Programming settings and recharge interval in a prospective study of a rechargeable sacral neuromodulation system for the treatment of overactive bladder

Abstract

Aims:The RELAX-OAB study is designed to confirm the safety, efficacy, and technical performance of the Axonics r-SNM System, a miniaturized, rechargeable SNM system approved in Europe and Canada for the treatment of bladder and bowel dysfunction. The purpose of this article is to describe study subjects' ability to charge the rechargeable neurostimulator and to document their neurostimulator program settings and recharge interval over time. Methods: Fifty-one OAB patients were implanted in a single-stage procedure.These results represent the 3-month charging experience for 48 subjects who completed the 3-month follow-up. Recharge intervals were estimated using therapy stimulation settings and subject experience was evaluated using questionnaires. Results: Forty-seven of forty-eight (98%) subjects were able to successfully charge their device prior to follow-up within 1-month post-implant. At 3-month post-implant, 98% of subjects were able to charge prior to their follow-up visit.Average stimulation amplitude across all subjects was 1.8 mA (±1.1 mA). A total of 69% of subjects had ≥14-day recharge intervals (time between charging) and 98% of subjects had ≥7-day recharge interval. No charging related adverse events occurred. Conclusions: Study subjects were able to charge the Axonics r-SNM System and stimulation settings provided 2 weeks of therapy between recharging for most subjects. Subject satisfaction indicates that subjects are satisfied with rechargeable SNM therapy. 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.

<p>Electrical stimulation in the treatment of bladder dysfunction: technology update</p>

“…15 This device is smaller in size compared to non-rechargeable devices: it is 5 cc in volume whereas the InterStim II is 14 cc in volume. At the last follow-up visit in a clinical study, the average amplitude was 1.7 (±1.1) mA, the frequency was 14.3 (±1.6) Hz, the pulse width was 210.6 (±11.6) microseconds, and the impedance was 1201 (±214) ohms 16. These parameter settings are comparable to those of the InterStim system.…”

“…This is done transcutaneously and takes approximately 1 hr. In a clinical study, the recharge interval for most patients (69%) was 14 days or more 16. Almost all patients were able to recharge their device 3 months after implantation.…”

The Management of Urine Storage Dysfunction in the Neurological Patient

“…Since none of the devices are yet approved for treatment, the clinical experience is currently still very limited and data for use in NLUTD are lacking. However, initial study results appear promising, at least in NNOAB patients, not only with respect to symptom relief but also in terms of cost-effectiveness [150][151][152].…”

Programming Algorithms for Sacral Neuromodulation: Clinical Practice and Evidence—Recommendations for Day-to-Day Practice

“…As long as the impedance is stable, both systems deliver the same amount of energy to the sacral nerve. There are no data to suggest that constant current systems require significantly fewer amplitude adjustments than constant voltage systems (20,21). Present and historical practice suggests strongly the use of subsensory stimulation with two objectives: to prolong battery life and to reduce adverse effects associated with stimulation.…”