Actively Recruiting
Add-On Efficacy of Home-Based Transcutaneous Tibial Nerve Stimulation Via the ZIDA Control Sock in Adults With Overactive Bladder on Preexisting Stable Pharmacotherapy
Led by Medical University of South Carolina · Updated on 2026-05-06
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
S
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the ZIDA Control Sock, an FDA-cleared, noninvasive wearable device that delivers mild electrical stimulation near the ankle, as an additional treatment for adults with overactive bladder (OAB) who continue to have symptoms despite stable medication. The study focuses on adults diagnosed with OAB-wet, which includes urgency urinary incontinence, to assess the device's effects alongside their usual pharmacologic therapy. Participants will use the ZIDA Control Sock at home once a week for 12 weeks while continuing their prescribed OAB medication. The device stimulates peripheral nerves involved in bladder control through low-level electrical signals. The study is a single-arm clinical investigation that includes participant training, remote support for proper device use, and safety monitoring during the treatment period. Throughout the study, participants will complete bladder diaries, questionnaires, and attend follow-up visits. Researchers will collect clinical and patient-reported information to measure changes in daily urgency urinary incontinence episodes and other bladder symptoms. Safety will be monitored, and device usability and patient impressions of improvement will be evaluated. The study duration is 12 weeks with ongoing assessment of device-related effects.
CONDITIONS
Brief Title
Add-On ZIDA Sock Therapy for Overactive Bladder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of overactive bladder with urgency urinary incontinence (OAB-wet) confirmed by a clinical diagnosis
- At least 1 urgency urinary incontinence episode per day averaged over a 3-day bladder diary at baseline
- Stable pharmacologic treatment for OAB for at least 4 weeks and intent to remain on this regimen during the study
- Ability to complete bladder diaries, questionnaires, and attend follow-up visits
- Cognitively intact adult able to understand study procedures and provide informed consent independently
You will not qualify if you...
- Neurologic diseases that affect bladder function such as multiple sclerosis, spinal cord injury, Parkinson's disease, or other neurogenic bladder conditions
- Significant pelvic organ prolapse or other pelvic issues that may interfere with bladder emptying or device effectiveness
- Active urinary tract infection or unexplained blood in urine at screening
- Clinically significant post-void residual urine volume above threshold (e.g., greater than 100 mL)
- History of or current use of neuromodulation therapies like percutaneous or transcutaneous tibial nerve stimulation, sacral neuromodulation, or implantable tibial devices
- Botulinum toxin injections into the bladder within 9 months prior to study entry
- Pregnancy, plans to become pregnant during the study, or women of childbearing age not using contraception
- Contraindications to electrical stimulation, such as cardiac pacemaker without clearance, unhealed wounds near stimulation site, or metal implants in the ankle area
- Significant uncontrolled medical conditions like unstable cardiac disease, poorly controlled diabetes, severe peripheral edema, or neuropathy affecting lower limbs
- Pelvic cancer or previous pelvic radiotherapy
- Participation in another investigational drug or device trial within the last 30 days
- Known allergy or intolerance to materials used in the ZIDA device (electrode adhesives, conductive gels)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants use the ZIDA Control Sock device at home once weekly as an add-on to their stable pharmacologic therapy for overactive bladder.
Weekly visits for device use and monitoring
Duration - Short term after 12 weeks of treatment
Participants are monitored for safety and changes in symptoms after completing device use.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Rutledge Tower at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
L
Louisa Keil
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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