Study of Diagnostic Tests for Vesicoureteric Reflux in Children Under 6 Years Old Comparing Contrast-Enhanced Voiding Ultrasonography and Direct Isotope Cystography

What this Trial Is About

This research aims to evaluate the use of contrast-enhanced voiding ultrasonography CEVUS compared to direct isotope cystography for diagnosing vesicoureteral reflux VUR in children under 6 years old. The goal is to find an accurate diagnostic method that classifies the severity of VUR while minimizing harm from the testing procedures. The study recruits pediatric patients who have experienced at least two culture-positive urinary tract infections and excludes those with abnormal bladder function or posterior urethral valves. Participants undergo both direct isotope cystography and CEVUS on the same day, using standardized bladder filling volume and speed. These diagnostic tests are performed by a radiologist and an isotope specialist independently, each blinded to the others results. The study focuses on comparing the diagnostic accuracy of these two imaging techniques for identifying and grading VUR. During the study, researchers monitor the accuracy of CEVUS in detecting VUR within one day and observe any adverse effects related to CEVUS over a one-year period. Participants will receive both diagnostic procedures and their results will be compared. The study is conducted by Turku University Hospital and involves 100 children under six years old. Total involvement includes the diagnostic testing day and follow-up monitoring for safety outcomes.

Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography