Add-On ZIDA Sock Therapy for Overactive Bladder

Add-On Efficacy of Home-Based Transcutaneous Tibial Nerve Stimulation Via the ZIDA Control Sock in Adults With Overactive Bladder on Preexisting Stable Pharmacotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: ZIDA Control Sock

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 an FDA-cleared, noninvasive wearable device that delivers low-level electrical stimulation near the ankle to stimulate peripheral nerves involved in bladder control.

The study is conducted as a prospective, single-arm clinical investigation in which participants use the device at home while continuing usual care. Device use is prescribed once weekly for 12 weeks. Study conduct includes participant training, remote support to ensure correct device use, and ongoing safety monitoring.

The study is designed to characterize changes observed during adjunctive device use, assess participant experience with home-based therapy, and evaluate device-related safety. Findings will contribute to understanding the feasibility and potential clinical role of wearable neuromodulation as an add-on treatment option in routine overactive bladder care.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louisa Keil; Phone Number: 843-792-1840; Email: Keill@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Rutledge Tower at Medical University of South Carolina
      • Principal Investigator: Eric Rovner, MD
      • Contact: Louisa Keil; Phone Number: 1840 843-792-2300; Email: Keill@musc.edu
      • Principal Investigator: Connie Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in daily urgency episodes (3-day bladder diary)	Change in the average number of daily urgency episodes recorded in a 3-day bladder diary at Baseline and Week 12.	Baseline to end of treatment at 12 weeks
Mean change in daily urinary frequency (3-day bladder diary)	Change in the average number of daily voids from a 3-day bladder diary collected at Baseline and Week 12.	Baseline to end of treatment at 12 weeks
Change in OAB-Q Short Form (1-Week Recall) Total Score	Change in total score on the OAB-Q Short Form (1-Week Recall), a validated 19-item questionnaire assessing OAB symptom bother and quality of life. Higher scores indicate worse symptoms.	Baseline to end of treatment at 12 weeks
Patient Global Impression of Improvement (PGI-I)	Participant-reported global impression of improvement rated on a 7-point scale (1 = very much improved to 7 = very much worse).	Baseline to end of treatment at 12 weeks
Device usability score (Usability & Satisfaction Survey)	Usability and satisfaction with the ZIDA device assessed using a six-item survey, including five Likert-scaled items evaluating ease of use, comfort, and clarity of instructions.	Baseline to end of treatment at 12 weeks
Participants with ≥1 device-related adverse event	Number of participants experiencing at least one device-related adverse event recorded through the Adverse Event Log during the 12-week treatment period.	Baseline to end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Medtronic; Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
• Investigators: Principal Investigator: Eric Rovner, MD, Medical University of South Carolina; Principal Investigator: Connie Wang, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Neuromodulation; Overactive Bladder; Urgency Urinary Incontinence; TTNS; Transcutaneous Tibial Nerve Stimulation; ZIDA Control Sock
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive
• Other Study ID Numbers: Pro00148326

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes