Peroneal Electric Transcutaneous NeuroModulation (eTNM®): A Novel Method for the Treatment of the Overactive Bladder

Abstract

Overactive bladder syndrome (OAB) is a prevalent medical problem with a significant impact on the quality of life of the affected individuals. Pharmacotherapy is considered the main treatment method, although it is discontinued in a significant proportion of patients due to inefficacy or associated side effects. If pharmacotherapy fails, patients can undergo peripheral neuromodulation of the somatic nerves of the lower limb or sacral neuromodulation; however, neither of these represents an ideal therapeutic tool. The Peroneal electric Transcutaneous NeuroModulation (Peroneal eTNM®), based on the selective stimulation of the peroneal nerve, is the new fully noninvasive neuromodulation method intended to treat OAB. The URIS® neuromodulation system, engineered to provide Peroneal eTNM®, consists of the URIS® device, URIS® active electrodes, and the biofeedback foot sensor (BFS). The unique design of the URIS® device and URIS® active electrodes allows for the use of a low voltage and current during neuromodulation, which significantly reduces the unpleasant sensations. The BFS allows for precise localization of the active electrodes and for continuous adjustment of the voltage and frequency to achieve the optimal therapeutic effect. The URIS® system adopts several principles of telemedicine, which makes it compatible with the US Food and Drug Administration (FDA) and European Union (EU) regulations for home-based use. This article describes both the Peroneal eTNM® method and the URIS® neuromodulation system, including its technical specifications and data from laboratory testing. Preclinical and early clinical data demonstrate the feasibility of this new method for noninvasive OAB treatment and possible implications for clinical practice.

Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous Neuromodulation vs Solifenacin in Treatment-naïve Patients With Overactive Bladder

“…The technical description of the URIS neuromodulation system has been previously published. 3 Stimulation parameters were as follows: an initial frequency of 4 Hz was set at the beginning and then continuously adjusted based on analysis of data from the biofeedback closed-loop system; the pulse width was 2 ms. Pulse voltage was adjusted individually to the motor threshold. The URIS neuromodulation system is depicted in Figure 1.…”

“…Fully noninvasive, highly selective nerve stimulation and continuous adjustment of the stimulation parameters during stimulation represent the main advantages of peroneal eTNM compared with the other methods used for peripheral neuromodulation. 3,4 The aim of this study was to assess the safety and efficacy of peroneal eTNM using the URIS neuromodulation system in home-based settings in comparison with standard treatment using solifenacin in treatment-na€ ıve OAB patients (Supplementary Video, https://www.jurology.com).…”

“…Fully noninvasive, highly selective nerve stimulation and continuous adjustment of the stimulation parameters during stimulation represent the main advantages of peroneal eTNM compared with the other methods used for peripheral neuromodulation. 3,4…”

Digital health innovations in urology: telemedicine, wearables, and mobile applications – a systematic review of literature

“…The proposed method for estimating the bladder volume has the advantage of being quicker than the ultrasound-based method for measuring the volume. Krhut et al [32] described the noninvasive URIS neuromodulation system to treat OAB. Data from preclinical and early clinical studies demonstrate the feasibility of this method and its potential clinical applications.…”

Peroneal Electrical Transcutaneous NeuroModulation as a New Treatment for Patients with Overactive Bladder: An Initial Clinical Experience

“…In addition, the system is equipped with a closed biofeedback loop based on continual evaluation of the foot motor response, allowing for continuous adjustment of neuromodulation parameters throughout the session. Peroneal eTNM ® using URIS ® device has a number of unique technical features, which distinguish it from other transcutaneous neurostimulation techniques [9].…”