NCT02601287已完成4 期
A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korean Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 168
- 试验地点
- 10
- 主要终点
- Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score
研究概览
简要总结
This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
- •Symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder
排除标准
- •Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- •Use of botulinum toxin therapy of any serotype in the 3 months prior to screening
- •Has acute urinary retention who do not routinely perform clean intermittent self-catheterization (CIC)
结局指标
主要结局
Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score
时间窗: Baseline, Day 28
次要结局
未报告次要终点
研究者
研究点 (10)
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