Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence
NCT ID: NCT03650244
Last Updated: 2022-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2016-11-16
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients fitted with REMEEX
REMEEX implantation
Device implantation
Interventions
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REMEEX implantation
Device implantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Locations
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CHU de Besançon
Besançon, , France
APHP Hôpital Henry Mondor
Créteil, , France
CHU de Dijon
Dijon, , France
CHU de Limoges
Limoges, , France
CHU Nancy
Nancy, , France
CHU Nice
Nice, , France
CHU Nimes
Nîmes, , France
CHU Strasbourg
Strasbourg, , France
Hôpital Foch
Suresnes, , France
CHU Toulouse
Toulouse, , France
Countries
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Facility Contacts
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Other Identifiers
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LOCAL/2016/LW-01
Identifier Type: -
Identifier Source: org_study_id
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