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Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence
Sponsor: Centre Hospitalier Universitaire de Nīmes
Summary
We wish to set up a multicentric prospective observational study across France to collate data on the efficacy and tolerance of the Male REMEEX® device in patients with moderate stress urinary incontinence following radical prostatectomy. Patient satisfaction, improvement in quality of life, side effects and complications will also be studied, as will the ease of use of the device from the point of view of the surgeon. A long-term follow-up of 5 years will be conducted.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2016-11-16
Completion Date
2028-11
Last Updated
2026-06-16
Healthy Volunteers
No
Conditions
Interventions
REMEEX implantation
Device implantation
Locations (10)
CHU de Besançon
Besançon, France
APHP Hôpital Henry Mondor
Créteil, France
CHU de Dijon
Dijon, France
CHU de Limoges
Limoges, France
CHU Nancy
Nancy, France
CHU Nice
Nice, France
CHU Nimes
Nîmes, France
CHU Strasbourg
Strasbourg, France
Hôpital Foch
Suresnes, France
CHU Toulouse
Toulouse, France