Diagnostic Performance of PIC Cystogram vs VCUG in Children

NCT07334821 · tracked via the Priya Life Science Turkey tracker

Sponsor

Tarik Emre Sener

Phase

Not applicable

Started

2026-02-01

Last updated

2026-01-12

Condition(s) studied

Pediatric Urology

Investigational drug(s) / intervention(s)

PIC cystographyVCUG

PIC cystography: 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

VCUG: VCUG performed

Study summary

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

Eligibility

Sex

ALL

Min age

—

Max age

18 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Marmara University School of Medicine Urology Department	Istanbul	Pendik

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07334821 on ClinicalTrials.gov ↗ ← All trials in Turkey