A Pilot Study Comparing the Effects of Botulinum Toxin A and Standard Oxybutynin Therapy as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy
研究概览
简要总结
The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy for children with neurogenic bladder due to spina bifida and compare results with standard oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain or improve bladder storage function without side effects associated with oxybutynin use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of spina bifida and neurogenic bladder
- •Performing clean intermittent catheterization (CIC)
- •Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder
- •Has not had previous bladder surgery
- •Has had a urodynamic or videourodynamic study done within the last 6 months
- •Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study
- •Urodynamic study (UDS) showing either detrusor leak point pressure >40cm H2O; 30cm below capacity <60% of total bladder capacity, 20 cm capacity <70% of bladder capacity
- •Able and willing to complete CIC Diaries and Quality of Life Questionnaires
- •Consent and assent given to participate in trial
排除标准
- •History of lung disease, recurrent aspiration or severe neurological impairment which may increase risk of Botox toxicity or anesthesia
- •Positive urine culture
- •Known allergy to Botox
研究组 & 干预措施
Oxybutynin
干预措施: Oxybutynin (Drug)
Botulinum Toxin A injection
干预措施: Botulinum Toxin A injection (Drug)
结局指标
主要结局
To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy
时间窗: Primary outcomes will be assessed at 3 and 6 months
The following urodynamic parameters will be measured; 1. Change in end fill pressure or detrusor leak point pressure (cm H2O) 2. Change in 20 and 30 cm H2O below volumes expressed as percentage of bladder capacity 3. Change in reflex volume (percentage of bladder capacity at which neurogenic detrusor overactivity starts)
次要结局
- Calculate accrual rate(Secondary outcomes will be assessed at 6 months)
- Calculate cross over rate(Secondary outcomes will be assessed at 6 months)
- Calculate drop out rate(Secondary outcomes will be assessed at 6 months)
- Calculate adverse event rates(Secondary outcomes will be assessed at 6 months)
- Compare the side effects of standard oral therapy compared to Botulinum toxin A injection(Secondary outcomes will be assessed at 6 months)
研究者
Sumit Dave
Principal Investigator
Lawson Health Research Institute