Amniotic membrane grafting added to mesh surgery for pelvic prolapse and incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the safety and potential benefits of incorporating a human amniotic membrane graft with polypropylene mesh during sacrospinous hysteropexy and mid-urethral sling procedures. Participants have pelvic organ prolapse stage II or higher and may have or be at risk for stress urinary incontinence, and are followed for at least 12 months. The trial will look at tissue integration and the rate of surgical complications to see if the graft improves outcomes. Recruitment is limited to a center in Buenos Aires, Argentina, led by Hospital General de Agudos J. M. Penna. The study does not list a formal phase or comparative randomization in the provided information.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital J M Penna
  Buenos Aires, Argentina Recruiting

Study contacts

• Study coordinator: Ileana Sanger, MD
• Email: ilesaenger@me.com
• Phone: 5491149113030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.