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

Recruiting now · Not applicable

Conditions studied: Pelvic Organ Prolapse Vaginal Surgery, Stress Urinary Incontinence in Women

In brief

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

Key facts

Study ID

NCT07414849

Run by

Hospital General de Agudos J. M. Penna

People needed

330

Starts

2026-03-01

Expected to finish

2028-12-31

Last updated by the study team

2026-06-17

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pelvic organ prolapse (POP) stage II C or greater, defined as C ≥ +1, in women without prior hysterectomy and/or with a diagnosis of stress urinary incontinence seeking surgical treatment.
• Ability to understand study information and provide written informed consent.
• Availability for follow-up for a minimum of 12 months.

You may not qualify if…

• Previous surgery with synthetic mesh (via vaginal or abdominal approach) for POP repair.
• Known adverse reaction to synthetic meshes.
• Unresolved or active chronic pelvic pain.
• History of prior abdominal or pelvic radiation.
• Contraindication to the planned surgical procedure.
• Current pregnancy.

Where it is running

• Hospital J M Penna — Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

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