Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder: A Hybrid Effectiveness-implementation Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 主要终点
- Consistency and Reliability of Stimulation Output as assessed by the percentage of sessions where the desired stimulation intensity is achieved (based on EMG waveform consistency) and time of day (morning, afternoon, evening)
研究概览
简要总结
The purpose of this study is to assess and optimize the Avation electric stimulation system output and electromyography (EMG) processing to stimulate the tibial nerve in people with chronic Spinal Cord Injury (SCI) who have foot muscle atrophy and edema, both of which may affect proper device operations, to evaluate the safety, feasibility, and effectiveness of Avation Electric Stimulation System for bladder neuromodulation in people with SCI and identify barriers to implementation of the existing Avation Electric Stimulation System to help with developing it towards a new indication for routine care of SCI NB.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Injury level above T
- •Diagnosis of neurogenic bladder (Performing intermittent catheterization).
- •English or Spanish Speaker.
- •Toe flexion upon tibial nerve stimulation with transcutaneous electric stimulation.
- •No adverse events during the Vivally 5-minute trial
排除标准
- •Intradetrusor Botulinum Toxin within six months.
- •Presence of urinary tract infection (UTI) symptoms.
- •Pregnancy or breastfeeding.
- •Known allergy to electrode or device materials.
- •Known intolerance to leg electric stimulation
- •Patient with no smartphone access.
- •Pain/discomfort or adverse reaction with the trial of toe flexion.
结局指标
主要结局
Consistency and Reliability of Stimulation Output as assessed by the percentage of sessions where the desired stimulation intensity is achieved (based on EMG waveform consistency) and time of day (morning, afternoon, evening)
时间窗: Daily during the 4-week optimization period
EMG Waveform Quality as assessed by the number of successful EMG detections per session versus unsuccessful ones
时间窗: Daily during the 4-week optimization period
Safety as assessed by the Pain score reported on the participant diary
时间窗: Continuous, daily monitoring throughout the 12-week study
Pain is scored on linear scale from 0(no pain)-10(worst pain), higher score indicating worse outcome
Safety as assessed by the adverse events self reported by participant
时间窗: Continuous, daily monitoring throughout the 12-week study
patient-reported adverse events, including changes in spasticity, their bowel programs, urinary tract infections, autonomic dysreflexia, and all other concerning changes
Feasibility as assessed by the number of participants who adhere to the protocol as reported on the patient dairy
时间窗: Weekly during the 12-week study
Effectiveness for Bladder Control as assessed by the changes in volume of catheterization reported in the voiding diary data
时间窗: Once a month for all 3 months
Effectiveness for Bladder Control as assessed by the changes in frequency of catheterization reported in the voiding diary data
时间窗: Once a month for all 3 months
Effectiveness for Bladder Control as assessed by the number of episodes of incontinence reported in the voiding diary data
时间窗: Once a month for all 3 months
Implementation Barriers as assessed by a survey
时间窗: end of study (12 weeks from baseline)
Patient-Reported Implementation Feedback as assessed by a survey
时间窗: end of study (12 weeks from baseline)
次要结局
- Patient-Reported Comfort as assessed by the participant survey(Daily during the 4-week optimization period)
- Patient-Reported Usability as assessed by the participant survey(Daily during the 4-week optimization period)
- Type and extent of adjustments (none, minor, major) required for System Operation needed for effective stimulation(End of the 4-week optimization period)
- Frequency of adaptations made to the device(End of the 4-week optimization period)
- Number of participants that had adaptations made to the device as assessed by a yes or no questionnaire(End of the 4-week optimization period)
- Change in Quality of Life as assessed by the The Neurogenic Bladder Symptom Score (NBSS)(Baseline, 4 weeks, 8 weeks and 12 weeks)
- Change in Quality of Life as assessed by the Incontinence Quality of Life Questionnaire(I-QOL)(Baseline, 4 weeks, 8 weeks and 12 weeks)
- Change in Quality of Life as assessed by the Neurogenic Bowel Dysfunction (NBD) score(Baseline, 4 weeks, 8 weeks and 12 weeks)
- Patient satisfaction as assessed by a survey(End of study (12 weeks form baseline))
- Qualitative assessment of edema or skin changes as assessed by photos of lower leg and foot(Weekly during the 12-week study)
- Patient-Reported Changes in Bladder Program(Weekly during the 12-week study)
- Number of caregivers who were satisfied as assessed by the interview(end of study (12 weeks from baseline))
- Number of clinicians who were satisfied as assessed by the interview(end of study (12 weeks from baseline))
- System Fidelity as assessed by the degree to which the the Avation electric stimulation system was used as intended by patients(end of study (12 weeks from baseline))
- Relative Advantage and Adaptability of the Innovation as assessed by the ratings on the perceived benefits and adaptability of the the Avation electric stimulation system compared to existing treatments(end of study (12 weeks from baseline))
研究者
Argyrios Stampas, MD
Associate Professor
The University of Texas Health Science Center, Houston