The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments.
The ARTISAN-SNM Trial which was a single-arm, prospective study that included 29 centers and enrolled 129 participants. The primary aim of the study was to evaluate the safety and efficacy of the Axonics SNM System for the treatment of UUI symptoms. Primary outcome was improvement in UUI episodes on a 3-day bladder diary. Secondary outcomes included quality of life using the ICIQ-OABqol questionnaire, patient satisfaction, and bowel symptoms captured using the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS). Participants were followed out to 2 years and data was reported at 6 months, 1 year and 2 years
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Axonics Sacral Neuromodulation System (SNM) System
UC Irvine Health
Irvine, California, United States
Cleveland Clinic
Cleveland, Ohio, United States
Maastricht University Medical Center
Maastricht, Netherlands
UCLH
London, United Kingdom
Proportion of Responders
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
Time frame: 2 years
ICIQ-OAB-qol
International Consultation on Incontinence Modular Questionnaire (ICIQ)- Overactive Bladder (OAB), Quality of Life (qol). Score range of 0-100, with greater values indicating better quality of life.
Time frame: 2 years
Daily Number of Urgency Leaks
The daily number of urgency leaks is measured by a bladder diary
Time frame: 2 years
Voids
Measured by a bladder diary
Time frame: 2 years
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