The aim of the prospective single-arm study was to assess efficacy of Axonics r-SNM System for the treatment of urge urinary incontinence (UUI). Study cohort included 129 participants with a primary UUI. Men and women with 4 or more UUI episodes on a 3-day voiding diary with at least one incontinence episode per day were included to the study. They underwent single non-staged procedure of lead placement at S3 or S4 in accordance with the site protocol (Figure 1).
Subjects were evaluated on a 3-day bladder diary, quality of life questionnaire (ICIQ-OABqol), fecal incontinence survey (Cleveland Clinic Fecal Incontinence Score), and adverse events. Primary endpoint was a reduction of UUI episodes by at least 50% at 6-month assessment visit.
Study sample characteristics at baseline included average age of 59, average BMI of 32, and 5,6 UUI leaks per day. Results indicate that primary endpoint was met: 80% of study participants reported a decrease in UUI episodes by 75% (Figure 2). Quality of life has improved by 10 points, which deemed statistically significant.
Overall study participants were satisfied with a system. According to the presenter, people recharged their devices via a wearable for about an hour on a weekly basis. The majority of subjects considered charging “easy” and “acceptable”. There were no serious adverse events related to the device. Adverse events were consistent with previous studies on implantable sacral modulation therapy.
Research demonstrates that Axonics r-SNM System can be a beneficial alternative for the treatment of urge urinary incontinence (UUI). Long-term efficacy and safety will be assessed for 2 years.
Presented by: Howard B. Goldman, MD, FACS; Cleveland Clinic
Written by: Hanna Stambakio, BS, Clinical Research Coordinator, Division of Urology, University of Pennsylvania @AStambakio at the American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois