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New treatment option for Prolapse, Vaginal
Official title Vaginal Native Tissues Repair for Pelvic Organ Prolapse
ClinicalTrials.gov ID: NCT03875989
What this study is testing
- What it's testing
- The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, women only
You may be able to join if
- 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...
- Able to give informed consent
- Performans Status score ≤ 2
You likely can't join if
- 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 .
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Brive-la-Gaillarde, France
- Clermont-Ferrand, France
- Guéret, France
- Limoges, France
- Saint-Etienne, France
- Toulouse, France
- Tulle, France
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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Brive-la-Gaillarde, France; Clermont-Ferrand, France; Guéret, France; Limoges, France; Saint-Etienne, France and 2 more location(s). 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.