Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Participants With Reduction in Bladder Medication
研究概览
简要总结
The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life using TTNS at home
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The Study is designed to look at the difference in "high dose" group, which will be submotor amperage, compared to "low dose" which will be set to 1 mA. Both groups will need to stimulate the tibial nerve and visualize toe movement, and then decrease to the amperage of either "high dose" or "low dose." Both groups will use the device for 30 minutes, 5 days per week. A urodynamic study will be performed to measure bladder capacity, sensations while filling, and detrusor pressures before starting using the device and one last time at the end of the study.
We are also conducting surveys to describe differences in preferences with using bladder medications versus devices.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic and non-traumatic SCI performing IC
- •Up to 2 anticholinergic overactive bladder (OAB) medications
- •No changes in OAB medications
- •Neurologic level of injury above T10
- •English and Spanish speaking
排除标准
- •Past history of genitourinary diagnoses or surgeries
- •History of central nervous system (CNS) disorders and/or peripheral neuropathy
- •Pregnancy
- •Lower motor neuron bladder
- •Concern for tibial nerve pathway injury
- •Absence of toe flexion or AD with electric stimulation
- •Bladder chemodenervation in past 6 months
- •Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis
结局指标
主要结局
Number of Participants With Reduction in Bladder Medication
时间窗: baseline, 3 months
Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline
时间窗: Baseline, 3 months
The Neurogenic Bladder Symptom (NBSS) Score is a questionnaire that measures bladder symptoms, with total score ranging from 0 to 74; a higher score indicating a worse outcome. Scores at baseline are compared to scores at 3 months, and a change is reported categorically as follows: Stable: A score change within + 5 or -5 points (not including 5) Worse: A score increase of 5 points or more from baseline Improved: A score decrease of 5 points or more from baseline These categories are mutually exclusive and exhaustive; each participant will fit into only one category based on their score change
Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary
时间窗: baseline, 3 months
次要结局
- Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline(baseline, 3 months)
- Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey(baseline, 3 months)
- Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study(baseline, 3 months)
研究者
Argyrios Stampas, MD
Associate Professor
The University of Texas Health Science Center, Houston