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JU INSIGHT Peroneal Electrical Transcutaneous Neuromodulation vs Solifenacin in Overactive Bladder

By: Jan Krhut, MD, PhD, University Hospital, Ostrava, Czech Republic, Faculty of Medicine, Ostrava University, Czech Republic; Michal Rejchrt, MD, 2nd Faculty of Medicine of Charles University and Motol University Hospital, Prague, Czech Republic; Martin Slovak, MSc, PhD, StimVia, Ostrava, Czech Republic; Roman V. Dvorak, MD, PhD, StimVia, Ostrava, Czech Republic; Lukas Peter, MSc, PhD, StimVia, Ostrava, Czech Republic, Faculty of Science, University of Hradec Králové, Czech Republic; Bertil F. M. Blok, MD, PhD, Erasmus Medical Center, Rotterdam, The Netherlands; Peter Zvara, MD, PhD, University of Southern Denmark, Odense, Odense University Hospital, Denmark | Posted on: 20 Apr 2023

Krhut J, Rejchrt M, Slovak M, et al. Prospective, randomized, multicenter trial of peroneal electrical transcutaneous neuromodulation vs solifenacin in treatment-naïve patients with overactive bladder. J Urol. 2023;209(4):734-741.

Study Need and Importance

Overactive bladder is a prevalent chronic condition that has severe impacts on patients’ quality of life for which a universally effective treatment is not yet available. Neuromodulation has shown significant therapeutic promise. It is currently applied through sacral nerve or tibial nerve neurostimulation. Peroneal electrical transcutaneous neuromodulation (eTNM) using the URIS neuromodulation system represents a new method based on selective stimulation of the peroneal nerve (see Figure). It is noninvasive, it does not cause pain, and is suitable for self-treatment at home. In previous studies, we presented initial data demonstrating its efficacy and safety. This study reports outcomes of a multicenter, prospective, randomized, active-controlled study comparing peroneal eTNM to solifenacin, a widely used pharmacological treatment of overactive bladder.

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Figure. The URIS neuromodulation system for peroneal electrical transcutaneous neuromodulation is attached to the mid-thigh and connected to the ground and active electrodes. The biofeedback closed-loop system attached to both feet is not displayed.

What We Found

Peroneal eTNM is well tolerated and has a significantly lower incidence of treatment-related adverse events (TRAEs), with 4 times as many TRAEs observed in the solifenacin group. Although this study was not primarily designed to compare efficacy, peroneal eTNM was shown to be similarly effective to solifenacin in the majority of assessed efficacy endpoints, showing a clinically meaningful response in number of severe urgency and urgency incontinence episodes in 87% of subjects.

Limitations

The study evaluates a cohort of 77 patients with heterogeneous baseline characteristics. Although it provides convincing safety data, it does not allow for definitive conclusions with regard to the comparison of efficacy between the 2 treatment methods.

Interpretation for Patient Care

Peroneal eTNM is safe and, if the efficacy trends suggested by these results are confirmed in a larger study, it may be considered as an alternative to pharmacotherapy, which is often discontinued due to significant side effects. When compared to other neuromodulation techniques, this modality has the potential for better accessibility because it can be self-administered at home without severe TRAEs.

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