Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 144
- 主要终点
- Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
研究概览
简要总结
This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.
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
- •At least 3 episodes of urinary incontinence over a 3-day period
- •History of Multiple Sclerosis (MS)
- •Urinary incontinence not adequately controlled by anticholinergic medication
排除标准
- •Current use of intermittent catheter or indwelling catheter to manage urinary incontinence
- •Previous or current botulinum toxin therapy of any serotype for any urological condition
- •Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks
- •Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis
研究组 & 干预措施
OnabotulinumtoxinA
OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA 100 U injection.
干预措施: OnabotulinumtoxinA (Biological)
Placebo (Normal Saline)
Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
干预措施: OnabotulinumtoxinA (Biological)
Placebo (Normal Saline)
Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
干预措施: Placebo (Normal Saline) (Drug)
结局指标
主要结局
Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
时间窗: Baseline, Week 6
Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).
次要结局
- Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score(Baseline, Week 6)
- Change From Baseline in Maximum Cystometric Capacity (MCC)(Baseline, Week 6)
- Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)(Baseline, Week 6)