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Diagnostic Performance of PIC Cystogram vs VCUG in Children

NCT07334821 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-12

No results posted yet for this 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

Conditions

  • Pediatric Urology

Interventions

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

VCUG

VCUG performed

Sponsors & Collaborators

  • Tarik Emre Sener

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-03-01
Completion
2026-04-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07334821 on ClinicalTrials.gov