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

Abstract

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. Methods: 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. Results: 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%). Conclusion: 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.