGICAL TREATMENT OF STRESS URINARY INCONTINENCE Outside-In Technique Emmanuel Delorme

Introduction and history In 1990, Mouchel (1) was the first to attempt to recreate the natural urethral supportive system with a mesh for the treatment of stress urinary incontinence (SUI). At about the same time, Delancey (2, 3) described the anatomy of the pelvic–pubic fascia and theory of occlusion of the urethra on the retrourethral fascia by the pressure generated by exertion. More recently Petros and Ulmsten (4, 5) applied DeLancey’s law to clinical practice and introduced the concept of tension-free tape, describing retropubic tape (RPT). The tape is held in place solely by friction with the tissues through which it passes. The principle of the transobturator sling links the concepts above and clinical experience: it reproduces, in location and orientation, the effect of the suburethral fascia covering the urogenital gutter, behind the urethra, from one puborectalis muscle to the other. The transobturator tape (TOT) sling is held in place by friction between the tape and the musculoaponeurotic structures of the obturator foramen. The perineal procedure is performed in an area located between the aponeurosis of the levator ani muscle above, the perineal membrane below, the obturator foramen laterally, and the urethra and paraurethral space medially (Figs. 74.1 and 74.2). This part of the perineum does not contain any vascular, nervous, or visceral structures. The transobturator urethral suspension pathway is flatter than for retropubic suspension. Compared to RPT, the primary aim of the transobturator route was to decrease the risk of visceral (bladder, bowels), and vascular (Santorini’s plexus, iliofemoral vessels) injuries. The second aim was to reduce voiding dysfunction because horizontal urethral suspension is theoretically less likely to cause dysuria than retropubic suspension. The first TOT was implanted in 1999 and the first retrospective series was published in 2001 (6). The TOT procedure described in the first article published was immature (surgical procedure using an oblique transobturator pathway) and incurred various complications, which led to the development of the so-called horizontal TOT which we have been practising since 2003. This is the procedure that is described in this chapter.

Anatomy The first anatomical studies published or communicated on TOT were based on the work of Delmas (7). The obturator foramen comprises, from outside in, the middle adductor muscle, the external obturator muscle, the obturator membrane, and the internal obturator muscle. In its medial aspect, the obturator foramen is divided into two parts by the parietal insertion of the levator ani muscle. The upper part, above the levator ani muscle,

DOI: 10.1201/9781003144243-81

is the pelvic area. At its superolateral angle it contains the obturator canal that is crossed by the obturator pedicle. On this level, the obturator foramen is very close to the bladder that rests on the levator ani muscle. The lower part of the obturator foramen is under the obturator insertion of the levator ani muscle (Fig. 74.2). The perineal space is located under the superior aponeurosis of the levator ani muscle, above the perineal membrane, and from bottom to top is laterally bound by the ischiopubic ramus and the internal obturator muscle; its medial boundary is the paraurethral space and urethra. This part of the perineal space does not contain any vascular, nervous, or visceral structures. The tape should be located within the perineal space (Figs. 74.1 and 74.2) and it is important to pay attention to three anatomical structures at risk along the transobturator pathway of the tape: The urethra, the neck and base of the bladder, which must be identified and protected by the finger when passing the tunneling device. There is little risk of injuring the bladder and urethra (1%) but endoscopy remains essential at the end of the procedure to confirm that the tape has not transfixed the urethra or the bladder. The posterior terminal sensory branch of the obturator nerve innervates the medial side of the thigh. This structure is located around 15mm outside of the angle between the ischiopubic branch and the pubic bone. Flexing the hip does not create a gap between the posterior terminal branch of the obturator nerve and the ischiopubic bone. Experience has shown that the most worrying complication of TOT (and the most difficult to treat) is pain in the groin, including injury of the posterior terminal branch of the obturator nerve. The best way of preventing this complication is to keep the needle in contact with the bone and never deviate from it (Fig. 74.2). The pudendal pedicle and more specifically its terminal branch, the dorsal nerve of the clitoris. This nerve follows the medial side of the ischiopubic ramus from back to front. Experience has shown that lesions of this nerve have rarely been reported in the literature.

Surgical technique (tunneling device from outside to inside) Prosthesis and surgical instruments

The tunneling device is a needle with the functional part shaped into a suitable curve, fitted with a fastening system to draw the tape through the obturator foramen. There are various types of tunneling devices with different systems for securing the tape to their tip. We prefer a straight needle (Fig. 74.2) that is, in our 807

Textbook of Female Urology and Urogynecology

808 Bladder

Obturator muscles

Pelvic area

Levator muscle TOT

TOT

Perineal area

Perineal membrane

Vagina

Urethra

FIGURE 74.1  Transobturator tape is a perineal tape. (With permission from Analytic Biosurgical Solutions ABISS, St-Etienne, France.)

opinion, easier to position than a helicoidal needle. The tape must be made of knitted monofilament polypropylene. The tapes are either highly elastic, requiring a plastic sheath for placement, or low-elasticity tapes that do not require a plastic sheath.

Patient position

Anesthesia

Surgical technique

Any type of anesthesia is acceptable, as the adjustment of the position of the tape does not necessarily require patient participation. The anesthesia can be general, regional (spinal), or local.

The patient is placed in the dorsal lithotomy position. In this position, the hips are slightly less flexed avoiding risk of neural compression consecutive to hyperflexion of the hip. For peroperative guidance, a urethral catheter may be useful to facilitate manual location of the urethra. Always use a urethral catheter of the same size to standardize the adjustment of the tape behind the urethra.

  FIGURE 74.2  (a) The straight needle is in the perineal area under the levator muscie. 1 – Pubic Bone, 2 – Levator muscle, 3 – Perineal membrane, 4 – Perineal area, 5 – Pelvic area. (b) Groin dissection: the needle, must be against the ischiopubic bone. 6 – Ischiopubic bone, 7 – Obturator fossa, 8 – Obturator cana, 9 – Anterior terminal branch of obturator nerve, 10 – Posterior terminal branch of obturator nerve. (With permission from Doctor JP Spinosa, Lausanne Switzerland.)

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FIGURE 74.3  Vaginal incision and dissection: (a) mucosal incision; (b) suburethral fascial incision; (c) dissection between urethra and fascia, respecting the perineal membrane. The sagittal retrourethral incision, which crosses the full thickness of the vaginal wall, must be wide enough to insert a finger (Fig. 74.3). From this incision, dissect the vagina laterally on either side of the urethra. The dissection is then continued up to the ischiopubic ramus. The dissection should be made in the deep anatomical plane, between the suburethral fascia and the urethra

and not in the superficial surgical plane between the suburethral fascia and the vaginal mucosa. This will reduce the risk of the tape eroding the vagina. The lateral dissection must not disrupt the perineal membrane. A finger inserted beside the urethra will perceive the resistance of the perineal membrane. Incising it will increase the risk of bleeding and eliminate a structure that is instrumental in maintaining the tape in position. The landmarks for the introduction of the transobturator needle are bony landmarks. The goal is to keep the needle against the ischiopubic bone, then turn around it via a horizontal trajectory located at the angle of the pubic bone and the ischiopubic branch (Fig. 74.4). The skin should be punctured vertically on the edge of each ischiopubic ramus, approximatively level with the clitoris (Fig. 74.5). The needle must make contact with the bony branch, then it should be slid along the bone from outside inwards. When the needle leaves contact with the bone it must be turned around it backward, crossing the obturator muscles horizontally. (Fig. 74.4). A finger should be inserted into the incision laterally to the urethra as a guide, but above and behind the pubic bone. In conclusion, the arrival point of the tip of the tunneling device on either side of the urethra determines at which level the tape will be positioned (Fig. 74.5). The tip of the tunneling device should emerge laterally to the urethra. The safest method is to guide the tunneling device around the ischiopubic ramus keeping it in close contact with the bone. When the tip of the tunneling device leaves contact with the bone, the needle crosses the obturator muscles, and can immediately be felt by placing the operative finger behind the pubic bone (at this point only the perineal membrane remains between the needle and finger). The “blind” part of the needle’s pathway is very short when using this method. The course of the tunneling device is horizontal and the needle comes out laterally to the urethra (in an acute angle between the ischiopubic bone and the urethra). Using this horizontal transobturator pathway aiming at the urethral meatus will reduce the risk of the tape slipping toward the neck of the bladder described in the outside/in TOT. By applying this technique, the tape will be located behind the middle third of the urethra, at a distance from the neck of the bladder (Figure 74.6). The aim of this movement is to trace a perineal trajectory with the surgical instrument whilst remaining underneath the superior fascia of the levator ani muscle. Use an index finger inserted into the incision to check that the tunneling device does not come through into the vagina and does indeed pass above the lateral fold at a distance from it. The tip of the index finger in the vaginal incision is then used to push the urethra back upward and inward, protecting it from the needle. The finger will thus come into contact with the tip of the tunneling device laterally under the pubic overhang. It can then be guided by the finger into the vaginal incision. The “blind” part of the pathway, when the tunneling device leaves the bone and comes into contact with the finger is very short (< 15 mm). If it seems longer, then it is advisable to withdraw the tunneling device and start again. Once the tunneling completed, it is advisable to inspect the vagina and check that it has not been pierced by the tunneling device. The tip of the tape is secured to the tip of the needle and then drawn into place.

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FIGURE 74.4  The bony landmarks of the trans-obturator route: (a) upper view of the pelvis (entrance point of the needle between pubic bone and ischio-pubic bone); (b) lateral view of the pelvis, needle against the bone; (c) lateral view of the pelvis, needle leaves and turns around the bone; (d) upper view of the pelvis, short blind horizontal pathway meeting the finger.

FIGURE 74.5  The horizontal pathway of the needle supports the tape level with the urethra – an oblique pathway would increase the risk of transfixing the bladder and position the tape level with the neck of the bladder: (a) obturator incision on the edge of the ischio-pubic bone; (b) the finger vertical behind the pubic bone and lateral to urethra; (c) the finger vertical behind the pubic bone; the horizontal route of the needle; (d) intra-operative view.

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  FIGURE 74.6  (a) Adjustment of the tape behind the urethra; the technique depends on the elasticity of the tape (a low-elasticity tape should be adjusted 5 mm away from the urethra). (b) Tape in place. The tape can also be adjusted behind the urethra by using anatomical parameters. Two points are important when adjusting the position of the tape so as to reduce the risk of urethral compression, which can induce dysuria: 1. With a low-elasticity tape and strong-grasping, a visible space must be left between the tape and urethra (around 5 mm) (Fig. 74.6). 2. With a high-elasticity tape, the tape must rest against the urethra without pressing on it. The best tape is the one that the surgeon is used to. Any change in tape will entail adjustment issues and faulty adjustment which in turn may lead to urethral obstruction or persistent stress incontinence. The surplus tape outside the skin is cut off. The vaginal incision is closed with a few simple resorbable sutures. The obturator incisions do not need to be sutured – take care to separate the skin from the tape. If the obturator incisions are punctiform and vertical, they will tend to close up naturally when the lower limbs are brought into the horizontal position at the end of the procedure. In this area suture material can cause discomfort. It is not necessary to insert a vaginal mesh.

Postoperative care

The catheter is usually removed at the end of surgery or the day after the procedure. Postmictional residue is measured by ultrasound or catheterization. If there is no significant postmictional residue, which is usually the case, the patient can be discharged. If the patient presents with pain, possibly of obturator or pudendal origin, during the period just after surgery, the tape must be removed as soon as possible. The patient must be informed that

it is urgent to consult if she experiences pain in the early postoperative period. If she has postoperative dysuria or urinary retention that persists beyond 4/5 days, it is preferable to loosen the tape by surgical approach before it becomes definitively fixed.

Clinical performance of TOT 1. Background of outside/in TOT Our preliminary series of patients who underwent surgery for SUI with TOT was only a retrospective feasibility study with less than 1 year’s follow-up in general (6, 8).This study proved the feasibility of the intervention. The synthetic material used (non-woven polypropylene with silicone) later proved to be the cause of vaginal erosion and sometimes severe infections. The outcome for the series of tapes placed by the transobturator route was burdened with a higher number of cases of vaginal erosion and infections than the retropubic sling. This was essentially due to the use of materials that were not suitable for the vaginal route: multifilament polypropylene or heat-welded sprayed polypropylene. In a comparative study on tension-free vaginal tape TVT®/IVS® Meschia (9) reported erosion rates of 0% and 9%, respectively. Other publications report infectious complications with this type of material (10, 11). When performing TOT procedures the consensus is currently to use monofilament knitted polypropylene mesh (12) as defined by Ulstem for the retropubic route. The rate of vaginal erosion with monofilament polypropylene knitted mesh tapes is 0.1–2.4% (13, 14). The TOT route has been described in detail thanks to the anatomical studies (15). Concerns about perioperative

Textbook of Female Urology and Urogynecology

812 lesions to the obturator pedicle have been lifted by dissection work that has shown that the tunneling device, then the tape, pass through the lower part of the obturator foramen, that is to say 2.2–2.5 cm from the pedicle with an average of 2.6 cm (20). The TOT remains within the perineal space between the perineal membrane and the levator ani muscles. The first series published on the outside-in transobturator route confirmed the anatomical data. The risk of perioperative complications is low, bladder wounds exceptional (0–0.8%), and urethral wounds rare (0–2.5%) (16, 17). In our prospective study (18) on 185 patients, there were no perioperative complications and no immediate revision surgery was performed. There were 23 immediate postoperative complications. Intermittent catheterization was required for a total of 16 patients. Fourteen of these cases required catheterization for less than 10 days. Two patients suffered from EVA > 3 postoperative pain. The same two patients continue to suffer from chronic pelvic pain with, respectively, 12 and 18 months follow-up. Four patients suffered from urinary tract infections and one patient suffered from pyelonephritis. There were no cases of lateonset serious complications (urethral or vaginal erosion), visceral injuries, or bleeding. The average median follow-up was 23 months. For 68 patients follow-up has been documented for more than 36 months. SUI was cured in 85.3% of cases and improved in 91.2% of cases. Among the urinary urgency patients in the preoperative phase, with urge urinary incontinence or without leakage, urinary urgency was cured in 51.4% of cases, improved in 22.9%, and unchanged in 25.7% of cases. The de novo dysuria rate amounted to 3.3% at 3 months and 4.4% at over 36 months. 2. Current results of TOT and comparison of outside-in TOT® with inside-out TOT In 2003, de Leval (19) proposed an inside-out transobturator route based on the following objectives: to retain the advantages of the transobturator route and to avoid the supposed disadvantages of the outside-in transobturator route (exceptional risk of bladder or urethra injury, caused by the introducer device passed from the outside in, to avoid an incision and excessive dissection of the vagina in order to insert a finger as far as the bone guiding the needle as it emerges in order to avoid any bladder/urethra injury). Anatomical studies have shown that the pathway of the tape was closer to the pudendal pedicle and the posterior

terminal branch of the obturator nerve than in the outsidein route (20, 21). We have several publications concerning the immediate postoperative results of TOT in the medium and long term. Results that are very satisfactory initially do not always remain effective in time. The decrease in efficacy is more or less marked according to the article published. (Table 74.1) Post-operative complications presented a different picture and varied from one series to another (Table 74.1), with several differences in the risk of complications according to the type of procedure: Outside-In TOT versus Insideout TOT. Peroperative complication for TOT were mainly related to bladder or urethral transfixion (1%). Although this complication was rare we still recommend urethrovesical endoscopy after surgery to check that there has been no urethral or bladder effraction. This type of complication is serious in the medium and long term and often complex to manage, sometimes requiring several stages of surgery. Sequellae are possible: Vesical lithiasis, recurrence of the incontinence and chronic pain) (25, 26). Vaginal erosion varied according to the study, in general the percentage reported most frequently ranged between 0 and 3.5% (10, 22–24). For Novara the Out/in version of TOT caused more vaginal erosion than In/Out TOT (27). Post-operative urethral obstruction can lead to either acute urinary retention requiring urethral catheterization (2.2%), or dysuria (10.5%) with, in 14% of the cases, significant post-mictional residu (28). Postoperative urinary retention ranged between 2 and 4.9% (24, 29). Hyperactivite bladder was difficult to assess and varied substantially according to the series and according to the patient population operated (pure stress incontinence or mixed incontinence). It was also assessed in a variable manner according to whether incontinence was due to a hyperactive bladder or even hyperactive bladders without incontinence were counted. In the long term, according to the series, between 10% and 15% (24) of the patients had a hyperactive bladder, which is close to the prevalence of hyperactive bladder in the female population (30). 3. Pain after TOT surgery The transobturator route and more particularly the insideout route may be implicated in the etiology and pathogenesis of postoperative pain (31, 32) and traumatic neuropathy (31). The risk of nerve injuries to the pudendal nerve and the posterior terminal branch of the obturator nerve is

TABLE 74.1: Outcomes for TOT

Follow Up Serati (22)

10 years

Addel Fattah (10)

9 years

Lienhart (23)

7 years

Cocchrane (24) 2017

Voiding Dysfunction Years: 1,5, 10

Pain

Years 10 14% Years: 1,3, 10 X/X/ 9.61% 27%

Years 10 1 patient -

Years 10 0.62% 4.32%

16%

-

1 year 8%

> 5 years 3.8%

6.6%

Number of Patients

SUI: Subjective Cure Rate

Urgency de novo Years: 1,5, 10

165-> 160 TVT-O 341-> 292 TVT-O/TOT 331

Years: 5, 10 92% / 91% Years: 1,3, 10 80%/73%/71% Years: 7 72% Years: 1, 5, 10 82.7-85.4-67.1%

-

Vaginal Erosion Bladder / Uretral Erosion 0 4.5% 0% Bladder and Vagina 0.6–2.2%

Transobturator Tape for Surgical Treatment

813

TABLE 74.2: Outcomes for TOT/RPT

Subjective cure rate < 5 years Subjective cure rate > 5 years Revision surgery

Nyyssönen (41) 2014

Megan. Schimpf (41) 2014

RPT 88.1 70.7 1.5

RPT 71.35

TOT 85.4 67.1 9.4

controversial from the anatomical point of view for the inside-out transobturator approach (15, 33). Pudendal nerve damage has been proven in some studies on the inside-out approach (34).The risk of injury to the posterior terminal branch of the obturator nerve has been demonstrated anatomically (21). Poorly discriminated pain in the groin and root of the thigh region, usually transient, is more common in inside-out procedures. Passing through the pelvic insertion of the adductor longus muscle may be a cause of postoperative pain (21). Inguinal pain is found in most of the inside-out TOT® series, but is found or described less often in outside-in series (35, 36). This difference was confirmed in Biardeau’s Out-in TOT 0.5% and In-Out TOT 1.76% meta-analysis (29). Cases of dyspareunia have been described after a TOT procedure, although studies on sexuality before and after a TOT procedure objectively show an overall improvement in the quality of patients’ sex lives after a TOT as SUI interferes with their sexual relationship (37). Pain can be due to several other etiologies: infection of the implant requiring its removal and also idiopathic retraction of the implant. Chronic inflammatory reactions have also been described perhaps due to painful scar neuroma during prosthetic ingrowth (38). Treatment of such pain requires the removal of the sling (39, 40). 4. Comparison of outside-in TOT and inside-out TOT with retropubic tape We currently have many articles in the literature and meta-analyses grouping together mainly prospective randomized studies including either all the surgical treatments for incontinence or only RPT and TOT (29, 41, 42, 43, 44). Although these are subject to a number of biases and include in part RCTs that are common to several reviews, they do enable us to make more objective comparisons of RPT and TOT. The type of fabric used to make the tape was rarely mentioned in all of these reviews. At the beginning of the TOT experience various different tapes were used: large-pore knitted polypropylene which increased the risk of complications, then only large-pore knitted polypropylene, but with more or less capacity to adhere to the tissues and with different elasticities. This had an influence on the efficacy of the procedures and complications. In his RCT in 2015 E. Constantini (45) compared TOT OBTAPE®, (a heatwelded polypropylene), which became flaky in time and RPT TVT® (large pore knitted polypropylene), which partly explains the bad medium and long-term outcome for TOT in comparison to RPT in this RCT. 5. Outcome of Stress urinary incontinence after TOT and RPT The subjective results of the treatment of urinary stress incontinence were comparable for RPT and TOT with no

TOT 74

Umberto (43) FU > 5 and 2017 RPT

TOT

76.5

81.3

Ford AA (24) Cochrane 2017 RPT 84.4 70.7 1.1

TOT 82.7 67.1 10

significant difference, but TOT revision surgery is more frequent than for RPT (see Table 74.2). For Ipek GurolUrganci et al., the risk of reoperation for SUI was higher (at all time points) in women who had transobturator insertion than in those who had a retropubic insertion (5.3% compared with 4.1% at 9 years after insertion). The risk of any reoperation was not statistically significantly different after retropubic or transobturator insertion with 9 years follow-up (46). In Imamura’s systematic review (44) the subjective cure rate was more significant and in favor of RPT. The odds ratio for RPT versus TOT was 0.74 (0.59 to 0.92), quality of evidence: moderate. In Song’s meta-analysis (42) comparing TVT-S® with RPT and TOT the subjective result for RPT was also better than for TOT. (RPT: OR = 3.3, 95% CI [1.7, 6.4]; TOT: OR = 2.4, 95% CI [1.1, 5.1]) However, in the same study the objective results were identical (RPT: OR = 2.4, 95% CI [1.6, 3.5]; TOT:OR = 2.3, 95% CI). For Megan et al (41) the objective cure rate was superior but not significantly so for RPT versus TOT For Song (OR 1.18, CI 0.95–1.47) the objective cure rate was superior for TOT. In Letícia Maria de Oliveira et al.’s meta-analysis (47) the subjective and objective results for RPT were significantly superior to those of TOT. Sphincteric deficiency is a special case and this may explain why RPT is more effective than TOT. The urodynamic definition of sphincter deficiency varies from one study to another. It is difficult to compare the different series of patients. For some, tapes yield results that are not as good in treating sphincter deficiency as SUI (48). TOT is less effective than RPT in cases of sphincter deficiency (18, 49, 50). Although tapes are not as effective on sphincter deficiency as SUI, they still have their uses in the treatment of sphincter deficiency; for Goktolga, 57.4% of patients are satisfied after 5 years of follow-up (51). Some studies show that placing a tape by the retropubic route is more effective in the short and medium term than the proposed (method for treating) TOT failure, with a 75% longterm success rate (52). This is confirmed by Schierlitz’s (53) prospective comparative study, which proves the greater efficacy of RPT compared to TOT in treating sphincter deficiency at 3-year’s follow-up. The median time to revision surgery for TOT was 15.6 months compared with 43.7 months for RPT (p < 0.001). A. Ford’s meta-analysis (24) confirmed these results with 12% of better results on continence for RPT in patients with sphincteric deficiency. Urethral hypermobility seems to be a criterion that is much more decisive than sphincteric deficiency, in the efficacy of tape and particularly of TOT. Fixity of the urethra is a factor of failure of TOT (54, 55).

Textbook of Female Urology and Urogynecology

814 TABLE 74.3: Complications for TOT/RPT Megan. (41) Schimpf 2014 Vascular and visceral injury Bladder/urethral perforation Vaginal erosion Retention > 6 weeks Second surgery for retention Overactive bladder Groin pain Suprapubic pain Total pain

X. Biardeau (29) 2016

Ford AA (24) Cochrane 2017

Imamura (44) 2019

RPT 0.42

TOT 0

RPT

TOT

RPT 2.06

TOT 0.44

RPT 2.4

TOT 0.5

4.01

0.9

4.33

0.45

4.9

0.6

5

0.2

0.73 2.7

2.08 2.4

2 4.13

2.5 2.07

2 7.2

2.2 3.8

2.1 7.5

2.4 3.5

1.2

1.1

0.87

0.51

6.9

5.3

3.49

5.10

8.2

8

9.5

7.6

6

1.4 2.9 4.3

6.6 0.8 7.4

1.3 4 5.3

6.3 1.2 7.5

1.5

6.5

2.07

6. The complications of RPT and TOT Serious (life-threatening) operative and postoperative complications were rare, accounting for 2.06% of the complications for RPT and 0.44% for TOT: these were vascular and bowel (24). Life-threatening complications were the worst complications of RPT. The most frequent complications for RPT were injuries to the bladder and urethral obstruction (Table 74.3). 4.5% of perforations of the bladder were reported on average according to the series (Table 74.3). They necessitated endoscopy once the tape had been put into place. In principle repositioning the tape corrected the complication. Urethral obstruction with complete urinary retention persisting for over 6 weeks after surgery occurred in 5.38% of the cases for RPT and 2.94% for TOT (mean value for the meta-analyses in Table 74.3). The risk of surgical revision for chronic urinary retention was greater for RPT than for TOT (RR 1.42 (0.53/3.80). Pain was the complication that had the biggest impact and was the most difficult to manage. Chronic pain was the complication that was of the greatest concern for TOT. We saw that it occurred two times more frequently after Inside-OUT TOT than after Outside-In TOT. In Biardeau’s meta-analysis, it occurred two times more frequently after Outside In TOT (4.45%) than after RPT (2.47%) and 3 times more frequently after Inside Outside TOT (6.05%) than after RPT (2.07%) (29). In the majority of IN/OUT and OUT/IN studies TOT was studied with no discrimination. In Cochrane 2017 (24) pain after TOT (7.4%) occurred almost twice as frequently as pain after RPT (4.3%). In Imamura’s meta-analysis (44) of pain after TOT (7.5%.) was 1/3 more frequent than after RPT (5.3%). In all the series infrapubic pain was the most frequently experienced after RPT and pain in the groin after TOT. Pain in the groin can be due to neuropathy (effraction of the terminal posterior branch of the obturator nerve, the pain irradiates to the medial side of the thigh) or, more often, muscular pain, which in most cases disappears spontaneously within less than 8 weeks. According to JC Hou et al. (56) 81% of the patients who present with chronic pain are cured once the tape is removed. Letícia Maria de Oliveira et al.’s review (47) gives a good summary of complications due to RPT/TOT: bladder perforation

(OR, 5.45, 95% CI, 3.33–8.90), urinary retention for less than 6 weeks (OR, 2.00, 95% CI, 1.45–2.77) and return to the operating room due to urinary retention (OR, 3.78, 95% CI, 2.00–7.13). Surgical treatment of SUI using the transobturator sling, in turn, produced significantly more cases of all of the following: leg pain (OR, 0.18, 95% CI, 0.11–0.30), groin pain (OR,0.17, 95% CI, 0.08–0.35), neurological injury (OR, 0.48, 95% CI, 0.27–0.87) and vaginal perforation (OR, 0.24, 95% CI, 0.14– 0.40). In the series studied, the other complications occurred at approximately the same rate whatever the procedure (RPT or TOT). Although there was a marginally lower rate of vaginal erosion in TOT over RPT, the difference was not significant. (5.6 vs. 6.4, p = 0.468). But the interval from insertion to presenting complications among the retropubic sling group was statistically longer than for the transobturator sling (TOT) group (4.26 ± 3.22 vs. 3.69 ± 2.41 years, p value 0.002) (57). To conclude the study of the bibliography, there is a trend that shows better long-term results for RPT than for TOT for treating stress urinary incontinence. However, the type of complication is different: RPT is burdened with life-threatening postoperative complications of the viscera (vascular and bowel) although these are rare and voiding dysfunction. TOT most frequently causes pain in the groin, which is complex to treat and the treatment is not always successful (26). Based on these facts Joseph K.-S. Lee and Peter L. Dwyer (58) recommend RPT rather than TOT based on strong arguments, keeping TOT for cases in which RPT is contraindicated. The difficulty in assessing TOT is due to the following parameters: • The large number of tapes made of materials other than knitted polypropylene at the beginning of the experience. • The surgical technique varies from one surgeon to another. It is true that for the IN/OUT procedure and also for OUT/ IN, the recommended procedure, i.e. sliding the needle along the ischio-pubic bone is not always respected, which anatomically increases the risk of neuropathy or myofascial pain (Fig. 74.2(b) and Fig. 74.4). The quality of medical and surgical management has a considerable impact on the results of this type of surgery. In Blayne’s retrospective study (59) there were 37% less complications when it was performed in a specialized department.

Transobturator Tape for Surgical Treatment According to the bibliography we agree with Lee and Dwyer (58) concerning indicating RPT first, before TOT. However, a preferred indication for TOT can be discussed when the patient has an increased risk of postoperative dysuria, a risk of vital complication and a risk of bladder perforation. Of course, the surgical technique must be perfect and preferentially OUT/IN with endoscopy of the bladder and urethra at the end of surgery. Post-operative follow-up must pay great attention to postoperative pain. It is preferable to remove a tape at an early stage if the patient has pain in her groin.

Conclusion The surgical technique for the implantation of a TOT (outside-in procedure), although simple, must be very strictly observed. The following technical points must be respected to ensure the safety of the procedure: • The vaginal incision must be deep to ensure that the dissection is performed in the anatomical plane between the urethra and retro-urethral fascia. • The trajectory of the tunneling device should be oriented toward the middle third of the urethra; this is achieved by aiming for the urethral meatus until it can be felt with the finger at the top inside the vaginal incision, behind the pubic bone; the needle pathway is horizontal. The needle must pass through the perineal membrane in the angle between the urethra and the ischio-pubic bone branch. • The tunneling device should remain in close contact with the bony ischiopubic ramus throughout its trajectory. • The tip of the finger must be inserted into the incision, to protect the urethra and then to accompany the tip of the tunneling device into the vaginal incision. The result of surgery depends on the indication, on the procedure which must be perfect and on postoperative follow-up.

References

1. Mouchel J. Fixation of Gore-Tex slings to the pubococcygeal tendons: a simple technic of treating stress urinary incontinence using only the vaginal approach. J Gynecol Obstet Biol Reprod (Paris). 1987;16(4):507–12. 2. DeLancey JO. Anatomy and biomechanics of genital prolapse. Clin Obstet Gynecol. 1993 December;36(4):897–909. 3. DeLancey JO. Stress urinary incontinence: where are we now, where should we go? Am J Obstet Gynecol. 1996 August;175(2):311–9. 4. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol. 1995 March;29(1):75–82. 5. Rezapour M, Ulmsten U. Tension-Free vaginal tape (TVT) in women with mixed urinary incontinence–a long-term follow-up. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S15–18. 6. Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Progres En Urol J Assoc Francaise Urol Soc Francaise Urol. 2001 December;11(6):1306–13. 7. Cohen D, Delmas V, Boccon-Gibod L. Anatomy of obturated foramen. Application to trans-obturator slings. Progres En Urol J Assoc Francaise Urol Soc Francaise Urol. 2005 September;15(4):693–9. 8. Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol. 2004 February;45(2):203–7. 9. Meschia M, Pifarotti P, Bernasconi F, Magatti F, Viganò R, Bertozzi R, et al. Tension-free vaginal tape (TVT) and intravaginal slingplasty (IVS) for stress urinary incontinence: a multicenter randomized trial. Am J Obstet Gynecol. 2006 November;195(5):1338–42.

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10. Abdel-Fattah M, Sivanesan K, Ramsay I, Pringle S, Bjornsson S. How common are tape erosions? A comparison of two versions of the transobturator tension-free vaginal tape procedure. Br J Urol Int 2006 September;98(3):594–598. 11. Juma S, Brito CG. Two years follow-up. Neurourol Urodyn 2007;26(1):37–41. 12. Falconer C, Söderberg M, Blomgren B, Ulmsten U. Influence of different sling materials on connective tissue metabolism in stress urinary incontinent women. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S19–23. 13. Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 January;81(1):72–7. 14. Tamussino KF, Hanzal E, Kölle D, Ralph G, Riss PA; Austrian Urogynecology Working Group. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol. 2001 November;98(5 Pt 1):732–6. 15. Delmas V. Anatomical risks of transobturator suburethral tape in the treatment of female stress urinary incontinence. Eur Urol. 2005 November;48(5):793–8. 16. Neuman M. TVT-obturator: short-term data on an operative procedure for the cure of female stress urinary incontinence performed on 300 patients. Eur Urol. 2007 April;51(4):1083–7; discussion 1088. 17. Spinosa JP, Dubuis PY. Suburethral sling inserted by the transobturator route in the treatment of female stress urinary incontinence: preliminary results in 117 cases. Eur J Obstet Gynecol Reprod Biol. 2005 December 1;123(2):212–7. 18. Castaings T, Abello N, Delorme E. Prospective study on 185 females with urinary incontinence treated by an outside-in transobturator suburethral sling. Pelviperineology 2012;18–23. 19. de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003 December;44(6):724–30. 20. Spinosa JP, Dubuis PY, Riederer B. Transobturator surgery for female urinary continence: from outside to inside or from inside to outside: a comparative anatomic study. Progres En Urol J Assoc Francaise Urol Soc Francaise Urol. 2005 September;15(4):700–6. 21. Spinosa JP, Dubuis PY, Riederer BM. Transobturator surgery for female stress incontinence: a comparative anatomical study of outside-in vs insideout techniques. BJU Int. 2007 November;100(5):1097–102. 22. Serati M, Braga A, Athanasiou S, Tommaselli GA, Caccia G, Torella M, et al. Tension-free Vaginal Tape-Obturator for treatment of pure urodynamic stress urinary incontinence: efficacy and adverse effects at 10-year followup. Eur Urol. 2017 April;71(4):674–9. 23. Lienhart J, Vautherin R, Grisard-Anaf M, Frobert JL. Seven-year followup of 331 I-Stop transobturator sling cases in female urinary incontinence treatment. Progres En Urol J Assoc Francaise Urol Soc Francaise Urol. 2014 October;24(12):750–6. 24. Ford AA, Rogerson L, Cody JD, Aluko P, Ogah JA. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017 July 31;7:CD006375. 25. Goujon E, Jarniat A, Bardet F, Bergogne L, Delorme E. Retrospective study on the management and follow-up of 18 patients with a mid-urethral sling penetrating the urethra or bladder. J Gynecol Obstet Hum Reprod. 2018 September;47(7):289–97. 26. Carter P, Fou L, Whiter F, Delgado Nunes V, Hasler E, Austin C, et al. Management of mesh complications following surgery for stress urinary incontinence or pelvic organ prolapse: a systematic review. BJOG Int J Obstet Gynaecol. 2020 January;127(1):28–35. 27. Novara G, Galfano A, Boscolo-Berto R, Secco S, Cavalleri S, Ficarra V, et al. Complication rates of tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol. 2008 February;53(2):288–308. 28. Ahn C, Bae J, Lee KS, Lee HW. Analysis of voiding dysfunction after transobturator tape procedure for stress urinary incontinence. Korean J Urol. 2015 December;56(12):823–30. 29. Biardeau X, Zanaty M, Aoun F, Benbouzid S, Peyronnet B. Approach and complications associated with suburethral synthetic slings in women: Systematic review and meta-analysis. Progres En Urol J Assoc Francaise Urol Soc Francaise Urol. 2016 March;26(4):254–69. 30. Phé V, Gamé X. Non-neurogenic overactive bladder. Progres En Urol J Assoc Francaise Urol Soc Francaise Urol. 2020 November;30(14):865. 31. Boyles SH, Edwards R, Gregory W, Clark A. Complications associated with transobturator sling procedures. Int Urogynecol J Pelvic Floor Dysfunct. 2007 January;18(1):19–22.

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32. Feng CL, Chin HY, Wang KH. Transobturator vaginal tape inside out procedure for stress urinary incontinence: results of 102 patients. Int Urogynecol J Pelvic Floor Dysfunct. 2008 October;19(10):1423–7. 33. Bonnet P, Waltregny D, Reul O, de Leval J. Transobturator vaginal tape inside out for the surgical treatment of female stress urinary incontinence: anatomical considerations. J Urol. 2005 April;173(4):1223–8. 34. Masata J, Hubka P, Martan A. Pudendal neuralgia following transobturator inside-out tape procedure (TVT-O)–case report and anatomical study. Int Urogynecology J. 2012 April;23(4):505–7. 35. Wang W Yan, Zhu L, Lang J He, Li B. A prospective randomized trial of comparing the clinical outcome of tension-free vaginal tape and transobturator tape for stress urinary incontinence. Zhonghua Yi Xue Za Zhi. 2011 April 5;91(13):898–901. 36. Zhu Y Fei, Gao G Lan, He L Sheng, Tang J, Chen Q Ke. Inside out transobturator vaginal tape versus tention-free vaginal tape for primary female stress urinary incontinence: meta-analysis of randomized controlled trials. Chin Med J (Engl). 2012 April;125(7):1316–21. 37. Dursun M, Otunctemur A, Ozbek E, Cakir SS, Polat EC. Impact of the transobturator tape procedure on sexual function in women with stress urinary incontinence. J Obstet Gynaecol Res. 2013 April;39(4):831–5. 38. Klosterhalfen B, Klinge U, Hermanns B, Schumpelick V. Pathology of traditional surgical nets for hernia repair after long-term implantation in humans. Chir Z Alle Geb Oper Medizen. 2000 January;71(1):43–51. 39. Misrai V, Rouprêt M, Xylinas E, Cour F, Vaessen C, Haertig A, et al. Surgical resection for suburethral sling complications after treatment for stress urinary incontinence. J Urol. 2009 May;181(5):2198–202; discussion 2203. 40. Pikaart DP, Miklos JR, Moore RD. Laparoscopic removal of pubovaginal polypropylene tension-free tape slings. JSLS. 2006 June;10(2):220–5. 41. Megan O Schimpf, Rahn David D, Wheeler Thomas L, Patel Minita, White Amanda B, Orejuela Francisco J, et al. Sling surgery for stress urinary incontinence in women: a systematic review and meta-analysis. Am J Obstet Gynecol. 2014 July;211(1):71.e1–27. 42. Song Pan, Wen Yibo, Huang Chuiguo, Wang Wancong, Yuan Naijun, Lu Yinliang, et al. The efficacy and safety comparison of surgical treatments for stress urinary incontinence: a network meta-analysis. Neurourol Urodyn. 2018 April;37(4):1199–211. 43. Maggiore Umberto Leone Roberti, Agrò Enrico Finazzi, Soligo Marco, Marzi Vincenzo Li, Digesu Alex, Serati Maurizio. Long-term outcomes of TOT and TVT procedures for the treatment of female stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2017 August;28(8):1119–30. 44. Imamura Mari, Hudson Jemma, Wallace Sheila A, MacLennan Graeme, Shimonovich Michal, Omar Muhammad Imran, et al. Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trials. BMJ. 2019 June 5;365:l1842. 45. Constantini E, Kocjancic E, Lazzeri M, Giannantoni A, Zucchi A, Carbone A, et al. Long-term efficacy of the trans-obturator and retropubic midurethral slings for stress urinary incontinence: update from a randomized clinical trial. World J Urol. 2016;34(4):585–93. 46. Gurol-Urganci Ipek, Geary Rebecca S, Mamza Jil B, Duckett Jonathan, El-Hamamsy Dina, Dolan Lucia, et al. Long-term rate of mesh sling





















removal following midurethral mesh sling insertion among women with stress urinary incontinence. JAMA. 2018 October 23;320(16):1659–69. 47. Oliveira Letícia Maria de, Dias Marcia Maria, Martins Sérgio Brasileiro, Haddad Jorge Milhem, Girão Manoel João Batista Castello, Castro Rodrigo de Aquino. Surgical treatment for stress urinary incontinence in women: a systematic review and meta-analysis. Rev Bras Ginecol Obstet. 2018 August;40(8):477–90. 48. Paick JS, Oh SJ, Kim SW, Ku JH. Tension-free vaginal tape, suprapubic arc sling, and transobturator tape in the treatment of mixed urinary incontinence in women. Int Urogynecol J Pelvic Floor Dysfunct. 2008 January;19(1):123–9. 49. Tomoe H, Kato K, Oguchi N, Takei M, Sekiguchi Y, Yoshimura Y. Surgical treatment of female stress urinary incontinence with a transobturator tape (Monarc): short-term results of a prospective multicenter study. J Obstet Gynaecol Res. 2010October;36(5):1064–70. 50. Romancik M, Kollarik B, Lenko V, Labudova V, Obsitnik M, Sedlar J, et al. Critical appraisal of prognostic factors for transobturator tape implantation. Bratisl Lek Listy. 2010;111(12):647–52. 51. Goktolga U, Atay V, Tahmaz L, Yenen MC, Gungor S, Ceyhan T, et al. Tension-free vaginal tape for surgical relief of intrinsic sphincter deficiency: results of 5-year follow-up. J Minim Invasive Gynecol. 2008 February;15(1):78–81. 52. Sabadell J, Poza JL, Esgueva A, Morales JC, Sánchez-Iglesias JL, Xercavins J. Usefulness of retropubic tape for recurrent stress incontinence after transobturator tape failure. Int Urogynecology J. 2011 December;22(12):1543–7. 53. Schierlitz L, Dwyer PL, Rosamilia A, Murray C, Thomas E, De Souza A, et al. Three-year follow-up of tension-free vaginal tape compared with transobturator tape in women with stress urinary incontinence and intrinsic sphincter deficiency. Obstet Gynecol. 2012 February;119(2 Pt 1):321–7. 54. Ghezzi F, Serati M, Cromi A, Uccella S, Salvatore S, Triacca P, et al. Tensionfree vaginal tape for the treatment of urodynamic stress incontinence with intrinsic sphincteric deficiency. Int Urogynecol J Pelvic Floor Dysfunct. 2006 June;17(4):335–9. 55. Haliloglu B, Karateke A, Coksuer H, Peker H, Cam C. The role of urethral hypermobility and intrinsic sphincteric deficiency on the outcome of transobturator tape procedure: a prospective study with 2-year follow-up. Int Urogynecology J. 2010 February;21(2):173–8. 56. Hou Jack C, Alhalabi Feras, Lemack Gary E, Zimmern Philippe E. Outcome of transvaginal mesh and tape removed for pain only. J Urol. 2014 September;192(3):856–60. 57. Miklos John R, Chinthakanan Orawee, Moore Robert D, Mitchell Gretchen K, Favors Sheena, Karp Deborah R, et al. The IUGA/ICS classification of synthetic mesh complications in female pelvic floor reconstructive surgery: a multicenter study. Int Urogynecol J. 2016 June;27(6):933–8. 58. Lee Joseph K.-S., Dwyer Peter L. Selection of midurethral slings for women with stress urinary incontinence. In Pelvic Floor Disorders pp 305–316/ First Online: 11 December 2020. 59. Welk Blayne, Al-Hothi Hana’a, Winick-Ng Jennifer. Removal or revision of vaginal mesh used for the treatment of stress urinary incontinence. JAMA Surg. 2015;150(12):1167–75.

75

SINGLE-INCISION MINI-SLINGS Mickey Karram and Ahmed Abdelaziz

Introduction In 2006, the single-incision synthetic midurethral sling (MUS) was introduced as a modification to traditional retropubic and transobturator MUSs. These slings were designed to require less dissection in the midurethral area without the need to make additional incisions suprapubically or in the groin. They are placed entirely through an incision in the vagina having no exit point. They were designed to minimize the risk of bladder perforation associated with traditional retropubic MUS and the risk of groin discomfort or other issues related to the inner thigh associated with passage of transobturator slings through the obturator membrane and adductor compartment. Single-incision mini-slings are anchored into the obturator internus muscles or connective tissues of the endopelvic fascia of the retropubic space behind the pubic bone, and more recently, some are anchored directly into the obturator membrane. Tension-free vaginal tape (TVT)-Secur was the first popular device that was used as a single incision mini slings. It had disappointing results and was associated with low cure rates [1]. Because of this, the manufacturer (Ethicon) decided to withdraw TVT-Secur in 2013. Modifications were made to the newer single-incision slings to improve anchoring mechanisms in hopes of fixing the early problems. In January 2012 the FDA ordered post market 522 surveillance studies to address safety and effectiveness related to the use of mini-slings for the treatment of stress urinary incontinence (SUI) [2]. Long-term outcome data have become more available regarding the effectiveness of SIMS as compared to their standard MUS counterparts.

Indications and patient selection Indications for SIMS are similar to the indications for the more traditional MUS in that they can be offered as an initial, definitive treatment of SUI. Because the mini-sling is less invasive than a retropubic or transobturator MUS, it may be desirous for some special patient populations. Because it avoids the retropubic space, the mini-sling may be considered specifically in patients who have undergone previous retropubic and abdominal procedures and may be at higher risk for significant pelvic adhesions. Because it does not entail complete passage of trocars to the skin level, it may be considered in patients with significant soft-tissue mass or obesity in the areas of traditional MUS trocar site exit (i.e., truncal or inter-trigonal obesity) that may surpass the length of the trocar. Because single-incision mini-sling procedures can be done under local anesthesia, they can also be considered in patients with significant comorbidities in whom general anesthesia is contraindicated.

Description of various types of single-incision slings There are different types of SIMS. They are not identical and may differ in the length of the sling, fixation method, fixation location,

DOI: 10.1201/9781003144243-82

and method of tension adjustment or control. TVT secur was one of the first introduced minislings and was withdrawn from the market in 2013. MiniArc (American Medical Systems, Minnetonka, MN), became popular but has since been discontinued by the manufacturer along with all its mesh products to avoid the risk of litigation. Currently there are three available single incision slings in the U.S.A. listed in Table 75.1. The Solyx SIS system (Fig. 75.1) includes a polypropylene mesh tape (9 cm in length) with permanent barbed self-fixating tips and a metal and plastic delivery device or trocar. This system was designed similarly to the MiniArc SIS system, in that each tip of the sling is sequentially attached to the end of the delivery device for mesh placement, which is removed after insertion. The edges of the center 4 cm of the mesh (advertised as the suburethral portion) are bonded together to potentially reduce irritation and the possibility of mesh erosion or extrusion. The Altis SIS system (Fig. 75.2) is a macroporous, knitted, monofilament polypropylene sling (7.75 cm) spanning between the obturator membrane complexes. The sling has a low elasticity at 7.5% similar to collagen fibers; it also has a radiopaque coating for imaging. Affixed to each side of the sling is a monofilament suture. The anchors on the sling are designed to secure maximum pullout force while allowing a flexible secure placement. The tensioning sutures on either end of the mesh allow for a movable anchor with two-way adjustability. This theoretically is meant to prevent sling movement during the healing period. Desara One (Caldera Medical) is a single incision sling that is made of a large pore size polypropylene mesh. It had bidirectional adjustability that features an anchor antirotation system that minimizes the potential for mesh twisting during placement.

Surgical technique 1. Preoperative considerations: Insertion of a mini-sling may be performed under many different types of anesthesia, including general, spinal or epidural, regional, and local. Perioperative antibiotics (e.g., fluoroquinolone or first-generation cephalosporin) are generally administered before the incision. 2. Patient positioning: The patient is positioned in the dorsal lithotomy position with legs in stirrups. The perineum and vagina are sterilely prepared and draped so as to exclude the anus. Lateral labia majora retraction stitches may be placed or a self-retaining retractor may be used to improve vaginal exposure. A weighted vaginal speculum is placed, and bladder drainage is accomplished with a Foley catheter. 3. Vaginal incision: A 1–1.5 cm midline incision is marked starting 1 cm below the urethral meatus, and the area is infiltrated with injectable grade saline or 1% lidocaine with epinephrine for hydrodissection of the periurethral tissues. An Allis clamp may be placed distal to the incision, with care taken not to traumatize the urethral meatus, to 817

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818 TABLE 75.1: Commercially Available Single Incision Miduretheral Sling Kits Solyx Altis Desara

Boston scientific, Marlborough, MA, USA Colpoplast, Minneapolis, MN, USA Caldera Medical, Agura Hills, CA, USA

facilitate visualization. An incision is made sharply with a scalpel. 4. Vaginal flap dissection: Dissection of lateral vaginal flaps proceeds in a standard fashion with attention to developing an appropriately robust and well-vascularized vaginal flap, while not jeopardizing the thickness of the periurethral tissue. This flap is carried laterally and anteriorly until the endopelvic fascia is encountered, but the retropubic space is not entered (Fig. 75.3(a) and (b)). 5. Preparation of the sling: The sling is prepared by inserting the tip of the delivery device or needle into the self-affixing end of the mesh apparatus, ensuring that the mesh is oriented on the outside of the delivery needle. 6. Insertion of sling: To place the SIS (Solyx or Desara), the tip of the delivery needle with mesh assembly attached is inserted into the previously dissected vaginal space and aimed along a path 45° from the midline (Fig. 75.4). The placement should be immediately posterior to the ischiopubic ramus; the needle can be “walked off ” the posterior aspect of the bone, maintaining a close proximity to the posterior surface of the bone. The tip should be advanced until the midline marking on the mesh is situated under the middle of the urethra. The needle is removed from the mesh, attached to the other end of the mesh device, and inserted on the contralateral side in a similar manner, ensuring the mesh lies flat under the urethra, until the proper degree of desired tension is achieved. The delivery device is disengaged and removed. The placement of the Altis adjustable SIS proceeds by the same initial steps (steps 1–4) as previously outlined. After appropriate dissection is completed, the fixed anchor is pushed into the tissue until it is slightly beyond the

FIGURE 75.1  Solyx single-incision sling. (Reproduced by courtesy of Boston Scientific Corporation, Marlborough, MA.)

FIGURE 75.2  Altis single-incision sling. (Reproduced by courtesy of Coloplast, Minneapolis, MN.) ischiopubic ramus. The handle is pivoted toward the obturator internus muscle and membrane. A metal tip of the trocar extends past the anchor allowing for easier placement of the anchor into the obturator membrane. The fixed anchor is pushed through the obturator internus muscle

FIGURE 75.3  (a) Distal anterior vaginal wall incision made prior to passage of a single-incision sling. (b) Note the index finger of the surgeon is used to palpate the lower edge of the inferior pubic ramus.

Single-Incision Mini-slings

819 and membrane. Gentle traction is applied to the suburethral sling to confirm proper fixation. The adjustability of the sling is independent of its insertion and does not lock, which allows the loosening of the sling should it be found to have been set too tightly. Because of the shorter length of inserted mesh, more tension is placed on the mini-sling at the time of insertion than is placed on other types of MUS. The implanted sling should be in close apposition to the urethra with no laxity in the material. The surgeon should use a clamp or right angle to determine that there is no redundancy in the sling material. 7. Cystoscopy: Cystoscopy should be performed to evaluate for bladder injury. 8. Vaginal closure: The vaginal incision is closed in the same way as described previously in which the anterior sulcus is trimmed, and the vaginal incision is closed.

Outcomes

FIGURE 75.4  Technique for placement of the Desara or sling single-incision sling. The sling is placed directly into the obturator internus muscle. (Reproduced from Baggish MS and Karram MM, Atlas of Pelvic Anatomy and Gynecologic Surgery, 3rd ed., Elsevier, St. Louis, MO, 2011. With permission.)

Table 75.1 reviews outcome data on single-incision MUSs. All studies were compared to either retropubic or transobturator MUS. Outcomes of the studies were objective and subjective and assessed at 12, 24, and 36 months postoperatively. There are 2 retrospective studies that reported the outcome of 10 years follow-up. Objective outcomes encompassed negative cough stress test (CST) and the 1 hour pad test. Subjective cure rates included the reported episodes of leaking following the procedure, subjective reports of SUI, self-assessment of cure, overall satisfaction with results, and resolution of symptoms. Randomized control trials included the use of MiniArc, Ajust, Ophira, and Solyx slings. Studies on tension-free tape (TVT)-Secur were excluded from Table 75.2.

TABLE 75.2: Outcome Data on Single Incision Mus Study, Dates

Design

Erickson T et al., 2021[3]

Prospective multicenter

Frigerio M et al., 2021[4]

Enrolled

Inclusion Criteria

Intervention

Outcome and Follow-Up

355

SUI symptoms and objective evidence of SUI

At 12 months, the objective and subjective cure rates appeared similar between the two groups

Retrospective

60

White AB 2020 et al.[5]

Prospective Multicenter, RCT

281

Manso M et al., 2021[6]

Retrospective

172

All women with subjective and urodynamically proven stress urinary incontinence (SUI) who underwent a single incision sling procedure between October 2008 and June 2011 Inclusion criteria included stress predominant urinary incontinence, a positive cough stress test Predominant SUI were consecutively treated with the minisling MiniArc from 2006 until 2013

Altis single-incision sling to retropubic and transobturator slings 10 year follow up with subjective and objective cure symptoms

Hwang JC, et al., 2021[7]

Retrospective

111

Patients with SUI and ISD. ISD was defined as a Valsalva leak point pressure (VLPP) ≤ 60 cmH2O or a maximal urethral closure pressure (MUCP) ≤ 20 cmH2O

Single incision slings Solyx and transobturator slings. 10 -year F/U on patients who received miniarc sling from 2006 to 2013 SIS vs. transobturator slings for SUI with ISD

The objective and subjective cure rates were 86.3% and 88.2%

The treatment success was similar between the two groups at 36 months (90.4% in Solyx, 88.9% in TOT) The objective cure rate at 10 years was 47%; subjective cure rate was 71.4%

The objective and subjective cure rates were similar after SIS and TOT procedures (objective: 76% vs. 76%, P = 0.8; subjective: 78% vs. 83%, P = 0.2) (Continued)

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820 TABLE 75.2 (Continued): Outcome Data on Single Incision Mus Study, Dates

Design

Enrolled

Munoz et al., 2018[8]

RCT

Bai et al., 2018[9]

Meta-analysis

8 studies with 1093

Enzensberger et al., 2010 [10]

RCT Austria

95

+CST, subjective SUI

MiniArc vs. TOT

Oliveira et al., 2008[11] Schellart et al., 2009–2011[12]

RCT Portugal

60

Clinical and urodynamic SUI

MiniArc vs. TVT-O

RCT Multicentered Netherlands

193

Urodynamic SUI

MiniArc vs. TOT

Basu et al., 2009–2012[13]

RCT United Kingdom

71

SUI symptoms and objective evidence of SUI, or failed conservative treatment

MiniArc vs. TVT

Mostafa et al., 2009–2010[14]

RCT Multicenter United Kingdom

137

SUI, failed or declined pelvic floor physical therapy, or primary continence procedure

Ajust vs. TOT

Djehdian et al., 2008–2011[15]

RCT Brazil

130

SUI, no prolapse > Stage I

Ophira vs. TOT

Natale et al., 2008–2010[16]

Prospective multicenter

95

Clinically symptomatic and urodynamic SUI

Ajust

246

Inclusion Criteria

Intervention

Outcome and Follow-Up

All participants SUI

MiniArc SIS and TVT Abbrevo midurethral sling

No significant differences in subjective and objective cure rates at 6 and 12months between MiniArc and TVT Abbrevo No significant difference in subjective and objective cure rates between adjustable SIMS and other slings (transobturator slings and MiniArc Mini-sling noninferior to TVT-O in objective cure rate. Postoperative pain at 48 hours, length of operation shorter for mini-sling. Objective and subjective cure rates equivalent. 1 year follow-up MiniArc noninferior to Monarc subjective and objective cure rate, less postoperative pain with MiniArc. 3-year failure rate significantly higher for single-incision sling vs. retropubic sling; both procedures had reduced efficacy over time. Lower postoperative pain profile in Ajust group, subject, and objective cure rates did not differ between Ajust and TVT-O slings. Mini-sling was inferior to TOT, mini-sling shorter operative time, and less postoperative thigh pain. Objective and subjective cure rates improved in patients treated with Ajust sling.

Adjustable SIMS and other slings (transobturator slings and MiniArc

Complications Complications related to slings are mainly either related to surgical technique or from the mesh material itself. Complications related to surgical techniques that can occur with SIS are similar to the complications that can occur with retropubic and transobturator MUS. In theory, the rate of complications with SIS should be less than the complication rate with MUS, as the surgical technique is simpler (one incision, less dissection). Complications include bladder injury or perforation, bleeding, vaginal mesh extrusion, urinary tract mesh erosion, voiding dysfunction, and urinary retention. Viscous organ damage and major vascular injury still may occur but in theory should be much less common because the needle/trocar trajectory through the retropubic or obturator space is significantly more truncated given the design of the minisling. In a recent systematic review comparing SIS with MUS, there was no significant

difference in the rates of bladder injury, UTI, urinary retention, de novo urgency, mesh extrusion, vaginal erosion, tape release, urgency and reoperation. However, voiding dysfunction was less observed in patients with SIMS [17]. SIS resulted in lower groin pain compared to TOT [18]. If bladder perforation occurs and is discovered on cystoscopy, the sling should be immediately removed. A secondary insertion should not be attempted at that operative time. In the authors’ opinion, cystoscopy should be routinely performed at the time of placement of a SIS. Complications related to the mesh size material are thought to be less common compared to traditional MUS, as less mesh is used. It is believed that the amount of artificial mesh material is the main reason for the severe complications including pelvic and inguinal pain [19]. That would explain why SIS has less pain compared to MUS [20] and why the improvement in sexual life is higher with mini-slings [21]. In recent meta-analysis and cochrance review, mini-slings were associated with significantly

Single-Incision Mini-slings shorter operation times, lower immediate postoperative pain, lower intraoperative blood loss, and lower postoperative voiding [17, 22]. Finally, SIS can be done in an office settings with local anesthesia, which might by another reason for less post operative pain and may contribute to decreasing the costs associated with the treatment of SUI [18, 22].

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Conclusion SISs initially were reported to have higher failure rates with increased rates of mesh erosion. However, several recent studies have found that long-term outcomes for single-incision slings are encouraging, with outcomes comparable with MUS, specifically transobturator slings. This could be secondary to improved design with alteration of the trajectory as well as improved surgeons’ understanding of the SIS procedure. The safety profile for singleincision slings appears to be as good as traditional midurethral slings, if not better, due to simpler technique, smaller amount of mesh used, no need for sling passage through retropubic or obturator spaces, and less need for pain relief. Single-incision slings have shorter operative time with less post-operative pain and can be performed safely as an outpatient surgery under local anesthesia. Improved RCTs with appropriate follow-up and comparison to retropubic slings are still needed.









References



1. Huang W, Wang T, Zong H, Zhang Y (2015) Efficacy and safety of tensionfree vaginal tape-secur mini-sling versus standard midurethral slings for female stress urinary incontinence: a systematic review and meta-analysis. Int Neurourol J 19:246–258. 2. FDA’s Activities: Urogynecologic Surgical Mesh | FDA. https://www.fda. gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh. Accessed 18 May 2021. 3. Erickson T, Roovers JP, Gheiler E et al. (2021) A multicenter prospective study evaluating efficacy and safety of a single-incision sling procedure for stress urinary incontinence. J Minim Invasive Gynecol 28:93–99. 4. Frigerio M, Milani R, Barba M et al. (2021) Single-incision slings for the treatment of stress urinary incontinence: efficacy and adverse effects at 10-year follow-up. Int Urogynecol J 32:187–191. 5. White AB, Kahn BS, Gonzalez RR et al. (2020) Prospective study of a singleincision sling versus a transobturator sling in women with stress urinary incontinence: 3-year results. Am J Obstet Gynecol 223:545.e1–545.e11. 6. Manso M, Botelho F, Silva C, Cruz F (2021) Mini-slings: do they stand the test of time? A 10-year cohort. Urol Int 105:143–147. 7. Hwang JC, Huang WC, Su TH, Lau HH (2021) Evaluation of efficacy and safety of single-incision sling versus transobturator sling in women with stress incontinence and intrinsic sphincter deficiency. Int Urogynecol J 33:985–990. https://doi.org/10.1007/s00192-021-04751-9











8. Melendez-Munoz J, Braverman M, Rosamilia A et al. (2018) TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence – a randomised controlled trial. Eur J Obstet Gynecol Reprod Biol 230:141–146. 9. Bai F, Chen J, Zhang Z et al. (2018) Adjustable single-incision mini-slings (Ajust®) versus other slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications. BMC Urol 18. https://doi.org/10.1186/s12894-018-0357-0 10. Enzelsberger H, Cemer I, Enzelsberger S et al. (2010) MiniArc1 versus Monarc1—a prospective randomized study of the treatment of female stress urinary incontinence with a follow-up of 2 years [in German]. Geburtsh Frauenheilk 70:499–502. 11. Schellart RP, Oude Rengerink K, Van der Aa F et al. (2014) A randomized comparison of a single-incision midurethral sling and a transobturator midurethral sling in women with stress urinary incontinence: results of 12-mo follow-up. Eur Urol 66:1179–1185. 12. Oliveira R, Botelho F, Silva P, et al (2011) Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up. Eur Urol 59:940–944. 13. Basu M, Duckett J. (2010) A randomised trial of a retropubic tensionfree vaginal tape versus a mini-sling for stress incontinence. BJOG 117:730–735. 14. Mostafa A, Agur W, Abdel-All M et al (2012) A multicentre prospective randomised study of single-incision mini-sling (Ajust®) versus tensionfree vaginal tape-obturator (TVT-O™) in the management of female stress urinary incontinence: pain profile and short-term outcomes. Eur J Obstet Gynecol Reprod Biol 165: 115–121 15. Djehdian LM, Araujo MP, Takano CC, et al. (2014) Transobturator sling compared with single-incision mini-sling for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol 123:553–561. 16. Natale F, Dati S, La Penna C, Rombolà P, Cappello S, Piccione E (2014) Single incision sling (Ajust™) for the treatment of female stress urinary incontinence: 2-year follow up. Eur J Obstet Gynecol Reprod Biol 182: 48–52. 17. Kim A, Kim MS, Park YJ, et al. (2019) Clinical outcome of single-incision slings, excluding TVT-Secur, vs standard slings in the surgical management of stress incontinence: an updated systematic review and meta-analysis. BJU Int 123:566–584. 18. Boyers D, Kilonzo M, Mostafa A, Abdel-Fattah M (2013) Comparison of an adjustable anchored single-incision mini-sling, Ajust®, with a standard mid-urethral sling, TVT-OTM: a health economic evaluation. BJU Int 112:1169–1177. 19. Chapple CR, Cruz F, Deffieux X, et al. (2017) Consensus statement of the European Urology Association and the European Urogynaecological Association on the use of implanted materials for treating pelvic organ prolapse and stress urinary incontinence. Eur. Urol 72:424–431. 20. Mostafa A, Lim CP, Hopper L, et al. (2014) Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: an updated systematic review and meta-analysis of effectiveness and complications. Eur. Urol 65:402–427. 21. Nambiar AK, Bosch R, Cruz F, et al. (2018) EAU guidelines on assessment and nonsurgical management of urinary incontinence. Eur Urol 73:596–609. 22. Nambiar A, Cody JD, Jeffery ST, Aluko P (2017) Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev 2017:1–121.

76

READJUSTABLE SLINGS SAFYRE and REMEEX Paulo Palma, Cassio Riccetto, and Carlos Errando Smet

Introduction Slings have been the chosen option for most of the patients complaining stress urinary incontinence (SUI) for a long time. Synthetic slings have turned major surgeries into minimally invasive procedures and also reduce operative time and hospital stay as well as postoperative discomfort and the recovery period. Complex patients include multiple recurrences after previous treatment attempts, specially using mesh, patients with dysfunctional voiding due to fixed urethra, and those with previous urethral reconstructive surgery. Until recently, autologous material was mostly used for this subset based on two major concerns: risk of prosthetic implant infection and urethral erosion leading to pain and urethral fistulas (1). For the management of recurrent stress urinary incontinence and intrinsic sphincteric deficiency (ISD), the EAU recommendations include five different surgeries based on only low-grade evidence (2). Readjustable slings were proposed to allow for a safe and effective management of complex incontinence. This chapter will focus on two most popular commercially available adjustable slings: SAFYRE and REMEEX.

SAFYRE The readjustable and self-anchoring SAFYRE sling (Promedon – Argentina) is a tension-free synthetic sling placed at the mid urethra that makes urethral erosion unlikely. It was developed in ’90s according to the Integral Continence Theory (3). This device allows for tension readjustment if postoperative persistent urinary leakage or retention occurs (4, 5).

Features

From a conceptual standpoint, SAFYRE corresponds to a sling. So, the creation of a suburethral support zone increases urethral resistance and diminishes the rotational as well as the descending movement of the urethra when abdominal pressure increases. Additionally, it improves the coaptation of the urethral lumen at rest and under stress. However, contrary to the classical pubovaginal slings, the SAFYRE is applied in the middle third of the urethra, where the pubourethral ligaments, responsible for natural stability of the urethra, are inserted (4). SAFYRE consists of a polypropylene monofilament mesh which acts as urethral support, held between 2 self-anchoring tails made of polydimethylsiloxane polymer (silicon) (Fig. 76.1). The SAFYRE self-anchoring system is created by a sequence of 4 mm cones displayed in a palm tree trunk conformation, creating a hook-like effect and attaching to the surrounding structures as the pelvic fascias and the abdominal rectus muscle as well. These tails are the key for the readjustable self-anchoring 822

system. In order to minimize the surgical damage to pelvic floor natural support structures, a special 3.5 mm in diameter needle, allows for both retropubic placement, though suprapubic and transvaginal approaches, according to the surgeon’s best skills. The versatile needle is assembled for transvaginal approach when the hooked extremity is introduced inside the needle holder, and for suprapubic approach when assembled the other way (Fig. 76.2). A special curved needle, with a hook-like extremity is used for the transobturator approach (Fig. 76.3). For this unique feature, i.e., universal approach, SAFYRE is the only sling so far that allows for comparing retropubic and transobturator procedures using the same device, in regard to efficacy, safety and complications. In a comparative study, SAFYRE VS and SAFYRE T were analyzed. After a mean follow-up period of 18 months (ranged from 12 to 36 months), according to Blaivas and Jacobs criteria, 116/126 patients (92.1%) who underwent SAFYRE VS procedure and 94/100 (94%) who underwent SAFYRE T were found continent, and 3/126 (2.4%) and 2/100 (2%), respectively, reported significant improvement. At the same study, the impact on quality of life was assessed using the International Consensus of Incontinence Questionnaire Short Form (ICIQUI-SF), which showed significant improvement in all questions compared with preoperative assessment (90% of patients reported that they had less urinary symptoms after surgery, in both groups). At the end of follow-up period, the stress test was negative in all the continent and incontinent patients and the incontinent group was using one pad per day at the most (6).

Retropubic placement through transvaginal or suprapubic approach (SAFYRE VS)

Two 0.5 cm transverse incisions are made close to the superior aspect of the pubic bone 5 cm apart from each other. A longitudinal vaginal incision, 1.5 cm in length is made, starting 1 cm from the urethral meatus. Notice that this incision is not allowed encroaching on the bladder neck. Dissection is done to create a 1 cm tunnel lateral to the urethra for the introduction of the needle. First, the needle is advanced through the vaginal tunnel until the perforation of pelvic floor at the level of the midurethra. Then, it is redirected against the back of pubic bone and advanced continuously to the previously made landmarks in the suprapubic area. Cystoscopy is performed to rule out bladder perforation. After the removal of the holder, SAFYRE SV is attached to the needle and pulled out to the suprapubic area. The same maneuvers are repeated on the other side. The proper tension of the sling is adjusted maintaining a Metzenbaum scissors between the urethra and the sling, to prevent undue tension. The extremities of the sling are cut and the Metzenbaum scissors removed. No further fixation is needed and the incisions are closed in the

DOI: 10.1201/9781003144243-83

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FIGURE 76.1  SAFYRE consists of a polypropylene mesh which acts as a urethral support, held between 2 self anchoring tails made of polydimethylsiloxane polymer.

 

FIGURE 76.3  (a) SAFYRE T Plus set. (b) Detail of the helical needle, with a hook-like extremity is used for the transobturator approach. usual manner (Fig. 76.4). An indwelling catheter is left in place overnight.

Transobturator approach (SAFYRE T)

FIGURE 76.2  (a) SAFYRE VS set. (b) SAFYRE’s needle can be assembled for retropubic transvaginal approach when the hooked extremity is introduced inside the needle holder, and for supra pubic approach when assembled the other way.

SAFYRE T, a monofilament polypropylene mesh, which is held between two self-anchoring silicone columns that associates the universal approach with re-adjustability (7). A 2-cm long vertical vaginal incision is performed at 0.5 cm from the urethral meatus. Minimal vaginal dissection is performed laterally toward the inferior ramus of the pubic bone; this minimal dissection avoids damage to the urethral innervations and allows for the passage of the needle and the anchoring columns. Skin punctures are made bilaterally in the genitofemoral folds at the level of the clitoris. The needle is passed around and under the ischiopubic ramus through the skin, obturator membrane and muscles, and finally out through the vaginal incision. This is accomplished by introducing the needle vertically in the previously made skin incision until the obturator membrane and muscle are perforated. Next, the needle is brought to a horizontal position with the tip heading

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FIGURE 76.4  SAFYRE SV technique. (a) Vaginal incision. (b) In the transvaginal, the needle is inserted through the vaginal incision, laterally to the urethra. approach. (c) Otherwise, in the suprapubic technique, the needle is inserted through the suprapubic punction and guided by surgeon’s finger until the vaginal incision. (d) The proper tension of the sling is adjusted maintaining a Metzenbaum scissors between the urethra and the sling, to prevent undue tension. (e) Scheme of the standard technique.

Readjustable Slings: SAFYRE and REMEEX

825 columns are cut leaving five cones over the skin. This extra length is introduced in the subcutaneous tissue, toward the labia majora for safety and to facilitate the anchoring tails postoperative identification should it be necessary. The skin and vaginal incisions are closed in the usual manner (Fig. 76.5). Cystoscopy should be performed if there is any concern about bladder injury (6, 7). Foley catheter was left in place overnight.

to the surgeon’s index finger in the vaginal incision. This maneuver allows the surgeon to bring the needle safely to the vaginal incision. SAFYRE T sling is then hooked by the tip of the needle and brought to the previously made incision. The same maneuvers are repeated on the other side. A forceps or scissors is placed between the tape and the urethra during intraoperative adjustment, avoiding any tension of the tape. The exceeding silicon

 

 

FIGURE 76.5  SAFYRE T technique. (a) The needle is passed around and under the ischiopubic ramus through the skin, obturator membrane and muscles, and finally out through the vaginal incision. (b) The same maneuvers are repeated in the other side. (c) SAFYRE T sling is then hooked by the tip of the needle and brought to the previously made incision. (d) A forceps or scissors is placed between the tape and the urethra during intraoperative adjustment, avoiding any tension of the tape. (e) In selected cases, a special silicon washer can be used to keep the proper sling adjustment in the postoperative period.

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Martius flap is gently interposed between the neourethra and SAFYRE T, which was left loosened. In this situation, we used to keep patients with a thin Foley catheter (12 or 14 French) for 21–28 days and then take it out and start adjustments if necessary.

Exceptionally, we advised the placement of SAFYRE T at the same moment of urethral reconstruction in selected patients as shown in Figure 76.6, based on the need to provide suburethral support for the neourethra. For this, a

 

 

  FIGURE 76.6  Single procedure urethroplasty plus SAFYRE T implant. A Martius Flap is interposed between the neourethra and SAFYRE to prevent neourethral erosion. SAFYRE was left loosened and adjustment can be performed after 30–40 days postoperative, if necessary. (a) Preoperative. (b) Urethroplasty with vaginal wall (double layer). (c) Harvesting of Martius Flap. (d) Placement of Martius flap. (e and f) SAFYRE implant.

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  FIGURE 76.6 (Continued)  (g) Immediate post operative. (h) 2 months postoperative.

Readjustment technique Tightening

The procedure to tighten SAFYRE can be performed under local or spinal anesthesia. As the extremities of the polydimethylsiloxane tails can be easily palpable in the subcutaneous tissue, local anesthesia with lidocaine 1% solution seems to be the method of choice. Usually, the readjustment of only one tail is enough, avoiding the risk of significant deviation of the urethral axis. A small incision is made over the palpable tail extremity (close to the superior aspect of the pubic bone or genitofemoral folds) and it is gently dissected out and pulled carefully until proper tension is achieved (Fig. 76.7). The bladder is filled with 300 ml saline solution before the procedure, so the patient can be asked to cough and do repeated Valsalva maneuvers to check if leakage occurs. Generally, the readjustment is ideally made within 30 days from the surgery but, theoretically, it can be done at any time after the procedure, because of the formation of a fibroblastic pseudocapsule surrounding the polydimethylsiloxane tail of the SAFYRE that permits easy dissection and mobilization of the tails inside this pseudocapsule, whenever it is necessary.

Loosening

The procedure to loosen the SAFYRE, should be done in the first month to avoid fibrosis and can be performed under spinal, intravenous or local anesthesia. A longitudinal vaginal incision, 1.5 cm in length is made, starting 1 cm below the urethral meatus, and the polypropylene mesh is dissected out from the urethropelvic fascia. The tails are dissected bilaterally, grasped with hemostatic clamps and pulled back, until a Metzenbaum scissors or a rightangle clamp can be comfortably interposed between the mesh and the urethra. A Foley catheter is left in place overnight.

