Relief II Study
Research type
Research Study
Full title
A Prospective, Non-Randomized, Multi-Center Clinical Investigation of the Safety and Performance of GT Urological, LLC’s Phenix Device Artificial Urinary Sphincter
IRAS ID
163726
Contact name
Matt Adams
Contact email
Sponsor organisation
Frost River Associates
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 4 days
Research summary
This study, RELIEF II, is an 82 patient trial involving leading reconstructive urologists in up to 20 research institutions across the globe. Six centers are located in Australia and New Zealand. The remaining are located in Europe.
RELIEF II is the second of two clinical studies focused on a new artificial urinary sphincter designed by a US medical device company called GT Urological, LLC. It follows on the heels of the successful 10 patient RELIEF I study. The artificial urinary sphincter is designed to provide improvements in reliability and ease of use relative to the current gold standard and, perhaps most importantly, it provides the unique ability to customize outcomes to the needs of an individual patient without the need for additional surgery. The latter is seen as a key advantage for men suffering from urinary incontinence following prostate surgery.
The RELIEF II trial tracks both subjective quality of life improvements and objective changes in the level of incontinence as well as safety endpoints typical to implanted technologies of this nature. While the study is designed to determine the change in outcomes from pre-surgery to 3 months post surgery, patients will continue to be monitored until 12 months post surgery.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0146
Date of REC Opinion
21 Jul 2015
REC opinion
Further Information Favourable Opinion