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Not Yet RecruitingNCT07334821

Diagnostic Performance of PIC Cystogram vs VCUG in Children

Comparison of the Effectiveness of PIC Cystogram and VCUG in the Diagnosis of Vesicoureteral Reflux in Children

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Tarik Emre Sener · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPIC cystographyPIC 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_TESTVCUGVCUG performed

Timeline

Start date
2026-02-01
Primary completion
2026-03-01
Completion
2026-04-01
First posted
2026-01-12
Last updated
2026-01-12

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07334821. Inclusion in this directory is not an endorsement.