Comments

The retropubic approach has become the most popular approach for SAFYRE implant, due to its preferable use in complex and recurrent patients, but as the transobturator approach avoids the scarred retropubic space in patients with previous failed procedures, it should be considered when retropubic area is considered inaccessible. The trans muscular insertion of transobturator SAFYRE, through the obturator and puborectalis muscles, along with the subcutaneous tunnel, provides good fixation and

anatomical reinforcement of the urethropelvic ligaments, reproducing the natural suspension fascia of the urethra. Among the advantages of this technique, safety, short-operative time and short hospital stay should be highlighted (7). SAFYRE is a hybrid sling for readjustability that is based on the pseudo capsule induced by the silicone columns that allows for moving the anchoring tails upward or downward as needed. As opposed to TVT or other polypropylene minimally invasive slings, the smooth surface of SAFYRE mesh allows for easy primary adjustment during the implant and even during eventual readjustment, besides keeping its resistance and shape due to its low deformity rate. Moreover, the elasticity of polymetylsyloxane tails can provide fine movements according to the changes of patient’s abdominal pressure, acting as a dynamic support. We have previously reported the good results using either the retropubic (5) or transobturator approach. In our series, readjustments were performed under local anesthesia with almost 60% of cure or improvement of residual incontinence. Another study compared the efficacy and safety of synthetic transobturator and aponeurotic retropubic slings for the treatment of stress urinary incontinence in women. Forty patients were randomized for SAFYRE T transobturator sling or aponeurotic retropubic sling. Healing rate was 90.5% (19/21) and 95% (19/20), respectively, after 12 months. The transobturator group presented lesser complication rate than the retropubic group. The authors concluded that the transobturator and the aponeurotic slings techniques were equally effective but the transobturator sling has shown fewer complications and lesser surgical time than the aponeurotic sling (9). The diagnosis of obstruction is frequently underestimated and most of the patients who do not develop complete urinary retention tend to be diagnosed in the late postoperative period, usually after they had presented with urinary tract infection. Although retention can subside after 4 weeks postoperatively, we advise the loosening procedure within this period in order to avoid fibrotic reaction around the sling and to allow for the patients to resume them as soon as possible. SAFYRE self-anchoring system is unique as far as postoperative readjustability is concerned. The procedure is minimally invasive and no large abdominal incision is required for harvesting fascia. Sling fixation to the aponeurosis of the abdominal rectus muscle as in classical slings is also unnecessary. Its late

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  FIGURE 76.7  The procedure for tightening SAFYRE is similar, even when retropubic or transobturator approach was used. A small incision is made over the palpable tail extremity (close to the superior aspect of the pubic bone or genitofemoral folds) and it is gently dissected out and pulled carefully, until proper tension is achieved. (a) Dissection of the tail extremity and insertion of silicon washer. (b) Adjust of the sling tension. During this procedure, the patient can be asked to cough or perform a Valsalva maneuver. (c) The extremity of silicon tail is then cut. (d) The procedure can be performed at one side or bilaterally, taking care to avoid deviation of the urethral axis. adjustments of sling tension are possible in patients presenting persistent incontinence or urinary retention, avoiding major surgeries such as urethrolysis or the need for another sling insertion. The readjustment rate in our series was 10% leading to a success of 40% of the cases and improvement in 20% of this subset of patients (6). It is our understanding that sling tightening in incontinent patients may be done at any time; on the other hand, loosening the sling must be done between 4 weeks and 6 weeks at the latest to avoid bladder outlet obstruction caused by fibrosis. Regarding complications, there were no vascular, bowel or obturator plexus injuries. No patients reported voiding symptoms after 4 weeks of the procedure, confirming the low “de novo” detrusor overactivity rate. In conclusion, results showed that transobturator approach is as effective as the retropubic procedure in the management of female stress urinary incontinence providing high cure rate along with a significant improvement in the quality of life. SAFYRE combines the advantages of the transobturator approach with readjustability and may be an attractive surgical alternative.

SAFYRE T crossover In spite of improvement in techniques and devices, there is a subset of patients who fail to respond to corrective standard antiincontinence procedures. These patients have lost completely the urethral sphincteric function and the urethra acts solely as a conduct. The subset of patients may benefit from undergoing a more obstructive sling that may be fixed with more tension than usually required or ideally by using a standard sling (6). In this scenario, patients must be informed about the possible need for postoperative intermittent self-catheterization and urinary symptoms that may occur subsequently. We firstly described transobturator crossover readjustable sling for treating these complex cases (10).

Technique

The procedure is performed using the SAFYRE T PLUS. This hybrid sling consists of a monofilament polypropylene mesh that acts as a urethral support held between two self-anchoring columns, which are made of an implant grade polydimethylsiloxane

Readjustable Slings: SAFYRE and REMEEX polymer. These columns are the basis of the readjustable selffixing system. The kit has also two soft and radiopaque silicone washers that not only improve fixation when tension is necessary but also allow for easy identification should readjustment become necessary. The procedure is performed with the patient in lithotomy position. An 18F Foley catheter is placed to empty the bladder. A 2-cm vaginal incision is made, 1 cm below the urethral meatus. The vaginal wall is dissected from the underlying periurethral fascia, bilaterally to the inferior ramus of the pubic bone. The urethra is identified and a right-angle clamp is passed between the pubic bone and the urethra, exiting on the other side. One of the extremities of the sling is grasped and brought about behind the urethra to the contralateral side. The same maneuvers are repeated on the other side. Next, bilateral skin punctures are made in the genitofemoral fold at the level of the clitoris, and curved needles are introduced through the obturator foramen. The path is made through the skin, obturator membrane and muscles, around the ischiopubic ramus, and finally out through the vaginal incision. The sling is hooked by the tip of the needle and brought out through the previously made incision. These steps are made on the opposite side to create a spiral sling for better coaptation of the urethra. Silicone washers are used to facilitate latter adjustments should it become necessary. The incisions are closed in the usual manner, and a Foley catheter is left in place overnight (Fig. 76.8). Figure 76.9 demonstrates the final position of the crossover sling using tridimensional helical computer tomography. For readjustment, local anesthesia is applied in the region (2% Lidocaine with epinephrine). A longitudinal incision is made of 2.5–3 cm in the previous surgical scar. Fat tissue is bluntly dissected and an attempt is made to reach out the silicon cones. These cones are often easily found but, in some cases, they may be found underneath the aponeurosis of adductor longus muscle, making an incision necessary. After identifying the silicon column, its extremity is grasped with an Allis clamp, pulled out, and the washer is moved downward increasing coaptation until no urine leakage is seen during Valsalva’s maneuver. After continence is achieved, the exceeding cones are trimmed off. Our first published series, which included 16 patients after 12-months follow-up, 15 women were continent by subjective and objective assessments, and only one remained incontinent. This patient denied any further treatment. If we defined failure as a patient report of less than 50% improvement, with subsequent need for further surgery, the failure rate would be 1 out of 16. The cure rate was 93.7%. Complications included one urethral perforation that was solved by primary closure of the urethral wall; “de novo” urge incontinence developed in 2/16 patients. One patient became incontinent 1 month after the procedure and underwent a successful sling readjustment. The readjustment was performed under local anesthesia. In the same series, there were two patients who had undergone a neourethral reconstruction associated to a Martius flap procedure to avoid vaginal erosion with good clinical outcome. These two patients experienced urinary retention after receiving the crossover sling and were put on clean intermittent self-catheterization for 2 weeks. There was no urethral or vaginal erosion during the follow-up (10).

Comments

Patients with multiple prior anti-incontinence procedures represent a difficult population to treat. They often have an incompetent, difficult to compress urethra, likely because of a combination

829 of urethral denervation and violation of the periurethral fascia as well as their underlying risk factors for SUI (11). They typically had an “open” urethra with low VLPP. The transobturator crossover sling is a relatively simple alternative to major operative procedures in women requiring salvage anti-incontinence surgery. The transobturator approach allows for the anatomical reconstruction of the natural support of the urethra and at the same time, avoids the scared retropubic space in patients with previous failed procedures. The insertion, through the obturator muscle and membrane and the adductor longus muscle aponeurosis, along with the washers, provide good fixation and anatomical reinforcement of the urethropelvic ligaments, reproducing the natural suspension fascia of the urethra. Readjustment can be easily performed under local anesthesia, and only one patient required readjustment in our first published series. Among the advantages of this technique, we can mention that it avoids retropubic dissection, can be performed in a short operative time with short hospital stay. We also treated two patients with neourethral reconstruction because of a urethrovaginal fistula resulting from a complicated labor. These patients had no previous anti-incontinence procedure but did have a nonfunctional neourethra after urethral reconstruction. In selected patients with severe SUI and failed multiple prior surgeries, we have performed transobturator crossover sling surgery as a salvage procedure. In our first published data, this technique has proved to be easy to perform, effective and had minimal complications, which led us to conclude that is was a significantly less-morbid alternative to bladder neck closure and continent diversion. Also, we describe a new transobturator procedure that provides circumferential coaptation of the urethra for SUI treatment in this difficult patient population. Rutman et al. (12) described a circumferential retro pubic sling procedure using a 1 × 15 cm2 piece of soft polypropylene mesh prepared with a zero polyglactin suture applied at each end mostly for neurogenic patients. A clamp was used to pass the mesh between the urethra and pubis. There was a mean 87% overall improvement in symptoms. Of the 37 patients described 92% remained dry between catheterizations. As the management of failed slings may be a difficult situation, spiral sling may be an attractive procedure, especially in patients with normal detrusor function. We believe that crossover sling supports the mid-urethra, preventing urethral hypermobility and improving coaptation.

REMEEX The management of recurrent stress urinary incontinence (rSUI) and intrinsic sphincter deficiency (ISD) remains a challenge in clinical practice, and the guidelines provide only low-grade evidence recommendations (2). The main feature of the REMEEX system (Neomedic Intl. Terrassa, Spain) is its ability to finely adjust the suburethral sling tension to obtain the minimum support necessary to achieve continence during stress, avoiding excessive tension of the sling, and thus infravesical obstruction. This is significant since infravesical obstruction, together with urgency, detrusor hyperactivity and urgency incontinence, has been cited as the explanation for incontinence in up to 76% of cases after surgery in ISD patients (13) and has accordingly been considered the main reason for poor results. In this setting, the ability to readjust the sling tension at any time during patient follow-up is important. This is achieved by

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FIGURE 76.8  SAFYRE T Crossover technique. (a) The urethra is identified and a right-angle clamp is passed between the pubic bone and the urethra, exiting on the other side. (b) One of the extremities of the sling is grasped and brought about behind the urethra to the contralateral side. The same maneuvers are repeated on the other side. (c) Bilateral skin punctures are made in the genitofemoral fold at the level of the clitoris, the silicon tails are push in the same manner of in a transobturator sling, creating a spiral sling for coaptation of the urethra. (d) Silicone washers are used to facilitate latter adjustments should it become necessary. (e) The incisions are closed in the usual manner.

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  FIGURE 76.9  Tridimensional helical computer tomography showing final position of the crossover sling. (a) rest. (b) stress. accessing the tension control system, which is located in the subcutaneous tissue, through a small incision under local anesthesia.

Device and surgical technique

The REMEEX sling consists of a 30 × 15 mm type I macroporous monofilament polypropylene mesh, with two pre-attached polypropylene sutures (Fig. 76.10). There is a tension adjustment system called the “varitensor” that consists of a titanium reel located

in an ultrahigh molecular weight polyethylene (Chirulen®) case. The sutures are connected to the varitensor, and the reel can be turned by means of an attachable stick-like external manipulator, thereby increasing or decreasing the sling tension. The manipulator can be attached and detached from the varitensor using a specific screwdriver (Fig. 76.11). The sling is placed under the mid-urethra through a vaginal incision in the same was as any other mid-urethral sling. Another incision is made in the suprapubic area. The sutures are passed from the vaginal field to the suprapubic field with needles retropubically (Fig. 76.12). Cystoscopy is subsequently performed to confirm bladder integrity. At this moment the nonabsorbable sutures attached to the sling are introduced into the varitensor and fixed by means of a screw (Fig. 76.13). Immediately, the reel into the varitensor is rotated clockwise using the manipulator so that the sutures are winded up into the titanium reel until the sling is left under the mid urethra in a tension-free fashion, and the wounds closed. Postoperatively, the manipulator, which temporarily protrudes through the suprapubic skin (Fig. 76.14), is used to adjust the postoperative sling tension.

Adjustment technique

FIGURE 76.10  Remeex System parts; polypropylene sling with attached polypropylene sutures, tension adjustment system (varitensor), attachable stick (manipulator).

Before removing the Foley catheter the day after the surgery, the bladder is filled to a comfortable capacity with saline. The patient is asked to cough in the standing position or to make other efforts that promote incontinence. In the event of leakage, the tension is increased by rotating the manipulator clockwise until continence is achieved (Fig. 76.15). Some authors perform a pad test at this juncture to confirm continence, and voiding difficulties may also be detected by means of a voiding diary, a post-void

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3

5

FIGURE 76.13  Sutures are fixed to the varitensor with a screw. Suture threads wind up into the titanium reel by turning the manipulator, leaving the sling tension-free under mid urethra.

FIGURE 76.11  The manipulator can be attached and detached from the varitensor using a screwdriver.

FIGURE 76.12  Retropubic passage of the polypropylene sutures from vaginal to the hipogastric field using needles.

FIGURE 76.14 Postoperative suprapubic aspect with varitensor in place and manipulator protruding through the skin.

Readjustable Slings: SAFYRE and REMEEX

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FIGURE 76.15  Adjustment of the sling tension: (a) sling too loose; (b) correct position; (c) sling too tight. residual bladder scan or uroflowmetry. If there is obstruction, the sling tension can be reduced by rotating the manipulator counterclockwise. Once the correct sling adjustment has been obtained, the manipulator is withdrawn (Fig. 76.11), leaving the varitensor in the subcutaneous tissue over the rectus fascia (Fig. 76.16). If further access to the varitensor is necessary, this can be achieved through a minimal skin incision under local anesthesia (Fig. 76.17), locking a new sterile manipulator in place to readjust the tension up or down, as necessary.

FIGURE 76.16  Situation of the varitensor over the rectus fascia, once the manipulator is detached.

Discussion

Since the initial description of the REMEEX device in 2003 (14), it has been regularly employed in patients with rSUI and ISD, and most studies reported in the literature support these indications (15–26). These studies have been of a varying nature, including both retrospective and prospective studies, and Table 76.1 provides a summary of some of the most important. Although there is significant disparity in the criteria used to define success and a lack of consensus regarding patient selection, most studies have reported a cure rate in excess of 80%. Among those studies involving a moderate number of patients, a prospective study by Barrington et al. found a cure rate of 53% among 17 patients with rSUI who were followed up at 5 years (18) and Campos et al. reported a similar rate of 55% among 18 patients with ISD (21); on the other hand, Araco et al. observed a cure rate of 95% in 38 ISD patients followed up at 25 months (16).

FIGURE 76.17  Way of access to the varitensor, generally under local anesthesia, in case of readjustment in the follow-up.

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834 TABLE 76.1: REEMEX – Summary of Clinical Data Author Year

Tipo

N

Indications

F-up

Results

Outcome

Complications

Iglesias 2003 (3)

Pros

21

1y

5%

Pros

29

8m

Subj

23%

Araco 2008 (5)

Pros

38

ISD

25 m

Subj + Obj (PT 10g)

8%

Yoo 2010 (6)

Pros

17

ISD (30%)

1y

Subj + Obj (PT 10g)

6% long term

Barrington 2013 (7)

Pros

17

rSUI

5y

Subj

42%

Yasa 2016 (8)

Pros

19

rSUI

21 m

Obj (CT)

37%

Errando 2017 (9)

Pros

205

rSUI ISD

7.4 y

90.5% Cure 9.5% Failure 93% Cure 7% Improvement 0% Failure 95% Cure 2.5% Improvement 2.5% Failure 82% Cure 18% Mejoradas 0% Failure 53% Cure 35% Improvement 12% Failure 84% Cure 11% Improvement 5.3% Failure 72% Cure Itt 82% Cure Pp

Subj + Obj (PT 10g)

Martinez 2003 (4)

ISD rSUI IOE + POP

Subj + Obj (CT, PT 70 years, previous anti-incontinence surgery, and pelvic radiotherapy

843 were risk factors for failure [5]. The overall reoperation rate for female AUS is vast, 0–80% with explantation ranging from 20% to 50%. This is higher than compared to male AUS implantation; however, the body of literature for female AUS remains limited and when stratified by non-neurogenic versus neurogenice patients it was found that a higher proportion of females with neurogenic causes of incontinence underwent device explantation as compared to males (50% versus 30% respectively) and may indicate better overall outcomes in the non-neurogenic placement setting [5, 18]. A surgical technique can minimize major intraoperative complications. Recognized injuries should be repaired primarily under direct visualization with the interposition of well-vascularized tissues if necessary. In many cases, inadvertent injury to the bladder, urethra, or vaginal wall should not preclude implantation of the device. Surgical judgment should be utilized to determine the safety of completing the procedure. Improvements in the design and manufacture of the device have significantly reduced AUS malfunctions. Device-related issues include fluid loss secondary to tubing fracture at connection sites, cuff leakage at stress points, and kinking of the tubing. Chronic failure may be due to atrophy of the periurethral tissues decreasing the compressive bulk within the cuff, not allowing for pressure to be dispersed evenly around the urethra, resulting in recurrent incontinence. Newly designed cuff backing has addressed this issue; however, it must be considered in cases of failure [19]. Surgical judgment should be used when replacing the malfunctioning portion of the device rather than the whole device. Indications for complete replacement of the device include fluid leakage, which may allow foreign material into the system, or chronic emplacement of the device (more than 3 years) [20]. Device erosion has decreased since the introduction of modified cuff architecture; however, it remains a concern with any foreign body implantation. Significant risk factors for erosions include perioperative injury, incorrect implantation technique, history of prior procedures, and infection [17]. Erosion of the sphincter cuff into the urethra is commonly associated with recurrent incontinence, although urinary tract infection and/or wound surgical site infection may be the first and only symptom. Erosion of the cuff through the vaginal wall is associated with vaginal bleeding and discharge. Erosion of the pressure-regulating reservoir into the bladder is rare and may present as a urinary tract infection or infection of the device. Pump erosion through the labium majora is diagnosed by direct examination. Infection or erosion should be treated with explantation of the entire device in the majority of cases. Reimplantation may be considered after 4–6 months. In cases of cuff erosion into the urethra, the placement of an omental flap between the cuff and urethra is recommended at reoperation. In cases of erosion of the cuff into the urinary tract, salvage of the AUS is not recommended. In the isolated case of erosion of the sphincter tubing through the abdominal skin or erosion of the pump through the labium, aggressive irrigation and debridement of the tissues may make replacement of certain AUS components and wound closure a possibility. When replacement of the pump is necessary, it should be moved to the opposite labium. The device with cuff erosion into the vaginal wall may be salvaged utilizing a Martius flap and vaginal wall closure. Before all salvage attempts, the patient should be counseled as to the high risk of eventual necessity for removal of the complete device.

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TABLE 77.1: Success Rates for Implantation of Artificial Urinary Sphincter Author

No. of Patients

Success

Complications 3 infxn (3%) 1 infxn (2.5%) 3 erosions 9 erosions (29%) 1 abuse (3%) 1 dehiscence (3%)

Scott [26] Light and Scott [27]

139 39

Donovan et al. [21]

31

84% 87% dry 5% 2–3 ppd 68%

Diokno et al. [23]

32

94% dry

Abbassian [13] Appell [1] Duncan et al. [28] Webster et al. [2]

4 34 29 25

Costa et al. [29]

54

100% dry 100% dry 52% improv 92% dry 8% 1–2 ppd 93% improv

Hadley et al. [20] Stone et al. [30]

18 54

89% dry 84% dry 12% improv

Costa et al. [17]

190

Chung et al. [31]

29

88% dry 8% improv 70% dry 13% improv

Revisions 21 revisions (11 cuff malf )

7 revisions 4 cuff malf 0 3 revisions (2 cuff malf ) 1 revision 4 revisions (3 cuff malf )

0 0 8 erosions (28%) 1 post-op death (4%) 3 erosions (6%) 1 infxn (2%) 2 erosions (11%) 4 lost to f/u 3 erosions (6%) 2 unable to use (4%) 12 explants (5.9%)

11 revisions

5 explants (17%)

13 revisions

Abbreviations:  f/u, follow-up; improv, improvement; infxn, infection; malf, malfunction; post-op, postoperative; ppd, pads per day.

Implantation results Success rates for implantation of the AUS in female patients are summarized in Table 77.1. The average success rate ranges from 68% in a series of 31 women studied by Donovan et al. [21] to 100% in women studied by Appell [1] and Abbassian [13]. In a large series of 190 patients, Costa et al. reported success rates of 88% and 81.8% in patients with nonneurogenic and neurogenic bladder, respectively [17]. A study comparing AUS and pubovaginal sling in 77 patients with confirmed ISD revealed favorable results for both procedures (84% vs. 91% respectively) [22]. Table 77.1 also includes the published complications from the same series. Infection was seen in 3–7% of cases. Erosions represented the most common complications, occurring in 7–29% of cases. Reoperation for cuff malfunction or tubing problems has

been as high as 21% in earlier series [23]; however, there is a clear trend toward reduced numbers of device failures due to technological advancements made over the years. Long-term follow-up data for the AUS in women are sparse. Existing reports indicate mechanical or nonmechanical reasons [3]. In a large series of 344 patients with an average follow-up of 9.6 years, 85.6% of women were continent, 26% had surgical revision of the device, and in 30% the device was explanted [24]. Similar continence rates were found in another series of 55 patients at an average follow-up of 9.3 years [25] (Table 77.2). Available data on the outcome of the endoscopic implantation suggest a similar outcome, suggesting that laparoscopic or robotic-assisted laparoscopic implantation of AUS in women is feasible by surgeons who are very experienced laparoscopically (Tables 77.3 and 77.4).

TABLE 77.2: Long-Term Outcome of Artificial Urinary Sphincter in Women Author

No. of Patients

Mean Follow-Up (Years)

Peters and Diokno [25] Vayleux et al. [5]

55 215

9.3 6

Costa et al. [24] Phé et al. [32]

344 34

9.6 17

*Phe et al. [33]

26

7.5 (median)

*Note: The study population was female neurologic urinary incontinence.

Success 84% 73.5% dry 79% satisfied 85.6% 10 years = 79% 15 years = 65% 20 years = 40% 57.5% dry

Revisions (%)

Explantation (%)

35 37

13 7

26 35.2

30 26

35.2

19.2

Artificial Urinary Sphincter for Treatment of SUI

845

TABLE 77.3: Success Rates for Endoscopic Implantation of Artificial Urinary Sphincter Author Ngninkeu et al. [34] Hoda et al. [35] Mandron et al. [36]

Rouprêt et al. [37] Trolliet et al. [38]

No. of Patients

Success (%)

4 2 25

75–100 100 92

12 2 conversions 26

88

3 conversions

19 improvement

Complications

Revisions

Balloon replacement

1

1 vaginal perforation 2 vaginal erosions 20% retention 45% urinary retention

61

30% acute retention, 2 pump migration, 1 vaginal injury, 1 vaginal erosion (2 explantation)

TABLE 77.4: Outcomes of Robot-Assisted Artificial Urinary Sphincter Implantation in Women Author

No. of Patients

Fouriner et al. [39] Biardeau et al. [40] Peyronnet 2016 et al. [41] Peyronnet 2019 et al. [15]

Post-op Complications (%)

Explantation (%)

Revision

16.7 33.3 25 18.3

0 22.2 12.5 2.1

0 0 0 6.1

6 9 8 49

Conclusion The AUS provides uniform circumferential compression of the bladder neck, without changing its position. The AUS is indicated for incontinent women with proven ISD and can be particularly useful in those patients who have undergone previous unsuccessful anti-incontinence procedures. In addition, in those women with ISD and a poorly contractile bladder, the AUS may be the initial treatment of choice over the sling due to its lower incidence of prolonged postoperative urinary retention. The AUS may be placed either with a transvaginal or transabdominal approach. The transvaginal approach affords direct visualization of the difficult dissection of the urethrovaginal plane and the option of a suprameatal incision to allow in the anterior dissection of the urethra. Advantages of the transabdominal approach include lack of a vaginal incision and improved exposure to the endopelvic fascia and anterior bladder neck dissection. Additionally, transabdominal exposure allows the opportunity to perform a deliberate cystotomy to assist in a particularly difficult dissection. The endoscopic implantation of the AUS is feasible, seeming to provide similar outcome in the hands of surgeons who are very experienced in laparoscopy. Regardless of operative approach, emphasis should be placed on meticulous surgical approach as intraoperative complication places the patient at risk for postoperative problems such as infection and erosion with eventual device explantation. The AUS compares well to the success of more traditional procedures for urinary incontinence. The data suggest that placement of the AUS is a safe and effective treatment option for the carefully selected patient with ISD.

References

1. Appell RA. Techniques and results in the implantation of the artificial urinary sphincter in women with type III stress urinary incontinence by a vaginal approach. Neurourol Urodyn 1988;7:613–619. 2. Webster GD, Perez LM, Khoury JM et al. Management of type III stress urinary incontinence using artificial urinary sphincter. Urology 1992;39:499–503.



3. Fulford SC, Sutton C, Bales G et al. The fatae of the “modern” artificial urinary sphincter with a follow-up of more than 10 years. Br J Urol 1997;79:713–716. 4. Wilson TS, Lemack GE, Zimmern PE. Management of intrinsic sphincteric deficiency in women. J Urol 2003;169:1662–1669. 5. Vayleux B, Rigaud J, Branchereau J et al. Pelvic radiotherapy and artificial urinary sphincter in women. Prog Urol July 2012;22(9):534–539. 6. Islah M, Cho SY, Son H. The current role of the artificial urinary sphincter in male and female urinary incontinence. World J Men’s Health 2013;31(1):21–30. 7. Peyronnet B, O’Connor E, Khavari R et al. AMS-800 Artificial urinary sphincter in female patients with stress urinary incontinence: a systematic review. Neurourol Urodyn 2019;38(S4):S28–S41. 8. Appell RA. Sphincter insufficiency: testing and treatment. Curr Opin Urol 1997;7:197–204. 9. Fishman IJ, Scott FB. Pregnancy in patients with the artificial urinary sphincter. J Urol 1993;150:340–341. 10. Burkhard C, Bosch JL, Cruz F, et al. EAU guidelines on urinary incontinence in adults. 2020. Available online at: https://uroweb.org/guideline/ urinary-incontinence/. Accessed 05/10/2020 11. Wang Y, Hadley HR. Artificial sphincter: transvaginal approach. In S Raz, ed. Female Urology, 2nd ed., Vol. 1. Philadelphia, PA: Saunders, 1996, pp. 428–434. 12. Hadley R. Transvaginal placement of the artificial urinary sphincter in women. Neurourol Urodyn 1988;7:292–293. 13. Abbassian A. A new operation for insertion of the artificial urinary sphincter. J Urol 1988;140:512–513. 14. Salisz JA, Diokno AC. The management of injuries to the urethra, bladder or vagina encountered during difficult placement of the artificial urinary sphincter in the female patient. J Urol 1992;148:1528–1530. 15. Long RL, Barrett DM. Artificial sphincter: abdominal approach. In S Raz, ed. Female Urology, 2nd ed., Vol. 1. Philadelphia, PA: Saunders, 1996, pp. 419–427. 16. Peyronnet B, Capon G, Belas O et al. Robot-assisted AMS-800 artificial urinary sphincter bladder neck implantation in female patients with stress urinary incontinence. Eur Urol 2019;75(1):169–175. 17. Costa P, Mottet N, Rabut B et al. The use of an artificial urinary sphincter in women with type III incontinence and a negative marshall test. J Urol 2001;165:1172–1176. 18. Venn SN, Greenwell TJ, Mundy AR. The long-term outcome of artificial urinary sphincters. J Urol 2000;164:702–707. 19. Kowalczyk JJ, Mulcahy JJ. Use of the artificial urinary sphincter in women. Int Urogynecol J 2000;11:176–179. 20. Hadley R, Loisides P, Dickinson M. Long-term follow-up (2–5 years) of transvaginally placed artificial urinary sphincters by an experienced surgeon. J Urol 1995;153:432A, abstract 812.

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21. Donovan MG, Barrett DM, Furlow WL. Use of the artificial urinary sphincter in the management of severe incontinence in females. Surg Gynecol Obstet 1985;161:17–20. 22. Mark SD, Webster GD. Stress urinary incontinence due primarily to intrinsic sphincteric deficiency: experience with artificial urinary sphincter and sling cystourethropexy. J Urol 1994;151(Suppl):420A, abstract 769. 23. Diokno AC, Hollander JB, Alderson TP. Artificial urinary sphincter for recurrent female urinary incontinence: indications and results. J Urol 1987;138:778–780. 24. Costa P, Poinas G, Naoum KB et al. Long-term results of artificial urinary sphincter for women with type III stress urinary incontinence. Eur Urol 2013;63:753–758. 25. Peters VG, Diokno AC. Comparison of the long-term outcomes between incontinent men and women treated with artificial urinary sphincter. J Urol 2006;175:605–609. 26. Scott FB. The use of the artificial urinary sphincter in the treatment of urinary incontinence in the female patient. Urol Clin N Am 1985;12:305–315. 27 Light JK, Scott FB. Management of urinary incontinence in women with the artificial urinary sphincter. J Urol 1985;134:476–478. 28. Duncan HJ, Nurse DE, Mundy AR. Role of the artificial urinary sphincter in the treatment of stress incontinence in women. Br J Urol 1992;69:141–143. 29. Costa P, Mottet N, Le Pellec L et al. Artificial urinary sphincter AMS 800 in operated and unoperated women with type III incontinence. J Urol 1994;151(Pt 2):477A, abstract 1000. 30. Stone KT, Diokno AC, Mitchell BA. Just how effective is the AMS 800 artificial urinary sphincter? Results of long-term follow-up in females. J Urol 1995;153(Pt 2):433A, abstract 817. 31. Chung E, Navaratham A, Cartmill RA. Can artificial urinary sphincter be an effective salvage option in women following failed anti-incontinence surgery? Int Urogynecol J March 2011;22(3):363–366. 32. Phé V, Benadiba S, Rouprêt M, Granger B, Richard F, Chartier-Kastler E. Long-term functional outcomes after the implantation of artificial urinary sphincter in women suffering from stress urinary incontinence. Br J Urol Int;2014;113(6):961–967.

Textbook of Female Urology and Urogynecology 33. Phé V, Léon P, Granger B et al. Stress urinary incontinence in female neurological patients: long-term functional outcomes after artificial urinary sphincter (AMS 800TM) implantation. Neurourol Urodyn 2017;36(3):764–769. 34. Ngninkeu BN, van Heugen G, di Gregorio M et al. Laparoscopic artificial urinary sphincter in women for type III incontinence: preliminary results. Eur Urol June 2005;47(6):793–797, discussion 797. 35. Hoda MR, Gauruder-Burmester A, Kümmel C et al. Management of female stress urinary incontinence. Endoscopic extraperitoneal artificial urinary sphincter-early experience. Urologe A August 2008;47(8):1004–1008. 36. Mandron E, Bryckaert PE, Papatsoris AG. Laparoscopic artificial urinary sphincter implantation for female genuine stress urinary incontinence: technique and 4-year experience in 25 patients. Br J Urol Int October 2010;106(8):1194–1198. 37. Rouprêt M, Misraï V, Vaessen C et al. Laparoscopic approach for artificial urinary sphincter implantation in women with intrinsic sphincter deficiency incontinence: a single-centre preliminary experience. Eur Urol March 2010;57(3):499–504. 38. Trolliet S, Mandron E, Lang H et al. Laparoscopic approach for artificial urinary sphincter implantation for women with severe stress urinary incontinence. Prog Urol September 2013;23(10):877–883. 39. Fournier G, Callerot P, Thoulouzan M, Valeri A, Perrouin-Verbe MA. Robotic-assisted laparoscopic implantation of artificial urinary sphincter in women with intrinsic sphincter deficiency incontinence: initial results. Urology 2014;84(5):1094–1098. 40. Biardeau X, Rizk J, Marcelli F, Flamand V. Robot-assisted laparoscopic approach for artificial urinary sphincter implantation in 11 women with urinary stress incontinence: surgical technique and initial experience. Eur Urol 2015;67(5):937–942. 41. Peyronnet B, Vincendeau S, Tondut L, Bensalah K, Damphousse M, Manunta A. Artificial urinary sphincter implantation in women with stress urinary incontinence: preliminary comparison of robot-assisted and open approaches. Int Urogynecol J 2016;27(3):475–481.

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DIAGNOSIS AND TREATMENT OF OBSTRUCTION FOLLOWING INCONTINENCE SURGERY Urethrolysis and Other Techniques Elisabeth M. Sebesta, Melissa R. Kaufman, W. Stuart Reynolds, Stephen Mock, and Roger R. Dmochowski

Introduction

Etiology

Stress urinary incontinence (SUI) is a common condition among women. This, in combination with an increase in public awareness, has more women actively seeking treatment for SUI. Over 200 surgeries have been described to treat SUI, however in the modern era, Burch colposuspension, pubovaginal sling (PVS), and mid-urethral sling (MUS) are the most popular and effective (1). The introduction of less morbid anti-incontinence procedures has led to a rise in the utilization of surgical management of SUI. In particular, the synthetic MUS has become popular over the last few decades, owing to high efficacy, minimal patient morbidity, and technical simplicity (2). This in turn has led to an increase in the number of patients having postoperative voiding issues. Postsurgical voiding dysfunction (VD) and urinary retention can be transient, however iatrogenic obstruction following anti-incontinence surgery requiring intervention will inevitably occur.

The risk of iatrogenic obstruction after anti-incontinence surgery is often related to technical factors. In a retropubic urethropexy, sutures elevating the bladder neck may be tied too tight and therefore result in overcorrection of the urethrovesical angle, or “hypersuspension.” Additionally, sutures placed too medially can cause urethral deviation. Excessive periurethral scarring can occur anteriorly between the urethra and the pubis and lead to urethral compression. Sutures or surgical material placed too distally can cause urethral kinking and obstruction. Similar mechanisms can occur with transvaginal bladder neck suspensions. With suburethral sling procedures, excessive tension on the sling is usually responsible for obstruction. There is considerable variability in opinion between surgeons as to what constitutes an appropriate amount of tension for a suburethral sling. For a PVS, tensioning may be performed under cystoscopic guidance to determine adequate coaptation of the proximal urethra. This approximately corresponds to a two fingerbreadth width between the rectus fascia and the sutures once tied down. A recent prospective cohort study aimed at developing a reliable objective tensioning technique for PVS found that tensioning with the standard 2–3 fingerbreadths above the fascia resulted in a 20% postoperative retention rate, of whom 50% required surgical intervention (10). Moreover, the authors determined that a sling height from rectus fascia to suture knot of less than 40 mm was significantly associated with rentention, and recommended a sling height of 40–60 mm to minimize retention while maximizing cure of SUI. For synthetic MUS, sling tension should be minimal and should easily accommodate a surgical instrument or metallic sound between the sling and the urethra. As a result, small nuances in tension may explain the difference in outcomes and complications reported by different groups (1). Less commonly, displacement of the sling from its intended position may result in obstruction. In regards to MUS, this is usually the result of the sling being placed too proximally at the bladder neck as opposed to mid-urethra. Sarnelli et al. found that patients with obstruction after TVT had a shorter distance between pubic symphysis and sling as measured on perineal ultrasound (11). The shorter distance either correlates to a sling placed more proximally or tighter, either of which may result in obstruction. Based on anecdotal experience in removing obstructive slings, the authors have found they are most likely to be placed too proximally near the bladder neck. In addition, the authors have found that progression of anterior and apical pelvic organ prolapse (POP) can cause a nonobstructive sling to become obstructive 10 years or more after placement of the sling. Occasionally, postoperative retention is caused by learned VD or failure of relaxation of the striated urethral sphincter (12). In

Incidence of obstruction and voiding dysfunction after anti-incontinence surgery The incidence of iatrogenic obstruction and VD varies widely in the literature, ranging from 2.5% to 24%, with the true incidence unknown and likely underestimated for a multitude of potential reasons (3) (Table 78.1). The American Urological Association (AUA) panel cited a 1–10% risk of either retention lasting greater than 28 days or requiring intervention after incontinence surgery (4). In a large review of 1,175 tensionfree vaginal tape (TVT) procedures, 23 women (1.9%) were found to have persistent VD that required sling release (5). Twenty women had urinary retention or incomplete emptying while three had refractory urgency/urge urinary incontinence (UUI). In the Finnish nationwide TVT database of 9,040 patients, 50 cases (0.6%) of sling release for urinary retention were reported (6). Although MUS has reportedly lower rates of postoperative obstruction, this has actually varied somewhat in the literature (7). When comparing difference anti-incontinence procedures, a meta-analysis from 2010 and its update from 2017 on colposuspensions, PVS, and MUS found the incidence of storage and voiding lower urinary tract symptoms (LUTS) to be similar among the different procedures (8, 9). In comparing retropubic (RP) versus transobturator (TO) MUS, the risk of voiding LUTS was significantly higher in RP slings (9.2% versus 5.7%), however the rates of storage LUTS, need for clean intermittent catheterization (CIC), and reoperation rates were similar (9).

DOI: 10.1201/9781003144243-85

847

848 TABLE 78.1: Potential Factors for Varying Incidence of Obstruction and Voiding Dysfunction after Stress Urinary Incontinence Surgery • • • • • •

No standardized definition of obstruction in this setting. Lack of consensus on urodynamic criteria for obstruction. Symptoms can range from irritative to obstructive. Patient loss to follow-up. Patient loss to seeking second opinion. Patient may elect to remain obstructed rather than undergo further surgery or risk recurrence of incontinence. • Diagnosis during early postoperative period when symptoms can be transient.

these cases, patient education, and sometimes biofeedback, can be helpful. When the problem persists, botulinum A toxin injection into the urethral sphincter has been reported to be successful, but should be used with caution (13). Finally, impaired detrusor contractility may be responsible for a “relative obstruction” after incontinence surgery. Sometimes, this can be diagnosed preoperatively and the patient may then be appropriately counseled prior to surgery. The pathophysiology of obstructive symptoms is fairly easy to explain, but that of de novo storage symptoms is more complex. However, it is important to remember that a portion of patients who preoperatively have mixed symptoms will have their urge symptoms assume a more prominent and bothersome role once the SUI has been cured postoperatively (14). Several authors have demonstrated detrusor instability in association with obstruction (15, 16). While obstruction may be evident immediately after surgery, storage symptoms tend to become increasingly prevalent as the bladder adjusts to the obstruction over weeks or months, with increasing incidence of UUI demonstrated over time after PVS (17). It is believed by some that detrusor overactivity secondary to obstruction develops due to the acquired parasympathetic denervation sensitivity, while others believe that damage inflicted on the autonomic innervation of the bladder by surgical dissection leads to this without obstruction (18, 19). Others have suggested alterations in cholinergic and purinergic afferent pathways due to obstruction play an integral role in the development of storage symptoms (20). Although the exact pathophysiological mechanisms may not be agreed upon, it is clear that de novo storage symptoms do develop in many patients with urethral obstruction.

Identifying risk factors for postoperative obstruction or voiding dysfunction Ideally, for both patient selection and informed preoperative counseling, clear risk factors for postoperative urinary retention and VD would be identified, however, there are no definitive conclusions in current literature. Some risk factors cited include prior anti-incontinence surgery (21), concomitant POP surgery (22, 23), patient age 75 years or older (24), elevated preoperative post-void residual (PVR) volume > 100 mL (25), and preoperative Qmax < 20 mL/s (25). A prospective study to identify predictors of passing voiding trial after MUS found only preoperative Qmax > 30 mL/s had a 100% positive predictive value for voiding trial passage postoperatively (26). Other characteristics such as prior incontinence procedure, concurrent anterior repair, and elevated PVR volume were not found to be

Textbook of Female Urology and Urogynecology significantly predictive of voiding trial passage using multivariate analysis in their study. While evidence exists that women who void with no/minimal detrusor pressure or who void primarily with Valsalva maneuvers are more likely to require prolonged catheterization postoperatively (27, 28); there are some conflicting reports with regards to this association (29, 30). Therefore, low detrusor pressure and Valsalva voiding should not exlude a woman from having an antiincontinence procedure. A secondary analysis of the Value of Urodynamics Evaluation (ValUE) trial looked at the effect of urodynamic testing on clinical diagnosis, treatment plan, and outcomes in women undergoing SUI surgery (31). Patients diagnosed with voiding phase dysfunction preoperatively had no change in the odds of self-voiding at discharge or developing postoperative VD. However, these results are confounded by the fact that surgical modification was allowed based on preoperative results, with nearly all modifications making surgery less obstructive, likely due to the theoretically higher risk of retention in those with detrusor underactivity/acontractility. Additionally, in the Stress Incontinence Surgical Treatment Efficacy (SISTEr) trial, there were no urodynamic variables predictive of postoperative retention (defined as need for catheter greater than 6 weeks or surgical intervention to improve voiding) following Burch colposuspension or PVS (32). Sling approach has been associated with sling obstruction. In the Trial of Mid-Urethral Slings ( TOMUS) comparing RP versus TOMUS, there was a significantly higher rate of retention requiring surgery (or permanent catheter) after RP sling compared with TO sling (2.7% vs. 0%) (33). Overall there is not a consensus in the literature on risk factors that predict postoperative VD after MUS.

Diagnostic evaluation No consensus has been reached on the optimal timing of evaluation of a patient with suspected obstruction and VD after antiincontinence procedure, but the single most important piece of clinical information used to determine if intervention to relieve obstruction is indicated in a clear temporal relationship of the onset of voiding or storage symptoms following incontinence surgery. While transient VD and urinary retention are common and expected after many types of anti-incontinence surgery, most cases will resolve within 4 weeks postoperatively. In a study evaluating early postoperative retention after TVT, Burch, and PVS, the return to normal voiding occurred at a mean of 9 (0–90) days after TVT, 5 (2–42) days after Burch, and 21 (2–210) after PVS (34). Urinary retention after PVS usually resolves or improves with time, and therefore most clinicians would advocate waiting 3 months prior to surgical interventions (35). Thereafter, there is a very low probability that any persistent obstruction will resolve without intervention. As a result, it had been common practice to delay evaluation of the patient with urinary retention or severe storage symptoms for approximately 3 months postoperatively to allow adequate time for obstruction/retention to resolve. Additionally, this time frame is thought to allow for adequate retropubic scaring and fibrosis, which may help minimize the risk of recurrent SUI. This is in contrast to obstruction and retention after MUS. In these cases, earlier intervention is suggested when obstruction is suspected (5, 21, 36). After MUS, temporary urinary retention has been reported to resolve in 25–66% of patients over 1–2 weeks (37, 38), but due to the ingrowth of fibroblastic tissue

Diagnosis and Treatment of Obstruction and subsequent immobility of the sling, patients with severe symptoms or urinary retention are less likely to improve after this time period. In a Finnish review of 1,455 women who underwent TVT, 2.3% had postoperative urinary retention, of whom 59% resolved with catheterization in 2 weeks or less (39). Interestingly 2/34 women did have resolution of their retention after 5–6 weeks of catheterization. Considering these facts, early evaluation and intervention may be warranted. However, some believe this carries an increased risk of recurrent SUI, although no formal studies or guidelines on this exist (21). Some studies have shown more favorable results in terms of SUI with earlier as opposed to delayed intervention (40, 41), while others do not (42). Regardless, the decision to proceed with workup and possible need for eventual intervention should be considered early and discussed with the patient and their symptomatology, level of dissatisfaction, and willingness to risk recurrence of SUI should guide when and what is done.

History and physical examination

The first step in the evaluation of a patient with retention or VD after anti-incontinence surgery is a targeted and thoughtful history and physical examination. Key points in the history are the patient’s preoperative voiding status and symptoms, and the temporal relationship of LUTS to the surgery. The type of procedure performed and the number and the type of prior procedures should be elicited. Urodynamic data from preoperatively is useful if available. Finally, it is important to determine if SUI persists. Symptoms related to obstruction lie along a continuum that includes storage and emptying symptoms. The most obvious signs of obstruction are complete or partial urinary retention, the inability to void continuously, the presence of a slow stream with or without intermittency, or the need to strain to void. Some patients may have more subtle symptoms, including the need to bend forward/change positions to void or recurrent urinary tract infections (rUTI) that are associated with an elevated PVR volume. However, many women will present with predominately storage symptoms of frequency, urgency, and UUI, with or without obstructive symptoms. In a review of presenting urinary symptoms in 51 women requiring urethrolysis after cystourethropexy, the authors found patients presented with storage (irritative) symptoms (75%), voiding (obstructive) symptoms (61%), de novo UUI (55%), need for CIC (40%), rUTI (8%), and painful voiding (8%) (43). Urinary retention as the sole symptom occurred in only 24%. In a more recent study of 93 cases of sling release, the indication for intervention was retention in 54%, obstructive or urge symptoms in 42%, and rUTI in 4% (44). A full genitourinary physical examination should be performed to assess urethral angulation, urethral mobility, vaginal estrogen status, POP, and evidence of mesh extrusion in the vagina. The examination may reveal overcorrection, or hypersuspension, where the angle of the urethra becomes more vertical than is normal, and the urethra and urethral meatus may appear to be pulled toward the pubic bone. When severe, this is usually quite obvious, but can be confirmed by a negative (downward) angle on Q-tip test. A ridge at the point of obstruction may be seen or felt as the Q-tip or a cystoscope passes through it. Other findings on physical exam can include nonpliable vagina, foreshortened urethra, or periurethral dimpling. While these signs may help solidify the diagnosis, their absence does not rule it out. Conversely, not all obstructed patients will appear to be overcorrected on physical exam (45).

849 Endoscopy and imaging

Cystourethroscopy may show scarring, narrowing, occlusion, kinking, or deviation of the urethra. As discussed prior, a hypersuspensed urethra that is fixed with poor mobility in the sagittal axis due to the pronounced vertical angulation of the urethra against the pubis is highly suggestive of obstruction, but its absence does not rule it out. The urethra and bladder should be carefully inspected for eroded sutures or sling material that could be contributing to symptoms. Secondary signs of obstruction, such as bladder trabeculations or diverticula may be seen, however may be absent in early evaluation. In cases where intervention is anticipated, endoscopy should be done routinely, either before surgery or at the time of surgery prior to incision. The addition of fluoroscopy to urodynamics to aid in the diagnosis of female bladder outlet obstruction (BOO) has been examined (46). In this study, patients were classified as obstructed if there was radiographic evidence of obstruction between the bladder neck and distal urethra in the presence of a sustained detrusor contraction of any magnitude. Fluoroscopy aided in localizing the site of obstruction and allowed for the diagnosis of obstruction even in cases where contractility was impaired. Using this definition, the authors were able to demonstrate significant differences between obstructed and unobstructed cases for the parameters of Qmax, Pdet at Qmax, and PVR. More recently, in a study comparing contemporary defintions of obstruction and how well they correlated with clinical suspicion, it was found that the fluoroscopic definition had the highest concordance (47). Radiographic imaging may also be done independent of videourodynamics. A static cystogram in the anteroposterior, oblique, and lateral positions, with and without straining, assesses the degree of bladder and urethral prolapse and displacement or distortion of the bladder. A voiding cystourethrogram can assess the bladder, bladder neck, and urethra during voiding to determine if there is narrowing, kinking, or deviation. The lack of midurethral dilation and funneling of the bladder neck would be suggestive of obstruction. The female pelvic floor can also be imaged via transabdominal, transperineal/translabial, or transvaginal ultrasound. On translabial or transvaginal ultrasound, a MUS appears echogenic and is usually easily visualized (48). Ultrasound in the setting of evaluation for an obstructive sling can provide information regarding sling location and dynamics of sling motion during rest and on Valsalva. A common finding in patients with an obstructive sling is angulation of the urethral axis (49). Other possible findings that may aid in the diagnosis of an obstructed sling include a shorter distance between the sling and the pubic symphysis and abnormal sling configurations around the urethra. While it is not mandatory in the diagnosis of obstruction after anti-incontinence surgery, imaging may provide useful information in equivocal cases.

Urodynamics

The inclusion of urodynamics as a standard component in the workup of postoperative obstruction and VD is controversial. This partly stems from the lack of a standardized criterion that reliably characterizes BOO in women with a high level of sensitivity or specificity. However, a number of investigators have attempted to address this, and several definitions have been proposed (Table 78.2). We feel urodynamics is helpful and can provide information on the presence of involuntary detrusor contractions, impaired compliance, or the presence of obstruction, even in cases of obvious urinary retention. Urodynamics

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TABLE 78.2: Various Female Bladder Outlet Obstruction Criteria Author

Year

Parameter

Chassagne et al. (53) Nitti et al. (46)

1998 1999

Blaivas et al. (54) Lemack et al. (55) Defreitas et al. (56) Kuo (57) Gravina et al. (58) Solomon et al. (59)

2000 2000 2004 2004 2007 2018

Qmax of 20 cm H2O Radiographic evidence of an obstruction between the bladder neck and distal urethra in the presence of a sustained detrusor contraction of any magnitude during voiding Qmax of 20 cm H2O Qmax of 21 cm H2O Qmax of 25 cm H2O Qmax of 35 cm H2O Qmax of 90%

can confirm the diagnosis of obstruction with the classic findings of high-pressure, low-flow voiding dynamics (see Table 78.2), however a patient should not be excluded from surgical intervention even if contractility is impaired or absent. Surface pad electromyography may help identify a lack of pelvic floor relaxation during voiding. For a patient with mainly storage symptoms but normal emptying, urodynamics may rule out obstruction and provide a specific diagnosis that can be helpful in directing therapy. However, urodynamic findings may be highly variable. In a study of 302 women presenting with clinical obstruction after anti-incontinence surgery (voiding LUTS or urinary retention), urodynamic studies revealed multiple voiding patterns including classic elevated pressure/poor flow, but also normal pressure/ low flow, normal pressure and flow but prolonged flow time, poor detrusor contractions and elevated PVR, and increased pressure but high flow (50). Some authors have found that urodynamic studies do not change outcomes in patients whose primary indication for surgery is urinary retention or increased PVR volume and therefore suggest reserving urodynamics for those who present with mainly storage symptoms (51). Additionally, patients with nondiagnostic urodynamic studies or those who fail to produce a detrusor contraction have been demonstrated to have the same outcome as those with classic high-pressure/low-flow voiding (52). The lack of consensus from such studies highlight the absolute critical importance of the temporal relationship between surgery and the onset of urinary symptoms as an indicator of obstruction. In summary, the diagnosis of obstruction is made on the basis of clinical presentation and diagnostic evaluation, depending on the circumstances. A temporal relationship between surgery and the onset of symptoms is the most critical factor in diagnosis. Patients with normal emptying before incontinence surgery who have significant retention or obstructive voiding symptoms after incontinence surgery need little in the way of a diagnostic workup prior to more invasive intervention.

Management of iatrogenic obstruction Conservative treatment

Treatment of obstruction is dictated by its timing and the degree of bother of symptoms. It is important to remember in the early postoperative period, urinary retention can be common and is usually transient, resolving in the first 10 days after surgery (60, 61).

The initial conservative management option includes CIC. This is a good option for patients prior to resolution of transient obstruction. In addition, patients may be managed with CIC longer term, as the risk of recurrent SUI with more invasive interventions is not an acceptable risk for some patients (7). Pharmacotherapy is also a non-invasive option. A selective α-blocker is a safe and low-risk alternative that can possibly provide some symptomatic relief by augmenting relaxation of the bladder neck resulting in improved voiding in patients with very mild BOO (2). Patients who are emptying well but have significant storage symptoms may be treated initially with behavioral modification or pharmacotherapy including anticholinergics or beta-3 agonists (7). In our experience, these measures are not usually successful when obstruction exists, but can be considered before surgery. In those patients that void with Valsalva, physical therapy may aid to help them learn how to relax pelvic floor and avoid straining to void, which may be compounding their problem. In patients with learned VD, some authors have suggested the use of diazepam 2–10 mg orally two to three times per day or baclofen 5–10 mg orally twice per day to aid in relieving urethral or pelvic floor spasm in lieu of or in conjunction with physical therapy (62). The role for urethral dilation in cases of postsurgical obstruction is not clear and there are conflicting reports in the literature (Table 78.3). In general, dilation would not be recommended as there are concerns about its potentially traumatic nature, which could induce scarring of the urethra or predispose to mesh erosion (2). When conservative measures fail, definitive surgical therapy may be required.

Surgical intervention

There are numerous ways to free up the obstructed urethra, which vary based on many factors including the type and number of anti-incontinence surgeries, prior attempts at relieving obstruction, timing after surgery, and surgeon and patient preferences. Success rates for various procedures range from 25% to 100% (Tables 78.3–78.5). Success appears to be independent of the particular procedure chosen, though no randomized head-tohead surgical trial has ever been performed. The patient should be counseled regarding specific risks of surgery, including bladder or urethral injury, persistence of storage symptoms, recurrent SUI, and persistence of obstruction. In this section, we will describe surgical techniques for the treatment of iatrogenic obstruction in order of invasiveness.

Diagnosis and Treatment of Obstruction

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TABLE 78.3: Summary of Series on Urethral Dilation or Sling Loosening for Obstruction after Incontinence Surgery

  Urethral dilation Karram et al. (21) Klutke et al. (36) Mishra et al. (38) Sokol et al. (65) Sling loosening Hammad et al. (66) Glavind et al. (67) Klutke et al. (36)

Lord et al. (68) Nguyen et al. (69) a

b

Total # Patients in Series

n (%)

Resolution of AntiResolution of Irritative Incontinence Time to Obstruction Voiding Procedure Intervention (%) Symptoms (%)

350 600 52 267

28 (8) 5 (0.8) 3 (5.8) 5 (1.9)

MUS MUS MUS MUS

6 weeks

Overall Successa Recurrent (%) SUIb (%) Notes

 

 

82 0 67  

100

100

6

 

80

  0

1459 143 600

7 (0.5) MUS 5 (3.5) MUS 17 (2.8) MUS

11 days 64 days

100 100

301 163

10 (3.3) MUS 10 (6) MUS

  4.8 days

  100

0  

 

Also includes unspecified number of patients undergoing sling incision  

Success is usually defined as cure or significant improvement in presenting symptoms (resumption of normal bladder emptying for patients in retention, and resolution of symptoms for patients with obstructive symptoms or frequency, urgency, or urge incontinence). Recurrent SUI is defined as percentage of patients without SUI before procedure to relieve obstruction who experienced SUI after.

Sling loosening (Table 78.3)

The vast majority of patients are able to empty fairly normally within 72 hours after MUS, but for those who remain in retention, early intervention is recommended prior to significant tissue ingrowth (2). Loosening of the MUS has been performed under local anesthesia in an office setting (63) or may be performed in an operating room. The prior incision on the anterior vaginal wall is opened. The MUS is usually easily visualized. The sling is hooked with a right-angle clamp (or similar instrument). Spreading of the right-angle clamp or downward traction on the sling will usually loosen it (1–2 cm) (36). The incision is closed, and the patient is given a voiding trial. With this technique, a 96% improvement in obtstructed patients has been reported in the literature (64). This intervention is usually possible if undertaken in the first 10 days postoperatively. The longer after surgery, the more scarring occurs and general anesthesia and a wider exposure or incision may be necessary in order to adequately loosen the sling. It should be noted that although there are some reports of loosening PVS either with a cystoscope or urethral dilator/sound in the bladder and performing downward traction, in general, this is not standard practice. As previously mentioned, it is customary to wait longer for urinary retention to resolve after PVS, as there is believed to be some breakdown and loosening over time.

Transvaginal sling incision/excision

Transvaginal incision of a sling has reported similar results as compared to formal urethrolysis for both PVS and MUS, but with potentially decreased morbidity (Table 78.4). Cystoscopy is performed at the start of the procedure to assess the urethra and rule out erosion or urethral injury. An inverted U or midline vaginal incision is used to expose the area of the bladder neck and urethra (70). As the vaginal flap is dissected off, the sling should be identified above the periurethral fascia. The sling may be encased in scar tissue and thus careful dissection is required to identify the sling. If the sling is under significant tension, it may be especially difficult to identify. Insertion of a cystoscope or sound into

the urethra with gentle upward torque improves visualization of the bladder neck and places tension on the sling, allowing for its identification. Once the sling is isolated, it should be separated from the underlying periurethral fascia with sharp or blunt dissection. The dissection may be facilitated by grasping the sling with an Allis clamp on either side of the midline and exerting downward pressure. Care should be taken to avoid injury to the bladder and urethra by beginning the dissection distally, identifying normal urethra then proceeding more proximally until the plane between the sling and urethra is identified. A right-angle clamp can be placed between the urethra and periurethral fascia and the sling. The sling is then lifted and cut in the midline (Fig. 78.1(a)). Alternatively, if scarring is dense and the plane between the sling and periurethral fascia cannot be developed easily, the sling can be isolated lateral to the midline, off of the urethra. For practitioners who do not routinely perform this procedure, this lateral approach followed by lateral incision provides a margin of safety in minimizing inadvertent urethral injury. The edges of the sling are then mobilized off the periurethral fascia to, but not through, the endopelvic fascia (Fig. 78.1(b)). Lateral support is preserved because the retropubic space is not entered, and the urethra is not freed from the undersurface of the pubic bone. Typically, synthetic material is excised and autografts/allografts are left in place. Cystourethroscopy should be done to rule out urethral or bladder injury. In cases of autologous or biological materials, if the sling cannot be clearly identified, then formal transvaginal urethrolysis (see the following section) should be performed. However, it is imperative to identify a synthetic MUS and cut it during this procedure. Conversion to urethrolysis without specifically cutting the sling may fail to relieve obstruction. Usually, the sling is easily found, and identification can be aided by palpation of the sling. However, sometimes this can be quite difficult, especially in cases where the sling has migrated proximally or has rolled onto itself and created a tight narrow band. In many cases, after the MUS is cut, it retracts away from the urethra. The cut ends

 

Total # Patients in Series

n (%)

Anti-Incontinence Procedure

Time to Intervention 39 weeks

241 NA

10 (4.1) 10

MUS PVS

Baekelandt et al. (75) Castellani et al. (76) Clifton et al. (44) Gamé et al. (77) Glavind et al. (67) Goldman et al. (45) Hammad et al. (66) Hinoul et al. (78) Hong et al. (79) Karram et al. (21) Kusuda et al. (80) Kuuva et al. (39) Laurikainen et al. (6) Liu e al. (81) Long et al. (82) Meschia et al. (83) Nitti et al. (70) Rardin et al. (5) Segal et al. (84) Sokol et al. (65) Song et al. (85) Thiel et al. (86) Tsivian et al. (87) Volkmer et al. (88) Wu et al. (89) Zubke et al. (90)

NA 163 NA NA 143 NA 1459 98 375 350 NA 1455 9040 286 71 404 NA 1175 NA 267 461 NA NA NA 405 NA

23 12 (7.4) 93 30 2 (1.4) 14 19 (1.3) 2 (2) 4 (1.1) 6 (1.7) 5 1 (0.07) 50 (0.6) 11 (3.9) 7 (9.9) 2 (0.5) 19 23 (2) 14 13 (4.9) 28 (6.1) 13 8 3 14 (3.5) 3

MUS MUS MUS, PVS MUS MUS MUS, PVS MUS MUS MUS MUS PVS MUS MUS MUS MUS MUS PVS MUS

a

b

MUS MUS PVS MUS MUS PVS MUS

15 months 4 weeks 5 months 381 days 6 months 8.6 months

61 days >6 weeks 6 weeks to 2 years >3 months 197 days 2 days to 3.7 years 28 days 10.6 months 17.3 weeks 4.25 months >6 weeks 63.5 days 65 days 420 days 214 days 148 days  

Resolution of Irritative Voiding Symptoms (%)

Overall Successa (%)

Recurrent SUIb (%)

94

67

100 84

40 11

100 100

34.8

100 86

50 57

70 93

100 100 100 100 100

100 88

100 100 81 100 69.2

86 88 30 0

100 84

100

 

 

77 100 100 85.7 100

13 8.3 14 9 100 21

Notes Outcomes include entire cohort Lateral sling transection

75 33 0 51 9 29

Lateral sling transection

17 13 61.5 24 7.7 25 33 0 0

Long follow up (5 years)

Midline incision with mesh lengthening

Success is usually defined as cure or significant improvement in presenting symptoms (resumption of normal bladder emptying for patients in retention, and resolution of symptoms for patients with obstructive symptoms or frequency, urgency, or urge incontinence). Recurrent SUI is defined as percentage of patients without SUI before procedure to relieve obstruction who experienced SUI after.

Textbook of Female Urology and Urogynecology

Abouassaly et al. (73) Amundsen et al. (74)

Resolution of Obstruction (%)

852

TABLE 78.4: Summary of Series on Sling Incision or Excision for Obstruction after Incontinence Surgery

Diagnosis and Treatment of Obstruction

853

FIGURE 78.1  (a) After an inverted U or midline incision, the sling is isolated in the midline and incised. A right-angle clamp may be placed between the sling and the periurethral fascia to avoid injury to the urethra. (b) The sling is freed from the undersurface of the urethra toward the endopelvic fascia. Ends may be excised or left in situ. (Reproduced from Nitti VW et al., Urology, 59, 47, 2002; discussion 51–52. With permission.) TABLE 78.5: Summary of Series on Urethrolysis after Incontinence Surgery

 

n (%)

Transvaginal urethrolysis Foster et al. (92) 48

Nitti et al. (52)

41

Starkman et al. (42)

19

Segal et al. (84) McCrery et al. (93)

20 31

Cross et al. (60)

39

Goldman et al. (96)

31

Amundsen et al. (74)

22

Scarpero et al. (97)

10

Anti-Incontinence Procedure

Resolution of Irritative Resolution of Voiding Overall Time to Obstruction Symptoms Successa Recurrent Intervention (%) (%) (%) SUIb (%) Notes

Needle suspension, retropubic suspension, PVS Needle suspension, retropubic suspension, anterior colporrhaphy, unspecified Retropubic suspension, PVS, MUS Unspecified Retropubic suspension, PVS, MUS, unspecified Needle suspension, retropubic suspension, PVS Needle suspension, retropubic suspension, PVS PVS

25.9 months

39 weeks

94

67

Needle suspension, retropubic suspension, anterior colporrhaphy, PVS

9 months

92

12

54 months

66

83

65

0

71

0

All patients got resuspension

52.6 43.6 months

72.2 79.1

11 months

18.8 36 85

14 months

13.3 16 72

2.6

84

19.4

84

11 18

Outcomes include entire cohort All patients undergoing repeat urethrolysis. Outcomes reported for whole cohort regardless of approach (Continued)

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TABLE 78.5 (Continued): Summary of Series on Urethrolysis after Incontinence Surgery

 

n (%)

Anti-Incontinence Procedure

Levin et al. (98) Hammad et al. (66) Carr et al. (43)

Resolution of Irritative Resolution of Voiding Overall Time to Obstruction Symptoms Successa Recurrent Intervention (%) (%) (%) SUIb (%) Notes

1 (0.3) MUS 7 (0.5) MUS 15 Needle suspension, retropubic suspension, anterior colporrhaphy, PVS Suprameatal urethrolysis Petrou et al. (95) 32 Needle suspension, retropubic suspension, anterior colporrhaphy PVS McCrery et al. (93) 23 Retropubic suspension, PVS, MUS, unspecified Carr et al. (43) 4 Needle suspension, retropubic suspension, anterior colporrhaphy, PVS Retropubic urethrolysis Petrou et al. (62) 12 PVS Segal et al. (84) 10 Unspecified Webster et al. (99) 15 Needle suspension, retropubic suspension Carr et al. (43) 35 Needle suspension, retropubic suspension, anterior colporrhaphy, PVS Scarpero et al. (97) 10 Needle suspension, retropubic suspension, anterior colporrhaphy, PVS

2 months

9 months

92

12

Anger et al. (91)

13 months

100

60

a

b

9

 Retropubic suspension

15 months

15 months

19.2 months 32.5 months 8 months

100

0

 

 

73

13.7

65

67

66

3

83

58

 

 

25

13.7

83 80 86

60 0 100

83

8 20

15 months

Recurrent SUI reported for entire cohort regardless of urethrolysis approach

9 Recurrent SUI reported for entire cohort regardless of urethrolysis approach

93 86

13.7

18

78

11

Recurrent SUI reported for entire cohort regardless of urethrolysis approach All patients undergoing repeat urethrolysis. Outcomes reported for whole cohort regardless of approach  

Success is usually defined as cure or significant improvement in presenting symptoms (resumption of normal bladder emptying for patients in retention, and resolution of symptoms for patients with obstructive symptoms or frequency, urgency, or urge incontinence). Recurrent SUI is defined as percentage of patients without SUI before procedure to relieve obstruction who experienced SUI after.

can be grasped with clamps and dissection proceeds hugging the sling to minimize injury to underlying tissue. The extent of excision largely depends on the primary indication for MUS removal with some suggesting dissecting to the level of the endopelvic fascia and excising the sling ends (70) while others do not (71). If sling incision is not successful in relieving obstruction, formal urethrolysis may be carried out. The timing of sling incision/excision for obstructing MUS varies in the literature, but most recommend waiting at least 2 weeks, but incision is often done within 4 weeks postoperatively in truly obstructed patients. However, the risk of earlier sling release must be balanced with the risk of recurrent SUI. In a recent series of 107 women who underwent sling incision or excision after MUS for obstruction, it was noted that women were significantly less likely to undergo repeat surgery for SUI when sling release was performed >24 months from initial surgery as compared to 3 months (72). Again, for PVS, the timing to surgery is general

longer postoperatively after a trial of conservative management. The risk of recurrent SUI after sling incision/excision is reported at 14–19% in the literature (7).

Urethrolysis

The ultimate goal of urethrolysis is to restore urethral mobility, and in present day, is often reserved for patients with severe obstruction who have failed prior attempts at sling loosening and/or incision/ excision. Formal urethrolysis can be accomplished via a retropubic or transvaginal approach, and can be utilized regardless of initial anti-incontinence procedure performed. The approach chosen depends on several factors that include patient presentation, type of initial anti-incontinence surgery, history of prior urethrolysis, and surgeon and patient preference. In general, proceeding from the least morbid transvaginal approach and reserving the retropubic approach for failures is prudent. However, a primary retropubic approach may be favored in patients with inadequate vaginal

Diagnosis and Treatment of Obstruction

855

access precluding a transvaginal approach, those who underwent an initial transabdominal anti-incontinence procedure (91), or in patients with other complications including fistula or intravesical mesh exposure requiring removal. There does not appear to be any consistent preoperative parameters that predict success or failure of urethrolysis. For example, several studies have found that patients with detrusor overactivity have a higher rate of failure (42, 51, 92). Nitti and Raz on the other hand reported increasing PVR correlated with increasing failure of urethrolysis, but that neither the presence nor the strength of detrusor contraction preoperatively, nor pressure flow analysis predicted postoperative outcomes (52). However, other studies have found no urodynamic parameters predictive of success or failure of urethrolysis (93) and that the only measure predictive of success was no prior history of urethrolysis (43). Overall recurrent SUI after urethrolysis ranges from 0% to 19%.

Transvaginal urethrolysis

In 1984, Leach and Raz described the transvaginal technique of urethrolysis, and though variations have been published since, it is still the most commonly used today (94). A midline or inverted U incision approximately 3 cm long is made in the anterior vaginal wall extending from the level of the midurethra to 1–2 cm proximal to the bladder neck. Dissection proceeds laterally along the glistening surface of the periurethral fascia to the pubic bone. The retropubic space is entered sharply by perforating the attachment of the endopelvic fascia to the obturator fascia (Fig. 78.2(a)). The urethra is dissected bluntly and sharply off the undersurface of the pubic bone, and completely freed proximally to the bladder neck. Some separation of the urethra from the pubis is done blindly with Metzenbaum scissors (Fig. 78.2(b)). Care should be taken to stay as close to the underside of the pubis as possible, and manual palpation of this plane along with an awareness of the location of the urethral catheter provides a proprioceptive map in this hard-to-visualize space. Once sufficient space is

developed in this plane, the remaining adhesions and scar can be swept down bluntly with an index finger. If suspension sutures are felt, a clamp can be used to bring it into view so it can be cut safely. After this initial mobilization, a right-angle clamp can be placed between the pubic bone and the urethra, and a Penrose drain is placed around the urethra. Downward traction is applied on the Penrose drain to aid visualization and all remaining retropubic attachments are dissected free (Fig. 78.3). At this point, the urethra should be freely mobile in all planes, and this can be tested with movement of an intraurethral sound or cystoscope. Cystoscopy should be performed to rule out urethral and/or bladder injury prior to vaginal closure. If injury is noted, a catheter is left in place. If all is intact, the catheter can be removed at the end of the procedure. It is also good practice to assess ureteral integrity by ensuring ureteral efflux. If an inadvertent injury to the urethra or anterior bladder wall near the bladder neck is caused, primary repair should be attempted, and completion of the procedure should be entertained as further bladder or urethral wall damage can occur. A Foley catheter is generally left for 2–3 weeks. Fistula formation is of minor postoperative risk, as the area of perforation is well away from the vaginal incision. If it is difficult to incise the scar tissue or if urethral mobility is still limited, a suprameatal technique has been described, either as part of the traditional transvaginal approach or by itself. In their description, Petrou et al. make an inverted U incision about 1 cm above the urethral meatus (95). Allis clamps are used to retract both edges of the incision. With tension on the upper edge, the perineal membrane is perforated and all attachments, scar, and sutures between the pubic bone and urethra are incised sharply with scissors. An index finger can follow along the underside of the pubis into the retropubic space. With a sweeping motion directed laterally and posteriorly, obstructing bands can be identified and either bluntly or sharply freed. The arms of the sling or suspending sutures are encountered with lateral dissection and should be divided sharply. Once done, urethral mobility

Urethra

(a)

(b)

FIGURE 78.2  Transvaginal urethrolysis. (a) An inverted U incision in the anterior vaginal wall and entrance into the retropubic space. (b) The urethra is sharply dissected off the undersurface of the pubic bone. The endopelvic fascia, periurethral fascia, and vaginal wall are retracted medially to expose the urethra in the retropubic space. (Reproduced from Nitti VW and Raz S, J Urol, 152, 93, 1994. With permission.)

856

Textbook of Female Urology and Urogynecology lower midline incision is made. The rectus fascia and muscle are opened in the midline to the level of the pubic symphysis. The retropubic space is developed and exposed. Any visible and palpable suspension sutures are cut and all attachments and scar between the urethra and pubis are incised sharply. Complications can be minimized by keeping the tips of the scissors up against the pubic symphysis during sharp dissection. Careful attention is paid to the location of the Foley catheter to avoid inadvertent bladder or urethral injury. The index finger of the surgeon’s nondominant hand or a sponge stick may be placed into the vagina to help identify the boundaries of the vagina in relation to the urethra and urethrovesical junction. At the end of the dissection, the urethra, bladder neck, and anterior vaginal wall should be mobile and free from the overlying pubic bone. It should be possible to pass fingers through the abdominal wound, under the pubis, and see your fingers pushing the vaginal skin out in the distal vagina. In cases of severe scarring, it may be necessary to mobilize laterally as far as the ischial tuberosities, creating a paravaginal defect. This defect should be repaired by reapproximating the paravaginal fascia to the fascia of the obturator internus along the arcus tendineus. An omental flap can be brought down and fixed between the pubis and urethra so that recurrent scarring is minimized (43). The paravaginal repair sutures are then tied and the abdomen is closed. Cystoscopy is performed to rule out urethral injury and confirm ureteral efflux.

Failed urethrolysis

FIGURE 78.3  Intraoperative photo after completed urethrolysis. A Penrose drain has been placed around the urethra, isolating it from the pubic bone. is assessed and if adequate, cystoscopy is performed to rule out inadvertent injury prior to vaginal incision closure. Because lateral dissection is limited, potential advantages of this approach include preservation of the lateral endopelvic fascia and urethropelvic ligament, which allows for continued urethral support, thus theoretically decreasing the risk of recurrent SUI. Clitoral denervation is a potential complication of this approach, limiting its wider application. In cases of extensive urethrolysis or coexistence of SUI with obstruction, resupporting the urethra at the time of urethrolysis has been introduced, though this remains controversial. In many of the original descriptions of urethrolysis, patients underwent resuspension irrespective of the presence of preoperative SUI. Resuspension poses the risk of persistent obstruction and if symptoms do not resolve, it is difficult to determine whether this resulted from inadequate urethrolysis or from the secondary suspension. Additionally, outcome studies have demonstrated a similar risk of recurrent SUI after resuspension at time of urethrolysis as after urethrolysis alone (3). There is also evidence that patients can be salvaged with less invasive bulking agent injections should SUI recur (96). As a result, it is our practice to attend to the presenting complaint of obstruction and address recurrent SUI at a later date should it occur.

Retropubic urethrolysis

With regards to a retropubic urethrolysis, the patient is placed supine on the operating table with the legs slightly spread or frog-legged to allow for vaginal access. Either a Pfannenstiel or

Failure of urethrolysis may be due to persistent or recurrent obstruction, inadequate initial lysis, detrusor overactivity, impaired detrusor contractility, or learned VD. Recurrent obstruction may result from periurethral fibrosis and scarring, or intrinsic damage to the urethra that has occurred as a consequence of the urethrolysis surgery. When obstruction persists, it is reasonable to attempt a repeat urethrolysis. In a report of repeat urethrolysis in 24 women who remained in urinary retention after initial urethrolysis (97), both transvaginal and retropubic approaches were chosen depending on the clinical situation. Obstruction was cured in 96%, but storage symptoms completely resolved in only 12% and were improved but required medication in 69%. Stress urinary incontinence recurred in 18%. In another series, repeat urethrolysis resulted in cure of obstructive symptoms in 72% and storage symptoms in 59% (93). These data support aggressive repeat urethrolysis for obstruction in the face of initial failure. In general, if an aggressive transvaginal urethrolysis fails, then a retropubic approach may be considered. In cases where the aggressiveness of the initial transvaginal procedure is unknown, or if only a sling incision was performed, then a repeat transvaginal approach may be appropriate. Consideration should also be given to the use of a Martius labial fat pad interposition flap to decrease recurrent fibrosis and provide some urethral support. The flap may be divided midway along its longitudinal axis to allow for circumferential coverage of the urethra, thereby supporting the undersurface and retropubic surface of the urethra (100). Residual and refractory storage symptoms after urethrolysis may be treated in the same matter as idiopathic symptoms after obstruction has been ruled out. Therefore pharmacologic and third-line therapies may be utilized. In particular, sacral neuromodulation has demonstrated success in such patients, with one study showing a >50% reduction in symptoms in 75% of patients, all of whom were subsequently able to stop antimuscarinic medications (101). The treatment algorithm flowchart summarizes the diagnosis and treatment approach discussed in this chapter (Fig. 78.4).

