Status:
COMPLETED
Comparative Study of Mesh Versus No Mesh in Prolapse Surgery
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborating Sponsors:
DRRC
Medtronic - MITG
Conditions:
Vaginal Prolapse
Cystocele
Eligibility:
FEMALE
60+ years
Phase:
NA
Brief Summary
Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-...
Eligibility Criteria
Inclusion
- Patients older than 60 years-old
- Anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
- Symptomatic prolapse
- Informed consent signature obtained
Exclusion
- Patient not able to read French language
- Patient with a anterior prolapse of stage 1
- Urinary of vaginal infection
- Hepatopathy with ascitis
- Diabetes uncontrolled
- Treatment by corticosteroids
- Previous pelvic irradiation
- Intraoperative bladder injury
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00153257
Start Date
April 1 2005
End Date
January 1 2013
Last Update
November 21 2019
Active Locations (1)
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1
Hôpital Carémeau
Nîmes, France, 30000