The AMPER Study: Evaluation of the Efficacy of Human Amniotic Membrane Grafting in Preventing Mesh Exposure in Vaginal Reconstructive Surgery Using Polypropylene Mesh.
Recruiting
N/A
Interventional Study
Pelvic Organ Prolapse Vaginal Surgery
Stress Urinary Incontinence in Women
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Sex
- Female
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 330 (estimated)
- Sponsor
- Hospital General de Agudos J. M. Penna · Other
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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
Trial Locations
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Eligibility Criteria
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.
* Availa…
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