Add-On Efficacy of Home-Based Transcutaneous Tibial Nerve Stimulation Via the ZIDA Control Sock in Adults With Overactive Bladder on Preexisting Stable Pharmacotherapy
Many people with overactive bladder (OAB) continue to experience symptoms despite pharmacologic treatment. This study evaluates the use of the ZIDA Control Sock, an FDA-cleared, noninvasive wearable device that delivers mild electrical stimulation near the ankle, as an adjunct to usual care. Adults with OAB-wet who remain symptomatic on stable medication will use the device at home once weekly for 12 weeks while continuing their prescribed therapy. The study collects clinical, patient-reported, and safety information during adjunctive device use.
• Age ≥18 years.
• Diagnosis of OAB-wet (OAB with urgency urinary incontinence) documented by clinical diagnosis
• Baseline ≥1 UUI episode/day averaged over a 3-day diary
• Is on a stable pharmacotherapy for OAB for ≥4 weeks, with intent to remain on their medication regimen for the duration of this study
• Has the ability to complete bladder diaries, questionnaires, and attend follow-up visits
• Cognitively intact adult and able to understand study procedures and provide informed consent independently