What is the Difference in the Applicability of the Uroflowmetry Between Children with Cerebral Palsy (CP) with Lower Urinary Tract Symptoms (LUTS) and Without Lower Urinary Tract Symptoms (LUTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Amount of pathological uroflow patterns - Quantitative assessment
研究概览
简要总结
Until now, the use of invasive urodynamics with use of catheters is still the gold standard for lower urinary tract evaluation in subjects with CP. This suggests a psychological and physical impact of invasive urodynamics in subjects with CP and further demonstrates the need to avoid standard use of invasive urodynamics in children and adults with CP.
The current study will evaluate usefulness of uroflowmetry, correlation between uroflowmetry parameters and different lower urinary tract symptoms will be investigated. Secondly, results of uroflowmetry indicating possible vulnerability of the upper urinary tract will be defined.
详细描述
A cross-sectional case-control study comparing children with CP and LUTS and children with CP without LUTS will be conducted with the primary objective to investigate correlation between uroflowmetry parameters and different LUTS.
Children will be evaluated with uroflowmetry and subsequent post void residual measurement and the validated vancouver symptom score for dysfunctional elimination syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral palsy
- •Dutch or French speaking child and parent
排除标准
- •History of urological surgery
研究组 & 干预措施
Standard toilet chair (hip angle 90°)
uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair.
干预措施: uroflow measurement (Device)
Standard toilet chair (hip angle 90°)
uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair.
干预措施: Bladder ultrasound (Device)
Toilet chair with decreased hip angle
uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle.
干预措施: uroflow measurement (Device)
Toilet chair with decreased hip angle
uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle.
干预措施: Bladder ultrasound (Device)
结局指标
主要结局
Amount of pathological uroflow patterns - Quantitative assessment
时间窗: During cross-sectional testing
Interpretation using Flow index methodology Measured during uroflowmetry
Maximal flow
时间窗: During cross-sectional testing
Measured during uroflowmetry Qmax (mililitres/seconds
Amount of pathological uroflow patterns - Qualitative assessment
时间窗: During cross-sectional testing
Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry
次要结局
- Influencing factors for uroflow measurement(During cross-sectional testing)
- Post void residual urine(During cross-sectional testing)
- Voided volume(During cross-sectional testing)