Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux
研究概览
简要总结
The purpose of this study is to examine the applicability of contrast enhanced voiding ultrasonography in diagnosing vesicoureteral reflux (VUR) in pediatric patients compared to direct isotope cystography. The aim of the study is to find a modality allowing the accurate diagnosis of VUR and the classification of the degree of VUR with the least possible harm from the examinations.
The investigators recruit 100 under 6 years old patients who have had at least 2 culture positive urinary tract infections. Exluding criteria are abnormal bladder function and posterior uretral valves. The investigators perform direct isotope cystography and contrast enhanced voiding urosonography during the same day to diagnose and grade VUR. The investigators use standardized volume and speed of bladder filling. The examinations are done by a radiologist and an isotope specialist and they are blinded to the result of the other examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The radiologist and the isotope specialist are not aware of the results of previous VUR investigations.
入排标准
- 年龄范围
- 0 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •under 6 years old patients who have had at least 2 culture positive urinary tract infections
排除标准
- •abnormal bladder function
- •posterior uretral valves
结局指标
主要结局
Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux
时间窗: 1 day
The primary outcome measure of this study is the diagnostic accoracy of CEVUS in detecting vesicoureteral reflux compared to direct isotope cystography, expressed as the sensitivity and specificity of each method
次要结局
- Incidence and severity of adverse effects associated with CEVUS(1 year)
研究者
Hanna-Reeta Viljamaa
Principal investigator
Turku University Hospital