Diagnosis and Treatment of Obstruction

857

Synthetic sling

Biological sling

Post-op voiding dysfunction

Post-op voiding dysfunction Observe >3 months

Observe 90% with endoscopic techniques using laser excision or resection in the treatment of mesh exposure in the urinary tract, although 2–25% of patients may need more than one endoscopic procedure to achieve this (43). Stress urinary incontinence was the most common complication in both groups, occurring in 24–28% of patients, although it was unclear whether this was de-novo or a pre-existing condition. The review failed to identify a clear superiority of either method but recognised the feasibility, short operating time, good outcomes and favourable safety profile of endoscopic techniques. Ultimately, all surgical options with their known risks and benefits should be discussed with the patient utilising a shared decision-making process, taking into account the patient’s comorbidities and expectations and not be limited by technological limitations or surgeon’s lack of expertise or inexperience with certain procedures. Onward referral to a mesh complications management centre in such instances is advisable.

Mesh Complications and Their Management Pain

Pain is a common complaint after transvaginal sling surgery and can occur at any time. It has been previously shown that abdominal or pelvic pain experienced prior to surgery is independently associated with pain post-operatively (17). The distribution of the pain and the timing of its onset are often suggestive of the underlying pathology. Post-operative pain can be caused by direct nerve injury, immunological processes or there may be a musculoskeletal component. Neuropathic pain presents as a typically burning sensation limited to the specific area of nerve distribution developing immediately after surgery and usually implies some degree of intraoperative nerve injury or nerve irritation. Depending on the type of mesh and surgical technique used, injury to the pudendal or obturator nerve can occur. In such cases, surgical management may be warranted by immediate return to the operating room for revision and explantation of the mesh. Alternatively, adopting an expectant approach for up to four weeks with analgesia and symptom monitoring may be pursued. If pain persists, early surgical removal before scarring develops may need to be considered. Myofascial pain caused predominantly by muscle spasms is the most common aetiology for pelvic pain following the placement of a synthetic mesh (17). It was postulated that women with urinary incontinence may have a naturally hypertonic pelvic floor in an attempt to maintain continence and that the mesh traversing these muscles can further exacerbate the already high muscle tone and contribute to the pain (17). Typically, this type of pain has a delayed and more insidious onset, commonly developing weeks to months after surgery. It is usually progressive in nature and often worsens over the course of years before patients seek medical attention. The distribution of the pain is dependent on the surgical technique and approach used at the time of sling implantation. The pain may also occur in remote locations away from the insertion point or presumed course of the mesh; it is likely that this is due to secondary distant muscle spasms potentially limiting the benefit of mesh removal surgery. Transobturator sling surgery can result in vaginal, groin and thigh pain that can be aggravated with hip extension and internal rotation. Retropubic sling surgery is usually associated with vaginal and both deep and superficial pelvic pain. Generalised pain experienced by some patients poses a considerable challenge as this type of pain appears to respond insufficiently to mesh removal and a holistic approach including a pain therapist and a psychologist is advisable. Management of chronic pelvic pain following synthetic mesh insertion can become extremely complex and, in the absence of clear guidance it further highlights the importance of a multidisciplinary team approach. It includes both conservative and surgical therapies. Conservative management may consist of physical therapy, medication, pudendal or obturator nerve blocks and botulinum toxin injections. Physical therapy makes up an integral part of myofascial pain management, although the evidence of its role is sparse and limited to mainly case reports (50). It should be led by a physical therapist with expertise in the treatment of pelvic floor dysfunction (51). Early review within three months to evaluate the effect of physical therapy is prudent to prevent delay of other treatment modalities if appropriate response is not achieved. Oral and topical muscle relaxants, e.g., vaginal diazepam or baclofen suppositories, can be trialled initially either independently, or as an adjunct to physical therapy with limited literature evidence. There is an argument to suggest that some patients may be experiencing a component of their pain as a result of

873 central sensitisation, in this instance, other medications such as gabapentin, pregabalin, amitriptyline or duloxetine may help with pain modulation (52). The position of injection therapy in the treatment of pain following mesh insertion still remains illdefined (53). Botulinum toxin has a proven therapeutic effect in alleviating pain in several myofascial disorders; however, a recent systematic review failed to support its effectiveness in chronic pelvic pain management despite encouraging reported outcomes of observational studies (54). Patients failing conservative management may require mesh removal surgery. There is conflicting data concerning pain relief after mesh removal, and it is unfortunately common for patients to experience continued pain after mesh explantation. Furthermore, the pain may even have altered in terms of its character and intensity, and therefore present as more bothersome than the pain they associated with the presence of the mesh. The appropriate amount of mesh to be excised with regards to post-operative complications and pain resolution remains to be determined (55, 56). Danford et al. reported that of 233 women who underwent transvaginal mesh removal, 73% described an overall improvement of pain following mesh removal surgery, 19% experienced no improvement and 8% reported worsened pain (57). Sub-analysis of patients revealed that those with underlying chronic pelvic pain had significantly worse outcomes. Comparison of partial versus complete removal of the vaginal portion of the mesh yielded similar rates of short-term pain resolution, in the region of 72–76% (41). More extensive surgery was however associated with a higher chance of stress urinary incontinence recurrence (22% for partial vs. 56% for all the vaginal components). One study suggested an increased probability of having an improved ‘mental’ quality of life, when using the SF-12 mental component score, for complete compared to partial mesh removal, although no difference in improving mesh complications and physical quality of life was noted (58). Site-specific removal of mesh can provide pain relief in some patients with pain limited to a specific location. Retropubic pain can be addressed with acceptable results by removal of the retropubic portions including the mesh portion above the rectus sheath and under the skin (58). Removal of the transvaginal portion of TOT provides release of tension and can thus effectively treat TOT-associated groin pain (42). However, as mentioned previously incomplete mesh removal for pain can make subsequent surgery more complicated or even impossible if the pain recurs or does not subside. Therefore, preoperative discussion covering all related risks remains the most important step in the process as the patient’s preference may be to have the mesh removed completely from end-to-end to prevent future surgeries.

Sexual dysfunction

Sexual dysfunction is a significant long-term complication following transvaginal mesh surgery. It is present in virtually every patient with chronic pelvic pain (17). It has a notable impact on patients’ quality of life and often has a detrimental effect on their relationships sometimes resulting in abandonment by the partner and an inability to form new relationships. Dyspareunia after mesh surgery can develop as a result of muscle spasms, vaginal mesh exposure, decreased compliance of the vaginal wall or vaginal wall changes associated with atrophy. Symptomatic management in the form of pelvic physiotherapy, topical oestrogen or muscle relaxant therapy and vaginal dilatations can be offered initially. The role of mesh removal surgery in the treatment of

Textbook of Female Urology and Urogynecology

874 mesh-related sexual dysfunction remains to be elucidated by further studies. Patients with ongoing or progressive sexual dysfunction following mesh removal may benefit from referral to specialised sexual therapists.

retropubic urethrolysis depending largely on the timing of the procedure and the amount of post-operative scarring.

Autoimmune/systemic complications

The role and appropriate extent of mesh removal surgery in the management of female pelvic mesh-related complications remain to be determined. There is no high-level evidence on the topic in the current published literature which poses a considerable challenge in providing guidance with regard to the type of surgery that can currently be offered to patients. Instead, this decision is mainly based on expert opinion which highlights the crucial role of the multidisciplinary team discussion in mesh removal surgery decision-making. The 2019 NICE guidelines on management of mesh complications recognised that although the removal of synthetic mesh may be the option of choice for some women experiencing mesh complications, the surgery itself is associated with considerable morbidity and therefore cannot be supported as a first-line treatment (38). Furthermore, many patients require multiple surgeries and in fact repetitive mesh revisions may complicate, or even render it impossible to successfully complete removal of the mesh. A crucial balance between under-treatment and overly aggressive management must be found. ‘Meshectomy’ can have many forms and so far, a generally accepted categorisation hasn’t been acknowledged. IUGA and the American Urogynecological Society (AUGS) recently presented a descriptive system for mesh removal surgery (Table 80.2) however the terminology used may be confusing especially when it comes to ‘complete vaginal excision’. Complete vaginal excision still represents a partial excision and certain patient groups in the United Kingdom have highlighted this issue and discouraged its further use (61). Management of patient expectations, setting realistic goals, ensuring patient full commitment and understanding and a

Some patients have claimed that transvaginal mesh implantation has induced a systemic autoimmune inflammatory response in the form of fibromyalgia, lupus, rheumatoid arthritis and other conditions. The association still remains under scrutiny. It was theorised that the pro-inflammatory chronic state causes gradual degradation of polypropylene, which may, in turn, lead to the development of autoimmune disorders in the post-operative period. Chughtai et al. failed, however, to establish a clear relationship between the development of systemic autoimmune diseases and mesh-based vaginal surgery in their six-year followup study (59). In contrast to this, a separate retrospective study presented a group of 40 patients who developed symptoms of a systemic illness after mesh operation (both post hernia and transvaginal) (60). They postulated that polypropylene mesh has the ability to cause systemic symptoms including chronic fatigue, myalgia, arthralgia, muscle weakness, irritable bowel syndrome, cognitive impairment, dry eyes, dry mouth and other non-specific symptoms. In this study approximately half of the patients developed an autoimmune disease, and approximately a quarter of the patients developed an immunodeficiency disorder. Importantly 75% of these patients had a pre-existing allergy. The conflicting evidence supports the need for further prospective studies to determine and evaluate the frequency of mesh-related systemic autoimmune sequelae. It is important that surgeons remain open-minded about this potential complication. From our experience some patients, after a full mesh removal, report immediate relief of some of the systemic symptoms including brain-fog, dry eyes and hair loss.

Lower urinary tract symptoms

MUT surgery is commonly complicated by lower urinary tract symptoms in the form of de novo urgency and bladder outlet obstruction that can result in complete urinary retention. Postoperative urgency is a common complaint after MUT and occurs more frequently after TVT than TOT (23). The rates range from 5.9% to 25% for TVT and 0% to 15.6% for TOT (27). The aim of the management is to rule out a reversible cause for urgency such as urinary tract infection, mesh exposure, local hematoma formation or bladder outlet obstruction. In these cases, treatment should be directed to the cause otherwise clinical management of urgency symptoms should follow overactive bladder syndrome management guidelines. Urinary retention is a relatively common early post-operative complication with a prevalence from 2.5% to 19% for TVT and from 1.5% to 8.6% for TOT (23). In the majority of patients, it presents as a transient voiding dysfunction with high post-void residuals that resolve within a few days or weeks. Initial management with prolonged catheter drainage or clean intermittent catheterisation is usually suggested. The sling may be pulled down to release tension within two weeks of the procedure by opening the wound and inserting a Mayo curved scissors or a metal dilator between the urethra and the mesh and pulling down the mesh. Up to 4.5% (27) of patients have persistent symptoms of bladder outlet obstruction for more than four weeks after MUT surgery that may require surgical intervention. The options include sling incision, sling lysis and partial removal and extensive vaginal or

Principles of mesh removal surgery

TABLE 80.2: IUGA/AUGS Mesh Removal Classification Mesh revision

Partial vaginal mesh excision

Complete vaginal mesh excision Extravaginal mesh excision

Total mesh excision Office based mesh trimming Source:

Compiled from Ref. (20).

Either no mesh is removed and dissection and primary closing of vaginal epithelium is achieved or a small edge of mesh is removed such that the structural integrity of the implant is left intact. A segment/component of the mesh in the vagina is removed or transected altering the structural integrity of the implant. The entirety of the mesh that is in contact with vagina is excised. Removal of segments or components of mesh beyond, or not in contact with the vagina. It should include additional anatomical description of the segments removed (e.g. retropubic, groin) The aim is complete extirpation of the implant. Removal of the vaginally exposed mesh.

Mesh Complications and Their Management thorough discussion of surgery-related complications builds a strong foundation for successful mesh removal surgery. The use of patient decision aids assists with shared decision-making (62). The risks associated with any mesh removal surgery include postoperative bleeding, infection and pain. New onset or worsening of preceding lower urinary tract symptoms, such as urinary frequency, urgency with or without urgency incontinence, stress incontinence including flooding, or voiding difficulties, are relatively common causes of distress to patients and can develop in up to 15% of cases (63). Iatrogenic injury of the urethra, bladder or ureters is less frequent and once identified requires prompt surgical repair in order to minimise the risk of subsequent fistula formation. To decrease the risk of developing such complications, strict adherence to several surgical principles is mandatory. Achieving adequate exposure involves careful planning including attention to patient positioning and preparation of the surgical field. If complete mesh removal is anticipated, either retropubic (TVT) or bilateral groin dissection (TOT) is inevitable. Purposeful dissection in the correct tissue planes whilst protecting adjacent organs and structures aids with mesh identification. Careful mesh mobilisation and handling respecting its presumed course and anatomy, meticulous haemostasis, diligent restoration of anatomy and tension-free closure will greatly facilitate a successful outcome of the mesh removal surgery. The role of minimally invasive techniques using laparoscopic and robotic approaches for both retropubic and transobturator mesh removal surgery has been described and is advocated by some surgeons. They have some theoretical advantages described in other pelvic surgeries, such as better visualisation of the retropubic space, smaller incisions and faster recovery. Improved technical feasibility and favourable outcomes with minimally invasive approaches have been described, in some instances with pain resolution rates between 70% and 100% (64, 65). However, there is lack of evidence on both the cost-effectiveness of these approaches and indeed whether these minimally invasive procedures can achieve total removal of TVTs or TOTs. A precise description of the mesh’s appearance including size, colour and number of removed fragments along with photo documentation after obtaining consent from the patient is an essential part of the patient’s medical record (Fig. 80.3). Routine submission of mesh specimens for microbiology and/or histology is advised. Follow-up at three to six months post-operatively is recommended as this provides a good opportunity to complete patient-reported outcome measures (PROMS). There are no mesh-specific PROMS available currently and the ones used are either symptom specific, e.g. ICIQ-FLUTS, ICIQ-VS, ICIQ-BS, or general quality of life measures e.g. EQ5D. As there is lacking data on long-term followup of patients after mesh removal, monitoring of patients’ symptoms with the use of disease-specific PROMS may be beneficial in providing evidence to guide future counselling of patients about

875 TABLE 80.3: The Conditions That Would Need to be Satisfied before a Lifting of the Pause on Incontinence Mesh in England* i. Surgeons should only undertake operations for SUI if they are appropriately trained, and only if they undertake operations regularly; ii. They report every operation to a national database; iii. A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery; iv. Reporting of complications via the MHRA (Medicines and Healthcare products Regulatory Agency) is linked to the register; v. Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh; vi. NICE guidelines on the use of mesh for SUI are published. *Recommendations of First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, OGL 2020

mesh removal and its outcomes as well as entering such data on national registries will become mandatory.

The role of the multidisciplinary team (MDT) According to the Mesh Oversight Group Report published in 2017 in the United Kingdom, all patients with mesh-related complications should be seen in a specialised mesh centre offering a multidisciplinary team approach consisting of urology, urogynaecology, radiology, specialist pain management and specialist diagnostic medical/allied health professional team members. In England, there has been a pause on the insertion of MUT since July 2018 until there was fulfilment of certain criteria and awaiting the outcome of the Cumberlege review published in 2020 (Table 80.3) This highlighted the complications that have arisen from MUT, and pelvic organ prolapse mesh and the need for specialised mesh centres to deal with such complications. This is a pivotal milestone in the management of mesh complications as these centres have now been established and are the first in the world. Mesh MDTs have now become a standard of practice in the UK, ensuring a holistic approach to mesh-related complications management. The role of the MDT discussion is further emphasised as many women often suffer from multiple mesh-related complications which call on relevant input and expertise from specialists/professionals to manage the specific complications.

Conclusion Many of the complications and symptoms from MUT can be long lasting and thus severely impact on quality of life by affecting many activities of daily living. There are no standardised

FIGURE 80.3  Retropubic tape fully removed with abdominal and vaginal incisions and measured at the end of the procedure.

Textbook of Female Urology and Urogynecology

876 History & examination

Complications

Investigations

Type and number of meshes

Storage LUTS

Voiding LUTS

TVT, TOT, Mini-sling

Bladder/Urethral extrusion

ICIQ-FLUTS, VS, B, LUTSqol, FLUTSsex ICIQ-BD Flow test + PVR Urinalysis

Vaginal exposure

Localised/ Generalised pain

CPAQ-R; PSEQ; PPIQ; BPI HADS; EQ5D; TSQ

Sexual dysfunction

Autoimmune disorders

Cystoscopy (flexible/rigid) Translabial/Transvaginal Ultrasound scan MRI scan of pelvis CT Urogram

Discuss in multidisciplinary meeting and consider referral to pain specialist, clinical psychologist, physiotherapist or other specialists, where indicated

Pre-surgical information

Surgical treatment

Post-mesh removal

Patient Information Leaflet

Patient decision aid

Discuss with patient Type of surgery: Covering of mesh vs division vs partial removal vs full removal Technique: Endoscopic vs open vs laparoscopic vs robotic

Measure the mesh

Take a photo of mesh and file in medical records

Send mesh to histology and/or microbiology

Register removal on National Database

FIGURE 80.4  Algorithm for the management of mesh complications. guidelines or consensus as to how MUT mesh complications should be managed and, as a result, current management principles are largely based on observational studies and expert opinion (Fig. 80.4). The current evidence suggests a multidisciplinary holistic approach to the management of mesh complications, of which surgery is just one option. Training in mesh removal is also limited with few surgeons around the world able to remove mesh fully and therefore fellowship programs and specialised societies will need to address these issues in order to improve the management of mesh-related complications.

References



1. Lee D, Bacsu C, Zimmern PE. Meshology: a fast-growing field involving mesh and/or tape removal procedures and their outcomes. Expert Rev Med Devices. 2015 March;12(2):201–16. 2. Mosser DM, Edwards JP. Exploring the full spectrum of macrophage activation. Nat Rev Immunol. 2008 December;8(12):958–69. 3. Nolfi AL, Brown BN, Liang R, et al. Host response to synthetic mesh in women with mesh complications. Am J Obstet Gynecol. 2016 August;215(2):206.e1–8. 4. Brown BN, Badylak SF. Expanded applications, shifting paradigms and an improved understanding of host-biomaterial interactions. Acta Biomater. 2013 February;9(2):4948–55. 5. Murray PJ, Wynn TA. Protective and pathogenic functions of macrophage subsets. Nat Rev Immunol. 2011 October 14;11(11):723–37. 6. Gigliobianco G, Regueros SR, Osman NI, et al. Biomaterials for pelvic floor reconstructive surgery: how can we do better? Biomed Res Int. 2015;2015:968087. 7. Amid PK. Classification of biomaterials and their related complications in abdominal wall hernia surgery. Hernia 1997;1:15–21. 8. Pierce LM, Rao A, Baumann SS, Glassberg JE, Kuehl TJ, Muir TW. Longterm histologic response to synthetic and biologic graft materials implanted in the vagina and abdomen of a rabbit model. Am J Obstet Gynecol. 2009 May;200(5):546.e1–8. 9. Mühl T, Binnebösel M, Klinge U, Goedderz T. New objective measurement to characterize the porosity of textile implants. J Biomed Mater Res B Appl Biomater. 2008 January;84(1):176–83.









10. Mangera A, Bullock AJ, Chapple CR, Macneil S. Are biomechanical properties predictive of the success of prostheses used in stress urinary incontinence and pelvic organ prolapse? A systematic review. Neurourol Urodyn. 2012 January;31(1):13–21. 11. Feola A, Abramowitch S, Jallah Z, et al. Deterioration in biomechanical properties of the vagina following implantation of a high-stiffness prolapse mesh. BJOG. 2013 January;120(2):224–32. 12. Klinge U, Klosterhalfen B. Modified classification of surgical meshes for hernia repair based on the analyses of 1,000 explanted meshes. Hernia. 2012 June;16(3):251–8. 13. Orenstein SB, Saberski ER, Kreutzer DL, Novitsky YW. Comparative analysis of histopathologic effects of synthetic meshes based on material, weight, and pore size in mice. J Surg Res. 2012 August;176(2):423–9. 14. Deprest J, Zheng F, Konstantinovic M, et al. The biology behind fascial defects and the use of implants in pelvic organ prolapse repair. Int Urogynecol J Pelvic Floor Dysfunct. 2006 June;17 Suppl 1:S16–25. 15. Cundiff GW, Varner E, Visco AG, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008;199(6):688.e1–688.e6885. 16. Kaufman Y, Singh SS, Alturki H, Lam A. Age and sexual activity are risk factors for mesh exposure following transvaginal mesh repair. Int Urogynecol J. 2011 March;22(3):307–13. 17. Gubbels AL, Hibner M. (2021). ‘Pain Arising from Pelvic Floor Implants’. In M Hibner (ed.). Management of Chronic Pelvic Pain: a practical manual (1st ed., pp. 182–194). Cambridge University Press. 18. National Collaborating Centre for Women’s and Children’s Health (UK). Urinary Incontinence: The Management of Urinary Incontinence in Women. London: RCOG Press; 2006 October. PMID: 21938861. 19. Haylen BT, Freeman RM, Swift SE, et al; International Urogynecological Association; International Continence Society; Joint IUGA/ICS Working Group on Complications Terminology. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Neurourol Urodyn. 2011 January;30(1):2–12. 20. Developed by the Joint Writing Group of the American Urogynecologic Society and the International Urogynecological Association. Joint position statement on the management of mesh-related complications for the FPMRS specialist. Int Urogynecol J. 2020 April;31(4):679–94. 21. Agnew G, Dwyer PL, Rosamilia A, Lim Y, Edwards G, Lee JK. Functional outcomes following surgical management of pain, exposure or extrusion following a suburethral tape insertion for urinary stress incontinence. Int Urogynecol J. 2014 February;25(2):235–9.

Mesh Complications and Their Management 22. Kristensen I, Eldoma M, Williamson T, Wood S, Mainprize T, Ross S. Complications of the tension-free vaginal tape procedure for stress urinary incontinence. Int Urogynecol J. 2010 November;21(11):1353–7. 23. Brubaker L, Norton PA, Albo ME, et al; Urinary Incontinence Treatment Network. Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study. Am J Obstet Gynecol. 2011 November;205(5):498.e1–6. 24. Ford AA, Rogerson L, Cody JD, Ogah J. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2015 July 1;(7):CD006375. 25. McLennan MT, Melick CF. Bladder perforation during tension-free vaginal tape procedures: analysis of learning curve and risk factors. Obstet Gynecol. 2005 November;106(5 Pt 1):1000–4. 26. Kuhlmann PK, Dallas K, Masterson J, et al. Risk factors for intraoperative bladder perforation at the time of midurethral sling placement. Urology. 2021 February;148:100–5. 27. Gomes CM, Carvalho FL, Bellucci CHS, et al. Update on complications of synthetic suburethral slings. International Braz J Urol 2017, 43(5), 822–34. 28. Morton HC, Hilton P. Urethral injury associated with minimally invasive mid-urethral sling procedures for the treatment of stress urinary incontinence: a case series and systematic literature search. BJOG. 2009 July;116(8):1120–6. 29. Israfil-Bayli F, Toozs-Hobson P. (2016). ‘Sling Procedures: Bowel Injury’. In A. Coomarasamy, MI Shafi, GW Davila and KK Chan (eds.). Gynecologic and Obstetric Surgery. 30. Kölle D, Tamussino K, Hanzal E, et al; Austrian Urogynecology Working Group. Bleeding complications with the tension-free vaginal tape operation. Am J Obstet Gynecol. 2005 December;193(6):2045–9. 31. Giri SK, Wallis F, Drumm J, Saunders JA, Flood HD. A magnetic resonance imaging-based study of retropubic haematoma after sling procedures: preliminary findings. BJU Int. 2005 November;96(7):1067–71. 32. Flock F, Reich A, Muche R, Kreienberg R, Reister F. Hemorrhagic complications associated with tension-free vaginal tape procedure. Obstet Gynecol. 2004 November;104(5 Pt 1):989–94. 33. Ko JK, Ku CH. Embolization for pelvic arterial bleeding following a transobturator tape procedure. J Obstet Gynaecol Res. 2014 March;40(3):865–8. 34. Aydogmus S, Kelekci S, Aydogmus H, Ekmekci E, Secil Y, Ture S. Obturator nerve injury: an infrequent complication of TOT procedure. Case Rep Obstet Gynecol. 2014;2014:290382. 35. Karmakar D, Dwyer PL, Nikpoor P. Mid-urethral sling revision for mesh exposure-long-term outcomes of two surgical techniques from a comparative clinical retrospective cohort study. BJOG. 2020 July;127(8):1027–1033. 36. Kobashi KC, Govier FE. Management of vaginal erosion of polypropylene mesh slings. J Urol. 2003 June;169(6):2242–3. 37. Illiano E, Giannitsas K, Li Marzi V, Natale F, Manicini V, Costantini E. No treatment required for asymptomatic vaginal mesh exposure. Urol Int. 2019;103(2):223–7. 38. National Guideline Alliance (UK). Urinary incontinence and pelvic organ prolapse in women: management. London: National Institute for Health and Care Excellence (UK); 2019 April. PMID: 31211537. 39. Abbott S, Unger CA, Evans JM, et al. Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study. Am J Obstet Gynecol. 2014 February;210(2):163.e1–8. 40. Domingo S, Alamá P, Ruiz N, Perales A, Pellicer A. Diagnosis, management and prognosis of vaginal erosion after transobturator suburethral tape procedure using a nonwoven thermally bonded polypropylene mesh. J Urol. 2005 May;173(5):1627–30. 41. Jambusaria LH, Heft J, Reynolds WS, Dmochowski R, Biller DH. Incontinence rates after midurethral sling revision for vaginal exposure or pain. Am J Obstet Gynecol. 2016 December;215(6):764.e1–764.e5. 42. Novara G, Galfano A, Boscolo-Berto R, et al. Complication rates of tensionfree midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol. 2008 February;53(2):288–308. 43. Karim SS, Pietropaolo A, Skolarikos A, et al. Role of endoscopic management in synthetic sling/mesh erosion following previous incontinence

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surgery: a systematic review from European Association of Urologists Young Academic Urologists (YAU) and Uro-technology (ESUT) groups. Int Urogynecol J. 2020 January;31(1):45–53. 44. Ogle CA, Linder BJ, Elliott DS. Holmium laser excision for urinary mesh erosion: a minimally invasive treatment with favorable long-term results. Int Urogynecol J. 2015 November;26(11):1645–8. 45. Deng DY, Rutman M, Raz S, Rodriguez LV. Presentation and management of major complications of midurethral slings: are complications underreported? Neurourol Urodyn. 2007;26(1):46–52. 46. Kowalik CG, Cohn JA, Kakos A, et al. Road to recovery after transvaginal surgery for urethral mesh perforation: evaluation of outcomes and subsequent procedures. Int Urogynecol J. 2018 June;29(6):887–92. 47. Hengel AR, Carlson KV, Baverstock RJ. Prevention, diagnosis, and management of midurethral mesh sling complications. Can Urol Assoc J. 2017;11(6Suppl2):S135–S140. 48. Mendonça TM, Martinho D, Dos Reis JP. Late urethral erosion of transobturator suburethral mesh (Obtape): a minimally invasive management under local anaesthesia. Int Urogynecol J. 2011 January;22(1):37–9. 49. Wang C, Zimmern PE, Lemack G. Long-term results of transurethral endoscopic excision using the holmium laser for urethral perforation of synthetic slings. Low Urin Tract Symptoms. 2019 April;11(2):O103–O110. 50. Parnell BA, Johnson EA, Zolnoun DA. Genitofemoral and perineal neuralgia after transobturator midurethral sling. Obstet Gynecol. 2012 February;119(2 Pt 2):428–31. 51. Rosenbaum TY, Owens A. The role of pelvic floor physical therapy in the treatment of pelvic and genital pain-related sexual dysfunction (CME). J Sex Med. 2008 March;5(3):513–23; quiz 524–5. 52. Duckett J, Baranowski A. Pain after suburethral sling insertion for urinary stress incontinence. Int Urogynecol J. 2013 February;24(2):195–201. 53. Duckett JR, Jain S. Groin pain after a tension-free vaginal tape or similar suburethral sling: management strategies. BJU Int. 2005 January;95(1):95–7. 54. Luo FY, Nasr-Esfahani M, Jarrell J, Robert M. Botulinum toxin injection for chronic pelvic pain: a systematic review. Acta Obstet Gynecol Scand. 2020;99:1595–602. 55. Leonard G, Perrouin-Verbe MA, Levesque A, et al. Place of surgery in the management of post-operative chronic pain after placement of prosthetic material based on a series of 107 cases. Neurourol Urodyn. 2018 September;37(7):2177–83. 56. Rigaud J, Pothin P, Labat JJ, et al. Functional results after tape removal for chronic pelvic pain following tension-free vaginal tape or transobturator tape. J Urol. 2010 August;184(2):610–5. 57. Danford JM, Osborn DJ, Reynolds WS, Biller DH, Dmochowski RR. Postoperative pain outcomes after transvaginal mesh revision. Int Urogynecol J. 2015;26(1):65–9. 58. Hokenstad ED, El-Nashar SA, Blandon RE, et al. Health-related quality of life and outcomes after surgical treatment of complications from vaginally placed mesh. Female Pelvic Med Reconstr Surg. 2015 May–June;21(3):176–80. 59. Chughtai B, Sedrakyan A, Mao J, Eilber KS, Anger JT, Clemens JQ. Is vaginal mesh a stimulus of autoimmune disease? Am J Obstet Gynecol. 2017 May;216(5):495.e1–e7. 60. Cohen Tervaert JW. Autoinflammatory/autoimmunity syndrome induced by adjuvants (Shoenfeld’s syndrome) in patients after a polypropylene mesh implantation. Best Pract Res Clin Rheumatol. 2018 August;32(4):511–20. 61. Cumberlege BJ. Our concern over partial mesh removal. The Independent Medicines and Medical Devices Safety Review 2019. 62. Treating complications from mesh used for stress urinary incontinence Patient decision aid NICE. 63. Lee D, Zimmern PE. An update on research and outcomes in surgical management of vaginal mesh complications. Expert Rev Med Devices. 2019 July;16(7):569–80. 64. Goodall EJ, Cartwright R, Stratta EC, Jackson SR, Price N. Outcomes after laparoscopic removal of retropubic midurethral slings for chronic pain. Int Urogynecol J. 2019 August;30(8):1323–8. 65. Greenwell T, Cutner A. The anatomy and an illustrated description of a technique for combined laparoscopic and vaginal total removal of an obturator mid urethral tape. Transl Androl Urol. 2018 December;7(6):978–81.

Section VIII Surgery for Urogenital Prolapse Section Editor: Peter Sand

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CLASSIFICATION AND EPIDEMIOLOGY OF PELVIC ORGAN PROLAPSE Steven E. Swift and Joel D. Winer

Introduction The study of pelvic organ prolapse (POP) is one area of medicine that seems so intuitive but in actuality this intuition makes it harder to form firm and scientifically validated definitions. Where do we draw the line between normal changes in pelvic organ support versus the disease state of POP? While a classification system to codify pelvic organ support has been defined and become the standard of international academic study, there is still a missing piece — we have yet to determine a scientifically validated and universally agreed-upon definition of the disease state of POP. This is akin to having a blood pressure cuff to measure blood pressure but not having a definition as to what represents normal versus hypertension. The current Pelvic Organ Prolapse Quantification (POPQ) classification system may be able to accurately and reproducibly codify pelvic organ support but it does not classify the aforementioned support into normal versus abnormal. Until we define the disease, we cannot properly identify its etiology, nor can we accurately make statements regarding therapy, prognosis, or natural history. Therefore scientific literature regarding POP should be viewed with caution – it is critical to pay particular attention to how POP is described and defined. The field of urogynecology continues to move forward and address the further study of the classification and epidemiology of POP research.

Classification of pelvic organ support The aforementioned title specifically does not use the term “prolapse” but instead uses “support” as none of the current POP classification systems attempts to define “prolapse.” Instead, they address where the vaginal walls or structures extend anatomically without making reference to what is normal versus what is abnormal, e.g. “prolapsed.” The history of classification systems for pelvic organ support extends back into the nineteenth century, with a new system appearing every generation or so, but with no system ever attaining widespread acceptance as the “gold standard” [1–7]. Several of these systems are diagramed in Figure 81.1. Over the last two decades, the Pelvic Organ Prolapse Quantification (POPQ) system has gained international recognition as the “gold standard” for classifying pelvic organ support, and it is the system recognized by major societies that study pelvic organ support defects: the International Urogynecological Association (IUGA), the International Continence Society (ICS), the American Urogynecologic Society (AUGS), the Society of Gynecologic Surgeons, and the American College of Obstetricians and Gynecologists [8, 9]. It is also one of the few systems to be extensively studied with several reports in the literature documenting excellent inter- and intraexaminer reliability [10–12]. Two other classification systems that have been studied include the Baden and Walker “half-way” system and a simplified POP classification 880

(S-POP) system. The Baden and Walker “half-way” system has been around for decades and has gained some widespread notoriety. In a survey of the literature on POP, it was the second most commonly employed classification system behind the more popular POPQ system [11, 13]. The S-POP system is a simplified version of the POPQ that has been studied in a large international multicentered trial [14]. It was shown to have very good intra- and interexaminer reliability and had good intersystem association with the POPQ [15]. Currently, there is only one internationally recognized classification system for codifying pelvic organ support—the POPQ. It has proven itself to be a reliable system, and it is the system that should be employed in research regarding pelvic organ support. The Baden and Walker “half-way” system remains a system used in clinical practice, and this may stem from its ease of use; however, it should not supplant the POPQ in research studies and the scientific literature [11].

Pelvic organ prolapse quantification system The POPQ system was first described and published in 1996, but it took more than a decade to become widely accepted and used in the majority of publications on POP [16–18]. As with other systems, the POPQ system does not provide a definition of what constitutes the normal range of anatomic support versus what is abnormal and thus prolapse, which can then be used to guide clinical care. There is a dearth of data regarding the use of the POPQ system outside the field of urogynecology. One study of obstetrics and gynecology house officers and students who were trained in the use of POPQ found that only 1 of the 54 participants reported seeing or using the system outside of their urogynecology rotation [19]. Since POPQ is now the widely accepted method for describing pelvic organ support in research and academic work in urogynecology, it is important for the practitioner to become familiar with its use. Other methods may be useful in clinical practice, but it is critical to know that previous methods do not have the same level of inter/intra provider reliability. Additionally, concerns about the length of time it takes to complete the POPQ exam are unwarranted as it only takes 2–3 minutes to complete the examination, even in neophytes [10]

Performing the pelvic organ prolapse quantification examination

The POPQ examination takes nine measures of the position of midline vaginal structures (Table 81.1). All of the measurements are in half-centimeter increments relative to the hymeneal ring. The remnant of the hymeneal ring is used as the reference point because it is a fixed and easily identified landmark, as opposed to the introitus (the “entrance into the vagina”), which is a nonstandardized anatomic structure. All of the points recorded during the examination, with the exception of total vaginal length, are measured with the subject performing a Valsalva or a deep

DOI: 10.1201/9781003144243-89

Classification and Epidemiology of Pelvic Organ Prolapse

1963 Severity (Porges)

1972 Vaginal profile (Baden)

1980 Grading system (Beecham) Midplane of vagina

Grade 1 Straining

881

Slight or first degree

Stage I First degree

Grade 2

Introitus

Hymenal ring

(–) 1 cm

At rest

Straining

(+) 1 cm Moderate or second degree

1996 Quantitative POP (ICS, AUGS, SGS)

Grade 3

Second degree

Stage II

Stage III

Complete eversion

Marked or third degree Grade 4

Third degree

Stage IV

FIGURE 81.1  Comparison of the four most commonly used pelvic organ prolapse grading systems. Abbreviations: AUGS, American Urogynecologic Society; ICS, International Continence Society; SGS, Society of Gynecologic Surgeons. cough. Structures that lie above the hymeneal ring are recorded as negative, whereas structures that prolapse beyond the hymeneal ring are recorded as positive (Fig. 81.2). Any structure that descends to the level of the hymeneal ring is recorded as 0 cm. Nine measurements are taken during the examination: two from TABLE 81.1: Sites Measure in the Quantitative Pelvic Organ Prolapse Examination Point

Description

A anterior (Aa)

A point on the anterior vaginal wall 3 cm above the hymeneal ring Most dependent or distal point on the anterior vaginal wall segment between A anterior and point C or the cuff if subject is status posthysterectomy Anterior lip of the cervix or the cuff if subject is status posthysterectomy A point on the posterior vaginal wall 3 cm above the hymeneal ring Most dependent or distal point on the posterior vaginal wall segment between A posterior and point D or the cuff if subject is status posthysterectomy Posterior fornix (this space is left blank in the subject who is status posthysterectomy) Middle of external urethral meatus to posterior hymeneal remnant Posterior hymen to middle of anal opening Hymeneal ring to vaginal apex

B anterior (Ba)

C A posterior (Ap) B posterior (Bp)

D

Genital hiatus (gh) Perineal body (pb) Total vaginal length (tvl)

the anterior vaginal wall, two from the apex of the vagina, two from the posterior vaginal wall, and one each recording the genital hiatus, perineal body, and the total vaginal length at rest (see Table 81.1). These points are depicted diagrammatically in Figure 81.2; note also the two diagrams representing a large anterior segment defect with some apical descent (Profile A) and a large posterior defect (Profile B). The nine points may be recorded in a convenient manner using a three-by-three grid as noted in the figure. Any rigid measuring device—such as a marked Pap smear spatula, the handle of a proctoswab or cotton-tipped applicator, a ruler, or an engraved instrument—may be used. An ordinal staging system is used to describe the prolapse stage, which is defined by the structure that demonstrates the greatest degree of prolapse (Table 81.2). An easy method to remember this staging system is to understand stage II. Any vaginal structure that descends such that the leading edge is at or between 1 cm above and 1 cm past the hymeneal ring is stage II. If the leading edge has some movement but remains above −1 cm, it is stage I, and any structure or leading edge that descends beyond +1 cm is stage III up to complete eversion, which is stage IV. Stage 0 is no descent of any vaginal segment. At a practical level, an efficient method of performing the examination consists of placing a bivalve speculum in the vagina and measuring apical descent using the posterior blade of the speculum to measure anterior and then posterior structures, and then measuring the perineal structures. Further information regarding the performance of the POPQ examination, including a video, is available at the AUGS website (www. augs.org). One aspect of this system that may be awkward, or even an anathema, to adherents of prior systems is the strict avoidance of terms such as cystocele, rectocele, or enterocele. The rationale behind this seemingly dogmatic practice is to avoid erroneous assumptions regarding the prolapsing organs. Since the vagina is

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882 C

D

3 cm

Ba

Aa tvl

Bp Ap gh

pb

(a)

Aa

Ba C

Aa C Bp Ba

Bp Ap Ap

+3Aa

+6Ba

–2C

–3Aa

–3Ba

–6C

4.5gh

1.5pb

6tvl

4.5gh

1pb

8tvl

–3Ap

–2Bp

—

+2Ap

+5Bp

—

(b)

Profile A

Profile B

FIGURE 81.2  (a) The nine points recorded for the pelvic organ prolapse quantification system. Terms are defined in Table 81.1. (b) Profile A represents a large anterior wall defect with some apical descent; Profile B represents a large posterior defect. Note the grid system used for recording the nine points.

TABLE 81.2: Staging of Pelvic Organ Prolapse Stage 0 I II III

IV

Description No descensus of pelvic structures during straining. The leading surface of the prolapse does not descend below 1 cm above the hymeneal ring. The leading edge of the prolapse extends to within 1 cm (+/−) of the hymeneal ring The prolapse extends more than 1 cm beyond the hymeneal ring, but there is not complete vaginal eversion. The vagina is completely everted.

relatively opaque, it is not possible to identify which organ is on the other side of the epithelium. It is often difficult even for experienced observers to discriminate between a high rectocele and a pulsion enterocele. Furthermore, patients who have had prior reconstructive pelvic surgery may have gross alterations in their vaginal axis, which result in unusual patterns of prolapse (e.g., anterior enterocele after sacrospinous ligament suspension). Another change from previous systems is the avoidance of staging individual vaginal segments, i.e., a patient having a stage II cystocele and stage III rectocele. Instead, the patient is given one overall stage; for example, the previously noted patient would be described as having a POPQ stage III examination.

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Simplified pelvic organ prolapse quantification system

In response to concerns regarding the clinical utility of the POPQ, the IUGA set up a task force to develop a more user-friendly system for classifying pelvic organ support. They also wanted a system that would demonstrate good association with the POPQ such that clinicians could use the user-friendly version in their clinical practice but take advantage of scientific literature using the standard POPQ system. The S-POP was developed by this task force. The S-POP is basically the ordinal staging of the POPQ system applied to each segment of the vaginal wall (anterior, posterior, apex, and cervix) without the need for nine separate measures. This idea stemmed from observations that several investigators were already reporting on simple ordinal staging for pelvic organ support without taking the nine measurements [12]. The S-POP is just a codification of applying what many investigators were already proposing.

Performing the simplified pelvic organ prolapse quantification exam

The technique for performing the simplified POPQ exam is as follows. Patients are asked to empty their bladder prior to the exam. The subject is then placed in the dorsal lithotomy position. Once the subject is positioned for examination, they are instructed to forcefully Valsalva or to cough—if the clinician feels the Valsalva is inadequate. The four areas to be examined and staged include the anterior and posterior vaginal walls, the apex/cuff, and the cervix. If a subject was status posthysterectomy, then only three measurements are taken: the anterior and posterior vaginal walls and the cuff scar/apex. For the exam of the anterior and posterior vaginal wall segments, a disarticulated posterior blade of a Graves speculum, Sims speculum or two fingers of the examiner is employed as a retractor. For examination of the anterior vaginal segment, the speculum blade or fingers are placed into the vagina and the posterior vaginal wall is retracted to allow for full visualization of the anterior vaginal wall. A point or rugal fold approximately 3 cm proximal to the urethral meatus on the anterior vaginal wall is identified. The patient is then instructed to perform a Valsalva maneuver or cough in a forceful fashion and where that point or rugal fold previously identified descends in relation to the hymenal remnants is noted and recorded as the stage of the anterior vaginal wall (noted in the following under staging). The posterior segment is examined in a similar fashion. The point chosen to represent the posterior vaginal segment is identified in a similar fashion retracting the anterior vaginal wall. The only difference is the point is approximately 3 cm proximal to the hymenal remnants instead of the urethral meatus. The cervix is evaluated by placing a speculum in the vagina and directly observing its descent during a Valsalva maneuver or cough to determine its stage in relation to the hymenal remnants. Care should be taken to make certain that the cervix is not inadvertently supported by the speculum during the exam. The vaginal apex or cuff scar is visualized in a similar fashion. If the cervix, apex, or cuff scar descends beyond the hymenal remnants with Valsalva or cough, then a speculum is not necessary. If the subject has a cervix, then the vaginal apex or posterior fornix is described separately from the cervix. The staging system for each segment is as follows: Stage I: Prolapse where the given point remains at least 1 cm above of the hymenal remnants during Valsalva or forceful cough

FIGURE 81.3  The four points measured for the simplified pelvic organ prolapse classification exam. Note the dotted line representing the hymenal remnants. Stage II: Prolapse where the given point descends an area extending from 1 cm above to 1 cm below the hymenal remnants (Fig. 81.3) Stage III: Prolapse where the given point descends greater than 1 cm past the hymenal remnants but does not represent complete vaginal vault eversion or complete procidentia uteri (Fig. 81.4) Stage IV: Complete vaginal vault eversion or complete procidentia uteri No specific measuring devices need to be used. The examining clinician can approximate the 1 cm above or below the hymenal remnants defining stage II. The subjects are assigned an overall stage as the highest value among the four segments, and each segment is assigned an individual stage. Assigning individual stages to the various vaginal segments while not part of the POPQ is a standard clinical practice. In addition, the task force that developed the simplified POPQ felt that a stage 0 was not necessary since it is asymptomatic and not different enough from stage I to warrant a separate classification stage.

Epidemiology of pelvic organ prolapse The National Institutes of Health (NIH) consensus conference recognized that without a standard validated definition of POP there could be little progress in studying the disease and its treatment. They noted that currently there are no clinically or scientifically validated definitions and felt that any proposed definition should take into account both a subject’s anatomy and their symptoms [20]. Despite the lack of knowledge on which to base a rational definition for POP, the NIH defined POP as ≥POPQ stage II exam.

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FIGURE 81.4  Simplified pelvic organ prolapse classification (S-POP) stage III anterior vaginal wall prolapse, stage II cervical support, and stage I apex and posterior vaginal wall support. Note the dotted line representing the hymenal remnants and the box representing S-POP stage II. Subsequent to the NIH consensus conference, there have been several published studies examining the distribution of pelvic organ support in various general female populations [21–28]. Four studies have looked at general populations of a significant age range employing the POPQ system [21–23, 29]. From the distribution of these four studies as plotted in Figure 81.5, it can be

n = 1004 pts

seen that POPQ stage II support represents between 30% and 50% of the populations studied. However, it is doubtful that POP is this prevalent; therefore, the NIH definition may be too broad. Only 2–11% of the subjects in these studies have stage III and IV examinations, which is more consistent with current estimates on the percent of subjects undergoing surgical treatment for this condition. There is an 11% lifetime risk of undergoing surgical correction of POP, and the incidence of surgery for POP/incontinence is 22.7 per 10,000 [30,31]. POP is a disease with essentially no mortality and only minimal morbidity; however, it is a condition that greatly impacts the quality of life. Therefore, symptoms play a central role in defining at what point a patient goes from “normal” pelvic organ support to “abnormal” POP. Most studies demonstrate that there is a very weak (if any) correlation between symptoms and advancing degrees of POP with the exception of the symptom of a bothersome vaginal bulge [32–36]. In the few studies that correlated the POPQ stage with symptoms, it appears that symptoms begin to significantly increase once the leading edge of the vaginal wall extends to or just beyond the hymen [22, 31]. Therefore, a reasonable definition of POP may be protrusion of any vaginal segment to or beyond the hymen in symptomatic patients. If one carefully reads the literature, this definition, while not recognized, is slowly becoming the standard. A review article has suggested that we should define the disease and outcomes regarding management strategies using composite scores based on objective and subjective findings [37].

Etiology of pelvic organ prolapse As previously noted, there is no currently accepted definition of POP; therefore, each study into its pathophysiology is left to employ its own definition. Generally, the literature defines prolapse in one of two ways—either anatomically by examination or by surgical admission for corrective surgery. The concern regarding surgical admissions is that they miss those patients that manage their prolapse conservatively; the concern regarding anatomic

n = 487 pts

n = 653

n = 394

80 70

67

60 50

30

0

22

22 9

35

37

24

20 10

47

43 38

40

29 9

6

Stage 0

3 2 Stage III 2

Stage I

Stage II

3

0 0 0 Stage IV

FIGURE 81.5  Percent of subjects in each pelvic organ prolapse quantification stage in three studies of general female populations. n is the number of subjects examined in each study. (n = 487: From Swift SE, Am J Obstet Gynecol, 183, 277, 2000; n = 1004: From Swift SE et al., Am J Obstet Gynecol, 192, 795, 2005; n = 653: From Slieker-ten HMCP et al., Distribution of pelvic organ prolapse in a general population: Prevalence, severity, etiology and relation with the function of pelvic floor muscles, Abstract Presented at the Joint Meeting of the ICS and IUGA, August 25–27, 2004, Paris, France; n = 394: From Trowbridge ER et al., Am J Obstet Gynecol, 198, 548.e1, 2008.)

Classification and Epidemiology of Pelvic Organ Prolapse TABLE 81.3: Definitions of Pelvic Organ Prolapse from the Various Epidemiological Studies Author

Definition

Jorgensen et al. [42]

Surgical admission for surgery to correct prolapse Surgical admission for surgery to correct prolapse Surgical admission for surgery to correct prolapse Baden and Walker stage II and greater Baden and Walker stage II and greater Presence of any cystocele, rectocele, uterine descent, or absence of the urethrovesical crease Any vaginal relaxation to the introitus (roughly equivalent to Baden and Walker stage II and greater) POPQ stage III prolapse Stage I or greater prolapse by a unique system defined for this study (stage I is defined as in the vagina) Leading edge at -0.5 cm above the introitus or greater (some POPQ stage II and all stage III and IV)

Olsen et al. [30] Mant et al. [24] Chiaffarino et al. [39] Marchionni et al. [40] Samuelsson et al. [26]

Gruel and Gruel [41]

Swift et al. [38] Hendrix et al. [28]

Swift et al. [22]

descriptions is that studies use a wide range of anatomic cutoffs [22, 24, 26, 28, 30, 38–42]. Examples of epidemiological studies and their definitions are provided in Table 81.3. This plethora of definitions makes it difficult to evaluate trends in the literature in the various etiologies and can lead to conflicting results. This portion of the chapter will examine the various proposed etiologies of POP, bearing in mind that the frequently conflicting results stem from the various definitions employed in each study. Currently, the International Urogynecologic Association (IUGA) and the International Continence Society (ICS) define POP as a bothersome vaginal bulge that most commonly occurs when the protruding vaginal segment or cervix is at or beyond the hymenal remnants [43]. The only universally accepted risk factor for POP is the increasing age. Regardless of the definition used, this factor is always identified as a risk for prolapse, and most estimates suggest that there is roughly a doubling in the risk of prolapse with every completed decade of life [21, 22, 28, 38]. The other proposed pathophysiologies for POP are many but for the most part involve two types of insult: either the acute damage that occurs with pregnancy or the chronic insults from conditions that lead to continuous intermittent increases in intra-abdominal pressure. In addition, other areas that have been investigated include prior pelvic surgery and genetic factors.

Effect of pregnancy

The relationship between pregnancy and POP has been extensively studied and is mentioned in almost every treatise on this subject. It is assumed that as the fetal vertex passes through the birth canal, there is direct damage to the nerves, fascia, and muscle that leads to eventual relaxation of the pelvic floor musculature and POP. While it is generally recognized that any parity is associated with an increased risk of prolapse, what role the delivery mode plays is more controversial [21–24, 26, 36–39, 41]. Specifically, can one delivery mode (i.e., cesarean section) provide

885 protection against prolapse? The majority of the literature supports the notion that increasing parity increases the risk of POP [21, 22, 24, 36, 39]. Studies suggest that anywhere from a 4- to an 11-fold increase in the risk of prolapse is dependent on parity, with increasing parity imparting greater risk [22, 24, 38]. However, the literature on the mode of delivery is somewhat mixed. In one report, patients who delivered only by cesarean section were compared to patients who had any vaginal delivery, the data are inconclusive and did not suggest a protective effect [22]. However, in a large population-based study from Sweden of over 1.4 million patients, a significant protective association between cesarean section and pelvic organ prolapse was noted. They demonstrated an adjusted OR of 0.18 (0.16–0.20) suggesting an 80% reduction in the risk of developing POP in subjects with only cesarean delivery [44]. The data on instrumented vaginal delivery are sparse, and in one study forceps delivery was not identified as a risk factor for the development of prolapse [39]. In addition, there is one study suggesting that episiotomy protects against prolapse [40]. The largest most recent study that evaluated patients almost 20 years following their delivery revealed that forceps delivery increased the risk of developing POPQ stage II POP or undergoing surgery for POP by 70% with an adjusted odds ratio of 1.74 (95% CI, 1.12–2.68; P = 0.01 [45]. The data regarding infant weight are more consistent, with most studies demonstrating an increase in prolapse with increasing fetal weight; delivery of a macrosomic infant carries the greatest risk [22, 26, 38, 39, 46]. Pregnancy and macrosomia are consistently identified as risk factors for POP, but whether cesarean delivery or avoidance of an operative vaginal delivery can protect against POP remains a topic of debate with no clear evidence to support or refute this supposition.

Modifiable lifestyle risk factors

There are several opinions regarding how to counsel patients in ways to prevent POP. Factors such as occupations that require a lot of lifting, together with obesity and smoking, all contribute to POP, and modifying or removing these insults will reduce the risk. One of the first publications to suggest that occupation may be a risk for prolapse stemmed from an article published in 1994 on nursing assistants in Denmark. The investigators noted a 60% increased risk of surgery to correct POP and herniated lumbar disks in nursing assistants over the general population [42] and felt this was due to the excess heavy lifting of patients inherent in their job description. Since then, two large studies have incorporated job descriptions into their data collection [22, 39]. Both found that manual workers and housewives had a slightly increased risk of prolapse over patients who classified themselves as professionals. However, in a case-control study of almost 400 subjects who retrospectively determined their level of both leisure and work-related activity expressed as a median overall lifetime activity, in metabolic equivalents-hours/week failed to demonstrate any difference between those with and those without POP [47]. Obesity is another risk factor commonly quoted for POP. It is felt that the increasing weight from abdominal adipose tissue increases the pressure on the intra-abdominal organs, leading to pelvic floor weakness and prolapse. Here, the literature is divided, with several studies suggesting it as a risk factor [22, 24, 28, 30, 40] and several studies finding no association [26, 38, 40].

886 Smoking is the final modifiable risk factor often associated with POP. Again, the data are mixed, with several studies suggesting that current smokers are at risk [24, 28, 30], two showing no relationship [26, 39], and one study suggesting smoking has some protection against POP [22]. Among the lifestyle or modifiable etiologies, there are no obvious and consistent data to suggest any factors are related to an increased risk of developing POP.

Medical illnesses

Other areas that are commonly discussed and implicated as being etiologies of POP are chronic medical or congenital illnesses that result either in increased intra-abdominal pressure or in microvascular disease and poor-quality collagen. The relationship between chronic illness and prolapse has been investigated in large epidemiological studies with mixed results. It would seem intuitive that those illnesses associated with chronic recurrent increases in intra-abdominal pressure, such as constipation, obesity, and chronic obstructive pulmonary disease (COPD) would increase the risk of POP. Constipation is an illness that can be difficult to define; however—when evaluated—it appears consistently related to an increase in prolapse [28, 48]. A recent meta-analysis of 22 observational studies on obesity and POP revealed the overweight and obese had a roughly 40% increased risk of developing POP over normal-weight individuals. They noted the association was strongest for clinically identified POP over symptomatically identified POP suggesting that this further validated their findings [49]. Two studies evaluated COPD and neither noted it as a risk for prolapse [30, 38]. In one of these studies, the number of subjects with COPD was very small, and in the other, the pelvic organ prolapse was defined by surgical admission so the data could be questioned. However, when taken with data on smoking, there does not appear to be a strong relationship between pulmonary disease and prolapse. Medical illnesses that lead to long-term damage to the microvasculature and peripheral neuropathies, such as hypertension and diabetes mellitus, have been suggested as potential causes of POP. However, as with many etiological studies, the results are mixed. In one large study, the presence of any chronic illness was not associated with an increased incidence of prolapse [22]; in another study, only hypertension was identified as a risk factor [38]. There are also a few studies in patients with collagen vascular diseases, such as Marfan and Ehlers–Danlos syndrome, which suggest that these patients are at an increased risk of prolapse [49, 50]. However, again the data are somewhat conflicting, and this may stem from the lack of any definition of prolapse in these studies.

Race

There is a long history of observational data suggesting that patients of certain racial groups are at a greater or lesser risk of POP. There were very early anecdotal reports of AfricanAmerican and Asian patients having a very low risk of POP in comparison to white patients [51–54]. The limited data seem to imply that African-American patients have a slightly decreased risk of prolapse when compared to non-Hispanic white patients, and Hispanic patients have a slightly increased risk when compared to non-Hispanic white patients [22, 28, 38]. The definitions of race used in a study are emblematic of the time and place in which it was conducted, and studies that implicate race as a risk

Textbook of Female Urology and Urogynecology factor should be viewed with caution as there are larger social and cultural phenomena that impact healthcare access and outcomes.

Menopausal status and hormone replacement therapy

The association between menopausal status, hormonal therapy, and POP is a very complicated issue. First, patients who are menopausal tend to be older than their premenopausal counterparts, and, as pointed out earlier, increasing age is probably the greatest risk factor for POP. In addition, patients who take hormone replacement therapy (HRT) may not have taken it consistently since menopause and can be on any of a myriad of dosing schedules, further complicating any comparative studies. The majority of the studies suggest that postmenopausal status increases risk; however, when a multiple logistic regression analysis takes age into account, the menopausal status becomes nonsignificant, suggesting that it may be the age factor more than the decreased estrogen levels that increase the risk for prolapse [22, 28, 38, 39]. In these same studies, when the role of HRT was evaluated in menopausal patients, the results are even less clear. One study suggested that past use decreases risk but not current use, another suggested no difference between ever and never using HRT, and one suggested that postmenopausal patients with current use had a risk equal to that of premenopausal patients. It should be noted that, while HRT may not protect menopausal patients from developing prolapse, it has never demonstrated a negative effect.

Prior pelvic surgery

This is another area where it is difficult to determine if there are any significant relationships. First, it is known that up to 30% of patients who undergo surgery for POP will require a second procedure to correct recurrent prolapse [30]. Therefore, subjects who have had prior prolapse surgery have many of the underlying conditions that put them at risk for prolapse, and using this as a risk factor is similar to noting the increased risk of cancer in patients undergoing treatment for cancer. Conversely, many patients who have undergone a hysterectomy had it done to correct POP, as pelvic relaxation was previously the third most common indication for hysterectomy in the United States [55]. Therefore, many of these patients have already been treated for prolapse and many will have been treated successfully. However, when hysterectomy is evaluated, most studies suggest that it does expose patients to an increased risk of POP [24, 26, 38, 40]. When the hysterectomy was done specifically for prolapse, it increases the risk even more [40]. The mechanism behind this phenomenon may be the disruption of the normal apical supports of the vagina in subjects with otherwise good support. This emphasizes the need to be ever mindful of providing strong attachment of the cardinal and uterosacral ligament complex to the vaginal cuff at the time of hysterectomy. In subjects who have undergone prior prolapse surgery, there appears to be upwards of a fivefold increase in their risk of developing POP [38].

Family history

One area of emerging data on the risk of developing POP is in genetics or inheritance. The most complete study to date involves a population-based study of over 1,200 patients in a Utah genealogy-defined population linked to more than a decade of hospital data. They identified a fourfold increase in the rate of POP procedures for first-degree relatives of patients undergoing POP procedures [56]. There are several studies where subjects who had undergone surgery for prolapse were asked about any family history of other relatives undergoing similar surgery [39].

Classification and Epidemiology of Pelvic Organ Prolapse The authors noted that there was an increased risk of POP surgery if a patient’s mother or sister had undergone prolapse surgery. In a recent meta-analysis of potential genetic markers for POP, there were no obvious candidates owing to the small number of subjects [57].

Natural history of pelvic organ prolapse

This is an area of study with almost no data. There is one good study that evaluated the effect of no treatment on subjects with minimally symptomatic POP followed over time. The 64 patients who were followed had minimally symptomatic prolapse (95% had POPQ stage II and stage III) and declined pessary or surgical management. They were followed on average for 16 months and in approximately 80% there were no changes in their POPQ examinations. Of the 64 patients, 20% eventually elected an intervention, but this study demonstrated that no intervention is an acceptable therapeutic option in minimally symptomatic subjects and that patients generally do not experience rapid progression of prolapse [58].

Summary While we are still in the infancy of understanding POP, we are moving forward. There is now a growing body of literature regarding the classification and epidemiology of POP incorporating the POPQ and well-described definitions of POP that are beginning to help us understand this complex disease. Currently, it is difficult to evaluate the pathophysiology of POP because of the lack of a standard definition. This makes the plethora of emerging data difficult to interpret because often we are comparing apples and oranges. There are a few consistencies, with age and pregnancy being acknowledged risk factors for POP. Other factors that probably play a role include obesity, a job with a greater proportion of manual labor and lifting, lack of HRT, hysterectomy, and family history. However, before recommendations can be made regarding preventive strategies, more studies using a consistent definition are required.

References

1. Scanzoni FW. Senkung und Vorfall des uterus und der scheide. In FW Scanzoni, ed. Lehrbuch der Krankheiten der Weiblichen Geschlechstorgane, 5th ed. Vienna, Austria: Braumueller, 1875, pp. 654–664. 2. Kelly HA. Operative Gynecology. New York: Appleton & Co., 1898. 3. Kuestner O. Prolapsus uteri et vaginea. In O Kuestner, E Bumm, A Doederlein, B Kroenig, and C Menge, eds. Kurzes Lehrbuch der Gynaekologie. Jena, Germany: G. Fischers, 1912, pp. 159–181. 4. Baden WF, Walker TA. Genesis of the vaginal profile: a correlated classification of vaginal relaxation. Clin Obstet Gynecol 1972;15:1048–1054. 5. Baden WF, Walker TA. Physical diagnosis in the evaluation of vaginal relaxation. Clin Obstet Gynecol 1972;15:1055–1069. 6. Beechum CT. Classification of vaginal relaxation. Am J Obstet Gynecol 1980;136:957–958. 7. Porges RF. A practical system of diagnosis and classification of pelvic relaxations. Surg Gynecol Obstet 1963;117:761–773. 8. Bump RC, Mattiasson A, Bo K et al. The standardization of terminology of female pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10–17. 9. Pelvic Organ Prolapse: ACOG Practice Bulletin, Number 214. Obstet Gynecol. 2019 November;134(5):e126–e142. doi: 10.1097/AOG.0000000000003519. PMID: 31651832. 10. Hall AF, Theofrastous JP, Cundiff GC et al. Interobserver and intraobserver reliability of the proposed International Continence Society, Society of Gynecologic Surgeons, and American Urogynecologic Society pelvic organ prolapse classification system. Am J Obstet Gynecol 1996;175:1467–1471. 11. Kobak WH, Rosenberger K, Walters MD. Interobserver variation in the assessment of pelvic organ prolapse. Int J Urogynecol Pelvic Floor Dysfunct 1996;7:121–124.

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12. Prien-Larsen J, Mouritsen L. Pelvic organ prolapse: is ICS-grading without POP-Q measurement reliable? [abstract]. Int Urogynecol J 2001;12(Suppl 3):S45. 13. Muir T, Stepp K, Barber M. Adoption of the pelvic organ prolapse quantification system in peer-reviewed literature. Am J Obstet Gynecol 2003;189:1632–1636. 14. Parekh M, Swift S, Lemos N et al. Multicenter inter-examiner agreement trial for the validation of simplified POPQ system. Int Urogynecol J 2011;22:645–650. 15. Manonai J, Mouritsen L, Palma P, Contreras-Ortiz O, Korte JF, Swift S. The inter-system association between the simplified pelvic organ prolapse quantification system (S-POP) and the standard pelvic organ prolapse quantification system (POPQ) in describing pelvic organ prolapse. Int Urogynecol J 2011;22:347–352. 16. Auwad W, Freeman R, Swift S. Is the pelvic organ prolapse quantification system (POPQ) being used? A survey of the members of the International Continence Society (ICS) and the American Urogynecology Society (AUGS). Int Urogynecol J 2004;15:324–327. 17. Pham T, Burgart A, Kenton K, Mueller ER, Brubaker L. Current use of pelvic organ prolapse quantification by AUGS and ICS members. Female Pelvic Med Reconstr Surg. 2011 March;17(2):67–69. 18. Treszezamsky AD, Rascoff L, Shahryarinejad A, Vardy MD. Use of pelvic organ prolapse staging systems in published articles of selected specialized journals. Int Urogynecol J. 2010 March;21(3):359–363. 19. Steele A, Mallipeddi P, Welgloss J, Soled S, Kohli N, Karram M. Teaching the pelvic organ prolapse quantification system. Am J Obstet Gynecol 1998;179:1458–1464. 20. Weber AM, Abrams P, Brubaker L et al. The standardization of terminology for researchers in female pelvic floor disorders. Int Urogynecol J 2001;12:178–186. 21. Swift SE. The distribution of pelvic organ support in a population of female subjects seen for routine gynecologic health care. Am J Obstet Gynecol 2000;183:277–285. 22. Swift SE, Woodman P, O’Boyle A et al. Pelvic Organ Support Study (POSST): the distribution, clinical definition and epidemiology of pelvic organ support defects. Am J Obstet Gynecol 2005;192:795–806. 23. Slieker-ten HMCP, Vierhout M, Bloembergen H, Schoenmaker G. Distribution of pelvic organ prolapse in a general population: prevalence, severity, etiology and relation with the function of pelvic floor muscles. Abstract presented at the Joint Meeting of the ICS and IUGA, August 25–27, 2004, Paris, France. 24. Mant J, Painter R, Vessey M. Epidemiology of genital prolapse: observations from the Oxford Family Planning Association study. Br J Obstet Gynaecol 1997;104:579–585. 25. Bland DR, Earle BB, Vitolins MZ, Burke G. Use of the pelvic organ prolapse staging system of the International Continence Society, American Urogynecologic Society, and the Society of Gynecologic Surgeons in perimenopausal women. Am J Obstet Gynecol 1999;181:1324–1328. 26. Samuelsson EU, Victor FTA, Tibblin G, Svardsudd KF. Signs of genital prolapse in a Swedish population of women 20 to 59 years of age and possible related factors. Am J Obstet Gynecol 1999;180:299–305. 27. Versi E, Harvey M-A, Cardozo L, Brincat M, Studd WW. Urogenital prolapse and atrophy at menopause: a prevalence study. Int Urogynecol J 2001;12:107–110. 28. Hendrix SL, Clark A, Nygaard I, Aragki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women’s Health Initiative. Am J Obstet Gynecol 2002;186:1160–1166. 29. Trowbridge ER, Fultz NH, Patel DA, Delancey JOL, Fenner DE. Distribution of pelvic organ support measures in a population-based sample of middleaged, community-dwelling African American and white women in southeastern Michigan. Am J Obstet Gynecol 2008;198:548.e1–548.e6. 30. Olsen AL, Smith VJ, Bergstrom VO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89:501–506. 31. Rown JS, Waetjen LE, Subak LL, Thom DH, Van Den Eeden S, Vittinghoff E. Pelvic organ prolapse surgery in the United States, 1997. Am J Obstet Gynecol 2002;186:712–716. 32. Swift SE, Tate SB, Nichols J. Correlation of symptomatology with degree of pelvic organ support in a general population of women: what is pelvic organ prolapse? Am J Obstet Gynecol 2003;189:372–379. 33. Barber M, Walters M, Bump R. Association of the magnitude of pelvic organ prolapse and presence and severity of symptoms. Abstract presented at the 24th Annual Scientific Meeting of the American Urogynecologic Society, September 11–13, 2003, Hollywood, FL. 34. Elkerman RM, Cundiff GW, Melik CF, Nihira M, Leffler K, Bent AE. Correlation of symptoms with location and severity of pelvic organ prolapse. Am J Obstet Gynecol 2001;185:1332–1338.

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35. Heit M, Culligan P, Rosenquist C, Shott S. Is pelvic organ prolapse a cause of pelvic or low back pain? Obstet Gynecol 2002;99:22–28. 36. Burrows LJ, Meyn LA, Walters MD, Weber AM. Pelvic symptoms in women with pelvic organ prolapse. Am J Obstet Gynecol 2004;104:982–988. 37. Parker-Autry CY, Barber MD, Kenton K, Richter HR. Measuring outcomes in urogynecological surgery: “Perspective is everything”. Int Urogynecol J 2013;24:15–25. 38. Swift SE, Pound T, Dias JK. Case-control study of etiologic risk factors in the development of severe pelvic organ prolapse. Int Urogynecol J 2001;12:187–192. 39. Chiaffarino F, Chatenoud L, Dindelli M et al. Reproductive factors, family history, occupation and risk of urogenital prolapse. Eur J Obstet Gynecol Reprod Biol 1999;82:63–67. 40. Marchionni M, Luca Braco G, Checcucci V et al. True incidence of vaginal vault prolapse: thirteen years’ experience. J Reprod Med 1999;44:679–684. 41. Gruel H, Gruel SA. Pelvic relaxation and associated risk factors: the results of logistic regression analysis. Acta Obstet Gynecol Scand 1999;78:290–293. 42. Jorgensen S, Hein HO, Gyntelberg F. Heavy lifting at work and risk of genital prolapse and herniated lumbar disc in assistant nurses. Occup Med 1994;44:47–49. 43. Haylen BT, Maher CF, Barber MD et al. Erratum to: an International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic organ prolapse (POP) Int Urogynecol J 2016;27:655–684. 44. Larsson C, Källen K, Andolf E. Cesarean section and risk of pelvic organ prolapse: a nested case-control study. Am J Obstet Gynecol. 2009 March;200(3):243.e1–243.e4. 45. Volløyhaug I, Mørkved S, Salvesen Ø, Salvesen KÅ. Forceps delivery is associated with increased risk of pelvic organ prolapse and muscle trauma: a cross-sectional study 16–24 years after first delivery. Ultrasound Obstet Gynecol. 2015 October;46(4):487–495. 46. Horst W, do Valle JB, Silva JC, Gascho CLL. Pelvic organ prolapse: prevalence and risk factors in a Brazilian population. Int Urogynecol J. 2017 August;28(8):1165–1170.



47. Nygaard IE, Shaw JM, Bardsley T, Egger MJ. Lifetime physical activity and pelvic organ prolapse in middle-aged women. Am J Obstet Gynecol. 2014 May;210(5):477.e1–477.e12. 48. Spence-Jones C, Kamm MA, Henery MM, Hudson CN. Bowel dysfunction: a pathologic factor in uterovaginal prolapse and urinary stress incontinence. Br J Obstet Gynaecol 1994;101:147–152. 49. Giri A, Hartmann KE, Hellwege JN, Velez Edwards DR, Edwards TL. Obesity and pelvic organ prolapse: a systematic review and meta-analysis of observational studies. Am J Obstet Gynecol. 2017 July;217(1):11–26. 50. Carley ME, Schaffer J. Urinary incontinence and pelvic organ prolapse in women with Marfan and Ehlers–Danlos syndrome. Am J Obstet Gynecol 2000;182:1021–1023. 51. McIntosh LJ, Stanitski DF, Mallett VT, Frahm JD, Richardson DA, Evans MI. Ehlers–Danlos syndrome: relationship between joint hypermobility, urinary incontinence and pelvic floor prolapse. Gynecol Obstet Invest 1996;41:135–139. 52. van Dongen L. The anatomy of genital prolapse. S Afr Med J 1981;60: 357–359. 53. Zacharin RF. ‘A Chinese anatomy’—the pelvic supporting tissues of the Chinese and Occidental female compared and contrasted. Aust N Z J Obstet Gynecol 1977;17:1–11. 54. Cox PSV, Webster D. Genital prolapse amongst the Pokot. East Afr Med J 1975;52:694–699. 55. Wilcox LS, Koonin LM, Pokras R, Struass LT, Xia Z, Peterson HB. Hysterectomy in the United States, 1988–1990. Obstet Gynecol 1994;83:549–555. 56. Norton PA, Allen-Brady K, Cannon-Albright LA. The familiality of pelvic organ prolapse in the Utah Population Database. Int Urogynecol J. 2013 March;24(3):413–418. 57. Ward RM, Velez Edwards DR, Edwards T, Giri A, Jerome RN, Wu JM. Genetic epidemiology of pelvic organ prolapse: a systematic review. Am J Obstet Gynecol. 2014 October;211(4):326–335. 58. Gilchrist A, Steele H, Brazell H, Campbell W, Swift SE. Outcomes of observation as therapy for pelvic organ prolapse: a study in the natural history of pelvic organ prolapse. Neurourol Urodynam 2013;32: 383–386.

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ANTERIOR VAGINAL WALL PROLAPSE Whitney K. Hendrickson and Matthew D. Barber*

Introduction Anterior vaginal prolapse occurs commonly and may coexist with disorders of micturition. The anterior vaginal wall is the most common compartment of the vagina to prolapse and is most likely to recur in the long term after surgical correction (1). Over 80% of greater than 300,000 vaginal prolapse surgeries performed annually in the United States include correction of anterior compartment prolapse. This chapter reviews the anatomy and pathology of anterior vaginal prolapse, with and without stress urinary incontinence, and describes methods of surgical repair.

Anatomy and pathology Anterior vaginal prolapse (cystocele) is defined as a pathological descent of the anterior vaginal wall. According to the International Continence Society (ICS) standardized terminology for prolapse, the term “anterior vaginal wall (compartment) prolapse” is preferred to “cystocele” (2). This is because the information obtained at the physical examination does not allow the exact identification of structures behind the anterior vaginal wall, although it usually is, in fact, the bladder. The ICS grading system for prolapse is discussed in detail in Appendix 1. The etiology of anterior vaginal prolapse is not completely understood but appears to be multifactorial. Although age is the most significant factor, other factors include pregnancy, childbirth, connective tissue defects, pelvic floor muscle weakness from denervation or avulsion, hysterectomy, and conditions such as chronic coughing or straining associated with elevated intra-abdominal pressure. Normal support of the vagina and adjacent pelvic organs is provided by the pelvic muscles and connective tissue (3). The upper vagina rests on the levator plate and is stabilized by superior and lateral connective tissue attachments. The midvagina is attached to the arcus tendineus fasciae pelvis (ATFP, “White line”) on each side (Level 2) and the apical portion of the anterior vaginal wall is attached to the endopelvic “fascia”, including the pubocervical “fascia” and cardinal and uterosacral ligaments (Level 1) (4). Loss of lateral and/or apical support may occur with damage to or impairment of the pelvic muscles, connective tissue attachments, or both, leading to anterior vaginal prolapse. Nichols and Randall described two types of anterior vaginal prolapse: distension and displacement (5). Distension was thought to result from overstretching and attenuation of the anterior vaginal wall, caused by overdistension of the vagina after vaginal delivery or atrophic changes associated with aging and menopause. Displacement was attributed to pathological detachment of the anterolateral vaginal supports to the ATFP. These often coexist with urethral hypermobility and apical prolapse. In 1976 Richardson et al. described transverse defects, midline defects, *

Mark D. Walters significantly contributed to this book chapter as a coauthor of the prior version.

