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Outcomes After Female Urinary Incontinence and Pelvic Organ Prolapse Surgery

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Outcomes After Female Urinary Incontinence and Pelvic Organ Prolapse Surgery D 1258 OULU 2014 D 1258 UNIVERSITY OF OULU P.O.BR[ 00 FI-90014 UNIVERSITY OF OULU FINLAND ACTA UNIVERSITATIS OULUENSIS ACTA UNIVERSITATIS OULUENSIS ACTA SERIES EDITORS DMEDICA Virva Nyyssönen ASCIENTIAE RERUM NATURALIUM Virva Nyyssönen Professor Esa Hohtola TRANSVAGINAL MESH- BHUMANIORA AUGMENTED PROCEDURES University Lecturer Santeri Palviainen CTECHNICA IN GYNECOLOGY Postdoctoral research fellow Sanna Taskila OUTCOMES AFTER FEMALE URINARY DMEDICA INCONTINENCE AND PELVIC ORGAN PROLAPSE Professor Olli Vuolteenaho SURGERY ESCIENTIAE RERUM SOCIALIUM University Lecturer Veli-Matti Ulvinen FSCRIPTA ACADEMICA Director Sinikka Eskelinen GOECONOMICA Professor Jari Juga EDITOR IN CHIEF Professor Olli Vuolteenaho PUBLICATIONS EDITOR Publications Editor Kirsti Nurkkala UNIVERSITY OF OULU GRADUATE SCHOOL; UNIVERSITY OF OULU, FACULTY OF MEDICINE, INSTITUTE OF CLINICAL MEDICINE, ISBN 978-952-62-0562-5 (Paperback) DEPARTMENT OF OBSTETRICS AND GYNECOLOGY; ISBN 978-952-62-0563-2 (PDF) OULU UNIVERSITY HOSPITAL ISSN 0355-3221 (Print) ISSN 1796-2234 (Online) ACTA UNIVERSITATIS OULUENSIS D Medica 1258 VIRVA NYYSSÖNEN TRANSVAGINAL MESH-AUGMENTED PROCEDURES IN GYNECOLOGY Outcomes after female urinary incontinence and pelvic organ prolapse surgery Academic dissertation to be presented with the assent of the Doctoral Training Committee of Health and Biosciences of the University of Oulu for public defence in auditorium L4 of Oulu University Hospital, on 10 October 2014, at 12 noon UNIVERSITY OF OULU, OULU 2014 Copyright © 2014 Acta Univ. Oul. D 1258, 2014 Supervised by Docent Markku Santala Docent Anne Talvensaari-Mattila Reviewed by Professor Seppo Heinonen Doctor Kari Nieminen Opponent Docent Pentti Kiilholma ISBN 978-952-62-0562-5 (Paperback) ISBN 978-952-62-0563-2 (PDF) ISSN 0355-3221 (Printed) ISSN 1796-2234 (Online) Cover Design Raimo Ahonen JUVENES PRINT TAMPERE 2014 Nyyssönen, Virva, Transvaginal mesh-augmented procedures in gynecology. Outcomes after female urinary incontinence and pelvic organ prolapse surgery University of Oulu Graduate School; University of Oulu, Faculty of Medicine, Institute of Clinical Medicine, Department of Obstetrics and Gynecology; Oulu University Hospital Acta Univ. Oul. D 1258, 2014 University of Oulu, P.O. Box 8000, FI-90014 University of Oulu, Finland Abstract Problems of female urinary incontinence and pelvic organ prolapse are common. Traditional operative techniques in the treatment of these conditions have unsatisfactory efficacy outcomes and involve complications. Attempts have been made to solve this problem with synthetic meshes, but with the use of meshes mesh-related complications have appeared. The situation is difficult because the number of different meshes, techniques and instrumentations is numerous. The present study was conducted to investigate the safety issues and complication rates of four structurally different polypropylene meshes used in transvaginal surgery when treating female urinary incontinence and apical or posterior vaginal prolapse. Vaginal mesh exposures were under special interest. Subjective outcome and patient satisfaction of tension-free vaginal tape (TVT) and transobturator tape (TOT) methods in the treatment of female urinary incontinence were reported. Objective and subjective cures of posterior intravaginal sling (PIVS) and Elevate®Posterior procedures were investigated. The incidence of vaginal mesh exposure varied between different meshes. The highest exposure incidence, 16–25%, was found with heavyweight microporous multifilament mesh. The lowest mesh exposure incidence, 0.9%, was seen with lightweight macroporous monofilament mesh. The subjective cures of the TVT and TOT procedures were 84% and 80%, and patient satisfaction rates were 79% and 74%, respectively. The objective cure of posterior IVS was only 69% and patient satisfaction rate 62%, while Elevate®Posterior reached 84–98% objective cure rate, depending on the definition used. Subjective efficacy of this procedure was 86%. According to this study, the use of heavyweight microporous multifilament should be abandoned because of the intolerably high vaginal mesh exposure incidence. The subjective efficacy and patient satisfaction of TVT and TOT procedures are satisfactory. Both objective and subjective cure rates of posterior IVS are poor, whereas the Elevate®Posterior technique with lightweight macroporous monofilament mesh presents promising results. Keywords: mid-urethral sling, objective cure, patient satisfaction, pelvic organ prolapse, subjective cure, transvaginal mesh, urinary incontinence, vaginal mesh exposure Nyyssönen, Virva, Verkkoavusteiset transvaginaaliset leikkaustekniikat