Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system

A. Pezzella*, R. McCrery, F. Lane, K. Benson, C. Taylor, O. Padron, B. Blok, S. de Wachter, J. Gruenenfelder, M. Pakzad, M.A. Perrouin-Verbe, P. van Kerrebroeck, J. Mangel, K. Peters, M. Kennelly, A. Shapiro, U. Lee, C. Comiter, M. Mueller, H.B. Goldman

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Web of Science)

Abstract

Aims Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics (R) 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.
Original languageEnglish
Pages (from-to)714-721
Number of pages8
JournalNeurourology and Urodynamics
Volume40
Issue number2
DOIs
Publication statusPublished - 1 Feb 2021

Keywords

  • clinical trial
  • implantable neurostimulator
  • overactive bladder
  • sacral neuromodulation
  • urinary urgency incontinence

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