NCT02590250已完成不适用
Evaluation of the Safety and Effectiveness of BOTOX® (Botulinum Toxin Type A) in the Treatment of Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Phase IV Non-interventional Post-marketing Surveillance Study in India
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
- 250
- 试验地点
- 12
- 主要终点
- Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
研究概览
简要总结
This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.
排除标准
- 未提供
结局指标
主要结局
Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
时间窗: at up to 4 months
次要结局
未报告次要终点
研究者
研究点 (12)
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