Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence (Remeex)

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Urinary Incontinence,Stress

Treatments: Device: REMEEX implantation

Study type: Observational

Funder types: Other

Identifiers

NCT03650244

LOCAL/2016/LW-01

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has been informed about the study
• The patient is at least 18 years old
• Patient suffering from moderate stress incontinence (pure or predominant) following radical prostatectomy surgery, for at least 12 months, unresolved after of pelvic floor reeducation
• Patient scheduled for REMEEX® implant

Exclusion criteria

• It proves impossible to give the patient clear information
• Patient refuses to participate
• Life expectancy of the patient estimated to be less than the 5 year follow-up
• Impossible to contact patient after hospitalization
• Radiotherapy of less than 6 month
• Patient unable to fill in questionnaire
• Incapably of performing pad test at 24 hours
• Recurrent symptomatic prostate cancer
• Mixed incontinence with urgency incontinence
• Bladder outlet obstruction: stenosis of the vesico-urethral anastomosis or untreated urethral stricture.
• Post void residual >100ml
• Other cancer under treatment or progressing
• Kidney injury, hepatocellular insufficiency
• Auto-immune disease
• Neurological-origin urinary incontinence (stroke, MS, Parkinson's)
• Incontinence arising from surgery other than prostatectomy
• recurrent gross hematuria
• Recurrent urinary infection
• Bladder stones

Trial design

150 participants in 1 patient group

Patients fitted with REMEEX

Treatment:

Device: REMEEX implantation