Urinary Incontinence,Stress
Conditions
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.
Interventions
DEVICEREMEEX implantation
Device implantation
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy | 1 month | PAD test \< 2 g / 24 h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normal clinical examination | month 1 | Yes / No |
| urinary output | Month 1 | ml/s |
| Volume of urine | month 1 | ml |
| Post-void residual urine volume | Month 1 | ml |
| cystoscopy | Month 1 | Yes / No |
| readjustment of the REMEEX medical device | Month 1 | Yes / No |
| General improvement of symptoms | 1 month | Patient Global Impression of Improvement Questionnaire (PGI-I) |
| Improvement of urinary symptoms | 1 month | Urinary Symptom Profile Questionnaire (USP) |
| Side effects or complications | 1 month | — |
| Reliability and ease of use of the device | 1 month | — |
| Patient incontinence-related quality of life | 1 month | Incontinence Quality of Life Questionnaire (I-QOL) |
| Patient sexual-related quality of life | 1 month | International Index of Erectile Function (IIEF-5) score |
| Satisfaction of use by the surgeon. | Day 0 | anological visual scale (between 0 and 10) |
Countries
France
Outcome results
None listed