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

Recruiting
Female
Phase N/A

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Overview

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 Criteria:

  • 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 Criteria:

  • 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.

Study details
    Pelvic Organ Prolapse Vaginal Surgery
    Stress Urinary Incontinence in Women

NCT07414849

Hospital General de Agudos J. M. Penna

27 June 2026

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