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ZIDA Control Sock for Overactive Bladder with Urgency Urinary Incontinence

This study is looking at whether the ZIDA Control Sock can help people with overactive bladder (OAB) who still have symptoms like urgency urinary incontinence (UUI) even while taking medication. The ZIDA Control Sock is an FDA-cleared, wearable device that gives mild electrical stimulation near the ankle to help with bladder control. If you are an adult aged 18 or older with OAB-wet (OAB with UUI) and have at least one UUI episode per day, you might be able to join. You need to be on a stable OAB medication for at least four weeks and plan to continue it. The study will measure how much your daily UUI episodes change over 12 weeks to see if the sock is helpful. The current recruitment status is unclear.

Study design
This is a single-arm study, meaning all 20 participants will receive the ZIDA Control Sock. It is an interventional study, but the phase is not specified.
What's involved
You would use the ZIDA Control Sock at home once weekly for 12 weeks while continuing your current OAB medication. You will also need to complete bladder diaries and questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at the end of treatment at 12 weeks.

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NCT07432659

Add-On ZIDA Sock Therapy for Overactive Bladder

Recruiting
NAAges 18+InterventionalTreatment
Medical University of South Carolina
~20 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:ZIDA Control Sock

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in daily urgency urinary incontinence (UUI) episodes (3-day bladder diary)
Measured over From baseline to at the end of treatment at 12 weeks

Conditions

Overactive Bladder

Explore related trials

Overactive Bladder

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • Connie Wang, MD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
  • Eric Rovner, MD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Louisa Keil
[email protected]
843-792-1840
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Mean change in daily urgency urinary incontinence (UUI) episodes (3-day bladder diary)From baseline to at the end of treatment at 12 weeks

    The primary outcome is the mean change in total daily urgency urinary incontinence (UUI) episodes after addition of ZIDA therapy to stable pharmacologic treatment for overactive bladder. Changes will be evaluated from baseline to Weeks 1, 4, and 8 for descriptive interim analyses and to Week 12 for final analysis. Interim analyses will not be used for early stopping or hypothesis testing.