DOI: 10.1201/9781003144243-90

and defects involving isolated loss of integrity of the pubourethral ligaments (6). Transverse defects were said to occur when the “pubocervical fascia” separated from its insertion around the cervix, whereas midline defects represented an anteroposterior separation of the endopelvic connective tissue between the bladder and vagina. A contemporary conceptual representation of vaginal and paravaginal defects is shown in Figure 82.1 (7). There have been few systematic or comprehensive descriptions of anterior vaginal prolapse based on physical findings and correlated with findings at the surgery to provide objective evidence for any of these theories of pathological anatomy. In a study of 71 women with anterior vaginal wall prolapse and stress urinary incontinence who underwent retropubic operations, DeLancey described paravaginal defects in 87% on the left and 89% on the right (8). The ATFP was usually attached to the pubic bone but detached from the ischial spine for a variable distance. The pubococcygeal muscle was visibly abnormal with localized or generalized atrophy in over half of the women. Improvements in pelvic imaging are leading to a greater understanding of normal pelvic anatomy as well as the structural and functional abnormalities associated with prolapse. Magnetic resonance imaging (MRI) and 3D ultrasound hold great promise. Various measurements can be made, such as the urethrovesical angle, the descent of the bladder base, the integrity of the levator muscles, the levator hiatal area, and the relationship between the vagina and its lateral and apical connective tissue attachments, which may be associated with anterior vaginal prolapse or urinary incontinence (9, 10). Aronson et al. used an endoluminal surface coil placed in the vagina to image pelvic anatomy with MRI and compared four continent nulliparous women with four incontinent women with anterior vaginal prolapse (11). Lateral vaginal attachments were identified in all continent women. In Figure 82.2, the “posterior pubourethral ligaments” (bilateral attachment of ATFP to posterior aspect of the pubic symphyses) are clearly seen, consistent with DeLancey’s 3 levels of pelvic organ support. In the two subjects with clinically apparent paravaginal defects, lateral detachments were evident (Fig. 82.3). These lateral defects can also be visualized using 3D perineal ultrasound. Figure 82.4 shows a similar paravaginal defect or levator avulsion on ultrasound imaging. More recent studies based on MRI analysis and computer modeling suggest that apical support abnormalities are at least as important as, if not more important than, paravaginal defects; the degree of apical descent can explain about half of the anterior wall descent (12). This supports studies that used clinical examination with pelvic organ prolapse quantification (POPQ) that also demonstrates a strong correlation between anterior and apical vaginal support (r = 0.89) (13). Imaging studies have also noted that women with a wider interspinal diameter and levator hiatus may be more likely to develop prolapse (14, 15). However, there is conflicting evidence as to whether the widening of the levator hiatus is due to levator avulsion (16, 17). Other factors, such as levator ani muscle impairment and greater anterior vaginal wall length also contribute to anterior vaginal prolapse (18–20). 889

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Paravaginal defect Midline defect Transverse defect

FIGURE 82.1  Three different defects can result in anterior vaginal wall prolapse. Lateral or paravaginal defects occur when there is a separation of the pubocervical fascia from the arcus tendineus fasciae pelvis, midline defects occur secondary to attenuation of fascia supporting the bladder base, and transverse defects occur when the pubocervical fascia separates from the vaginal cuff or uterosacral ligaments. (Reproduced from Karram MM, Vaginal operations for prolapsed, in Baggish MS and Karram MM, eds., Atlas of Pelvic Anatomy and Gynecologic Surgery, Saunders, Philadelphia, PA, 2001. With permission.)

FIGURE 82.3  Axial T1-weighted image from a 57-year-old woman, para 5, with stress urinary incontinence. The paravaginal detachment (arrow) is seen at the level of the urethrovesical junction. Abbreviations: v, anterior vaginal wall; p, posterior pubic symphysis; u, urethra; o, obturator internus muscle; c, endovaginal coil; r, rectum; l, levator ani musculature. (Reproduced from Aronson MP et al., Am J Obstet Gynecol, 173, 1702, 1995. With permission.) Anterior vaginal prolapse commonly coexists with stress urinary incontinence. Some features of pathophysiology may overlap, such as the loss of anterior vaginal support with bladder-base descent and urethral hypermobility. Other features, such as sphincteric dysfunction, may occur independently of vaginal and urethral support. The pathophysiology of stress urinary incontinence is covered more fully in Chapter 25.

Evaluation History

FIGURE 82.2  Axial T1-weighted image from a continent 38-year-old nulliparous woman, showing the connection of the anterior vaginal wall (v) to the posterior pubic symphysis (p) by the pubourethral ligaments (pul). The anterior vaginal wall and endopelvic fascia function as a sling or hammock for support of the urethra (u). Abbreviations: o, obturator internus muscle; r, rectum; l, levator ani musculature. (Reproduced from Aronson MP et al., Am J Obstet Gynecol, 173, 1702, 1995. With permission.)

When evaluating women with pelvic floor dysfunction attention should be paid to all aspects of pelvic organ support. The reconstructive surgeon must determine the specific sites of weakness for each patient, with the ultimate goal of restoring both anatomy and function. Patients with anterior vaginal prolapse complain of symptoms due to vaginal protrusion or associated symptoms such as urinary incontinence or voiding difficulty. Symptoms related to prolapse may include the sensation of a vaginal bulge, pelvic pressure, and sexual difficulty. Stress urinary incontinence commonly occurs in association with anterior vaginal prolapse, particularly when the prolapse is mild. In contrast, women with anterior vaginal prolapse that extends beyond the hymen are less likely to report stress urinary incontinence but may have a history of resolved stress urinary incontinence. They are also more likely to have obstructive voiding symptoms such as urinary hesitancy, intermittent flow, weak or prolonged stream, a

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FIGURE 82.4  3D ultrasound in the midsagittal plane (a) showing a large cystocele and a complete right-sided avulsion (*) on tomographic imaging (b). The tomographic imaging was obtained on pelvic floor muscle contraction. (Reproduced from Dietz, HP Best Practice & Research Clinical Obstetrics and Gynaecology 54(2019):12–30.) feeling of incomplete emptying, the need to reduce the prolapse manually (splint) to initiate or complete urination, and, in rare cases, urinary retention. These are likely due to urethral kinking from the prolapse.

Physical examination

The physical examination may be conducted with the patient in the lithotomy position. If physical findings do not correspond to symptoms or if the maximum extent of the prolapse cannot be confirmed, the woman should be reexamined in the standing position. The genitalia are inspected, and the labia are gently separated to expose the vestibule and hymen. The integrity of the perineal body is evaluated, and the approximate size of all prolapsed compartments is assessed during Valsalva or vigorous coughing. During this maneuver, the extent of descent of the pelvic organs is noted, as is the relationship of the pelvic organs at the peak of straining using the POP-Q system to describe each compartment (21). Anterior vaginal wall descent usually represents bladder descent with or without concomitant urethral hypermobility. In 1.6% of women with anterior vaginal prolapse, an anterior enterocele mimics a cystocele on physical examination (22). Other uncommon conditions, such as large suburethral diverticulum, anterior vaginal cysts, or myomas, can also mimic anterior vaginal prolapse.

Diagnostic tests

Beyond careful history and physical examination, few diagnostic tests are needed to evaluate patients with anterior vaginal prolapse. A urinalysis should be performed to evaluate for urinary tract infection if the patient complains of any lower urinary tract dysfunction. Hydronephrosis occurs in a small proportion of women with prolapse, though it usually does not change management in women for whom surgical repair is planned (23). Therefore, routine imaging of the kidneys and ureters is not necessary. If surgical repair is planned, it is important to check urethral function after the prolapse is supported. Women with severe prolapse may be paradoxically continent because of urethral kinking; when the prolapse is reduced, urethral dysfunction may be unmasked with the demonstration of incontinence (occult stress

incontinence) (24). A pessary, vaginal retractor, or vaginal packing can be used to reduce the prolapse before office bladder filling or urodynamic testing. Urinary leakage with coughing or Valsalva maneuvers after reduction of prolapse occurs in 17–69% of women with stage III or IV prolapse. In this situation, the surgeon should consider adding an anti-incontinence procedure in conjunction with anterior vaginal prolapse repair (25). Urodynamics (simple or complex) may be indicated when symptoms of mixed urinary incontinence, pain, or voiding dysfunction are present. Urodynamics may also be useful to assess the risk of developing de novo stress urinary incontinence after prolapse repair if the cough stress test was negative. If stress urinary incontinence is not present, even after reduction of the prolapse, an anti-incontinence procedure may still decrease the rate of postoperative urinary incontinence but results in more complications, voiding dysfunction, and higher cost (25, 26). A validated, individualized computer prediction model for de novo stress urinary incontinence after prolapse surgery is available (27–29). Voiding function should be assessed to evaluate the completeness of the bladder emptying with a measured void, followed by urethral catheterization or bladder ultrasound to measure postvoid residual urine volume. Although valuable for research, the value of MRI for the clinical evaluation of anterior vaginal prolapse has yet to be demonstrated. Ultrasound is likely only valuable in order to evaluate anterior vaginal masses, such as Skene glad cystis, urethral diverticula, Gartner duct cysts, fibroids, or the location of previously placed mesh (30).

Surgical repair techniques Anterior colporrhaphy

The objective of anterior colporrhaphy is to plicate the layers of vaginal muscularis and adventitia overlying the bladder (“pubocervical fascia”) or to plicate and reattach the paravaginal tissue to reduce the protrusion of the bladder and vagina. Modifications of the technique depend on how lateral the dissection is carried, whether apical support is added, and whether additional layers (biological or synthetic grafts) are placed in the anterior vagina for extra support.

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892 The operative procedure begins with the patient in high dorsal lithotomy position. Antibiotics should be given within 60 minutes of incision to achieve minimal inhibitory concentrations by the time the incision is made based on current guidelines (31). In general, all patients undergoing vaginal prolapse surgery are at moderate risk for thromboembolic events and require a prevention strategy (32). Low-dose unfractionated heparin (5000 units every 12 hours), lowmolecular-weight heparin (e.g., 40 mg enoxaparin or 2500 units of dalteparin), an intermittent pneumatic compression device, or a combination are recommended based on patient risk factors. Either form of heparin should be administered 2 hours before surgery and/or compression device placed before incision. These treatment approaches should be continued until the patient is ambulatory. The abdomen, vagina, and perineum are sterilely prepped and draped, and a 16 Fr Foley catheter with a 10 mL balloon is inserted for easy identification of the bladder neck. Hemostatic solutions

(such as 0.5% lidocaine with 1:200,000 epinephrine or 20 units of vasopressin diluted in 60–100 mL of normal saline) may be injected below the epithelium along the planned areas of dissection, to decrease bleeding and to aid in dissection. If a vaginal hysterectomy has been performed, the incised apex of the anterior vaginal wall is grasped transversely with two Allis clamps and elevated. Otherwise, the vaginal cuff or the anterior vesicocervical junction is grasped with an Allis clamp. An additional Allis clamp is placed about 2 cm below the posterior margin of the urethral meatus. If a midurethral sling is to be done, then the incision is only made to the bladder neck; a separate incision is made for the sling. The vaginal epithelium is incised in the midline, and the incision is continued to the level of the midurethra (or bladder neck if a sling is being done). As the vagina is incised, the edges are grasped with Allis clamps and drawn laterally for further mobilization (Fig. 82.5a, b). Dissection of the vaginal

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FIGURE 82.5  Anterior vaginal repair: (a) initial anterior vaginal wall incision is at midline, (b) the incision is extended to the level of the proximal urethra, (c) sharp dissection and traction on the bladder facilitate dissection of the bladder off the vaginal wall, and (d) mobilization of the cystocele off the vaginal wall is completed. (Reproduced from Karram MM, Vaginal operations for prolapsed, in Baggish MS and Karram MM, eds., Atlas of Pelvic Anatomy and Gynecologic Surgery, 2nd edn., Saunders, Philadelphia, PA, 2001. With permission.)

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893 retropubic colposuspension) effectively treat mild distal anterior vaginal prolapse associated with urethral hypermobility and stress urinary incontinence. A midurethral or bladder neck sling is best done through a separate midurethral incision after the anterior vaginal repair is complete.

Anterior prolapse repair with grafts

FIGURE 82.6  Anterior vaginal repair. Sharp dissection is used to mobilize the bladder base from the vaginal apex during anterior colporrhaphy. flaps is then accomplished by turning the clamps back across the forefinger and incising the vaginal muscularis with a Mayo or Metzenbaum scissors. An assistant maintains constant traction medially on the remaining vaginal muscularis and underlying vesicovaginal adventitia. This procedure is performed bilaterally until the entire extent of the anterior vaginal prolapse has been dissected (Fig. 82.5c, d). The spaces lateral to the urethrovesical junction are sharply dissected toward the ischiopubic rami. It is also important to use sharp dissection to mobilize the bladder base from the vaginal apex as shown in Figure 82.6. Once the vaginal flaps have been completely developed, the urethrovesical junction can be identified visually or by pulling the Foley catheter downward until the bulb obstructs the vesical neck. Repair should begin at the urethrovesical junction, using No. 2-0 or 0 delayed absorbable suture. The first plicating stitch is placed into the periurethral endopelvic fascia and tied without excessive tension (Fig. 82.7a). Depending on the severity of the prolapse, one or two rows of plication sutures or a pursestring suture followed by plication sutures are placed (Fig. 82.7b). Surgical judgment is required to perform the bladder plication tight enough to reduce the anterior vaginal prolapse sufficiently, yet preserve some mobility of the vaginal wall. Some place 1-2 additional stitches to support the length of the urethra and urethrovesical junction similar to a Kelly-Kennedy plication though no longer used to treat mild stress urinary incontinence due to low success rates. Of note, this procedure may lead to voiding difficulty post-operatively. The vaginal epithelium is then trimmed bilaterally, and the remaining anterior vaginal wall is closed with a No. 2-0 running locked suture. Anti-incontinence operations can be performed at the same time as anterior vaginal prolapse repair to treat coexistent stress urinary incontinence. Midurethral or bladder neck sling placement may also improve the cure rate of the prolapse (33). Bladder neck suspension procedures (pubovaginal sling procedures or

Currently “off-label” in most countries, a prosthetic material can be used to provide support in the anterior vagina. In 2010, approximately 25% of surgeries for pelvic organ prolapse in the United States included transvaginal placement of biological or synthetic mesh. Graft materials include synthetic absorbable grafts (e.g., polyglactin 910 mesh), synthetic permanent meshes (e.g., polypropylene), and biological materials (e.g., autografts of harvested rectus fascia and fascia lata, human allografts including dermis, fascia lata, and dura mater, and xenografts such as porcine dermis, porcine small intestinal submucosa, and bovine pericardium.) Many surgeons used transvaginal graft placement in an attempt to increase the efficacy and durability of their surgical repair. For anterior prolapse, studies have demonstrated improved anatomical outcomes after transvaginal placement of permanent synthetic mesh when compared to anterior colporrhaphy without mesh (“native-tissue repair”) (34, 35). However, this comes at the expense of an increased rate of complications unique to synthetic mesh placement including longer operating time and higher blood loss, vaginal mesh exposure or extrusion, mesh perforation into an adjacent organ (bladder, urethra, or rectum), and vaginal mesh contraction with associated pain and dyspareunia (34, 35). The concerns over increased adverse events from transvaginal mesh placement led the U.S. Food and Drug Administration (FDA) to mandate that manufacturers of transvaginal prolapse meshes stop the sale and distribution of their products citing a failure to demonstrate reasonable assurance of safety and effectiveness (36). In 2017 the European Association of Urology and European Urogynecological Association published a consensus review that backed the European Commission SCENIHR opinion on mesh stating that “synthetic mesh for prolapse should only be used in complex cases with recurrent prolapse in the same compartment and restricted to those surgeons with appropriate training who are working in multidisciplinary referral centres”, noting that the amount of mesh should be limited when possible (37). The Royal Australian and New Zealand College of Obstetricians and Gynaecologists published an opinion that was renewed in November 2016, stating that the use of transvaginal polypropylene mesh was not recommended as the first-line treatment for any vaginal prolapse (38). The report also highlighted the importance of informed consent and appropriate surgical training/credentialing. At the time this chapter was written, transvaginal mesh products to treat prolapse were withdrawn from the market in New Zealand, Australia, the United Kingdom, Canada, and the United States of America and only allowed to be used in the context of clinical studies in France (39). Regardless, there are several situations where mesh use is contraindicated. Many surgeons would not use mesh in a patient with a previous mesh complication or if colorectal surgery is being performed concurrently. In patients with prior pelvic radiation, mesh placement is not recommended because of the risk of poor wound healing. Similarly, preexisting local or systemic infection or other causes of a compromised immune system such as chronic steroid use, smoking, and uncontrolled diabetes

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FIGURE 82.7  Anterior vaginal repair. (a) Kelly plication sutures have been placed and tied, plicating the pubocervical fascia across the midline at the level of the bladder neck. (b) The bladder base has been plicated. Inset: preferential support of the bladder neck when compared to the bladder base. (Reproduced from Karram MM, Vaginal operations for prolapsed, in Baggish MS and Karram MM, eds., Atlas of Pelvic Anatomy and Gynecologic Surgery, 2nd edn., Saunders, Philadelphia, PA, 2001. With permission.)

melitus are a contraindication for vaginal mesh placement. Mesh augmentations should not be used in pregnant women or women who are contemplating future pregnancy, as the vaginal mesh does not stretch significantly. Pelvic pain syndromes such as endometriosis, vulvodynia, interstitial cystitis, fibromyalgia, and dyspareunia should be evaluated preoperatively to allow for comprehensive counseling prior to treatment. Finally as noted above in most countries, the use of these products is considered “offlabel” and thus should be used with caution. Careful and thorough informed consent is required. Chapter 89 provides further details on the utilization of biological and synthetic grafts and the management of their complications. In most countries, the only “off-label” mesh/graft available is self-tailored mesh, whereby the surgeon customizes the synthetic or biological graft to match the size and shape of each patient’s individual pelvic anatomy. The mesh/graft is cut into a trapezoid or multiarmed shape for anterior compartment augmentation and fixed to sacrospinous ligaments, obturator fascia, ATFP, and/ or the distal bladder neck (Fig. 82.8). This type of surgery requires

a strong set of vaginal surgical skills and a thorough understanding of pelvic anatomy and the dynamics of mesh. The initial incision for anterior vaginal mesh placement usually involves significant hydrodissection and a deeper colpotomy incision than usually performed for a traditional native-tissue anterior colporrhaphy so that the perivesical space is entered. Despite the lack of evidence that any one placement technique is best in managing a patient’s symptoms, most experts would agree on some basic perioperative tenets: • The bladder should be drained with a transurethral catheter. • A well-estrogenized vaginal wall is preferred prior to surgery. (We use intravaginal estrogen cream daily [0.5–1.0 g/day] for at least 2–3 weeks preoperatively.) • A vaginal pessary should be removed 1–2 weeks prior to surgery to limit vaginal epithelium irritation. • Avoid making inverted “T-shaped” incisions from a concurrent hysterectomy and colporrhaphy, if possible.

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FIGURE 82.8  Anterior vaginal repair with mesh: (a) the bladder is dissected bilaterally and off the vaginal apex; (b) midline plication is completed; (c) after entering the left paravaginal space and exposing the arcus tendineus fasciae pelvis (white line), the prosthetic mesh is sewn to it; and (d) the mesh is attached bilaterally and all sutures are tied, supporting the bladder.

• Exposure of the correct vesicovaginal space is performed with hydrodissection of 20–80 mL of 0.5% lidocaine with 1:200,000 epinephrine or dilute Vasopressin (20 units in 60–100 mL of saline), or normal saline. A wheal or blanching illustrates incorrect intraepithelial placement of the fluid. Hydrodissection in the correct plane will create a fluid bubble in the avascular vesicovaginal and rectovaginal spaces. • As opposed to an anterior colporrhaphy where the vaginal epithelium and muscularis are split for plication, the mesh should be placed underneath the vaginal muscularis. It is vital that the surgeon performs a full-thickness dissection deep into the vesicovaginal and rectovaginal spaces to avoid exposure of the mesh postoperatively. • It is unknown whether or not the bladder wall should be plicated in the midline below the graft, but some routinely perform an anterior plication using delayed absorbable suture.

• Loosely place the graft because the mesh can contract by up to 20% following placement, compromising vaginal length and caliber. Allow enough room for Mayo scissors to be easily placed between the mesh and the vagina. Also, ensuring that the mesh is placed flat and with minimal tension will improve fibroblast growth and minimize complications of pain or erosion. • The colpotomy incision is closed utilizing an absorbable suture.

Vaginal paravaginal repair

The aim of paravaginal defect repair for anterior vaginal prolapse is to reattach the detached lateral vagina to its normal place of attachment at the level of the ATFP. This can be accomplished using a vaginal, open, or laparoscopic retropubic approach. Retropubic surgeries such as the Burch colposuspension are discussed in Chapter 98. The preparation for vaginal paravaginal repair begins similar to an anterior colporrhaphy. Marking sutures are placed on the

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the appropriate plane, one should easily enter the retropubic space, visualizing retropubic, and paravaginal adipose tissue. The ischial spine can then be palpated on each side. The ATFP coming off the spine can be followed to the back of the symphysis pubis. After dissection is complete, midline plication of the bladder adventitia can be performed, either at this point or after placement and tying of the paravaginal sutures (Fig. 82.9b and c). On the lateral pelvic sidewall, the obturator internus muscle and the ATFP are identified by palpation and then visualization. Retraction of the bladder and urethra medially is best accomplished with the Breisky–Navratil retractor, and posterior retraction could be provided with a lighted right-angle retractor. Using No. 0 nonabsorbable or delayed absorbable suture, the first stitch is placed around the tissue of the white line just anterior to the ischial spine. A push and catch suturing device (Capio®, Boston

anterior vaginal wall on each side of the urethrovesical junction, identified by the location of the Foley balloon after gentle traction is placed on the catheter (Fig. 82.9a). In patients who have had a hysterectomy, marking sutures are also placed at the vaginal apex. If a culdoplasty or apical suspension procedure is being performed, the stitches are placed but not tied until completion of the paravaginal repair and closure of the anterior vaginal wall. As for anterior colporrhaphy, vaginal flaps are developed by incising the vagina in the midline and dissecting the vaginal muscularis laterally. The dissection is performed bilaterally until a space is developed between the vaginal wall and obturator internus muscle within the paravaginal space. Blunt dissection using the surgeon’s index finger is used to extend the space anteriorly along the ischiopubic rami, medially to the pubic symphysis, and laterally toward the ischial spine. If the defect is present and dissection is occurring in

Marking sutures at bladder neck

Vaginal wall

Marking sutures at vaginal apex (a) Bilateral paravaginal defects

(b) Midline cystocele repair

Detached edge of pubocervical fascia Iliococcygeus muscle Arcus tendineus fascia pelvis (white line)

Obturator internus muscle Ischial spine

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FIGURE 82.9  Technique of vaginal paravaginal repair. (a) Marking sutures are placed at the bladder neck and vaginal apex. A midline anterior vaginal wall incision is made. (b) The bladder is dissected bilaterally and off the vaginal apex. Midline plication is performed. (c) Midline plication is completed; obvious bilateral paravaginal defects are present. (d) The bladder is retracted medially and numerous sutures are passed through the arcus tendineus fasciae pelvis (white line). Technique of vaginal paravaginal repair. (Continued)

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FIGURE 82.9 (Continued)  (e) Sutures are then passed through the detached pubocervical or endopelvic fascia. (f) Sutures are passed through the inside of the vaginal wall, thus completing the three-point closure. (Reproduced from Karram MM, Vaginal operations for prolapsed, in Baggish MS and Karram MM, eds., Atlas of Pelvic Anatomy and Gynecologic Surgery, 2nd edn., Saunders, Philadelphia, PA, 2001. With permission.)

Scientific, Natick, MA) works well to facilitate suture placement. If the white line is detached from the pelvic sidewall or clinically not felt to be durable, then the attachment should be to the fascia overlying the obturator internus muscle. A series of three to six stitches are placed and held, working anteriorly along the white line from the ischial spine to the level of the urethrovesical junction (Fig. 82.9d). Starting with the most anterior stitch, the surgeon picks up the edge of the periurethral tissue (vaginal muscularis or pubocervical fascia) at the level of the urethrovesical junction and then tissue from the undersurface of the vaginal flap at the previously marked sites. Subsequent stitches move posteriorly until the last stitch closest to the ischial spine is attached to the vagina nearest the apex, again using the previously placed marking sutures for guidance. Stitches in the vaginal wall must be placed carefully to allow adequate tissue for subsequent midline vaginal closure. After all the stitches are placed on one side, the same procedure is carried out on the other side. The stitches are then tied. This repair is a three-point closure involving the vaginal epithelium, vaginal muscularis and endopelvic fascia (pubocervical fascia), and lateral pelvic sidewall at the level of the ATFP (Fig. 82.9e and f). Suture bridges must be avoided by careful planning of suture placement. Once all sutures are tied, the vaginal flaps are trimmed and closed with a running delayed absorbable suture.

Cystoscopy

Cystoscopy with visualization of ureteral flow is usually performed after cystocele repair, especially if slings or apical suspension procedures are also being performed. The purpose is to ensure that no sutures or mesh have been placed in the bladder and to verify the patency of both ureters. Intravenous indigo carmine 5 mL, IV 10% sodium fluorescein 0.25 mL, preoperative oral pyridium 200mg, transurethral infusion of 5% or 10% dextrose or 20% mannitol can aid in evaluating ureteral patency (40, 41). Ten percent dextrose is less ideal compared to other

methods due to the increased incidence of postoperative urinary tract infection (42). Cystotomy or bladder injury occurs in 0.2% of anterior colporrhaphy, though the rate is higher with the addition of polypropylene mesh occurring in up to 2.5% of surgeries (RR 0.21, 0.06–0.82) (34). The rate of ureteral obstruction after simple anterior colporrhaphy is only 0.4% and increases with the addition of some types of apical suspension (43). Intraoperative release of the offending sutures almost always releases the ureteral obstruction without further sequelae.

Results

The main indication for surgical repair of anterior vaginal prolapse is to relieve symptoms when they exist or as part of a comprehensive reconstructive pelvic procedure for multiple sites of pelvic organ prolapse with or without stress urinary incontinence. Few studies have addressed the long-term success of surgical treatments for anterior vaginal prolapse. While the majority of studies evaluating anterior vaginal prolapse repairs are uncontrolled series, an increasing number of randomized surgical trials have been done in recent years. Success rates vary considerably depending upon the outcome measure used to define success. Reported success rates for native-tissue anterior colporrhaphy range from 37% to 100% with most cohorts reporting success rates greater than 80%. In 2001, Weber et al. studied three variations of anterior colporrhaphy using a prospective randomized study design and a strict definition of success (Aa and Ba points ≤ −2 cm or stage I) (44). Standard anterior colporrhaphy resulted in 30% of patients with an optimal or satisfactory anatomic result; anterior colporrhaphy with polyglactin 910 mesh overlay had 42% optimal or satisfactory result and unilateral plication under tension a 46% optimal or satisfactory result. No difference was seen in anatomic or functional outcomes and most patients reported satisfaction with their symptom improvement. However, these data were reanalyzed by Chmielewski et al. using more clinically relevant

898 definitions of success and reported considerably better outcomes with only 10% of subjects developing anatomic recurrence beyond the hymen, 5% of subjects developing symptomatic recurrence, and less than 1% having another surgery for prolapse at 23 months follow-up (45). In general, it appears that native-tissue anterior colporrhaphy commonly results in asymptomatic anterior vaginal descent to within 1 cm of the hymen (POPQ stage 2), however, prolapse beyond the hymen, development of symptomatic prolapse (e.g., vaginal bulging symptoms), and reoperation for recurrent prolapse are uncommon events in the first 2–3 years after surgery. Long-term results of anterior colporrhaphy are largely unknown, although Lavelle et al reported outcomes of isolated anterior native tissue repair for women with surgery over an 18-year period (46). With a mean follow-up of 5.8 years, they found a 7.4% rate of recurrent isolated anterior compartment prolapse, 10.7% apical prolapse, 8.3% posterior prolapse and 19% had multicompartment prolapse with failure defined as Stage 2 or greater. Overall 33% required a repeat surgery 0.6 to 13 years after their initial surgery. As previously noted, apical support can correct more than half of the anterior wall prolapse. Similarly, higher prolapse recurrence has been demonstrated among women who do not undergo apical repair. A 2013 study of over 2700 women undergoing isolated anterior repair or combined anterior and apical repair found that the 10-year reoperation rates were lower in the combined anterior and apical repair group – 11.6% vs. 20.2% (47). No randomized trials have been performed evaluating the efficacy of paravaginal defect repair for the treatment of anterior vaginal prolapse. Single-center uncontrolled case series suggest good anatomic results for both open retropubic (success rate 75–97%) and vaginal (success rate 67–100%) approaches (48, 49). The vaginal approach appears to be associated with high risk of hemorrhage, with one series reporting a 21% blood transfusion rate (48). Two studies evaluated the use of absorbable polyglactin 910 mesh to augment anterior colporrhaphy and reported mixed results. The Weber et al. trial described earlier found no benefit, while a randomized trial by Sand et al. found a 75% success rate 1 year after surgery in those receiving absorbable mesh compared with a 57% success in those receiving native-tissue anterior colporrhaphy. The difference in results may be due to the placement of the mesh, where the Sand trial placed the absorbable mesh underneath the colporrhaphy sutures to enhance agglutination of the imbricated endopelvic connective tissue and the Weber trial used the mesh as a non-anchored overlay (44, 50). The results from the 2016 Cochrane review, noted that the Sand et al. paper heavily weighted the meta-analysis, showing some benefit from absorbable mesh compared to native tissue (RR 1.5 [95% CI 1.09–2.06]). There was no difference between prolapse severity, urinary incontinence, or dyspareunia noted in the SGS Systematic Review when comparing the use of polygalatin 910 mesh and native tissue anterior colporrhaphy (35). In 2017, the PROSPECT Study [PROlapse Surgery: Pragmatic Evaluation and Randomized Controlled Trials] was published that included two parallel-group pragmatic randomized controlled trials investigating augmentation of transvaginal anterior and posterior prolapse surgery with synthetic non-absorbable (type 1 monofilament microporous polypropylene) or biological grafts (porcine acellular collagen matrix, porcine small intestinal submucosa, or bovine dermal) conducted across 35 UK sites (51). Participants were followed for 2 years with 865 women included

Textbook of Female Urology and Urogynecology in the mesh trial and 735 in the graft trial. Mesh/grafts were selftailored and surgeons were allowed to choose any synthetic or biologic graft available depending upon the group assignment, consistent with a pragmatic approach. No difference was found in patient-reported prolapse symptoms and condition-specific quality of life between native-tissue repair and biologic or synthetic graft augmentation at 1 or 2 years after surgery. Prolapse beyond the hymen was noted in 14–18% of patients at 1 year, symptoms of prolapse were noted in 31–40% of women at 1–2 years and, overall, 5% of patients underwent surgery for recurrent prolapse at 2 years with no differences between groups. There was a 12% cumulative rate of mesh complications in those who received synthetic mesh by 2 years with 9% requiring surgical removal. In the biologic graft arm, only 4 patients had a mesh complication and all had received concomitant synthetic mesh (i.e. midurethral sling). Similar to the results of the PROSPECT Trial, the current evidence does not demonstrate benefit of biological graft augmentation for anterior prolapse surgery. The Society of Gynecologic Surgeons (SGS) Systematic Review Group identified 8 studies comparing native tissue anterior colporrhaphy with biological graft augmentation for anterior vaginal wall prolapse (35). Based on high-quality evidence there seems to be no difference in anatomical or quality-of-life outcomes when biological grafts are used compared with native tissue repair. Two of the seven available trials did find an anatomical benefit over native tissue repair but no difference in symptoms or quality of life. There was variability in biological grafts used in these studies, and the most commonly used graft (Pelvicol; porcine dermis; CR Bard, Murray Hill, NJ) is no longer on the market in the US. Given the different characteristics of biological grafts, it seems likely that results may depend on the specific biological graft used; however, no headto-head comparisons have been performed. Importantly though, less than 1% of patients in these studies required reoperation for graft complication. The 2016 Cochrane Review on surgery for women with anterior compartment prolapse concurred with the SGS Systematic Review Group, concluding that biological graft repair or absorbable mesh provides a minimal advantage compared with native tissue repair. With no evidence of differences between biological graft and native tissue in rates of awareness of prolapse or repeat surgery for prolapse (34). The Cochrane Review, however, concluded that the anatomical recurrent anterior prolapse rate was higher after native tissue repair than after any biological graft (anterior colporrhaphy: 34% versus biological graft: 26%; RR 1.32 [95% CI 1.06–1.65]). In regards to synthetic mesh, the SGS Systematic Review Group identified 20 studies comparing outcomes of native tissue anterior colporrhaphy to permanent synthetic mesh (35). The mesh was placed using a trocar-based kit in approximately half of the studies, with the remainder being self-tailored. The meta-analyses showed that mesh repairs provided superior relief of subjective symptoms and improved anatomical outcomes. However, there was also high-quality evidence to suggest no difference in other subjective outcomes, including quality of life and urinary and sexual function. Mesh exposure rates ranged from 1.4% to 19%, with most of these treated in the office. Operative mesh revision rates ranged from 3% to 8%. The 2016 Cochrane Review concurred, in a meta-analysis of 16 clinical trials, showing that permanent mesh resulted in lower rates of awareness of prolapse, recurrent anterior wall prolapse, and repeat surgery for prolapse compared with native tissue repair over 1–3 years (34). However, native tissue repair was associated with reduced risk of

Anterior Vaginal Wall Prolapse new stress urinary incontinence, reduced bladder injury, fewer blood transfusions, shorter operative time, and reduced rates of any repeat surgery (prolapse, stress urinary incontinence, and mesh exposure combined). The lower rates of repeat surgery for prolapse, stress urinary incontinence, and mesh exposure with native tissue are likely owing to the higher rates of surgery for mesh exposure in the permanent mesh arm. The rate of mesh exposure in those receiving permanent mesh was 11.3% with 7.3% requiring surgery for a mesh complication at one to three years (34). As noted, in the FDA’s view, these benefits likely do not outweigh the risks associated with transvaginal mesh implantation in all patients. Since these systematic reviews, the 3-year outcomes of the SUPeR trial were published, which randomized 183 participants to vaginal mesh hysteropexy using the UpHold Lite™ system (Boston Scientific) or transvaginal hysterectomy with uterosacral ligament suspension (52). Although there was no significant difference in composite failure (re-treatment of prolapse, prolapse beyond the hymen, or symptoms of prolapse) at 3 years, there was a lower mean operative time in the hysteropexy group. Hysteropexy mesh exposure at 3 years was 8% and de novo dyspareunia rates were 5% and 7% in the hysteropexy and native tissue groups, respectively. The follow-up for these participants has been extended to 10 years, which will help to understand the long-term outcomes after synthetic mesh. Risk factors for failure of anterior vaginal prolapse repair have not been specifically studied separately from studies of total prolapse. Vaginal prolapse in general recurs with increasing age and length of follow-up, but the actual frequency is unknown and tends to vary with different definitions of prolapse. Recurrence of anterior prolapse is more likely to occur with more severe initial prolapse and probably with transvaginal, compared to abdominal, repairs (53). Recurrence may represent a failure to identify and repair all support defects, or weakening, stretching, or breaking of patients’ tissues, as it occurs with advancing age and after menopause. Sacrospinous ligament suspension of the vaginal apex, with exaggerated retrosuspension of the vagina, may predispose patients to recurrence of anterior vaginal prolapse; however, a recent clinical trial comparing sacrospinous ligament fixation to uterosacral ligament suspension did not demonstrate a difference in anterior recurrence between these two apical procedures (54). Other characteristics that may increase chances of recurrence are genetic predisposition, subsequent pregnancy, heavy lifting, chronic pulmonary disease, chronic straining at stool, smoking, and obesity.

Complications

Intraoperative complications are uncommon with native-tissue anterior vaginal prolapse repair. Excessive blood loss may occur, requiring blood transfusion, or a hematoma may develop in the anterior vagina. This is probably more common after vaginal paravaginal repair than anterior colporrhaphy. The lumen of the bladder or urethra may be entered in the course of dissection. Accidental cystotomy, occurring in 0.2–2.5% of anterior prolapse repairs, depending on the approach, should be repaired in layers at the time of the injury (34). After repair of cystotomy, the bladder is generally drained for 7–14 days to allow adequate healing. Ureteral damage or obstruction occurs rarely (0.4–2%), usually with very large cystoceles or with apical prolapse (43, 55). Other rare complications include intravesical or urethral suture placement (and associated urologic problems such as bladder stones) and fistulae, either urethrovaginal or vesicovaginal.

899 De novo stress urinary incontinence occurs in up to 20–30% of women after anterior vaginal prolapse repair. This risk is higher in women who demonstrate a positive cough stress test with prolapse reduction prior to surgery than those who do not. However, the performance of an anti-incontinence procedure such as a midurethral sling or Burch colposuspension decreases this risk whether the preoperative stress test is positive or not (26). As noted above Jelovsek et al. developed and validated a clinical prediction model, available publicly as an online calculator, to determine a women’s personal risk of developing de novo stress urinary incontinence after prolapse surgery to help guide patients and surgeons about the risks and benefits of performing a concurrent incontinence procedure at the time of prolapse repair (27). This was externally validated by two 14-center randomized trials in the Netherlands (56). Voiding difficulty can occur after anterior vaginal prolapse repair in approximately 20% of women (57). Treatment is continuous bladder drainage or intermittent self-catheterization until spontaneous voiding resumes, usually within 2 weeks. Urinary tract infections are common, (especially with concurrent catheter usage), but other infections such as pelvic or vaginal abscesses are uncommon. Sexual function may be positively or negatively affected by vaginal operations for anterior vaginal prolapse (58). As many as 50% of patients with advanced prolapse report dyspareunia prior to surgery. In general, dyspareunia rates decrease after prolapse surgery. However, de novo dyspareunia can be seen, especially if a posterior colporrhaphy is also performed. Vaginal topography, except for perhaps vaginal length, appears to have little relationship with postoperative sexual satisfaction (58). A systematic review of 40 studies showed that after an anterior repair with or without graft (biological or synthetic) dyspareunia improved with only a 5–11% de novo dyspareunia rate (59). Comparisons of sexual outcomes between native-tissue and mesh-augmented repairs have had mixed results with some showing worse sexual function after mesh repairs and others show no difference between the groups. The Cochrane reviews found no difference in postoperative de novo dyspareunia between native-tissue prolapse repair and those augmented with synthetic or biological grafts (34). Complications unique to synthetic mesh use in the vagina include vaginal mesh exposure, extrusion or perforation into an adjacent organ including the bladder, urethra, and rectum, and vaginal mesh contraction with associated pain and dyspareunia (60, 61). Complications made more severe by the presence of synthetic mesh include bleeding, infection, fistulas, pelvic pain, sexual dysfunction, and dysfunction of the lower urinary and lower gastrointestinal tract. While some of these complications can be managed nonsurgically, a significant proportion will require one or more surgical excision of some or all of the mesh (57). The incidence of these complications varies from 3% to 39%. A systematic review of 110 studies by Abed et al. found the average rate of graft exposure to be 10.3% with permanent synthetic grafts, which is consistent with the SGS Systematic Review showing 1.4–19% mesh exposure rate (35, 60). Vaginal mesh exposures can be a particularly difficult problem and a small but significant number require reoperation for mesh removal due to chronic discharge, bleeding, pain, and other serious complications. Approximately, 20–66% of women with a mesh exposure after permanent synthetic mesh placement require some surgery to correct the exposure; in some cases, multiple procedures are required (34, 60, 62, 63). In contrast, the rate of mesh exposures with biological grafts in the SGS Systematic Review Group review was less than 1% (35). The creation of thicker vaginal flaps with an

Textbook of Female Urology and Urogynecology

900 attached fibromuscularis, limiting vaginal trimming, and avoiding inverted “T” colpotomy incisions or concurrent vaginal hysterectomy probably decreases the mesh erosion rate. For a more detailed discussion of incidence and management of mesh or graft complications see Chapters 80 and 90.

References









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23. Beverly CJ, Walters MD, Weber AM. Prevalence of hydronephrosis in patients undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 1997;90:37–41. 24. Bump RC, Fantl JA, Hurt WG. The mechanism of urinary continence in women with severe uterovaginal prolpase: Results of barrier studies. Obstet Gynecol. 1988;72:291–5. 25. Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton J, et al. A midurethral sling to reduce incontinence after vaginal prolapse repair. NEJM. 2012;366:2358–67. 26. van der Ploeg JM, van der Steen A, Oude Rengerink K, van der Vaart CH, Roovers JP. Prolapse surgery with or without stress incontinence surgery for pelvic organ prolapse: a systematic review and meta-analysis of randomised trials. BJOG. 2014;121(5):537–47. 27. Jelovsek JE, Chagin K, Brubaker L, Rogers RG, Richter HE, Arya L, et al. A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery. Obstet Gynecol. 2014;123(2 Pt 1):279–87. 28. Yasa C, Gungor Ugurlucan F, Dural O, Yalcin O. External validation of a model predicting de novo stress urinary incontinence after pelvic organ prolapse surgery. Neurourol Urodyn. 2021;40(2):688–94. 29. Sabadell J, Salicru S, Montero-Armengol A, Rodriguez-Mias N, GilMoreno A, Poza JL. External validation of de novo stress urinary incontinence prediction model after vaginal prolapse surgery. Int Urogynecol J. 2019;30(10):1719–23. 30. Shobeiri SA, Rostaminia G, White D, Quiroz LH, Nihira MA. Evaluation of vaginal cysts and masses by 3-dimensional endovaginal and endoanal sonography. J Ultrasound Med. 2013;32(8):1499–507. 31. ACOG Practice bulletin no. 195: prevention of infection after gynecologic procedures. Obstetrics and Gynecology. 2018;131(6):e172–e89. 32. Clarke-Pearson DL, Abaid LN. Prevention of venous thromboembolic events after gynecologic surgery. Obstet Gynecol. 2012;119(1):155–67. 33. Goldberg RP, Koduri S, Lobel RW, Culligan PJ, Tomezsko JE, Winkler HA, et al. Protective effect of suburethral slings on postoperative cystocele recurrence after reconstructive pelvic operation. Am J Obstet Gynecol. 2001;195:1307–12. 34. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016;11:CD004014. 35. Schimpf MO, Abed H, Sanses T, White AB, Lowenstein L, Ward RM, et al. Graft and mesh use in transvaginal prolapse repair: a systematic review. Obstet Gynecol. 2016;128(1):81–91. 36. FDA Urogynecologic surgical mesh implants. https://wwwfdagov/ NewsEvents/Newsroom/PressAnnouncements/ucm636114htm). (accessed Dec 2022). 37. European Commission, Directorate-General for Health and Food Safety, Final opinion on surgical meshes, available at: https://health.ec.europa.eu/ other-pages/health-sc-basic-page/final-opinion-surgical-meshes_en. 38. RANZCOG, Polypropylene vaginal mesh implants for vaginal prolapse (C-Gyn 20), available at: https://ranzcog.edu.au/wp-content/ uploads/2022/05/Polypropylene-vaginal-mesh-implants-for-vaginalprolapse.pdf. 39. Ng-Stollmann N, Funfgeld C, Gabriel B, Niesel A. The international discussion and the new regulations concerning transvaginal mesh implants in pelvic organ prolapse surgery. Int Urogynecol J. 2020;31(10):1997–2002. 40. Grimes CL, Patankar S, Ryntz T, Philip N, Simpson K, Truong M, et al. Evaluating ureteral patency in the post-indigo carmine era: a randomized controlled trial. Am J Obstet Gynecol. 2017;217(5):601.e1–e10. 41. Stitely ML, Harlow K, MacKenzie E. Oral riboflavin to assess ureteral patency during cystoscopy: a randomized clinical trial. Obstet Gynecol. 2019;133(2):301–7. 42. Siff LN, Unger CA, Jelovsek JE, Paraiso MF, Ridgeway BM, Barber MD. Assessing ureteral patency using 10% dextrose cystoscopy fluid: evaluation of urinary tract infection rates. Am J Obstet Gynecol. 2016;215(1):74.e1–6. 43. Gustilo-Ashby AM, Jelovsek JE, Barber MD, Yoo EH, Paraiso MF, Walters MD. The incidence of ureteral obstruction and the value of intraoperative cystoscopy during vaginal surgery for pelvic organ prolapse. Am J Obstet Gynecol. 2006;194(5):1478–85. 44. Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior colporrhaphy: a randomized trial of three surgical techniques. Am J Obstet Gynecol. 2001;185(6):1299–304; discussion 304–6. 45. Chmielewski L, Walters MD, Weber AM, Barber MD. Reanalysis of a randomized trial of 3 techniques of anterior colporrhaphy using clinically relevant definitions of success. Am J Obstet Gynecol. 2011;205(1): 69.e1–8.

Anterior Vaginal Wall Prolapse 46. Lavelle RS, Christie AL, Alhalabi F, Zimmern PE. Risk of prolapse recurrence after native tissue anterior vaginal suspension procedure with intermediate to long-term followup. J Urol. 2016;195(4 Pt 1):1014–20. 47. Eilber KS, Alperin M, Khan A, Wu N, Pashos CL, Clemens JQ, et al. Outcomes of vaginal prolapse surgery among female Medicare beneficiaries: the role of apical support. Obstet Gynecol. 2013;122(5):981–7. 48. Young SB, Daman JJ, Bony LG. Vaginal paravaginal repair: one-year outcomes. Am J Obstet Gynecol. 2001;185(6):1360–6; discussion 6–7. 49. Mallipeddi PK, Steele AC, Hohli N, Karram MM. Anatomic and functional outcome of vaginal paravaginal repair in the correction of anterior vaginal wall prolapse. Int Urogynecol J. 2001;12:83–8. 50. Sand PK, Koduri S, Lobel RW, Winkler HA, Tomezsko J, Culligan PJ, et al. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. Am J Obstet Gynecol. 2001;184(7):1357–62; discussion 62–4. 51. Glazener CMA, Breeman S, Elders A, Hemming C, Cooper KG, Freeman RM, et al. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). The Lancet. 2017;389(10067):381–92. 52. Nager CW, Visco AG, Richter HE, Rardin CR, Rogers RG, Harvie HS, et al. Effect of vaginal mesh hysteropexy vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse. JAMA. 2019;322(11):1054–65. 53. Whiteside JL, Weber AM, Meyn LA, Walters MD. Risk factors for prolapse recurrence after vaginal repair. Am J Obstet Gynecol. 2004;191(5):1533–8. 54. Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, et al. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA. 2014;311(10):1023–34.

901 55. Kwon CH, Goldberg RP, Koduri S, Sand PK. The use of intraoperative cystoscopy in major vaginal and urogynecologic surgeries. Am J Obstet Gynecol. 2002;187(6):1466–71; discussion 71–2. 56. Jelovsek JE, Ploeg JMV, Roovers JP, Barber MD. Validation of a model predicting De Novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery. Obstet Gynecol. 2019;133(4):683–90. 57. Abbott S, Unger CA, Evans JM, Jallad K, Mishra K, Karram MM, et al. Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study. Am J Obstet Gynecol. 2014;210(2):163.e1–8. 58. Edenfield AL, Levin PJ, Dieter AA, Amundsen CL, Siddiqui NY. Sexual activity and vaginal topography in women with symptomatic pelvic floor disorders. J Sex Med. 2015;12(2):416–23. 59. Antosh DD, Kim-Fine S, Meriwether KV, Kanter G, Dieter AA, Mamik MM, et al. Changes in sexual activity and function after pelvic organ prolapse surgery: a systematic review. Obstet Gynecol. 2020;136(5):922–31. 60. Abed H, Rahn DD, Lowenstein L, Balk EM, Clemons JL, Rogers RG, et al. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J. 2011;22(7):789–98. 61. Ganj FA, Ibeanu OA, Bedestani A, Nolan TE, Chesson RR. Complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapse repair. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20(8):919–25. 62. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013(4):CD004014. 63. Wihersaari O, Karjalainen P, Tolppanen AM, Mattsson N, Jalkanen J, Nieminen K. Complications of pelvic organ prolapse surgery in the 2015 Finnish pelvic organ prolapse surgery survey study. Obstet Gynecol. 2020;136(6):1135–44.

83

ENTEROCELE Kaven Baessler

Definition and scope The term “enterocele” is derived from the roots “enter”, meaning intestine and “cele” meaning hernia. An enterocele is a herniation into the vagina that typically presents as a posterior enterocele, which develops in the recto-vaginal space (pouch of Douglas or cul-de-sac). The anterior enterocele in the vesicovaginal space is a rare entity (1) that might occur after cystectomy or after a prior hysterectomy (2–4). An enterocele is a form of pelvic organ prolapse with the bowel protruding into the vagina, which may also be labeled as a vaginal vault prolapse after hysterectomy. The etiology, pathophysiology, prevention, non-surgical, and operative treatment of enteroceles will be reviewed in this chapter.

Anatomy, etiology, and pathophysiology Normal anatomy

A posterior enterocele develops in the pouch of Douglas, which plays an important and probably predisposing etiologic role in the development of an enterocele. The pouch of Douglas is normally closed and does not contain intestine or omentum. In anatomy textbooks, the distal extent of the pouch of Douglas has traditionally been described as 2–3 cm below the uterosacral ligaments (e.g. Gray's Anatomy). Histological studies by Uhlenhuth and colleagues have demonstrated that in the fetus, the pouch of Douglas may extend to the perineal body (5). The fusion of the anterior and posterior peritoneum forms the rectovaginal septum and determines the depth of the pouch of Douglas (5–7). According to Uhlenhuth, the rectovaginal septum is distinguishable from the “fascial” capsule of the vagina and rectum. In contrast to the anatomy textbooks, intra-abdominal measurements of the depth of the pouch of Douglas in young nulliparous women revealed great variations with 25–75% of the posterior vaginal wall covered with peritoneum (8). The mean depth of the pouch of Douglas was 49% of vaginal length in nulliparas, 46% in parous women, and was significantly deeper (72%) in patients with posterior vaginal wall prolapse. Age and parity did not have an influence. It seems that a deep pouch of Douglas is frequently present in young nulliparous women without pelvic organ prolapse, which implies a congenital variation and predisposition (8). Normal pelvic organ support depends on several anatomical and functional factors like the size of the cross-sectional area of the pelvis (9), anterior and posterior endopelvic “fascia” with intact attachments with normal tone, position, and functionality of the levator ani muscles (10). A larger anterior pelvic crosssectional area is associated with an increased risk for prolapse. Normal pelvic floor muscle structure and tone are essential for the configuration and axis of the vagina to allow for normal intraabdominal pressure distribution (11). It is apparent that fascial defects in the three levels of vaginal support and the posterior compartment may contribute to pelvic organ prolapse including enteroceles (10, 12, 13). These elements might also be important in keeping the pouch of Douglas closed. 902

Deep pouch of Douglas as a predisposing factor (Fig. 83.1)

Figure 83.1 illustrates the different characteristics in the development of enteroceles. Intra-abdominal measurements of the depth of the pouch of Douglas have shown that in women with posterior vaginal wall and anterior rectal wall prolapse, the pouch of Douglas is significantly deeper and may reach the level of the perineal body (8). In women with severe pelvic organ prolapse, a large or voluminous rectovaginal pouch was a consistent anatomic finding requiring obliteration during pelvic reconstructive surgery (14–16). Apart from a mobile vaginal axis and a dehiscence of the levator hiatus, French authors reported a “grande fosse pelvi-périnéale” – a large pelvic pouch – to be a principal lesion in women with enteroceles (17). Other authors described this phenomenon as an abnormally deep and wide cul-de-sac with a three-dimensional enlargement and a recto-sigmoid colon that closely follows the sacral curve (18) (Fig. 83.2). Baessler and Schuessler found 64% of women with enteroceles and all women with anterior rectal wall procidentia to have these features termed a “grande fosse pelvienne”. A grande fosse pelvienne was also present in six of 43 women (14%) in the control group who did not have pelvic organ prolapse. Three of them were nulliparous (19). Given these findings, it seems reasonable to regard a deep pouch of Douglas as a risk factor for enterocele formation. However, a deep pouch of Douglas does not necessarily result in an enterocele, which can only develop when other factors open and expose the deep pouch of Douglas to increase in intraabdominal pressure.

Vaginal axis

In a woman with normal pelvic organ support, the pouch of Douglas remains closed with increased intra-abdominal pressure, irrespective of its depth, and lies nearly horizontally between the levator plate and the vagina (20, 21). MRI studies measured the mean levator-vaginal angle with a horizontal line at 35–53° in different ethnic nulliparous populations (22) or at 41 ± 22° (10). It is known that operations that change the vaginal axis can lead to increased prolapse in the “unprotected” area. This is true for the higher incidence of cystoceles after sacrospinous fixations where the axis of the vagina may be deviated posteriorly. (23, 24) Conversely, there is a relatively high incidence of rectoceles and enteroceles after Burch colposuspensions or ventrofixations where the vagina is displaced anteriorly (25, 26). Another process that changes the vaginal axis is excessive perineal descent (or descending perineum syndrome) which is often seen clinically in women with significant posterior vaginal wall prolapse (27) (Fig. 83.3). A deep pouch of Douglas is likely to accentuate the process of enterocele development once the vaginal axis is changed.

Endopelvic “fascia”

The integrity of the anterior and posterior endopelvic connective tissue and its attachments is essential for normal pelvic organ

DOI: 10.1201/9781003144243-91

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FIGURE 83.1  The pouch of Douglas – “normal” depth, deep, grande fosse pelvienne. (a) “Normal” pouch of Douglas: the pouch of Douglas covers approximately one-third of the posterior vaginal wall and is closed. (b) Deep pouch of Douglas: peritoneum covers the posterior vaginal wall down to the level of the levator ani. Normal pelvic floor support prevents opening and exposure of the pouch of Douglas. (c) An enterocele has developed in the rectovaginal space displacing the posterior vaginal wall: The vaginal axis and rectal axis are vertical and the pelvic floor position is lower leaving the pouch of Douglas unprotected. (d) Apical enterocele with separation of the anterior and posterior endopelvic fascia after hysterectomy. (e) Enterocele after Burch colposuspension with ventral displacement of anterior compartment: The pouch of Douglas was not protected. (f) Enterocele bulging primarily into the rectum: anterior rectal wall prolapse. Intact posterior endopelvic fascia.

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FIGURE 83.2  Laparoscopic view of a grande fosse pelvienne: note the deep and wide pouch of Douglas, the lack of prominent uterosacral ligaments and the rectal course close to the sacrum with a short mesentery. support (13). A defect in this endopelvic “fascia” or insufficiency is necessary for an enterocele to protrude. However, an intact endopelvic connective tissue might only prevent the enterocele from bulging into the vagina but not into the rectum causing anterior rectal wall procidentia or prolapse (28) (Fig. 83.1f). It is not entirely apparent whether the endopelvic “fascia” is identical to the rectovaginal septum, as the latter can be rather short (29) depending on the depth of the pouch of Douglas. Whole-thickness biopsies of the leading edge of radiologically proven enteroceles showed that in none of the examined 13 women was the vaginal epithelium in direct contact with the peritoneum and all had a well-defined vaginal wall muscularis (30). These findings add to the ongoing controversy on whether

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FIGURE 83.4  Mallory – Trichrome stain of a biopsy taken from the tissue used in posterior vaginal wall repairs. The biopsy site was approximately 2 cm below the ischial spine. This stain is used to differentiate fibrous tissue (green) and smooth muscle (red). Note the amount of smooth muscle, organised connective tissue, and areolar tissue. (With permission from Dr Christopher Maher.) endopelvic “fascia” exists or not. It has been suggested that it is a structure that is artificially created during surgical dissection. This debate is complicated by inconsistent histological studies, some of which do not substantiate the concept of a fascia between rectum and vagina. However, it might simply be a question of definition. Fascia is connective tissue usually with smooth muscle cells and may also contain fatty or areolar tissue (31) (Fig. 83.4). Whether the “fascia” is part of the vagina or rectum or whether it is a separate structure is of scientific but not clinical value. “Fascia” in the clinical sense means connective tissue that has

FIGURE 83.3  Excessive perineal descent. These photos demonstrate a nearly normal position of the perineum at rest but a “ballooning” of the perineum on straining. This patient had a large rectocele and enterocele that did not protrude outside the introitus.

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tensile strength and is strong enough to hold sutures and support the underlying organs.

Descending perineum syndrome

This syndrome was described first by colorectal surgeons as a “ballooning” of the perineum during straining (Fig. 83.3) (32). Apart from bowel symptoms, which can be similar to complaints of patients with rectoceles or enteroceles, excessive perineal descent of more than 2 cm (measured in relation to the ischial tuberosities) is seen more frequently in women with posterior vaginal wall prolapse (33). A solitary rectal ulcer, rectal prolapse, and intussusception are common concomitant findings (33, 34). The etiology is unclear but reduced pelvic floor tone (35) with insufficient perineal and endopelvic “fascial” attachment, a deep pouch of Douglas, and sigmoid colon elongation have all been implicated as putative factors (27). The term “ballooning” is also used to describe an enlargement of the genital hiatus during straining on perineal three-dimensional ultrasound and is associated with pelvic organ prolapse (36).

The pathophysiology of enterocele development: pulsion, traction, sliding, true and congenital

There are different theories and each one of them might be true in an individual patient as no one theory fits all enteroceles. Enteroceles may develop as a true hernia with a hernia sac and neck through a defect in the endopelvic connective tissue. A true “internal hernia” with an isolated defect in the peritoneum is a rare condition (37), with only a few case reports. A traction enterocele develops secondary to the loss of pelvic organ support (20) with apical vault descent and normal anatomical connections between the pouch of Douglas and the vagina (38). In contrast, according to Nichols and Genadry (20), a pulsion enterocele is secondary to increased abdominal pressure. However, Zacharin states that a pulsion enterocele occurs as a late complication of pelvic surgery like hysterectomies, and is associated with a large rectovaginal pouch (38). Nichols and Genadry described iatrogenic enteroceles as a sequela of operations that alter the vaginal axis like Burch colposuspension and congenital enteroceles which are associated with an “unusually” deep pouch of Douglas (Fig. 83.1e). Anterior enteroceles have been described after cystectomies (39, 40).

639 women aged 45–85 years using the pelvic organ prolapse quantification system of the International Continence Society, only 22% had no prolapse at all, 37% had stage 1, 29% stage 2, 9% stage 3 and 3% had complete eversion (49).

Symptoms As with any other kind of pelvic organ prolapse, an enterocele may cause prolapse symptoms including the feeling of a bulge, a dragging sensation, and may interfere with bladder, bowel, and sexual function. Unlike a cystocele or rectocele, an enterocele does not appear to cause any stereotypical and pathognomonic symptoms, and very often symptoms cannot be distinguished from those of any coexisting pelvic organ prolapse. Some women primarily complain of rectal symptoms like fullness and incomplete or difficult bowel emptying (42). Anorectal symptoms and the degree of posterior prolapse do not seem to correlate (50, 51). Partial or complete obstruction of the urethra might result in voiding difficulties or retention (52, 53). Dyspareunia, “slackness at intercourse”, vaginal dryness, and coital incontinence are frequently reported by women with pelvic organ prolapse (54). Mainly complication of previous pelvic floor surgery and hysterectomy, vaginal rupture, and evisceration have been reported in women with enteroceles (55).

Clinical assessment and investigations Vaginal and rectal examination is probably capable of identifying most enteroceles although some studies claim an inferiority of clinical examination to radiological studies (51). Defects in the endopelvic connective tissue and their location with diminished vaginal rugae are a clue (Fig. 83.5). Simultaneous bimanual examination of the tissues between vagina and rectum under straining or in the standing position usually helps. An enterocele may be located in the anterior vaginal wall after cystectomy, in the posterior vaginal wall (posterior enterocele) or at the vaginal vault (apical enterocele). Occasionally peristalsis of the intestine bulging into the vagina establishes the diagnosis. Perineal ultrasound may easily depict an enterocele, (56) especially when performed in an upright position. This is the

Rectal prolapse

Rectal prolapse might originate from the pouch of Douglas as an enterocele bulging into the rectum (41, 42) (Fig. 83.1f; see also Fig. 83.6c). Altemeier described three types of rectal prolapse: Type 1 is a false prolapse due to mucosal redundancy, type 2 is an intussusception without an association with the pouch of Douglas and type 3 is a sliding hernia of the rectovaginal pouch (43). Enteroptosis or elongation of the recto-sigmoid colon is considered contributing factors (44).

Epidemiology The prevalence of enteroceles is inseparable from that of other pelvic organ prolapse. Isolated enteroceles may occur after pelvic surgery. Enteroceles may occur after Burch colposuspension in up to 32% of cases (45, 46). It has also been recognised that enteroceles and rectal prolapse frequently coexist with other defects of pelvic floor support. (42, 47, 48). Specific data on enteroceles from women in the community is scarce. In a prevalence study of

FIGURE 83.5  Rectocele and enterocele with diminished vaginal rugae.

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Textbook of Female Urology and Urogynecology Dynamic MRI including defecation MRI provides superb images (Fig. 83.8) but has some disadvantages. It is expensive and functional MRI in an upright position is not yet widely available. Defaecation supine might be impossible for some patients but defaecation may be indispensable for the diagnoses of enteroceles and intussusception (59–62). Given that perineal ultrasound can be performed standing, it might be considered the imaging technique of first choice (63).

Prevention of enterocele

FIGURE 83.6  (a) Enterocele between vagina and rectum (dotted line). Note the shadow caused by gas in the bowel. (b) Enterocele between vagina and rectum at rest (dotted line). (c) On straining, the enterocele descends not only more into the vagina but also into the rectum causing anterior rectal wall descent. advantage over MRI; it can be performed standing, during straining or coughing, and even during simulated defaecation with gel in the rectum. No opacification is required and the equipment is widely available. In Figure 83.6a, an enterocele descends between the rectum and vagina in a patient after hysterectomy. In a different patient, bulging into the rectum is also noted, explaining the patient's evacuation problems (Fig. 83.6b and c). Three-dimensional ultrasound can also produce astounding images (Fig. 83.7). Perineal ultrasound may therefore replace defecography Viscerography or fluoroscopic imaging includes the opacification of the bladder, rectum, and vagina with contrast medium. An additional barium meal will show the small bowel on X-ray. Ideally, the investigation is performed dynamically during straining or coughing and comprises defecography in a functional position, i.e. sitting. Bowel evacuation is crucial for some enteroceles to descend. It will also provide further information on rectal emptying, rectal prolapse or intussusception (50, 57) although there are great variations of “normal” findings. Shorvon et al. demonstrated that rectoceles and intussusception are frequently present in young and asymptomatic women (58). It is therefore most valuable when the clinician performs the radiological investigations and interprets the findings in context with the symptoms.

Controlled studies assessing the prevention of enteroceles and pelvic organ prolapse are scarce. (Modified) McCall sutures with (re-)attachment of the uterosacral ligaments to the vaginal vault during hysterectomy have long been advocated (64). At the time of hysterectomy, Cruikshank & Kovac compared three available methods to prevent an enterocele in a randomized controlled trial (65). They studied the obliteration of the pouch of Douglas by suturing the uterosacral ligaments in the midline, called a vaginal Moschcowitz-type operation; a McCall-type culdoplasty where the uterosacral ligaments are plicated and attached to the vaginal vault and the sutures externalized, and closing the peritoneum with a purse-string suture. Up to three months postoperatively all procedures were equally successful (100%). After three years, the McCall type method was found to be superior for enterocele prevention with none of these 32 patients developing a symptomatic enterocele (65). To prevent an enterocele after Burch colposuspension one study compared additional pouch of Douglas obliteration by either approximation of the uterosacral ligaments or Moschcowitz type horizontal purse-string sutures. Follow up after 3–16 years (mean 9 years) showed that without obliteration of the Pouch of Douglas, postoperative enterocele formation occurred significantly more often in 19% compared to 11% after an additional Moschcowitz procedure and 2% after uterosacral ligament plication (45).

Conservative treatment Treatment of pelvic organ prolapse depends on the patient's preferences for management, associated symptoms, the extent of prolapse, and whether the patient has completed her family. Conservative treatment of pelvic organ prolapse in general includes the use of pessaries (66, 67) and pelvic floor muscle training (68, 69). Vaginal pessaries might prevent deterioration of the prolapse, alleviate symptoms of prolapse, and are especially useful if there is a long waiting list for surgery (66). Pessaries are an option and a trial of pessary fitting can easily be performed in clinics and may be managed by educated nurses or continence advisers.

Surgical treatment There are procedures that only obliterate the pouch of Douglas by plicating the peritoneum like the Moschcowitz or Halban operations or the uterosacral ligaments like the McCall procedure (Fig. 83.9). Several horizontal circular, purse-string type, sutures, beginning at the most distal part of the pouch of Douglas/enterocele form the so-called Moschcowitz procedure which was described by Moschcowitz in 1912 after extensive anatomical studies of rectal prolapse (41). Although he found it a successful operation in his patients, it has subsequently been associated with

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FIGURE 83.7  Three-dimensional ultrasound. (a) The enterocele between vagina and rectum can be seen in all three dimensions; the levator is partly damaged but the 3D modulation shows it to be intact in some levels. (b) A rectocele with an intact levator ani and in the 3D image, the ventral displacement of the posterior vaginal wall is visible.

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  FIGURE 83.8  Enterocele, with considerable pelvic floor, perineal descent, and uterine and bladder prolapse: MRI pictures (a) at rest and (b) during straining. a high failure rate and complications like ureteral kinking and small bowel obstruction (70) – although there is a lack of controlled studies. Currently, it is usually used only as an adjunct to other pelvic floor operations. Occlusion of the pouch of Douglas as described by Halban in his textbook in 1912 includes several

FIGURE 83.9  McCall procedure: This is one of several different methods of suture placement.

sagittal sutures positioned along the pouch in a vertical direction (71). Although there is less risk for ureteral damage, the ureters should be checked carefully. As with the Moschcowitz operation, this approach has not been studied systematically and is currently performed concomitantly with other pelvic floor operations. Both the Moschcowitz and Halban obliteration procedures were initially described as abdominal procedures but can also be achieved transvaginally, laparoscopically (72) or even extraperitoneally (73). Laparoscopic enterocele repair and uterosacral ligament suspension (USLS) have the advantage of enhanced visibility of the uterosacral ligaments and ureters (72, 74). However, optimal anatomical results might only be achieved when the pouch of Douglas obliteration is combined with surgery to support the apical compartment. This can be accomplished by native tissue repairs like sacrospinous, iliococcygeous (75, 76), or uterosacral ligament fixations (74, 77), by using mesh interposition between the vaginal vault and the sacrum (open abdominal, laparoscopic, or robotic sacrocolpopexy) (74, 77, 78) or by vaginal mesh placement and attachment at the sacrospinous ligaments (77, 79). Sacrospinous ligament fixation, sacrocolpopexy, and (anterior) rectopexy appear effective to control enteroceles (77, 80–86). The plication of the uterosacral ligaments in the midline, the McCall culdoplasty, or USLS of the vaginal vault at the time of hysterectomy have numerous modifications (Fig. 83.10). The principal structure employed are the uterosacral ligaments, which are sutured together in the midline with interrupted stitches or one continuous stitch. Modifications include the incorporation of the vaginal vault or cervix into the sutures. After the suture is passed through the uterosacral ligaments on either side with or without inclusion of the rectosigmoid serosa, it is tied and the ends are passed through the upper vaginal wall. Permanent or

Enterocele

909 The stapled transanal rectal resection (STARR) for obstructive defaecation, rectocele and/or intussusception is also an option. In a systematic review of surgical interventions for posterior compartment prolapse and obstructed defecation symptoms, STARR showed postoperative improvement of posterior compartment anatomy and of obstructed defecation in validated questionnaires. Complications include bleeding, fecal urgency and incontinence as well as pain (97). An enterocele has been recognized as a risk factor for recurrent prolapse and for persistent obstructive defaecation symptoms after STARR (100, 101).

Synopsis

FIGURE 83.10  Combination of a Halban-type pouch of Douglas obliteration with sagittal sutures and a McCall-part with incorporation of the uterosacral ligaments after concomitant abdominal hysterectomy. Note that the anterior and posterior endopelvic fascia are joined over the vaginal vault and incorporated in the pouch of Douglas obliteration. delayed absorbable sutures should be used although there are no controlled studies to establish which are more effective. Nonabsorbable multifilament sutures should not be passed through the whole thickness of the vagina to avoid any sinus formation or abscess (87, 88). Long-term success rates of McCall culdoplasty USLS and pouch of Douglas obliteration are very good (74, 77, 89). A vaginal technique to suspend the vaginal vault and re-attach the endopelvic fascia to the uterosacral ligaments has been described by Shull et al. (90). Using one suture, the anterior and posterior endopelvic connective tissue is connected to the uterosacral ligaments with two or three permanent stitches along the uterosacral ligament passed. The success rate for vault prolapse and enteroceles was reported to be 99%. Discrete vaginal enterocele repair is comprised of identification, preparation, and opening of the enterocele sac, high closure of the peritoneum with a purse-string suture, and excision of the sac if preferred. The failure rate with this repair was reported at 33% in one study although 72% of women also received a posterior repair and 22% had a Burch colposuspension (91). Although there are many studies employing vaginal grafts and mesh in the posterior vaginal compartment without significant benefit (92), few analyze enteroceles separately. Graft reinforcement may reduce enterocele recurrence (93) but controlled studies are lacking. There are two randomized controlled trials comparing the transvaginal and transanal rectocele repair (94, 95). The authors reported a higher incidence of postoperative enteroceles and recto-enteroceles in the transanal repair group. It was suggested that the transvaginal posterior repair with continuous plication of the endopelvic connective tissue from the perineal body to the vaginal apex offers protection against enterocele formation (96).

An isolated enterocele is rare and usually occurs after pelvic surgery that displaces the vaginal axis, leads to disruption of the anterior and posterior endopelvic connective tissue or exposes the pouch of Douglas. A deep pouch of Douglas might predispose to enterocele formation. Enteroceles are frequently associated with pelvic organ prolapse in other compartments. Symptoms vary widely and include prolapse sensation, disturbance of defecation and micturition, and dyspareunia. During the clinical vaginal and rectal examination, enteroceles can usually be identified but imaging techniques such as perineal ultrasound and MRI may be helpful. Direct horizontal or sagittal closure of the peritoneum of the pouch of Douglas and uterosacral ligaments plication performed vaginally, abdominally, or laparoscopically, often in combination with other pelvic floor reconstructive surgery can effectively address enteroceles and their prevention.

