Last updated on August 2016

Clinical Investigation of GT UrologIcal LLC's Artificial Urinary Sphincter (RELIEF II)

Brief description of study

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).

Detailed Study Description

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.

Clinical Study Identifier: NCT02288455

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