Overactive Bladder
Conditions
Keywords
Overactive Bladder, Urgency Urinary Incontinence, Transcutaneous Tibial Nerve Stimulation, TTNS, Neuromodulation, ZIDA Control Sock
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.
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.
Interventions
DEVICEZIDA 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.
Sponsors
Medical University of South Carolina
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
Medtronic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in daily urgency urinary incontinence (UUI) episodes (3-day bladder diary) | From baseline to at the end of treatment at 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in daily urgency episodes (3-day bladder diary) | Baseline to end of treatment at 12 weeks | Change in the average number of daily urgency episodes recorded in a 3-day bladder diary at Baseline and Week 12. |
| Mean change in daily urinary frequency (3-day bladder diary) | Baseline to end of treatment at 12 weeks | Change in the average number of daily voids from a 3-day bladder diary collected at Baseline and Week 12. |
| Change in OAB-Q Short Form (1-Week Recall) Total Score | Baseline to end of treatment at 12 weeks | 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. |
| Patient Global Impression of Improvement (PGI-I) | Baseline to end of treatment at 12 weeks | Participant-reported global impression of improvement rated on a 7-point scale (1 = very much improved to 7 = very much worse). |
| Device usability score (Usability & Satisfaction Survey) | Baseline to end of treatment at 12 weeks | 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. |
| Participants with ≥1 device-related adverse event | Baseline to end of treatment at 12 weeks | Number of participants experiencing at least one device-related adverse event recorded through the Adverse Event Log during the 12-week treatment period. |
Countries
United States
Contacts
CONTACTLouisa Keil
PRINCIPAL_INVESTIGATORConnie Wang, MD
Medical University of South Carolina
PRINCIPAL_INVESTIGATOREric Rovner, MD
Medical University of South Carolina
Outcome results
None listed