Partially absorbable mesh or native tissue repair for pelvic organ prolapse: a randomized controlled trial.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The objective was to compare medium-term efficacy and safety of a partially absorbable mesh kit and native tissue repair in pelvic organ prolapse (POP). MATERIALS AND METHODS: Women with primary POP stage ≥ II were randomized to transvaginal trocar-guided partially absorbable mesh (81 women) or native tissue repair (82 women). Primary outcome was overall anatomical success (POP < stage II) at 24 months. Secondary outcomes were composite success, global improvement, and adverse events. RESULTS: Sixty-nine (85%) of the women allocated to partially absorbable mesh underwent mesh surgery; 8 (10%) crossed over to native tissue repair and 4 women (5%) withdrew from the study. Eighty (98%) of the women allocated to native tissue repair underwent the assigned treatment and 2 (2%) withdrew. Twenty-four months later, 140 surgically treated women (89%) demonstrated an overall anatomical success of 39%; 45% (32 out of 71 women) for mesh, and 32% (22 out of 69) for native tissue repair (RR 1.4, 95% CI 0.92 to 2.2). Composite success was 88 and 73% respectively (RR 1.1, 95% CI 0.93 to 1.4). There was global improvement in 86% (48 out of 56 women) in the mesh group and in 77% (47 out of 60 women) in the native tissue group (RR 1.1, 95% CI 0.92 to 1.3). Four women were diagnosed with mesh exposure at 2 years (6%). CONCLUSION: At 24 months, no significant anatomical or composite benefit of partially absorbable mesh over native tissue repair could be demonstrated in women who had been surgically treated for primary POP.