Add-On Efficacy of Home-Based Transcutaneous Tibial Nerve Stimulation Via the ZIDA Control Sock in Adults With Overactive Bladder on Preexisting Stable Pharmacotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean change in daily urgency urinary incontinence (UUI) episodes (3-day bladder diary)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: ZIDA Control Sock (Device)
结局指标
主要结局
Mean change in daily urgency urinary incontinence (UUI) episodes (3-day bladder diary)
时间窗: 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.
次要结局
- 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)
- Participants with ≥1 device-related adverse event(Baseline to end of treatment at 12 weeks)
研究者
Connie Wang
Clinical Instructor-Faculty
Medical University of South Carolina