Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous NeuroModulation versus Solifenacin in Treatment of Naïve Patients with Overactive Bladder.

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.

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.

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.

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.

The Journal of urology. 2022 Dec 29 [Epub ahead of print]

Jan Krhut, Michal Rejchrt, Martin Slovak, Roman V Dvorak, Lukas Peter, Bertil F M Blok, Peter Zvara

Department of Urology, University Hospital, Ostrava, Czech Republic., Department of Urology, 2nd Faculty of Medicine of Charles University and Motol University Hospital, Prague, Czech Republic., STIMVIA®, Ostrava, Czech Republic., Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands., Biomedical Laboratory and Research Unit of Urology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.