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

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Incontinence,Stress

Intervention / Treatment
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* Device: REMEEX implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients fitted with REMEEX<br> | Device: REMEEX implantation<br>* Device implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy | PAD test < 2 g / 24 h | 1 month | 
| Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy | PAD test < 2 g / 24 h | 6 months | 
| Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy | PAD test < 2 g / 24 h | 1 year | 
| Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy | PAD test < 2 g / 24 h | 2 years | 
| Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy | PAD test < 2 g / 24 h | 3 years | 
| Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy | PAD test < 2 g / 24 h | 4 years | 
| Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy | PAD test < 2 g / 24 h | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal clinical examination | Yes / No | month 1 | 
| Normal clinical examination | Yes / No | Month 6 | 
| Normal clinical examination | Yes / No | Year 1 | 
| Normal clinical examination | Yes / No | Year 2 | 
| Normal clinical examination | Yes / No | Year 3 | 
| Normal clinical examination | Yes / No | Year 4 | 
| Normal clinical examination | Yes / No | Year 5 | 
| urinary output | ml/s | Month 1 | 
| urinary output | ml/s | Month 6 | 
| urinary output | ml/s | year 1 | 
| urinary output | ml/s | year 2 | 
| urinary output | ml/s | year 3 | 
| urinary output | ml/s | year 4 | 
| urinary output | ml/s | year 5 | 
| Volume of urine | ml | month 1 | 
| Volume of urine | ml | month 6 | 
| Volume of urine | ml | year 1 | 
| Volume of urine | ml | year 2 | 
| Volume of urine | ml | year 3 | 
| Volume of urine | ml | year 4 | 
| Volume of urine | ml | year 5 | 
| Post-void residual urine volume | ml | Month 1 | 
| Post-void residual urine volume | ml | Month 6 | 
| Post-void residual urine volume | ml | year 1 | 
| Post-void residual urine volume | ml | year 2 | 
| Post-void residual urine volume | ml | year 3 | 
| Post-void residual urine volume | ml | year 4 | 
| Post-void residual urine volume | ml | year 5 | 
| cystoscopy | Yes / No | Month 1 | 
| cystoscopy | Yes / No | Month 6 | 
| cystoscopy | Yes / No | year 1 | 
| cystoscopy | Yes / No | year 2 | 
| cystoscopy | Yes / No | year 3 | 
| cystoscopy | Yes / No | year 4 | 
| cystoscopy | Yes / No | year 5 | 
| readjustment of the REMEEX medical device | Yes / No | Month 1 | 
| readjustment of the REMEEX medical device | Yes / No | Month 6 | 
| readjustment of the REMEEX medical device | Yes / No | Year 1 | 
| readjustment of the REMEEX medical device | Yes / No | Year 2 | 
| readjustment of the REMEEX medical device | Yes / No | Year 3 | 
| readjustment of the REMEEX medical device | Yes / No | Year 4 | 
| readjustment of the REMEEX medical device | Yes / No | Year 5 | 
| General improvement of symptoms | Patient Global Impression of Improvement Questionnaire (PGI-I) | 1 month | 
| General improvement of symptoms | Patient Global Impression of Improvement Questionnaire (PGI-I) | 6 months | 
| General improvement of symptoms | Patient Global Impression of Improvement Questionnaire (PGI-I) | 1 year | 
| General improvement of symptoms | Patient Global Impression of Improvement Questionnaire (PGI-I) | 2 years | 
| General improvement of symptoms | Patient Global Impression of Improvement Questionnaire (PGI-I) | 3 years | 
| General improvement of symptoms | Patient Global Impression of Improvement Questionnaire (PGI-I) | 4 years | 
| General improvement of symptoms | Patient Global Impression of Improvement Questionnaire (PGI-I) | 5 years | 
| Improvement of urinary symptoms | Urinary Symptom Profile Questionnaire (USP) | 1 month | 
| Improvement of urinary symptoms | Urinary Symptom Profile Questionnaire (USP) | 6 months | 
| Improvement of urinary symptoms | Urinary Symptom Profile Questionnaire (USP) | 1 year | 
| Improvement of urinary symptoms | Urinary Symptom Profile Questionnaire (USP) | 2 years | 
| Improvement of urinary symptoms | Urinary Symptom Profile Questionnaire (USP) | 3 years | 
| Improvement of urinary symptoms | Urinary Symptom Profile Questionnaire (USP) | 4 years | 
| Improvement of urinary symptoms | Urinary Symptom Profile Questionnaire (USP) | 5 years | 
| Side effects or complications |  | 1 month | 
| Side effects or complications |  | 6 months | 
| Side effects or complications |  | 1 year | 
| Side effects or complications |  | 2 years | 
| Side effects or complications |  | 3 years | 
| Side effects or complications |  | 4 years | 
| Side effects or complications |  | 5 years | 
| Reliability and ease of use of the device |  | 1 month | 
| Reliability and ease of use of the device |  | 6 months | 
| Reliability and ease of use of the device |  | 1 year | 
| Reliability and ease of use of the device |  | 2 years | 
| Reliability and ease of use of the device |  | 3 years | 
| Reliability and ease of use of the device |  | 4 years | 
| Reliability and ease of use of the device |  | 5 years | 
| Patient incontinence-related quality of life | Incontinence Quality of Life Questionnaire (I-QOL) | 1 month | 
| Patient incontinence-related quality of life | Incontinence Quality of Life Questionnaire (I-QOL) | 6 months | 
| Patient incontinence-related quality of life | Incontinence Quality of Life Questionnaire (I-QOL) | 1 year | 
| Patient incontinence-related quality of life | Incontinence Quality of Life Questionnaire (I-QOL) | 2 years | 
| Patient incontinence-related quality of life | Incontinence Quality of Life Questionnaire (I-QOL) | 3 years | 
| Patient incontinence-related quality of life | Incontinence Quality of Life Questionnaire (I-QOL) | 4 years | 
| Patient incontinence-related quality of life | Incontinence Quality of Life Questionnaire (I-QOL) | 5 years | 
| Patient sexual-related quality of life | International Index of Erectile Function (IIEF-5) score | 1 month | 
| Patient sexual-related quality of life | International Index of Erectile Function (IIEF-5) score | 6 months | 
| Patient sexual-related quality of life | International Index of Erectile Function (IIEF-5) score | 1 year | 
| Patient sexual-related quality of life | International Index of Erectile Function (IIEF-5) score | 2 years | 
| Patient sexual-related quality of life | International Index of Erectile Function (IIEF-5) score | 3 years | 
| Patient sexual-related quality of life | International Index of Erectile Function (IIEF-5) score | 4 years | 
| Patient sexual-related quality of life | International Index of Erectile Function (IIEF-5) score | 5 years | 
| Satisfaction of use by the surgeon. | anological visual scale (between 0 and 10) | Day 0 |