Add-On ZIDA Sock Therapy for Overactive Bladder

NCT07432659 | Recruiting DMC FDA Device

• 1 other identifier: Pro00148326
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean change in daily urgency urinary incontinence (UUI) episodes (3-day bladder diary)

  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.

  From baseline to at the end of treatment at 12 weeks

Secondary Outcomes (6)

• Mean change in daily urgency episodes (3-day bladder diary)

  Baseline to end of treatment at 12 weeks

• Mean change in daily urinary frequency (3-day bladder diary)

  Baseline to end of treatment at 12 weeks

• Change in OAB-Q Short Form (1-Week Recall) Total Score

  Baseline to end of treatment at 12 weeks

• Patient Global Impression of Improvement (PGI-I)

  Baseline to end of treatment at 12 weeks

• Device usability score (Usability & Satisfaction Survey)

  Baseline to end of treatment at 12 weeks

Study Arms (1)

ZIDA Add-On Therapy

EXPERIMENTAL

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.

Device: ZIDA Control Sock

Interventions

ZIDA Control Sock DEVICE

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.

ZIDA Add-On Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction: collaborator
• Medtronic: collaborator

Study Sites (1)

Rutledge Tower at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Connie Wang, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Eric Rovner, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louisa Keil

CONTACT

843-792-1840; Keill@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor-Faculty

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 25, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)