Artificial Urinary Sphincter vs. Adjustable Male Sling for Treating male stress urinary INcontinence
Phase 4
Recruiting
- Conditions
- N39.3Stress incontinence
- Registration Number
- DRKS00015253
- Lead Sponsor
- niversitätsmedizin Mainz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 270
Inclusion Criteria
> age min. 18 years
> moderate-severe urinary incontinence
> cause of incontiennce: radical prostatectomy
> signed inform consent
Exclusion Criteria
> neurological disease
> medical or operative therapy or urge incontiennce
> prior surgery for stress urinary incontiennce
> cause for incontinence: salvage prostatectomy or any other cause than primary radical prostatectomy
> impaired cognitive or manual skills for usage of an artificial urinary sphincter
> missing informed consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure of urinary incontinence. Definition: Usage of 0 or 1 Pad
- Secondary Outcome Measures
Name Time Method • complications rates <br>• revision and explantation free survival<br>• Quality of life according standardized and validated questionaires (ICIQ-SF, IQoL, PGI-I) und 24h Pad-Test<br>• Timeperiod for urinary continence (Periode from cure until recurrence of urinary incontinence