References

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45. Langer R, Lipshitz Y, Halperin R, Pansky M, Bukovsky I, Sherman D. Prevention of genital prolapse following Burch colposuspension: comparison between two surgical procedures. Int Urogynecol J Pelvic Floor Dysfunct. 2003;14(1):13–6; discussion 6. 46. Alcalay M, Monga A, Stanton SL. Burch colposuspension: a 10–20 year follow up. Br J Obstet Gynaecol. 1995;102(9):740–5. 47. Peters WA, 3rd, Smith MR, Drescher CW. Rectal prolapse in women with other defects of pelvic floor support. Am J Obstet Gynecol. 2001;184(7):1488–94; discussion 94–5. 48. Thompson JR, Chen AH, Pettit PD, Bridges MD. Incidence of occult rectal prolapse in patients with clinical rectoceles and defecatory dysfunction. Am J Obstet Gynecol. 2002;187(6):1494–9; discussion 9–500. 49. Slieker-ten Hove MCP, Vierhout M, Bloembergen H, Schoenmaker G. Distribution of pelvic organ prolapse (POP) in the general population: prevalence, severity, etiology and relation with the function of the pelvic floor muscles. Neurourol Urodyn. 2004;23(5/6):401–2. 50. da Silva GM, Gurland B, Sleemi A, Levy G. Posterior vaginal wall prolapse does not correlate with fecal symptoms or objective measures of anorectal function. Am J Obstet Gynecol. 2006;195(6):1742–7. 51. Groenendijk AG, van der Hulst VP, Birnie E, Bonsel GJ. Correlation between posterior vaginal wall defects assessed by clinical examination and by defecography. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(9):1291–7. 52. Marinkovic SP, Stanton SL. Incontinence and voiding difficulties associated with prolapse. J Urol. 2004;171(3):1021–8. 53. Haylen BT, Law MG, Frazer M, Schulz S. Urine flow rates and residual urine volumes in urogynecology patients. Int Urogynecol J Pelvic Floor Dysfunct. 1999;10(6):378–83. 54. Weber AM, Walters MD, Piedmonte MR. Sexual function and vaginal anatomy in women before and after surgery for pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol. 2000;182(6):1610–5. 55. Croak AJ, Gebhart JB, Klingele CJ, Schroeder G, Lee RA, Podratz KC. Characteristics of patients with vaginal rupture and evisceration. Obstet Gynecol. 2004;103(3):572–6. 56. Beer Gabel M, Teshler M, Schechtman E, Zbar AP. Dynamic transperineal ultrasound vs. defecography in patients with evacuatory difficulty: a pilot study. Int J Colorectal Dis. 2004;19(1):60–7. 57. Kelvin FM, Maglinte DD, Hornback JA, Benson JT. Pelvic prolapse: assessment with evacuation proctography (defecography). Radiology. 1992;184(2):547–51. 58. Shorvon PJ, McHugh S, Diamant NE, Somers S, Stevenson GW. Defecography in normal volunteers: results and implications. Gut. 1989;30(12):1737–49. 59. Pannu HK, Scatarige JC, Eng J. Comparison of supine magnetic resonance imaging with and without rectal contrast to fluoroscopic cystocolpoproctography for the diagnosis of pelvic organ prolapse. J Comput Assisted Tomogr. 2009;33(1):125–30. 60. El Sayed RF, Alt CD, Maccioni F, Meissnitzer M, Masselli G, Manganaro L, et al. Magnetic resonance imaging of pelvic floor dysfunction - joint recommendations of the ESUR and ESGAR Pelvic Floor Working Group. Eur Radiol. 2017;27(5):2067–85. 61. Maccioni F, Al Ansari N, Buonocore V, Mazzamurro F, Indinnimeo M, Mongardini M, et al. Prospective comparison between two different magnetic resonance defecography techniques for evaluating pelvic floor disorders: air-balloon versus gel for rectal filling. Eur Radiol. 2016;26(6):1783–91. 62. Lienemann A, Anthuber C, Baron A, Reiser M. Diagnosing enteroceles using dynamic magnetic resonance imaging. Dis Colon Rectum. 2000;43(2):205–12. 63. Perniola G, Shek C, Chong CC, Chew S, Cartmill J, Dietz HP. Defecation proctography and translabial ultrasound in the investigation of defecatory disorders. Ultrasound Obstet Gynecol. 2008;31(5):567–71. 64. Chene G, Tardieu AS, Savary D, Krief M, Boda C, Anton-Bousquet MC, et al. Anatomical and functional results of McCall culdoplasty in the prevention of enteroceles and vaginal vault prolapse after vaginal hysterectomy. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(7):1007–11. 65. Cruikshank SH, Kovac SR. Randomized comparison of three surgical methods used at the time of vaginal hysterectomy to prevent posterior enterocele. Am J Obstet Gynecol. 1999;180(4):859–65. 66. Abdool Z, Thakar R, Sultan AH, Oliver RS. Prospective evaluation of outcome of vaginal pessaries versus surgery in women with symptomatic pelvic organ prolapse. Int Urogynecol J. 2011;22(3):273–8. 67. Baessler K, Aigmuller T, Albrich S, Anthuber C, Finas D, Fink T, et al. Diagnosis and therapy of female pelvic organ prolapse. Guideline of the DGGG, SGGG and OEGGG (S2e-Level, AWMF Registry Number 015/006, April 2016). Geburtshilfe Frauenheilkd. 2016;76(12):1287–301.

Enterocele

68. Hagen S, Stark D, Glazener C, Dickson S, Barry S, Elders A, et al. Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial. Lancet. 2014;383(9919):796–806. 69. Hagen S, Stark D. Conservative prevention and management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2011(12):CD003882. 70. Dicke JM. Small bowel obstruction secondary to a prior Moschcowitz procedure. Am J Obstet Gynecol. 1985;152(7 Pt 1):887–8. 71. Halban J, Tandler J. Anatomie und Atiologie der Genitalprolapse beim Weibe: Wilhelm Braumuller, Wien und Leipzig; 1907. 72. Paraiso MF, Falcone T, Walters MD. Laparoscopic surgery for enterocele, vaginal apex prolapse and rectocele. Int Urogynecol J Pelvic Floor Dysfunct. 1999;10(4):223–9. 73. Zilberlicht A, Dwyer PL, Karmakar D, Carswell F, Schierlitz L. Extraperitoneal high vaginal cuff suspension at the time of vaginal hysterectomy for advanced uterovaginal prolapse: results of a modified McCall technique from a longitudinal clinical study. Aust N Z J Obstet Gynaecol. 2020;61(2):258–62. 74. Szymczak P, Grzybowska ME, Wydra DG. Comparison of laparoscopic techniques for apical organ prolapse repair – a systematic review of the literature. Neurourol Urodyn. 2019;38(8):2031–50. 75. Maher CF, Murray CJ, Carey MP, Dwyer PL, Ugoni AM. Iliococcygeus or sacrospinous fixation for vaginal vault prolapse. Obstet Gynecol. 2001;98(1):40–4. 76. Maher CF, Cary MP, Slack MC, Murray CJ, Milligan M, Schluter P. Uterine preservation or hysterectomy at sacrospinous colpopexy for uterovaginal prolapse? Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):381–4; discussion 4–5. 77. Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013;24(11):1815–33. 78. Nair R, Nikolopoulos KI, Claydon LS. Clinical outcomes in women undergoing laparoscopic hysteropexy: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2017;208:71–80. 79. Maher CF, Baessler KK, Barber MD, Cheon C, Consten ECJ, Cooper KG, et al. Summary: 2017 international consultation on incontinence evidencebased surgical pathway for pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2020;26(1):30–6. 80. Hefni MA, El-Toukhy TA. Long-term outcome of vaginal sacrospinous colpopexy for marked uterovaginal and vault prolapse. Eur J Obstet Gynecol Reprod Biol. 2006;127(2):257–63. 81. Baessler K, Schuessler B. Abdominal sacrocolpopexy and anatomy and function of the posterior compartment. Obstet Gynecol. 2001;97(5 Pt 1):678–84. 82. Baessler K, Stanton SL. Sacrocolpopexy for vault prolapse and rectocele: do concomitant Burch colposuspension and perineal mesh detachment affect the outcome? Am J Obstet Gynecol. 2005;192(4):1067–72. 83. Maher CF, Qatawneh A, Dwyer PL, Carey MP, Cornish A, Schluter P. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse. A prospective randomized trial. Am J Obstet Gynecol. 2004;190:20–6. 84. Tsiaoussis J, Chrysos E, Athanasakis E, Pechlivanides G, Tzortzinis A, Zoras O, et al. Rectoanal intussusception: presentation of the disorder and late results of resection rectopexy. Dis Colon Rectum. 2005;48(4):838–44.

911 85. Coolen AWM, van IMN, van Oudheusden AMJ, Veen J, van Eijndhoven HWF, Mol BWJ, et al. Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol. BMC Womens Health. 2017;17(1):52. 86. Faucheron JL, Trilling B, Girard E, Sage PY, Barbois S, Reche F. Anterior rectopexy for full-thickness rectal prolapse: technical and functional results. World J Gastroenterol. 2015;21(16):5049–55. 87. Patel M, Currie J, Tulikangas PK. Abdominal extraperitoneal excision of a foreign body in the pararectal space. Female Pelvic Med Reconstr Surg. 2011;17(3):144–6. 88. Shepherd JP, Higdon HL, 3rd, Stanford EJ, Mattox TF. Effect of suture selection on the rate of suture or mesh erosion and surgery failure in abdominal sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2010;16(4):229–33. 89. Silva WA, Pauls RN, Segal JL, Rooney CM, Kleeman SD, Karram MM. Uterosacral ligament vault suspension: five-year outcomes. Obstet Gynecol. 2006;108(2):255–63. 90. Shull BL, Bachofen C, Coates KW, Kuehl TJ. A transvaginal approach to repair of apical and other associated sites of pelvic organ prolapse with uterosacral ligaments. Am J Obstet Gynecol. 2000;183(6):1365–73; discussion 73–4. 91. Tulikangas PK, Piedmonte MR, Weber AM. Functional and anatomic follow-up of enterocele repairs. Obstet Gynecol. 2001;98(2):265–8. 92. Mowat A, Maher D, Baessler K, Christmann-Schmid C, Haya N, Maher C. Surgery for women with posterior compartment prolapse. Cochrane Database Syst Rev. 2018;3:CD012975. 93. Molsted-Pedersen L, Rudnicki M, Lose G. Transvaginal repair of enterocele and vaginal vault prolapse using autologous fascia lata graft. Acta Obstet Gynecol Scand. 2006;85(7):874–8. 94. Kahn MA, Stanton SL, Kumar D, Fox SD. Posterior colporrhaphy is superior to the transanal repair for treatment of posterior vaginal wall prolapse. Neurourol Urodynam. 1999;18(4):70–1. 95. Nieminen K, Hiltunen KM, Laitinen J, Oksala J, Heinonen PK. Transanal or vaginal approach to rectocele repair: a prospective, randomized pilot study. Dis Colon Rectum. 2004;47(10):1636–42. 96. Nieminen K, Heinonen PK. Sacrospinous ligament fixation for massive genital prolapse in women aged over 80 years. BJOG. 2001;108(8):817–21. 97. Grimes CL, Schimpf MO, Wieslander CK, Sleemi A, Doyle P, Wu YM, et al. Surgical interventions for posterior compartment prolapse and obstructed defecation symptoms: a systematic review with clinical practice recommendations. Int Urogynecol J. 2019;30(9):1433–54. 98. Guerra F, La Torre F, Pescatori M. Urogynecological prolapse and enterocele are predictive of poor functional outcome after failed or complicated STARR procedures. Tech Coloproctol. 2014;18:765–6. 99. Reibetanz J, Boenicke L, Kim M, Germer CT, Isbert C. Enterocele is not a contraindication to stapled transanal surgery for outlet obstruction: an analysis of 170 patients. Colorectal Dis. 2011;13(6):e131–6. 100. Gagliardi G, Pescatori M, Altomare DF, Binda GA, Bottini C, Dodi G, et al. Results, outcome predictors, and complications after stapled transanal rectal resection for obstructed defecation. Dis Colon Rectum. 2008;51(2):186– 95; discussion 95. 101. Pescatori M, Zbar AP. Reinterventions after complicated or failed STARR procedure. Int J Colorectal Dis. 2009;24(1):87–95.

84

RECTOCELE Anatomic and Functional Repair Olivia H. Chang, James H. Ross, and Marie Fidela R. Paraiso

Introduction A rectocele is an out pocketing of the anterior rectal and the posterior vaginal wall into the lumen of the vagina and is fundamentally a defect of the rectovaginal septum, not of the rectum. The prevalence of rectoceles ranges from 12.9% to 18.6% with an average annual incidence estimated to be 5.7 cases per 100 women years [1, 2]. With an aging population, the rate of prolapse surgery is estimated to increase 47% by 2050 from the 166,000 women who had pelvic organ prolapse surgery in 2010 [3]. Surgical repair of the posterior compartment is performed in approximately half of the surgeries performed for pelvic organ prolapse [4]. This chapter reviews the anatomy, pathophysiology, diagnosis, and management of rectoceles.

Anatomy In 1839, Denonvilliers first described a layer of “fascia” found in males, which he named the “rectovesical septum.” Nichols and Milley later recorded the existence of this septum in surgical dissections and autopsies of fresh female cadavers [5]. This layer of connective tissue is fused to the undersurface of the posterior vaginal wall. The rectovaginal “fascia” extends downward from the posterior aspect of the cervix and the cardinal–uterosacral ligaments to its attachment on the upper margin of the perineal body (PB) and laterally to the fascia over the levator ani muscle. Histologically, the rectovaginal septum shows that the distal portion contains dense connective tissue; the mid-portion contains fibrous tissue, fat, and neurovascular tissue; and the proximal portion is mostly fat cells [6]. When Kleeman et al. performed cadaveric dissections and histologic examinations, they did not find evidence of fascia or a septum between the rectum and vagina [7]. The most commonly used term, and the term used in this chapter is what prior researchers such as Nichols and Milley described as the “rectovaginal septum”. The pararectal fascia, originating from the pelvic sidewalls, divides into fibrous anterior and posterior sheaths, which encompass the rectum. These layers provide additional support to the anterior rectal wall [6]. Further support is provided by the levator ani, which are composed of paired iliococcygeus, puborectalis, and pubococcygeus muscles. These muscles function to maintain a constant level of baseline tone and a closed urogenital hiatus. This constant tone prevents descent of the pelvic viscera on a daily basis and ensures equalization of pressure from the anterior and posterior vaginal walls. Delancey went further in defining the anatomical support of the posterior vagina and rectum with his description of three layers of pelvic support involving endopelvic “fascia” [8]. This “fascia” is, like the rectovaginal fascia above, not a true fascial layer but a connective tissue sheet. The three levels involve the apex of the vagina (Level I), the paravaginal supports (Level II), and 912

the perineal body and associated structures (Level III). Level I support includes the condensed endopelvic fascia that forms the uterosacral and cardinal ligaments. This endopelvic fascia runs distally to the midvagina and out laterally to the Level II support of the posterior pelvis, attaching from the posterolateral vaginal wall out toward the arcus tendinous fascia rectovaginalis. Most distally the endopelvic fascia creates Level III support as a dense connection to the perineal body (PB), providing staunch support to resist downward force.

Etiology Rectoceles were once thought to be a condition affecting only multiparous females. However, available data show that rectoceles are prevalent amongst both parous and nulliparous women, although childbirth is associated with the increase in prevalence and size of rectoceles [9]. Even in healthy, young, nulliparous, asymptomatic women, 81% (17/21) of women had small or moderate-sized rectoceles on defecography [10]. Some rectoceles may be asymptomatic, whereas others may cause symptoms such as incomplete bowel emptying, a sensation of the vaginal bulge, pain, and pressure. The size of the defect does not necessarily correlate with the amount of functional derangement or severity of bowel symptomatology [11, 12]. Risk factors for the development of rectoceles include obstetrical events, functional defecatory dysfunction, genetic predisposition, and conditions associated with a chronic increase in intra-abdominal pressure, such as obesity, chronic constipation, and pulmonary disease [13, 14]. Traumatic obstetrical events may damage levator ani muscles and result in an enlarged genital hiatus. With an enlarged genital hiatus, pressure within the rectum is not countered against the equalization of pressure from the anterior vaginal wall, and the stress onto the posterior vaginal wall may create a rectocele. Perineal lacerations may also disrupt the attachments of the levator ani fascia and bulbocavernosus muscles causing a distal detachment. With regard to defecatory dysfunction, it is difficult to determine whether rectoceles are the cause or the result of chronic obstructive defecation. Chronic straining may lead to the weakening of the rectovaginal septum by continuous straining against the posterior vaginal wall [15]. Along with other conditions, increases in intra-abdominal pressure (obesity and pulmonary disease) push against the posterior vaginal wall resulting in rectoceles.

Clinical presentation Patient symptoms

The symptoms associated with a rectocele are summarized in Table 84.1. Clinical symptoms vary from being nonexistent to severe defecatory dysfunction. Secondary analyses of the two

DOI: 10.1201/9781003144243-92

Rectocele: Anatomic and Functional Repair

913

Diagnostic studies

TABLE 84.1: Symptoms Associated with a Rectocele • • • • • •

Pelvic pressure Vaginal bulge Constipation Straining to have a bowel movement Sensation of stool trapping in the rectum Incomplete stool evacuation

largest randomized controlled trials on rectocele, or posterior repairs (PR) showed that common preoperative bowel symptoms included straining (51–74%), incomplete evacuation (66– 74%), and splinting (51–56%) [12, 16–20]. Vaginal digitation is when pressure is applied to the rectocele vaginally or along the perineal body to facilitate defecation. It is also important to note that many women with rectoceles do not have to splint with defecation, and women without rectoceles may require splinting [11]. Several studies have shown an association between defecatory symptoms and physical exam findings. Based on a crosssectional study of 721 women, in those who splint to have bowel movements, the odds of having posterior compartment prolapse was 1.63 for POP-Q Bp≥ Stage 2, or 2.04 for POP-Q Bp≥0 [21]. Another study also demonstrated that posterior compartment prolapse is associated with obstructive defecation symptoms [22]. As a result, understanding the patient's symptoms is valuable to discern the degree of bother and to predict the extent of posterior compartment prolapse.

Physical examination

A rectocele is detected by observing a bulge in the posterior vaginal wall during maximum Valsalva or cough. The patient may be in the dorsal lithotomy position (for the gynecologist) or in the left lateral decubitus position (for the colorectal surgeon). The use of the posterior blade of a speculum will support the apex and the anterior compartment and can aid in visualization. An exam may also be performed with the patient standing in cases where an exam in dorsal lithotomy does not recreate the amount of prolapse reported by the patient. Rectoceles are asymptomatic in up to 80% of affected women and can only be diagnosed on physical examination [23, 24]. A rectal examination should be performed to evaluate anal sphincter tone and symmetry along with the integrity of the PB. A rectovaginal exam can assist in detecting an enterocele or sigmoidocele with bowel contents entering between the vagina and rectum. This finding can be augmented in the standing position. Finally, it is important to evaluate for rectal prolapse or intussusception. The current standardized system used for prolapse assessment is termed the pelvic organ prolapse quantification (POPQ) system and was described by Bump et al. [25]. In the POPQ system, the posterior segment includes points Ap and Bp. Point Ap corresponds to a point 3 cm proximal to the hymen in the midline of the posterior segment. Possible values range from −3 to +3 cm from the hymenal ring. Point Bp represents the most distal portion of the posterior vaginal wall. The minimum value is -3 in the absence of any posterior wall prolapse. In the presence of complete vaginal eversion, the maximum value equals the value of C. The genital hiatus (GH) is measured from the midurethra to the posterior midline hymen. The PB is measured from the posterior margin of the genital hiatus to the midanal opening.

Imaging studies

Clinical examination has excellent sensitivity for the identification of a rectocele, making the routine use of imaging studies unnecessary for the patient with an isolated rectocele. However, the use of imaging studies does become useful when combined with other ancillary data, especially for the following situations: 1. Symptomatology and physical findings do not correlate. 2. The pelvic anatomy is unusual or altered due to previous pelvic surgery or a congenital defect. 3. The patient is unable to exert maximal straining during pelvic examination. 4. Concern for rectal intussusception or rectal prolapse which may require concurrent colorectal surgery. Imaging may also be useful to highlight the presence of an enterocele, as these may appear similar to a high rectocele on physical exam. Defecography will detect many enteroceles and sigmoidoceles not seen on pelvic examination due to poor straining effort during POPQ exam [26]. Studies have shown that enteroceles are only identified approximately 50% of the time on physical examination, which is far less than the rates of identifying rectoceles and cystoceles [27, 28]. While helpful, imaging results should not be used alone to make treatment decisions as studies have noted that radiographic findings of posterior compartment defects do not necessarily correlate with patient symptomatology [29, 30]. Currently, universally accepted radiologic criteria for defining pelvic organ prolapse are lacking [27]. To identify a rectocele on imaging, a measurement is made from a reference line to a predefined point. Multiple reference lines have been described in the literature, i.e., midpelvic line, pubococcygeal line, or midperineal line [31, 32], leading to the difficulty in interpreting and comparing radiographic results.

Defecography

The use of contrast media in pelvic fluoroscopy allows the various prolapsed organs to be opacified and seen in real time providing a two-dimensional view of rectal emptying. The addition of vaginal contrast can highlight the vaginal axis to demonstrate vaginal length and the presence and degree of multicompartment prolapse. Images are taken at rest, during straining efforts, and during and after evacuation. A rectocele is seen radiographically as an anterior rectal bulge that is usually measured as the distance from the anterior border of the anal canal to the maximal point of the bulge of the anterior rectum into the posterior vagina wall. Many asymptomatic women will have a small rectocele 2 cm or less in depth while 2–4 cm is considered a moderate rectocele and anything greater than 4 cm would be large [10, 33, 34]. Wallace et al. retrospectively reviewed 200 patients who had the diagnosis of a rectocele and underwent defecography. They found a positive correlation between rectocele size on defecography and rectocele stage on exam and like the previously mentioned study, all bowel symptoms with the exception of splinting were not associated with rectocele size on defecography or exam [35]. Defecography will also note the finding of post-evacuation barium trapping, which may help to explain any evacuation dysfunction [36]. Defecography may suggest the diagnosis of pelvic floor dyssynergia, which may be the main contributor to a patient's

914 bowel dysfunction rather than a rectocele [37]. This has important implications because pelvic floor dyssynergia is treated with biofeedback therapy rather than with surgery. An enterocele is noted as a herniation of the small bowel into the vagina, rectovaginal space, or both. If oral contrast is given 30 minutes prior to defecography, the small bowel can be easily visualized to facilitate this diagnosis. Defecography will also detect rectal intussusception, which is difficult to diagnose on digital rectal exam. Intussusception is an occult form of rectal prolapse where the rectal wall telescopes on itself without protruding through the anal canal.

Magnetic resonance imaging

MRI was first introduced as a diagnostic modality for pelvic organ prolapse by Yang et al. [38]. It has many advantages over dynamic defecography. It contrasts soft tissue structures well and thus can assess pelvic floor musculature, and examine subtle pelvic floor changes such as superior rectovaginal, paravaginal, and uterine defects. It also does not expose the patient to ionizing radiation. Another advantage is that the cervix and vaginal vault are often easier to see on MRI imaging than on fluoroscopy. The main limitation of MRI is that it is performed in the supine position which is not reflective of the usual position for bowel evacuation. It also has increased costs compared to fluoroscopy.

Ultrasonography

Transperineal or translabial ultrasound has been described in the assessment of dynamic function of the pelvic floor [39]. Dietz and Lekskulchai performed translabial ultrasound to define cutoff points for prolapse on the basis of the patient's symptoms. They concluded that descent of the rectum >15 mm below the symphysis pubis was associated with symptoms [40]. One study demonstrated moderate agreement between a digital rectal exam for rectocele and translabial ultrasound findings of a rectocele [41]. Dietz et al further expanded on their work with translabial ultrasound and found that the appearance of a true rectocele on ultrasound was not significantly correlated with subjective complaints of prolapse [42]. Unlike the prior study, Tan et al. were able to find a significant relationship between a true rectocele and complaints relating to obstructive defecation [43]. The use of endoanal ultrasound may be indicated in patients with decreased anal sphincter tone to evaluate the integrity of the anal sphincter complex, which, if damaged, may lead to consideration of a sphincteroplasty.

Anal manometry

Anal manometry measures rectal pressures by a transducer and/ or balloon. Its measurement of rectal sensation evaluates the first sensation, urge, and discomfort which is used to distinguish causes of constipation. The impaired rectal sensation is when an individual is able to tolerate increased volumes without signs of increased discomfort or the urge to defecate. Some patients with anal incontinence have impaired rectal sensation [44]. In addition, patients are asked to expel the rectal balloon to see if the pelvic floor muscles and anal sphincter muscles are coordinated to allow for normal rectal evacuation. Patients with pelvic floor dyssynergia may not be able to evacuate the balloon.

Electromyography and nerve conduction studies

EMG and nerve conduction studies also have been used to evaluate defecation disorders. EMG is useful for the evaluation of denervation and to evaluate pelvic floor muscle coordination. EMG activity is measured at rest, with squeeze, and with

Textbook of Female Urology and Urogynecology straining. Obstetrical trauma denervates and causes atrophy of the pelvic floor muscles, which may lead to subsequent pelvic floor weakness. Patients with pelvic floor muscles dyssynergia may produce counter-productive movement, which can be observed as increased EMG activity with pushing, when there should be a decrease in EMG activity.

Non-surgical management Treatment should only be undertaken if the patient is symptomatic. Once the clinical diagnosis has been made and (if necessary) confirmed by ancillary studies, the decision to operate or to treat conservatively may be made. Non-surgical treatments may include expectant management, bowel regimen, pelvic floor physical therapy, and/or the use of a pessary. These steps are the most important when the primary complaint is constipation. Nonsurgical therapies available for posterior prolapse symptoms include expectant management and/or the use of a vaginal pessary. In a study of 100 patients with symptomatic pelvic organ prolapse, patients successfully fitted with a pessary noted significant decreases in the vaginal bulge, pelvic pressure, and the need to splint with defecation (14% down to 0%) [45]. For patients diagnosed with dyssynergic defecation, the use of pelvic physical therapy and/or biofeedback is the mainstay therapy [46, 47].

Surgical management Symptoms that respond well to surgery include pelvic pressure, vaginal bulge, vaginal digitation or splinting (which occurs in 20–75% of symptomatic patients), and outlet obstruction constipation. Gustilo-Ashby et al. analyzed bowel function 1 year after surgery in a randomized trial of three techniques of rectocele repair. They concluded that posterior vaginal wall repair was specifically associated with a reduction in symptoms of incomplete emptying and straining [18]. Janssen and van Dijke noted that repair increased rectal sensitivity, causing the urge to defecate earlier as a positive predictor of a good outcome [48]. In the colorectal literature, it has been noted that defecography showing a rectocele >2 cm with symptoms is also a good indicator for surgery; however, this finding has not been conclusive in all studies [49]. All patients who undergo a surgical repair should be appropriately counseled that some bowel dysfunction may persist following surgical repair, especially if a motility disorder is present. Traditionally, vaginal and transrectal approaches have been used by gynecologists and colorectal surgeons, respectively, as a result of training and familiarity with each technique. The transrectal approach is often used if perianal/rectal pathology such as hemorrhoids, anterior rectal wall prolapse, or rectal mucosal redundancy is surgically treated concurrently with the rectocele. However, transanal posterior colporrhaphies are not commonly performed at the moment particularly with data suggesting that a transvaginal repair is more effective for posterior wall prolapse [50]. As a result, the following section will be dedicated to discussing techniques for transvaginal approaches to posterior colporrhaphies and minimally-invasive sacrocolpoperineopexy with or without ventral rectopexy. When performing transvaginal repair of the posterior compartment, two main methods exist traditional posterior colporrhaphy and site-specific repair. Graft materials have been employed in both the traditional posterior colporrhaphy and the site-specific technique in an attempt to strengthen the repair. Graft materials include xenografts, allografts, and

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permanent synthetic material. Some authors advocate the use of mesh or graft in recurrent rectoceles in patients with deficient rectovaginal septum and weak tissue, in the presence of advanced prolapse, vaginal stricture, or with the coexistence of risk factors such as obesity and/or chronic constipation [51]. Currently, we no longer use synthetic mesh for any posterior compartment repair but will consider biological grafts for carefully selected patients. An abdominal approach via a sacrocolpoperineopexy may be utilized for the correction of a rectocele when accompanied by multicompartment prolapse, rectal intussusception, or rectal prolapse. This is most commonly performed with minimally invasive techniques.

Traditional posterior colporrhaphy with midline plication

The traditional rectocele approach has been described and illustrated by Nichols, Wheeless, and others. It is a procedure that involved plicating the rectovaginal septum in the midline. Before starting any rectocele repair, the surgeon should approximate the introitus by using Allis clamps bilaterally to help determine the amount of, if any, perineal and vaginal tissue that should be excised to correct an enlarged introitus. As this has the potential to narrow the introital caliber, it is important to keep in mind patients’ goals in terms of their desire for sexual activity. Next, Allis clamps are placed on the posterior perineum and proximal over the rectocele in the posterior vagina. The tissue is then infiltrated with an injection of lidocaine with dilute epinephrine or vasopressin below the vaginal epithelium which aids with hydrodissection and hemostasis. An inverted triangle or diamond-shaped perineal incision is made with the overlying epithelium excised. However, if the introitus is already narrow, a vertical perineal incision may be performed to maintain adequate vaginal caliber. The length and width of the perineal incision are dependent on the epithelium needed for restoration of the PB. Sharp dissection is usually required over the PB because of the previous scarring from obstetric perineal lacerations, and caution should be taken during the dissection of the PB to avoid a proctotomy. Mayo or Metzenbaum scissors are used to dissect a plane in the rectovaginal space bilaterally. The posterior vaginal epithelium is dissected away from the underlying fibromuscularis (see Figs. 84.1 and 84.2). This is continued laterally to the tendinous arch of the levator ani and extends inferiorly to the PB as seen in Figure 84.3. The surgeon performs blunt and sharp dissection to a level proximal to the bulge, which may correspond with the vaginal apex as seen in Figure 84.4. If an enterocele is encountered, it can first be repaired in a purse-string fashion with a 2-0 delayed absorbable suture. The rectocele is then depressed in the midline with the surgeon's finger to reveal the margin of the puborectalis portion of the levator ani muscle. With the rectocele still depressed, a No. 2-0 delayed absorbable suture is used to plicate the fibromuscularis in an interrupted fashion. Alternatively, with a finger in the rectum, plication sutures can be placed in the midline with tactile feedback on the width of the rectocele defect and the integrity of the plication. This plication is done in an interrupted, or a running fashion from the proximal vagina to the perineal body (Figs. 84.5 and 84.6). These sutures should be placed in close proximity to each other to repair any noticeable defects. The surgeon should intermittently evaluate the repair both vaginally and rectally to ensure minimal ridging or narrowing of the vagina. Once at the most distal aspect of the rectocele, the last suture should include the perineal body in order to reattach it to the rectovaginal septum.

FIGURE 84.1  Initial view following excision of posterior vaginal epithelium. Perineorrhaphy is routinely performed along with a rectocele repair. A diamond or triangular incision is made at the level of the posterior hymen extending to the midline of the perineal skin, and the vaginal epithelium is dissected off the underlying musculofascial complex. This part is already completed if a posterior colporrhaphy is done first. The bulbocavernosus muscles are then plicated in the midline using No. 0 absorbable suture in an interrupted fashion followed by the plication of the transverse perineii muscles. It is important to reattach the perineal body to the rectovaginal septum in order to correct a perineocele. At the completion of this, the

FIGURE 84.2  Dissection of the fibromuscularis layer from the lateral posterior vaginal epithelium.

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FIGURE 84.3  Lateral dissection to the level of the levator ani tendon.

Textbook of Female Urology and Urogynecology

FIGURE 84.5  Traditional colporrhaphy with tissue plication in the midline.

vaginal and perineal incisions are closed with 2-0 absorbable suture in a running and subcuticular fashion, respectively. In women who have an enlarged hiatus, it may be appropriate to place another set of interrupted sutures horizontally to provide a muscular posterior shelf and narrowing of the levator hiatus.

Site-specific rectocele repair

According to Richardson, rectoceles are caused by a variety of breaks in the rectovaginal septum [5]. He described the most

FIGURE 84.4  Apical dissection to a level beyond the identified defect.

FIGURE 84.6  Traditional colporrhaphy with tissue plication in the midline. (Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography © 2021; all rights reserved.)

Rectocele: Anatomic and Functional Repair

FIGURE 84.7  Site-specific defects along the rectovaginal septum. (Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography © 2021; all rights reserved.)

common break as being a transverse separation above the attachment to the PB, resulting in a low rectocele. Figure 84.7 shows the common sites of defects. Richardson recommended performing the repair with a finger in the rectum, so that defects could be easily identified and the septum can be appropriately approximated with interrupted sutures. To begin a site-specific rectocele repair, the dissection of the vaginal epithelium from the fibromuscularis of the rectovaginal space is performed in a similar fashion to the traditional colporrhaphy. The rectovaginal septum is inspected by the surgeon by inserting a finger of the nondominant hand into the rectum (Fig. 84.8). The rectal wall is brought forward, distinguishing the uncovered muscularis (fascial defect) from the muscularis covered by the smooth semitransparent rectovaginal septum. According to the plane of dissection and the location of the defect, frequently the rectovaginal septum must be mobilized off the lateral vaginal epithelium. Defects are individually isolated and repaired with an absorbable No. 2-0 suture. Figure 84.9 is highlighting a transverse defect followed by Figure 84.10 with surgical approximation. A perineorrhaphy is performed, if indicated, followed by closure of the vaginal epithelium with a running No. 2-0 absorbable suture. One option of note is that some surgeons will perform bilateral ileococcygeus fascia suspension to correct high apical rectoceles. No. 0 delayed absorbable sutures are used to attach the highest portion of the rectovaginal septum to the ileococcygeus fascia.

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FIGURE 84.8  Defects along the rectovaginal septum can be appreciated with a rectal exam. (Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography © 2021; all rights reserved.)

Graft-augmented posterior repair

If using a biological graft, the graft is first prepared by perforating the graft with a hypodermic needle (unless it is already perforated). We utilize this technique as we believe that it assists with graft uptake. Afterward, the graft is then soaked in an antibiotic

FIGURE 84.9  Transverse rectocele defect grasped between the Allis clamps.

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Textbook of Female Urology and Urogynecology rectum. This same piece of mesh is then secured to the posterior vaginal cuff/cervix. The rest of the sacrocolpopexy procedure is as described above. Alternatively, a biologic mesh may be used for the rectopexy though in this instance we would then typically use a piece of Y-mesh to attach to the anterior and posterior vagina. Both the biological mesh and the Y-mesh would then be secured to the sacrum, followed by closure of the peritoneum.

Results and complications Traditional posterior colporrhaphy with midline plication

FIGURE 84.10  Site-specific surgical correction of defect. solution. Following the dissection of the vaginal epithelium off of the posterior vaginal muscularis, either a traditional colporrhaphy or a site-specific repair is performed. The graft is then oriented to match the rectocele defect, typically in a diamond shape. The graft is then secured to the apex with a delayed-absorbable suture first, followed by attachment to the vaginal muscularis, levator ani muscles bilaterally and perineal body distally with a series of interrupted sutures. The vaginal epithelium is then closed over the graft. If there is anticipated tension with closure of the vaginal epithelium, the biologic graft can serve as a bridge for the epithelial defect [51].

Abdominal sacrocolpopexy (colpoperineopexy) with or without concurrent ventral rectopexy

For a colpoperineopexy, the right ureter is identified prior to opening the pelvic peritoneum. The peritoneum is opened in a vertical fashion from the sacral promontory to the pelvic culde-sac along the lateral border of the colon and medial to the right ureter. Next, sharp and blunt dissection is used to expose the anterior longitudinal ligament of the sacrum being mindful of the surrounding vasculature. With the aid of an end-to-end anastomosis (EEA) sizers placed in the vagina and the rectum, the rectovaginal space is identified and entered sharply. This avascular plane is then dissected down to the level of the PB and bilateral pubococcygeus muscles for correction of a distal rectocele and perineal descent (colpoperineopexy) if indicated. Following this, dissection of the bladder off the anterior vaginal wall is performed to the level of the bladder neck. The mesh is then attached to the PB and posterior and anterior vaginal wall with a series of interrupted No. 2-0 delayed absorbable sutures. Finally, the mesh is affixed to the anterior longitudinal ligament with permanent suture taking care not to place the mesh on excess tension and avoiding the middle sacral vessels. The mesh is then trimmed and the peritoneum is closed over the mesh. If there is concomitant rectal prolapse or intussusception, a combined case with a colorectal surgeon can be performed to repair the posterior compartment defect with a ventral rectopexy. Synthetic mesh is introduced and sutured to bilateral levator muscles using No. 2-0 permanent suture. Then, proceeding distal to proximal on the anterior rectum, ten to twelve No. 2-0 delayed-absorbable sutures are used to secure the mesh to the

Anatomical cure rates after posterior colporrhaphy with or without levator plication range from 76% to 96% after a mean follow-up period of 12–64 months [52–60]. Results are shown in Table 84.2. One study revealed a decrease in defecatory dysfunction from 100% preoperatively to 12% postoperatively in 25 patients who were prospectively followed and evaluated pre- and postoperatively with standardized questionnaires, defecography, colon transit studies, anorectal manometry, and electrophysiology. This study also showed improvement in symptoms of the vaginal bulge from 21% preoperatively to 4% postoperatively [52]. Maher et al. reported an anatomical cure rate of 87% and 79% at 12 and 24 months, respectively. Additionally, a prospective study of 60 women who underwent posterior colporrhaphy with or without perineorrhaphy reported significant improvement of subjective bowel symptoms within 3–6 months postoperatively. Bowel evacuation scores improved by 42% and continence by 37% based on a validated questionnaire given pre- and postoperatively [61]. Some patients had persistent defecatory dysfunction. The study by Kahn and Stanton showed an increase in rates of incomplete bowel emptying and fecal incontinence (4% preoperatively vs. 11% postoperatively) after posterior colporrhaphy [53]. It is possible that some patients may have functional dyssynergic defecation which led to persistent defecatory symptoms. Overall, all bowel function parameters showed improvement with overall patient satisfaction of 97% [57].

Site-specific rectocele repair

The surgical outcomes after a defect-specific rectocele repair are summarized in Table 84.3 [55, 58, 62–68]. Anatomical cure rates range from 56% to 100% after a mean follow-up period of 3–18 months. Improvements in constipation were seen in 43–84% of patients [64, 69, 70] with a de novo constipation rate of 3–4%. Improvement in the symptoms of manual evacuation was noted in 36–63% [64, 69, 70] with a de novo rate of 7% in one study [70]. Abramov et al. compared outcomes of site-specific repair to posterior colporrhaphy. This study showed a higher anatomical recurrence rate in the site-specific repair group with similar rates of dyspareunia and bowel symptoms [55]. One prospective randomized trial by Paraiso et al. compared three surgical techniques of rectocele repair: traditional colporrhaphy, site-specific repair, and site-specific rectocele repair augmented with a porcine-derived graft in 106 patients [58]. The results included both anatomic results and subjective conditionspecific validated quality of life questionnaires. Anatomical cure of prolapse ≤ Stage II at 1 year was comparable between the traditional colporrhaphy and the site-specific groups (86% vs. 78%), and significantly higher than the site-specific graft-augmented cure rate of 54%. Recurrence of the prolapse to or beyond the level of the hymen developed in 20% of those who underwent a

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TABLE 84.2: Posterior Colporrhaphy

Study Mellgren Preoperative Postoperative Kahna Preoperative Postoperative Weber Preoperative Postoperative Sand Preoperative Postoperative Mäher Preoperative Postoperative Abramova Preoperative Postoperative Paraiso Preoperative Postoperative Grimes Preoperative Postoperative Gillora Preoperative Postoperative a

n

Mean Follow-up (Months)

Anatomic Cure (%)

Defecatory Dysfunction (%)

Vaginal Bulge (%)

Vaginal Digitation (%)

Fecal Incontinence (%)

Dyspareunia (%)

De Novo Dyspareunia n (%)

25 25

12

96

100 12

21 4

50 0

8 8

2(8)

231 171

42

76

22 33

64 31

4 11

27(16)

33

53 53

12

70 70

12

90

38 38

12.5

89

183 183

12

82

37 33

12

86

43 42

12

10

78

64

23

33

39 39

14 (26)

100 13

100 5

80 32

100 16

43

3 0

37 5

1(4)

17 18

8 17

18(11)

56

Retrospective, all other studies prospective.

graft-augmented approach, compared to 7.1% in the traditional colporrhaphy group and 7.4% in the site-specific repair group. There was no significant difference between the groups in regard to preoperative or postoperative dyspareunia, but improvement in sexual function was noted after rectocele repair, regardless of the technique used.

Graft-augmented rectocele repair

The ideal mesh or graft material used to augment repairs of pelvic fascial defects should improve recurrence rates, should not be rejected, and should cause no detriment to sexual and bowel function. The results of graft augmentation are summarized in Table 84.4 [56, 58, 67, 71–73]. In a prospective controlled trial, Sand et al. randomly assigned 160 patients to undergo anterior and posterior colporrhaphy with (80 patients) or without (80 patients) polyglactin 910 mesh reinforcement. In the treatment group, a strip of mesh was incorporated into the imbricating rectovaginal septum during the midline plication. Thirteen recurrent rectoceles were noted at 1-year follow-up, with no differences observed between the two groups (10% vs. 8%) [74]. Another randomized trial by Sung et al. evaluated the use of a porcine subintestinal submucosal graft as an augmentation for rectocele repair compared to native tissue repair alone. A total of 80 patients were allocated to each group with results reported

at 12 months. In the non-graft group, 8.6% (6/70) compared to the graft group 12% (8/67) experienced an anatomic failure that was defined as points Ap or Bp at −1 or greater. Subjectively, there were no statistically significant differences between the groups for vaginal bulge symptoms or defecatory dysfunction. The authors concluded that augmentation with porcine submucosal graft was not superior to native tissue repair at 12 months [72]. To date, the largest study comparing mesh, graft, or standard posterior repair is the PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials (PROSPECT) [67]. This was a two pragmatic, parallel-group randomized controlled trial in women undergoing transvaginal prolapse repair of the anterior and posterior compartment across 35 centers. Women were randomly assigned to native tissue repair, or native tissue repair with either synthetic or biological graft augmentation. A total of 300 patients who had a biological graft were followed up 2 years after surgery with 82% of patients reporting symptomatic prolapse compared to 81% in the native-tissue alone arm. There were no significant differences in anatomical outcomes between the two groups with 16% of patients in the native tissue arm having Stage 2 or greater prolapse recurrence on POP-Q exam, compared to 18% of patients in the biological graft arm (p = 0.47). When compared to synthetic mesh, the anatomic recurrence rate was 16% compared to 14% in the standard arm (p = 0.52). The authors

Textbook of Female Urology and Urogynecology

920 TABLE 84.3: Site-Specific Repair Defecatory Dysfunction (%)

Vaginal Bulge (%)

Vaginal Digitation (%)

Fecal Incontinence (%)

Dyspareunia (%)

82

71 39

100 28

39 25

13 8

29 19

1(2)

12

90

41 57

86 9

30 15

30

28 8

3(7)

125 72

6

82

60 50

38 14

24 21

24 21

67 46

3(4)

124 124

12

56

33 37

11

15 19

8 16

12(11)

42 33

18

92

57 27

78 7

9 5

31 38

67 67

3

100

40 4

37 29

12

78

85 35

140 138

16

Study Cundiff Preoperative Postoperative Kenton Preoperative Postoperative Porter Preoperative Postoperative Abramov Preoperative Postoperative Singha Preoperative Postoperative Glavinda Preoperative Postoperative Paraisoa Preoperative Postoperative Guzman Rojas Preoperative Postoperative a

Mean Follow-up (Months)

Anatomic Cure (%)

69 61

12

66 46

n

86

70 34

12 6 58 21

De Novo Dyspareunia in Sexually Active Patients, n (%)

2(3)

48 28

82 25

18 15

12(9)

Prospective, all other studies retrospective.

TABLE 84.4: Graft-Augmented Rectocele Repair Mean Follow-up (months)

Anatomic Cure (%) 92

Study

n

de Tayrac Preoperative Postoperative Sanda

26 25

13

73 65

12

92

Polyglactin

31 29

12

54

Acellular porcine dermis (Fortagen)

79 67

12

88

Porcine subintestinal submucosal graft

32

60

63

368 300

24

52

Preoperative Postoperative Paraisoa Preoperative Postoperative Sunga Preoperative Postoperative Winkelman Preoperative Postoperative Glazenerb Preoperative Postoperative a b

Graft Type Cadaveric dermis

Defecatory Dysfunction (%)

Vaginal Bulge (%)

19 16

Prospective, all other studies retrospective. Study included placement of the biologic graft in the anterior or posterior compartment.

De Novo Dyspareunia in Sexually Active Patients, n (%)

1(7)

97 21

51 7

11.9

Not-specified Porcine acellular collagen matrix, porcine small intestinal submucosa, bovine dermal grafts

Vaginal Digitation (%)

82

50 28

7(12.5)

Rectocele: Anatomic and Functional Repair concluded that there was no benefit to the use of either synthetic or biologic graft augmentation for posterior compartment prolapse repair. When the findings of these three randomized controlled trials were pooled, there was insufficient evidence to show a difference between rates of prolapse awareness (RR 1.09, 95% CI 0.45–2.62) when comparing the use of biological graft compared to native tissue repair alone [50]. Postoperative complications were more common with biological graft repair (RR 1.82, 95% CI 1.22–2.82). Postoperative dyspareunia was higher in those who had biological graft placement but this difference was not statistically significant (RR 1.26, 95% CI 0.59–2.68) [75]. In the PROSPECT, of the patients who had a biologic graft implanted at the time of anterior and/or posterior repair and followed-up at 1 year, 1/3 of TVL or anterior or posterior vaginal walls beyond the hymen, re-treatment of prolapse, or bothersome vaginal bulge symptoms on several questionnaires. They also investigated secondary outcomes such as operative time, duration of hospitalization, blood loss, and perioperative complications. With a mean duration of 7 months follow-up in 80 patients (36 in the intraperitoneal USL vs. 44 in the extraperitoneal USL group), there were no differences in the surgical success (72% vs. 81%, P = 0.307); however, the operative time, hospitalization, and blood loss were lower in the extraperitoneal group. The authors concluded that the extraperitoneal technique for PHVP repair had a similar short-term success rate to the intraperitoneal approach.

Sacrospinous fixation for PHVP

SSLS was first described in the literature in 1958 by Sederl. This transvaginal technique involves suspending the sacrospinous ligament to the vaginal apex extraperitoneally using either a dissolvable

931 or permanent suture. The suspension is performed either unilaterally or bilaterally. In an RCT (n = 95) in 2004, comparing SSLS to ASC at a two-year follow-up, there was no difference in anatomical success (91 vs. 94%) or improvement in QOL, but the SSLS group had a 19% reoperation rate (49). A meta-analysis of 17 RCTs and observational studies reported that SSLS failed to relieve patients’ symptoms in 10.3%, and 13% of patients were dissatisfied with their results (50). The complications associated with SSLS include bleeding, nerve or rectal injury, buttock pain, vaginal stricture, SUI, and possible reoperation due to recurrence. In a review of 1229 patients who had SSLS performed, 2% (n = 27) required transfusion, and 3% (n = 32) experienced buttocks pain which resolved by six weeks without treatment (51). The anterior and posterior sacrospinous suspensions can be performed unilaterally or bilaterally. The right-sided unilateral suspension is most commonly performed due to ergonomic considerations for a right-hand-dominant surgeon. Performing the procedure on the patient’s right side also avoids the risk of trauma to the sigmoid colon. The bilateral suspension has been emphasized in older reports. Pohl and Frattarelli reported no recurrent apical prolapse among 40 women treated with bilateral sacrospinous ligament suspension after 6–40 months of follow-up (52). Cespedes reported success after bilateral SSF by the anterior vaginal approach. At 17 months, no recurrent vault prolapse was seen in 27 of 28 women with grade 3 or 4 prolapses (53). However, there is little evidence to suggest that the more extensive dissection involved in a bilateral suspension improves outcomes compared with the unilateral approach. Because of this, the unilateral technique is used more frequently in post-hysterectomy vault prolapse.

Iliococcygeus vault suspension for PHVP

Inmon described the original technique in 1963 (54) and illustrated the point of pelvic sidewall attachment. “To avoid an abdominal approach in the absence of uterosacral ligaments, the lateral angles of the vagina may be attached to the fascia overlying the iliococcygei. A chromic one suture begins in the left lateral angle of the vaginal cuff, enters the iliococcygeus below the ischial spine and is brought back through the cuff and tied. In like manner, the right lateral angle of the vaginal cuff is attached to the right iliococcygeus.” Modifications to this procedure since 1963 have only been minor, and good results are reported (55–57). In women with post-hysterectomy vaginal eversion, a midline vertical incision is made the length of the prolapsed vagina. If the anterior vaginal wall is well supported, a smaller incision is made over the prolapsed posterior wall and vault. Little or no vaginal epithelium needs to be excised as the upper vagina is fixed bilaterally to maintain good vaginal length and caliber. The ischial spines can be approached through either an anterior or posterior vaginal wall incision. The rectum and any enterocele sac or bladder are dissected free from the vagina. This dissection is carried laterally to the pelvic sidewall to the ischial spine on both sides. The prominent ischial spines are easily palpated, and the coccygeal and sacrospinous ligament complex can be identified running posteromedially from the spines with the iliococcygeal fascia covering the muscle anteriorly. Any midline pubocervical or rectovaginal fascial defect should be repaired. If an enterocele sac is identified, it is opened. The peritoneum is closed with a high purse-string suture of 2/0 PDS, sutured to any remnant of the uterosacral or CLs. These sutures are left long to complete the vaginal vault suspension and to provide further apical support. A 1 PDS (Ethicon) is then placed into the iliococcygeus fascia anterior to the ischial spine

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932 using an automated suturing device (Fig. 85.4). The suture placement is determined by palpation with adequate suture anchorage confirmed by traction. The 1 PDS is retrieved and then passed through the entire thickness of the lateral vaginal wall at the upper and middle third junction. This is then repeated on the contralateral side. The position for suture placement can also be marked preoperatively by resting the vagina against the ischial spine. The suspension sutures are tied over the vaginal epithelium once the anterior colpoperineorrhaphy and posterior colpoperineorrhaphy have been completed and the epithelium is closed. If non-absorbable suture material is used, the suture should be passed subepithelial to avoid vaginal exposure and suture granuloma. The vaginal approach using apical support to the uterosacral complex, sacrospinous ligament, or the iliococcygeus fascia allows vaginal repair of all “fascial” defects and securing the vaginal vault without jeopardizing vaginal length or sexual function. Few studies have compared the iliococcygeal and the SSF procedures of the vaginal vault. SSF is usually unilateral as a bilateral attachment, although possible, makes close apposition of the vagina to ligament difficult. Iliococcygeal fixation sutures are bilateral and anterior to the unilaterally placed sacrospinous sutures that create a more anatomically correct vaginal axis than the SSF, which pulls the vagina wall posteriorly and to one side. Iliococcygeal suspension may also be used with a sacrospinous suspension when one side of the vagina is shorter than the other and unable to reach the sacrospinous ligament on the short side. Maher et al. (57) evaluated 128 women who had surgery for symptomatic vaginal vault prolapse in our department. Patients were matched for eight or more clinical criteria. Sacrospinous and iliococcygeal fixation were equally effective for vaginal vault prolapse with a similar rate of recurrent prolapse and complications. Anterior vaginal wall prolapse is the most challenging area to provide long-term support in women with vaginal eversion. The incidence of gluteal pain following iliococcygeal fixation was 19%, similar to the sacrospinous group (14%). This resolved spontaneously in all cases by 2–3 months.

Obliterative procedures Total colpocleisis and the Le Fort partial colpocleisis are procedures that involve closing the vagina to reduce the prolapse or prevent uterine or vaginal prolapse recurrence (3). Colpocleisis can be performed in post-hysterectomy women or with a concomitant VH or uterine conservation (Le Fort). The procedure is completed by creating flaps of the vaginal epithelium and closing the vagina by approximating these flaps with a series of sutures to invert the prolapse. A routine anterior and posterior repair may be done to reinforce the repair, followed by a high perineorrhaphy. In both procedures, the edges of the vagina are closed together to create channels to allow vaginal/cervical discharge drainage. These procedures should be reserved for older patients who are no longer desirous of sexual function as they completely obliterate the vagina. Patients have reported significant improvement in QOL with obliterative procedures. In 2013, a large, single-center retrospective study (n = 325) evaluated Le Fort colpocleisis (58). They reported anatomical success at 98.1%, with patient-reported satisfaction of “greatly improved” or “cured” in 92.9%, with a mean follow-up of 45 (2–392) weeks. The complication rate was 15.2%, including UTI, pulmonary embolism, anemia, hematoma formation, delirium, cardiovascular events, and mortality. The mean age of the cohort was 81.3 years, with 74.1% of patients having a least one underlying medical condition. This has been one

of the largest reports on the Le Fort procedure to date, demonstrating the high efficacy of this procedure. The operation can be performed under local anesthesia when necessary. In a review by the FIGO working group “Pelvic Floor Medicine and Reconstructive Surgery,” they concluded after reviewing the evidence that among the vaginal operative procedures, the SSLF and the USLS show comparable outcomes and efficacy with a different but relatively low complication pattern and a favorable cost-benefit profile (8).

Conclusion Conservative treatments should be offered to women with POP with options such as pelvic floor exercises and pessaries. The decision to operate should be based on the patient’s symptoms, degree of bother, and medical health. Symptoms should correlate with the examination findings of the site of prolapse and its severity. Surgical repair of apical prolapse aims to restore anatomical support while maintaining or restoring normal bowel and bladder function, maintaining the normal sexual and reproductive function if desired. Surgery is an effective treatment for POP but has operative morbidity and risk of recurrence. The risks of surgery will vary with the type of operation performed and the surgeon’s experience. Women with significant apical loss of support with uterocervical or vaginal vault prolapse will frequently have a concomitant cystocele and enterocele. The options are whether to repair this vaginally or abdominally and if abdominally by an open, laparoscopic, or robotic procedure. Both approaches may be necessary at times, so surgeons should have the training and experience to do both safely. There are advantages and disadvantages of all techniques, and a decision should be made by the patient and doctor on what surgery best meets the patient’s needs. The abdominal approach using the abdominal sacropexy and synthetic mesh has a proven track record of effectiveness but increases morbidity. But if the abdominal approach is most appropriate if the vaginal capacity is reduced in a sexually active woman or there is co-existing abdominal pathology requiring surgical treatment. Other variations of abdominal hystereropexy without mesh are not as well investigated, with long-term retrospective or prospective randomized data supporting their widespread use. However, there is a consumer push against synthetic mesh in many countries with the risk of mesh complications occurring after many years and thus the need for long-term surveillance. The vaginal apical approaches using native tissue have continued to be the predominant repairs performed worldwide using the uterosacral CL complex or sacrospinous ligament with or without uterine conservation. The recent controversies involving synthetic mesh have increased the popularity of native tissue procedures with patients and doctors. Finally, the surgeon’s training, preference, and experience, especially surgical volumes, should have a considerable influence on the safety and effectiveness of all procedures and will influence the informed decision-making by the patient. The vaginal procedures described in this chapter have a reported efficacy between 85% and 100%, with patients followed for up to four to ten years. The morbidity and postoperative recovery associated with the transvaginal uterosacral vault suspension is acceptable and lessens the risk of life-changing complications such as significant bladder and bowel injuries, osteomyelitis, and

Vaginal Approach to Apical Suspension severe bleeding related to ASC. The morbidity is even less when an extraperitoneal route is used with no significant difference in success and reoperation rates than with the intraperitoneal approach. This is our preferred procedure for uterine conservation (MR) or post-hysterectomy vault prolapse. VIDEO 85.1  The Manchester repair for hysteropexy. (Accessible at https://resourcecentre.routledge.com/books/9780367700164) (From (25) with permission.) VIDEO 85.2  Modified McCall culdoplasty during vaginal hysterectomy in a woman with procidentia. (Accessible at https:// resourcecentre.routledge.com/books/9780367700164) (From (32) with permission.) VIDEO 85.3  Extraperitoneal uterosacral suspension for posthysterectomy vault prolapse. (https://resourcecentre.routledge. com/books/9780367700164) (From (39) with permission.)

References













1. Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Neurourology and urodynamics. 2017;36(2):221–244. 2. Naqa E, Guerrero K, Fattah A. Post-hysterectomy vaginal vault prolapse. Green-top Guideline no 46. RCOG/BSUG joint guideline. 2015. 3. Ramalingam K, Monga A. Management of vault prolapse. The obstetrician and gynaecologist. 2013;15(3):167–70. 4. Alas AN, Anger JT. Management of apical pelvic organ prolapse. Current urology reports. 2015;16(5):33. 5. DeLancey J. The anatomy of the pelvic floor. Current opinion in obstetrics and gynecology. 1994;6(4):313–6. 6. Marchionni M, Bracco GL, Checcucci V, Carabaneanu A, Coccia E, Mecacci F, et al. True incidence of vaginal vault prolapse. Thirteen years of experience. The journal of reproductive medicine. 1999;44(8):679–84. 7. Aigmueller T, Dungl A, Hinterholzer S, Geiss I, Riss P. An estimation of the frequency of surgery for posthysterectomy vault prolapse. International urogynecology journal. 2010;21(3):299–302. 8. Betschart C, Cervigni M, Contreras Ortiz O, Doumouchtsis SK, Koyama M, Medina C, et al. Management of apical compartment prolapse (uterine and vault prolapse): a FIGO Working Group report. Neurourology and urodynamics. 2017;36(2):507–13. 9. Blandon RE, Bharucha AE, Melton III LJ, Schleck CD, Babalola EO, Zinsmeister AR, et al. Incidence of pelvic floor repair after hysterectomy: a population-based cohort study. American journal of obstetrics and gynecology. 2007;197(6):664. e1–e7. 10. Aarts JWM, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BWJ, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane database of systematic reviews. 2015;2015(8): CD003677. 11. Chrysostomou A, Djokovic D, Edridge W, van Herendael BJ. Evidencebased guidelines for vaginal hysterectomy of the International Society for Gynecologic Endoscopy (ISGE). European journal of obstetrics and gynecology and reproductive biology. 2018;231:262–7. 12. Cvach K, Dwyer P. Surgical management of pelvic organ prolapse: abdominal and vaginal approaches. World journal of urology. 2012;30(4):471–7. 13. Karmakar D, Dwyer PL. Failure of expectations in vaginal surgery: lack of appropriate consent, goals and expectations of surgery. Current urology reports. 2016;17(12):87. 14. Anand M, Weaver AL, Fruth KM, Borah BJ, Klingele CJ, Gebhart JB. Perioperative complications and cost of vaginal, open abdominal, and robotic surgery for apical vaginal vault prolapse. Female pelvic medicine and reconstructive surgery. 2017;23(1):27–35. 15. Haya N, Baessler K, Christmann-Schmid C, de Tayrac R, Dietz V, Guldberg R, et al. Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Development in 2012. American journal of obstetrics and gynecology. 2015;212(6):755. e1–e27.

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16. Slopnick EA, Chapman GC, Roberts K, Sheyn DD, El-Nashar S, Mahajan ST. Apical suspension is underutilized for repair of stage IV pelvic organ prolapse: an analysis of national practice patterns in the United States. International urogynecology journal. 2021;32:791–7. 17. Vermeulen CK, Coolen ALW, Spaans WA, Roovers JPW, Bongers MY. Treatment of vaginal vault prolapse in The Netherlands: a clinical practice survey. International urogynecology journal. 2019;30(4):581–7. 18. Vu D, Haylen BT, Tse K, Farnsworth A. Surgical anatomy of the uterosacral ligament. International urogynecology journal. 2010;21(9):1123–8. 19. Karmakar D, Dwyer P, Thomas E, Schierlitz L. Extraperitoneal uterosacral suspension technique for post hysterectomy apical prolapse in 472 women: results from a longitudinal clinical study. BJOG: an international journal of obstetrics and gynaecology. 2019;126(4):536–42. 20. Cruikshank SH. Preventing posthysterectomy vaginal vault prolapse and enterocele during vaginal hysterectomy. American journal of obstetrics and gynecology. 1987;156(6):1433–40. 21. Korbly NB, Kassis NC, Good MM, Richardson ML, Book NM, Yip S, et al. Patient preferences for uterine preservation and hysterectomy in women with pelvic organ prolapse. American journal of obstetrics and gynecology. 2013;209(5):470.e1–e6. 22. Karmakar D, Hayward L. What can we learn from the vaginal mesh story? Climacteric. 2019;22(3):277–82. 23. Anglim B, O’Sullivan O, O’Reilly B. How do patients and surgeons decide on uterine preservation or hysterectomy in apical prolapse? International urogynecology journal. 2018;29(8):1075–9. 24. Donald A. Operation in cases of complete prolapse. BJOG: an international journal of obstetrics and gynaecology. 1908;13(3):195–7. 25. Walsh CE, Ow LL, Rajamaheswari N, Dwyer PL. The Manchester repair: an instructional video. International urogynecology journal. 2017;28(9):1425–7. 26. Oversand SH, Staff AC, Borstad E, Svenningsen R. The Manchester procedure: anatomical, subjective and sexual outcomes. International urogynecology journal. 2018;29(8):1193–201. 27. Husby KR, Larsen MD, Lose G, Klarskov N. Surgical treatment of primary uterine prolapse: a comparison of vaginal native tissue surgical techniques. Int Urogynecol J. 2019 Nov;30(11):1887–893. 28. Tolstrup CK, Husby KR, Lose G, Kopp TI, Viborg PH, Kesmodel US, et al. The Manchester-Fothergill procedure versus vaginal hysterectomy with uterosacral ligament suspension: a matched historical cohort study. International urogynecology journal. 2018;29(3):431–40. 29. Kapoor S, Sivanesan K, Robertson JA, Veerasingham M, Kapoor V. Sacrospinous hysteropexy: review and meta-analysis of outcomes. International urogynecology journal. 2017;28(9):1285–94. 30. Nager CW, Visco AG, Richter HE, Rardin CR, Rogers RG, Harvie HS, et al. Effect of vaginal mesh hysteropexy vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: a randomized clinical trial. The journal of the American Medical Association. 2019;322(11):1054–65. 31. Zilberlicht A, Dwyer PL, Karmakar D, Carswell F, Schierlitz L. Extraperitoneal high vaginal cuff suspension at the time of vaginal hysterectomy for advanced uterovaginal prolapse: results of a modified McCall technique from a longitudinal clinical study. Australian and New Zealand journal of obstetrics and gynaecology. 2021;61(2):258–62. 32. Zilberlicht A, Dwyer PL, Rajamaheswari N, Dykes N, Karmakar D. Video of uterovaginal procidentia repair incorporating a high extraperitoneal uterosacral vault suspension. International urogynecology journal. 2020;31(10):2173–5. 33. Vanspauwen R, Seman E, Dwyer P. Survey of current management of prolapse in Australia and New Zealand. Australian and New Zealand journal of obstetrics and gynaecology. 2010;50(3):262–7. 34. McCall ML. Posterior culdeplasty; surgical correction of enterocele during vaginal hysterectomy; a preliminary report. Obstetrics and gynecology. 1957;10(6):595–602. 35. Chene G, Tardieu A-S, Savary D, Krief M, Boda C, Anton-Bousquet M-C, et al. Anatomical and functional results of McCall culdoplasty in the prevention of enteroceles and vaginal vault prolapse after vaginal hysterectomy. International urogynecology journal and pelvic floor dysfunction. 2008;19(7):1007–11. 36. Singh P, Lim Wei Liang B, Han HC. A retrospective observational study on the outcomes and efficacy of the Manchester procedure as a uterinesparing surgery for uterovaginal prolapse. Journal of gynecologic surgery. 2018;34(6):275–8. 37. Cam C, Karateke A, Asoglu MR, Selcuk S, Namazov A, Aran T, et al. Possible cause of failure after McCall culdoplasty. Archives of gynecology and obstetrics. 2011;283(4):791–4.

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38. Coolen A-LW, Bui BN, Dietz V, Wang R, van Montfoort AP, Mol BWJ, et al. The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis. International urogynecology journal. 2017;28(12):1767–83. 39. Ow LL, Walsh CE, Rajamaheswari N, Dwyer PL. Technique of extraperitoneal uterosacral ligament suspension for apical suspension. International urogynecology journal. 2016;27(4):637–9. 40. Cruikshank SH, Cox DW. Sacrospinous ligament fixation at the time of transvaginal hysterectomy. American journal of obstetrics and gynecology. 1990;162(6):1611–9. 41. Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. American journal of obstetrics and gynecology. 1998;179(1):13–20. 42. Shull BL, Bachofen C, Coates KW, Kuehl TJ. A transvaginal approach to repair of apical and other associated sites of pelvic organ prolapse with uterosacral ligaments. American journal of obstetrics and gynecology. 2000;183(6):1365–73. 43. Karram M, Goldwasser S, Kleeman S, Steele A, Vassallo B, Walsh P. High uterosacral vaginal vault suspension with fascial reconstruction for vaginal repair of enterocele and vaginal vault prolapse. American journal of obstetrics and gynecology. 2001;185(6):1339–43. 44. Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, et al. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. The journal of the American Medical Association. 2014;311(10):1023–34. 45. Margulies RU, Rogers MA, Morgan DM. Outcomes of transvaginal uterosacral ligament suspension: systematic review and metaanalysis. American journal of obstetrics and gynecology. 2010;202(2):124–34. 46. Dwyer PL, Fatton B. Bilateral extraperitoneal uterosacral suspension: a new approach to correct posthysterectomy vaginal vault prolapse. International urogynecology journal and pelvic floor dysfunction. 2008;19(2):283–92. 47. Fatton B, Dwyer PL, Achtari C, Tan P. Bilateral extraperitoneal uterosacral vaginal vault suspension: a 2-year follow-up longitudinal case series of 123 patients. International urogynecology journal and pelvic floor dysfunction. 2009;20(4):427–34.











48. Mounir D, Vasquez-Tran NO, Lindo FM, Antosh DD, Muir TW. Vaginal intraperitoneal versus extraperitoneal uterosacral ligament vault suspensions: a comparison of a standard and novel approach. International urogynecology journal. 2021;32(4):913–8. 49. Maher CF, Qatawneh AM, Dwyer PL, Carey MP, Cornish A, Schluter PJ. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. American journal of obstetrics and gynecology. 2004;190(1):20–6. 50. Morgan DM, Rogers MA, Huebner M, Wei JT, DeLancey JO. Heterogeneity in anatomic outcome of sacrospinous ligament fixation for prolapse: a systematic review. Obstetrics and gynecology. 2007;109(6):1424–33. 51. Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstetrics and gynecology. 1997;89(3):466–75. 52. Pohl JF, Frattarelli JL. Bilateral transvaginal sacrospinous colpopexy: preliminary experience. American journal of obstetrics and gynecology. 1997;177(6):1356–61. 53. Cespedes RD. Anterior approach bilateral sacrospinous ligament fixation for vaginal vault prolapse. Urology. 2000;56(6):70–5. 54. Inmon W. Pelvic relaxation and repair including prolapse of vagina following hysterectomy. Southern medical journal. 1963;56(6):577–82. 55. Meeks GR, Washburne JF, McGehee RP, Wiser WL. Repair of vaginal vault prolapse by suspension of the vagina to iliococcygeus (prespinous) fascia. American journal of obstetrics and gynecology. 1994;171(6):1444–52. 56. Shull BL, Capen CV, Riggs MW, Kuehl TJ. Bilateral attachment of the vaginal cuff to iliococcygeus fascia: an effective method of cuff suspension. American journal of obstetrics and gynecology. 1993;168(6):1669–74. 57. Maher CF, Murray CJ, Carey MP, Dwyer PL, Ugoni AM. Iliococcygeus or sacrospinous fixation for vaginal vault prolapse. Obstetrics and gynecology. 2001;98(1):40–4. 58. Zebede S, Smith AL, Plowright LN, Hegde A, Aguilar VC, Davila GW. Obliterative LeFort colpocleisis in a large group of older women. Obstetrics and gynecology. 2013;121(2 Pt 1):279–84.

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OPEN ABDOMINAL APPROACH TO SUPPORTING THE VAGINAL APEX Russell Stanley, T. Clark Powell, and Holly E. Richter*

Introduction Prolapse of the vaginal apex may occur with the uterus in situ or following a previous hysterectomy. The vaginal apex is normally supported by the uterosacral–cardinal ligament complex and the levator ani musculature, described by DeLancey [1] as Level 1 support. This defect in most cases occurs due to weakness in the muscular levator ani complex, which can be a result of obstetrical injury with muscular tearing or denervation, aging, chronic pelvic floor pressure, connective tissue disorders, or even congenital defects such as spina bifida or bladder exstrophy. Apical loss of support secondary to muscular injury may be unilateral or bilateral resulting in apical prolapse. This often occurs in the presence of anterior and/or posterior compartment prolapse. Identifying the extent of apical prolapse during the clinical examination and addressing it fully during prolapse surgery are crucial to providing a durable repair. The route by which prolapse surgery takes place is a decision based on the patient's characteristics as well as the surgeon's preference and expertise. Both abdominal (open, laparoscopic, and robotic-assisted laparoscopic) and vaginal routes are utilized with various surgical techniques performed in order to recreate Level 1 support. This chapter will focus on the open abdominal techniques used to treat apical prolapse at the time of a hysterectomy in the post-hysterectomy patient and in the patient with uterine descent wishing to preserve her uterus.

Sacrocolpopexy Technique

Abdominal sacrocolpopexy (ASC) was first described by Frederick Lane in 1962 [2]. It is performed in the post-hysterectomy patient and involves attaching the vaginal apex to the sacrum with the use of an intervening graft. In brief, the patient is placed in low lithotomy and the abdomen is entered. With a probe or retractor in the vagina to aid visualization and provide countertraction, the peritoneum, bladder, and rectum are dissected off the vagina. Currently used graft material is made of synthetic polypropylene mesh. This has been shown to be superior to cadaveric fascia lata graft and porcine dermis or acellular matrix in limited studies of long-term outcomes (Fig. 86.1a). The graft material (either selfmade strips, self-made “Y,” or precut “Y”) is then attached to the vagina using either delayed-absorbable or permanent sutures. The anterior longitudinal ligament overlying the sacral promontory is exposed by incising the overlying peritoneum. Care must be taken to identify the right ureter and bilateral iliac vessels as these structures are all within 3 cm of the promontory [3]. The middle sacral artery and vein should be avoided both during dissection and suture placement as injury to them may cause *

With acknowledgment to the authors of the chapter in the prior edition, Kristina Cvach and Peter Dwyer.

DOI: 10.1201/9781003144243-94

bleeding that is difficult to adequately control due to the vessel retraction. The dissection is then continued caudally down the right paracolic gutter to the rectovaginal space. The tail of the graft is attached to the anterior longitudinal ligament just below the most prominent point of the sacral promontory (Fig. 86.1). In an MRI study, Abernethy et al. showed that the L5–S1 disc was situated at the promontory in 73% of cases [4]. Therefore, attaching the graft with permanent suture or surgical tacks just below may avoid the complication of discitis. White et al. provided evidence in a cadaver study that sutures placed at or above the sacral promontory and in a horizontal orientation are stronger than those placed more caudally or in the vertical orientation (Fig. 86.1b). Care must be taken not to over-suspend the vagina—the graft material should be of adequate length (15–20 cm) in order to achieve tension-free attachment to the sacrum. Over-suspension can lead to an increased incidence of de novo stress urinary incontinence and anterior compartment prolapse. The peritoneum is closed over the graft to avoid entrapment of the sigmoid colon, volvulus, and development of bowel adhesions to the graft. Vaginal assessment is performed to ascertain whether any concomitant anterior or posterior compartment repairs are required. Anti-incontinence procedures may be performed concurrently if indicated. However, it is important to note that there could be an increased risk of post-op urinary tract infections within the first 30 days of surgery when performing anti-incontinence procedures concurrently with ASC [5]. Cystoscopy is performed to ensure bladder integrity and ureteral patency during the sacrocolpopexy. Patients with uterine prolapse may undergo a concomitant total hysterectomy at the time of sacrocolpopexy. However, any opening of the vagina increases the risk of subsequent vault mesh exposure (ME), with one study reporting an odds ratio (OR) of 4.9 when a concomitant total hysterectomy was performed [6]. In an effort to mitigate this risk, a number of authors advocate that supracervical hysterectomy be performed in hopes of reducing the risk of ME and overall complication rates [7–9]. Further, they report that the residual apical support provided by the uterosacral ligaments to the cervix may also be an advantage [10].

Efficacy outcomes

ASC has been shown to be an effective procedure for apical prolapse [11]. Nygaard et al. published a comprehensive review of all studies reporting outcomes on ASC [12]. Efficacy was reported in 64 studies with a mean follow-up between 6 months and 3 years. The success rate for apical prolapse was reported as 78–100%, and for all compartments, the success rate was 58–100%. The median reoperation rate for prolapse was 4.4%. Many of these studies were retrospective case series or cohort studies with relatively short follow-up. The Colpopexy and Urinary Reduction Efforts (CARE) trial assessing the utility of retropubic urethropexy performed at the time of ASC in women without stress incontinence symptoms at baseline reported outcomes at 7 years [13]. This is a valuable 935

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Posterior area of vaginal vault with EEA sizer inserted transvaginally overlying peritoneum retracted laterally, and graft applied (1)

Sacral promontory (2)

(a)

 

FIGURE 86.1  Sacrocolpopexy. A: Illustrates (1) graft attachment to the posterior area of the prolapsed vagina to or below the rectal–sigmoid junction after the overlying peritoneum has been dissected and flapped laterally and (2) exposure of the presacral space with suture placement through the anterior sacral ligament. An appropriate shaped second graft is placed anteriorly. B: Illustrates attachment of both grafts without tension to the sacrum. Prevention of subsequent enterocele and/or sigmoidocele is accomplished by box closure of the cul-de-sac peritoneum lateral to the left side of the sigmoid, attachment of the presigmoid fat to the graft centrally, and reperitonealization of the graft through the right side of the cul-de-sac. EEA, end-to-end anastomosis sizer. (Reprinted from [57].)

study as it provides longer term data on the efficacy of ASC in the framework of a randomized controlled trial (RCT). When using a composite definition of treatment failure for prolapse incorporating both anatomic and symptomatic definitions, this study reported prolapse failure rates considerably higher than previously published. The estimated probability of failure at 7 years for the urethropexy group was 34% and that of the no urethropexy group was 48%. Despite this high failure rate, only 5% of women underwent surgical correction of the recurrent prolapse, which is consistent with other studies. This study highlights the need for long-term reporting of the efficacy of prolapse repair procedures, as failure rates appear to increase over time. Previous studies reveal that open ASC compares favorably to other apical suspension procedures such as the sacrospinous ligament suspension (SSLS) [14–16] (Table 86.1). Despite similar findings, a Cochrane review on surgical management of prolapse has shown the superiority of ASC compared to SSLS [11]. While there are a limited number of studies comparing open ASC to other vaginal procedures, previous studies demonstrate a favorable comparison of open ASC to other vaginal procedures for treating apical prolapse [17–20] (Table 86.2). The choice of graft material, synthetic versus biologic, remains an important topic in surgical planning for ASC. Tate et al. have reported on 5 year follow-up of an RCT of ASC with polypropylene

mesh versus cadaveric fascia lata [21]. Objective results at 5 years reflected 1 year data, with superior results in the polypropylene group (93% vs. 62%; p = 0.02). Subjective results, however, did not reach statistical significance (97% vs. 90%; p = 0.61). Reoperation for recurrent prolapse occurred in two patients, one in each group. There were two MEs in the mesh group and one in the fascia lata group. Culligan et al. compared surgical outcomes using either porcine dermis or polypropylene mesh. They found similar objective cure rates of 80.7% and 89.2%, respectively [22]. A retrospective study by Quiroz et al. found more apical failures following ASC with the use of porcine acellular collagen matrix graft (11%) compared with polypropylene mesh (1%) or autologous fascia (7%). All of the repeat operations occurred in the porcine acellular collagen matrix group. Further, this graft was associated with higher graft-related complications [23]. Salamon et al. found objective and clinical cure rates of 89% and 94% using ultra-lightweight polypropylene mesh, with no mesh complications [24]. Overall, at this time, polypropylene mesh is the preferred graft material for most surgeons. All studies, comparing open ASC to vaginal procedures, show that the ASC procedure has higher intraoperative morbidity with longer operating time, higher blood loss, longer hospital stay, and slower return to activities of daily living. With regard to longer term outcomes, a recent multicenter analysis comparing

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TABLE 86.1: Randomized Controlled Trial Results Comparing Abdominal Sacrocolpopexy to Sacrospinous Ligament Suspension

Reference

Number

Mean Follow-Up (years)

Maher et al., 2004 [14]

47 ASC, 48 SSLS

Benson et al., 1996 [15]

Lo and Wang 1998 [16]

Success Rate (%) ASC vs. SSLS

Criteria for Success

Reoperation Rate

Comments

2

Objective: 76 vs. 69 (p = 0.48); subjective: 94 vs. 91 (p = 0.19)

No POP beyond halfway point of the vagina; absence of POP symptoms

ASC had longer operating time, slower return to ADL, and greater cost (p < 0.01).

