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

<jats:sec> <jats:title>Importance</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Objective</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Study Design</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>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%, <jats:italic toggle="yes">P</jats:italic> = 0.022), urgency episodes (−31.2%, <jats:italic toggle="yes">P</jats:italic> = 0.02), and urgency urinary incontinence episodes (−31.4%, <jats:italic toggle="yes">P</jats:italic> = 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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>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.</jats:p> </jats:sec>