Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB): a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Incontinence episodes
研究概览
简要总结
A non-intervention cohort study on the use of Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB). Primary endpoint was the reduction of urinary incontinence.
详细描述
The investigators wanted to cunduct an analysis of children with urinary incontinence who received intradetrusor injection of BoNT-A in the period 01.01.2016 to 31.12.2020 at their centre. All patients were refractory to standard urotherapy, anticholinergics, mirabegron and combination of treatments. Patients with neurogenic bladder were excluded.
Primary endpoints were the effect on the frequency of urinary incontinence episodes. Secondary endpoints included urodynamic parameters and uroflow characteristics in relation to side effects and response to treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intradetrusor BoNT-A
排除标准
- •Neurogenic OAB
结局指标
主要结局
Incontinence episodes
时间窗: 1 month after treatment until request for additional treatment (up to 12 months)
Change of incontinence episodes
次要结局
- Response(1 month after treatment until request for additional treatment (up to 12 months))
- Side effects(1 month after treatment)