Recruiting

ZIDA Control Sock

Sponsor:

Medical University of South Carolina

Code:

NCT07432659

Conditions

Overactive Bladder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ZIDA Control Sock

Study Details

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 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

Overactive Bladder

Study ID

NCT07432659

Start date

Apr 17, 2026

Status verified date

May, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ZIDA Add-On Therapy

Participants will continue usual pharmacologic treatment for overactive bladder and will use the ZIDA Control Sock at home once weekly over the study treatment period. Device use is evaluated as an adjunct to standard care.

Interventions

ZIDA Control Sock

The ZIDA Control Sock is an FDA-cleared, noninvasive wearable neuromodulation device designed for home use. The device delivers low-level electrical stimulation near the ankle to stimulate peripheral nerves involved in bladder control. In this study, the device is used as an adjunct to usual pharmacologic care.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Louisa Keil

843-792-1840Keill@musc.edu

Locations

Rutledge Tower at Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Louisa Keil

843-792-2300Keill@musc.edu

Principal Investigator:

Connie Wang, MD

More Information

Sponsor

Medical University of South Carolina

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Overactive Bladder
  • Urgency Urinary Incontinence
  • Transcutaneous Tibial Nerve Stimulation
  • TTNS
  • Neuromodulation
  • ZIDA Control Sock

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-05-06.