Comparison of the Effectiveness of PIC Cystogram and VCUG in the Diagnosis of Vesicoureteral Reflux in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Detection of vesicoureteral reflux (VUR) by PIC cystography compared with VCUG
研究概览
简要总结
The goal of this interventional diagnostic clinical trial is to evaluate and compare the diagnostic effectiveness of PIC cystography and voiding cystourethrography (VCUG) for the detection of vesicoureteral reflux (VUR) in children undergoing endoscopic procedures, including those who previously underwent VCUG for urinary tract infection (UTI) or other indications, as well as children who did not require VCUG.
The main questions it aims to answer are:
Does PIC cystography detect VUR at a rate comparable to VCUG?
How well do PIC cystography and VCUG correlate in identifying low-grade versus high-grade VUR?
Researchers will compare PIC cystography findings with prior VCUG results to determine agreement between the two diagnostic methods and their ability to detect clinically relevant reflux.
Participants will:
Undergo PIC cystography performed during endoscopic surgery
Have contrast instilled near each ureteral orifice under fluoroscopic monitoring
Be evaluated for the presence and grade of vesicoureteral reflux
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
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
Single-blind (physician blinded to VCUG results)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 0-18 years
- •Undergoing endoscopic urological surgery
- •With or without a prior VCUG performed for urinary tract infection or other clinical indications
- •Availability of VCUG results for participants who previously underwent VCUG
- •Written informed consent obtained from parents or legal guardians
排除标准
- •History of previous ureteral reimplantation or anti-reflux surgery
- •Known neurogenic bladder or severe lower urinary tract dysfunction
- •Active urinary tract infection at the time of endoscopic procedure
- •Inability to undergo fluoroscopic imaging (e.g., contrast allergy)
- •Incomplete clinical or imaging data
研究组 & 干预措施
PIC cystography
干预措施: PIC cystography (Diagnostic Test)
PIC cystography
干预措施: VCUG (Diagnostic Test)
VCUG Group
干预措施: VCUG (Diagnostic Test)
结局指标
主要结局
Detection of vesicoureteral reflux (VUR) by PIC cystography compared with VCUG
时间窗: During endoscopic surgery (single intraoperative assessment)
Detection of vesicoureteral reflux (VUR) by PIC cystography compared with VCUG, assessed as the presence or absence of reflux and categorized as low-grade (Grade 1-3) or high-grade (Grade 4-5) on a renal unit basis.
次要结局
未报告次要终点
研究者
Tarik Emre Sener
Associated Professor
Marmara University