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

Abstract

Purpose:We investigated the safety and efficacy of peroneal electrical transcutaneous neuromodulation using the URIS neuromodulation system in a home-based setting in comparison with standard treatment using solifenacin in treatment-naïve female patients with overactive bladder.Materials and Methods:A total of 120 patients were screened, of whom 77 were randomized in a 2:1 ratio to 12 weeks of treatment with daily peroneal electrical transcutaneous neuromodulation or solifenacin 5 mg. The primary endpoint was safety; efficacy assessments included proportion of responders, defined as subjects with ≥50% reduction in bladder diary–derived variables; Overactive Bladder-Validated 8-question Screener, and European Quality of Life-5 Dimensions questionnaire; and treatment satisfaction after 12 weeks of therapy.Results:Seventy-one out of 77 randomized patients completed the study. In the peroneal electrical transcutaneous neuromodulation group 6/51 (12%) patients reported a treatment-related adverse event vs 12/25 (48%) in the solifenacin group (P < .001). No clinically significant changes were observed in any other safety endpoint. The proportions of responders in the peroneal electrical transcutaneous neuromodulation group vs the solifenacin group were 87% vs 74% with respect to Patient Perception of Intensity of Urgency Scale grade 3 urgency episodes, 87% vs 75% with respect to grade 3+4 urgency episodes, and 90% vs 94% with respect to urgency incontinence episodes. In post hoc analyses we observed significant improvement over time in multiple efficacy variables in both treatment arms.Conclusions:Peroneal electrical transcutaneous neuromodulation is a safe and effective method for overactive bladder treatment associated with a significantly lower incidence of treatment-related adverse events compared to solifenacin and a considerably better benefit-risk profile.

Differences between brain responses to peroneal electrical transcutaneous neuromodulation and transcutaneous tibial nerve stimulation, two treatments for overactive bladder

“…In addition, several other technical features that distinguish peroneal eTNM® from TTNS are described elsewhere. 5 Based on the results of the present study, we propose that highly selective stimulation of the nerve originating from the sacral spinal roots represents a key factor in the therapeutic success of any peripheral neuromodulation method for treating OAB.…”

“…The principles, efficacy, and safety of peroneal eTNM® in OAB treatment have been recently described. 5 The mechanism of action of neuromodulation for treating OAB is not fully understood; thus, studies designed to elucidate this mechanism are warranted. 6 Only a single study by Finazzi-Agrò et al demonstrating brain activation in response to PTNS, have been published to date.…”

“…This guarantees effective and consistent peroneal nerve stimulation. The principles, efficacy, and safety of peroneal eTNM® in OAB treatment have been recently described 5 …”

This Month in Adult Urology

“…Krhut et al (page 734) in a multinational study report a randomized trial in women with symptoms of overactive bladder who were treatment na€ ıve, comparing peroneal nerve neuromodulation in a home-based setting to standard treatment using solifenacin. 5 Although the primary end point was safety, the secondary assessments of efficacy over the study period suggest quite comparable results with reduced treatmentrelated adverse events with neuromodulation. Issues with maintenance of results from neuromodulation strategies cannot be answered by this study, but the authors conclude that home-based peroneal nerve stimulation had a considerably better initial riskbenefit profile.…”

Does Cutaneous Stimulation of the Peroneal Nerve Treat Overactive Bladder?

“…This study by Krhut et al (page 734) is targeting the peroneal nerve in hopes of improving OAB symptoms. 8 The common peroneal nerve (L4-S2) is a terminal branch of the sciatic nerve and carries both sensory and motor components. It courses along the upper, lateral side of the popliteal fossa and can be palpated behind the head of the fibula as it courses down to innervate the dorsum of the foot.…”