RELAX-OAB 105-0010
Research type
Research Study
Full title
Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System: RELAX-OAB
IRAS ID
190848
Contact name
Courtney Lane
Contact email
Sponsor organisation
AXONICS MODULATION TECHNOLOGIES, U.K. LIMITED
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 17 days
Research summary
Overactive Bladder (OAB) is a problem that causes either a sudden urge to urinate that happens eight or more times a day and/or involuntary leakage of urine with a sudden, strong desire to urinate. Sacral neuromodulation (SNM) is a well-established clinically proven therapy that uses electrical pulses to change bladder nerve activity to treat patients with OAB. Axonics® has developed a new system that includes a rechargeable implantable device and easy to use components to improve patient experiences.\nThis study is being conducted to learn more about how well the Axonics SNM System performs in people who have OAB. \nApproximately 80 patients will participate in this study at approximately 12 hospitals located in Europe and North America. All patients enrolled in the study will receive the same treatment. \nParticipants will be in the study for about two years and will require at least 10 visits to the study center.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/0406
Date of REC Opinion
13 Apr 2016
REC opinion
Further Information Favourable Opinion