Actively Recruiting
Vaginal Native Tissues Repair for Pelvic Organ Prolapse
Led by University Hospital, Limoges · Updated on 2023-08-29
214
Participants Needed
9
Research Sites
443 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vaginal Native Tissues Repair for Pelvic Organ Prolapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient at 50 years of age or older
- Symptomatic primary prolapse of the anterior vaginal wall defined by Aa and/or Ba points 50 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
- Performance Status score 2
You will not qualify if you...
- Need for surgical treatment for myorraphy of levator ani muscles
- Previous surgical cystocele repair
- Evolving gynecologic cancer
- Pregnancy, desire for future pregnancy, or lactating woman
- Inability to participate in study follow-up or to provide informed consent
- Lack of social insurance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
CHU de Bordeaux
Bordeaux, France, 33000
Actively Recruiting
2
CH de Brive
Brive-la-Gaillarde, France, 19100
Actively Recruiting
3
CHU de Clermont Ferrand
Clermont-Ferrand, France, 63100
Actively Recruiting
4
CH de Gueret
Guéret, France, 23000
Actively Recruiting
5
CHU de Limoges
Limoges, France, 87000
Actively Recruiting
6
CHU de Saint-Etienne
Saint-Etienne, France, 42000
Actively Recruiting
7
CHU de Toulouse - Paule de Viguier
Toulouse, France, 31059
Actively Recruiting
8
CHU de Toulouse - Rangueil
Toulouse, France, 31400
Actively Recruiting
9
CH de Tulle
Tulle, France, 19000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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