Document Type

Conference Proceeding

Publication Date

2-2021

Abstract

Introduction: Sacral neuromodulation is a guideline-recommended therapy for treatment of urinary urgency incontinence (UUI) patients [1]. The Axonics® System is the first FDA-approved rechargeable SNM system that is qualified to delivery therapy for at least 15 years. The ARTISAN-SNM study is a prospective, pivotal study, designed to evaluate the safety and effectiveness of the Axonics System for UUI treatment. Clinical outcomes at 2 years are presented. Methods: 129 UUI participants across 19 centers in the US and Europe were implanted with the Axonics System in a single, non-staged procedure. Clinical outcomes were reported from 3-day bladder diaries, a validated quality of life questionnaire (ICIQ-OABqol), as well as participant satisfaction and recharging questionnaires. Therapy responders were defined by a ≥50% reduction in UUI episodes per day compared to baseline. As-treated and Completers analyses were performed, with Completers as the primary analysis method. Results: Average participant age at baseline was 59.3 years (range: 21-86 years) and the average body mass index (BMI) was 32 (range: 18-58). Average baseline UUI episodes were 5.6 ± 0.3 per day. At 2 years, 93% of the participants were therapy responders (Figure 1A). Of the responders, 82% demonstrated a ≥75% reduction in UUI episodes and 37% achieved full urinary continence. Average UUI episodes per day reduced to 1.0 ± 0.2, an average reduction of 82% (p<0.0001; Fig 1B). Quality of life scores (ICIQ-OABqol) improved by 36-points, which was clinically and statistically significant (p<0.0001, 10-point improvement is considered clinically significant). All participants were able to recharge their device and 94% of participants reported that the recharging duration and frequency was acceptable. There was no correlation between participant demographic factors and clinical outcomes or recharging experience. No serious or unanticipated device-related adverse events were reported throughout the study. Conclusion: At 2 years, the Axonics System demonstrated sustained safety and efficacy for treatment of UUI, with significant improvements in quality of life. Participant demographics were not correlated with therapeutic or recharging outcomes, indicating applicability of results to a wide population. References: 1. Gormley et al., 2015, J Urol

Comments

The Annual Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, Virtual, February 25-27, 2021.

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