BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 114
- 试验地点
- 62
- 主要终点
- Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes
研究概览
简要总结
This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urinary incontinence due to neurogenic detrusor overactivity
- •Regularly using clean intermittent catheterization to empty the bladder
排除标准
- •Surgery of the spinal cord within 6 months
- •Diagnosis of cerebral palsy
- •Current or planned use of a baclofen pump
- •Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
- •Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder
- •Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
- •Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
结局指标
主要结局
Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes
时间窗: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAE)(First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection))
- Change From Baseline in Average Urine Volume at First Morning Catheterization(Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6)
- Time to Participant Request for Retreatment(48 weeks)
- Percentage of Participants With Night Time Urinary Incontinence(Baseline (Day -28 to Day -1), Week 6)
- Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase(Baseline (Day 1) to Week 6)
- Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase(Baseline (Day -28 to -1) to Week 6)
- Change From Baseline in Maximum Cystometric Capacity (MCC)(Baseline (Day -28 to Day -1) to Week 6)
- Percentage of Participants With Involuntary Detrusor Contractions (IDC)(Baseline (Day -28 to -1) and Week 6)
- Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC(Baseline (Day-28 to Day-1) to Week 6)
- Time to Participant Qualification for Retreatment(48 weeks)