Last updated: September 27, 2022
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting
Phase
N/A
Condition
Enuresis
Urinary Incontinence
Treatment
N/AClinical Study ID
NCT03650244
LOCAL/2016/LW-01
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
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) followingradical prostatectomy surgery, for at least 12 months, unresolved after of pelvicfloor reeducation
- Patient scheduled for REMEEX® implant
Exclusion
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 untreatedurethral 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
Study Design
Total Participants: 150
Study Start date:
November 16, 2016
Estimated Completion Date:
November 30, 2023
Connect with a study center
CHU de Besançon
Besançon,
FranceActive - Recruiting
APHP Hôpital Henry Mondor
Créteil, 94000
FranceActive - Recruiting
CHU de Dijon
Dijon,
FranceActive - Recruiting
CHU de Limoges
Limoges,
FranceActive - Recruiting
CHU Nancy
Nancy,
FranceActive - Recruiting
CHU Nice
Nice,
FranceActive - Recruiting
CHU Nimes
Nîmes, 30029
FranceActive - Recruiting
CHU Strasbourg
Strasbourg,
FranceActive - Recruiting
Hôpital Foch
Suresnes, 92151
FranceActive - Recruiting
CHU Toulouse
Toulouse,
FranceActive - Recruiting
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