Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous Neuromodulation vs Solifenacin in Treatment-naïve Patients With Overactive Bladder
Language English Country United States Media print-electronic
Document type Randomized Controlled Trial, Multicenter Study, Journal Article
- Keywords
- lower urinary tract symptoms, overactive, peroneal nerve, solifenacin succinate, transcutaneous electric nerve stimulation, urinary bladder,
- MeSH
- Muscarinic Antagonists MeSH
- Urinary Bladder, Overactive * drug therapy MeSH
- Quality of Life MeSH
- Humans MeSH
- Prospective Studies MeSH
- Solifenacin Succinate * therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Muscarinic Antagonists MeSH
- Solifenacin Succinate * MeSH
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.
Department of Surgical Studies Faculty of Medicine Ostrava University Ostrava Czech Republic
Department of Urology Erasmus Medical Center Rotterdam The Netherlands
Department of Urology Odense University Hospital Odense Denmark
Department of Urology University Hospital Ostrava Czech Republic
References provided by Crossref.org
The mechanism of action of neuromodulation in the treatment of overactive bladder
