Status:
RECRUITING
Vaginal Native Tissues Repair for Pelvic Organ Prolapse
Lead Sponsor:
University Hospital, Limoges
Conditions:
Prolapse, Vaginal
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
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 functiona...
Detailed Description
Pelvic organ prolapse is usually the result of loss of pelvic support. It is widely accepted that 50% of women after 50 years old will develop prolapse, evaluated through the POPQ Classification . Pel...
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
September 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 27 2028
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT03875989
Start Date
September 27 2019
End Date
March 27 2028
Last Update
August 29 2023
Active Locations (9)
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1
CHU de Bordeaux
Bordeaux, France, 33000
2
CH de Brive
Brive-la-Gaillarde, France, 19100
3
CHU de Clermont Ferrand
Clermont-Ferrand, France, 63100
4
CH de Gueret
Guéret, France, 23000