Prospective multicenter trial assessing type I, polypropylene mesh placed via transobturator route for the treatment of anterior vaginal prolapse with 2-year follow-up

Abstract

Introduction and hypothesis: Two-year outcomes of treating cystocele with a polypropylene mesh (Perigee System with IntePro, AMS, Inc.) placed via a transobturator approach are reported.

Methods: A prospective, multicenter trial was conducted evaluating 114 women with >or= stage II anterior wall prolapse defined using International Continence Society guidelines. Treatment success was defined as anterior stage <or= I at a 24-month follow-up. Quality of life questionnaires were administered at baseline and follow-up. Complications were reported via adverse events.

Results: Efficacy at 24 months was 88.5% (77/87). Pelvic floor distress inventory, pelvic floor impact questionnaire-7, and pelvic organ prolapse/urinary incontinence sexual questionnaire were all significantly improved from baseline (p < 0.001). Complication rates reported were vaginal mesh extrusion 10.5% (12/114) and groin, pelvic, or vaginal pain 4.4% (5/114). Six subjects reported de novo dyspareunia. Out of the 49 subjects reporting dyspareunia at baseline, 15 were resolved postoperatively.

Conclusions: The Perigee System is an effective treatment to repair anterior wall prolapse with a low rate of complications through a 2-year follow-up.