Add-On Efficacy of Home-Based Transcutaneous Tibial Nerve Stimulation Via the ZIDA Control Sock in Adults With Overactive Bladder on Preexisting Stable Pharmacotherapy
Medical University of South Carolina
Summary
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.
Description
This study evaluates the use of a home-based neuromodulation device as an adjunct to standard pharmacologic therapy for overactive bladder with urgency urinary incontinence. The ZIDA Control Sock is an FDA-cleared, noninvasive wearable device that delivers low-level electrical stimulation near the ankle to stimulate peripheral nerves involved in bladder control. The study is conducted as a prospective, single-arm clinical investigation in which participants use the device at home while continuing usual care. Device use is prescribed once weekly for 12 weeks. Study conduct includes participant…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Neurologic disease affecting bladder function,…
Interventions
- DeviceZIDA Control Sock
The ZIDA Control Sock is an FDA-cleared, noninvasive wearable neuromodulation device designed for home use. The device delivers low-level electrical stimulation near the ankle to stimulate peripheral nerves involved in bladder control. In this study, the device is used as an adjunct to usual pharmacologic care.
Location
- Rutledge Tower at Medical University of South CarolinaCharleston, South Carolina