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.
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 training, remote support to ensure correct device use, and ongoing safety monitoring. The study is designed to characterize changes observed during adjunctive device use, assess participant experience with home-based therapy, and evaluate device-related safety. Findings will contribute to understanding the feasibility and potential clinical role of wearable neuromodulation as an add-on treatment option in routine overactive bladder care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Rutledge Tower at Medical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGMean change in daily urgency urinary incontinence (UUI) episodes (3-day bladder diary)
The primary outcome is the mean change in total daily urgency urinary incontinence (UUI) episodes after addition of ZIDA therapy to stable pharmacologic treatment for overactive bladder. Changes will be evaluated from baseline to Weeks 1, 4, and 8 for descriptive interim analyses and to Week 12 for final analysis. Interim analyses will not be used for early stopping or hypothesis testing.
Time frame: From baseline to at the end of treatment at 12 weeks
Mean change in daily urgency episodes (3-day bladder diary)
Change in the average number of daily urgency episodes recorded in a 3-day bladder diary at Baseline and Week 12.
Time frame: Baseline to end of treatment at 12 weeks
Mean change in daily urinary frequency (3-day bladder diary)
Change in the average number of daily voids from a 3-day bladder diary collected at Baseline and Week 12.
Time frame: Baseline to end of treatment at 12 weeks
Change in OAB-Q Short Form (1-Week Recall) Total Score
Change in total score on the OAB-Q Short Form (1-Week Recall), a validated 19-item questionnaire assessing OAB symptom bother and quality of life. Higher scores indicate worse symptoms.
Time frame: Baseline to end of treatment at 12 weeks
Patient Global Impression of Improvement (PGI-I)
Participant-reported global impression of improvement rated on a 7-point scale (1 = very much improved to 7 = very much worse).
Time frame: Baseline to end of treatment at 12 weeks
Device usability score (Usability & Satisfaction Survey)
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Usability and satisfaction with the ZIDA device assessed using a six-item survey, including five Likert-scaled items evaluating ease of use, comfort, and clarity of instructions.
Time frame: Baseline to end of treatment at 12 weeks
Participants with ≥1 device-related adverse event
Number of participants experiencing at least one device-related adverse event recorded through the Adverse Event Log during the 12-week treatment period.
Time frame: Baseline to end of treatment at 12 weeks