NCT07432659 · Medical University of South Carolina
Add-On ZIDA Sock Therapy for Overactive Bladder
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Charleston, South Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations