ZIDA Control Sock added to medication for overactive bladder with leakage
Add-On Efficacy of Home-Based Transcutaneous Tibial Nerve Stimulation Via the ZIDA Control Sock in Adults With Overactive Bladder on Preexisting Stable Pharmacotherapy
This trial will try using the ZIDA Control Sock once a week at home for 12 weeks to see if adding it to your current medication reduces urgency urinary incontinence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07432659 on ClinicalTrials.gov |
What this trial studies
This prospective, single-arm study enrolls adults with overactive bladder and urgency urinary incontinence who remain symptomatic on stable OAB medication. Participants are trained to use the FDA-cleared ZIDA Control Sock at home once weekly for 12 weeks while continuing their prescribed therapy, with remote support and safety monitoring. The study collects bladder diaries, patient-reported outcomes, clinical data, and device safety information to characterize changes during adjunctive use. Findings will inform feasibility, patient experience, and the potential clinical role of wearable neuromodulation as an add-on treatment.
Who should consider this trial
Good fit: Adults (≥18) with OAB-wet who average at least one urgency urinary incontinence episode per day and are on a stable OAB medication regimen willing to use a home neuromodulation sock and attend follow-ups.
Not a fit: People with neurologic bladder disease, significant pelvic organ prolapse, active urinary tract infection, unexplained hematuria, or other contraindications are unlikely to receive benefit from this adjunctive device.
Why it matters
Potential benefit: If successful, adding the ZIDA Control Sock could reduce leakage episodes and improve bladder control without invasive procedures.
How similar studies have performed: Prior trials of percutaneous and transcutaneous tibial nerve stimulation have shown benefit for OAB symptoms, but evidence for home wearable ankle-sock devices is limited and still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
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, 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 this trial is running
Charleston, South Carolina
- Rutledge Tower at Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Connie Wang, MD — Medical University of South Carolina
- Study coordinator: Louisa Keil
- Email: Keill@musc.edu
- Phone: 843-792-1840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.