Trials / Unknown
UnknownNCT03650244
Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de Nīmes · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | REMEEX implantation | Device implantation |
Timeline
- Start date
- 2016-11-16
- Primary completion
- 2023-11-01
- Completion
- 2023-11-01
- First posted
- 2018-08-28
- Last updated
- 2022-09-28
Locations
10 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03650244. Inclusion in this directory is not an endorsement.