Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence
NCT03650244 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150
Last updated 2022-09-28
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.
Conditions
- Urinary Incontinence,Stress
Interventions
- DEVICE
-
REMEEX implantation
Device implantation
Sponsors & Collaborators
-
Centre Hospitalier Universitaire de Nīmes
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-16
- Primary Completion
- 2023-11-30
- Completion
- 2023-11-30
Countries
- France
Study Locations
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