A Research Study for Patients With Overactive Bladder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 313
- 主要终点
- Change in Number of Urinary Urge Incontinence Episodes
研究概览
简要总结
The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be between 18-85 years old
- •Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
- •Must weigh at least 50 kg (110 lbs)
- •Must be willing and able to record information regarding bladder function into a diary (provided)
- •Must be willing and able to complete the entire course of the study
排除标准
- •Cannot currently be catheterizing as a way to control incontinence
- •Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition
研究组 & 干预措施
Placebo
Placebo (normal saline) injected into detrusor on Day 1
干预措施: Placebo (Drug)
BOTOX 100 U
botulinum toxin Type A 100 U injected into detrusor on Day 1
干预措施: botulinum toxin Type A (Biological)
BOTOX 200 U
botulinum toxin Type A 200 U injected into detrusor on Day 1
干预措施: botulinum toxin Type A (Biological)
BOTOX 300 U
botulinum toxin Type A 300 U injected into detrusor on Day 1
干预措施: botulinum toxin Type A (Biological)
BOTOX 150 U
botulinum toxin Type A 150 U injected into detrusor on Day 1
干预措施: botulinum toxin Type A (Biological)
BOTOX 50 U
botulinum toxin Type A 50 U injected into detrusor on Day 1
干预措施: botulinum toxin Type A (Biological)
结局指标
主要结局
Change in Number of Urinary Urge Incontinence Episodes
时间窗: Baseline, Week 2, Week 6, Week 12
Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.
次要结局
- Change in Number of Nocturia Episodes(Baseline, Week 12)
- Incontinence Quality of Life Instrument (I-QOL)(Baseline, Week 2, Week 6, Week 12)
- Change in Number of Micturitions(Baseline, Week 2, Week 6, Week 12)
- Maximum Cystometric Capacity (MCC) by Urodynamic Measurements(Baseline, Week 12)