Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Bladder capacity and pressures: measures from cystometry
研究概览
简要总结
The purpose of this study is to examine how injection of botulinum toxin in the bladder affects bladder function. The trial is carried out in children born with malformation of the spinal cord and subsequent overactive bladders. The purpose of treating the bladder (with different drugs) is to prevent damage to the kidneys and renal function. The aim of this study is to compare a conventionally used drug (oxybutynin) with botulinum toxin. The hypothesis of the study is that botulinum toxin is equal to oxybutynin in the treatment of overactive bladder.
详细描述
Neurogenic bladder is often seen in children with myelomeningocele, tumors in the spinal canal, or a traumatized spinal cord. The majority of the patients have high pressure bladders which can lead to reflux and frequent infections in the urinary tract. Although children experience insufficient bladder emptying, many of them also experience urinary incontinence and have to perform clean intermittent catheterization (CIC). If no intervention is made, the children are at high risk of renal deterioration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myelomeningocele
- •Neurogenic bladder with untreated leak point pressures > 40 mmH2O
- •Treated with oxybutynin or other parasympatholytics
排除标准
- •Acute urinary tract infection
- •Compromised neuromuscular transmission
结局指标
主要结局
Bladder capacity and pressures: measures from cystometry
时间窗: at 4 weeks and 6 months
次要结局
- Urinary continence: score from an incontinence rating scale(2 days before and 4 weeks and 6 months after)
- Constipation: score on the Bristol scale(4 weeks)