Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse
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Introduction and hypothesis
The aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair.
Prospective, randomized, multicenter study conducted between April 2005 and December 2009 comparing anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5–8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires.
Of the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%).
Seven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.
KeywordsLong-term outcome Pelvic organ prolapse Cystocele Vaginal surgery Polypropylene mesh Anterior colporrhaphy
We would like to show our gratitude to our colleagues from the other participating centers: Dr. Nizar Aflak, Dr. Jérôme Blanchot, Dr. Pierre-Louis Broux, Dr. Olivier Guilbaud, Dr. Aslam Monsoor, Prof. Xavier Deffieux, Prof. Loïc Marpeau, Dr. Vincent Descheemaeker, Dr. Philippe Ferry, and Dr. Sandrine Campagne. We also wish to thank the members of the BESPIM for the data management and statistical analysis (especially Dr. Pascale Fabbro-Peray, methodologist and Stéphanie Salles, data manager), and Dr. Sarah Kabani (for English editing), Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), Nîmes University Hospital, Nîmes, France.
This research was supported by the Nîmes University Hospital (Local Project 2013).
Compliance with ethical standards
Conflicts of interest
R. de Tayrac is consultant for Boston Scientific, has had research funding from Sofradim-Covidien, Boston Scientific, and has accepted speaker’s fees from Boston Scientific, Coloplast, and American Medical Systems. G. Eglin has acted as a consultant for Sofradim. H. Fernandez is a consultant for American Medical Systems. L. Allègre, G. Callewaert, A. Cornille, O. Guilbaud, A. Mansoor, and S. Alonso have no conflicts of interest to declare.
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