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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Page 1 of 1 (1 locations)

1

Rutledge Tower at Medical University of South Carolina

Charleston, South Carolina, United States, 29425