The AMPER Study: Evaluation of the Efficacy of Human Amniotic Membrane Grafting in Preventing Mesh Exposure in Vaginal Reconstructive Surgery Using Polypropylene Mesh.
The Amper Study: Amniotic Membrane for the Prevention of Mesh Exposure in Vaginal Reconstructive Surgery
Hospital General de Agudos J. M. Penna
330 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria3
- 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.
Exclusion Criteria6
- 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.
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Interventions
Sacrospinous Hysteropexy with polypropylene mesh
Retropubic mid-urethral sling (bottom-up approach) using polypropylene mesh for the treatment of stress urinary incontinence.
Transobturator mid-urethral sling (out-in) using polypropylene mesh for the treatment of stress urinary incontinence.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07414849