Repairing pelvic organ prolapse using vaginal native tissues
Vaginal Native Tissues Repair for Pelvic Organ Prolapse
This study is testing if using a vaginal patch made from natural tissue works better than traditional surgery for fixing pelvic organ prolapse in women over 50.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 9 sites (Bordeaux and 8 other locations) |
| Trial ID | NCT03875989 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 and older with symptomatic primary prolapse of the anterior vaginal wall.
Not a fit: Patients with previous surgical cystocele repair or those requiring treatment for myorraphy of levator ani muscles may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective surgical option for women suffering from pelvic organ prolapse.
How similar studies have performed: Other studies have shown varying success rates with native tissue repairs, but this specific comparison of vaginal patch plastron and anterior colporraphy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bordeaux and 8 other locations
- 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)
- CHU de Toulouse - Paule de Viguier — Toulouse, France (Recruiting)
- CHU de Toulouse - Rangueil — Toulouse, France (Recruiting)
- CH de Tulle — Tulle, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.