Diagnostic Performance of PIC Cystogram vs VCUG in Children

N/ANot Yet RecruitingNCT07334821

Tarik Emre Sener60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Pediatric Urology

Interventions

PIC cystography is performed intraoperatively during endoscopic surgery. A pediatric cystoscope is positioned adjacent to each ureteral orifice, and contrast medium is instilled by gravity from a height of 1 meter under fluoroscopic guidance. The presence and grade of vesicoureteral reflux are recorded for each renal unit. The procedure is carried out in a standardized manner by an investigator blinded to prior VCUG findings

Eligibility

Sex: ALLMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Detection of vesicoureteral reflux (VUR) by PIC cystography compared with VCUG

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.

Time frame: During endoscopic surgery (single intraoperative assessment)