RecruitingNot ApplicableNCT07414849

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

Sponsor

Hospital General de Agudos J. M. Penna

Enrollment

330 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Pelvic Organ Prolapse Vaginal Surgery Stress Urinary Incontinence in Women

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

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Retropubic Mid-urethral Sling (Bottom-Up), a procedure called Sacrospinous Hysteropexy with Mesh, and others for people with pelvic organ prolapse vaginal surgery and stress urinary incontinence in women. The study is currently recruiting participants at 1 location. People eligible for this study include women.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESacrospinous Hysteropexy with Mesh

Sacrospinous Hysteropexy with polypropylene mesh

PROCEDURERetropubic Mid-urethral Sling (Bottom-Up)

Retropubic mid-urethral sling (bottom-up approach) using polypropylene mesh for the treatment of stress urinary incontinence.

PROCEDURETransobturator Mid-urethral Sling (Out-In)

Transobturator mid-urethral sling (out-in) using polypropylene mesh for the treatment of stress urinary incontinence.

Locations(1)

Hospital J M Penna

Buenos Aires, Argentina

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NCT07414849

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