Status:
RECRUITING
Add-On ZIDA Sock Therapy for Overactive Bladder
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
Medtronic
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 d...
Detailed Description
This study evaluates the use of a home-based neuromodulation device as an adjunct to standard pharmacologic therapy for overactive bladder with urgency urinary incontinence. The ZIDA Control Sock is a...
Eligibility 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)
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07432659
Start Date
March 1 2026
End Date
March 1 2028
Last Update
February 25 2026
Active Locations (1)
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1
Rutledge Tower at Medical University of South Carolina
Charleston, South Carolina, United States, 29425