Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery: a Multicentre, Phase 11-111, Partially Randomised Patient Preference Trial

What this Trial Is About

This research aims to compare the effectiveness of the OviTex 1S permanent mesh with the standard polypropylene mesh in minimally invasive pelvic floor surgeries for patients with pelvic organ prolapse. It addresses the ongoing debate over synthetic versus biological mesh use, especially following FDA restrictions on transvaginal mesh and concerns about complications such as fistulation and mesh exposure. The study is a prospective, multicenter trial focusing on robotic ventral mesh rectopexy (VMR) and sacrocolporectopexy (SCR) or cervicopexy. Participants will undergo robotic-assisted surgery using either the standard polypropylene mesh or the OviTex 1S mesh, which combines sheep extracellular matrix with polypropylene fibers to potentially offer strength with reduced inflammatory response. All surgeries use the da Vinci Si-HD robotic system. The study includes several phases assessing feasibility, safety, and efficacy, with a focus on complications within 90 days post-surgery and longer-term outcomes over 24 months. The trial is a partially randomized patient preference study. During the study, participants will be monitored through questionnaires assessing pelvic floor distress, constipation, incontinence, sexual function, and quality of life before and up to 24 months after surgery. Researchers will also track complications, recurrence rates of prolapse, hospital stay length, and additional medical visits. This detailed follow-up aims to capture both functional outcomes and safety data to evaluate the potential of OviTex as an alternative mesh for pelvic floor repair.

Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery