Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 548
- 主要终点
- Change From Baseline in Number of Daily 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 (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
- •Inadequate response or limiting side effects with anticholinergics for the treatment of OAB
排除标准
- •Overactive Bladder caused by neurological condition
- •Patient has predominance of stress incontinence
- •History or evidence of pelvic or urological abnormality
研究组 & 干预措施
onabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
干预措施: onabotulinumtoxinA (Biological)
placebo/onabotulinumtoxinA
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
干预措施: onabotulinumtoxinA (Biological)
placebo/onabotulinumtoxinA
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
干预措施: normal saline (Drug)
结局指标
主要结局
Change From Baseline in Number of Daily Episodes of Urinary Incontinence
时间窗: Baseline, Week 12
A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
次要结局
- Change From Baseline in Volume Voided Per Micturition(Baseline, Week 12)
- Change From Baseline in Number of Daily Micturition Episodes(Baseline, Week 12)