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

Hospital General de Agudos J. M. Penna

Status: Not yet enrolling

Conditions: Pelvic Organ Prolapse Vaginal Surgery; Stress Urinary Incontinence in Women

Treatments: Procedure: Sacrospinous Hysteropexy with Mesh; Procedure: Transobturator Mid-urethral Sling (Out-In); Procedure: Retropubic Mid-urethral Sling (Bottom-Up)

Study type: Interventional

Funder types: Other

Identifiers

NCT07414849

18099

Details and patient eligibility

About

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

Enrollment: 330 estimated patients

Sex: Female

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 2 patient groups

With amniotic membrane

Experimental group

Description:

Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh in whom a dehydrated human amniotic membrane patch was placed over the mesh or sling prior to vaginal closure.

Treatment:

Procedure: Retropubic Mid-urethral Sling (Bottom-Up)

Procedure: Transobturator Mid-urethral Sling (Out-In)

Procedure: Sacrospinous Hysteropexy with Mesh

without amniotic membrane, surgery alone

Active Comparator group

Description:

Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh without human amniotic membrane patch

Treatment:

Procedure: Retropubic Mid-urethral Sling (Bottom-Up)

Procedure: Transobturator Mid-urethral Sling (Out-In)

Procedure: Sacrospinous Hysteropexy with Mesh