跳至主要内容
临床试验/NCT06138080
NCT06138080招募中不适用

Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月15日最近更新:
适应症

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

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hanna-Reeta Viljamaa

Principal investigator

Turku University Hospital

研究点 (2)

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