StimRouter Neuromodulation System Improves Lower Urinary Tract Symptoms in Multiple Sclerosis

Chiara Zecca, MD

Data from a prospective, single-center, 24-week trial showed that neuromodulation through the StimRouter system resulted in objective and subjective improvements in refractory lower urinary tract symptoms (LUTS) among patients with multiple sclerosis (MS). Above all, the data showed that StimRouter may be a potentially beneficial therapeutic option for patients with MS who experience LUTS.¹

After underdoing self-administered stimulation sessions of 60 minutes, performed 5-7 days/week over a 24-week period, investigators observed progressive decreased in Overreactive Bladder questionnaire (OAB-q) symptoms (ß = –0.50; P <.001) and increases in OAB-q quality of life scores (ß = 0.47; P <.001). The cohort, which featured 23 patients with MS, reported high treatment satisfaction as well (median, 8; IQR, 6-9).

These data were presented at MSMilan 2023, the 9th Joint ECTRIMS-ACTRIMS Meeting, held October 11-13, in Milan, Italy, by senior author Chiara Zecca, MD, professor at the Neurocenter of Southern Switzerland of Università della Svizzera Italiana. In the study, 23 patients with MS were treated with percutaneous tibial nerve stimulation delivered by the implantable StimRouter neuromodulation system. Of these, 6 had neurogenic detrusor overactivity (NDO), 5 detrusor sphincter dyssynergia (DSD), and 12 had both NDO and DSD.

StimRouter is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy. The programming system is designed to be simple and intuitive, with an interface that features simple navigation and easy to use buttons, tabs, and drop-down menus. The external electric field conductor (E-EFC) is considered the “brains” of the system, sending electrical signals through the skin to the implanted StimRouter lead. The E-EFC can store up to 8 custom stimulation programs and attaches to the disposable user patch, transmitting stimulation through the patch’s gel electrodes.

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In the study, among those with NDO (n = 17), median bladder volume at first uninhabited contraction significantly increased from baseline (median, 136 ml; IQR, 101-244) to week 24 (median, 343 ml; IQR, 237-391; ß = 138.2; P = .001). No significant changes of urodynamic parameters were found in patients with DSD. While investigators observed changes on OAB-q scores, there was no significant change in MSQoL-54 scores (ß = 0.24; P = .084) in the overall population. Above all, the therapy appeared to be safe, as indicated by no serious adverse events.

To date, StimRouter has the only published randomized, controlled trial for peripheral nerve stimulation targeting multiple nerves. Published in Neuromodulation in 2016, the trial featured 94 patients with chronic peripheral nerve pain in the upper extremity, lower extremity or trunk, who were implanted and randomized to active treatment (n = 45) or control (n = 49). At the conclusion of the trial, 50% of the treatment group rated their satisfaction 8 or higher on a 10-point scale. Furthermore, 31% of the treatment group rated their satisfaction at a 10 on a 10-point scale.²

The primary outcome of that study was to determine pain relief achieved using the new peripheral lead system, where at least a 30% decrease in pain without an increase in pain medicine use defined the responders. At the 3-month follow-up, the difference between overall mean reduction in average pain in the treatment group vs controls was statistically significant (P <.0001 by t-test) with 27.2% improvement in the treatment group vs 2.3% among controls.

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REFERENCES
1. Sacco R, Maino P, Koetsier E, et al. Efficacy and safety profiles of percutaneous tibial nerve stimulation with the implantable StimRouter neuromodulation system for the treatment of refractory lower urinary tract symptoms in multiple sclerosis patients. Presented at: MSMilan 2023, October 11-13; Milan, Italy. Abstract 354
2. How StimRouter PNS Works. Stimrouter.com. https://stimrouter.com/patients-targeted-relief/how-stimrouter-works/. Accessed October 11, 2023.
3. Deer T, Pope J, Benyamin R, et al. Prospective, multicenter, randomized, double-blinded, partial crossover study to assess the safety and efficacy of the novel neuromodulation system in the treatment of patients with chronic pain of peripheral nerve origin. Neuromodulation. 2016;19(1):91-100. doi:10.1111/ner.12381