NCT03043287已完成不适用
Voiding Efficiency, a Predictor of CIC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 420
- 试验地点
- 3
- 主要终点
- Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX®
研究概览
简要总结
This study is a retrospective chart review of patients treated with onabotulinumtoxinA (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE) cutoff ratios that predict post-procedure urinary retention requiring catheterization.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patient with documented idiopathic OAB diagnosis
- •Patient was treated with 100-200U of BOTOX® for OAB
- •Urodynamics assessment within prior to first BOTOX® injection.
排除标准
- •Patient had received botulinum toxin formulations other than BOTOX® in the bladder
- •Patient had symptoms of OAB associated with a neurological condition (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc).
结局指标
主要结局
Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX®
时间窗: 12 Weeks
Pre-BOTOX® Injection VE Cutoff-Ratios that Predict the Risk of CIC following Treatment with 100-200U of BOTOX®
时间窗: Pre-BOTOX® Injection (Baseline)
VE was calculated as the ratio of voided volume to the total bladder capacity.
次要结局
未报告次要终点
研究者
研究点 (3)
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