Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 416
- 试验地点
- 14
- 主要终点
- Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（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
- •Inadequate response to anticholinergic medication used to treat overactive bladder
排除标准
- •History of evidence of pelvic or urologic abnormality
- •Previous or current diagnosis of bladder or prostate cancer
- •Urinary tract infection at time of enrollment
研究组 & 干预措施
1
botulinum toxin Type A (200U)
干预措施: botulinum toxin Type A (200U) (Biological)
2
botulinum toxin Type A (300U)
干预措施: botulinum toxin Type A (300U) (Biological)
3
placebo; botulinum toxin Type A (200U)
干预措施: Normal Saline (Placebo); botulinum toxin Type A (200U) (Other)
4
placebo; botulinum toxin Type A (300U)
干预措施: Normal Saline (Placebo); botulinum toxin Type A (300U) (Other)
结局指标
主要结局
Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
时间窗: Baseline, Week 6
Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
次要结局
- Change From Baseline in Maximum Cystometric Capacity (MCC)(Baseline, Week 6)
- Change From Baseline in Maximum Detrusor Pressure (MDP)(Baseline, Week 6)
- Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire(Baseline, Week 6)