Evaluation of Local Injection of Botulinium Toxin-A in Children With Dysfunctional Voiding or Refractory Nocturnal Eneuresis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
The aim of this study is to evaluate the outcome of botulinum toxin A (BTX-A) injection for management of children with :
A-Dysfunctional voiding who are not responding to traditional treatment. B-Refractory nocturnal enuresis.
详细描述
Dysfunctional voiding (DV) is a habitual voiding disorder caused by involuntary contraction or non relaxation of the external urethral sphincter (EUS) during voiding.
This contraction causes high post void residuals (PVR), The disorder can occur at any age. In young children it often presents as urinary incontinence, nocturnal enuresis, or recurrent urinary tract infections (UTIs).
Nocturnal enuresis (NE) is common, affecting 15-20 % of children by five years old, and 8-10 % of children by eight years old.
Refractory nocturnal enuresis is defined as monosymptomatic nocturnal enuresis (bedwetting without daytime urinary symptoms) that persists despite at least 3-6 months of appropriate and compliant first line therapy.
Botulinum toxin has been found to inhibit the release of a number of neurotransmitters (including acetylcholine, adenosine triphosphate, and neuropeptides such as substance P) and to down regulate the expression of purinergic and capsaicin receptors on afferent neurons within the bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children < 18 years.
- •Both sexes.
- •Patients with refractory nocturnal enuresis or dysfunctional voiding who are not responding to the traditional treatment.
排除标准
- •Bleeding disorders.
- •Neuromusclar disorder(e.g.,Myasthenia gravis).
- •Patients who are not fit for anaesthesia.
- •Active urinary tract infection (UTI).
研究组 & 干预措施
Study group
Children with refractory nocturnal enuresis or dysfunctional voiding.
干预措施: Botulinium Toxin-A (Drug)
结局指标
主要结局
Success rate
时间窗: 24 hours postoperatively
Success rate regarding improvement of clinical symptoms will be recorded.
次要结局
- Incidence of complications(24 hours postoperatively)
研究者
Ahmad Mohamed Elsaied Shalaby
Resident of Urology, Tanta University, Tanta, Egypt
Tanta University