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Tests treatment safety and results for Pelvic Organ Prolapse Vaginal Surgery
Official title The AMPER Study: Evaluation of the Efficacy of Human Amniotic Membrane Grafting in Preventing Mesh Exposure in Vaginal Reconstructive Surgery Using Polypropylene Mesh.
ClinicalTrials.gov ID: NCT07414849
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only
You may be able to join if
- 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...
- Ability to understand study information and provide written informed consent.
- Availability for follow-up for a minimum of 12 months.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.