NCT07414849

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Hospital General de Agudos J. M. Penna · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Pelvic Organ Prolapse Vaginal Surgery
• Stress Urinary Incontinence in Women

Interventions

Type	Name	Description
PROCEDURE	Sacrospinous Hysteropexy with Mesh	Sacrospinous Hysteropexy with polypropylene mesh
PROCEDURE	Retropubic Mid-urethral Sling (Bottom-Up)	Retropubic mid-urethral sling (bottom-up approach) using polypropylene mesh for the treatment of stress urinary incontinence.
PROCEDURE	Transobturator Mid-urethral Sling (Out-In)	Transobturator mid-urethral sling (out-in) using polypropylene mesh for the treatment of stress urinary incontinence.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Argentina