Add-On ZIDA Sock Therapy for Overactive Bladder

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (6)

• Mean change in daily urgency episodes (3-day bladder diary) [Срок оценки: Baseline to end of treatment at 12 weeks]
• Mean change in daily urinary frequency (3-day bladder diary) [Срок оценки: Baseline to end of treatment at 12 weeks]
• Change in OAB-Q Short Form (1-Week Recall) Total Score [Срок оценки: Baseline to end of treatment at 12 weeks]
• Patient Global Impression of Improvement (PGI-I) [Срок оценки: Baseline to end of treatment at 12 weeks]
• Device usability score (Usability & Satisfaction Survey) [Срок оценки: Baseline to end of treatment at 12 weeks]
• Participants with ≥1 device-related adverse event [Срок оценки: Baseline to end of treatment at 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Rutledge Tower at Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT07432659 · Pro00148326

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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