Sacral neuromodulation (SNM) is a guideline-recommended treatment for urinary dysfunctions and fecal incontinence [1]. The Axonics® System is the first rechargeable SNM System approved in United States, Europe, Canada and Australia to provide therapy for at least 15 years. Use of rechargeable SNM systems could potentially eliminate or significantly reduce the number of replacement surgeries required due to battery depletion of non-rechargeable neurostimulators. Further, the use of long-lived rechargeable systems could result in significant cost savings for healthcare systems [2]. The ARTISAN-SNM study treated urinary urgency incontinence (UUI) patients with the rechargeable Axonics System. Study participants’ long-term recharging experience is presented.

129 participants with UUI across 19 centers in the US and Europe were implanted with the Axonics System in a single, non-staged procedure. Participants were provided detailed instructions on how to recharge their implanted neurostimulator (INS), including the audiovisual feedback designed to indicate a fully recharged INS. Participants were instructed to recharge every 7 days but were not discouraged from forming recharging habits that suited their lifestyle.  For example, participants may choose a longer recharging session every 14 days instead of a shorter recharging duration every 7 days. Patients reported their typical charge frequency and duration at each scheduled follow-up visit. Recharge duration per week was calculated as (Recharge duration / Number of days between recharge) * 7. Average and standard error (SE) are reported as appropriate. Recharging outcomes at 18 months are compared with recharging outcomes at 3 months to evaluate how the charging experience changed over time. The completers analysis is presented.

Across the 129 study participants, average age was 59.3 years old (range: 21 - 86 years) and the average body mass index (BMI) was 32 (range: 18-58). 

The average (± SE) participant reported recharge duration per week was 46 ± 2 minutes at 3 months (Figure 1). At 18 months, the average study participant reported recharge duration per week was 44 ± 2 minutes, which was slightly shorter but not significantly different as compared to the recharge duration per week at 3 months (p = 0.1). A vast majority of the study participants (84%) reported recharging for less time or within 10 minutes more than their charging duration at 3 months (Figure 1). Ninety-six percent (114 of 119) of the study participants reported recharging their Axonics SNM System every 7 days or less frequently, and 89% of the study participants reported recharging for an hour or less. Ninety three percent of the study participants reported that recharging was easy and acceptable, and 94% of the study participants were satisfied with the SNM therapy. Participant satisfaction with therapy and perception that recharging was easy and acceptable was consistently high across study visits (Figure 2).

Study participant age was not correlated with recharging duration per week (R2 = 0.03). Study participant BMI was not correlated with recharging duration per week (R2= 0.01).

A vast majority of study participants find recharging to be easy & acceptable through 18 months post-implant. Recharging duration per week at 18 months was consistent with that at 3 months, indicating no decline in battery efficiency. Age and BMI were not correlated to recharging duration per week, indicating the applicability of results to a wide population. Participant recharging experience and satisfaction with the Axonics System is consistent with similarly high satisfaction rates with rechargeable spinal cord and deep brain neurostimulators [3].

A vast majority of the study participants, with diverse demographics, reported that the recharging experience with the Axonics System is easy and acceptable. These results provide compelling rationale for widespread adoption of the rechargeable Axonics SNM system.

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