Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study

McCrery, Rebecca; Lane, Felicia; Benson, Kevin; Taylor, C. B.; Padron, Osvaldo F.; Blok, Bertil; Wachter, Stefan De; Pezzella, Andrea; Gruenenfelder, Jennifer; Pakzad, Mahreen; Perrouin-Verbe, M.-A.; Normand, L. Le; Kerrebroeck, Philip Van; Mangel, Jeffrey; Peters, Kenneth M.; Kennelly, Michael; Shapiro, A. M. James; Lee, Una; Comiter, Craig V.; Mueller, Margaret; Goldman, Howard B.

doi:10.1097/ju.0000000000000458

Cited by 27 publications

(51 citation statements)

References 3 publications

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“…At 2 years, the subject acceptance of the duration and frequency of charging remained high at 86%. A high rate of acceptance of charging the system was also reported in the ARTISAN‐SNM study 11 . Given the chronic nature of this condition and the need for ongoing therapy, this data is reassuring and supports high patient satisfaction with the charging experience over the long term.…”

Section: Discussionsupporting

confidence: 64%

“…Our data support this assumption, with only one subject (2%) in the RELAX‐OAB study reporting pain at the neurostimulator site up to 2 years, which was resolved with reprogramming. Similarly, at 6‐months in another study using this miniaturized implant, less than 2% of subjects reported pain at the neurostimulator site 11 . The low rate of implant site pain with the Axonics neurostimulator contrasts with the Insite study results, where 7% (20) of subjects experienced pain at the neurostimulator site at 1 year, 65% (13) of whom had to undergo surgical intervention with two having permanent explant.…”

Section: Discussionmentioning

confidence: 80%

“…The results of the RELAX‐OAB multicenter study are consistent and comparable with the current SNM literature and confirm the sustained long‐term safety and sustained efficacy of the Axonics System at 2 years. Another study investigating the Axonics System, ARTISAN‐SNM, reported high responder rates (90%) at 6 months in 129 urinary urgency incontinence patients 11 …”

Section: Discussionmentioning

confidence: 99%

“…The RELAX‐OAB study was a postmarket prospective clinical follow‐up study in Europe designed to test the safety and efficacy of the Axonics System up to 2 years. A favorable clinical safety and efficacy profile of the Axonics System has been reported up to 12 months 9‐11 . Two‐year safety and efficacy outcomes of the RELAX‐OAB study are presented here.…”

Section: Introductionmentioning

confidence: 91%

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Two‐year safety and efficacy outcomes for the treatment of overactive bladder using a long‐lived rechargeable sacral neuromodulation system

Blok

Kerrebroeck

Wachter

et al. 2020

Neurourology and Urodynamics

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Aims: Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long-term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion. The Axonics System is the first rechargeable SNM device and is qualified to last a minimum of 15 years in the body. The study objective was to evaluate the safety and efficacy of this rechargeable SNM system. This study reports 2-year outcomes.Methods: A total of 51 subjects were implanted with the Axonics System in a single nonstaged procedure. Subjects had OAB, confirmed on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72 hours). Test Responders were defined as subjects that were responders at 1 month postimplant. The efficacy analysis included therapy responder rates, change in the quality of life, and subject satisfaction reported in Test Responders (n = 30) and all implanted subjects (n = 37) that completed the follow-up visits. Adverse events (AEs) are reported in all implanted subjects.Results: At 2 years, 90% of the Test Responders continued to respond to the therapy based on voiding diary criteria. Satisfaction with therapy was reported by 93% of subjects and 86% found their charging experience acceptable. Of the urinary incontinence Test Responders, 88% continued to be responders at 2 years, and 28% were completely dry. There were no unanticipated (AEs) or serious device-related AEs. Conclusions: The Axonics System® provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device-related AEs. Subjects reported continued satisfaction with their therapy. K E Y W O R D S overactive bladder, rechargeable, sacral neuromodulation, single-stage implant, urgency frequency, urinary incontinence ---This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Section: Discussionsupporting

confidence: 64%

Section: Discussionmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 91%

See 2 more Smart Citations

Two‐year safety and efficacy outcomes for the treatment of overactive bladder using a long‐lived rechargeable sacral neuromodulation system

Blok

Kerrebroeck

Wachter

et al. 2020

Neurourology and Urodynamics

Self Cite

View full text Add to dashboard Cite

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“…In a large, multicenter, prospective study of 272 patients with overactive bladder only 7% reported implant site pain with the current recharge-free InterStim II device [8]. For comparison, with smaller, rechargeable SNM devices pain at the neurostimulator site has been observed in less than 2% of the patients [9]. Therefore, although the smaller size of a rechargeable device does matter for some patients, the vast majority of patients will do equally well with the Inter-Stim II device, which is about the size of a heart pacemaker.…”

Section: Device Size Comparisonmentioning

confidence: 99%

New Technologies and Applications in Sacral Neuromodulation: An Update

et al. 2019

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Recently rechargeable devices have been introduced for sacral neuromodulation (SNM) with conditional safety for full-body magnetic resonance imaging (MRI). Currently a recharge-free SNM device represents the standard implant; however, it is only approved for MRI head scans. As further new technologies with broader MRI capabilities are emerging, the advantages as well as disadvantages of both rechargeable versus recharge-free devices will be briefly discussed in this commentary from the perspective of patients, healthcare professionals, and providers.

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

Benson

McCrery

Taylor³

et al. 2020

Neurourology and Urodynamics

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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.

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Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study

Cited by 27 publications

References 3 publications

Two‐year safety and efficacy outcomes for the treatment of overactive bladder using a long‐lived rechargeable sacral neuromodulation system

Two‐year safety and efficacy outcomes for the treatment of overactive bladder using a long‐lived rechargeable sacral neuromodulation system

New Technologies and Applications in Sacral Neuromodulation: An Update

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

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