Clinical Trial

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

Study acronym: AMPER
Recruiting
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Summary
This study evaluates the efficacy of adding a human amniotic membrane graft to polypropylene mesh surgery for pelvic prolapse and stress urinary incontinence. The goal is to assess improvements in tissue integration and the reduction of surgical complications
Protocol Amendment History 3 changes
critical Recruitment opened 2026-06-18
notable Primary completion pushed: 2026-12-31 -> 2028-12-31 2026-06-18
minor Completion pushed: 2027-12-31 -> 2028-12-31 2026-06-18
Trial Details
NCT Number NCT07414849
Lead Sponsor Hospital General de Agudos J. M. Penna
Conditions Pelvic Organ Prolapse Vaginal Surgery, Stress Urinary Incontinence in Women
Enrollment 330 participants
Start Date 2026-03-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-17