Study of Human Amniotic Membrane Graft to Prevent Mesh Exposure in Vaginal Surgery for Pelvic Organ Prolapse and Stress Urinary Incontinence in Women

What this Trial Is About

This research evaluates the addition of a human amniotic membrane graft to polypropylene mesh surgery in women undergoing vaginal reconstructive surgery for pelvic organ prolapse and stress urinary incontinence. The study aims to assess whether this combination improves tissue integration and reduces complications related to mesh exposure during surgery. Participants are randomly assigned to one of two groups one group receives the standard polypropylene mesh surgery with a dehydrated human amniotic membrane patch placed over the mesh before vaginal closure, while the other group undergoes the mesh surgery without the amniotic membrane. The surgical procedures involved include sacrospinous hysteropexy with mesh, retropubic mid-urethral sling, and transobturator mid-urethral sling, all using polypropylene mesh. Throughout the study, participants are monitored for 12 months after surgery to measure the number of cases with mesh exposure, which is the primary outcome. Follow-up visits during this period will help assess surgical outcomes and complications. The study is sponsored by Hospital General de Agudos J. M. Penna and aims to prevent mesh exposure after vaginal reconstructive surgery.

The AMPER Study: Evaluation of the Efficacy of Human Amniotic Membrane Grafting in Preventing Mesh Exposure in Vaginal Reconstructive Surgery Using Polypropylene Mesh.