Study on Overactive Bladder Treatments

Compared with solifenacin, electrical transcutaneous neuromodulation delivers important benefits in overactive bladder suggests a new study published in the Journal of Urology.

Researchers 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.

Study Details

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
• European Quality of Life-5 Dimensions questionnaire
• 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
• 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 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.

Reference

Jan Krhut, Michal Rejchrt, Martin Slovak, Roman V. Dvorak, Lukas Peter, Bertil F. M. Blok, and Peter Zvara. Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous Neuromodulation vs Solifenacin in Treatment-naïve Patients With Overactive Bladder. https://doi.org/10.1097/JU.0000000000003141