Cannabinoid Modulation for Neurogenic Lower Urinary Tract Dysfunction in Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Completion of 72-hour voiding diary
研究概览
简要总结
The goal of this feasibility study is to learn whether Cannabidiol (CBD) can improve urinary incontinence and other symptoms in people with recent spinal cord injury (SCI).
Participants will take Epidiolex (purified CBD) for 90 days
详细描述
This pilot study assesses the feasibility of using 100mg of twice daily cannabidiol (Epidiolex) in adult spinal cord injury with neurogenic lower urinary tract dysfunction following resolution of spinal shock.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •History of supra-sacral spinal cord injury of any mechanism
- •Urinary incontinence with ≥2 episodes of urinary incontinence per day (outside of spinal shock)
- •Willingness to participate in drug intervention trial
- •English-speaking (able to provide consent and complete questionnaires)
排除标准
- •History of intravesical Botox
- •Actively taking >15 mg of Oxybutynin single dose or equivalent dose of alternative anticholinergic medication for bladder symptoms
- •Use of Cannabis (any form) outside of study as determined by urine drug screen after washout period of 1 month if prior Cannabis use reported
- •Thought or mood disorder aside from depression
研究组 & 干预措施
CBD for urinary incontinence
Participants will take CBD for 90 days
干预措施: CBD (Drug)
结局指标
主要结局
Completion of 72-hour voiding diary
时间窗: 90 days
This assessment involves electronic participant documentation of urinary episodes at home.
Adherence to CBD (Epidiolex) regimen
时间窗: 90 days
Participants will complete a daily smartphone application-based drug diary recording when they take study drug.
Number of adverse events
时间窗: 120 days
Participants will be followed for adverse events for at least 30 days after the last dose of study drug.
次要结局
- Change in urinary incontinence (UI) episodes(Baseline to 90 days)
- Change in symptoms associated with UI(Baseline to 90 days)
- Change in urinary symptoms associated with neurogenic bladder(Baseline to 90 days)