ARTISAN-SNM 105-0050
Research type
Research Study
Full title
Axonics SacRal NeuromodulaTIon System for UrinAry Urgency Incontinence TreatmeNt: ARTISAN-SNM
IRAS ID
235607
Contact name
M Pakzad
Contact email
Sponsor organisation
AXONICS MODULATION TECHNOLOGIES, U.K. LIMITED
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 16 days
Research summary
To evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of Urinary Urge Incontinence (UUI) designed to gain pre-market approval in the United States.
UUI is a problem that causes 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 UUI. Axonics® has developed a new system that includes a rechargeable implantable device and easy to use components to improve patient experiences.
This study is being conducted to learn more about how well the Axonics SNM System performs in people who have UUI. Up to 145 patients will participate in this study at approximately 20 hospitals located in Europe and North America. All patients enrolled in the study will receive the same treatment.
Participants will be in the study for about two years and will require at least 10 visits to the study center.REC name
London - South East Research Ethics Committee
REC reference
18/LO/0047
Date of REC Opinion
31 Jan 2018
REC opinion
Further Information Favourable Opinion