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

Rebecca McCrery, Felicia Lane, Kevin Benson, Chris Taylor, Osvaldo Padron, Bertil Blok, Stefan De Wachter, Andrea Pezzella, Jennifer Gruenenfelder, Mahreen Pakzad, Marie Aimee Perrouin-Verbe, Loïc Le Normand, Philip Van Kerrebroeck, Jeffrey Mangel, Kenneth Peters, Michael Kennelly, Andrew Shapiro, Una Lee, Craig Comiter, Margaret MuellerHoward B. Goldman

Research output: Contribution to journalArticle

3 Scopus citations

Abstract

PURPOSE: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. MATERIALS AND METHODS: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. RESULTS: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

Original languageEnglish (US)
Pages (from-to)185-192
Number of pages8
JournalThe Journal of urology
Volume203
Issue number1
DOIs
StatePublished - Jan 1 2020

Keywords

  • implantable neurostimulators
  • overactive
  • patient reported outcome measures
  • quality of life
  • urge
  • urinary bladder
  • urinary incontinence

ASJC Scopus subject areas

  • Urology

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    McCrery, R., Lane, F., Benson, K., Taylor, C., Padron, O., Blok, B., De Wachter, S., Pezzella, A., Gruenenfelder, J., Pakzad, M., Perrouin-Verbe, M. A., Le Normand, L., Van Kerrebroeck, P., Mangel, J., Peters, K., Kennelly, M., Shapiro, A., Lee, U., Comiter, C., ... Goldman, H. B. (2020). Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study. The Journal of urology, 203(1), 185-192. https://doi.org/10.1097/JU.0000000000000458