Last updated: February 3, 2023
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting
Phase
N/A
Condition
Genitourinary Prolapse
Treatment
N/AClinical Study ID
NCT03766048
2017_74
PHRCN-17-0226
2018-A01487-48
Ages 40-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women with a urogenital prolapse (anterior wall and/or uterus or vaginal apex) stage = 2 (Ba and/or C points ≥ - 1 cm using the POP-Q system),
- without significant posterior vaginal wall prolapse (Bp < -1 cm when apical prolapseis reduced using a retractor leaving the posterior vaginal wall free),
Exclusion
Exclusion Criteria:
- Previous surgical repair for Pelvic Organ Prolapse
- Any associated prolapse requiring any non-authorized additional surgical repair (Authorized additional surgical procedures are hysterectomy, ovariectomy, adnexectomy,salpingectomy, myomectomy, or suburethral vaginal tape.)
- Wish for future pregnancy
- Lack of health insurance
- Woman not reading French or unable to consent
- Woman under law protection
Study Design
Total Participants: 834
Study Start date:
September 11, 2019
Estimated Completion Date:
December 31, 2025
Connect with a study center
Hopital Estaing
Clermont-Ferrand,
FranceActive - Recruiting
Ch Dunkerque
Dunkerque,
FranceActive - Recruiting
Hopital Saint-Louis - La Rochelle
La Rochelle,
FranceActive - Recruiting
Clinique Du Pre
Le Mans,
FranceActive - Recruiting
Hop Jeanne de Flandre Chu Lille
Lille, 59037
FranceActive - Recruiting
Hopital Saint Vincent - Saint Antoine
Lille, 59037
FranceActive - Recruiting
Chu de Nice Hopital de L'Archet
Nice,
FranceActive - Recruiting
Chu Nimes - Nimes
Nîmes,
FranceActive - Recruiting
Chi Poissy St Germain Site de Poissy
Poissy,
FranceActive - Recruiting
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