Male Stress Urinary Incontinence Clinical Trial
Official title:
A Prospective, Non-Randomized, Multi-Center Clinical Investigation of the Safety and PeRformancE of GT UroLogIcal, LLC's ArtiFicial Urinary Sphincter (RELIEF II)
The purpose of this investigation is to demonstrate the safety and efficacy of the GTU artificial urinary sphincter device in restoring continence in males who have confirmed urinary stress incontinence for a minimum of 12 months with primary etiology being radical prostatectomy or transurethral resection of the prostate (TURP).
Prospective, non-randomized multi-center study testing the safety and efficacy of the GTU
artificial urinary sphincter device in males with urinary incontinence.
Up to 20 sites in Europe, Australia & New Zealand
A sample size of 73 subjects is estimated to provide 80% power for efficacy. Accounting for
10% attrition, 82 subjects will be enrolled to provide non-missing data on 73 subjects.
First Subject Enrolment: July 2014 Last Subject Enrolment: September 2015 Last Subject
Follow-up: September 2016 Study Primary Endpoint Completion: January 2016
Each subject will be followed for approximately 14 months. Study duration is approximately 27
months.
Subjects will be evaluated at the screening, pre-implant, implant, 6 weeks post implant for
device activation, 1-month, 2-month, 3-month, 6-month, and 12-month post device activation.
The Sponsor (GT Urological, LLC) will work with a Contract Research Organization (CRO) to
assist in investigative site monitoring for this clinical investigation.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05771168 -
Surgery for Male Stress Urinary Incontinence
|
||
| Completed |
NCT01779323 -
Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling
|