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

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07414849

Acronym

AMPER

Enrollment

330

Registered

2026-02-17

Start date

2026-03-01

Completion date

2028-12-31

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse Vaginal Surgery, Stress Urinary Incontinence in Women

Keywords

amniotic membrane graft, polypropylene mesh

Brief 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

Interventions

PROCEDURESacrospinous Hysteropexy with Mesh

Sacrospinous Hysteropexy with polypropylene mesh

PROCEDURERetropubic Mid-urethral Sling (Bottom-Up)

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

PROCEDURETransobturator Mid-urethral Sling (Out-In)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Mesh exposure	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.

Countries

Argentina

Contacts

CONTACTIleana Sanger, MD

ilesaenger@me.com5491149113030

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026