Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Improved my Quality of Life"
研究概览
简要总结
Determine the safety, feasibility, compliance, and efficacy of a daily home TTNS protocol in chronic SCI provided by self or caregiver for 4 weeks.
详细描述
In Specific Aim 1, we will monitor for safety, feasibility, and compliance of a home TTNS program for bladder management. In Specific Aim 2, the efficacy of home TTNS will be compared to baseline Incontinence- Quality of Life questionnaire. A bladder diary will also capture important information such as frequency and volume of catheterization, incontinence episodes, and other related observations.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Neurologically stable SCI for ≥ 6 months
- •Intermittent catheterization to empty bladder
- •Stable bladder medications for ≥ 3 months
排除标准
- •Multiple medications for the bladder
- •Other diagnoses to explain incontinence (ex: UTI, bladder stones, multiple sclerosis, etc.)
- •2+ pitting edema that does not resolve
- •Known peripheral neuropathy or injury to the path of the tibial nerve
- •Demand-type cardiac pacemaker or implanted defibrillator
- •Cancer in the tibial nerve path and/or bladder
- •Inability to elicit toe/plantar flexion with electric stimulation during the clinic visit.
- •Inability to understand directions
- •Non-English speaking
研究组 & 干预措施
4-week TTNS home based protocol
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
干预措施: 4-week TTNS home-based protocol (Device)
结局指标
主要结局
Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Improved my Quality of Life"
时间窗: week 4
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Not Painful"
时间窗: week 4
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
时间窗: week 4
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Overall Satisfaction of Daily Use of TTNS at Home
时间窗: week 3
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "I Enjoyed Using TTNS"
时间窗: week 4
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
时间窗: week 4
Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "Overall, I Would Recommend TTNS for Those With Neurogenic Bladder"
时间窗: week 4
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Easy to Use"
时间窗: week 4
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Not Embarrassing to Use TTNS"
时间窗: week 4
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Easy to Remember to Use TTNS"
时间窗: week 4
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Did Not Irritate my Skin"
时间窗: week 4
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "If TTNS Works as Well as Medications, I Would Switch to TTNS"
时间窗: week 4
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
时间窗: week 1
Noted on bladder diary will be description of observed changes including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
时间窗: week 2
Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
时间窗: week 3
Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
时间窗: week 1
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
时间窗: week 2
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
时间窗: week 3
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Overall Satisfaction of Daily Use of TTNS at Home
时间窗: week 1
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Overall Satisfaction of Daily Use of TTNS at Home
时间窗: week 2
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
次要结局
- Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey(week 4)
- Number of Catheterizations Per Day(week 1, week 2, week 3, week 4)
- Volume of Catheterization(week 1, week 2, week 3, week 4)
- Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire(week 4)
- Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey(week 0)
- Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey(Week 2)
- Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire(week 0)
研究者
Argyrios Stampas, MD
Assistant Professor
The University of Texas Health Science Center, Houston