NCT01465581终止不适用
A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life
研究概览
简要总结
The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy.
The study hypothesis is that patients who under go cutting the filum terminale - the string-like lower end of the spinal cord - will have improved bladder function at 6-month follow up.
Bladder function and its effects on quality of life will be measured before surgery and at 6-month follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary daytime urinary incontinence, persistent over at least 6 months of medical treatment.
- •Abnormal urodynamic testing
- •Normal conus on magnetic resonance imaging of the spine
- •Dysfunctional Voiding Symptom Scale score greater than 6 for girls or greater than 9 for boys
排除标准
- •Bladder outlet obstruction
- •Bladder atony
- •Congenital anorectal malformation
- •Additional diagnoses independently associated with neurogenic bladder dysfunction
- •Encephalopathy precluding reasonable expectation of attainment of continence
- •Inability to comply with medical management
- •Unwillingness to comply with initial or follow up urodynamic testing
结局指标
主要结局
Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life
时间窗: 6-month follow up
次要结局
- Change from baseline in a 24-hour voiding log(6-month follow up)
- Change from baseline in the Dysfunctional Voiding Symptom Scale(6-month follow up)
- Change from baseline urodynamic testing(6-month follow up)
研究者
研究点 (1)
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