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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.

RecruitingNAAges any - anyFemaleHospital General de Agudos J. M. Penna
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Pelvic organ prolapse (POP) stage II C or greater, defined as C โ‰ฅ +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.
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What it tests

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

1 site
Hospital J M Penna
Buenos Aires, Argentina
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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