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NCT Number: NCT07414849

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

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

Recruiting

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Key information

Conditions

Pelvic Organ Prolapse Vaginal Surgery Stress Urinary Incontinence in Women

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital J M Penna

Buenos Aires, Argentina

Location status: Recruiting

Location contact

Ileana Sanger, MD

CONTACT

[email protected]

549114911-5555

Ileana Sanger, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sacrospinous Hysteropexy with Mesh

Procedure

Sacrospinous Hysteropexy with polypropylene mesh

Retropubic Mid-urethral Sling (Bottom-Up)

Procedure

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

Transobturator Mid-urethral Sling (Out-In)

Procedure

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

Primary outcomes

  1. Number of Participants with Mesh exposure

    Time frame: From enrollment through the end of the 12-month follow-up

    Comparison of mesh exposure incidence between the control group and the amniotic membrane group through scheduled postoperative follow-up and self-administered questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Ileana Sanger, MD

CONTACT

[email protected]

5491149113030

Sponsors and collaborators

Lead sponsor

Hospital General de Agudos J. M. Penna

Other

Registry information

Official study title

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

Acronym: AMPER

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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