NCT01477736已完成不适用
A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Centro de Reabilitação e Readaptação Dr. Henrique Santillo1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- The primary study outcome measure was the variation mean in the number of episodes of urinary incontinence per 24 hours, maximum cystometric capacity, maximum detrusor pressure and bladder compliance
研究概览
简要总结
The purpose of this study is to compare the effects of oral oxybutynin and intradetrusor injections of botulinum toxin type A on urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity following spinal cord injury.
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
- None
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
- •Spinal cord injury
- •Detrusor overactivity
- •Age over 18 years
- •Spinal cord injury at least 12 months duration
- •Undergoing regular clean intermittent catheterisation
排除标准
- •Pregnancy
- •Desire to become pregnant during the study period
- •Breastfeeding
- •Blood coagulation disorder
- •Neuromuscular transmission disorder
- •Use of any intravesical pharmacologic agents
- •Previous use of botulinum toxin A
研究组 & 干预措施
Botulinum toxin A
Active Comparator
干预措施: Oxybutynin (Drug)
Botulinum toxin A
Active Comparator
干预措施: Botulinum toxin A (Drug)
oxybutynin
Active Comparator
干预措施: Oxybutynin (Drug)
oxybutynin
Active Comparator
干预措施: Botulinum toxin A (Drug)
结局指标
主要结局
The primary study outcome measure was the variation mean in the number of episodes of urinary incontinence per 24 hours, maximum cystometric capacity, maximum detrusor pressure and bladder compliance
时间窗: Beginning and 24 weeks of the study
次要结局
- The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire(Beginning and 24 weeks of the study)
研究者
Ruiter Silva Ferreira
Dr
Centro de Reabilitação e Readaptação Dr. Henrique Santillo
研究点 (1)
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