Efficacy of the Predictive Programming Algorithm of the Axonics SNM System

Objectives: Determining patient program settings after lead implant has not been well studied and historically have followed generic recommendations that did not consider an individual patient’s intraoperative responses during lead placement. The Axonics Clinician Programmer (CP) has a proprietary algorithm which utilizes intraoperative patient responses to recommend therapy settings. The CP recommends 4 therapy settings (in rank order). If necessary, additional settings can be provided. This analysis evaluates the proportion of participants who were set to one of the top 2 programs (1 or 2) at baseline and remained on those therapy settings at 6 months. Additionally, the CP therapy settings were correlated with symptom improvement.

Methods: Participants were programmed on the day of implant (day 0) based on the CP-recommended therapy settings and patient comfort with stimulation. Therapy settings were recorded on day 0 and 6 months and compared to the CP-recommendations. Evaluation included the proportion of participants who maintained therapy settings from baseline and the number of program changes prior to 6-months. Paired analyses were used to correlate symptom improvement using condition-specific validated questionnaires (ICIQ-OABqol, CCF-FIS, and AUA-SI) at baseline and 6 months. Minimally important difference (MID) of the ICIQ-OABqol is 10 points.[1]




[1] Coyne KS, Matza LS, Thompson CL, Kopp ZS, Khullar V. Determining the importance of change in the overactive bladder questionnaire. J Urol. 2006;176(2):627‐632.

Results: Of the 200 participants with therapy settings recorded at implant, 191 (96%) were programmed to one of the top 2 recommended therapy settings, 3 (2%) were programmed to recommendation 3 or 4 and 6 (3%) to customized settings (Fig. 1). At the time of this analysis, 108 participants had completed the 6-month visit. 102 (94%) were programmed to one of the top 2 programs (Fig. 1) and 92% maintained the same program from the implant procedure. Eight (8%) required a program change prior to the 6-month visit. The condition-specific validated questionnaires showed meaningful improvement from baseline to 6-months for OAB, UR, and FI (Fig. 2).

Conclusions: These data demonstrate the Axonics CP algorithm accurately predicts effective programming evidenced by 96% of participants utilizing one of the top 2 programs and 92% remaining on the same therapy settings with meaningful improvement seen in the condition-specific validated questionnaires at 6 months. This unique programming approach may reduce the need for patients to self-adjust stimulation therapy or be reprogrammed in the clinic.