Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Dev… (NCT03650244) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence
France100 participantsStarted 2016-11-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
Timeframe: 1 month
2
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
Timeframe: 6 months
3
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
Timeframe: 1 year
4
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
Timeframe: 2 years
5
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
Timeframe: 3 years
6
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
Timeframe: 4 years
7
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy