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ACTIVE NOT RECRUITING
NCT03650244

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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