40 ASC, 48 SSLS

2.5

58 vs. 29 (RR = 2.03; 95% CI, 1.22–9.83)

Composite, incorporating the absence of POP symptoms and no protrusion beyond the hymen

Recurrence of anterior or vault prolapse: 13% ASC vs. 45% SSLS. Reoperation rate for recurrence not described Recurrent vault prolapse: 2.6% ASC vs. 12% SSLS; recurrent cystocele: 10.5% ASC vs. 29% SSLS

52 ASC, 66 SSLS

2.1

94.2 vs. 80.3 (p = 0.03)

No POP > Stage 2

Incidence of postoperative complications requiring surgical correction: 7.69% ASC vs. 10.6% SSLS (p = 0.75)

High rate of concomitant procedures performed in both groups. Surgical failures occurred sooner in SSLS (mean 11.2 mos) vs. ASC (mean 22.1 mos). Operating time and cost significantly increased in the ASC group. Greater intraoperative blood loss in the SSLS group.

Abbreviations:  ASC, abdominal sacrocolpopexy; SSLS, sacrospinous ligament suspension; POP, pelvic organ prolapse; ADL, activities of daily living.

TABLE 86.2: Studies Comparing ASC and Other Vaginal Apical Suspension Procedures Reference

Study Type

Intervention and Follow-Up

Outcomes

Braun et al., 2007 [17]

Prospective randomized study

Anatomic failure rates of 0% for TAH with ASC compared to 17% for VH with McCall

Rondini et al., 2010 [18]

RCT

Abdominal hysterectomy (TAH) and ASC to (VH) and Mayo McCall culdoplasty at 33 months follow-up ASC vs. HUSLS with follow-up of 1 year

Lim et al., 2012 [19]

RCT

ASC vs. VEULS with anterior mesh reinforcement

Sanses et al., 2009 [20]

Retrospective cohort study

VMP vs. USLS and ASC with short-term follow-up (3–6 months)

Anatomical success (point C less than −1 cm) in 100% of ASC compared to 83% of HUSLS

Objective success was 76.5% for ASC and 70% for VEULS (p = 0.38). There were no betweengroup differences for subjective outcomes based on changes in symptoms as measured by the PFDI-20, PFIQ-7, and PISQ-12 Equivalent apical success rates for all procedures of >98%

Comments

Recurrent anterior or posterior compartment prolapse was 5.5% in ASC compared to 33.9% in HUSLS with corresponding lower rates of reoperation in ASC (5%) compared to HUSLS (17.8%). Mesh exposure occurred in three women in the ASC group and in two women in the VEULS group

VMP showed a significant reduction in total vaginal length

Abbreviations: TAH, total abdominal hysterectomy; ASC, abdominal sacrocolpopexy; VH, vaginal hysterectomy; RCT, randomized controlled trial; HUSLS, high uterosacral vault suspension; VEULS, vaginal extraperitoneal uterosacral ligament suspension; PFDI-20, Pelvic Floor Distress Inventory; PFIQ-7, Pelvic Floor Impact Questionnaire; PISQ-12, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; VMP, vaginal mesh procedures.

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938 the success and outcomes of open sacrocolpopexy to vaginal repairs reported that while POP-Q measurements and symptoms improved in both the open sacrocolpopexy and vaginal repairs group, treatment success (defined as no bulge symptoms, no prolapse beyond the hymen, and no retreatment at 24 months) was higher in the ASC group (OR, 6.00, 95% confidence interval [CI], 3.45–10.44). By 24 months, fewer patients had undergone retreatment in the ASC cohort (2%) versus the vaginal cohort (5%). Serious adverse events did not differ significantly at 6 weeks (13% vs. 5%; OR, 2.0; 95% CI, 0.9–4.7) and 12 months (26% vs. 13%; OR, 1.6; 95% CI, 0.9–2.9), respectively [25].

Increased morbidity associated with the open ASC has led to the development of less invasive approaches using laparoscopy. In a recent analysis of perioperative outcomes comparing open versus minimally invasive approaches to sacrocolpopexy, minimally invasive sacrocolpopexy was associated with lower rates of 30-day complications (p = 0.001), deep vein thrombosis/pulmonary embolism (p = 0.02), surgical site infections (p < 0.0001), shorter hospitalization (p < 0.001), and fewer blood transfusions (p = 0.01) [26]. Several studies, including RCTs and systematic reviews, are presented comparing outcomes of the open ASC to laparoscopic sacrocolpopexy (LSC) and robotic sacrocolpopexy (Table 86.3).

TABLE 86.3: Studies Comparing Outcomes of Open ASC vs. LSC (Laparoscopic) and RSC (Robotic) Reference

Study Type

Costantini et al., 2016 [27]

RCT

Coolen et al., 2017 [38]

Intervention and Follow-Up

Outcomes

Comments

Open ASC vs. LSC 1 year follow up

LSC showed significantly earlier recurrence (p = 0.030), mostly in the first 12 months after surgery. A statistically significant difference was observed between the laparoscopic and abdominal approaches for anterior compartment descensus (11 vs. 1; p = 0.004)

Conclusion was that LSC provides outcomes equivalent to ASC for apical anatomic correction but not for anterior compartment prolapse

Systematic review

Looked at the treatment of post-hysterectomy vaginal vault prolapse across all prolapse procedures

The meta-analysis concluded that LSC appears preferable to ASC

Campbell et al., 2016 [39]

Systematic review and metaanalysis

Open ASC vs. LSC (looked at 7 studies including 1461 patients—589 in LSC group, 872 in open ASC group)

Freeman et al., 2013 [50]

RCT

Open ASC vs. LSC 1 year follow-up (study included 53 women)

Anatomic results of LSC (both laparoscopic and robot-assisted) and ASC were favorable (62–91%) compared to vaginal mesh procedures. Found that the highest percentage of complications were reported after ASC (2–19%), vaginal mesh (6–29%), and RSC (54%) The operative time was significantly greater with LSC (mean difference 25 minutes; 95% CI, 5.43–45.07 minutes); however, ASC had significantly greater intraoperative blood loss (mean difference, 107 ml; 95% CI, −2.21 to −1.22 days), and increased risk of postoperative ileus/ small bowel obstruction (odds ratio, 2.88; 95% CI, 1.31–6.33). There was no significant difference in the rate of bladder injury, bowel injury, mesh exposure, or repeat prolapse surgery Anatomic outcomes for point C showed equivalence (−6.63 ASC vs. −6.65 LSC); subjective improvement (90% ASC vs. 80% LSC)

Coolen et al., 2017 [51]

RCT

Open ASC vs. LSC 1 year follow up

Ichikawa et al., 2018 [52]

Systematic review

Open ASC vs. LSC for addressing multicompartment prolapse. Authors included 3 RCTs comparing open ASC to LSC which included 247 total patients, 123 for LSC, and 124 for open ASC.

Utilized domain scores of the UDI as a primary outcome and found that after 12 months of follow-up, there was no significant difference between the ASC and LSC groups (p = 0.93). There was no significant difference in anatomic outcomes at 12 months There was no evidence of recurrence or reoperation in either group for the apical compartment. Reoperation for the posterior compartment was performed in three cases (2.5%) in the LSC group and one case (0.8%) in the ASC group. The combined repeat surgery and mesh removal surgery rate was higher in the LSC group (8/119 [6.7%]) than in the ASC group (2/121 [1.7%]; p = 0.049).

Conversion rate for LSC to ASC was 3% (17 cases); one LSC and 1 ASC were each converted to vaginal procedures

Reoperation occurred in 2 ASC and 3 LSC; LSC had less blood loss, less narcotic use, and shorter length of stay (4.1 days ASC vs. 3.2 days LSC) There was less blood loss and a shorter hospital stay after laparoscopy; 2 (IQR 2–3) versus 4 (IQR 3–5) days, which was statistically different The conclusion of the review was that anterior compartment recurrence, repeat surgery for the posterior compartment, and mesh-related complications were more frequent following LSC (Continued)

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TABLE 86.3 (Continued): Studies Comparing Outcomes of Open ASC vs. LSC (Laparoscopic) and RSC (Robotic) Intervention and Follow-Up

Reference

Study Type

Geller et al. 2012 [53]

Retrospective cohort study

Comparing clinical outcomes of ASC to RSC at 44 months, 51 subjects were evaluated with 23 in the robotic group and 28 in the abdominal group. Mean time since surgery was 44.2 + 6.4 months

Paraiso et al., 2011 [54]

RCT

Comparing LSC and RSC with follow-up at 1 year

Outcomes

Comments

Postoperative POP-Q improved similarly from baseline in both the robotic and abdominal groups: C (−8 vs. −7), Aa (−2.5 vs. −2.25), Ap (−2 vs. −2) (all p > 0.05 based on the route of surgery). Pelvic floor function also improved similarly in both groups: PFDI-20 (51.0 vs. 54.8), PFIQ-7 (19.1 vs. 15.7), with high sexual function PISQ-12 (35.1 vs. 33.1) (all p > 0.05 based on the route of surgery). The primary outcome was total operating time, with RSC taking significantly longer (+67-minute difference; 95% CI, 43–89; p < 0.001). Women in the RSC group also had significantly more pain and longer use of nonsteroidal anti-inflammatory drugs. RSC incurred a higher cost than LSC (+$1936; 95% CI, $417–$3454; p = 0.008).

Two mesh exposures occurred in each group for a rate of 8% and 7%, respectively

There were no differences in anatomic or subjective outcomes between groups, with significant improvements from baseline in both groups.

Abbreviations: RCT, randomized controlled trial; ASC, abdominal sacrocolpopexy; LSC, laparoscopic sacrocolpopexy; UDI, Urinary Distress Inventory; IQR, interquartile range; CI, confidence interval; PFDI-20, Pelvic Floor Distress Inventory; PFIQ-7, Pelvic Floor Impact Questionnaire; PISQ-12, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire; RSC, robotic sacrocolpopexy.

Overall, the open ASC and LSC have comparable results in terms of restoration of anatomy with the exception of one study where the LSC had a higher failure in the anterior compartment [27]. However, LSC has a shorter length of hospital stay and less blood loss than the open ASC. While the laparoscopic approaches to sacrocolpopexy appear to have some advantages over the open approach, they require a different skill set. There is a learning curve for both techniques, and the surgeon embarking on these must undergo appropriate training and mentorship. Surgeon proficiency and patient selection are vital in achieving the best outcomes regardless of modality.

Enterocele repair

A consideration at the time of ASC is the obliteration of the cul-de-sac. There are two major techniques for abdominal enterocele repair that have been described: the Moschcowitz and Halban procedures [28]. The Moschcowitz procedure is performed by placing a series of concentric sutures around the cul-de-sac which includes the posterior vaginal wall, the right pelvic side wall, the serosa of the sigmoid, and the left pelvic side wall. The initial suture is placed at the base of the cul-de-sac followed by three or four sutures that, once tied in a purse-string fashion, will obliterate the cul-de-sac in theory to help prevent small bowel entrapment or enterocele recurrence as well as support the vaginal apex. Caution must be taken to ensure that the ureters are not included in the purse string or kinked as a result of tying the sutures. Halban described a technique using sutures that are placed sagittally between the uterosacral ligaments [28]. Four or five sutures are placed sequentially in a longitudinal fashion through the serosa of the sigmoid and into the deep peritoneum of the cul-de-sac and up the posterior vaginal wall. The sutures are then tied to close the space in which an enterocele would develop. Although these techniques have been utilized for obliterating the cul-de-sac, there is little evidence that either the Moschcowitz or Halban techniques prevent the recurrence of an enterocele in the long term.

Abdominal uterosacral ligament suspension Abdominal uterosacral colposuspension has been used in a prophylactic manner after hysterectomy and therapeutically for apical prolapse with cardinal/uterosacral defects [29]. For the therapeutic procedure, a delayed absorbable or no. 1 polypropylene suture is placed cephalad and at the same level posterior as the ischial spines, which may be palpated transabdominally. One technique is to place one or two permanent sutures through one ligament, then after reefing across the cul-de-sac peritoneum at the sigmoid border, through the contralateral ligament, and through the fibromuscular tissue just anterior to the vaginal cuff. Tying the suture suspends the vaginal cuff and can obliterate an enterocele defect [29]. Another technique employs separate sutures placed at the same level into each uterosacral ligament and anchored anteriorly and posteriorly to the ipsilateral side of the vaginal cuff, similar to procedures performed transvaginally. Cystoscopy is performed after the procedure to document ureteral patency. One study found subjective and objective recurrences to be low (12% and 5%, respectively) [30].

Sacrohysteropexy Technique

Open abdominal sacrohysteropexy (ASH) is a uterine-conserving procedure for women with uterovaginal prolapse. Current cervical or uterine pathology should be excluded prior to this procedure, and women at high risk of developing endometrial carcinoma should not undergo uterine conservation. Women should continue to have their cervical screening following the procedure and be counseled about the potential difficulties of future pelvic surgery in the presence of mesh. While preservation of fertility is one of the reasons women may wish to avoid hysterectomy, there are few published cases of pregnancy and prolapse outcomes following ASH [31–33]. In general, it is preferable that women have completed childbearing prior to the prolapse surgery. In those contemplating future pregnancy, there is little evidence to guide

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In Costantini's study of ASH versus TAH with ASC discussed earlier, uterine conservation was associated with a shorter operating time (89 vs. 115 minutes; p < 0.001), less intraoperative blood loss (325 vs. 200 mL; p < 0.001), and shorter hospital stay (p < 0.05). A 2018 meta-analysis of uterine preservation compared to hysterectomy in pelvic organ prolapse surgery found that compared to hysterectomy plus mesh sacrocolpopexy, uterine preservation with sacrohysteropexy reduces ME, operative time, blood loss, and surgical cost without differences in prolapse recurrence. Compared to vaginal hysterectomy with uterosacral suspension, uterine preservation in the form of laparoscopic sacrohysteropexy improves the C point and vaginal length on pelvic organ prolapse quantification exam, estimated blood loss, postoperative pain and functioning, and hospital stay, but open sacrohysteropexy has increased operative time and may worsen urinary symptoms and quality of life [37]. FIGURE 86.2 Abdominal (Reprinted from[58].)

sacrohysteropexy

technique.

the discussion regarding the mode of delivery, and it is conceivable that pregnancy per se, as well as vaginal delivery, increases the risk of recurrent uterine prolapse following ASH. After entry into the abdomen, the sacral, paracolic, and posterior vaginal dissections are carried out as described for ASC. Synthetic mesh may be attached over the upper posterior vagina and cervix and suspended to the anterior longitudinal ligament at the sacrum (Fig. 86.2). If there is significant anterior compartment prolapse, synthetic mesh can also be attached over the anterior vaginal wall. An incision is made in the anterior leaf of the broad ligament bilaterally, inferior to the fallopian tubes, and extended down to the uterovesical fold. The bladder is mobilized off the cervix to expose 3–4 cm of the underlying anterior vaginal wall. Windows are made in the broad ligament bilaterally at the level of the cervicouterine junction, lateral to the uterine artery. Two mesh strips are then fashioned; one is bisected to produce a Y-configuration for the anterior mesh. The anterior mesh arms are passed through the broad ligament windows. Both the anterior and posterior mesh strips are attached to the vagina using permanent or delayed absorbable sutures (Fig. 86.2). Other surgeons attach the broad end of the anterior Y mesh to the vagina and pass the arms of the Y through the broad ligament, attaching these to the posterior mesh [32, 34, 35], or have reported on the use of a single mesh strip attached only posteriorly [36]. Irrespective of the mesh strip configuration, the proximal end(s) are attached to the anterior longitudinal ligament and the peritoneum closed over the mesh as per the ASC technique performed on a vaginal cuff.

Efficacy outcomes

Most studies assessing the efficacy of open ASH are case series of 12–55 subjects with variable follow-up of up to 5 years (Table 86.4). Overall, studies assessing the efficacy of ASH have shown excellent results for the apical compartment. Anterior and posterior compartment results are variable and may reflect differences in the configuration of the mesh (such as the use of posterior mesh only), the anchoring of the anterior mesh (broad end or mesh arms), and whether concomitant anterior or posterior vaginal repairs are performed. There may be an advantage in intraoperative and short-term postoperative morbidity in avoiding hysterectomy at the time of uterine prolapse surgery.

Complications Complications following open ASC/ASH can be divided into those occurring intraoperatively or postoperatively.

Intraoperative complications

Intraoperative complications are similar to those of any open abdominal procedure. In Nygaard et al.'s review of ASC [12], median rates of complications were cystotomy 3.1%, ureteral injury 1%, enterotomy/proctotomy 1.6%, and hemorrhage requiring transfusion at a rate of 2.6–4.4% [12, 15]. Specific to ASC/ASH is hemorrhage occurring during the presacral dissection due to injury to the presacral venous plexus. Bleeding from these vessels can be difficult to control as they may retract into the bony surface of the sacrum and often require the use of prolonged pressure, bone wax, or sterile tacks to achieve hemostasis. In a recent meta-analysis looking at complications of open abdominal ASC versus LSC, there were more complications after an ASC than after an LSC; however, this result is not significantly different (mean difference of 0.53 events; 95% CI, 0.2–1.7; two RCTs; n = 127). There were five reported complications in the LSC group versus nine in the ASC group. There was no statistically significant difference between reoperations for POP between ASC and LSC; however, fewer reoperations were seen in the ASC group (MD 4.0 events; 95% CI, 0.6–25; two RCTs; n = 127). In the LSC group, five reoperations were performed versus one in the ASC group [38].

Postoperative complications

Urinary tract infection is the most common postoperative complication (10.9%), followed by abdominal wound infections (4.6%), ileus (3.6%), deep vein thrombosis or pulmonary embolism (3.3%), operation for small bowel obstruction (SBO, 1.1%), and incisional hernia repair (5%) [6]. Open ASC is associated with increased risk of postoperative ileus and SBO (OR, 2.88; 95% CI, 1.31–6.33) [39]. This analysis was performed on five studies involving 520 women undergoing LSC and 804 undergoing abdominal ASC. Nosti et al. found that postoperative ileus and SBO were significantly more common in the open abdominal group (5% vs. 1.8%; p < 0.01); however, it was noted that patients in the abdominal group were more likely to have had previous abdominal surgery [40]. In a recent retrospective cohort study looking at mesh reperitonealization versus no reperitonealization at the time of sacrocolpopexy [41], a total of 18 intraoperative or postoperative complications (8.6%) were recorded. Relative risk of complication

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TABLE 86.4: Abdominal Sacrohysteropexy Studies Reference Barranger et al., 2003 [32] case series

Number 30

Roovers et al., 41 ASH, 2004 [34] RCT 41 VH/ USLS/ VR

Mean Follow-Up

Criteria for Success

Reoperation Rate

Objective: Objective: 93.4; 44 mos; subjective: 96.7 subjective: 94.6 mos 12 mos Apex: 95% ASH vs. 95% VH; anterior: 64% ASH vs. 61% VH; posterior: 95% ASH vs. 85% VH

Grade 0/1 POP; absence of POP symptoms

Reoperation 1/30 (3.3%)

No POP > Stage 1

Performed or planned POP surgery in 1st year: 9 ASH vs. 1 VH

Success Rate (%)

Comments All women underwent Burch colposuspension and posterior repair; three spontaneous pregnancies, all early terminations Change in UDI subscales for OAB, obstructive micturition, and discomfort/pain favored VH group. For urinary incontinence, the mean + SD UDI domain score for urinary incontinence before surgery was 24.7 + 4.7 for the vaginal approach compared to 21.8 + 3.0 for the abdominal approach. For urinary incontinence, the mean + SD UDI domain score 1 year after surgery was 7.2 + 2.1 for the vaginal approach and 13.2 + 3.5 for the abdominal approach with a mean difference of 6 {−2.0 to 14.0} [95% CI]. For overactive bladder, the mean + SD UDI domain score before surgery was 28.0 + 3.4 for the vaginal approach and 31.7 + 3.8 for the abdominal approach. At one year after surgery, the mean + SD UDI domain score for overactive bladder was 9.4 + 2.2 for the vaginal approach and 18.1 + 3.5 for the abdominal approach with a mean difference of 8.7 {0.5 to 16.9} [95% CI]. Improved urinary symptoms and QOL; no cervical or uterine abnormalities detected on annual screening. Mean ± SD, UDI 6 score prior to surgery was a mean of 6 + 3.6 with a postop UDI 6 score of 1.5 + 2.6 and IIQ7 mean of 7.8 + 4.7 prior to surgery and a mean IIQ7 score of 1.4 + 3 in the postoperative period. All women underwent anti-incontinence surgery and posterior repair

Costantini et al., 2011 [35] case series

52

5 years

Apex: 100%; anterior: 92.3%; posterior: 94.3%

No POP > Stage 1

0%

Demirci et al., 2006 [36] case series

20

25 mos

Objective: 80%

No POP > Stage 0

Objective: 91 ASH vs. 92 TAH/ASC (NS); subjective: 85.3% ASH vs. 81.6% TAH/ASC (NS) Apical: 100% for both groups; Anterior: 44% ASH vs. 87% TAH/ASC; posterior: 83% ASH vs. 63% TAH/ASC; composite: 83% ASH vs. 100% TAH/ASC

Recurrence anterior/ posterior POP 1/20 (5%) 1/38 TAH/ASC (2.6%)

Point C at −6 or ASH significantly less intraoperative blood greater; no POP > loss, shorter operating time, and hospital Grade 1; absence stay. of POP or incontinence symptoms on UDI Point C/D + ASH 1 repeat Improvement on PGI-I 89% ASH vs. 87% (TVL-2) ≤ 0; no posterior TAH/ASC POP > Stage 1; repair, 1 anatomical cure endometrial plus absence of sampling; bulge symptoms TAH/ASC 2 mesh exposure excisions

Costantini et al., 34 ASH, 51 mos 2005 [55] 38 TAH/ prospective ASC cohort study

Cvach et al., 2012 [56] cohort study

18 ASH, 9 19 mos TAH/ ASC

Abbreviations: POP, pelvic organ prolapse; mos, months; ASH, abdominal sacrohysteropexy; TAH/ASC, total abdominal hysterectomy/abdominal sacrocolpopexy; VH/ USLS/VR, vaginal hysterectomy/uterosacral ligament suspension/vaginal repair; UDI, Urogenital Distress Inventory; QOL, quality of life; TVL, total vaginal length; PGI-I, Patient Global Impression of Improvement; RCT, randomized controlled trial.

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942 with mesh reperitonealization was 0.81 (95% CI, 0.1–1.70). Complications for subjects without mesh reperitonealization included four cystotomies, one urethrotomy, three postoperative ileuses, and one SBO. Among subjects with mesh reperitonealization, complications included five cystotomies, two proctotomies, one ureteral obstruction, and one SBO. The conclusion from the study was that there was no significant difference in rates of complications or readmissions among patients with or without mesh reperitonealization at the time of sacrocolpopexy.

Mesh complications

ME is a recognized complication of open ASC/ASH and can occur at any time point following the surgery. ME rates vary according to the synthetic material used with the overall ME rate reported by Nygaard et al. at 3.4% [12]. It is thought that the Amid classification of the material with regard to pore size and weave has a bearing on the risk of ME, with macroporous, monofilament meshes having lower ME rates compared with those having a microporous, multifilament design (Table 86.5). Currently, polypropylene mesh is the most commonly used mesh in prolapse surgery. For published ME rates to be meaningful, long-term follow-up of women with reporting of these data is crucial. The 7 year follow-up of the CARE trial reported a 10% probability of ME, much higher than previously reported [13]. It is important to note that 48% of women in this trial had Mersilene or GORE-TEX mesh, both of which are recognized to have higher rates of ME than polypropylene. ME may be affected by other factors. Concomitant hysterectomy may increase the risk of ME, with an ancillary study of the CARE trial reporting an OR of 4.9 [6]. The same study showed current smoking increased ME with an OR of 5.2. In a meta-analysis comparing ME between open ASC and LSC, no difference was found between the two procedures in terms of ME (OR, 1.45; 95% CI, 0.78–2.69). This analysis was performed on six studies involving 546 women undergoing LSC and 830 undergoing ASC [39]. In the study by Nosti, the ME rate was similar between the two groups (MISC, 3.21%; ASC, 2.6%; p = 0.2); however, there was a significantly increased risk of ME in those women who underwent concomitant total hysterectomy compared with supracervical hysterectomy (4.8% vs. 0.6%; p < 0.01) [40]. TABLE 86.5: Comparison of Mesh Type and Mean Exposure Rate Mesh Type Autologous or cadaveric fascia Polypropylene Polyethylene terephthalate Polytetrafluoroethylene Polyethylene Polytetrafluoroethylene a b c d e

Manufacturer

Mean Exposure Rates 0% (0/88)

Prolene, Ethicona Mersilene, Ethiconb

0.5% (1/211) 3% (25/811)

GORE-TEX, W.L. Gorec Marlex, Phillips Sumikad Teflon, EI Duponte

3.4% (12/350) 5% (20/402) 5.5% (6/119)

Prolene, Ethicon Endosurgery Inc., Blue Ash, OH. Mersilene, Ethicon Endosurgery Inc., Blue Ash, OH. W.L. Gore & Associates Inc., Flagstaff, AZ. Marlex, Phillips Sumika Polypropylene Co., Houston, TX. EI Dupont de nemours and Co., Wilmington, DE.

Management of ME requires thorough counseling of the patient. Rarely does conservative management with the application of topical estrogen rectify the problem. Most women will require surgical revision of the mesh with an initial vaginal approach to excise the exposed mesh. Complete excision of the mesh may be required if the initial partial excision fails. Quiroz et al. reported on a series of women undergoing mesh revision surgery, with only 48% success with initial vaginal surgery. Most women required more than one mesh revision, often through an abdominal approach [42]. Multiple case reports of SBO related to abdominal mesh or scar tissue occurring up to 14 years following ASC have been published, highlighting the need for ongoing follow-up of any women undergoing these procedures [32, 43–45]. A small number of case reports of discitis and osteomyelitis occurring 2 months–8 years after ASC have been published [46–49]. All required open exploration and removal of the mesh, with debridement of the L5–S1 disc.

Conclusion The open ASC or sacrohysteropexy is an effective procedure for the treatment of apical vaginal prolapse and continues to be the surgical approach for many surgeons. However, the morbidity associated with the open abdominal approach must be carefully weighed against potential benefits when considering this option. There are advantages and disadvantages of all techniques, and the decision should be based on the patient's needs and wishes once an evidencebased discussion has occurred. Relevant clinical factors in making this decision are the patient's age and general health, whether further pregnancies are desired, sexual activity, presence of dyspareunia, and vaginal length. The abdominal approach will be preferable in the presence of other abdominal pathology requiring treatment such as an ovarian cyst or when vaginal capacity is already reduced from prior surgery in a sexually active woman. In most cases, further vaginal surgery is more likely to decrease vaginal capacity and cause coital difficulty than the open abdominal approach. However, the vaginal approach may be preferable in the presence of adhesive disease increasing the difficulty and risk of an abdominal approach. Older women with medical comorbidities will be better served by shorter operations with a lower risk profile performed vaginally. The risk of recurrence may influence the decision in favor of the abdominal approach and the use of synthetic mesh. However, poor publicity and outcomes with vaginal mesh have also impacted patient's perceptions. The physician's surgical training, experience, and proficiency should have an influence on operative choice so that the procedure can be completed safely. Finally, pelvic floor dysfunction is frequently caused by multiple defect sites. Apical prolapse may be associated with rectoceles, perineal defects, and stress or fecal incontinence that may require concomitant correction and surgical repair. In many cases, these are best performed vaginally, so a combined approach may be indicated.

References

1. DeLancey JO. The anatomy of the pelvic floor. Curr Opin Obstet Gynecol August 1994;6(4):313–316. 2. Lane FE. Repair of posthysterectomy vaginal-vault prolapse. Obstet Gynecol July 1962;20:72–77. 3. Good MM, Abele TA, Balgobin S, Montoya TI, McIntire D, Corton MM. Vascular and ureteral anatomy relative to the midsacral promontory. Am J Obstet Gynecol June 2013;208(6):486.e1–486.e7.

Open Abdominal Approach to Supporting the Vaginal Apex

4. Abernethy M, Vasquez E, Kenton K, Brubaker L, Mueller E. Where do we place the sacrocolpopexy stitch? A magnetic resonance imaging investigation. Female Pelvic Med Reconstr Surg January–February 2013;19(1):31–33. 5. Boysen W, Adamsky M, Cohen A, Rodriguez J, Faris S, Bales G. Thirty-day morbidity of abdominal sacrocolpopexy is influenced by additional surgical treatment for stress urinary incontinence. Urology 2017;109:82–87. 6. Cundiff GW, Varner E, Visco AG et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol December 2008;199(6):688. e1–688.e5. 7. Tan-Kim J, Menefee SA, Luber KM, Nager CW, Lukacz ES. Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy. Int Urogynecol J 2011;22:205–212. 8. Warner WB, Vora S, Hurtado EA, Welgoss JA, Horbach NS, von Pechmann WS. Effect of operative technique on mesh exposure in laparoscopic sacrocolpopexy. Female Pelvic Med Reconstr Surg 2012;18:113–117. 9. Parkes IL, Shveiky D. Sacrocolpopexy for treatment of vaginal apical prolapse: evidence-based surgery. J Minim Invasive Gynecol 2014;21:546–557. 10. Chen L, Asthon-Miller JA, Hsu Y, DeLancey JO. Interaction among apical support, levator ani impairment, and anterior vaginal wall prolapse. Obstet Gynecol 2006;108:324–332. 11. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2013;(4):CD004014. pub5. 12. Nygaard IE, McCreery R, Brubaker L et al. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol October 2004;104(4):805–823. 13. Nygaard I, Brubaker L, Zyczynski HM et al. Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. May 15 JAMA 2013;309(19):2016–2024. 14. Maher CF, Qatawneh AM, Dwyer PL, Carey MP, Cornish A, Schluter PJ. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol January 2004; 190(1):20–26. 15. Benson JT, Lucente V, McClellan E. Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Am J Obstet Gynecol December 1996;175(6):1418–1421; discussion 1421–1422. 16. Lo T-S, Wang AC. Abdominal colposacropexy and sacrospinous ligament suspension for severe uterovaginal prolapse: a comparison. J Gynecol Surg 1998;14(2):59–64. 17. Braun HF, Fernandez M, Dell’Oro A, Gonzalez F, Cuevas R, Rojas I. Prospective randomised study to compare colposacropexy and Mayo McCall technique in the correction of severe genital central prolapse (Abstract number 19). Int Urogynecol J 2007;18(Suppl 1):12. 18. Rondini C, Braun H, Alvarez J, Descouvieres C, Wenzel C, Aros S. Prospective-randomized study comparing high uterosacral vault suspension vs. abdominal sacrocolpopexy for the repair of apical defects and vaginal vault prolapse (Abstract number 90). Neurourol Urodyn 2010;29(6):939. 19. Lim YN, Rosamilia A, Dwyer PL et al. Randomised controlled trial of posthysterectomy vaginal vault prolapse treatment with extraperitoneal vaginal uterosacral ligament suspension with anterior mesh reinforcement vs sacrocolpopexy (open/laparoscopic). Int Urogynecol J Pelvic Flood Dysfunct 2012;23(Suppl 2):S48–S49. 20. Sanses TVD, Shahryarinejad A, Molden S et al. Anatomic outcomes of vaginal mesh procedure (Prolift) compared with uterosacral ligament suspension and abdominal sacrocolpopexy for pelvic organ prolapse: A Fellows’ Pelvic Research Network study. Am J Obstet Gynecol November 2009;201(5):519.e1–519.e8. 21. Tate SB, Blackwell L, Lorenz DJ, Steptoe MM, Culligan PJ. Randomized trial of fascia lata and polypropylene mesh for abdominal sacrocolpopexy: 5-year follow-up. Int Urogynecol J February 2011;22(2):137–143. 22. Culligan PJ, Salamon C, Priestley JL, Shariati A. Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy: a randomized controlled trial. Obstet Gynecol 2013;121:143–151. 23. Quiroz LH, Gutman RE, Shippey S et al. Abdominal sacrocolpopexy: anatomic outcomes and complications with Pelvicol, autologous and synthetic graft materials. Am J Obstet Gynecol 2008;198:557.e1–557.e5. 24. Salamon CG, Lewis C, Priestley J, Gurshumov E, Culligan PJ. Prospective study of an ultra-lightweight polypropylene Y mesh for robotic sacrocolpopexy. Int Urogynecol J 2013;24:1371–1375. 25. Rogers R, Nolen T, Weidner A et al. Open sacrocolpopexy and vaginal apical repair: retrospective comparison of success and serious complications. Int Urogynecol J 2018;29(8):1101–1110. 26. Linder B, Occhino JA, Habermann EB, Glasgow AE, Bews KA, Gershman B. A national contemporary analysis of perioperative outcomes of open versus minimally invasive sacrocolpopexy. J Urol 2018;200(4):862–867.













943 27. Costantini E, Luigi M, Massimo L et al. Laparoscopic versus abdominal sacrocolpopexy: a randomized, controlled trial. J Urol 2016;196(1):159–165. 28. Walters MD, Karram MM. Urogynecology and Reconstructive Pelvic Surgery. 4th edition. Philadelphia: Elsevier; 2015. 29. Berek J. Berek & Novak's Gynecology. 16th edition. Philadelphia: Wolters Kluwer; 2020. 30. Lowenstein L, Fitz A, Kenton K, FitzGerald MP, Mueller ER, Brubaker L. Transabdominal uterosacral suspension: outcomes and complications. Am J Obstet Gynecol 2009;200:656.e1–656.e5. 31. Banu LF. Synthetic sling for genital prolapse in young women. Int J Gynaecol Obstet April 1997;57(1):57–64. 32. Barranger E, Fritel X, Pigne A. Abdominal sacrohysteropexy in young women with uterovaginal prolapse: long-term follow-up. Am J Obstet Gynecol November 2003;189(5):1245–1250. 33. Lewis CM, Culligan P. Sacrohysteropexy followed by successful pregnancy and eventual reoperation for prolapse. Int Urogynecol J July 2012;23(7):957–959. 34. Roovers JP, van der Vaart CH, van der Bom JG, van Leeuwen JHS, Scholten PC, Heintz APM. A randomised controlled trial comparing abdominal and vaginal prolapse surgery: effects on urogenital function. BJOG January 2004;111(1):50–56. 35. Costantini E, Lazzeri M, Zucchi A, Bini V, Mearini L, Porena M. Five-year outcome of uterus sparing surgery for pelvic organ prolapse repair: a single-center experience. Int Urogynecol J March 2011;22(3):287–292. 36. Demirci F, Ozdemir I, Somunkiran A, Doyran GD, Alhan A, Gul B. Abdominal sacrohysteropexy in young women with uterovaginal prolapse: results of 20 cases. J Reprod Med July 2006;51(7):539–543. 37. Meriwether K, Antosh D, Olivera C et al. Uterine preservation vs hysterectomy in pelvic organ prolapse surgery: a systematic review with meta-analysis and clinical practice guidelines. Am J Obstet Gynecol 2018;219(2):129–146. 38. Coolen A-LWM, Bui BN, Dietz V et al. The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis. Int Urogynecol J 2017;28:1767–1783. 39. Campbell P, Cloney L, Swati J. Abdominal versus laparoscopic sacrocolpopexy: as systematic review and meta-analysis. Obstet Gynecol Surv 2016;71(7):435–442. 40. Nosti PA, Andy UU, Kane S et al. Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg 2014;20:33–37. 41. Glass Clark SM, Shannon MB, Gill E, Clark MD, Lamb E, Carroll A. Complications after reperitonealization of mesh at time of sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg 2020:26(2):116–119. 42. Quiroz LH, Gutman RE, Fagan MJ, Cundiff GW. Partial colpocleisis for the treatment of sacrocolpopexy mesh erosions. Int Urogynecol J Pelvic Floor Dysfunct February 2008;19(2):261–266. 43. Pue LB, Lo T-S, Wu P-Y, Tan YL. Strangulated small bowel 14 years after abdominal sacrocolpopexy. J Obstet Gynaecol Res February 2014;40(2):611–613. 44. Vulliamy P, Berner AM, Farooq MS, Srilekha A. Near-fatal small bowel ischaemia secondary to sacrocolpopexy mesh. BMJ Case Rep 2013;2013:bcr2012008179. 45. Rozet F, Mandron E, Arroyo C et al. Laparoscopic sacral colpopexy approach for genito-urinary prolapse: Experience with 363 cases. Eur Urol February 2005;47(2):230–236. 46. Rajamaheswari N, Agarwal S, Seethalakshmi K. Lumbosacral spondylodiscitis: an unusual complication of abdominal sacrocolpopexy. Int Urogynecol J March 2012;23(3):375–377. 47. Grimes CL, Tan-Kim J, Garfin SR, Charles WN. Sacral colpopexy followed by refractory Candida albicans osteomyelitis and discitis requiring extensive spinal surgery. Obstet Gynecol August 2012;120 (2 Pt 2):464–468. 48. Weidner AC, Cundiff GW, Harris RL, Addison WA. Sacral osteomyelitis: an unusual complication of abdominal sacral colpopexy. Obstet Gynecol October 1997;90(4 Pt 2):689–691. 49. Collins SA, Tulikangas PK, LaSala CA, Lind LR. Complex sacral abscess 8 years after abdominal sacral colpopexy. Obstet Gynecol August 2011; 118(2 Pt 2):451–454. 50. Freeman RM, Pantazis K, Thomson A et al. A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study. Int Urogynecol J March 2013;24(3):377–384.

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51. Coolen A-LWM, van Oudheusden AMJ, J Mol BWJ, van Eijndhoven HWF, Roovers J-PWR, Bongers MY. Laparoscopic sacrocolpopexy compared with open abdominal sacrocolpopexy for vault prolapse repair: a randomized controlled trial. Int Urogynecol J 2017;28:1469–1479. 52. Ichikawa M, Kaseki H, Shigeo A. Laparoscopic versus abdominal sacrocolpopexy for treatment of multi-compartmental pelvic organ prolapse: a systematic review. Asian J Endosc Surg 2018;11(1):15–22. 53. Geller EJ, Parnell BA, Dunivan GC. Robotic vs abdominal sacrocolpopexy: 44-month pelvic floor outcomes. Urology 2012;79(3):532–536. 54. Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol November 2011;118(5):1005–1013.

Textbook of Female Urology and Urogynecology 55. Costantini E, Mearini L, Bini V, Zucchi A, Mearini E, Porena M. Uterus preservation in surgical correction of urogenital prolapse. Eur Urol October 2005;48(4):642–649. 56. Cvach K, Geoffrion R, Cundiff GW. Abdominal sacral hysteropexy: a pilot study comparing sacral hysteropexy to sacral colpopexy with hysterectomy. Female Pelvic Med Reconstr Surg September–October 2012;18(5):286–290. 57. Ballard A, Meyer I, Varner R, Gleason, J, Richter, H (2020). Pelvic Organ Prolapse. In J Berek and D Berek (Eds.), Berek & Novak's Gynecology (16th ed, p. 760). Philadelphia: Wolters Kluwer. 58. Mikhail S, Maher C. Surgical pathway for the treatment of pelvic organ prolapse. Obstet Gynaecol Reprod Med. 2018;28(4):105–109.

87

UTERINE PRESERVATION AND HYSTEROPEXY Roger P. Goldberg and Nani P. Moss

Uterine prolapse Uterine prolapse results from compromised muscular and connective tissue supports investing the pivotal region of the vaginal apex and cervix. Symptomatic uterine prolapse is one of the most common conditions encountered by urogynecologists. It is also a common finding within the general population, as demonstrated by the Women's Health Initiative (1), where over 16,000 women with a uterus were evaluated, and uterine prolapse (of any degree) was detected in 14.2%. Beyond the challenge of providing longlasting relief of symptoms associated with a vaginal bulge, it is also important for the pelvic reconstructive surgeon to remember that for many women, the uterus represents a valued symbol of sexual and reproductive identity. Rather than applying a uniform treatment to all uterine prolapse cases, today's surgical toolbox allows tailored therapies to address the goals of individual patients. Along with offering conservative treatment options, such as pelvic floor physical therapy (PFPT) and pessaries, gaining familiarity with uterine-sparing surgical procedures will enhance any surgeon's ability to match an appropriate procedure to specific clinical scenarios and patient treatment goals. Several risk factors have been identified for uterine prolapse. Age is an independent risk factor, and Swift et al. (2) identified a twofold increased incidence of severe pelvic organ prolapse (POP) with each additional decade of life. Parity and childbirth represent the primary risk factors associated with uterovaginal prolapse. Samuelsson et al. (3) reported a 44% versus 6% prevalence of genital prolapse among parous and nonparous women, respectively. Another population-based study (4) found that prolapse risk was significantly increased in women with one (OR, 2.8), two (OR, 4.1), and three or more (OR, 5.3) vaginal deliveries compared to nulliparous women. Non-obstetrical risk factors, in addition to age, include obesity, chronic heavy lifting, straining due to chronic constipation, chronic obstructive pulmonary disease, connective tissue disorders (5) including Marfan and Ehlers-Danlos syndromes, and neurological or spinal cord injury. Symptoms of uterine prolapse include vaginal bulging, pelvic heaviness, incomplete bladder emptying, and the need to splint to facilitate voiding. Low back and pelvic pain do not appear to exhibit significant associations with POP (6). Rates of symptomatic prolapse increase with advancing age from an estimated 6.6% among women aged 20–29 to 56% among those aged 50–59 (3). Urinary retention may accompany uterine prolapse, due to the concomitant prolapse of the anterior vaginal wall, with anatomic kinking of the urethra or obstruction of the bladder neck by the prolapsing cervix and uterus. Most women feel symptoms of prolapse when the leading edge reaches 0.5 cm distal to the hymen (7). The negative impact of symptomatic uterine prolapse on quality of life has been well-established (8). Using the International Continence Society's Pelvic Organ Prolapse Quantification (POP-Q) staging system (9), the degree of uterine prolapse can be quantified. For apical prolapse, the key measurement is point C, which represents the maximal prolapsed

DOI: 10.1201/9781003144243-95

position of the most distal edge of the anterior cervix or the vaginal cuff after hysterectomy with Valsalva. POP-Q point D may approximate the level of uterosacral ligament attachment to the proximal posterior cervix, and this point has debatable clinical utility, but it can be used along with point C to quantify cervical length. Cervical elongation, which may occur in up to onethird of women with pelvic prolapse (10), should be assessed by bimanual examination with palpation of the length of the cervix, and its relative location in the vagina, while the apical vagina is maximally elevated with the examining fingers suspending each lateral fornix and then by visualization using a full bivalve speculum to elevate the vaginal apex to the level of the ischial spines. If the cervix extends to mid-vagina or beyond even with the support of the apex, this suggests cervical elongation – with the implication that uterine-sparing surgery may be at higher risk for failing to relieve symptoms, even if the apex has been successfully resuspended. An elongated cervix should therefore be considered a relative contraindication to uterine preservation surgery. Absolute differences between POP-Q points C and D (“C-D discrepancy”) may provide a means to quantify and study cervical elongation, but clinical decisions tend to be based more on clinical assessment than quantitative cutoffs (11). As an alternative to the POP-Q system, the Baden-Walker “halfway” system (12) may be used to describe the position of the cervix relative to the hymen. Pelvic examination accompanied by Valsalva or repetitive coughing and examination in the standing position are often required to fully appreciate the degree of uterine descent and for accurate prolapse quantification regardless of which grading system is used. Accurate assessment of apical support is essential when considering surgical options for uterine prolapse, and surgeons should be aware that quantitative apical measurements may vary depending on how and where the assessment is performed. For instance, significant differences are observed between examinations performed in the office and in the operating room under anesthesia (13), with one study reporting that when examined under anesthesia with traction, point C may measure 3.5 cm lower on average in comparison with awake in-office examination of the same patient (14). This is an important consideration, as it can impact preoperative patient counseling and surgical consent. In our patients planning to undergo transvaginal POP repair, but whose office evaluation revealed “borderline” uterine descent, it is not unusual for our team to provide counseling on the possibility of discovering more significant uterine prolapse once they are relaxed under anesthesia. In these circumstances, having the patient aware and consented for possible hysteropexy can be of great value. For surgeons, gaining comfort with transvaginal hysteropexy methods (such as sacrospinous hysteropexy) creates great confidence that if an unexpected degree of apical descent is discovered during surgery, uterine suspension may be efficiently and effectively incorporated into the surgical procedure. Having this flexibility in the treatment of the apex, with every vaginal case, increases the likelihood of each vaginal surgery concluding 945

Textbook of Female Urology and Urogynecology

946 with an optimal outcome in which all compartments have been addressed.

Principles of uterine support The cardinal and uterosacral ligaments comprise the primary apical support structures of the uterus and upper vagina (15). These structures (misnamed “ligaments” as an historical footnote) are actually connective tissue condensations containing blood and lymphatic vessels, nerves, adipose tissue, and areolar loose connective tissue. In comparing the histologic composition of the apical ligaments between those with and without prolapse, there is no difference in smooth muscle content, but there is in the collagen composition. Those with prolapse have more type III collagen, which provides flexibility and distention to tissue and lower levels of type I collagen responsible for resistance to tension. The arrangement of collagen fibers also differs; those with prolapse have thicker and more loosely packed collagen fibers with increased distances between the fibers (13). The endopelvic fascia circumferentially envelops the vagina. The paracolpia are located laterally to and fuse with the endopelvic connective tissue often mislabeled “fascia” (16). The paracolpium is the caudal extension of the cardinal ligament, continuous with the parametrium, and helps to support the upper two-thirds of the vagina to the pelvic sidewall (17). The lateral aspect of the upper third of the vagina (level I) is suspended from the pelvic walls by vertical fibers of the paracolpium. In the middle third of the vagina (level II), the paracolpium attaches the vagina laterally to the arcus tendineus and to the fascia of the levators ani muscles (15). The cervix and vaginal apex should be regarded as central structures receiving numerous important connective tissue insertions including the proximal components of the pubocervical and rectovaginal septae and cardinal-uterosacral ligaments laterally and posteriorly. The overall architecture of the vagina largely relies on the integrity of these attachments and on a tethering of the vaginal apex and cervix to approximately the level of the ischial spines. Hysterectomy, by definition, involves transection of these connective tissue structures fusing through and around the paracervical ring and vaginal apex; hysteropexy, in contrast, elevates and suspends this nexus of apical connective tissues in its intact and undisturbed state. The levator ani complex provides a foundation of pelvic support. The levator ani musculature is exposed to substantial risk of damage during vaginal delivery with 10–30% of women sustaining avulsion injuries and denervation (18, 19). In a supplemental study of the Mothers’ Outcomes After Delivery (MOAD) study, a longitudinal cohort study of parous women, Handa et al. (19) found that levator avulsion was identified in 15% (66/453) of patients 6–17 years after vaginal delivery. Levator ani avulsion was more likely to occur after a forceps-assisted vaginal delivery with 45% (30/66) demonstrating the ultrasound finding after at least one forceps-assisted vaginal delivery. Levator avulsion was strongly associated with prolapse beyond the hymen (OR, 2.7; 95% CI, 1.3–5.7) and with symptoms of prolapse (OR, 3.0; 95% CI, 1.2–7.3). When well-toned and anatomically intact, the levator ani muscles maintain closure of the urogenital hiatus through which the urethra, vagina, and rectum pass. The hiatus is supported anteriorly by the pubic bones and the levator ani muscles, and posteriorly by the perineal body and external anal sphincter.

Sacrum

Uterus

Uterosacral and cardinal ligaments (level I support)

Vagina

Ischial spine

Pubic bone

Paravaginal support (level II support) Arcus tendineus

FIGURE 87.1  “It's all about the apex.” (From Seitz M, Goldberg RP, Uterine prolapse, in Cardozo L, Staskin D, eds, Textbook of Female Urology and Urogynecology, 4th ed., CRC Press, 2017, with permission.)

These muscles actively promote reflex urogenital hiatal closure during physical activity by compressing the vagina, urethra, and rectum against the pubic bone, the pelvic floor, and organs in the cephalad direction. The interaction between the pelvic floor muscles and the supportive ligaments is critical to pelvic organ support including normal suspension of the uterus. As long as the levator ani muscles properly maintain closure of the genital hiatus, the ligaments and fascial structures supporting the pelvic organs are buffered against excess physical stress and tension (20). Conversely, the disruption of levator ani architecture and, consequently, the levator plate axis are believed to represent the seminal events leading to strain on secondary and tertiary connective tissue supports leading to uterine prolapse. The levator plate is formed by an overlap of the puborectalis, iliococcygeus, and pubococcygeus muscle fibers, and its position is determined by the levator ani muscles (21). There are no existing surgical techniques to effectively repair pelvic floor musculature; therefore, compensatory repairs with the reinforcement of connective tissue supports represent the overarching goal when addressing the uterine prolapse of any degree. While all vaginal compartments should be addressed in order to achieve an optimal clinical outcome, elevating and suspending the apical connective tissues are crucial. This principle applies equally to cases involving hysterectomy and hysteropexy. As illustrated in Figure 87.1, “it's all about the apex.”

Treatments of uterine prolapse Patients with symptomatic uterine prolapse should be informed of the full array of treatment options starting with noninvasive measures such as pelvic floor physiotherapy and pessaries. Counseling on the “best” surgical procedural options should be individualized to each patient, taking into consideration the severity and anatomic sites of prolapse, comorbidities, and patient goals. Both hysterectomy and uterine preservation have unique pros and cons and meet different patient needs. Navigating these alternatives requires discussion and understanding of key anatomic factors, each patient's personal and cultural beliefs and expectations, and the technical expertise of the surgical team.

Uterine Preservation and Hysteropexy

Pelvic floor physical therapy The goal of PFPT is to reduce the impact of pelvic floor dysfunction by improving the function and strength of pelvic floor muscles (22) and thereby reduce symptoms associated with POP. Braekken et al. (23) compared PFPT to no intervention in women with symptomatic POP. Those in the PFPT group had significantly reduced frequency (74% vs. 31%; p < 0.0001) and bother (67% vs. 42%; p = 0.04) of prolapse symptoms of bulging and/or vaginal heaviness when compared with women in the control group. The POPPY trial was a multicenter randomized controlled trial of 447 women, the majority with Stage II POP, randomized to PFPT or to a prolapse lifestyle advice leaflet focused on weight loss, and avoidance of triggers such as constipation, heavy lifting, and chronic cough and high-impact exercise. Participants in the PFPT group had a significantly greater reduction in the POP symptom scores at 12 months (mean reduction from baseline 3.77 vs. 2.09, p = 0.005), and at 12 months, 57% in the intervention group and 45% in the control group reported better prolapse symptoms compared to their baseline (p = 0.01). Nearly half of the women in the control group (71/143 [50%]) pursued further treatment within 12 months, significantly more than in the intervention group (35/145 [24%]; p < 0.0001) (24). A more recent randomized trial of women with symptomatic POP, comparing pelvic floor muscle training to watchful waiting over a 2-year period, found that PFPT (n = 145) resulted in significantly greater improvement in the PFDI-20 score as compared to watchful waiting (n = 142). However, while the improvement in the PFDI-20 scores was significant (12.2-point reduction), this was below the a priori presumed minimal clinically important difference of 15 points. Self-reported improved symptoms, when compared to baseline, were improved in 43% of PFPT patients versus 14% in the watchful waiting group. There was no difference between the groups in the change in the degree of vaginal prolapse as measured by POP-Q. Post hoc analysis indicated that PFPT was more effective in women experiencing higher pelvic floor symptom distress at baseline (25). A 2016 meta-analysis identified 13 studies with 2,340 patients (26). Five trials with a total of 1,449 patients (PFPT group = 721 and control group = 728) reported on the number of patients who felt their prolapse symptoms were improved after PFPT intervention was higher (i.e., self-reported change in prolapse) as compared to controls (RR, 5.48; 95% CI, 2.19– 13.72). This meta-analysis also included four trials with a total of 607 patients who reported the change in prolapse severity by POP-Q. The pooled results showed significantly greater improvement in POP-Q score after PFPT in comparison with controls (RR, 1.70; 95% CI, 1.19–2.44). In looking at the individual compartments, the pooled results showed that PFPT resulted in a greater improvement for anterior prolapse (RR, 2.15; 95% CI, 1.38–3.35) but not for posterior prolapse (RR, 1.25; 95% CI, 0.64–2.43) as compared to controls. The specific impact of PFPT on objective apical support is not fully clear; however, one study by Wiegersma et al. (27) examined apical support, and they found no significant change in POP-Q stage between those who underwent PFPT as compared to women in the control group. The 2013 International Consultation on Incontinence report concluded that level I, grade A evidence supports PFPT for the treatment of POP (28). Nonetheless, patient knowledge and

947 perception of this option remain generally poor, with some prolapse patients dismissing the option of PFPT due to a lack of awareness of the potential benefits or apprehension over intravaginal exams. Adherence to therapy is often low as patients may be time-restricted, and symptom improvement may require multiple sessions. Patient education regarding treatment details and expectations for treatment goals may reduce the negative perception and anxiety surrounding PFPT (29).

Vaginal pessaries Vaginal pessaries are another conservative treatment option for symptomatic uterine prolapse, and they should be offered to nearly all patients. Physicians and their staff treating uterine prolapse should be proficient in the fitting of and caring for pessaries to provide an alternative for women with uterine prolapse who are poor surgical candidates or who wish to avoid or delay surgery. Chapter 43 will provide a more comprehensive overview of pessaries.

Surgery Historically, uterine prolapse has been treated reflexively with hysterectomy. However, today's surgical “toolbox” for uterine prolapse is broader and more capable of matching surgical techniques to individual patient expectations and needs. The surgeon's role is to help each patient create a surgical plan that carries the greatest odds of relieving symptoms and improving the quality of life, while minimizing the risk of complications and failure. Though achieving a successful objective anatomical cure remains an important goal, the ultimate benchmark for success today is based less on objective POP-Q measurements and more on subjective patient satisfaction. Uterine preservation expands the overall ability of our specialty to meet patient expectations and to accommodate their personal goals. Surgeons who gain expertise in hysteropexy methods, and who can integrate these techniques into their skill set, will enjoy the ability to offer an enriched and more flexible array of surgical options.

Vaginal versus abdominal uterine prolapse surgery Both vaginal and abdominal approaches to POP, and to hysteropexy in particular, have advantages and disadvantages. Factors for the surgeon to consider include perioperative risk, previous pelvic surgery, and the general health status of the patient. Vaginal surgery is relatively safe and efficient, minimizing entry into the peritoneal cavity and providing the ability to concurrently perform native tissue anterior and posterior vaginal wall repairs and midurethral slings. Abdominal hysteropexy methods provide an opportunity to incorporate mesh augmentation (sacrohysteropexy and sacrocervicopexy) – which may lead to improved anatomical success rates but with potentially increased morbidity. These abdominal hysteropexy options, along with its associated benefits and risks, will be covered in Chapter 86, Chapter 99, and Chapter 100. This chapter will focus on transvaginal methods. Viable techniques to address uterine prolapse should achieve an effective and durable suspension of the vaginal apex.

948

Hysterectomy versus uterine preservation The question of whether hysterectomy tends to help, hinder, or not significantly impact anatomical and subjective symptom improvement after POP surgery remains an interesting source of debate within our field. However, over the past decade, an increasing body of scientific evidence has emerged to inform the discussion. Decisions surrounding uterine preservation versus hysterectomy should be considered from both patient and physician perspectives, incorporating a variety of factors ranging from anatomical, health and general function, and psychosocial. Anatomically, uterine prolapse does not result from an intrinsic abnormality of the uterus itself but rather from relaxation or detachment involving the cardinal-uterosacral ligament complex and nearby vaginal apical supports. With hysterectomy, there is the purposeful detachment of what remains of the pivotal connective tissue supports and structures surrounding the vaginal apex, cervix, and paracolpium. The prevalence of post-hysterectomy vaginal vault prolapse is estimated at 0.2–43% with more recent data suggesting an incidence of 11.6% following hysterectomy for prolapse and 1.8% when performed for non-POP indications (30). Hysterectomy may increase the susceptibility of the anterior compartment to subsequent prolapse (31). An epidemiological study from Oxford (32) found that the risk of prolapse following hysterectomy was 5.5 times higher in women whose initial hysterectomy was performed for POP, as opposed to other reasons. The repair of post-hysterectomy prolapse may be even more challenging than the primary surgery due to an absence of normal connective tissue structure and strength. In theory, effective hysteropexy procedures may preserve the architecture of the vaginal apex better than hysterectomy, suspending rather than transecting the cardinal-uterosacral ligament complex and envelope of connective tissue attachments surrounding the paracervical ring. Patient choice is often a driving factor for uterine preservation, and a patient's choice may be multifactorial based on fertility, cultural beliefs, age, nationality, religious considerations, and personal preference (33). In one study exploring patient preferences regarding uterine preservation and hysterectomy in females undergoing surgery for POP, Korbly et al. (34) found that geographic region, educational level, and social class were predictors of preference for uterine preservation. Women achieving a higher educational level were more likely to choose hysteropexy compared with those who received a high school education or less. Women with an income >$80,000 were more likely to select uterine preservation (42% vs. 14%), and those who were premenopausal were twice as likely to decide on uterine preservation. Patients who believed the uterus was important for a sense of self were also more likely to choose uterine preservation (44% vs. 5%). Some studies have demonstrated that uterine preservation is associated with shorter operative time, less estimated blood loss (35–38), and a quicker recovery when compared with vaginal hysterectomy (39, 40). Hysteropexy also allows for knowledge of the natural timing of menopause (37). Younger women may occasionally pursue hysteropexy to preserve fertility. These cases require careful consideration and conservative counseling. Manodoro et al. (41) reviewed the data on pregnancies after prolapse surgery and concluded that the safest option for uterine prolapse included sacrospinous hysteropexy and high uterosacral ligament hysteropexy. They concluded that these procedures might be considered first-line treatments due to the higher level of evidence and lack of adverse obstetrical outcomes. All of the pregnancies included

Textbook of Female Urology and Urogynecology in their review were delivered by cesarean section (42, 43). The potential impact of pregnancy after uterine suspension and optimal delivery mode remains unanswered by the existing literature. Patients should be informed that the impact of the pregnancy on hysteropexy and the effect of the surgery on the pregnancy are unknown (33). We encourage women considering future childbearing to delay POP surgery (including hysteropexy), whenever possible, until after their family is complete. It has been hypothesized that hysterectomy can adversely affect sexual function by the disruption of the nerves and anatomic positions of the pelvic organs. Other possible factors that may contribute to sexual dysfunction after a hysterectomy include scarring or foreshortening of the vaginal apex, prevention of full ballooning of the upper vagina, and reduction in vaginal capacity for vasocongestion, with or without nerve damage, which could reduce arousal, reduce orgasm, or cause dyspareunia (33). Whether hysteropexy may help to preserve sexual function remains uncertain as the research on sexual function in women after surgical correction of POP is conflicting. In an observational prospective cohort study, Costantini et al. (44) evaluated the impact of uterus-sparing surgery or hysterectomy, both accompanied by colposacropexy, on sexual function. Both groups had significant improvements in the total Female Sexual Function Index (FSFI) score (sacrohysteropexy group: 24.3 vs. 19.1, p = 0.006; hysterectomy with CSP 22.4 vs. 19.1, p = 0.010) as well as in the domains of desire, arousal, and orgasm. Furthermore, median postoperative scores of desire, arousal, and organism showed a significant improvement in the uterussparing group compared to the hysterectomy group. In contrast, Jeng et al. (45) found a decrease in the frequency of orgasm after both vaginal hysterectomy and sacrospinous hysteropexy, and no significant differences in postoperative sexual function were observed between the two groups. Nager et al. (46) studied sexual function in a randomized controlled trial comparing vaginal mesh sacrospinous hysteropexy to vaginal hysterectomy with native tissue repair, and among 175 subjects, 40% were sexually active before surgery. According to the PISQ-IR total score, sexual function improved by an adjusted mean of 0.4 points (95% CI, 0.2–0.6) after hysteropexy and 0.3 points (95% CI, 0.1–0.5) after hysterectomy (p = 0.69). Dyspareunia among sexually active women decreased from 38% to 19% after hysteropexy and 46% to 16% after hysterectomy. Postoperative dyspareunia occurred in 10% after hysteropexy and 2% after hysterectomy group (risk difference, 0.07; 95% CI, 0.01–0.14; p = 0.03). De novo dyspareunia, as measured by the PISQ-IR, was only recorded in three women in the hysterectomy group and two in the hysteropexy group. Overall, surgical safety, and the risk of complications which in some cases may be related to patient-specific comorbidities and/ or previous intra-abdominal surgery, must be factored into decisions relating to hysterectomy versus uterine preservation. In a retrospective case-control study, Yuan et al. (36) examined the adverse events associated with vaginal surgery for uterovaginal prolapse after sacrospinous hysteropexy and hysterectomy procedures. One hundred and thirty hysteropexy (89 sacrospinous, 41 uterosacral) patients were matched to 260 concurrent hysterectomy (6 sacrospinous, 253 uterosacral, 1 both) patients. Hysterectomy cases within this cohort were longer, had higher blood loss, and a longer hospital stay in comparison with hysteropexy. The overall incidence of adverse events was 29.0% in the hysterectomy group versus 10.5% in hysteropexy cohort (p = 0.02). In a subanalysis comparing sacrospinous hysteropexy

Uterine Preservation and Hysteropexy with uterosacral hysteropexy, there were no significant differences in adverse events. A decision to remove rather than preserve the uterus, in some cases, is influenced largely by the goal of eliminating the risk of future interventions for pathology such as fibroids, cervical dysplasia and cancer, or endometrial hyperplasia and cancer. In a retrospective analysis of pathology findings after reconstructive pelvic surgery with hysterectomy, 17 of 644 patients (2.6%) had unanticipated premalignant or malignant uterine pathology, with two (0.3%) having endometrial carcinoma (47). Finally, it should be acknowledged that vaginal hysterectomy is an alternative that is associated with a long and established track record of success. This factor of hysterectomy being “tried and true” and culturally familiar may provide a significant degree of reassurance for women. This needs to be acknowledged during surgical decision-making. Before performing a uterus-sparing procedure, abnormal uterine bleeding and/or undiagnosed gynecologic symptoms should be addressed. An up-to-date cervical cytology, as per screening recommendations for each patient's age and prior history, is necessary. While there are no guidelines mandating endometrial tissue sampling in women planning hysteropexy without high-risk factors such as excessive unopposed estrogen, irregular bleeding, or a strong family history for endometrial carcinoma, the decision to perform endometrial biopsy or a PAP test should be considered by surgeons based on a patient's specific risk factors for present and future pathology. Contraindications to uterine preservation include the presence of cervical or uterine pathology (i.e., dysplasia and undiagnosed bleeding) and a significant risk of developing endometrial, cervical, or ovarian cancer in women who are unable to comply with routine gynecological surveillance (48). Uterine preservation operations fall into two major categories: (i) hysteropexy procedures that attempt to reconstruct normal anatomy and (ii) obliterative procedures designed to resolve the prolapse bulge and not preserve the normal anatomy of the vagina. Here, we will discuss the vaginal uterine-sparing procedures to treat uterine prolapse: sacrospinous hysteropexy, uterosacral hysteropexy, the Manchester-Fothergill (uterine sparing), and the obliterative, LeFort colpocleisis discussed in Chapter 88.

Uterine-sparing procedures Hysteropexy procedures may be performed vaginally or abdominally, with mesh (abdominally placed) or utilizing suture-based native tissue methods. Yet, even today, many surgeons still reflexively consider hysterectomy as a necessary component of uterovaginal prolapse repair and do not offer hysteropexy as an option despite the fact that descriptions of uterine-sparing prolapse repairs in the scientific literature date back to the 1880s. Alwin Mackenrodt (1859–1925) provided an early description of prolapse, with an accurate description of the cardinal and uterosacral ligaments. Thomas Watkins (1898) described an interposition operation for postmenopausal women, involving cervical amputation and fixation of the bladder against the posterior uterine wall, thereby elevating the lower uterine segment. Dr. Watkins advised against uterine removal for prolapse unless the organ was diseased. By the end of the 19th century, several techniques had been proposed for ventral fixation of the uterine fundus to the abdominal wall by surgeons including Harris, Murphy, and Kocher. In the early 20th century, a combined vaginal and abdominal procedure including dilatation and

949 curettage, trachelorrhaphy, anterior and posterior colporrhaphy, and abdominal uterosacral plication with uterine suspension was described. Influential gynecological surgeons have suggested that the uterus plays a passive rather than active role in uterovaginal prolapse (49). Dr. David Nichols, in his classic textbook on vaginal surgery, described the uterus as an innocent bystander, “… the result of genital prolapse and not the primary cause of the symptomatology” (50). In 2004, Diwan et al. (51) concluded that hysterectomy had not been proven to improve the durability of POP repair and may instead carry several disadvantages including increased morbidity, blood loss, operative and recovery times, increased pelvic neuropathy, and disruption of natural support structures. The authors cited a potential risk for new-onset urinary incontinence, bladder dysfunction, prolapse, and possibly adverse effects on sexual identity with hysterectomy. In addition, uterine preservation procedures may be associated with shorter operative time, less blood loss, and faster return to activities compared with hysterectomy (35–38, 41). These potential benefits of hysteropexy will naturally vary according to the route of hysteropexy and experience of the surgical team. While the published literature on transvaginal hysteropexy may not account for all subtle differences relating to factors such as dissection technique, choice of suture, and surgeon experience, there is a solid base of evidence establishing its safety and efficacy.

Sacrospinous hysteropexy

An early case series of sacrospinous hysteropexy included an initial report on five patients by Richardson et al. in 1989 (52). In 1993, Kovac and Cruikshank (53) described the successful vaginal deliveries in 5 of 19 patients undergoing sacrospinous hysteropexy, performed by a posterior approach to the sacrospinous ligament with unilateral fixation of the apex. These authors reported successful long-term support even among four of five younger women undergoing subsequent pregnancy and childbirth. While promising, these results did not include the more rigorous objective and subjective measures presently used to define failure and success. Several studies have compared outcomes of sacrospinous hysteropexy with vaginal hysterectomy accompanied by vaginal apical suspension. In 2001, Maher et al. (35) retrospectively compared 34 patients who underwent sacrospinous hysteropexy with 36 patients who underwent vaginal hysterectomy with sacrospinous ligament fixation. Standardized questionnaires and blinded postoperative examinations were performed at a mean follow-up of 33 months in the hysterectomy group and 26 months in the hysteropexy group (p = 0.34). The subjective success, defined as no awareness of prolapse, was 86% in the hysterectomy group and 78% in the hysteropexy group (p = 0.7). Objective success rate, described as no prolapse beyond the mid-vaginal point, was 72% in the hysterectomy patients, and 74% in the hysteropexy group (p = 1.00). Rates of patient satisfaction were high for both groups: 85% for hysteropexy and 86% for vaginal hysterectomy (p = 0.64). Hefni et al. (39), in 2003, compared 61 sacrospinous hysteropexy cases to 48 vaginal hysterectomies with sacrospinous ligament fixation. The two groups had comparable satisfactory results (93.5% of the hysteropexy group vs. 95.9% in the hysterectomy group, p = 0.6) and similar rates of cervical and/or vault descent (hysteropexy group: 4.9% vs. hysterectomy group = 4.1%; p = not significant). Four patients had recurrent uterovaginal prolapse after sacrospinous hysteropexy, three were symptomatic and requested surgical intervention with hysterectomy, while two

950 patients after vaginal hysterectomy underwent repeat procedures for recurrent vaginal vault prolapse. In another observational study, Dietz et al. (54) evaluated 133 women after sacrospinous hysteropexy. At a mean follow-up time of 22 months, 99 patients returned questionnaires about urogenital symptoms and quality of life, with only 60 presenting for a postoperative exam. These investigators reported a 2.3% recurrence rate for uterine descent requiring surgery; however, 35% of subjects developed a subsequent cystocele. The same authors performed a randomized controlled trial where sixty-six women were randomized to receive a sacrospinous hysteropexy (n = 35, only 34 followed up at 1 year) or vaginal hysterectomy (n = 31) for the treatment of stage 2–4 uterine prolapse (40). At 1 year, 27% (9/34) of the subjects who underwent sacrospinous hysteropexy had recurrent uterine prolapse to stage 2 or beyond, as compared to only one in the vaginal hysterectomy group (p = 0.01). Of note, three patients who were randomized to receive a sacrospinous hysteropexy had stage 4 prolapse prior to surgery, and these three experienced recurrent uterine descent within 1 year. Eighteen (51%) of the patients who had a sacrospinous hysteropexy developed stage 2–4 anterior vaginal wall prolapse compared to 20 (64%) patients who had a vaginal hysterectomy (p = 0.3). The SAVE U trial is the largest randomized controlled trial evaluating sacrospinous hysteropexy published to date (55). In this study, 208 patients with stage ≥ 2 uterine prolapse were randomized to undergo sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension. After 12 months, bothersome symptoms or repeat surgery were reported by four subjects in the vaginal hysterectomy treatment arm versus none in the hysteropexy group (56). In the 5-year follow-up of the SAVE U trial (57), which included 204 of the original 208 patients, surgical failure of the apical compartment was seen in 3% (3/102) of those who underwent sacrospinous hysteropexy and in 7% (7/102) in the vaginal hysterectomy group. Apical prolapse beyond the hymen was seen in 0% (0/102) of those who had a hysteropexy and in 4% (4/101) in the vaginal hysterectomy group. Three of 102 women (3%) underwent surgery for recurrent prolapse in the sacrospinous hysteropexy group compared with 7 of 102 women (7%) in the vaginal hysterectomy group. A meta-analysis by Kapoor at al. (58) found similar results when comparing sacrospinous hysteropexy and vaginal hysterectomy. The authors included two randomized controlled trials and four cohort studies. There was no significant difference reported in apical failure rate between the two groups, although the trend favored outcomes after vaginal hysterectomy. Most published studies on suture-based sacrospinous hysteropexy have reported only short-term outcomes. However, one observational cohort study by Ng et al. (59) attempted to assess long-term outcomes, with a mean follow-up of 13.3 years, among patients who underwent sacrospinous hysteropexy and vaginal hysterectomy with sacrospinous vaginal vault suspension. The study included 139 women with stage 3 or 4 POP: 75 (54%) in the hysterectomy group and 64 (46%) who had undergone sacrospinous hysteropexy. For patients who underwent sacrospinous hysteropexy, 7 (11%) reported failure, 23 (35.9%) reported improvement, and 34 (53.1%) reported success. For those who underwent hysterectomy and sacrospinous ligament fixation, 9 (12%) reported failure, 30 (40%) reported improvement, and 36 (48%) reported success. There was no statistically significant difference in the subjective success rate between women who underwent uterine

Textbook of Female Urology and Urogynecology preservation as compared to those who underwent hysterectomy (89% vs. 88%, p > 0.05). Studies report that approximately 85% of patients are highly satisfied with sacrospinous hysteropexy (35, 54). One study examining patient's quality of life and urogenital and defecatory symptoms before and after sacrospinous hysteropexy demonstrated improved scores in all domains of urogenital symptoms and defecatory symptoms, with the exception of pain and fecal incontinence subscales. Self-reported quality of life was improved for all domains, and no major complications were encountered in this cohort. Sacrospinous hysteropexy and vaginal hysterectomy were found to be equally effective in improving urogenital/defecatory symptoms, with no differences found in quality-of-life scores and self-reported urogenital/defecatory symptoms at 1-year follow-up between the two procedures (60). Lin et al. (61) performed a stepwise cohort study to examine risk factors for anatomic failure after sacrospinous hysteropexy and found that preoperative prolapse of the uterus beyond the introitus and cervical elongation were independent risk factors for recurrent prolapse. This conclusion is supported by Dietz et al. (40). As previously mentioned, surgeons should regard cervical elongation as a relative contraindication to sacrospinous hysteropexy; although some surgeons may have anecdotal experience performing partial trachelectomy to reduce cervical dimensions at the time of hysteropexy, this approach cannot be guided by the published literature. Traditionally, sacrospinous hysteropexy is performed as a unilateral fixation to the posterior aspect of the cervix, with a posterior (rectocele) approach to the ligament. As detailed by Richter and Albrich (62), Nichols (63), Morley and DeLancey (64), and others, the vagina is usually suspended to the patient's right side to avoid the rectosigmoid anatomy. The vaginal apex is attached, using either permanent or absorbable sutures, to the mid-portion of the sacrospinous ligament with care, as the most serious complications from this repair are trauma to the pudendal neurovascular structures and inferior gluteal vessels. In a study to simulate sacrospinous ligament fixation, and describe the relevant anatomy, Katrikh et al. (65) used eight freshtissue cadavers. They described that the fourth sacral spinal nerve was seen most commonly associated with the medial third of the ligament. The pudendal nerve and the nerves to coccygeus and levator ani muscles were associated with the lateral third. The inferior gluteal artery was seen leaving the greater sciatic foramen a median 15.8 mm (range, 1.8–48.0; CI, 14.9–22.3) above the ligament, whereas the internal pudendal artery exited just posterior to the ischial spine. Two sets of sutures were placed 20.5 mm (range, 9.2–34.4; CI, 19.7–24.7) and 24.8 mm (range, 12.4–46.2; CI, 24.0–30.0) medial to the ischial spine, respectively. No structures were directly damaged by the suture placement. The nerves to the coccygeus and levator ani were closest and those to arteries were farthest from the placed sutures. This study emphasizes that the middle segment of the sacrospinous ligament has the lowest incidence of nerves and arteries, and it is the safest location to place sutures (Fig. 87.2). The classical right-sided sacrospinous suspension has limitations. First, the vagina deviates to one side, creating an esthetic, but not usually functional, disadvantage. Secondly, the traditional sacrospinous fixation technique appears to confer a significant risk of recurrent anterior vaginal wall relaxation (66). For the past 20 years, our center has utilized an approach whereby the sacrospinous ligaments are accessed through the

Uterine Preservation and Hysteropexy

951 5 4 3 2 S4 S3 S2 S1

1 Rectum

6 Sciatic nerve 7 Pudendal nerve and artery 8 Inferior gluteal artery 9 Ischial spine 10 Coccygeus muscle (overlying sacrospinous ligament)

11 Sacrospinous ligament (under coccygeus muscle)

FIGURE 87.2  Sacrospinous ligament anatomy and fixation of suture into the mid-portion of the sacrospinous ligament: 1, rectum; 2, S1; 3, S2; 4, S3; 5, S4; 6, sciatic nerve; 7, pudendal nerve and artery; 8, inferior gluteal artery; 9, ischial spine; 10, coccygeus muscle (overlying sacrospinous ligament; 11, sacrospinous ligament (under coccygeus muscle).

anterior rather than posterior dissection, with bilateral, rather than unilateral suspension of the apex. For the vast majority of cases, fixation into the sacrospinous ligament is performed with no vaginal retractors, utilizing a push-and-catch suturing device. We have found the bilateral anterior approach to anchoring the vaginal apex to the sacrospinous ligament allows the surgeon to address the anterior compartment with the same dissection, providing an opportunity to address anterior compartment prolapse, if present. In 2001, our group published the results of a retrospective cohort study of consecutive sacrospinous vaginal vault suspension procedures with 92 posterior suspensions and 76 anterior suspensions. After anterior sacrospinous vault suspension, vaginal length and apical suspension were slightly increased, and recurrent anterior vaginal prolapse decreased compared with the posterior sacrospinous method. Upper vaginal caliber and sexual function were preserved using either technique (67). The anterior approach to the sacrospinous ligament was also described by Cespedes (68) who reported on 28 women undergoing bilateral sacrospinous apical suspension. At a mean follow-up of 17 months (range 5–35), one patient had an asymptomatic unilateral grade 1 vault prolapse, and two patients developed small asymptomatic cystoceles. Our center has used the anterior bilateral sacrospinous method for 20 years, and we have found certain benefits to be extremely consistent: it results in a balanced suspension with less narrowing of the upper vagina and less unilateral deviation that tends to be associated with the traditional posterior method with excellent preservation of total vaginal length.

