MedTrace Logo

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

NCT07414849 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-06-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospital General de Agudos J. M. Penna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Argentina

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07414849 on ClinicalTrials.gov