Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder (OAB). A Multicenter Phase II, Randomized, Double-blind, Placebo Controlled 6 Month Study . VESITOX
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of urgency and urge incontinence episodes at 3 months after injection
研究概览
简要总结
Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.
详细描述
This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to 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
- Double (Participant, 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
- •Overactive bladder with more than 3 episodes of urgency of urge incontinence per day
排除标准
- 未提供
结局指标
主要结局
Number of urgency and urge incontinence episodes at 3 months after injection
时间窗: at 3 months
次要结局
- Number of micturition episodes on micturition chart per day(per day)
- Mean value of volume of urine per micturition
- Mean delay between urgency and leakage Quality of life improvement by Iqol and EuroQol (EQ-5D)
- Urodynamic parameters : Volume at first contraction, volume at first desire to void, volume at urgency, maximal bladder capacity, maximal detrusor pressure
- Number of pads used per day
- Number of patients with less than 3 episodes per day of leakages by urge incontinence or urgency per day
- Residual volume of urine after flowmetry
- Maximal flow
- Visual analogic scale for pain for procedure
- Biologic modifications
- Ultrasound of kidneys
- Toxin A antibodies