Actively Recruiting
Add-On ZIDA Sock Therapy for Overactive Bladder
Led by Medical University of South Carolina · Updated on 2026-05-06
20
Participants Needed
1
Research Sites
97 weeks
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
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.
CONDITIONS
Official Title
Add-On ZIDA Sock Therapy for Overactive Bladder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- Clinical diagnosis of overactive bladder with urgency urinary incontinence (OAB-wet)
- At least 1 urgency urinary incontinence episode per day averaged over a 3-day bladder diary at baseline
- Stable pharmacologic treatment for overactive bladder for 4 weeks or more, with intent to continue during the study
- Ability to complete bladder diaries, questionnaires, and follow-up visits
- Cognitively intact adult able to understand study procedures and provide informed consent independently
You will not qualify if you...
- Neurologic diseases affecting bladder function, including multiple sclerosis, spinal cord injury, Parkinson's disease, or other neurogenic bladder conditions
- Significant pelvic organ prolapse or pelvic pathology likely to interfere with bladder emptying or study assessments
- Active urinary tract infection or unexplained blood in urine at screening
- Post-void residual urine volume above clinically significant threshold (e.g., over 100 mL)
- History of or current use of neuromodulation therapies such as tibial nerve stimulation or sacral neuromodulation
- Botulinum toxin bladder injections less than 9 months before study entry
- Pregnancy or plans for pregnancy during the study, and women of childbearing potential not using contraception
- Contraindications to electrical stimulation, including pacemaker without clearance, unhealed wounds near stimulation site, or metal implants around the ankle
- Significant uncontrolled medical conditions affecting lower-limb sensation or response to stimulation
- Pelvic cancer or prior pelvic radiotherapy
- Current participation in another investigational drug or device trial or use of investigational therapy within 30 days
- Known allergy or intolerance to materials in the ZIDA device such as electrode adhesives or conductive gels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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