Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Safety as assessed by the number of device-related adverse events
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.
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)
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
- •Non-progressive chronic (>1 year) SCI
- •Neurologic level of injury T9 and above
- •Stable over active bladder (OAB) medications (≥3 months)
- •No contraindication to MRI (per MRI Safety Questionnaire)
- •English or Spanish speaking
- •Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted)
- •Pass the tTNS competency checklist to perform or direct performance of tTNS.
排除标准
- •Ongoing/active genitourinary oncologic diagnoses
- •History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy
- •Pregnancy or planning to become pregnant.
- •Lower Motor Neuron bladder
- •Restorative bladder surgery such as augmentation cystoplasty
- •Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed)
- •Anticoagulation treatment or prophylaxis
- •Advanced peripheral vascular disease (gangrene, amputation, etc.)
- •History of intolerance to electrical stimulation, particularly of the leg
研究组 & 干预措施
Sham iTNS
participants will receive one one sham tibial nerve stimulation (TNS) device for bilateral use.
干预措施: Sham iTNS (Device)
Bilateral iTNS
participants will receive one active tibial nerve stimulation (TNS) device and both legs will receive active stimulation
干预措施: iTNS (Device)
Unilateral iTNS
participants will receive one active and one sham tibial nerve stimulation (TNS) device. The treatment will only be delivered to the leg with the active device.
干预措施: iTNS (Device)
Unilateral iTNS
participants will receive one active and one sham tibial nerve stimulation (TNS) device. The treatment will only be delivered to the leg with the active device.
干预措施: Sham iTNS (Device)
结局指标
主要结局
Safety as assessed by the number of device-related adverse events
时间窗: From baseline to 8 weeks
Adverse events include lead migration and fracture, hematoma, wound infection, delayed healing, nerve injury, and autonomic dysreflexia occurrence during the procedure.
Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs.
时间窗: From baseline to week 8
Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracy
时间窗: From baseline to week 8
Feasibility of Injectrode procedure as assessed by surveys
时间窗: Week 8
Feasibility to check if reproducible training pathway can enable non-interventional physicians to competently perform Injectrode implantation and removal
Physician acceptability of Injectrode device as assessed by a survey
时间窗: Week 8
The acceptability survey ranges from 0 - 32, with a higher score indicating greater acceptability of the Injectrode device.
Participant acceptability of Injectrode device as assessed by a survey
时间窗: Week 8
The acceptability survey ranges from 0 - 25, with a higher score indicating greater acceptability of the Injectrode device.
Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interview
时间窗: Week 8
A semi-structured interview will be conducted with participants and providers to explore their perceptions of the Injectrode treatment. Responses will be summarized using qualitative coding and descriptive statistics of themes.
次要结局
- Number of participants for whom bladder medication dosage reduced(from baseline to 8 weeks)
- Change in magnitude of dosage of medication(from baseline to 8 weeks)
- Change in bladder function during urodynamics as assessed by the maximum detrusor pressure (Max Pdet) in cmH20.(Baseline, Week 4, and Week 8)
- Change in Bladder function as assessed by the presence or absence of detrusor overactivity (DO) during urodynamics.(baseline, Week 4, and Week 8)
- Change in bladder capacity (maximum volume in mL) during urodynamics before voiding or discomfort.(baseline, Week 4, and Week 8)
- Change in the presence or absence of leaks during urodynamics.(baseline, Week 4, and Week 8)
- Change in bladder sensation during urodynamics as defined by the infused volume (mL) at time of reported first sensation of filling.(baseline, Week 4, and Week 8)
- Change in bladder sensation during urodynamics as defined by infused volume (mL) at time of reported urgency/ desire to void.(Baseline, Week 4, and Week 8)
- Change in bladder sensation during urodynamics as defined by the infused volume (mL) at the time of reported discomfort.(Baseline, Week 4, and Week 8)
- Change in detrusor compliance during urodynamics as reported by the change in bladder volume divided by the change in bladder pressure.(baseline, Week 4, and Week 8)
- Change in the number of incontinence episodes as self-reported in the bladder diary.(Baseline, Week 4, and Week 8)
- Change in the frequency of catheterization as self-reported in the bladder diary.(Baseline, Week 4, and Week 8)
- Change in the volume of catheterization as self-reported in the bladder diary.(Baseline, Week 4, and Week 8)
研究者
Argyrios Stampas, MD
Associate Professor
The University of Texas Health Science Center, Houston