OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 254
- 试验地点
- 39
- 主要终点
- Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence
研究概览
简要总结
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.
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
- Triple (Participant, 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
- •Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.
排除标准
- •Symptoms of OAB due to a neurological reason
- •Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
- •Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
- •Use of botulinum toxin therapy of any serotype for any urological condition
- •Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
- •History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
- •Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
研究组 & 干预措施
OnabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
干预措施: onabotulinumtoxinA (Biological)
Placebo/OnabotulinumtoxinA
Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
干预措施: onabotulinumtoxinA (Biological)
Placebo/OnabotulinumtoxinA
Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U 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 the Daily Average Number of Episodes of Urinary Incontinence
时间窗: Baseline, Week 12
Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.
Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes
时间窗: Baseline, Week 12
Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.
次要结局
- Change From Baseline in the Daily Average Number of Nocturia Episodes(Baseline, Week 12)
- Change From Baseline in the Daily Average Number of Urgency Episodes(Baseline, Week 12)
- Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores(Baseline, Week 12)
- Change From Baseline in the Daily Average Number of Micturition Episodes(Baseline, Week 12)