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NOT YET RECRUITING
NCT07414849
NA

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

Sponsor: Hospital General de Agudos J. M. Penna

View on ClinicalTrials.gov

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

Official title: The Amper Study: Amniotic Membrane for the Prevention of Mesh Exposure in Vaginal Reconstructive Surgery

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2026-03-01

Completion Date

2027-12-31

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

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.

Locations (1)

Hospital J M Penna

Buenos Aires, Argentina