Pilot Study of a Novel At-Home Posterior Tibial Nerve System for Overactive Bladder Syndrome.

IMPORTANCE: Urgency urinary incontinence and overactive bladder are common conditions. Third-line therapies are often underutilized because of either being too invasive or being burdensome for the patient. OBJECTIVE: We aimed to determine the efficacy and acceptability of a noninvasive, home-based posterior tibial nerve treatment system for the treatment of overactive bladder syndrome. STUDY DESIGN: In this pilot study, 10 postmenopausal women with urgency urinary incontinence were given the SoleStim System for home-based posterior tibial nerve stimulation. Symptoms at baseline and completion of the 8-week study were determined by 3-day voiding diary and quality-of-life questionnaire (Overactive Bladder Questionnaire) to assess for reduction in incontinence episodes. RESULTS: All patients were 100% adherent to the SoleStim System application over the 8-week period and reported statistically significant reductions in the mean number of voids (-16.3%, P = 0.022), urgency episodes (-31.2%, P = 0.02), and urgency urinary incontinence episodes (-31.4%, P = 0.045). Forty percent of participants reported a decrease of ≥50% in their urgency urinary incontinence episodes. SoleStim was scored a value of 1.8 ± 2.0 (mean ± SD) on a 10-point usability scale, indicating that it was highly acceptable from an ease-of-use perspective. No adverse events were reported. CONCLUSIONS: The SoleStim System improved key overactive bladder (frequency, urgency, and urgency urinary incontinence episodes) and quality-of-life metrics. The results from this pilot study suggest that the SoleStim System may be a safe, effective, and highly acceptable at-home overactive bladder therapy.