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.
Highlights
Overactive bladder syndrome (OAB) represents lower urinary tract dysfunction; it is a sudden, compelling desire to pass urine that is difficult to defer, with or without involuntary loss of urine associated with the urgency [1]
4.2. e Volt-Ampere Characteristics of the Impulses Generated by the URIS® and transcutaneous tibial nerve stimulation (TTNS) Devices
Comparison of the URIS® Electrode versus Percutaneous tibial nerve stimulation (PTNS) Needle and TTNS Self-Adhesive Electrodes. e measured current intensity was significantly higher than that of the in vivo measurement due to the much lower impedance of saline compared to the human body
Summary
Overactive bladder syndrome (OAB) represents lower urinary tract dysfunction; it is a sudden, compelling desire to pass urine that is difficult to defer (urgency), with or without involuntary loss of urine associated with the urgency (urgency urinary incontinence) [1]. A significant proportion of patients with OAB suffer from frequent voiding (frequency) and getting up at night to pass urine (nocturia) [2]. OAB has a significant impact on quality of life (QoL), employment, social status, and relationships [4]. Initial conservative treatment includes lifestyle interventions, behavioral techniques, and pelvic floor muscle exercises. Pharmacotherapy is the most widely used treatment method. Its efficacy is insufficient in at least 30% of patients [5].
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