NCT03650244
Recruiting
Not Applicable
Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence
Centre Hospitalier Universitaire de Nīmes10 sites in 1 country150 target enrollmentNovember 16, 2016
ConditionsUrinary Incontinence,Stress
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Incontinence,Stress
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 150
- Locations
- 10
- Primary Endpoint
- Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
Time Frame: 5 years
PAD test \< 2 g / 24 h
Secondary Outcomes
- Normal clinical examination(Year 5)
- cystoscopy(year 5)
- urinary output(year 5)
- Volume of urine(year 5)
- Patient incontinence-related quality of life(5 years)
- Patient sexual-related quality of life(5 years)
- Post-void residual urine volume(year 5)
- readjustment of the REMEEX medical device(Year 5)
- Side effects or complications(5 years)
- Reliability and ease of use of the device(5 years)
- Satisfaction of use by the surgeon.(Day 0)
- General improvement of symptoms(5 years)
- Improvement of urinary symptoms(5 years)
Study Sites (10)
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