Add-On ZIDA Sock Therapy for Overactive Bladder

Recruiting now · Not applicable

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT07432659

Run by

Medical University of South Carolina

People needed

20

Starts

2026-04-17

Expected to finish

2028-03-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Neurologic disease affecting bladder function, including multiple sclerosis, spinal cord injury, Parkinson's disease, or other neurogenic bladder conditions.
• Significant pelvic organ prolapses or other pelvic pathology likely to interfere with bladder emptying, neuromodulation efficacy, or study assessments in the opinion of the investigator
• Active urinary tract infection or unexplained hematuria at screening
• Clinically significant post-void residual volume above threshold (e.g., >100 mL)
• History of, failure of, or current use of neuromodulation therapies, including percutaneous or transcutaneous tibial nerve stimulation, sacral neuromodulation (InterStim), implantable tibial devices (eCoin)
• Intravesical botulinum toxin injections less than 9 months prior to entry into the study
• Pregnancy or plans to become pregnant during study participation, and women of childbearing age not using contraception. A urine pregnancy test will be performed for women of childbearing potential to confirm non-pregnant status prior to enrollment.
• Contraindications to electrical stimulation (cardiac pacemaker or implanted defibrillator without physician clearance, unhealed wounds near stimulation site, metal implants in the ankle region)
• Significant uncontrolled medical conditions, such as unstable cardiac disease, poorly controlled diabetes mellitus, severe peripheral edema, or severe peripheral neuropathy that may affect lower-limb sensation or response to stimulation in the opinion of the investigator
• Pelvic malignancy or prior pelvic radiotherapy.
• Current participation in another investigational drug or device trial, or use of an investigational therapy within the last 30 days
• Known hypersensitivity or intolerance to materials used in the ZIDA device (electrode adhesives, conductive gels)

Where it is running

• Rutledge Tower at Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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