Satisfaction with a rechargeable sacral neuromodulation system-A secondary analysis of the ARTISAN-SNM study.

Abstract

To describe factors associated with satisfaction with the Axonics sacral neuromodulation (SNM) System at 1 year. This was a secondary analysis of data collected in the ARTISAN-SNM study-a single arm, prospective, multicenter trial of the Axonics r-SNM System™. ARTISAN-SNM recruited participants with urgency urinary incontinence (UUI) to undergo a single, nonstaged implant of the lead and rechargeable neurostimulator. Participants were considered therapy responders if they had ≥50% reduction in UUI episodes in a 3-day period at 1-month post-implant. Bladder diaries and satisfaction (7-point Likert scale) were assessed at 1 year. In all, 124 participants (110 "responders" and 14 "non-responders") had complete data at baseline, 1 month and 1 year following implant. Most participants were satisfied with Axonics at 1 year: 68.5% were "very satisfied," 25.8% were "moderately satisfied," and 2.4% were "slightly satisfied." At 1 year, treatment efficacy, as measured by electronic bladder diaries, was significantly associated with satisfaction. Participants who were "very satisfied" had a larger reduction in voids per day (p = .01), leaks per day (p = .004), urgent leaks per day (p = .04), and voids in which the urgency was desperate per day (p = .03) compared to those less satisfied. Twelve of the 14 "non-responders" continued to see improvements in symptom reduction from 1 month to 1 year; 9/14 (64%) were "responders" at 1 year with six reporting being "very satisfied" and one reporting being "moderately satisfied." Satisfaction 1 year after implantation of Axonics SNM is extremely high and correlates with the degree of symptom improvement, which increases over time.