NCT00213577终止2 期
Evaluation of the Efficacy and Tolerance of 2 Dosages of Type A Botulinic Toxin in Neurogenic Areactive Bladder Resistant to Oral Medical Treatment
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2003年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- complete urinary continence at baseline, and days 30, 90, 180, and 360
研究概览
简要总结
The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.
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, Care Provider, Investigator)
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
- •Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic
排除标准
- •Pregnancy
- •Bladder cancer
- •Symptomatic urinary infection
结局指标
主要结局
complete urinary continence at baseline, and days 30, 90, 180, and 360
次要结局
- urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure
- number of mictions or self catheterizations a day
- number of leakages, urgency adverse events
- guarding times
研究者
研究点 (1)
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