A Randomized Trial of Two Lightweight Polypropylene Meshes for Sacrocolpopexy.

Abstract

Introduction and hypothesis: Sacrocolpopexy is considered the most durable repair for apical pelvic organ prolapse. There are no data available to compare similar meshes used for sacrocolpopexy. The objective was to evaluate surgical success in women undergoing mesh sacrocolpopexy using two mesh grafts.

Methods: This is a randomized single-blind trial evaluating two ultra-lightweight Y mesh grafts used in laparoscopic sacrocolpopexy. Participants were randomized to one of two meshes and were blinded to arm assignment. Participants were followed for 2 years postoperatively. The primary outcome was surgical success defined as prolapse retreatment or patient-reported vaginal bulge. Validated questionnaires were used to assess patient-reported outcomes. Power analysis indicated 90 participants were needed.

Results: One hundred six patients underwent laparoscopic sacrocolpopexy: 54 in the Restorelle® arm and 52 in the Vertessa® Lite arm. Mean age and BMI for all participants were 60±9 years, 28.1±5.2 kg/m², respectively. Surgical success was similarly high in both study arms. At 6 months, two (2.1%) patients, one in each arm reported subjective bulge symptoms. At 12 months, there were no recurrences. At 24 months, three (3.3%) additional patients experienced recurrence, two in the Restorelle® arm and one in the Vertessa® Lite arm. Compared to baseline, validated questionnaires demonstrated improvement for all patients at 6, 12, and 24 months.

Conclusions: In this randomized comparison of two lightweight meshes for sacrocolpopexy, we demonstrated similar surgical success and low reoperation rates for both meshes. Two years postoperatively, minimally invasive sacrocolpopexy is associated with significant improvement in pelvic floor symptoms regardless of mesh used.