Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system. Issue 2 (28th January 2021)

• Record Type: Journal Article
• Authors: Pezzella, Andrea; McCrery, Rebecca; Lane, Felicia; Benson, Kevin; Taylor, Chris; Padron, Osvaldo; Blok, Bertil; de Wachter, Stefan; Gruenenfelder, Jennifer; Pakzad, Mahreen; Perrouin‐Verbe, Marie‐Aimee; van Kerrebroeck, Philip; Mangel, Jeffrey; Peters, Kenneth; Kennelly, Michael; Shapiro, Andrew; Lee, Una; Comiter, Craig; Mueller, Margaret; Goldman, Howard B.
• Is Part Of: Neurourology and urodynamics. Volume 40:Issue 2(2021)
• Page Start: 714
• Page End: 721
• Publication Date: 2021-01-28
• Subjects: clinical trial -- implantable neurostimulator -- overactive bladder -- sacral neuromodulation -- urinary urgency incontinence; Urinary organs -- Periodicals; Urodynamics -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1002/nau.24615
• Languages: English
• ISSNs: 0733-2467

Abstract

Abstract: Aims: Sacral neuromodulation (SNM) is a guideline‐recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration‐approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN‐SNM study was designed to evaluate UUI participants treated with the Axonics System. Two‐year follow‐up results are presented. Methods: One hundred and twenty‐nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3‐day voiding diaries, ICIQ‐OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post‐treatment. As‐treated and Completers analyses are presented. Results: At 2 years, 93% of the participants ( n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ‐OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device‐related adverse events occurred. Conclusions: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant‐related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.