Repairing pelvic organ prolapse using vaginal native tissues

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 study aims to evaluate the effectiveness of vaginal patch plastron compared to anterior colporraphy for treating pelvic organ prolapse in women aged 50 and older. It focuses on assessing both anatomic and functional success rates at one year post-surgery. The study addresses the significant psychological distress and quality of life issues caused by prolapse, which affects a large percentage of older women. By utilizing native tissue repair methods, the study seeks to minimize complications associated with synthetic mesh repairs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient at 50 years of age or older
* Symptomatic primary prolapse of the anterior vaginal wall defined by Aa and/or Ba points ≥0 according to the POP-Q system
* A positive response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the PFDI-20)
* Able to give informed consent
* Performans Status score ≤ 2

Exclusion Criteria:

* Patient with need for surgical treatment for myorraphy of levator ani muscles
* Patient with previous surgical cystocele repair.
* Patient with evolving gynaecologic cancer.
* Pregnancy or wish for future pregnancy, lactating woman.
* Inability to participate in study follow-up or to provide informed consent.
* Lack of social insurance .

Where it's running

• CHU de Bordeaux
  Bordeaux, France Recruiting
• CH de Brive
  Brive-la-Gaillarde, France Recruiting
• CHU de Clermont Ferrand
  Clermont-Ferrand, France Recruiting
• CH de Gueret
  Guéret, France Recruiting
• CHU de Limoges
  Limoges, France Recruiting
• CHU de Saint-Etienne
  Saint-Etienne, France Recruiting

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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.