The "UroMonitor Trial": Safety, Feasibility, and Tolerability of UroMonitor Insertion in Spinal Cord Injury.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Device Insertion Form for Urology Specialist
研究概览
简要总结
This study aims to determine if a non-functioning UroMonitor device can be safely inserted, monitored, and removed in patients with SCI.
详细描述
This prospective, observational study will be conducted with 10 patients with chronic thoracolumbar SCI who are already undergoing routine UDS studies as part of their care. Following their routine UDS, a non-functioning UroMonitor device will be inserted and removed after 3 hours. Participants' symptoms will be monitored after the UroMonitor is inserted, following the 3 hour monitoring period, and again after UroMonitor removal. A second cystoscopy will be conducted for research purposes after removal to examine the urethra and bladder for any irritation or trauma. During insertion and removal, the urologist will document the time required for insertion and any difficulties encountered
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cervical or Thoracolumbar (T2-L1 spinal level) spinal cord injury with AIS A, B, C, or D severities of injury.
- •At least 1 year post-injury.
- •At least one prior urodynamics study in the past 12 months that has objectively documented abnormalities on bladder function consistent with an upper motor neuro lesion.
- •History of neurogenic bladder symptoms requiring some form of intervention (e.g. clean intermittent catheterization, condom catheter)
排除标准
- •Lumbar injuries (L2-S1 spinal level) where the injury is primarily to the cauda equina and not to spinal cord.
- •History of autonomic dysreflexia (such individuals are excluded to minimize the chance of inducing autonomic dysreflexia with device insertion).
- •Active urinary tract infection.
- •Past urethral or bladder reconstruction surgery
结局指标
主要结局
Device Insertion Form for Urology Specialist
时间窗: Day 1 Timepoint: post insertion
Study form registers the data on application of the device, such as the time and ease of insertion.
Participant Symptoms During Implantation
时间窗: Day 1 Timepoint: post insertion
11-point numerical visual analogue scale for the participant to document discomfort during the implantation of the UroMonitor.
Device Removal Form for Urology Specialist
时间窗: Day 1 Timepoint: post device remove
Study form used for the purpose of recording the condition of the device and patient's experience at the time of sensor removal
Participant Symptoms During 3-Hour Monitoring
时间窗: Day 1 Timepoint: 1 hr post insertion
Study form used for the purpose of registering data on details of participant symptoms during the 3-hour monitoring period
Participant Symptoms during Device Removal Form
时间窗: Day 1 Timepoint: post device remove
Data on details of patient symptoms during device removal is recorded with this form
Second Cystoscopy Form for Urology Specialist
时间窗: Day 1 Timepoint: post secondary cyctoscopy
This form is used for the purpose of recording the existence of irritation in bladder or urethra after the removal of the device
次要结局
未报告次要终点
研究者
Brian Kwon
Principal Investigator
University of British Columbia