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

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.