Shock therapy sock could curb bladder leaks
NCT ID NCT07432659
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special sock called the ZIDA Control Sock that gives mild electrical pulses near the ankle to help people with overactive bladder who still have leaks despite taking medicine. About 20 adults will use the sock at home once a week for 12 weeks while staying on their usual medication. The goal is to see if the sock reduces daily bladder leaks and other symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rutledge Tower at Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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