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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorHospital General de Agudos J. M. Penna

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Sacrospinous Hysteropexy with Mesh
  • Retropubic Mid-urethral Sling (Bottom-Up)
  • Transobturator Mid-urethral Sling (Out-In)

Treatment groups

330 Participants
are divided into 2 treatment groups