For cases of uterine prolapse accompanied by advanced cystoceles, the anterior sacrospinous hysteropexy has been combined with augmentation of the anterior compartment with a biograft or polypropylene mesh (69). One study by Seitz et al. (70) compared allograft- and mesh-reinforced anterior sacrospinous hysteropexy, using the anterior sacrospinous method, and a composite outcome for failure. Among 274 patients returning for 1-year postoperative examination, the sacrospinous mesh hysteropexy group had fewer objective POP recurrences and also a better composite score (19% vs. 33%; p = 0.007) when compared to allograft-reinforced sacrospinous hysteropexy cohort. Fewer patients in the mesh group felt a bulge at 1 year (4.5% vs. 20.9%; p < 0.0001), and QOL questionnaire data improved more in the mesh than in the allograft group (p < 0.0001). Mesh hysteropexy is no longer an available treatment option, and graft augmentation is largely beyond the scope of this chapter; nonetheless, this study remains notable as it offers a rare comparison of two materials used to augment sacrospinous hysteropexy with an estimate of their long-term impact. In a retrospective cohort study, 50 women undergoing suture-based anterior unilateral sacrospinous hysteropexy were compared to 97 undergoing vaginal hysterectomy with apical suspension. Symptomatic (94% vs. 94%; p = 1.000), anatomic (93% vs. 92%; p = 1.000), and composite success (92% vs. 92%; p = 1.000) were high in both hysteropexy and hysterectomy groups, respectively. Six percent of patients in each group reported postoperative bulge symptoms. Among patients undergoing anterior sacrospinous hysteropexy, three patients were subsequently re-treated for symptomatic prolapse: two of them fitted

952 with a pessary, and one received surgical management. In the hysterectomy group, three patients were fitted for a pessary, and none underwent surgery. Median time to symptomatic failure, in both groups, was 7.5 months (38). The most common complications of sacrospinous ligament fixation during hysteropexy are bleeding, and gluteal pain, with other complications including rectal injury and ureteral injury. Hemorrhage is most commonly due to the laceration of the inferior gluteal or pudendal vessels (71). Buttock pain has a reported incidence rate of 9% (55). This symptom often resolves spontaneously. In the randomized controlled trial by Detollenaere et al. (56), 9 of 103 patients experienced buttock pain, with 8 reporting their pain resolved within the first 6 weeks. The patient with persistent pain underwent sacrospinous hysteropexy suture cutting and hysterectomy after 4 months. Her pain resolved after the removal of the suture. This is consistent with a literature review by Dietz et al., which noted that persistent buttock pain was the most common indication for further surgery after sacrospinous hysteropexy (72). Gluteal pain after sacrospinous suspension is a known and accepted complication of sacrospinous fixation, which resolves spontaneously with rare exception. The presence of more severe pain radiating to the labia and other areas of pudendal innervation and/or weakness or numbness should raise concern over pudendal nerve entrapment and lead to early suture removal. At our center, although self-limited peripheral nerve injuries have been encountered, including the occasional need to remove a suture due to postoperative gluteal pain, pudendal vascular injuries have been completely avoided by suturing into, and never over, the ligament. This translates into a fixation point on the sacrospinous ligament located from one to two fingerbreadths medial to the ischial spine.

Anterior sacrospinous hysteropexy technique: a few technical notes

By entering proper planes and staying cognizant of a few key steps, the anterior sacrospinous hysteropexy technique should involve minimal blood loss. A vertical anterior vaginal incision is made from the bladder neck to the vaginal apex (just distal to the cervix). The anterior vaginal epithelium is dissected from the underlying bladder and endopelvic connective tissue using a combination of sharp (Metzenbaum scissors) and blunt dissection in the standard fashion of the anterior colporrhaphy. This dissection is carried out laterally to the descending pubic rami, distally to the bladder neck, and cephalad to the cervix. Using a blunt dissection technique, sweeping along the surface of the obturator muscle laterally and posteriorly in the paravesical plane until the ischial spine becomes palpable. Establishing the right plane during this “sweeping” motion is critical, and it is best accomplished by maintaining firm lateral pressure with the index finger against the medial obturator surface. “Pressing laterally and sweeping down,” following the course of the arcus tendineus remnants, the ischial spine is reached. Once the ischial spine is palpated, the sacrospinous-coccygeus complex can be located as the firm, fixed soft tissue just medial to the spine. With modern suturing devices, if the ischial spine is palpated, it is not necessary to widely dissect the surrounding anatomy. One needs only a large enough space to accommodate the suturing device and one finger (some surgeons prefer to introduce two fingers into the space) and a palpable “target” along the mid-ligament approximately 2 cm medial to the ischial spine. This minimized

Textbook of Female Urology and Urogynecology dissection technique may help to reduce the risk of intraoperative bleeding and postoperative pain. The bladder and paravesical tissues can then be retracted medially using the inserted index finger, as the push-and-catch suturing device is gently introduced into the dissection tunnel. The head of the device is stabilized against the ligament. The suture is placed into the sacrospinous ligament located approximately 2 cm medial to the ischial spine. Several commercially available devices now provide two free suture ends, and either a delayedabsorbable or permanent suture may be used. The dissection and suture placement are then repeated on the contralateral side. At this point, an anterior colporrhaphy may be performed if clinically appropriate. Proper anchoring of the SSL sutures into the vaginal apex, or in the case of hysteropexy, the cervix, is essential for success, as suture pullout from these locations poses the greatest risk for failure. For the bilateral technique, each sacrospinous suture (permanent monofilament or delayed absorbable suture) is most commonly anchored into the vaginal apex approximately 1 cm lateral to the cervical edge at 3 and 9 o’clock. In other words, “hysteropexy” with this method is actually a bilateral sacrospinous colpopexy with the cervix not being directly sutured but rather being elevated into position as each side of the vaginal apical support is restored. If a unilateral sacrospinous hysteropexy technique is performed, then two suspension sutures are usually passed directly into the cervical stroma – a true “cervicopexy/ hysteropexy” fixation. Alternatively, one suture may be placed in the cervix at the level of the internal cervical stroma on the right and the left sacrospinous suture may be placed at the left vaginal apex. The sacrospinous suspension sutures are then tied resulting in suspension of the cervix and the vaginal apex. The authors of this chapter have found that both unilateral and bilateral sacrospinous hysteropexy methods provide reliable functional outcomes and that gaining proficiency with both of these techniques, as well as both posterior and anterior methods, creates great flexibility to meet the needs of different anatomical scenarios. However, it should be noted that for the posterior approach, we perform only right-sided unilateral cervical fixation using two sutures. This is because with the posterior approach, attempting a bilateral fixation may introduce a risk of restricting the anterior rectal wall – which may lead to obstructed defecation symptoms and/or rectal discomfort. In contrast, the anterior approach allows the option of bilateral vaginal fixation with no discernable risk of de novo defecatory function. The bilateral anterior sacrospinous hysteropexy approach has provided impressive aesthetic, anatomical, and functional outcomes. With experience, this may be performed with a short operative time and often as an outpatient procedure.

Mesh-augmented sacrospinous hysteropexy: a few historical notes

Mesh-augmented sacrospinous hysteropexy was utilized and studied until the FDA categorically withdrew approval for transvaginal mesh products for the repair of POP in April 2019. While this method is no longer available, and while discussion of the significant controversies relating to transvaginal POP mesh is well beyond the scope of this chapter, the clinical results achieved with this hysteropexy technique are worth mentioning – particularly since they were eventually studied with robust, highly structured multicenter randomized clinical trials. Sacrospinous hysteropexy utilizing anterior-apical mesh, delivered without

Uterine Preservation and Hysteropexy trocars into the sacrospinous ligaments, was published early by Vu et al. (73) in 2012 in an observational series reporting a 1-year recurrence rate of 1.89% (no anterior and one apical prolapse [C ≥ 1] with recurrence defined as POP-Q Stage ≥2 in the anterior and/or apical compartments. PFDI scores were improved in all domains postoperatively. There were no surgeries performed for recurrence, and 93% of patients reported they would choose the surgery again. The risk of vaginal mesh exposure associated with this repair was 1.9%. Kulkarni et al. (74) completed a prospective patient preference study comparing 50 women with stage ≥ 2 uterine descent after vaginal hysterectomy to 51 women undergoing bilateral meshaugmented sacrospinous hysteropexy. The primary outcome was defined as the absence of stage ≥ 2 apical prolapse, and secondary outcomes included a composite cure of no leading edge beyond the hymen, absence of bulge symptoms, and no re-treatment. Patient-reported outcomes were also reported using validated questionnaires. At a median follow-up of 25 months (range of 23–96 months), no differences were observed in objective apical outcomes; stage 2 prolapse occurred in 0% after vaginal hysterectomy (VH) and in 2% after mesh hysteropexy (p = 0.50). No differences were found in the composite cure rate (78% VH vs. 85% HP (HP stands for hysteropexy); p = 0.45) between the groups. Surgical complications per Clavien-Dindo classification were similar between groups (p = 0.33), and surgery for mesh exposure was performed in 2% of women in the mesh hysteropexy group. In the United States, the Pelvic Floor Disorders Network conducted a large, multicenter-blinded RCT including 183 women randomized to either vaginal hysterectomy with uterosacral suspension or bilateral mesh-augmented sacrospinous hysteropexy called the SUPeR Trial (46). A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The 3-year follow-up data were published in September 2019. Among 169 (97%) patients, there were no differences between hysteropexy and hysterectomy groups. The investigators used a primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) assessed with survival models. The adjusted failure incidence was 24% in the hysteropexy group versus 36% in the hysterectomy group (p = 0.06; 95% CI, 0.37–1.02). The mean operative time was shorter in the hysteropexy group versus the hysterectomy group (111.5 [SD, 39.7] min vs. 156.7 [SD, 43.9] min; difference, −45.2; 95% CI, −57.7 to −32.7; p ≤ 0.001). Adverse events in the hysteropexy versus hysterectomy groups included mesh exposure (8% vs. 0%), ureteral kinking managed intraoperatively (0% vs. 7%), and presence of granulation tissue after 12 weeks (1% vs. 11%). Permanent suture exposure occurred more commonly after hysterectomy (21%) versus hysteropexy (3%) after 12 weeks. In the 5-year follow-up to the SUPeR Trial, 156 (89%) completed all study visits (75). The primary outcome showed fewer failures for hysteropexy compared to hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% CI, 0.36–0.94; p = 0.03), with failure rates of 37% versus 54%, respectively, resulting in a difference of −18% (95% CI, −33% to −3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% (129/183) of participants reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy versus hysterectomy included

953 mesh exposure (8% vs. 0%), granulation tissue after 12 weeks (1% vs. 12%), and suture exposure after 12 weeks (3% vs. 21%), respectively.

Uterosacral hysteropexy

Hysteropexy involving the uterosacral ligaments may be performed abdominally or vaginally and remains a feasible uterine suspension technique. In this chapter, our focus is limited to the vaginal approach. There are relatively few published studies of vaginal uterosacral ligament hysteropexy, when compared to the literature focused on the sacrospinous method. One retrospective study by Milani et al. (42) compared transvaginal uterosacral hysteropexy with vaginal hysterectomy and uterosacral suspension. Fifty-two patients underwent uterosacral hysteropexy and completed at least 1 year of follow-up. These patients were matched with 52 controls who underwent transvaginal hysterectomy with uterosacral ligament suspension. Hysteropexy was associated with shorter operative time and less bleeding compared with hysterectomy (p < 0.0001), and complication rates were similar between groups. The anatomic cure rate was 73.1% in the hysteropexy group and 75.0% after hysterectomy (p = 0.82); however, the rate of apical recurrence was significantly higher in the hysteropexy group (21.2% vs. 1.9%; p = 0.002). Notably, 9 out of 11 recurrences (81.8%) in the hysteropexy group were associated with cervical elongation (mean, 6.7 ± 1.5 cm). The reoperation rate was significantly higher after hysteropexy (13.5% vs. 1.9%; p = 0.04). Interestingly, subjective recurrence rates and patient satisfaction evaluated with the Patient Global Impression of Improvement (PGI-I) were comparable between groups. In the hysteropexy group, three of seven patients (42.9%) desiring subsequent childbirth became pregnant and delivered at term by elective cesarean section. One patient not desiring childbirth terminated an unwanted pregnancy. In another observational study by Romanzi and Tyagi (76), 200 patients with Baden-Walker grade 2–4 uterine prolapse underwent uterosacral ligament hysteropexy (n = 100) or vaginal hysterectomy (n = 100) between 1994 and 2011. Women in the hysterectomy group were older (mean, 57 vs. 57; p = 0.001) and more likely to be postmenopausal (73% vs. 45%; p = 0.0001). Uterine and anterior vaginal wall prolapse were similar between the groups, but patients in the uterosacral ligament hysteropexy group presented at baseline with higher grade rectoceles. Of the 51 women with grade 3–4 uterine prolapse, 41 elected for uterine preservation and 10 chose vaginal hysterectomy. Three apical recurrences were noted in each group. All three patients with uterosacral hysteropexy recurrences had initially presented with grade 3 uterine prolapse at baseline, and all recurred within 3 months of the procedure. In the vaginal hysterectomy group, vaginal vault prolapse recurred between 8 months and 2 years. In this study, three patients in the hysteropexy group returned for hysterectomy unrelated to prolapse: one due to a personal history of breast cancer, another for BRCA-positive status, and the third for rapidly enlarging fibroids. Each underwent vaginal hysterectomy with no technical challenges or complications associated with the prior hysteropexy. One premenopausal nulliparous patient conceived 1.5 years after her hysteropexy, delivering by elective cesarean section at term. She remained prolapse-free through the pregnancy and at 6 weeks postpartum. In a smaller case series of 40 women undergoing transvaginal uterosacral ligament hysteropexy from 2009 to 2017 (77), after a

954 mean follow-up of 17.2 months, all patients had significant objective improvement (p < 0.001) and also improvement in urinary incontinence and overactive bladder symptoms (p < 0.001). No patients within this cohort underwent reoperation for symptomatic POP. Uterosacral hysteropexy methods vary; however, a standard approach would involve a transverse incision along the posterior vaginal fornix with entry into the posterior cul-de-sac to gain access into the peritoneal cavity. The uterosacral ligaments are identified with the application of traction on the incised vagina. We find the ligament is most consistently identified with direct upward/ventral traction with clamps placed on the lateral aspect of the posterior vaginal incision at around 4 and 8 o’clock. Alternatively, Allis clamps may be placed transperitoneally to grasp the caudal portion of the ligament itself. Up to three sutures may be placed and target the proximal ligament near the ischial spine, then 1–2 cm proximally. To reduce the risk of ureteral injury, the direction of needle penetration should be lateral to medial in order to avoid accidental deviation. The posterior arm of the suture is passed through the peritoneum and vaginal fornix, while the anterior arm of the suture may be passed through the peritoneum, paracervical ring (78), and vaginal fornix. When these sutures are tied, the cervix is suspended and the colpotomy is closed (79). A concurrent partial trachelectomy has also been described as an adjunct to uterosacral hysteropexy (42). An extraperitoneal technique for uterosacral suspension has been described by Ossin et al. (80). In a case series of 15 patients with a median follow-up of 24 weeks (range 21–100 weeks), the subjective cute rate, defined as resolution of prolapse symptoms, was 100% (15/15), and the reoperation rate was 0% (0/15). There were no suture exposures, and no ureters were obstructed. This procedure begins by incising the posterior vaginal wall and dissecting both sharply and bluntly into the perirectal space. Once the perirectal space is opened, the uterosacral ligament and the posterior cervical stroma can be identified. Grasping the vaginal epithelium with an Allis clamp near the distal insertion of the uterosacral ligament can help to identify the ligament. Once visualized, an Allis clamp is placed on the ligament at the level of the ischial spine, which then allows for medial traction to draw the uterosacral ligament away from the ureter. The authors then describe placing a 0-polypropylene suture through the left uterosacral ligament with two passes in a reefing fashion at the level of the Allis clamp. The procedure is then repeated on the contralateral side. A culdoplasty is then performed by placing a second 0-polypropylene suture distal to the previously placed suture in the left uterosacral ligament, then the posterior cervical stroma, and then the contralateral ligament. The remaining 0-polypropylene sutures are then passed into the posterior cervical stroma, and tied, resulting in suspension.

The Manchester-Fothergill procedure

The Manchester procedure was first described and performed in 1888 by Archibald Donald of Manchester, England. In 1921, Dr. Donald's protégé William Edward Fothergill augmented the procedure with suturing the cardinal ligaments to the remaining cervical stump (81). While technically a uterine-sparing procedure, traditionally it was a surgery to repair true cervical elongation (41). While not widely performed in the United States, it is gaining popularity in Europe (82). To perform, a circumferential incision of the cervix is made followed by dissection of the bladder off of the cervix and lower uterine segment. The uterosacral ligament and cardinal ligament are

Textbook of Female Urology and Urogynecology clamped, cut, and suture ligated. The cervix is amputated at the lower uterine segment. A Sturmdorf suture is placed next, and it is responsible for reattaching the posterior vaginal epithelium to the truncated cervix. The suture is placed in the posterior vaginal epithelium in the midline, and then, the two ends of the suture are brought through the dilated cervix and then exteriorized through the posterior vaginal epithelium. The uterosacral cardinal ligament complex is then reattached to the anterior aspect of the lower uterine segment. The Sturmdorf suture is also placed anteriorly and then tied. At this stage, an anterior and posterior colporrhaphy and perineorrhaphy can be performed (82). In a retrospective, matched cohort study, Thys et al. (81) reported no differences in POP symptoms, objectified recurrence rates, and re-intervention rates at 75 months between those receiving the Manchester-Fothergill procedure (n = 98) versus vaginal hysterectomy (n = 98). Patients in the ManchesterFothergill group were significantly more likely to have postoperative urinary retention (34% vs. 11%). Ayhan et al. (83) performed a retrospective observational study, and they evaluated 204 patients (mean age, 34.68 ± 4.24 years) with grade 2–3 uterine prolapse undergoing the Manchester procedure; 95.1% had associated cystoceles, and 51.3% had associated rectoceles. Postoperatively, 27 patients (13.2%) had febrile morbidity, urinary retention occurred in 45 (22.0%), and 23 (11.3%) developed cervical stenosis. Within the 1st year, one patient underwent abdominal hysterectomy because of an unsuccessful cervical dilation, and at a mean of 3.6 years following the procedure, eight patients (3.9%) had undergone a vaginal hysterectomy for recurrent uterine prolapse. Another retrospective cohort study by de Boer et al. (84) sought to compare a modified Manchester procedure with a vaginal hysterectomy and uterosacral ligament suspension. After 1 year, no patients in the modified Manchester group had recurrent apical prolapse, as compared to 2 (4%) in the vaginal hysterectomy group. Anterior and posterior compartment prolapse recurrences (stage ≥ 2) were similar between groups. The Manchester operation is not widely utilized in North America but is still used in the United Kingdom and Europe. It may be an effective treatment for select cases in women who wish to retain their uterus. It is unclear whether the procedure is effective in patients presenting with severe uterine prolapse and/ or cervical elongation as most studies involve mixed populations.

Obliterative uterine-sparing procedure: LeFort colpocleisis

The LeFort colpocleisis represents an excellent alternative for a select group of older women with severe prolapse, who are not sexually active with penetrative vaginal intercourse and have no plans to resume these activities in the future, and who wish to undergo a low-morbidity surgical repair with quick recuperative times. The LeFort (partial colpocleisis) was first described by its namesake in 1877, and it results in the closure of the vagina, leaving small (pencil-width) lateral channels on each side (85). The LeFort procedure and total colpocleisis are thoroughly described in Chapter 88.

Conclusion Uterine prolapse is among the most common conditions encountered by reconstructive pelvic surgeons and remains challenging even in experienced hands, not only with respect to achieving a long-lasting favorable outcome but also in terms of

Uterine Preservation and Hysteropexy navigating individual patient beliefs, priorities, and treatment goals. Conservative therapies such as PFPT and pessary management remain important and effective strategies that should be offered as an alternative to surgical repair. For patients electing to undergo surgery, vaginal hysterectomy followed by apical suspension remains a common and appropriate solution for many patients. On the other hand, surgeons should be aware that removal of the uterus, in anatomical terms, may often confer no structural benefits and arguably may disrupt more than benefit apical structure and support in some cases. Uterine prolapse, after all, is most often a result of disordered vaginal apical supports rather than the cause, in other words, an “innocent bystander.” Vaginal hysteropexy is an effective alternative whose efficacy has been established by an increasingly robust body of scientific evidence, particularly for the sacrospinous hysteropexy. Although numerous questions remain open for future research, the existing evidence suggests that favorable results may be achieved using uterine-preserving surgery. Both subjective and objective outcomes are, according to many studies, generally equivalent to the traditional vaginal hysterectomy approach. Undoubtedly, surgeon experience and proper patient selection are critical factors that will ultimately predict consistently favorable outcomes and high rates of satisfaction. As new and improved minimally invasive hysteropexy techniques emerge, uterine preservation may have the potential for increased appeal among both surgeons and patients. Choosing the “right” treatment strategy for uterine prolapse, whether surgical or nonsurgical, should take into consideration the individual patient's sexual and reproductive activity, personal feelings, sites and degrees of pelvic prolapse, concurrent pelvic pathology, and overall health status. By offering several treatment alternatives, clinicians may help to ensure that the largest number of symptomatic patients achieve their personal goals.

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References

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956 35. Maher CF, Carey MP, Slack MC, Murray CJ, Milligan M, Schluter P. Uterine preservation or hysterectomy at sacrospinous colpopexy for uterovaginal prolapse? Int Urogynecol J Pelvic Floor Dysfunct. 2001;12:381–4. 36. Yuan AS, Chang OH, Ferrando CA. Perioperative adverse events in women undergoing vaginal prolapse repair with uterine preservation versus concurrent hysterectomy: a matched cohort study. Female Pelvic Med Reconstr Surg. 2021 Jan 19. doi: 10.1097/SPV.0000000000001011. Epub ahead of print. PMID: 33476105. 37. Ridgeway BM. Does prolapse equal hysterectomy? The role of uterine conservation in women with uterovaginal prolapse. Am J Obstet Gynecol. 2015 Dec;213(6):802–9. 38. Plair A, Matthews C. Native tissue sacrospinous hysteropexy from an anterior approach. Int Urogynecol J. 2020 Nov 21. doi: 10.1007/s00192-02004601-0. Epub ahead of print. PMID: 33219824. 39. Hefni M, El-Toukhy T, Bhaumik J, Katsimanis E. Sacrospinous cervicocolpopexy with uterine conservation for uterovaginal prolapse in elderly women: an evolving concept. Am J Obstet Gynecol. 2003;188:645–50. 40. Dietz V, van der Vaart CH, van der Graaf Y, Heintz P, Schraffordt Koops SE. One-year follow-up after sacrospinous hysteropexy and vaginal hysterectomy for uterine descent: a randomized study. Int Urogynecol J. 2010 Feb;21(2):209–16. 41. Manodoro S, Braga A, Barba M, Caccia G, Serati M, Frigerio M. Update in fertility-sparing native-tissue procedures for pelvic organ prolapse. Int Urogynecol J. 2020 Nov;31(11):2225–31. 42. Milani R, Manodoro S, Cola A, Bellante N, Palmieri S, Frigerio M. Transvaginal uterosacral ligament hysteropexy versus hysterectomy plus uterosacral ligament suspension: a matched cohort study. Int Urogynecol J. 2020 Sep;31(9):1867–72. 43. Cavkaytar S, Kokanalı MK, Tasdemir U, Doganay M, Aksakal O. Pregnancy outcomes after transvaginal sacrospinous hysteropexy. Eur J Obstet Gynecol Reprod Biol. 2017;216:204–7. 44. Costantini E, Porena M, Lazzeri M, Mearini L, Bini V, Zucchi A. Changes in female sexual function after pelvic organ prolapse repair: role of hysterectomy. Int Urogynecol J. 2013 Sep;24(9):1481–7. 45. Jeng CJ, Yang YC, Tzeng CR, Shen J, Wang LR. Sexual functioning after vaginal hysterectomy or transvaginal sacrospinous uterine suspension for uterine prolapse: a comparison. J Reprod Med. 2005 Sep;50(9):669–74. 46. Nager CW, Visco AG, Richter HE, et al. Effect of vaginal mesh hysteropexy vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: a randomized clinical trial. JAMA. 2019 Sep 17;322(11):1054–65. 47. Frick AC, Walters MD, Larkin KS, Barber MD. Risk of unanticipated abnormal gynecologic pathology at the time of hysterectomy for uterovaginal prolapse. Am J Obstet Gynecol. 2010 May;202(5):507.e1–507.e4. 48. Gutman RE. Does the uterus need to be removed to correct uterovaginal prolapse? Curr Opin Obstet Gynecol. 2016;28(5):435–40. 49. Bonney V. The principles that should underlie all operations for prolapse. J Obstet Gynaecol Br Empire. 1934;41:669–83. 50. Nichols DH, Randall CL. Types of prolapse. In Nichols DH, Randall CL, eds. Vaginal Surgery, Baltimore: Williams & Wilkins, 1996: 107–9. 51. Diwan A, Rardin CR, Strohsnitter WC, et al. Laparoscopic uterosacral ligament suspension compared with vaginal hysterectomy with vaginal vault suspension for uterovaginal prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17:79–83. 52. Richardson DH, Scotti R, Ostergard D. Surgical management of uterine prolapse in young women. J Reprod Med. 1989;34:388–92. 53. Kovac SR, Cruikshank SH. Successful pregnancies and vaginal deliveries after sacrospinous uterosacral fixation in five of nineteen patients. Am J Obstet Gynecol. 1993;168:1778–83. 54. Dietz V, de Jong J, Huisman M, Schraffordt Koops S, Heintz P, van der Vaart H. The effectiveness of the sacrospinous hysteropexy for the primary treatment of uterovaginal prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18:1271–6. 55. Detollenaere RJ, den Boon J, Stekelenburg J, et al. Treatment of uterine prolapse stage 2 or higher: a randomized multicenter trial comparing sacrospinous fixation with vaginal hysterectomy (SAVE U trial). BMC Womens Health. 2011 Feb 15;11:4. 56. Detollenaere RJ, den Boon J, Stekelenburg J, et al. Sacrospinous hysteropexy versus vaginal hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse stage 2 or higher: multicenter randomized non-inferiority trial. BMJ. 2015 Jul 23;351:h3717.



57. Schulten SFM, Detollenaere RJ, Stekelenburg J, IntHout J, Kluivers KB, van Eijndhoven HWF. Sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension in women with uterine prolapse stage 2 or higher: observational follow-up of a multicentre randomised trial. BMJ. 2019 Sep 10;366:l5149. 58. Kapoor S, Sivanesan K, Robertson JA, Veerasingham M, Kapoor V. Sacrospinous hysteropexy: review and meta-analysis of outcomes. Int Urogynecol J. 2017 Sep;28(9):1285–94. 59. Ng S-C, Tsui K-P, Huang L, Chen G-D. Effects of uterine preservation on long-term subjective outcomes of sacrospinous ligament fixation for the treatment of pelvic organ prolapse. Eur J Obstet Gynecol Reprod Biol. 2019 Sep;240:167–71. 60. Dietz V, Huisman M, de Jong JM, Heintz PM, van der Vaart CH. Functional outcome after sacrospinous hysteropexy for uterine descensus. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19:747–52. 61. Lin TY, Su TH, Wang YL, Lee MY, Hsieh CH, Wang KG, Chen GD. Risk factors for failure of transvaginal sacrospinous uterine suspension in the treatment of uterovaginal prolapse. J Formos Med Assoc. 2005; 4:249–253. 62. Richter K, Albrich W. Long-term results following fixation of the vagina on the sacrospinal ligament by the vaginal route (vaginaefixatio sacrospinalis vaginalis). Am J Obstet Gynecol. 1981 Dec 1;141(7):811–6. 63. Nichols DH. Sacrospinous fixation for massive eversion of the vagina. Am J Obstet Gynecol. 1982;142:901–4. 64. Morley GW, DeLancey JO. Sacrospinous ligament fixation for eversion of the vagina. Am J Obstet Gynecol. 1988;158:872–81. 65. Katrikh AZ, Ettarh R, Kahn MA. Cadaveric nerve and artery proximity to sacrospinous ligament fixation sutures placed by a suture-capturing device. Obstet Gynecol. 2017 Nov;130(5):1033–38. 66. Shull BL, Capen CV, Riggs MW, Kuehl TJ. Preoperative and postoperative analysis of site-specific pelvic support defects in 81 women treated with sacrospinous ligament suspension and pelvic reconstruction. Am J Obstet Gynecol. 1992; 166: 1764–8. 67. Goldberg RP, Tomezsko JE, Winkler HA, Koduri S, Culligan PJ, Sand PK. Anterior or posterior sacrospinous vaginal vault suspension: long-term anatomic and functional evaluation. Obstet Gynecol. 2001 Aug;98(2):199–204. 68. Cespedes RD. Anterior approach bilateral sacrospinous ligament fixation for vaginal vault prolapse. Urology. 2000 Dec 4;56(6 Suppl 1):70–5. 69. Jirschele K, Seitz M, Zhou Y, Rosenblatt P, Culligan P, Sand P. A multicenter, prospective trial to evaluate mesh-augmented sacrospinous hysteropexy for uterovaginal prolapse. Int Urogynecol J. 2015 May;26(5):743–8. 70. Seitz M, Jirschele K, Tran A, et al. A comparison of sacrospinous hysteropexy augmented with polypropylene mesh versus human dermis at 12-month follow-up: an ambidirectional study. Female Pelvic Med Reconstr Surg. 2020 Oct;26(10):607–11. 71. Doğanay M, Aksakal O. Minimally invasive sacrospinous ligament suspension: perioperative morbidity and review of the literature. Arch Gynecol Obstet. 2013 Jun;287(6):1167–72. 72. Dietz V, Schraffordt Koops SE, van der Vaart CH. Vaginal surgery for uterine descent; which options do we have? A review of the literature. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Mar;20(3):349–56. 73. Vu MK, Letko J, Jirschele K, et al. Minimal mesh repair for apical and anterior prolapse: initial anatomical and subjective outcomes. Int Urogynecol J. 2012;23:1753–61. 74. Kulkarni M, Young N, Lee J, Rosamilia A. Hysterectomy with uterosacral suspension or Uphold™ hysteropexy in women with apical prolapse: a parallel cohort study. Int Urogynecol J. 2020 Oct;31(10):2137–46. 75. Nager CW, Visco AG, Richter HE, et al. Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5 year results of a randomized clinical trial. Am J Obstet Gynecol. 2021 Mar 11:S0002– 9378(21)00163-0. doi: 10.1016/j.ajog.2021.03.012. Epub ahead of print. PMID: 33716071. 76. Romanzi LJ, Tyagi R. Hysteropexy compared to hysterectomy for uterine prolapse surgery: does durability differ? Int Urogynecol J. 2012 May;23(5):625–31. 77. Aserlind A, Garcia AN, Medina CA. Uterus-sparing surgery: outcomes of transvaginal uterosacral ligament hysteropexy. J Minim Invasive Gynecol. 2021 Jan;28(1):100–6. 78. López CC, De Los Ríos JF, González Y, et al. Barbed suture versus conventional suture for vaginal cuff closure in total laparoscopic hysterectomy: randomized controlled clinical trial. J Minim Invasive Gynecol. 2019;26(6):1104–09. 79. Milani R, Frigerio M, Spelzini F, Manodoro S. Transvaginal uterosacral ligament hysteropexy: a video tutorial. Int Urogynecol J. 2017;28(5):789–91.

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80. Ossin D, Ramirez-Caban L, Hurtado E. Extraperitoneal uterosacral ligament hysteropexy: a novel treatment for apical compartment prolapse. Urology. 2020 Jun;140:181–2. 81. Thys SD, Coolen A, Martens IR, et al. A comparison of long-term outcome between Manchester Fothergill and vaginal hysterectomy as treatment for uterine descent. Int Urogynecol J. 2011 Sep;22(9):1171–8. 82. Walsh CE, Ow LL, Rajamaheswari N, Dwyer PL. The Manchester repair: an instructional video. Int Urogynecol J. 2017 Sep;28(9):1425–27. 83. Ayhan A, Esin S, Guven S, Salman C, Ozyuncu O. The Manchester operation for uterine prolapse. Int J Gynaecol Obstet. 2006 Mar;92(3):228–33.

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84. de Boer TA, Milani AL, Kluivers KB, Withagen MI, Vierhout ME. The effectiveness of surgical correction of uterine prolapse: cervical amputation with uterosacral ligament plication (modified Manchester) versus vaginal hysterectomy with high uterosacral ligament plication. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Nov;20(11):1313–9. 85. FitzGerald MP, Richter HE, Siddique S, Thompson P, Zyczynski H, Ann Weber for the Pelvic Floor Disorders Network. Colpocleisis: a review. Int Urogynecol J Pelvic Floor Dysfunct. 2006 May;17(3):261–71.

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SURGERY FOR UROGENITAL PROLAPSE Colpocleisis Emilly Santos and G. Willy Davila Colpocleisis is the partial or complete closure of the vaginal canal to prevent prolapse of the genital organs. This was once a controversial procedure within the reconstructive surgeon's armamentarium. As we have witnessed the aging of our population, with many elderly women wanting to maintain their active lifestyle, colpocleisis has achieved a renewed status as a standard and proven option for women with advanced prolapse who want a simple, low-risk procedure to address an otherwise complex problem.

Background When faced with an elderly woman, typically over 80 years of age with multiple medical comorbidities and uterovaginal prolapse beyond the hymenal ring, what surgical options can you offer her? Pessaries may be a viable option, but many women with large degrees of prolapse may not be satisfactorily fit with a pessary, and pessary care may present a series of daunting challenges. Often a pessary may not be the right answer for many of these women, and a surgical option may be preferred. Surgically, closure of the vaginal canal under spinal, light general or even local anesthesia may be the optimal approach for women who have not been sexually active for many years – and are highly unlikely to be sexually active for the rest of their lives (1). This is a situation where colpocleisis becomes a valuable part of our surgical armamentarium. As the elderly population has grown around the world, more women are entering the 8th and 9th decades of their life. In 2020, around 1 in 6 Americans are of age 65 and over, and this is projected to rise to 1 in 5 as soon as 2030 (2). This not only represents a change in age composition but also a large increase in the number of older Americans, from 56 million in 2020 to 73 million in 2030, according to the United States Census Bureau. Pelvic organ prolapse (POP) is a common problem in women whose prevalence increases with age, with approximately 200,000 surgical procedures performed for prolapse in the United States each year (3, 4). This disorder decreases the quality of life due to urinary and defecatory dysfunction, recurrent urinary tract infections and alterations in self-image. It has been reported that 1 in 9 women over age 80 will undergo surgery for incontinence or genital prolapse (5). There are several approaches to the surgical management of symptomatic POP, and these should all be taken into account when selecting procedures to recommend to patients (6). Reconstructive approaches may offer restoration of vaginal depth and function. Obliterative procedures, such as colpocleisis, accomplish prolapse reduction by the closure of the vaginal canal in a predominantly less invasive approach (7, 8). Colpocleisis offers a highly effective, minimally invasive option for women who cannot tolerate, or do not desire, extensive reconstructive surgery and who do not desire future vaginal intercourse (9). 958

Historical aspects Colpocleisis is arguably the prolapse correction surgery with the longest track record. This useful procedure was first described by Gerardin in 1823, but it was not until 1877 that Léon Clément LeFort, a French surgeon, performed and published the technique for the procedure now known as LeFort partial colpocleisis in a dissertation entitled “Defects in conformation of the uterus and vagina and remedies”. This technique, although old, is still widely used, especially in the United States, where it still accounts for 20% of procedures for prolapse, without any decrease in recent years (10).

Indications and preparation Traditionally, colpocleisis was reserved for frail elderly patients, at high surgical risk, with advanced POP who were thought to be unsuitable candidates for traditional vaginal reconstructive procedures. More recently, increasing numbers of older, but otherwise healthy, women, are choosing this option for its high success rate and quick recovery. Factors that should be considered include the women's age, medical comorbidities, degree of prolapse and especially desire for future intercourse (11). Patient counseling is of utmost importance because postoperative intercourse is precluded. But in the properly selected patient, reported regret is low. We frequently involve the husband or partner in the discussion regarding surgical options. Since erectile dysfunction is extremely common in elderly men, sexual function is frequently described in ways other than vaginal intercourse. It is imperative that the clinician having the discussion with the patient – and possibly her family – be comfortable with initiating the discussion regarding sexual function and the desires of the patient. For some women, having a closed vagina can impact their self-image – even if they are not sexually active – and this factor should be discussed. During the initial office evaluation, the pelvic exam should include a careful speculum exam with a visual inspection of the cervix and vagina with palpation of the entire vagina. A bimanual and rectal exam should be done with cervical cytology, transvaginal ultrasound (TVUS) and endometrial sampling when indicated. The role of TVUS as a preoperative tool in the assessment of gynecologic pathology has been suggested by several authors. We recommend a TVUS in all advanced POP patients in order to confirm no endometrial or adnexal pathology is present. If a partial colpocleisis is performed, reaching the cervix may be very difficult. If there is any suspicion of pelvic pathology, colpocleisis may not be a viable option for the patient – at least until the pathology is evaluated. Vaginal tissue quality should be assessed prior to a planned colpocleisis. If there is vaginal ulceration, it should be allowed

DOI: 10.1201/9781003144243-96

Surgery for Urogenital Prolapse to heal completely prior to any surgery since submucosal tissues will certainly be involved making intraoperative dissection difficult. Alternatively, surgical planning should include the potential of excluding the ulceration from the operative area. This may be possible if the ulceration is restricted to the apical region. Due to the high incidence of reduced mobility in this population, positioning during surgery can be challenging. We “practice” high lithotomy positioning during the preoperative evaluation in order to ascertain whether appropriate positioning would be achievable. There will frequently be reduced lateral mobility in 1 hip or the other, and this should be noted as part of surgical planning. Routine urogynecological preoperative evaluation should be performed. We recommend multichannel urodynamics in all advanced POP patients. In a colpocleisis candidate, management of any urodynamic abnormalities should be performed as in any POP patient undergoing reconstructive surgery. Approximately half of these women will have latent urodynamic stress incontinence with the reduction of their prolapse. Elderly women have a higher incidence of detrusor overactivity, intrinsic sphincteric deficiency and urinary retention. Intra- and post-operative care may need to be adjusted in order to optimize bladder function after colpocleisis. Surgical preparation should include medical clearance as with any elderly patient. This is particularly important in this population due to the high prevalence of associated comorbidities. Many of these patients are on anticoagulants, and these should be stopped for 3–5 days preoperatively to prevent hematoma formation. The role of local estrogen cream to improve vaginal epithelial health cannot be overemphasized. We recommend local estrogen cream ½–1 gram twice a week at bedtime – when already in bed – for at least 6 weeks before surgery in order to achieve better tissue quality with better vascularization, microbiome and overall improved vaginal health. Asymmetrical POP (i.e. a very large cystocele with significantly less posterior POP) may also be addressed with a colpocleisis, but preoperative planning needs to be performed in order to determine the sites and sizes of the dissection rectangles to be approximated front to back. The rectangles will also need to be asymmetric in size.

959 (or not) of hysterectomy and management of an enlarged genital hiatus. Our preferred modified technique entails the creation of two large rectangles – one on the anterior wall (Fig. 88.1) and the other along the posterior wall (Fig. 88.2) – which are approximated anterior to posterior with dissolvable sutures for the edges and the submucosal tissues (12). We mark the anterior and posterior rectangles with sterile markers at the initiation of the procedure – the distal edge along the hymeneal remnants along the anterior and posterior vaginal wall and the proximal extent based on the degree of symmetry of the prolapse. If the cervix is present, enough vaginal epithelium needs to be left in situ proximally to be able to cover the cervix without tension on the sutures. We then inject the entire area of the rectangles with hemostatic 1% lidocaine with epinephrine (Fig. 88.3). We remove the vaginal epithelium within each rectangle with sharp dissection preserving as much underlying endopelvic connective tissue as possible (Fig. 88.4). Once hemostasis is achieved, we initiate closure. We typically separate the procedure into two segments: proximal and distal for ease of closure. We initially approximate the proximal ½ of the rectangle edges and deep tissues anterior to posterior (Fig. 88.5). We then close the distal ½ and include an anti-incontinence sling at this point if indicated. Closure of the deep submucosal tissues (Fig. 88.6) is critically important, as the main reason for the failure of a colpocleisis is the formation

Techniques Colpocleisis vs. colpectomy

Colpocleisis involves closure of the midportion of the vagina, leaving the lateral edges intact as two lateral channels. Colpectomy involves the removal of all the vaginal epithelium and the closure of the entire vagina. Colpocleisis is simpler and leaves the more vascular lateral vaginal edges alone, and potential blood loss is less with colpocleisis. It is also a faster procedure, and there is no reported difference in long-term success rates.

Our preferred technique

Through our extensive experience with colpocleisis, we have adopted a standard approach to colpocleisis which is a modified version of the original LeFort approach. The original LeFort approach entailed a series of narrow vertical mucosal channels which would be approximated front to back with silver sutures. There have been many reported modifications of this technique over the years. Modifications have included sizes of the rectangles, techniques for mucosal dissection, suture choice, performance

FIGURE 88.1  Anterior vaginal wall rectangle marked with sterile marking pen.

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FIGURE 88.4  Anterior rectangle after vaginal mucosa has been sharply resected.

FIGURE 88.2  Posterior vaginal wall rectangle marked with sterile marking pen.

FIGURE 88.3  Vaginal epithelium within the marked rectangles infiltrated with hemostatic agent.

FIGURE 88.5  Rectangles are approximated front to back starting with the proximal cut edges.

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FIGURE 88.7  Distal portion rectangles are approximated front to back, and deep potential spaces are closed. FIGURE 88.6  Submucosal tissues approximated front to back to prevent hematoma formation. of a subcutaneous hematoma with the disruption of suture line healing. It is therefore important to maintain hemostasis. Once we have completed the closure of the distal part of the rectangle (Fig. 88.7), the colpocleisis is completed. We then perform a perineoplasty at the end of the procedure – in order to add support to the colpocleisis by reducing the size of the introitus to 1 cm. We mark the perineoplasty site with a marking pen such that only the urethral meatus is visible once the perineal tissues are approximated side to side (Figs. 88.8 and 88.9). We prefer 2-0 vicryl sutures for the procedure. If the procedure is for a recurrence, we will use 2-0 Prolene sutures for the epithelial edges and are very methodical in the closure of the deep tissues to prevent hematoma formation. The included images provide clarity to this technique. In addition, our technique has been featured in video format in various publications which are accessible online.

Variations in colpocleisis technique

Various modifications of the original LeFort technique as well as many novel variations have been published. No head-to-head comparisons have been performed, and all the techniques have the same purpose: to eliminate the vaginal canal so that the anterior and posterior pelvic organs support each other.

Keys to success

There is a very high success rate for the LeFort colpocleisis procedure. Besides performing a meticulous dissection and careful

FIGURE 88.8  Perineoplasty area demarcated with sterile marking pen.

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FIGURE 88.9  Once perineoplasty has been performed, only the urethral meatus is accessible. surgical technique, two aspects of the procedure appear to be particularly important: • The role of perineoplasty is crucial. Once the colpocleisis has been completed, further reducing the vaginal introital size adds further support to the colpocleisis suture lines and supports the relaxed perineal body. • Prevention of hematoma formation is crucial. When we see a recurrence, it typically starts as a focal separation of the anterior-to-posterior closure associated with increased vaginal bleeding, suggesting that the formation of a hematoma within the deep closure space is at the root of the recurrence. Thus, meticulous attention to hemostasis is recommended during this surgical procedure.

Other important factors Bladder function management

Stress urinary incontinence (SUI) and vaginal prolapse frequently coexist as both are commonly related to aging, obstetrical trauma and chronic increases in intra-abdominal pressure. SUI symptoms may be present along with POP, be obscured by alterations in anatomy due to kinking of the lower urinary tract (occult SUI) or may develop after surgical repair of the POP. Many women with advanced POP may also have urinary retention, urinary urgency, frequency and possibly urgency urinary incontinence due to an overactive detrusor. To further add complexity, lower urinary tract dysfunctions may coexist – such that

Textbook of Female Urology and Urogynecology a woman with advanced POP may have both retention and SUI. The surgeon must always balance the risk that a patient will have symptomatic incontinence symptoms or abnormal voiding after colpocleisis, with the associated negative impact on quality of life despite the POP being repaired (13). Many clinicians use some form of urinary testing with prolapse reduction, and the fact that “occult” or “potential” SUI will be present on testing in approximately half of the patients with advanced POP is well known. Therefore, a thorough preoperative assessment, including urodynamic or clinical evaluation with the prolapse reduced, is essential in the diagnosis of urinary disorders and subsequent management during or after a colpocleisis. We recommend the performance of multichannel urodynamics in all patients with advanced POP, including those planning on undergoing a colpocleisis. The management of any identified urinary incontinence should be planned in conjunction with the colpocleisis. Thus, if a patient demonstrates urodynamic stress incontinence on urodynamics, she should undergo an anti-incontinence procedure as part of the colpocleisis. If the surgeon does not have the luxury of preoperative urodynamics, as when dealing with a nursing home patient who cannot be brought to the office, bedside evaluation should be performed and consideration be given to the performance of a Kelly-type suburethral plication or empiric midurethral sling procedure – especially if incontinence is demonstrated with prolapse reduction. We published on a cohort of 210 patients who underwent a LeFort colpocleisis, who demonstrated both overt and occult SUI and underwent concomitant midurethral sling placement (14). We reported a 92.5% stress continent rate, with a low risk of voiding dysfunction and normalization of post-void residual in all patients within a period of 2 years. Urgency urinary incontinence and urinary retention should be managed as in any other POP patient, knowing that the reduction of the POP may itself have a beneficial impact on the patient's lower urinary tract function.

Bowel function management

Bothersome colorectal symptoms are common in older women with advanced prolapse stages. Fortunately, most defecatory dysfunction symptoms improve after colpocleisis with perineorrhaphy. In a recent report, all bothersome obstructive symptoms and almost all fecal incontinence symptoms were less prevalent after surgery, and the development of new bothersome bowel symptoms was uncommon (15). Fecal incontinence, especially if significant and having a negative impact on the quality of life, merits specific evaluation in the preoperative phase. Management should be based on specifically identified dietary, functional and anatomical variables.

Results and complications We reported on the largest published case series of patients who underwent colpocleisis in 2013, demonstrating that this surgery resulted in very high success rates and few associated complications (16). According to the literature, there is a consensus that this procedure is safe and efficacious, with reported success rates between 91% and 100% in follow-up periods of 2 weeks to 15 years. Colpocleisis appears to have fewer perioperative complications compared with traditional vaginal reconstructive surgery. Most reported complications are related to associated comorbidities

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rather than direct consequences of the surgical procedure itself. This adds emphasis to the importance of preoperative clearance, anesthesia choice and perioperative monitoring related to the performance of a colpocleisis. It is possible to perform this procedure entirely under local anesthesia with minimal intravenous sedation. Post-operative care is usually very straightforward. Pain is minimal, and frequently, patients do not require any pain medications. Bleeding will occur post-operatively, but it is usually mild. Preoperative prophylactic antibiotics are crucial for the prevention of infection. Return of normal voiding function postoperatively can sometimes be delayed as many of these patients have preexisting urinary retention. We will frequently accept higher degrees of post-void residual volumes in colpocleisis patients (up to 200–250 mL) as voiding typically improves with time and residuals normalize. Women with an overactive detrusor on preoperative urodynamics require closer follow-up and may need additional therapy post-operatively. Urgency urinary incontinence tends to improve over time but may not resolve as the cause may be neurogenic. Operative times are shorter than most reconstructive surgeries, but surgeons should be methodical in their tissue dissection and suturing techniques in order to optimize outcomes. We typically allot 1 hour of surgical time for each colpocleisis. We find that our colpocleisis patients are “our most satisfied customers”, as they typically come in for consultation with fears of needing a complex risky procedure after having failed pessary use. Education of the patient and her family – as well as her primary care provider – regarding the low associated anesthetic and surgical morbidity, pain and other feared complications is a very important part of surgical planning for this procedure.

endometrial sampling was not cost-effective in asymptomatic women who underwent colpocleisis.

Recurrence



The rate of prolapse recurrence after LeFort colpocleisis is estimated to be approximately 4.2% (17). The management of POP recurrence depends on the timing and type of recurrence. We typically perform a repeat modified LeFort colpocleisis, utilizing permanent sutures, as the best option in patients with recurrence. According to other surgeons, colpectomy appears to be the best option for recurrences. Nevertheless, the success rate of repeat obliterative surgery is very high. We have never seen a recurrence of a repeat surgery. Performance of a perineoplasty appears to be an important component to enhance the success rate of a colpocleisis.

Malignancies

Due to the obliterative nature of colpocleisis, the post-operative ability to perform gynecologic evaluation will be limited for abnormal vaginal bleeding, cervical intraepithelial neoplasia (CIN) and cervical neoplasia. This has been listed as a potential major disadvantage of this procedure, particularly as related to the development of gynecological malignancies (18). Lateral channels provide a passage for any fluid drainage and may allow for a timely diagnosis of several malignancies, particularly when associated with persistent vaginal bleeding or discharge. Recently, attention has been focused on the incidence of uterine malignancy, the role of routine hysterectomy and preoperative uterine evaluation, particularly in women undergoing surgery for POP (19). These studies indicated that unexpected uterine cancer occurred in only 0–0.8% of women undergoing POP surgery (20, 21). In addition, a recent cost-utility analysis concluded that universal endometrial evaluation with ultrasound and/or

Regret after colpocleisis

One commonly cited drawback of vaginal obliterative surgery is the possibility of patient regret (22). This concern may be minimized with adequate preoperative counseling. In a recent study evaluating 334 women with LeFort colpocleisis with a median follow-up of 3 years, none of the women was reported to regret her decision. A systematic review concluded that reasons for regret, when present, are mostly due to the onset of urinary symptoms and failure rather than the loss of coital function.

Summary A 2016 survey completed by pelvic floor surgeons from 18 Latin American countries revealed that 62% of urologists and 31% of gynecologists do not offer obliterative surgery to sexually inactive women (23). This statistic likely holds true in most parts of the world, whether due to a lack of training in the procedure or a bias against obliterative surgery. Clearly, colpocleisis should be an integral part of every pelvic surgeon's armamentarium (24). The advantages offered by colpocleisis include shorter operative time, decreased perioperative morbidity, low risk of POP recurrence and high patient satisfaction. These are lofty benefits of a procedure indicated for high-risk patients with the most advanced degrees of vaginal or uterovaginal prolapse. All pelvic surgeons should be able to offer this option to their patients.

References

1. Moore RD, Miklos JR. Colpocleisis and tension-free vaginal tape sling for severe uterine and vaginal prolapse and stress urinary incontinence under local anesthesia. J Am Assoc Gynecol Lap 2003;10(2): 276–280. 2. Federal Interagency Forum on Aging-Related Statistics. Older Americans 2020: key indicators of well-being. Washington, DC: U.S. Government printing office; 2020. 3. Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979–2006. Am J Obstet Gynecol 2010; 202(5):501.e1–501.e7. 4. Elterman DS, Chughtai BI, Vertosick E, Maschino A, Eastham JA, Sandhu JS. Changes in pelvic organ prolapse surgery in the last decade among United States urologists. J Urol 2014;191:1022–1027. 5. Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979–1997. Am J Obstet Gynecol 2003;188(1):108–115. 6. Skoczylas LC, Turner LC, Wang L, Winger DG, Shepherd JP. Changes in prolapse surgery trends relative to FDA notifications regarding vaginal mesh. Int Urogynecol J 2014;25:471–477. 7. Walters MD, Karram MM. Obliterative procedures for pelvic organ prolapse. In: Walters MD, Karram MM, eds. Urogynecology and Reconstructive Pelvic Surgery. Philadelphia, PA: Elsevier;2015:400–410. 8. Buchsbaum GM, Lee TG. Vaginal obliterative procedures for pelvic organ prolapse: a systematic review. Obstet Gynecol Surv 2017;72:175–183. 9. Deffieux X, Thubert T, Donon L, Hermieu JF, Le Normand L, Trichot C. Colpocleisis: guideline for a clinical practice. Prog Urol 2016 Jul;26 Suppl 1:S61–S72. 10. Rosenblatt P. LeFort colpocleisis: where does this procedure fit in today? Menopause 2016;23(6):591–592. 11. Neimark M, Davila GW, Kopka SL. LeFort colpocleisis: a feasible treatment option for pelvic organ prolapse in the elderly woman. J Pelv Med Surg 2003;9(2):83–89. 12. Plowright L, Davila GW. Colpocleisis. In WebMD/Medscape, Drugs and Diseases. Updated April 20, 2021. 13. FitzGerald MP, Brubaker L. Colpocleisis and urinary incontinence. Am J Obstet Gynecol 2003;189(5):1241–1244. 14. Smith AL, Karp DR, Lefevre R, Aguilar VC, Davila GW. LeFort colpocleisis and stress incontinence: weighing the risk of voiding dysfunction with sling placement. Int Urogynecol J 2011;22(11):1357–1362.

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15. Gutman RE, Bradley CS, Ye W, et al. Effects of colpocleisis on bowel symptoms among women with severe pelvic organ prolapse. Int Urogynecol J 2010 Apr;21(4):461–466. 16. Zebede S, Smith AL, Plowright LN, Hegde A, Aguilar VC, Davila GW. Obliterative LeFort colpocleisis in a large group of elderly women. Obstet Gynecol 2013;121(2), 279–284. 17. Mikos T, Chatzipanteli M, Grimbizis GF, Tarlatzis BC. Enlightening the mechanisms of POP recurrence after LeFort colpocleisis. Case report and review. Int Urogynecol J 2017 Jul;28(7):971–978. 18. Cho MK, Kim CH, Kim YH. Primary invasive carcinoma of the vagina after Le Fort partial colpocleisis for stage IV pelvic organ prolapse: a case report. Int Urogynecol J 2011;22(11):1459–1461. 19. Wan OYK, Cheung RYK, Chan SSC, Chung TKH. Risk of malignancy in women who underwent hysterectomy for uterine prolapse. Aust N Z J Obstet Gynaecol 2013;53(2):190–196.



20. Renganathan A, Edwards R, Duckett JRA. Uterus conserving prolapse surgery—what is the chance of missing a malignancy? Int Urogynecol J 2010;21(7):819–821. 21. Bonnar J, Kraszewski A, Davis WB. Incidental pathology at vaginal hysterectomy for genital prolapse. J Obstet Gynaecol Br Commonw 1970;77(12):1137–1139. 22. Hullfish KL, Bovbjerg VE, Steers WD. Colpocleisis for pelvic organ prolapse: patient goals, quality of life, and satisfaction. Obstet Gynecol 2007;110 (2 Pt 1):341–345. 23. Plata M, Bravo-Balado A, Robledo D, et al. Trends in pelvic organ prolapse management in Latin America. Neurourol Urodyn 2018;37:1039–1045. 24. Jones K, Wang G, Romano R, St Marie P, Hamanli O. Colpocleisis: a survey of current practice. Female Pelvic Med Reconstr Surg 2017 Jul/ Aug;23(4):276–280.

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BIOLOGICAL AND SYNTHETIC GRAFTS IN RECONSTRUCTIVE PELVIC SURGERY Katrina M. Knight, Brittany R. Egnot, William R. Barone, and Pamela A. Moalli

Introduction To date, synthetic meshes and biological grafts are the two most commonly used devices to treat pelvic organ prolapse (POP or prolapse). Utilizing patient’s own tissues to restore support to the pelvic organs (native tissue repair, NTR) is associated with high recurrence rates with up to 70% of women who undergo an NTR, experiencing POP recurrence for 5 years1,2 . These unacceptably high recurrence rates are likely the result of structurally compromised connective tissues and muscles in women with prolapse3–8. Synthetic meshes and biological grafts have been adopted in POP surgeries to reenforce repairs, replace failed connective tissue support, and improve patient outcomes. Synthetic nonabsorbable meshes are designed to provide support to the pelvic organs throughout the duration of implantation (i.e. for the lifetime of the patient) as they are typically nondegradable. Most biological grafts are meant to degrade over time while concomitantly repairing and replacing “damaged” tissue. Others are chemically crosslinked with the intention of providing more durable support and slower rates of degradation. Support is therefore provided by the newly formed tissue during the process of graft degradation. The purpose of this chapter is to review our current understanding of how the properties and mechanics of synthetic meshes and biological grafts impact the host response and contribute to complications. This chapter is divided into two parts: the first will focus on biological grafts and the second on synthetic meshes. For the biological grafts, we begin with an overview of the different types of biological grafts followed by a discussion of the in vivo function and then discuss their clinical application. For synthetic meshes, we begin with an overview of the history of synthetic meshes for use in prolapse repair followed by a review of the results from ex vivo mechanical testing. Next, the host response to synthetic meshes implanted in the vagina in vivo will be reviewed, and finally, we conclude with a discussion of how mesh properties impact the host response. The future outlook on basic science research, particularly in the area of novel treatment method development, and the use of biological grafts and synthetic meshes in pelvic reconstructive surgery will be considered.

Biological grafts Pelvic reconstructive surgeons continue to encounter significant difficulty ensuring the success of surgical repair procedures for POP. The high recurrence rates of procedures particularly in the anterior vaginal wall after NTR have motivated the incorporation of biomaterials in an attempt to prevent or delay such recurrence. These materials can be synthetic or biological in origin, such as permanent or absorbable synthetic mesh, allografts, or xenografts. Frequent complications with synthetic mesh motivated the 2011 FDA safety update and 2019 order to remove surgical mesh intended for transvaginal repair of POP from the market9. A 2013 American Urogynecologic Society (AUGS) survey reported

DOI: 10.1201/9781003144243-97

that transvaginal mesh (TVM) use decreased from 90% in AUGS survey responders to 61% after the FDA safety update in 201110. One of the arguments for using a biological graft in place of a synthetic mesh is to minimize the risk of mesh exposure, infection, or pain. Autologous grafts have been used to provide additional support for decades, although their use is hindered by donor site morbidity11–13. Usage of xenogenic, cadaveric, or composite biological grafts does not risk donor site morbidity although current literature describes a highly variable host response and complication rate in both human and animal models. Biological grafts represent an important option in transvaginal pelvic reconstruction, especially following heightened public and governmental scrutiny of synthetic materials and the subsequent declining utilization of transvaginal permanent mesh.

Graft types

In urogynecological reconstruction, biological grafts consist of three primary types: autologous grafts, allografts, and xenografts14. The use of autologous grafts, which are grafts derived from the host recipient, dates back to the early 20th century when gracilis flaps were incorporated into anti-incontinence procedures11. Other landmark innovations using autologous grafts include the 1942 Aldridge and 1978 rectus fascia sling procedures12,13. Current clinical strategies that utilize autologous grafts often harvest fascia lata or rectus fascia from the host recipient. Allografts are derived from cadaveric sources of dermis or fascia lata and must be sterilized prior to implantation in the recipient. Xenografts consist of porcine dermis, small intestinal submucosa (SIS), urinary bladder matrix (UBM), bovine pericardium and dermis, and xenograft synthetic composites (acellular crosslinked porcine dermis with polypropylene mesh) (Table 89.1). Some commercially available xenografts are also chemically crosslinked to confer additional mechanical strength. Given that many of these grafts were initially developed for abdominal hernia repair, experimental composite materials tailored to vaginal tissue through the incorporation of cells or other biologics are also in development. However, many of these materials have only undergone limited in vivo testing and have yet to see widespread clinical use14–16. Biological grafts, due to the nature of their source, do exhibit a small but nonzero risk of severe complications such as host versus graft response, prion transmission (estimated to be 1 in 3.5 million), and HIV transmission (estimated to be 1 in 8 million)14. Autologous grafts offer the benefit of avoiding the effects of processing, graft rejection, and transmissible infections. Because the patient serves as their own donor, these grafts induce very little foreign body reaction, and there is usually good incorporation of the graft into the native tissue. These grafts, unlike others, may also be used for infected surgical sites. Rectus fascia is often used over fascia lata due to the ease of harvest17. Major downsides to using these grafts, however, are longer operating times due to harvesting and the potential for donor site morbidity18. 965

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TABLE 89.1: Biological Grafts Used for Reconstructive Pelvic Surgery Tissue

Brand Name

Processing

Cadaveric fascia lata

Suspend Tutoplast (Mentor, Santa Barbara, CA)

γ irradiated Solvent dehydrated Preserved γ irradiated Freeze-dried Freeze-dried, Allowash (removes cells, bacteria, virus, fungi, and spores) Freeze-dried Cryopreservation without ice crystal Damage γ irradiated Freeze-dried γ irradiated Solvent dehydrated γ irradiated Hexamethylene diisocyanate HMDI crosslinked γ irradiated HMDI crosslinked Fenestrated γ irradiated HMDI crosslinked Freeze-dried Solvent dehydrated Freeze-dried Non-crosslinked Solvent dehydrated Freeze-dried Non-crosslinked Solvent dehydrated Freeze-dried Non-crosslinked γ irradiated 1-ethyl-3-[(3-dimethylamino) propyl]-carbodiimide hydrochloride crosslinked

FasLata (C.R. Bard, Covington, GA) ReadiGRAFT (LifeNet, Virginia Beach, VA) Cadaveric dermis

Alloderm (LifeCell Corp., Branchburg, NJ) Repliform (Boston Scientific, Natick, MA) Bard Dermal Allograft (C.R. Bard, Murray Hill, NJ)

Porcine dermis

Axis Tutoplast Processed Dermis (Mentor, Santa Barbara, CA) Pelvicol Acellular Collagen Matrix (C.R. Bard, Murray Hill, NJ) PelviSoft Biomesh (C.R. Bard, Murray Hill, NJ)

Porcine SIS

PelviLace Biourethral Support System (C.R. Bard, Murray Hill, NJ) Intexen (American Medical Systems, Minnetonka, MN) Symphysis Smart Remodeling Matrix (Cook Urological, Inc., Bloomington, IN) Surgisis Soft Tissue Graft (Cook Urological, Inc., Bloomington, IN) Stratasis Tension-Free Urethral Sling (Cook Urological, Inc., Bloomington, IN) FortaGen (Organogenesis, Canton, MA)

Porcine UBM Bovine pericardium Bovine dermis

MatriStem/Gentrix Veritas (Synovis Surgical Innovations, St. Paul, MN) Xenform Soft Tissue Repair System (Boston Scientific, Natick, MA)

Since their first use in pelvic reconstruction, the popularity of allografts has been surpassed by the use of other materials as a result of questions regarding the durability19. One notable risk of using allograft includes the fact that tissues harvested from older patients may also be weak and more prone to failure. Additionally, graft dimensions and suture placement can influence the distribution of tension over the graft area and predispose to certain kinds of failure. Choe reported changes in tensile strength of cadaveric grafts ex vivo dependent on the processing method. When these grafts were shaped into patch suture slings, the overall risk of suture pull-through increased and tensile strength decreased20. A reanalysis of 5-year data on the apical repair with cadaveric fascia lata reported success rates exceeding 90% when a composite score was used to define success21,22 . This was markedly higher than the 68% success rate at 5 years when only anatomic outcomes were measured. The limitation of this analysis from this randomized controlled trial was that the

Non-crosslinked Non-crosslinked

subjective query of patients was not blinded and did not utilize validated instruments. Xenografts and cadaveric grafts must undergo decellularization and sterilization processes to prevent antigenic responses and infection, respectively. Decellularization is a primarily detergent-based process to lyse cells and remove residual antigenic lipids, DNA, and glycosaminoglycans (GAGs), leaving only a protein scaffold for surgical implantation. Sterilization methods include freeze-drying, immersion in peracetic acid, exposure to gaseous ethylene oxide, and irradiation to remove any residual pathogens. However, these harsh treatments have documented negative effects on the mechanical properties of the donor tissue and may not completely remove all immunogenic or infectious agents16. Changes in the mechanical properties may be a side effect of the deformation of extracellular matrix proteins that provide essential mechanical support to the tissue. Studies of biological implants used as slings reported that freeze-dried cadaveric fascia

Biological and Synthetic Grafts in Reconstructive Pelvic Surgery lata demonstrated the most diminished biomechanical properties and intra-tissue consistency after graft implantation19,23. Decellularization and sterilization of xenogenic grafts differ between tissue type, manufacturer, and end use of the graft. Graft preservation after processing typically involves storage in saline with antibiotics at 4°C for short-term use or at −20°C for long-term storage. The formation of ice crystals and subsequent damage to structural proteins during the freezing process is a currently unavoidable aspect of using biological grafts24. While highly vascular structures used in other surgical applications can be perfused to achieve decellularization, tougher tissues such as SIS or UBM are often immersed in chemical baths from hours to days and agitated to facilitate the process. Exposure to these agents must be controlled as overexposure may compromise tissue architecture, strength, or specific cell adhesion motifs24–26. Detergents such as Triton X-100, sodium dodecyl sulfate, and sodium deoxycholate lyse cells through disruption of the cell membrane, and enzymes such as trypsin and nucleases break down nucleic acids and cell-matrix adhesions. Notably, some solvent or detergent-based methods have been known to damage the tissue microstructure (sodium dodecyl sulfate) or alter mechanical properties (peracetic acid). Non-solvent-based methods such as freeze-thaw cycles and exposure to supercritical carbon dioxide result in better retention of mechanical properties but are not as effective in removing residual DNA from tissues27–29. Peracetic acid, ethylene oxide, and gamma irradiation are common sterilization agents that also exert varying effects on tissue microstructure. Ventura et al. reported that detergent choice in the decellularization of porcine dermis influences the retention of vascular endothelial growth factor and bone morphogenetic protein 2, two growth factors with known roles in tissue development30. Xenografts may also undergo supplemental crosslinking to decrease degradation after host implantation or to recoup lost mechanical integrity after sterilization and decellularization. The formation of additional bonds between molecules via the crosslinking agent can give grafts additional mechanical strength. Chemical crosslinking agents include hexamethylene diisocyanate (HMDI), carbodiimide, glutaraldehyde, or photooxidizers. Physical crosslinking methods such as photooxidation and thermal dehydrogenation are available to manufacturers but are often not utilized due to the harsh nature of these reactions24,26. Although crosslinks exist in native collagen present in dermal grafts, additional processing increases the number of collagen crosslinks. This supplemental crosslinking is purported to prolong the life span of the implant but may impede natural degradation processes fueled by collagenase or other enzymes in the body. This is particularly problematic considering how the rate of extracellular matrix degradation can impact the local liberation of matrikines, growth factors, and other regulatory peptides31. The effect of supplemental crosslinking on xenograft behaviors appears to play a large role in host tissue response. Glutaraldehyde is a commonly used crosslinking agent, with ideal concentrations in tissue grafts being characterized as early as 1986. However, its potential for cytotoxicity and calcification becomes apparent at high concentrations. Carbodiimide and hexamethylenediamine carbamate crosslinkers face similar challenges24,32. Additionally, though in vitro studies report generally improved graft resistance to enzymatic degradation to host collagenases with increased collagen crosslinks, this has not always correlated to clinical efficacy33. Crosslinked biological grafts in plastic surgery were found to behave more as permanent synthetics. In both translational

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animal models and in vivo, supplemental crosslinks may have a significantly higher immunologic disadvantage, which may result in graft rejection. In the hernia literature, crosslinked dermal grafts were found to be completely degraded in infected wounds. In uninfected implants, no evidence of tissue remodeling was seen. In vivo, crosslinked porcine dermal grafts can behave more as a permanent foreign body or a synthetic due to a lack of integration into the host tissue and likely resultant fibrous encapsulation34. Non-crosslinked implants facilitate tissue ingrowth without encapsulation and promote tissue remodeling. As has been shown in the literature, alternative crosslinking mechanisms in biological grafts need to be explored for the sake of long-term patient safety. Experimental crosslinking procedures have incorporated biological agents such as genipin, tannic acid, proanthocyanidins, and nordihydroguaiaretic acid. Genipin specifically has shown promise as a crosslinking agent in a rat model of suburethral slings24,35. The balance between extracellular deposition and scaffold degradation is necessary for effective tissue graft reinforcement during tissue remodeling. While some study investigators have reported deposition of new matrix at the site of biological graft implantation, tissue regeneration within a degrading scaffold can be mimicked by fibrotic scar formation. The distinction between these two states is not always apparent in routine histologic analysis. Differences in the host response to graft implantation and subsequent changes in graft macro- or microstructure are likely a result of the host response, tissue types, and processing methods. Hyperacute rejection of xenografts, such as porcine dermal tissue, can occur via reaction to the galactose-α(1,3)-galactose terminal carbohydrate epitope or α-gal. Here, “epitope” refers to the domain of a molecule to which antibodies bind. Humans and other old-world primates lack α-gal and are sensitized to it after consuming meat from mammals. As shown by Connor et al. in a Caribbean vervet model, when α-gal peptides are enzymatically cleaved prior to implantation, graft removal at 6 months showed negligible scarring or graft deformation with cell infiltration and vascularization visible on histology36. Tissue processing such as decellularization and sterilization can alter the immunogenic and foreign body response to these grafts through either cleaving potential epitopes or exposing new ones. Furthermore, crosslinking can introduce additional pro-inflammatory cytotoxic reagents. The density of graft fibers may impede cellular repopulation of the graft, preventing reintegration into the surrounding tissue. Porous grafts may better facilitate angiogenesis and more rapid host infiltration of fibroblasts for collagen deposition. Increased porosity of the graft material may also reduce seroma formation and the risk of infection26,36–38. Graft failure may be due to rapid or unbalanced degradation without the necessary time for establishing proper support via the deposition of collagen and other extracellular matrix components. Gradual tissue remodeling or reduced rates of degradation of an implanted tissue graft are essential for success in pelvic reconstructive procedures. Novel experimental grafts, such as enhanced biological or bio-synthetic composites, are currently being researched due to their capability for conjugation of biological agents or tunable microstructure, for example. Biological agents range from cytokines to whole cells, and microstructures may vary in terms of porosity, fiber alignment, and stiffness. Decellularized tissues seeded with fibroblasts or modified with growth factors or antibodies have the potential for improved biocompatibility and productive remodeling but risk inflammatory reaction from the host due to retained DNA. Synthetic

968 grafts coated with platelet-rich plasma or extracellular matrix components have improved biocompatibility at the cost of little to no capacity for degradation or remodeling15,16. Novel materials and fabrication schema are emerging in the research literature in the form of 3D printing, electrospinning, and the development of scaffold-nanofiber composites. In an attempt to enhance biocompatibility and regeneration, these methods are utilizing collagen fibers and native growth factors24,26,37. Experimental bio-synthetic composite materials have shown robust mechanical properties in animal models as reported by Liang et al. and Konstantinovic et al. Liang et al. characterized greater graft elongation to failure 84 days post-implantation in a primate sacrocolpopexy model, and Konstantinovic et al. reported increased graft tensile strength in a rat fascial reconstruction model over a similar time scale39,40.

