Status:
COMPLETED
UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Cystocele
Eligibility:
FEMALE
60+ years
Phase:
NA
Brief Summary
The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE I.
Detailed Description
Secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years): A. The anatomic failure rate of cystocele (POP-Q stage \> or = 2...
Eligibility Criteria
Inclusion
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patient included in, randomized and analysed in the PROCURE study (NCT00153257)
Exclusion
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- Patient not included in the PROCURE study
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2015
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02255994
Start Date
October 1 2014
End Date
December 7 2015
Last Update
November 19 2025
Active Locations (12)
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1
Clinique Champeau
Béziers, France, 34500
2
APHP - Hôpital Antoine Beclere
Clamart, France, 92141
3
CHU de Clermont Ferrand - Hôpital Estaing
Clermont-Ferrand, France, 63003
4
APHP - Hôpital Beaujon
Clichy, France, 92110