gynekologiassa. Naisen virtsankarkailu- ja laskeumakirurgian tulokset Oulun yliopiston tutkijakoulu; Oulun yliopisto, Lääketieteellinen tiedekunta, Kliinisen lääketieteen laitos, Synnytys ja naistentaudit; Oulun yliopistollinen sairaala Acta Univ. Oul. D 1258, 2014 Oulun yliopisto, PL 8000, 90014 Oulun yliopisto Tiivistelmä Virtsankarkailu ja emättimen monimuotoiset laskeumat ovat naisilla yleisiä. Näitä vaivoja perin- teisillä leikkaustekniikoilla hoidettaessa leikkaustulokset ovat olleet epätyydyttäviä sekä tehon että komplikaatioiden ilmaantuvuuden osalta. Ongelmaa on yritetty ratkaista synteettisien verk- kojen avulla, mutta verkkojen käytön myötä niihin on havaittu liittyvän myös ongelmia. Tilan- netta hankaloittaa myös erilaisten verkkomateriaalien, tekniikoiden ja instrumentaatioiden run- saslukuisuus. Tässä tutkimuksessa selvitettiin neljän rakenteeltaan erilaisen polypropyleenistä valmistetun verkon turvallisuutta ja komplikaatioiden esiintyvyyttä hoidettaessa verkkoavusteisesti naisen virtsankarkailua ja emättimen pohjukan tai emättimen takaseinämän laskeumaa. Erityisenä kiin- nostuksen kohteena olivat verkkoihin liittyvät eroosiot. Virtsankarkailun hoidon subjektiivinen teho ja potilastyytyväisyys selvitettiin käytettäessä tension-free vaginal tape- (TVT) ja transob- turator tape (TOT) -tekniikoita. Laskeumien hoidon objektiivinen ja subjektiivinen teho arvioi- tiin käytettäessä posterior intravaginal sling- (PIVS) ja Elevate®Posterior -tekniikoita. Verkon eroosioiden ilmaantuvuus vaihteli rakenteeltaan erilaisten verkkojen välillä siten, että tiivistä mikroporoottista multifilamenttinauhaa käytettäessä eroosioiden ilmaantuvuus oli 16–25 %, kun taas kevyttä makroporoottista monofilamenttiverkkoa käytettäessä eroosioprosentti oli 0.9. TVT-menetelmällä saavutettiin 84 %:n ja TOT menetelmällä 80 %:n subjektiivinen teho. TVT-potilaista hoitoon tyytyväisiä oli 79 % ja TOT-potilaista 74 %. Posteriorinen IVS saavutti vain 69 %:n objektiivisen tehon pohjukan laskeuman hoidossa. Potilastyytyväisyys oli samaa luokkaa, 62 %. Sen sijaan Elevate®Posterior-menetelmää käytettäessä saavutettiin käytetystä tehon määritelmästä riippuen 84–98 %:n objektiivinen teho. Subjektiivinen teho tällä menetel- mällä oli 86 %. Tämän tutkimuksen perusteella tiiviin mikroporoottisen multifilamenttiverkon käyttöön liit- tyvä verkkoeroosioiden määrä on sietämättömän suuri. Vakiintuneiden TVT- ja TOT-menetelmi- en subjektiivinen teho ja potilastyytyväisyys ovat hyväksyttäviä. PIVS-metodia käytettäessä sekä objektiivinen että subjektiivinen tulos on huono, kun taas Elevate®Posterior-menetelmän ja siinä käytetyn kevyen verkon käytöstä saadut tulokset ovat lupaavia. Asiasanat: emättimen laskeuma, keskiuretraaliset nauhaleikkaukset, objektiivinen tulos, potilastyytyväisyys, subjektiivinen tulos, transvaginaalinen verkko, verkkoeroosio, virtsankarkailu To my precious ones 8 Acknowledgements This study was conducted at the Department of Obstetrics and Gynecology, University of Oulu, from 2004 to 2014. I express my deepest gratitude to my two magnificent supervisors, Docent Markku Santala and Docent Anne Talvensaari-Mattila, for their expert guidance and advice in the world of science through these years. Their amazing patience and never-ending support and optimism helped me to keep my spirits up also during tough times. The help and knowledge that Docent Santala has given me in statistics is invaluable. This study was mostly carried out “by email” as I have lived in Joensuu most of these years. I must say that the awesome linguistic virtuosity of Docent Santala in these emails has put a smile on my face numerous times. Despite the long distance, Docent Talvensaari-Mattila has always been available for me whenever I have been in urgent need of help. She has been my helping hand with all practical issues, which were challenging to handle because of the long distance. I am very grateful to Doctor Mervi Haarala and Doctor Seija Ala-Nissilä for their valuable advice and instructions regarding the last article of the thesis. I also thank my colleagues Eila Heiskanen, MD, Pekka Kulju, MD, Kirsi Kuismanen, MD, Päivi Selänne, MD, and Doctor Satu Tarjanne for providing the data for the last article. Risto Bloigu, PhD, is acknowledged for statistical help with the last manuscript. I am deeply appreciative to the reviewers of the thesis, Professor Seppo Heinonen and Doctor Kari Nieminen, for the precise observations and valuable comments, which truly improved the content of this thesis. I wish to thank the study nurses Irma Krankka and Eija Sorola for their important input in conducting studies II and III. Anna Vuolteenaho, MA, is acknowledged for her fast and expert revisions of both English and Finnish languages in all the articles and in the thesis. I am privileged to work with wise and skillful colleagues and friends in the Department of Obstetrics and Gynecology
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