Informations générales (source: ClinicalTrials.gov)
Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence (Remeex)
Observational
Centre Hospitalier Universitaire de Nīmes (Voir sur ClinicalTrials)
novembre 2016
novembre 2023
07 septembre 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | vendredi 11 mars 2022 | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Besançon - Besançon - France | Chabannes, MD | Contact (sur clinicalTrials) | |||
| CHU de Dijon - Dijon - France | Eric Mourey, MD | Contact (sur clinicalTrials) | |||
| CHU de Limoges - Limoges - France | Descazeaux, MD | Contact (sur clinicalTrials) | |||
| CHU Nancy - Nancy - France | Lemelle, MD | Contact (sur clinicalTrials) | |||
| CHU Strasbourg - Strasbourg - France | Christian Saussine, MD | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Toulouse - France | Game, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP Hôpital Henry Mondor - 94000 - Créteil - France | Rene Yiou, MD | Contact (sur clinicalTrials) | |||
| CHU Nice - Nice - France | Daniel Chevalier, MD | Contact (sur clinicalTrials) | |||
| CHU Nimes - 30029 - Nîmes - France | Laurent Wagner, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
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
- 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
- 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