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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients fitted with REMEEX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REMEEX implantation | Device | Device implantation |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Normal clinical examination | Yes / No | month 1 |
| Normal clinical examination | Yes / No | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients over 18 suffering from moderate stress incontinence (pure or predominant) following radical prostatectomy surgery for prostate cancer, for at least 12 months, unresolved after of pelvic floor reeducation, regardless of the surgical procedure used or of treatment with radiotherapy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Besançon | France | ||||
| APHP Hôpital Henry Mondor |
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| 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 |
| Créteil |
| 94000 |
| France |
| CHU de Dijon | Dijon | France |
| CHU de Limoges | Limoges | France |
| CHU Nancy | Nancy | France |
| CHU Nice | Nice | France |
| CHU Nimes | Nîmes | 30029 | France |
| CHU Strasbourg | Strasbourg | France |
| Hôpital Foch | Suresnes | 92151 | France |
| CHU Toulouse | Toulouse | France |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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