One‐year outcomes of the ARTISAN‐SNM study with the Axonics System for the treatment of urinary urgency incontinence

Abstract

Aims Sacral neuromodulation (SNM) is a guideline‐recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non‐rechargeable SNM system. The ARTISAN‐SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1‐year are presented. Methods A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3‐day bladder diary, a validated quality of life questionnaire (ICIQ‐OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants. Results At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ‐OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device‐related adverse events. Conclusions The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.

Satisfaction with a rechargeable sacral neuromodulation system—A secondary analysis of the ARTISAN‐SNM study

“…Similarly, of the 113 participants classified as "responders" at 1 month, 3 exited the study and T A B L E 2 Comparison between "very satisfied" participants and all others "Very satisfied" (Likert Scale 7), N = 85 "Moderately," "slightly," or "unsatisfied" (Likert Scale [1][2][3][4][5][6] 106 (96%) remained therapy "responders" at the 1-year follow-up. Four participants dropped below the 50% improvement threshold at 1 year.…”

“…At 1 year, participants completed a health‐related quality of life questionnaire which has been previously reported 3 . Participants also rated their satisfaction with the Axonics therapy on a 7‐point Likert scale (1— very unsatisfied , 2— moderately unsatisfied , 3— slightly unsatisfied , 4— neutral , 5— slightly satisfied , 6— moderately satisfied , 7— very satisfied ), and given the same outcome, their likelihood to make the same choice to undergo Axonics therapy (1— definitely not , 2— probably not , 3— possibly not , 4— neutral , 5— possibly would , 6— probably would , 7— definitely would ).…”

“…The 6-month and 1-year treatment and safety outcomes have been previously published. 2,3 Briefly, the ARTISAN-SNM study recruited participants age 21 years or older with at least a 6-month history of UUI, and minimal to no symptoms of stress incontinence or painful bladder syndrome. Those participants who met inclusion/exclusion criteria underwent a single, nonstaged implant of the tined lead and the rechargeable neurostimulator.…”

Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system

“…These results are consistent with the satisfaction rates at 6 and 12 months, respectively. 6,7 Participants also rated their therapy satisfaction for treating their FI symptoms. At 2 years, a total of 45 participants self-reported as having FI symptoms and 82% of these participants reported being "satisfied" with their SNM therapy for treating their bowel symptoms ( Figure S1B).…”

“…At 2 years, 91% of participants rated recharging as "easy" ( Figure 5B) and 94% rated recharging as "acceptable" (Figure 5B), results that are similar to the participant perception at 6 and 12 months. 6,7 A vast majority of the participants (88%) reported recharging session duration of less than 1 h, and 98% of participants reported at least 7 days between recharging sessions.…”