Vaginal Native Tissues Repair for Pelvic Organ Prolapse
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 functional.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CHU de Bordeaux
RECRUITING
Bordeaux
CH de Brive
RECRUITING
Brive-la-gaillarde
CHU de Clermont Ferrand
RECRUITING
Clermont-ferrand
CH de Gueret
RECRUITING
Guéret
CHU de Limoges
RECRUITING
Limoges
CHU de Saint-Etienne
RECRUITING
Saint-etienne
CHU de Toulouse - Paule de Viguier
RECRUITING
Toulouse
CHU de Toulouse - Rangueil
RECRUITING
Toulouse
CH de Tulle
RECRUITING
Tulle
Time Frame
Start Date: 2019-09-27
Estimated Completion Date: 2028-03-27
Participants
Target number of participants: 214
Treatments
Active_comparator: Arm A
Experimental: Arm B
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Limoges