Basic science of biological grafts

The purported function of biologics is to provide a regenerative framework for extracellular matrix and remodeling with new collagen deposition, resulting in new tissue formation with eventual replacement or complete integration of the graft into the native tissue depending on its intended permanence in the body. It is essential for these grafts to be durable pre-, peri-, and postoperatively to maintain support for the pelvic organs while withstanding fluctuating intra-abdominal pressures. Essential functions any graft of this kind must possess include the ability to provoke an acute inflammatory response that can trigger remodeling weeks, months, or years post-implantation41. The acute inflammatory response that occurs immediately after implantation is the same foreign body response that occurs in wound healing after any insult. Mononuclear cells (macrophages and mast cells) populate and penetrate the graft scaffold. The typical sequence of wound healing follows this with mononuclear cells secreting signaling factors such as cytokines and growth factors. Fibroblasts are attracted to the site to initiate the synthesis of collagen, predominated by type 3 collagen initially. Eventually, matrix proteins are produced, which begin the remodeling process. Early cellular and vascular infiltration of a graft scaffold is critical for fibroblast proliferation and new collagen deposition. In the absence of angiogenesis, tissue remodeling does not occur, and instead scar formation results. It should be understood that cross-species differences in the cellular response to tissue repair do exist, and abdominal repair procedures may provoke different host responses than transvaginal repair. In animal models, we have seen that vaginal site implantation displays different behaviors than abdominal site implantation of prosthetic grafts41–44. Graft implantation in the anterior rectus fascia in a rabbit model resulted in a variety of changes in graft mechanical strength and surface area post-implantation. A decrease in tensile strength for cadaveric, autologous, and xenogenic grafts was observed after 12 weeks45. Claerhout et al. compared the performance of synthetic Pelvicol and polypropylene mesh with SIS in a rabbit model of full-thickness abdominal defects. At 2 months, SIS grafts showed evidence of remodeling on histology while the polypropylene mesh became scarred and stiff. At 6 months, explanted Pelvicol grafts were found to be encapsulated and partially degraded44. Differences in animal models, tissue types, and mechanical environment of the abdomen versus vagina should be kept in mind when interpreting animal research. A highly variable initial inflammatory response can lead to either graft integration, excessive scarring, graft encapsulation,

Textbook of Female Urology and Urogynecology or graft degradation. This balance between normal wound healing and a heightened inflammatory response is largely controlled by the action of chemical signaling molecules at the host/graft interface. In vitro studies of abdominal hernia repair demonstrated Alloderm (acellular cadaveric dermis) inducing a smaller cytokine response than non-crosslinked porcine dermal grafts and porcine intestinal submucosa46,47. Animal models have also shown that crosslinked porcine dermal grafts are associated with a heightened foreign body response and pronounced early inflammatory response. Similar tissue response has been observed in humans. Histopathological analysis of crosslinked, nonperforated, porcine dermal grafts used as transvaginal suburethral slings in recurrent stress incontinent patients demonstrated an increased lymphocytic cell reaction and multinucleated giant cells infiltrating the specimen at 42 weeks post graft implantation with no graft material detected thereafter. The consequences of eventual loss of the graft on the structural and functional integrity of the surgical repair in pelvic reconstructive procedures need to be determined34 (Fig. 89.1). When scaffold degradation of the graft is accompanied by cellular infiltration, extracellular matrix deposition, and neovascularization, tissue remodeling occurs48. If this process fails to take place in the host, the graft, instead of being replaced by newly regenerated tissue, is replaced by a nonfunctional scar. Vaginally, this can result in undesirable outcomes such as vaginal shortening, constriction, or dyspareunia. On the other hand, a too rapid degradation of a graft scaffold without deposition of new collagen can predispose to implant failure. In the New Zealand white rabbit model, the histopathology and biomechanical properties of polypropylene mesh and crosslinked porcine dermis at two anatomical sites (vagina and abdomen) were investigated. At the 9-month endpoint of these studies, it was observed that crosslinked porcine dermal grafts induced variable host tissue responses compared to milder, more uniform responses to polypropylene. Some dermal grafts demonstrated encapsulation with minimal host tissue infiltration, while others showed a severe foreign body reaction. Degradation of the dermal grafts was also observed. Compared to the abdominal site, vaginal grafts scored higher for inflammation and lower for fibroblast proliferation. Preimplantation graft properties did not predict post-implantation biomechanical graft behavior. Porcine dermal grafts displayed increased stiffness at the 9-month endpoint, but degraded dermal grafts had markedly reduced ultimate tensile strength and elasticity. Polypropylene grafts experienced greater shrinkage but were lower in stiffness. The investigators concluded that in this animal model, the dermal graft did not offer more mechanical support than synthetic mesh48,49. As shown in both animal models and clinical studies, porcine dermis crosslinked grafts induce different long-term responses in different hosts. Giogliobianco and Regueros’ review of host response to crosslinked materials indicated a relationship between crosslinking, degradation, and cellular infiltration, with non-crosslinked materials degrading and experiencing cellular infiltration at a greater rate. The authors noted that porcine dermal grafts maintain their mechanical properties for 3 months while the tensile strength of porcine SIS may actually increase after 2 years41. Suburethral tissue specimens in patients with recurrent SUI after sling surgery with HMDI crosslinked porcine dermis showed some specimens with limited collagen remodeling and minimal inflammation while others induced a strong foreign body response. Gandhi et al. reported unpredictable tissue reactions with this graft in stress urinary incontinence (SUI)

Biological and Synthetic Grafts in Reconstructive Pelvic Surgery

(a)

(b)

(c)

(d)

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FIGURE 89.1  Hexamethylene diisocyanate–crosslinked porcine dermal implants may integrate or encapsulate and undergo degradation and not be incorporated into host tissue. (a) Suburethral graft 15 weeks after implantation. The periphery of the graft demonstrates a thin layer of new collagen formation with minimal fibroblast infiltration. (b) Suburethral graft 19 weeks after implantation. Graft demonstrates mild fibroblast proliferation with neovascularization at its periphery. There is a mild lymphocytic reaction at the interface of the graft and new collagen formation. (c) Suburethral graft 21 weeks after implantation. Graft demonstrates moderate fibroblastic proliferation and collagen formation with a more prominent lymphocytic reaction at the interface. (d) Suburethral graft 42 weeks after implantation. Graft demonstrates histiocytes and multinucleated giant cells infiltrating the thickness of the specimen (a, d, hematoxylin and eosin, 20× magnification; b, c, hematoxylin and eosin, 10× magnification). (From Ref. (34), with permission.)

surgery34,48. Variable changes in tensile strength of cadaveric allografts have also been reported after implantation and can be accompanied by a wide range of host responses (inflammation, encapsulation, and neovascularization)50. Composite biological materials, such as polypropylene (MatriStem), have demonstrated the evidence of reduced inflammation and apoptosis surrounding the implanted graft compared to polypropylene mesh. In the rhesus macaque model, these findings were seen along with preserved smooth muscle contractility but less mechanical integrity of the vagina than sham samples. Additionally, extracellular matrix composition resembled sham samples with the exception of a lower observed collagen content. A follow-up study in rhesus macaque analyzed the ability of the graft to restore mechanical support of resected uterosacral

ligament and paravaginal support tissues. Transabdominal and transvaginal insertion models for prolapse repair were analyzed 3 months postoperatively for the evidence of graft remodeling. The transvaginal insertion model, which required a vaginal incision for proper graft placement, experienced worse outcomes in the form of decreased vaginal stiffness and decreased collagen content suggesting an independent impact of the incision on the host response39,51.

Clinical use of biological grafts Anterior compartment defects

Biological graft augmentation in the anterior compartment has been an area of scientific interest as reflected by the largest number of prospective, retrospective, and randomized controlled

970 trials to support its use. A recent clinical trial exploring apical suspension procedures reported up to 70% surgical failure rates at 5 years, defined as either anatomic failure (involving the apex, anterior, or posterior compartments) or recurrence of bulge symptoms2 . Studies have shown that anterior compartment defects benefit from graft-reinforced repairs. Older trials comparing native tissue versus mesh repair reported higher longterm anatomical success rates with mesh compared to traditional NTRs (46% vs. 14%)52 . More recent studies, such as the Study of Uterine Prolapse Procedures Randomized Trial, have reported no differences in failure rate between mesh hysteropexy and hysterectomy with uterosacral ligament suspension53,54. However, the anticipated benefit of synthetic permanent reinforced repair must be balanced against its increased potential risk of mesh exposure, pelvic pain, and dyspareunia. In 2019, the FDA halted the sale of mesh for prolapse repair, an escalation of their previous class II designation in 2016. To minimize the risk of exposure to synthetic mesh, Sand et al., in a prospective, randomized controlled trial, used a polyglactin 910 mesh imbricated into an anterior application compared to an NTR with a midline colporrhaphy for vaginal repair of the anterior compartment. Anatomic success (measured as Baden Walker 18 months) of prospective work by Clemons et al. demonstrated that when cadaveric dermal grafts were attached adjacent to the arcus tendineus fascia bilaterally, the anatomic recurrence (Pelvic Organ Prolapse Quantification [POP-Q] stage ≥2) rate was 58.3%. Among these recurrences, only 28.6% were symptomatic. They concluded that Alloderm graft has good subjective success despite a moderate rate of objective failure within 24 months of placement56. In Clemons’ initial study, 33 patients had a 59% objective success rate and a 97% subjective success rate. Conversely, in a retrospective comparative study, Botros et al. reported a significantly higher success preventing recurrent anterior prolapse (≥stage 2) when using a human dermal graft for a paravaginal repair (attached directly to the arcus tendineus fasciae) in addition to standard anterior colporrhaphy when compared to only anterior colporrhaphy alone (19% vs. 43%, p = 0.004)57. Favorable subjective outcomes were reported but limited by the response. The differences in outcomes between these two trials using barrier grafts of human dermis may be attributed to the surgical technique. While many studies have described tension-free placement of biological grafts or anchoring to sites along the pelvic wall, Botros et al. described the fixation of the graft to the arcus tendineus fasciae pelvis with minimal tensioning. Intuitively, this makes sense as simply placing a graft on the vagina as opposed to attaching it to each pelvic sidewall to provide support would be more beneficial to restoring vaginal support The 2013 Cochrane meta-analysis of two randomized controlled trials of primary prolapse repair with or without HMDI crosslinked porcine dermis in the anterior compartment concluded that anterior colporrhaphy had a nearly twofold (RR 1.7) risk of recurrence as compared to augmentation with an acellular porcine dermal implant (CI 1.1–2.6)58,59. Two other well-designed randomized controlled trials by Natale et al. and Menefee et al. demonstrated lower recurrence rates with synthetic meshes compared to the porcine dermis. Natale et al. reported a 72% anatomic success rate (≤2) with polypropylene versus a 56% in the porcine dermal graft group. Exposure was only observed in the synthetic mesh group (6.3%).

Textbook of Female Urology and Urogynecology Both groups reported improvement in the quality of life (QOL)60. Menefee et al. compared success between polypropylene, porcine dermis, and native tissue anterior colporrhaphy in a randomized controlled trial with blinded postoperative outcome observers61. The authors reported the highest success rate with polypropylene (82%) versus porcine dermis (54%) and 42% with NTRs. Exposure rates were higher in the polypropylene group (14%) versus 4% in the porcine dermal group and none in the native tissue group. Higher exposure rates have also been noted in other trials with synthetic grafts52 . When anterior colporrhaphy with NTR was compared to using an adjuvant porcine dermal graft in three randomized trials, the objective failure was significantly higher in the native tissue group (27%) compared to the porcine dermis group (16%)58,59,61. When used in the anterior compartment for vaginal reconstructive surgery, it may be the method of implantation that impacts the success of preventing recurrence. In a prospective, randomized controlled trial, Gandhi et al. reported that a 2 × 4 cm cadaveric fascia lata graft overlay did not reduce the rate of recurrent cystocele. At 13 months, the objective (>stage 2) and subjective failure rates of the anterior colporrhaphy were not statistically significantly different: 29% and 21% from the 10.5% and 10.9% noted in the fascial patch group, respectively23. In a study using cadaveric fascia lata grafts, which were attached to the pubic bone using transvaginal bone anchors, only 2 out of 132 patients at 12 months had recurrent cystoceles of greater than second degree. However, one case of osteitis pubis was reported in the bone anchor group62. A randomized controlled trial of standard native tissue anterior colporrhaphy compared to utilization of adjuvant small intestine submucosa grafts reported a 59.3% anatomic cure (defined as prolapse stage I or 0) versus 86.2% with the adjuvant small intestine submucosa intestine grafts. No differences were noted in QOL measures or subjective outcomes, and no inflammatory complications were reported63. Guerette et al. compared anterior colporrhaphy with bovine pericardium graft-reinforced repairs in the anterior compartment. At the study conclusion (1–2 years), no difference in outcome using both subjective and objective measures was found64. Rates of surgical success are highly dependent on how the outcome is defined. When defined as the absence of bulge symptoms or the absence of retreatment, then the success rates of graftaugmented repairs are generally high (>95%). However, if based on objective measures such as prolapse beyond the hymenal ring, success rates are lower (60–70%). These wide variations in reported success were also demonstrated in apical prolapse compartment repairs. As seen by Barber et al., utilization of a composite definition (subjective and objective outcomes) altered the reported success of various biological adjuvant grafts in anterior compartment repairs21.

Posterior compartment defects

Posterior vaginal wall prolapse is commonly associated with functional symptoms of vaginal bulging, obstructed defecation, and sexual dysfunction. Repair of posterior compartment defects should theoretically work to restore normal anorectal caliber and support to improve anorectal symptoms. However, studies have reported variable functional responses to anatomical correction65–68. Although transvaginal use of biological grafts for posterior compartment defects is proposed to reinforce repairs, there is a paucity of studies to support this hypothesis. When cadaveric dermal grafts were used to augment site-specific defect repairs

Biological and Synthetic Grafts in Reconstructive Pelvic Surgery in the posterior compartment, Kohli and Miklos reported that 93% of patients had a POP-Q point Ap measurement of 6 31 3 1 ? 12 3 3 3 2 12 6 6 14 years 48 3 52 28 years 6 56 2 9 78 24–48 ? 25 3 4 3 3 ? 3.6 3 15 18 12–60 4 12 30 years 15 5

Anal (fecal) Incontinence (%) 15 (10) 15 (14) 17a (7) 20 (7) 21 (4) 22 (22) 23 (6) 24 (?) 25 (7) 25 (11) 25 (3) 29 (?) 30 (15) 30 (?) 31 (?) 33 (25) 33 (12) 37 (25) 39% (13) 40 (16) 40 (?) 41 (9) 41 (2) 42 (?) 42 (17) 42 (?) 42 (17) 42 (15) 43 (13) 44 (?) 45 (25) 50 (?) 50 (?) 53 (6) 53 (32) 54 (17) 57 (23) 57 (29) 59 (11) 59 (28) 61 (10) 67 (42) 37 (12)

Source: Ref [9], with permission. Note: Fecal incontinence rates are shown in parentheses. “?” indicates that the figure for fecal incontinence has not been stated by the authors. a Includes 2 with secondary sphincter repair.

A meta-analysis of 103 studies involving 16,110 women [72] showed that in those who delivered vaginally, OASIS were diagnosed on ultrasound in 26% (95%CI, 21–30, I 2 = 91%), and 19% experienced anal incontinence (95%CI, 14–25, I 2 = 92%). In women without clinical suspicion of OASIS (n = 3688), sphincter

defects were observed in 13% (10–17, I 2 = 89%) and anal incontinence experienced by 14% (95% CI: 6–24, I 2 = 95%). Following primary repair of OASIS, 55% (46–63, I 2 = 98%) of 7549 women had persistent sphincter defects with 38% experiencing anal incontinence (33–43, I 2 = 92%). There was a significant association

Textbook of Female Urology and Urogynecology

1016

TABLE 92.2: Summary of Studies Using Sultan Classification of OASIS and Anal Incontinence Symptoms Score Following Primary Repair Mean AI Score According to Degree of OASIS Authors, Year and Country Patton et al. [63] 2019 Australia Ramage et al. [64] 2017 UK *Linneberg et al. [65] 2014 Denmark *Visscher et al. [66] 2014 Netherlands

n 265

FU 6m

3a 1.2

3b 2.1

3c 3.3

4th 2.9

117

6–12 m

4.1

5.1

5.2

4.6

54

7 Yrs

1

1.5

Not documented

3

16

3m

9.7

-

8.3

-

*Cerro et al. [67] 2017 Spain

95

6m

*Anglim et al. [68] 2019 Ireland *Roos et al. [69] 2010 UK

437

12 m

531

9w

4.4 (combined 3a & 3b) 3.5 (combined 3a & 3b) 1.8 1.6

0 (0-2) 3a + 3b Faecal urgency – 2.24 (SD, 0.94) Flatus inc (1.95 (SD, 1.14) Loose FI 1.12 (SD, 0.44) Solid FI (1.04 (SD, 0.25)

Questionnaire Used and Statistical Significance Mean St Mark’s score Significant Mean Wexner score Not significant Median St Mark’s Not significant

1.66 (SD, 0.92),

St Mark’s (3a & 3b) v 3c Significant Wexner (3a & 3b) v 3c Significant Mean Wexner (3a &3b) v (3c & 4) Significant Median St Mark’s (IQR) Significant Mean Manchester Significant Significant

1.05 (SD, 0.30),

Significant

1.02 (SD, 0.21),

Not significant

6.7 (3c + 4) 2 (0-5) 3c + 4 2.04 (SD, 0.94),

Note: Linneberg [65] did not document 3c tears whereas Vicscher, Cerro, Anglim, and Roos [66–69] combined different degrees of OASIS due to small numbers. Abbreviations:  n, number; FU, follow up; AI, anal incontinence; IQR, interquartile range.

between ultrasound-diagnosed OASIS and anal incontinence (RR 3.74, 2.176.45, I 2 = 98%). However, this meta-analysis did not specify the type of OASIS classification used. Anal resting and squeeze pressures are consistently lower in women who have previously sustained OASIS [13, 14, 27, 45, 47, 53, 56], and the anal canal is shorter after repair [13, 34]. The development of incontinence does not appear to be directly related to pelvic neuropathy as demonstrated by EMG [37, 48] and pudendal nerve motor latency conduction studies [4, 13, 45]. Tetzschner et al. [48] reported that 3-month pudendal latency measurements are longer in women with a risk of incontinence. However, these measurements were still within the normal range and no relationship was demonstrated between abnormal latency and incontinence. Although anal sphincter disruption and repair is invariably associated with some degree of denervation and atrophy, current available neurophysiological tests are neither sensitive nor specific enough to quantify pudendal neuropathy. There is, however, evidence to show that poor outcome following primary [13, 37, 45] and secondary [4] repair may be related more to persistent mechanical disruption as demonstrated by anal endosonography rather than pudendal neuropathy. There is also evidence that persistent defects could be the result of repair of the wrong muscle namely the superficial transverse perineal muscle instead of the external sphincter [73]. Unsatisfactory outcome following primary sphincter repair may be attributed either to operator inexperience or repair

techniques and subsequent management. The training and experience of clinicians performing perineal repair have been questioned [74, 75] and hands-on training workshops have been shown to influence a change in clinical practice [76].

Technique of primary repair In 1930, Royston [77] described a commonly practiced technique of repair following OASIS where the ends of the torn sphincter were approximated by inserting a deep catgut suture through the inner third of the sphincter muscle and a second set (mattress or interrupted) through the outer third of the sphincter. Subsequently, Ingraham et al. [78] described a modification of the Royston technique [77], where the sutures were only inserted in the fascial sheath or capsule of the sphincter ani. Fulsher and Fearl [79] also described this technique but emphasized that no sutures should pass through the sphincter muscle. More specifically, Cunningham and Pilkington [80] inserted four interrupted sutures in the capsule of the external sphincter at the inferior, posterior, and superior points. In 1948, Kaltreider and Dixon [81] described the end-to-end repair technique that was used since 1935 in which one mattress or figure-of-eight suture was inserted to approximate the sphincter ends. Obstetricians have used the end-to-end repair technique for decades either by single-interrupted sutures, “figure-of-eight” sutures, or mattress sutures [13] (Fig. 92.3). However, as shown

Primary Repair of Obstetric Anal Sphincter Injuries

FIGURE 92.3  End-to-end approximation of the disrupted external sphincter (E) with two mattress sutures. The internal sphincter (I) has also been repaired by the end-to-end technique. in Table 92.1, despite repair, anal incontinence still occurs in 37% of women (range 15% [28] to 67% [62]). In addition, fecal urgency can affect a further 6% [13, 24] to 28% [25]. Frank fecal incontinence affected 14% (range 2% [46] to 42% [62]). Persistent anal sphincter defects following repair have been reported in 34% [26] to 91% [24] of women (Figs. 92.4 and 92.5). By contrast, when fecal incontinence is due to sphincter disruption, colorectal surgeons favor the “overlap technique” for secondary sphincter repair as described by Parks and

FIGURE 92.4  Anal endosonographic image demonstrating an external sphincter defect (between arrows) in a woman complaining of fecal incontinence following an end-to-end repair. The arrows overlie the two retracted ends of the muscle.

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FIGURE 92.5  Anal endosonographic image demonstrating a missed internal anal sphincter injury (defect between solid arrows) and scarring of the external anal sphincter following primary repair (dotted arrows).

McPartlin [82]. Jorge and Wexner [21] reviewed the literature and reported on 21 studies using the overlap repair with good results ranging from 74% to 100%. Engel et al. [4] prospectively studied 55 patients with fecal incontinence undergoing an overlapping anterior anal sphincter repair and reported a good clinical outcome in 80%. A poor result was found to be associated with an external anal sphincter (EAS) defect while a demonstration of an overlap by anal endosonography correlated with a favorable outcome. It is now known that similar to other incontinence procedures, outcome can deteriorate with time and the follow-up study at 5-year follow-up reported 50% continence [83]. However, a number of women in this study had more than one attempt at sphincter repair [83]. Another prospective study reported success in 80% at a 7-year follow-up [84]. Sultan et al. [85] first evaluated the EAS overlap technique for acute OASIS and more importantly, advocated separate identification and repair (Fig. 92.6) of the internal anal sphincter (IAS). Sultan et al. [85] evaluated the feasibility of this technique in 27 women and demonstrated that EAS overlap repair, as well as identification and end-to-end repair of the IAS, was possible following acute OASIS. They observed that compared to matched historical controls [13, 85] who had an end-to-end repair, anal incontinence could be reduced from 41% to 8% using the overlap technique and separate repair of the internal sphincter. Based on this, they recommended a randomized trial between end-to-end and overlap repair. The first published randomized trial by Fitzpatrick et al. [57] reported no significant difference between the two methods of repair at 3 months. In this study, they included partial EAS tears, and the torn IAS was not identified and repaired separately. They used a constipating agent for 3 days after the repair. However, a true overlap [13, 82] is not possible if the sphincter ends are not

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FIGURE 92.6  End-to-end approximation of the torn ends of the internal anal sphincter. The torn ends of the external sphincter (E) can also be seen.

completely torn, and attempts at overlapping would only place tension on the repair. Garcia et al. [51] also performed a randomized trial of the two techniques, including only complete ruptures of the EAS (full-thickness 3b, 3c, and fourth-degree tears). Of the 23 women in the end-to-end group and 18 in the overlap group, only 15 and 11 women, respectively, returned for follow-up at 3 months. No significant difference was found between the groups in terms of symptoms of fecal incontinence or transperineal ultrasound findings. However, the authors acknowledged that the major limitations of their study were that randomization was inaccurate and that their study was underpowered. Williams et al. [49] performed a factorial, randomized, controlled trial (n = 112) in which women were randomized into four groups: overlap with polyglactin (Vicryl; Ethicon, Edinburgh, United Kingdom), end-to-end repair with Vicryl, overlap repair with polydioxanone (PDS; Ethicon, Edinburgh, United Kingdom), and end-to-end repair with PDS. This trial was specifically designed to test the hypothesis regarding suture-related morbidity. At 6 weeks, there were no differences in terms of the need for suture removal due to pain, suture migration, or dyspareunia. The authors claim that there were no differences in outcome based on repair technique. Unfortunately, the majority of patients included in this trial were partial tears of the EAS (3a tears, and as mentioned earlier), a true overlap cannot be performed if the EAS is only partially torn. Furthermore, their follow-up rate at 12 months was only 54%. These data, therefore, need to be interpreted with caution.

Textbook of Female Urology and Urogynecology Fernando et al. [86] performed an adequately powered randomized trial (n = 64) of the end-to-end vs. overlap technique. At 12 months, they had an 81% follow-up rate and found that 24% in the end-to-end and none in the overlap group reported fecal incontinence (p = 0.009). Fecal urgency was reported by 32% in the end-to-end and 3.7% in the overlap group at 12 months (p = 0.02). There were no significant differences in dyspareunia and quality of life between the groups. After 12 months, 16% of women in the end-to-end group and no subjects in the overlap group reported deterioration of defecatory symptoms (p = 0.01). Rygh and Korner [87] performed another randomized controlled trial (n = 101) with the primary outcome measure “of at least weekly solid stool incontinence.” They concluded that the overlap technique was not superior to the end-to-end repair. However, there were more women with symptoms of anal incontinence in the end-to-end repair group (34% vs. 20%). Farrell et al. [88] performed a randomized controlled trial with a 6-month follow-up of an end-to-end (n = 62) vs. overlap (n = 63) EAS repair in primiparous women. They reported significantly higher rates of flatal but not fecal incontinence in the overlap group. However, there were more fourth-degree tears in the overlap group and therefore more IAS injuries that could explain the increased flatal incontinence in this group [89]. At a 3-year follow-up, however, there was no significant difference in anal incontinence between the groups, but the rate of fecal incontinence in the end-to-end group doubled while it remained static in the overlap group [90]. These support the findings of Fernando et al. [86], who demonstrated a significantly higher risk of deterioration in anal incontinence over time in the end-to-end group. This highlights the importance of longer-term follow-up as one technique may prove to be more robust. The Cochrane review [91] concluded that, compared with the immediate primary end-to-end repair of OASIS, immediate primary overlap repair appears to be associated with a reduced risk for fecal urgency, anal incontinence score, and deterioration of anal incontinence symptoms at 12 months. At 36 months (based on only two small trials), there appeared to be no difference in flatus or fecal incontinence between the two techniques. They concluded that either an end-to-end or overlap repair of the EAS may be performed at the discretion of the clinician. It is important, however, to emphasize that the overlap technique has only been described for full-thickness EAS tears [85]. Kairaluoma et al. [92] presented results of 31 women who had sustained OASIS (3b and fourth degree) and had an EAS overlap repair immediately after delivery performed by two colorectal surgeons. In addition to an end-to-end repair of the IAS, they also performed a levatorplasty to approximate the levators in the midline with two sutures. At a median follow-up of 2 years, 23% complained of anal incontinence, 23% developed wound infection, 27% complained of dyspareunia, and one developed a rectovaginal fistula. Levatorplasty should be avoided during primary anal sphincter repair. By contrast, when primary repair with EAS overlap and separate repair of the IAS was performed by urogynecologists, none had fecal incontinence or any complications at 9 months [93].

Principles and techniques of repair [11] Ideally, primary repair should be conducted as soon as possible after delivery. However, a delay in repair may be justified in exceptional circumstances when an experienced obstetrician may not be available. In a randomized study, Nordenstam et al.

Primary Repair of Obstetric Anal Sphincter Injuries [15] found no difference in anal incontinence 12 months after primary repair when women who had repair immediately after the tear were compared to others when the repair was delayed for 8–12 hours. They concluded that there is no justification for delaying suturing except when a doctor competent in the repair of OASIS is unavailable. OASIS should only be repaired by a doctor who has been formally trained and is experienced in primary sphincter repair or by a trainee under supervision. Ideally, the repair should be conducted in the operating theater where there is access to good lighting, appropriate equipment, and aseptic conditions. In our unit, we have a specially prepared instrument tray containing a Weitlander self-retaining retractor, four Allis tissue forceps, McIndoe/Metzenbaum scissors, tooth forceps, two artery/mosquito forceps, stitch scissors, and a needle holder (www.perineum.net). General or regional (spinal, epidural, caudal) anesthesia is important as the inherent tone of the EAS can result in retraction of the torn muscle ends within its sheath. Muscle relaxation is necessary to retrieve the ends especially if the intention is to overlap the muscles without tension. The full extent of the injury should be evaluated by a careful vaginal and rectal examination in lithotomy and graded according to the classification earlier (Fig. 92.1). If there is any uncertainty about the grading of Grade 3a or Grade 3b, it should always be given a higher grade. On rare occasions, an isolated buttonhole–type tear (Fig. 92.2) can occur in the rectum without disrupting the anal sphincter. This is best repaired transvaginally using interrupted Vicryl sutures. To minimize the risk of a persistent rectovaginal fistula, a second layer of tissue should be interposed between the rectum and vagina by approximating the recto-vaginal fascia [10]. A colostomy is rarely indicated for acute OASIS unless there is a large tear extending above the pelvic floor, or there is gross fecal contamination of the wound. A case review by Roper et al. [10] of nine buttonhole tear repairs found that four case reports described a two-layer closure and five described a three-layer closure. Two cases were repaired in collaboration with colorectal surgeons. All nine cases made an uneventful recovery with follow-up between 6 weeks to 3 months. One patient had a defunctioning stoma at a later date due to a second breakdown of the recto-vaginal fistula repair. In the presence of a fourth-degree tear, the torn anorectal epithelium is repaired with a continuous non-locking fine suture such as Vicryl 3-0. The technique of interrupted sutures with the knots tied in the anal lumen was recommended when catgut was used, as catgut undergoes phagocytosis in tissues and increases the risk of infection. A subcuticular repair of the anal epithelium via the transvaginal approach has also been described [5] although there is some concern that the thin anorectal mucosa could tear with the passage of stool. The sphincter muscles are repaired with 3-0 PDS dyed sutures (Fig. 92.3). Compared to a braided suture, these monofilamentous sutures are believed to be less likely to precipitate infection. Nonabsorbable monofilament sutures such as nylon or Prolene (polypropylene) can cause stitch abscesses, and the sharp ends of the suture can cause discomfort, necessitating removal. Complete absorption of PDS takes longer than Vicryl, and therefore, to minimize the risk of suture migration, care should be taken to cut suture ends short and ensure that they are adequately buried by the overlying superficial perineal muscles. Alternatively, one randomized study has suggested that Vicryl 2-0 can also be used

1019 although the primary outcome was not the success of the repair but suture migration [49]. The IAS should be identified and, if torn, repaired separately from the EAS. The IAS lies between the EAS and the anal epithelium. It is thinner and paler than the striated EAS. The appearance of the IAS can be described as being analogous to the flesh of raw fish as opposed to the red meat appearance of the EAS. The ends of the torn muscle are grasped with Allis forceps and an end-to-end repair is performed with interrupted or mattress 3-0 PDS sutures. A torn IAS should be approximated with mattress sutures as overlapping can be technically difficult and will require unnecessary dissection. Mahony et al. [94] followed 500 women who sustained OASIS and found that a persistent IAS defect was independently associated with fecal incontinence. Nichols et al. [35] followed 56 women who sustained OASIS and found that, compared to an intact sphincter, combined defects of the IAS and EAS were associated with the highest risk of bowel symptoms. Roos et al. [69] performed a prospective study of 531 women who sustained OASIS and found that the outcome of primary repair of major (Grade 3c/fourth-degree) tears compared with that of minor (Grade 3a/3b) tears was less favorable. This suggests that tears involving the IAS are a poor prognostic factor. In women with major tears, defecatory symptoms were more prevalent and associated quality of life was worse. Furthermore, these women were more likely to have endosonographic isolated IAS or combined IAS and EAS defects and the maximum resting and squeeze pressures were lower. Women with endosonographic combined defects of the IAS and EAS were associated with a higher risk of loose fecal incontinence, lower maximum resting and squeeze pressures, lower incremental squeeze pressures, and a shorter anal canal length [69]. The torn ends of the EAS may retract and should be grasped and retrieved with Allis tissue forceps (Fig. 92.7). In order to perform an overlapping repair, the muscle may need mobilization by dissection with a pair of McIndoe or Metzenbaum scissors, separating it from the ischioanal fat laterally. When performing an overlap repair, the EAS should be grasped with Allis forceps (Fig. 92.8) and pulled across to overlap in a “double-breasted” fashion. The torn ends of the EAS can then be overlapped

FIGURE 92.7  Torn ends of the external sphincter being elevated by two pairs of Allis forceps. Note the landmark yellow ischioanal fat lateral to the external sphincter.

1020

FIGURE 92.8  Full length of the external sphincter after mobilization. (Reproduced from ref [85]. With permission.)

(Fig. 92.9a and b) using PDS 3-0 (Ethicon) sutures. A proper overlap is only possible when the entire thickness is torn and the torn ends of the EAS in full length are free and mobile. Therefore an overlap repair is not possible with a grade 3a tear or a partial thickness 3b tear. Overlapping allows for a greater surface area of contact between muscles (Fig. 92.9a and b). By contrast, an end-to-end repair can be performed without identifying the full length of the EAS giving rise to incomplete apposition [11]. Consequently, the woman may maintain continence in the short term but would be at risk of developing incontinence later in life. A shorter anal length has been reported following an end-to-end primary repair of the EAS [13, 95]. It has also been shown that a shorter anal length is the best predictor of fecal incontinence following secondary sphincter repair [96]. Unlike end-to-end repair, if further retraction of the overlapped muscle ends were to occur, it is highly probable that muscle continuity would be maintained. However, if the operator is not familiar with the overlap technique or if the EAS is only partially torn (Grade 3a and some 3b), then an end-to-end repair should be performed. Two or three mattress

Textbook of Female Urology and Urogynecology sutures (Fig. 92.3) should be inserted similar to that described for IAS repair. Hemostatic “figure-of-eight” sutures should not be used to repair the sphincters (or anorectal mucosa) as they could cause ischemia. After the repair of the sphincter, the perineal muscles should be sutured to reconstruct the perineal body. A short deficient perineum would make the anal sphincter more vulnerable to trauma during a subsequent vaginal delivery [97]. The vaginal skin is sutured and the perineal skin is approximated with a Vicryl 3-0 subcuticular suture. A rectovaginal examination should be performed to confirm complete repair and ensure that all packs or swabs have been removed. Intravenous broad-spectrum antibiotics such as cefuroxime 1.5 g and metronidazole 500 mg should be commenced intraoperatively, and we prefer to continue this orally for at least 3 days. In a prospective, randomized placebo-controlled study [98] of patients who had sustained OASIS (n = 147), it has been shown that patients who received a single dose of intravenous secondgeneration cephalosporin had a significantly lower risk of perineal complications (8% compared to 24%) compared to a placebo by 2 weeks after the repair. A Cochrane review addressing antibiotic prophylaxis for third- and fourth-degree perineal tears, comparing prophylactic antibiotics against placebo or no antibiotics, included only one randomized controlled trial of 147 participants. Although the data suggested that prophylactic antibiotics help to prevent perineal wound complications following third- or fourth-degree perineal tears, loss to follow-up was very high [99]. Severe perineal discomfort, particularly following instrumental delivery, is a known cause of urinary retention, and following regional anesthesia, it can take up to 12 hours before bladder sensation returns. A Foley catheter should be inserted for 12–24 hours unless the midwifery staff can ensure that spontaneous voiding occurs at least every 3 hours. Detailed notes should be made of the findings and repair. A pictorial representation of the tears proves very useful when notes are being reviewed following complications, audit, or litigation [11]. As passage of a large bolus of hard stool may disrupt the repair, a stool softener (lactulose 15 mL bd) is prescribed up to 10 days postoperatively. The dose can be titrated to ensure that stools are

FIGURE 92.9  The technique of overlap repair of the external anal sphincter. (a) The first suture is inserted about 1.5 cm from the torn edge of the muscle and carried through to within 0.5 cm of the edge of the other arm of external sphincter. (b) A second row of sutures is inserted to attach the loose end of the overlapped muscle. (From ref [11], with permission.)

Primary Repair of Obstetric Anal Sphincter Injuries soft. A randomized trial (n = 105) of constipating versus laxative regimens found that the use of laxatives was associated with a significantly earlier and less painful first bowel motion as well as earlier discharge from the hospital [100]. Compared to 5% in the laxative regimen group, 19% in the constipated regimen group experienced troublesome constipation (two required hospital admission for fecal impaction). There were no significant differences in continence scores, anal manometry, or endoanal scan findings. Bulking agents such as Ispaghula husk (Fybogel) should be avoided as another randomized study [101] has indicated that incontinence occurred significantly more often (33% versus 18%) when lactulose and Fybogel were consumed compared to lactulose only. It is important that the woman understands the implications of sustaining OASIS and should be informed on how to seek help if symptoms of infection or incontinence develop. Ideally, these women should be followed up in a dedicated perineal clinic by a team with a special interest in OASIS. All women should be advised on pelvic floor exercises while others with weak or absent sphincter contractility may need electrical stimulation [102].

Management of subsequent pregnancy after primary repair of OASIS

Women who sustain OASIS need careful counseling regarding their management in a subsequent pregnancy. It is known that the risk of recurrence of anal sphincter injury in centers that practice mediolateral episiotomy is 4.4% [71, 103] to 7.1% [104, 105]. Two large cohort studies showed the rate of recurrent OASIS to be 7.2–10% [106] for women who had previously sustained OASIS during their first vaginal delivery, compared with a rate of 1.3% for women who did not sustain OASIS [107]. All women who sustained OASIS should be assessed in a hospital by a senior obstetrician about 12 weeks after delivery. As there appears to be a rise in OASIS rates [17], there appears to be a need for dedicated multidisciplinary perineal or pelvic floor clinics. In a survey conducted in 2010 [108], 30% of hospitals in the United Kingdom had such a dedicated clinic. A structured bowel symptom questionnaire or scoring system should be used. A proper vaginal and rectal examination should be performed to check for complete healing, scar tenderness, and sphincter tone. Mild incontinence (fecal urgency, flatus incontinence, infrequent soiling) may be controlled with dietary advice, constipating agents such as loperamide, physiotherapy, and/or biofeedback. Women who have severe incontinence should, in addition, be assessed by a colorectal surgeon for a secondary sphincter repair or sacral nerve modulation. In order to counsel women with previous OASIS appropriately, Sultan and Thakar [11] advocate the use of a symptom questionnaire, anal ultrasound (Figs. 92.4 and 92.5), and manometry results [9]. If vaginal delivery is contemplated, then these tests should be performed during the current pregnancy unless performed previously and found to be normal. Therefore, asymptomatic women who have no evidence of compromised anal sphincter function (ideally, confirmed by anal ultrasound and manometry) should be counseled accordingly and encouraged to have a vaginal delivery [105]. Cesarean section is associated with increased morbidity and mortality [109]. Therefore, unless it is the explicit wish of the woman, it should be reserved for those who are symptomatic or women who had undergone a successful secondary anal sphincter repair for fecal incontinence. In a prospective study over a 5-year period, Scheer et al. [105] found that when women who had no evidence of significant anal sphincter compromise, based on anal endosonography and manometry, were

1021 allowed a vaginal delivery, there was no deterioration in symptoms, anorectal function, or quality of life. A recently published RCT [110] where 222 women who had a third-degree tear and/or a forceps delivery in their first pregnancy with no symptoms of anal incontinence were randomized to have a vaginal birth or a planned cesarean section. The authors concluded that a cesarean section had no significant impact on anal continence 6 months after the second delivery in women with asymptomatic obstetric anal sphincter lesions diagnosed by ultrasound. However, in this study 49 of 222 women had OASIs diagnosed and repaired at the time of delivery and the rest were detected by endoanal ultrasound scan subsequently. In addition, the patients did not undergo anal manometry. In effect, the RCT by Abramowitz does not fit into the criteria recommended by the RCOG and difficult to make any recommendations. There are few observational studies where women were offered a vaginal birth or a cesarean section based on their symptoms, endoanal scan findings, and anal manometry [105, 111, 112]. These studies showed no significant worsening of bowel symptoms and sphincter integrity postpartum in the vaginal birth group if they were asymptomatic and normal endoanal scan and anal manometry prior to the second pregnancy. A recent study of 74 women who sustained a fourth-degree tear and a review of subsequent deliveries following previous OASIS by Taithongchai [113] concluded that as there are only a few units offer specialist investigations to their OASI cohort, it would be reasonable to offer cesarean section to all women who have sustained a fourth-degree tear and not base this on the presence of symptoms alone. However, in centers where EAUS and AM are available, clinicians should offer these investigations for more individualized counseling. The women would need to understand the short- and long-term risks, including the recovery period of each mode of delivery, as well as the fact that a cesarean section would be a recurring indication for all subsequent pregnancies.

Conclusion OASIS are the major cause of anal incontinence and can have a devastating effect on women’s quality of life. Until the advent of anal endosonography, the cause was attributed largely to pelvic neuropathy. However, despite identification and immediate repair of OASIS, the outcome was suboptimal as more than a third of women suffer from impaired continence. Since the introduction of the new Sultan classification and hands-on workshops, the identification and results following primary repair have improved. The majority of the obstetricians perform immediate primary repair for OASIs with variable outcomes using validated symptom questionnaires, endoanal ultrasound scan defects, and anal manometry findings. Evidence for the mode of the subsequent delivery following OASIS is currently based on the symptoms, anal sphincter defects, and anal manometry findings. We now have to focus on prevention strategies such as manual perineal protection [114], preference for vacuum versus forceps [114], and secondary prevention of recurrence of OASIS with the use of mediolateral episiotomy [106].

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SURGERY FOR FECAL INCONTINENCE Emanuela Silva-Alvarenga, Yasmin Zerhouni, and Steven D. Wexner

Introduction Fecal incontinence (FI) is a common problem that may have a substantial negative impact on a person's life. Anal incontinence may range from mild leakage of gas causing social embarrassment to complete daily loss of control of feces and avoidance of all social activities. It is important to have an approach to quantifying the severity of FI when speaking with a patient, as this result may impact their desire to undergo therapy and allow the physician to recommend the most appropriate treatment. There are many scoring systems and scales that have been developed to qualify the severity of FI; the Wexner/Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS) is the most cited scoring system [1]. The CCF-FIS ranges from 0 to 20 and measures incontinence to gas, liquid, and solid stool, the need to wear a protective pad, and the impact of FI on daily activities [2]. Patients with a CCF-FIS >10 have been shown to have a significantly lower quality of life and are more likely to seek medical attention for their FI than individuals with scores 100 mL), the patient is discharged home with an indwelling catheter. An outpatient trial of the void is carried out 1 week later. We no longer use suprapubic catheters. The use of bladder scanners and outpatient follow-up have removed the need for clamping and unclamping suprapubic catheters. This has resulted in less discomfort and earlier ambulation.

The role of laparoscopic colposuspension The indications for laparoscopic colposuspension will be influenced on patient and surgical preference. Due to the obvious increased recovery time and morbidity compared to the mid-urethral tape, particularly associated with the open procedure, the indications for colposuspension had previously narrowed. It is certainly useful as an option for those women who have significant anterior vaginal wall or bladder neck mobility, for those women undergoing other concomitant abdominal surgery, and for those women with previous failed mid-urethral tape surgery. Indeed, De Cuyper et al. reported the successful outcomes for laparoscopic colposuspension following failed mid-urethral tape surgery. In this retrospective study, subjective cure rates of 93% were reported at a median followup of 2 years [65]. In more recent times, concerns regarding mesh implantation and the widespread suspension of synthetic MUS have further driven the readoption of colposuspension as a more commonplace first-line surgical therapy.

Textbook of Female Urology and Urogynecology Both short- and long-term high-quality data exist to support the open retropubic approach to colposuspension [52, 66–68]. Recent long-term data from a large-matched cohort study by Karmakar et al. reported a subjective cure rate of 76% at an average of 13 years following open colposuspension which was no different than that reported in the MUS cohort [69]. This mirrors findings from a meta-analysis comparing these two approaches [70]. Another meta-analysis published in 2020 suggested open colposuspension to be similarly efficacious as compared to traditional suburethral sling procedures [71]. We would argue that the laparoscopic approach remains the logical 21st-century progression for this procedure. While debates about laparoscopic surgery have raged since its inception as a surgical technique, laparoscopic surgery should be considered the same as open surgery but carried out through smaller incisions with longer instruments. The advantages of the laparoscopic approach include better visualisation of anatomy, reduced postoperative pain, and a return to normal activities [72]. Data presented later within this chapter make a convincing argument for safety, perioperative morbidity, and recovery advantages with a laparoscopic approach to colposuspension [73, 74]. Technological advances in visualisation together with advances in theatre design have further enabled more complex laparoscopic surgery to become mainstream [75]. Although there is increased exposure and magnification deep in the pelvis, this is at the expense of less tactile feedback. As with any emergent procedure, however, there has been healthy scepticism of its merits and careful consideration of its risks. The problems cited have previously centred around efficacy, morbidity, cost, and operative duration. These problems from the early phase of laparoscopic surgery were, in part, explained by the limitations in the optics and the instruments available. Advances in these areas have enabled the surgeon to operate in a more dexterous manner. SynOptics launched the tube camera in 1978, and William Chang invented the first solid-state medical video camera in 1981. The first three-chip camera to be produced giving better clarity of vision arrived in 1989. The S-Video signal was developed in 1992, and the first digital zoom and digital enhancement capabilities were developed in 1999. There have been ongoing steps forward in image clarity with the advent of high-definition 3D technology. Alongside this, instrumentation has advanced to be ergonomically more suitable, further aiding surgical movements. Operating rooms have also been modified, with integrated theatres being developed, allowing the operating surgeon to modify the theatre and equipment controls to their own desired settings. This theatre environment potentially reduces stress and, hence, may result in enhanced surgical safety [76]. The development of robotic surgery may result in further advances [77]. While a small series of robotic colposuspension with promising data has been published, as yet there are no data to suggest any advantages in robotic urogynaecology over the laparoscopic approach [78]. Numerous studies have compared open colposuspension to laparoscopic colposuspension with variable success rates reported. Discussion on the merits of laparoscopic colposuspension should mirror that of the open counterpart. The reported effectiveness of any procedure is dependent on the outcome measures used and how subjective and objective improvement and cure are defined. Other compounding factors include surgical technique and experience. The requirement to learn new surgical skills for the different operative environment results in a learning curve, which has led some surgeons to develop “shortcut” approaches to surgery. These so-called “evolutions” are often given the same name as the traditional counterpart but must be assessed in their own right

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and should not be considered analogous. It would appear that most alterations to the traditional colposuspension are due to the difficulty that surgeons have had in learning suturing techniques. When evaluating operative outcomes, careful consideration should be given to who performs the surgery as well as carefully deliberating which patients are appropriate for surgery. In the UK, a minimum standard framework within which this decisionmaking process should occur is outlined by NICE, specifying the infrastructure of services and multidisciplinary teams and the procedures offered to patients [11]. The guidance states that a discussion with the woman should include the following:

not performed at the time of the colposuspension, a practice that differs from our own routine use of cystoscopy.

• The benefits and risks of all surgical treatment options for SUI that NICE recommends, whether or not they are available locally. • The uncertainties about the long-term adverse effects of all procedures, particularly those involving the implantation of mesh materials. • The differences between procedures in the type of anaesthesia, expected length of hospital stay, surgical incisions, and expected recovery period. • Any social or psychological factors that may affect the woman’s decision.

TABLE 98.2: Reported Cure Rates for Laparoscopic Colposuspension with Sutures

With respect to procedures offered, these should be colposuspension (open or laparoscopic) or an autologous rectus fascial sling. Discussion should also include the option of a retropubic mid-urethral mesh sling, although at present their use is paused. Consideration should be made for peri-urethral bulking agents to manage SUI if alternative surgical procedures are not suitable for, or acceptable to, the woman with the caveats around longterm safety and efficacy. Having established an indication for laparoscopic colposuspension, one must then consider safety and efficacy data, the cost of the laparoscopic approach, and how it compares to other surgical techniques.

Non-suture colposuspension Table 98.1 demonstrated the various methods that have been used to carry out laparoscopic colposuspension. Apart from the traditional suture method, the principal alternative that has been adopted has been the use of mesh and tacks to carry out the suspension. One RCT of 60 women has compared suturing and non-suturing laparoscopic methods [37]. The authors demonstrated a higher objective failure rate at 1 year of 26.9% with the mesh technique compared to 11.1% with sutures. Ankardal et al. similarly demonstrated a statistically significant difference in cure rate using sutures as opposed to that achieved with mesh and staples [79]. There are further studies in the literature that compare the laparoscopic route using mesh to the open procedure using sutures [38, 80]. Both studies reported a lower success rate with the laparoscopic approach. However, these studies are in fact comparing two entirely different operative procedures, and the results cannot therefore be interpreted as outcome data for all laparoscopic colposuspension procedures. There are also the issues surrounding adverse events associated with mesh use and non-absorbable tacking devices. Kenton et al. have reported two cases of women who presented with complications following laparoscopic colposuspension with Prolene mesh and tacks. Both women had tacks removed retropubically from the bladder and retropubic space, and no tacks were seen in Cooper’s ligaments in either patient [81]. In both cases, postoperative cystoscopy was

Efficacy of laparoscopic colposuspension Table 98.2 shows the reported success rates for laparoscopic colposuspension in the literature where sutures were used to elevate the vagina. There is significant heterogeneity between reported subjective and objective definitions of cure or success within the literature for women following laparoscopic colposuspension. A

Author Langebrekke et al. [87] Gunn et al. [88] Samiee et al. [89] Bunyavejchevin and Wisawasukmongchol [90] Üstün et al. [91] Summitt et al. [92] Burton [93] Burton [93] Zullo et al. [37] Kung et al. [94] Ross [95] Papasakelariou and Papasakelariou [94] Ross [96] Jelovsek et al. [97] Nezhat et al. [98] Maher et al. [99] Su et al. [100] Cheon et al. [101] Ross [102] Lee et al. [103] Foote et al. [104] Dietz and Wilson [105] Ankardal et al. [79] Adile et al. [106] Liu [107] Hong et al. [86] Fatthy et al. [108] Persson and WolnerHanssen [63] (1 suture) Huang and Yang [99] Persson and WolnerHanssen [63] (2 sutures) Carey et al. [85] Lam et al. [109] Liu and Paek [22] Yang et al. [110] Kitchener et al. [111] Liu [112] Barr et al. [84]

No. of Patients

Length of Follow-up (Months)

Cure Rate (%)

8 15 16 21

3 4–9 3 60

88 100 75 76

23 28 30 30 30 31 32 32

18 12 12 36 12 14.4 12 24

82 88 73 60 89 97 94 90.6

35 36 40 42 46 47 48 48 48 50 53 56 58 68 74 78

12 12–88 30 18 12 12 24 26 48 12 12 6–24 22 52 18 12

91 43 91.9 81 80.4 85 89 93.8 81 74 90 45 94.8 72 87.9 58

82 83

12 12

89 83

96 107 107 116 123 132 139

36–60 16 18 12 24 3–27 120

78 98 97.2 95 80 97.2 52

1068 Cochrane meta-analysis published in 2019 reported the subjective short-term success rates to be between 57% and 97% [74]. The ICS 6th consultation on incontinence published the collated data from the available level 1 and 2 evidence in the same year; most studies report success rates for laparoscopic colposuspension in excess of 80% [41]. In the UK, NICE has appraised the evidence more recently and reported a 1–5 year success rate for both open and laparoscopic colposuspension of 70% [82]. In the largest RCT, Kitchener et al. reported 2 year outcome data for 123 women randomised to laparoscopic colposuspension, with an objective cure rate of 80% [83]. A subjective cure rate of 55% was reported, defined as a composite outcome of being both “perfectly happy/ pleased”, as well as for patient-reported continence of “never leaking/leaking 0.05 Obj: OC 73% vs. LMC 52%, p > 0.05 Composite: OC 81% vs. LC 81%

2

8

9

3y 12

Üstün et al. [126] (2005)

RCT

OC vs. LC

OC = 26; LC 26

1y

Comments

Obj: OC 92% vs. LMC 74% Subj: OC 89% vs. LMC 62% Subj. OC 92% vs. LC 90% vs. LMC 63%, p < 0.05 open vs. mesh

4

7

3–5y

Cure (Objective or Subjective)

1

2

Following randomisation, 12 women changed operation and 5 had not operation. Analysis undertaken on ITT. Objective data on 83% of participants. No direct comparison in SUI outcomes between the two study arms, only pre- and postoperative for each. Large proportion of LSC patients underwent subsequent open procedure (n = 14). Prestated sample size calculation required 152 participants. No significant difference in objective outcomes between groups. Three laparoscopies converted to open. Objective success was no longer requiring continence pad. Composite of subjectively dry with negative stress test and urodynamic test.

Abbreviations: ITT = Intention to treat; OC = Open colposuspension; LSC = Laparoscopic suture colposuspension; LMC = Laparoscopic mesh colposuspension; RCT = Randomised controlled trial; SUI = Stress urinary incontinence; VAS = visual analogue scale.

1070 With respect to objective measures of cure, included studies used either urodynamic testing or a negative pad test, and the meta-analysis found no difference in laparoscopic versus open colposuspension in the short term at up to 18 months (RR 0.94, 95% CI 0.86–1.02; 1117 women). This was mirrored in the findings from the longer term follow-up of up to 5 years, where there was no significant difference between the two approaches (RR 0.89, 95% CI 0.28–2.80, two studies;107 women) [74]. Significant heterogeneity in the reporting of quality-of-life scores in the included studies meant that meaningful analysis of this data was not possible. An RCT by Kitchener et al., the Medical Research Council (MRC) funded COLPO (COlposuspension; is Laparoscopic Preferable to Open?), was the largest study included in the Cochrane analysis, recruiting 291 women in six UK centres [83]. A non-absorbable suture (Ethibond) was used for both the open and laparoscopic approaches. Of the 144 women allocated to laparoscopic surgery, 11 received open surgery and 2 had no operation. Amongst the 147 women allocated to open surgery, 1 had laparoscopic surgery and 3 had no operation. Using an intention-to-treat analysis at 2 years with the objective outcome data (1 hour pad test) showed 80% of women were cured in the laparoscopic group (85.4% data available) and 70% were cured in the open group (79.6% data available). The subjective cure rate was 55% in both groups. Using a number of validated generic and symptom-specific quality-of-life measures, there was no difference in condition-specific or generic quality of life. This was the highest quality data set used within the meta-analysis, and findings from this study demonstrate that in the hands of surgeons experienced with laparoscopic surgery, an endoscopic approach does not produce an inferior cure rate as compared to open colposuspension. Another study within the Cochrane analysis was an RCT by Cheon et al. which enrolled 90 women to compare open and laparoscopic colposuspension, reporting similar objective cure rates at 1 year (86% versus 85%) [101]. Fatthy et al. also reported similar success rate for open and laparoscopic approaches [108]. A randomised study not included within the meta-analysis of subjective cure due to methodological flaws with randomisation and concurrent surgery was that undertaken by Su et al. [100]. In the majority of their cases, only one suture was placed in the laparoscopic group as compared to two or three sutures in the open group. They reported similar operating times but lower blood loss in the laparoscopic group and lower success rate at 1 year compared to open group (80.4% versus 95.6%). The complication rate in the open group was higher than in the laparoscopic group (17.4% versus 10.8%). An analysis in a systematic review by Moehrer et al. also excluded this paper and found no statistically significant difference in objective cure when comparing both approaches [119]. A further study excluded from the Cochrane analysis of subjective cure was that by Burton, which randomised 60 women to either open or laparoscopic colposuspension, using two absorbable sutures on either side of the urethra for both techniques [93]. At 3-year follow-up, women who underwent laparoscopic colposuspension were more likely to have objective stress incontinence than those who underwent an open procedure (60% versus 93%, p ≤ 0.05). Data have only been published as a conference abstract and therefore not subject to formal peer review, making the evaluation of the findings difficult. Tan et al. published an additional meta-analysis in 2007 that identified 16 studies published between 1995 and 2006 comparing the results of laparoscopic versus open colposuspension [120]. Analysis was undertaken in 1807 patients, with 861 (47.6%)

Textbook of Female Urology and Urogynecology undergoing laparoscopic and 946 (52.4%) undergoing open colposuspension. This study concluded that the approaches are associated with similar subjective and objective cure rates. Two published retrospective studies have compared laparoscopic and open routes and have shown similar success rates at 1 year [121, 122]. Surgeons used non-absorbable sutures in both studies and reported lower use of analgesia, shorter hospital stay, and earlier return to work in the laparoscopic groups. A third study comparing the anatomic result of the two procedures by assessing the bladder neck position with postoperative ultrasound found no difference in urethral mobility or resting and straining bladder neck positions at 1 year postoperatively [123]. As outlined, there are limited long-term comparative efficacy data available. At 3–5 years following surgery, Carey et al. found no difference in self-reported stress incontinence between the two operative routes [85]. Data from a conference abstract by Morris et al. concluded that the laparoscopic approach gave a significantly higher objective cure rate after a median follow-up of 6 years [118]. Using structured interviews at least 10 years following surgery, Barr et al. reported a deterioration in subjective cure rates (defined as no urinary leakage in the last 6 months) from 71% and 67% at 6 months to 48% and 32% at 10 years for the laparoscopic and open procedures, respectively [84]. This study also found no statistical difference between the two surgical approaches. From a perspective of safety and adverse events, findings from the 2019 Cochrane study favour a laparoscopic approach [74]. The meta-analysis found significantly fewer perioperative complications following laparoscopic colposuspension (RR 0.67, 95% CI 0.47–0.94; 1369 women), with the exception of bladder injuries which occurred in 3.9% (19/489) of patients versus 1.5% (7/468) of those undergoing open colposuspension (RR 1.72, 95% CI 0.90–3.29). Duration of catheterisation and blood loss favoured a laparoscopic technique although, interestingly, operative time favoured an open approach, more likely a reflection of laparoscopic skills rather than the technique itself [74]. Authors also concluded that women who underwent a laparoscopic colposuspension appeared to have less pain and lower postoperative analgesia requirements although these data were not analysed quantitatively. There were no statistically significant differences in the rates of voiding dysfunction or DO in the short or long term nor between the groups. Tan et al. reported similar findings in that a laparoscopic approach was associated with a lower operative blood loss, earlier postoperative recovery, and an earlier return to work in a 2007 meta-analysis [120]. Such a finding has been mirrored in the more recent database study by Sappenfield et al who found a laparoscopic approach to colposuspension to be significantly lower morbid procedure as compared to an open approach [73]. Su et al. reported shorter operative time with the laparoscopic approach, although there was less suturing as compared to an open technique [100]. In contrast, Carey et al. reported a shorter operative time for the open technique (44 versus 85 minutes) [85]. The laparoscopic approach took 17 minutes longer in the trial undertaken by Fatthy et al. (in keeping with findings from the MRC trial), with nearly 200 mL less blood loss, 40 hours shorter hospital stay, and return to light work 23 days earlier [108, 111]. Fatthy et al. and Su et al. both reported a longer hospital stay after an open approach. There was no significant difference in length of hospital stay in the studies by Cheon et al. and Carey et al. [85, 101]. The latter group did however report a significantly quicker return to normal activities in the laparoscopic arm of patients. It is worth

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noting that in the MRC study, all patients had a suprapubic catheter which may have resulted in a longer hospital stay.

Laparoscopic compared with synthetic mid-urethral sling Safety and efficacy data

Having presented evidence outlining comparable efficacy between the open and laparoscopic approaches to colposuspension, as well as clear advantages with respect to safety and recovery with laparoscopy, a comparison must then be made with what has been the gold standard approach to SUI, the synthetic MUS.

The 2019 Cochrane analysis included nine studies to compare laparoscopic colposuspension with vaginal synthetic MUS procedures, and these are shown in Table 98.4 [74]. Three of the studies used were only published as abstracts. It should also be noted that both the TVT and the SPARC® system were analysed as well as both suture and mesh colposuspension. Analysis revealed that at 18 months follow-up, there was no significant difference in rates of subjective cure between the two approaches (RR 0.91, 95% CI 0.80–1.02; 377 women), and in a study with 4–8 year follow-up by Jelovsek et al., this continued to be the case [97]. The various trials define objective cure as either a negative clinical stress test, negative pad test, negative urodynamic test, or the absence of leaks recorded on

TABLE 98.4: RCTs Comparing Synthetic MUS versus Laparoscopic Colposuspension [89, 91, 97, 99, 104, 106, 127–131] Number Study

Type

Comparators

1

Adile et al. (2001)

RCT

TVT vs. LC

2

Foote et al. (2006)

RCT

3

Mirosh and Epp (2005) Maher et al. (2004)

Paraiso et al. (2004)

4

5

N (Numbers at Follow-up)

Sub: TVT 89% vs. LC 45%

SPARC device MUS = 49; LC = 48 vs. LC (44:43)

2y

Subj: MUS 77.4% vs. LC 81.4%

RCT

TVT vs. LC

12m

Not reported

RCT

TVT vs. LC

TVT = 16; LC = 14 (16:14) TVT = 40; LC = 42 (31:42)

18m

RCT

TVT vs. LC

TVT = 33; LC = 33 (not reported)

12–43m (median 18m) 12–88m (median 65m) 12m

Subj: TVT 85% vs. LC 81% (p = 0.77) Obj: TVT 85% vs. LC 78% (p = 0.56) Obj: TVT 81% vs. LC 97% (18m)

TVT = 36; LC = 36 (25:28)

6

Persson et al. (2002)

RCT

TVT vs. LC

TVT = 38; LC = 33 (37:31)

7

Samiee et al. (2009)

RCT

TOT vs. LC

TOT = 19; LC 16 (18:12)

8

Ü.53) et al. (2003) Valpas et al. (2004)

RCT

TVT vs. LC

9

Valpas et al. (2004)

Cure (Objective or Subjective)

6–24m

Jelovsek et al. (2008)

TVT = 57; LC = 56 (57:56)

Follow-up

RCT

RCT

TVT = 23; LC = 23 (not reported) TVT vs. LMC TVT = 70; LMC = 51 (not reported)

3m

3m 6w

1y

Level of Evidence Comments

2

2

1

Subj: TVT 52% vs. LC 43% (65m)

2

Subj: TVT 57% vs. LC 52% Obj: TVT 89% vs. LC 87%

1

Subj: no difference (p = 0.23) Obj: TOT 84% vs. LC 75% (p = 0.53) Obj: TVT 83% vs. LC 83% Obj: TVT 93% vs. LMC 88% (p = ns)

2

Obj: TVT 8% vs. LMC 57% (diff 95% CI 12.7–43.9, p = 0.000)

Abstract data only. Subjective cure rates reported were satisfaction only. SPARC device used as MUS. Cure/improvement defined as no leaks/week and VAS < 2, or 50% improvement in leaks/week and VAS Abstract only. No difference in QoL scores. Abstract data only. No difference in symptom or QoL scores. Objective cure was no evidence of leakage on urodynamic studies. Subjective cure defined as reporting to be leak free. No details on method of determining subjective cure. Objective cure was a negative postoperative pad test. Subjective according to ISI PROM. Objective was based on evidence of leakage on urodynamic studies.

2 2

2

Objective cure was negative stress test (coughing) with 300 mL bladder capacity. Stress test as above. Sample size calculation required 176.

Abbreviations: TVT = Tension-free vaginal tape; MUS = Mid-urethral sling; LC = Laparoscopic suture colposuspension; LMC = Laparoscopic mesh colposuspension; RCT = Randomised controlled trial; QoL = Quality of life; PROM = Patient-reported outcome measure; TOT = transobturator tape; VAS = visual analogue scale.

Textbook of Female Urology and Urogynecology

1072 a bladder diary and was reported by all studies with the exception of that by Mirosh and Epp. [127]. This analysis favoured the TVT procedure over laparoscopic suture colposuspension for objective cure rates at 18 months (RR 0.88, 95% CI 0.81–0.95). With respect to quality of life, while a heterogeneous group of measures was used, making comparison difficult, the Cochrane analysis noted that in all studies, both groups had significant improvements in measures, with no significant difference between the two groups. The study with the longest follow-up by Jelovsek et al. that included 72 patients found that 88% of subjects in the laparoscopic Burch group reported that if they had to do it all over again, they would choose the same treatment as compared to 79% in the TVT group [97]. When comparing the MUS with laparoscopic colposuspension, data concerning safety and morbidity must also be examined. Seven studies within the Cochrane review reported perioperative complications, and there were no statistically significant differences in the perioperative complication rates between laparoscopic colposuspension and vaginal sling procedures (RR 0.99, 95% CI 0.60–1.64; 514 women). Laparoscopic surgery took significantly longer, by an average of 20 minutes, than MUS surgery, although the clinical significance of this is undetermined [74]. A sling was associated with a shorter time to return to normal activities, lower analgesic use, and shorter length of stay [74]. Two studies in the review looked at postoperative pain relief. A study by Paraiso et al. reported similar length of use for patient-controlled analgesia in both groups, while Valpas et al. found lower rates of analgesia use following TVT [128, 131]. The data regarding postoperative bladder function seems to be conflicting, particularly with respect to OAB symptoms. Two studies have shown urgency to be more common after a sling procedure, and a further three studies report higher rates of overactivity [91, 104, 106, 128, 131]. This contrasts with the findings by Maher et al., and the meta-analysis found no difference in de novo DO at 18 months (RR 0.80, 95% CI 0.34–1.88) [99]. The numbers of women with voiding dysfunction following the two procedures were too small to allow for an adequate analysis, and therefore, there appeared to be no difference in the groups. To summarise, comparison between the MUS and laparoscopic colposuspension suggests potential advantages to a sling procedure in term of short-term subjective and objective cure as well as reduced morbidity. Yet, this must be considered within the context of the controversies that have surrounded the use of mesh-augmented techniques. Large population studies have suggested that the use of a synthetic MUS may be associated with up to a 2% risk of mesh-associated complications requiring reoperation, a complication avoided in suture colposuspension [132]. As laparoscopic colposuspension supersedes MUS for the surgical treatment of SUI, there will be a need for further high-quality comparative studies that include outcomes such as pain with long-term follow-up.

Cost analysis Differences in costs are difficult to assess as there is a great variation in each country as to how long patients tend to stay in hospital following surgery, and there are differing costs of operating time. The laparoscopic approach is generally reported to require longer operating time than the open colposuspension or MUS procedures. The other cited factor against the laparoscopic approach is the increased cost of disposables associated with minimal access

procedures. With greater adoption of laparoscopic surgery, there has been a continued drive for industry to produce better and more cost-effective equipment, and there is a growing competitive market for this, which ultimately may further drive down costs with no compromise on quality. It is also important to mention that the cost of sterilisation of reusable instruments is rarely if ever allowed for during cost comparisons of techniques. A recent systematic review by Javanbakht et al. has outlined the overwhelming evidence in support of the MUS as the most cost-effective intervention for SUI, although three studies were identified comparing laparoscopic and open colposuspension, all favouring the laparoscopic approach from this perspective [133]. As part of the COLPO study group, Dumville et al. undertook a cost-effective analysis comparing laparoscopic colposuspension versus open colposuspension [134]. The health outcome measure for the economic analysis used was quality-adjusted life years (QALYs). This is a measure reflecting both patient’s health-related quality of life and mortality into a single index. Interestingly, in this study, both groups had a suprapubic catheter inserted at the time of surgery, and both groups were subjected to a particular postoperative trial of void regimen. This is likely to have influenced the length of inpatient stay and may have inadvertently minimised the actual differences between the two study arms in terms of length of hospital stay. While short-term costs favoured an open approach, those who underwent laparoscopic surgery had higher QALYs when compared with those who underwent open surgery. They had shorter inpatient stays and fewer postoperative visits. The total theatre costs for the laparoscopic group were, as expected, markedly higher than the open surgery group (£944 versus £464), mainly due to the longer theatre time used and the extra equipment required for the laparoscopic surgery. The total cost of laparoscopic surgery at 6 months of follow-up was higher than the total cost of open surgery (£1805 versus £1433), with a differential mean of £372 (95% CI 274–471). At 24 months, the authors concluded “the laparoscopic approach might be a costeffective alternative in the medium term, provided that there are no major cost implications from treatment failure compared with the open group”. Given that there is little evidence to suggest that failure rates of the two procedures are particularly divergent after 2 years, the laparoscopic colposuspension could be assumed to be cost-effective at this time interval. Kohli et al. have reported a retrospective 2-year cost analysis of laparoscopic suture colposuspension compared with open colposuspension [135]. They found that the laparoscopic approach was more expensive, costing $4960 versus $4079, although the postoperative care costs were lower than in the open group ($1068 versus $1561). Persson et al. reported that a laparoscopic colposuspension is cheaper than a TVT (€1273.4 versus €1342.8), despite the TVT procedure being performed in less time [129]. In contrast, a more recent Swedish study reported that the TVT procedure generated a lower direct cost than colposuspension, either by the open or laparoscopic approach [136]. Cody et al. have undertaken an analysis of cost-effectiveness comparing TVT with three alternatives, open Burch colposuspension, laparoscopic colposuspension, and bladder neck injectables [137]. Utilising data from a systematic review, they modelled 10 year follow-up based on experience and data from the UK’s NHS and reported a cost, as of 2001, of £1058 per woman for TVT, compared to £1317 for laparoscopic colposuspension. Improved laparoscopic skills and therefore reduced operating times, as well as lower cost instruments, mean more contemporaneous cost-efficiency analysis are needed.

Laparoscopic Colposuspension

Conclusion Colposuspension avoids the placement of a permanent mid-urethral tape and therefore offers an attractive alternative to the MUS in the era of heightened concerns about mesh use in gynaecology. Current evidence suggests that laparoscopic colposuspension performed with sutures has comparable cure rates as compared to the open approach and the TVT procedures. The laparoscopic approach is associated with a quicker return to normal activity than the open procedure although inferior in this respect as compared to the MUS. The use of mesh, tacks, or staples and only one suture appears to reduce the success rate and is supported by few data and is of low quality. The recent controversies associated with the placement of vaginal mesh have stimulated the rebirth of the colposuspension in its modern-day form, and a growing number of pelvic floor surgeons are able to include it in their repertoire of anti-incontinence procedures. Each of the many available procedures for SUI offers its own set of advantages and disadvantages, and one single procedure is unlikely to offer a universal panacea. A successful anti-incontinence procedure takes into account patient symptoms, medical comorbidities, and the presence of other pelvic floor problems. The ability to choose from a range of surgical techniques will inevitably optimise treatment for the individual patient. The laparoscopic colposuspension requires a surgeon competent in minimal access surgery as well as urogynaecology. We believe that efforts should now be directed towards improvements in training and theatre environment, both of which can act as either facilitators or barriers to surgical uptake. Data on long-term success rates and the role of absorbable sutures remain sparse although they are not unique to laparoscopic colposuspension.

References

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LAPAROSCOPIC SACROCOLPOPEXY* Mugdha Kulkarni, Anna Rosamilia, and Marcus Carey

Introduction Sacrocolpopexy (SCP) is defined as the suspension of the vaginal apex to the anterior longitudinal ligament of the sacrum using a graft with possible incorporation of the graft into the fibromuscular layer of the anterior and/or posterior vaginal walls (1). According to the British Society of Urogynaecology (BSUG), 4469 SCPs were performed between 2008 and 2017: 47% were performed laparoscopically and 53% were open procedures. National Inpatient Sample (NIS) data that represent 20% of US hospital admissions showed 160717 sacral colpopexies were performed in the period 2010–2014, and an increase of 2.4% per year in laparoscopic procedures was noted over this time period (2). Over the past decade in the United States, 9327 cases of SCP with concurrent hysterectomy (46% subtotal and 54% total) were performed; 83% were minimally invasive procedures (3). A comparison of the rate of SCP in OECD (Organization for Economic Cooperation and Development) nations showed a wide variation with 66% of all apical procedures in France being SCP compared with 5% in Sweden in 2012 (4). Younger patients (age