Shock therapy sock could curb bladder leaks

NCT ID NCT07432659

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Rutledge Tower at Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

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