Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous NeuroModulation versus Solifenacin in Treatment of Naïve Patients with Overactive Bladder
Abstract
PURPOSE: To investigate the safety and efficacy of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM) using the URISneuromodulation 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 eTNM 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; OAB V8 questionnaire, and EQ-5D-5L questionnaire; and treatment satisfaction after 12 weeks of therapy. RESULTS: Seventy one out of 77 randomized patients completed the study.
In the peroneal eTNM group 6/51 (12%), in the solifenacin group 12/25 (48%) patients reported a treatment-related adverse event, respectively (P<.001). No clinically significant changes were observed in any other safety endpoint.
The proportions of responders in the peroneal eTNM group vs the solifenacin group were, respectively, 87% vs 74% with respect to Patient Perception of Intensity of Urgency Scale (PPIUS) Grade 3 urgency episodes, 87% vs 75% with respect to PPIUS 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 eTNM is a safe and effective method for OAB treatment associated with significantly lower incidence of treatment-related adverse events compared to solifenacin and considerably better benefit-risk profile.