Recruiting NCT06138080

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

No phase Interventional VUR - Vesicoureteric Reflux

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography.
Who it may be relevant to: Registry conditions: VUR - Vesicoureteric Reflux. Basic parameters: 0 years — 6 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Finland
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The purpose of this study is to examine the applicability of contrast enhanced voiding ultrasonography in diagnosing vesicoureteral reflux (VUR) in pediatric patients compared to direct isotope cystography. The aim of the study is to find a modality allowing the accurate diagnosis of VUR and the classification of the degree of VUR with the least possible harm from the examinations. The investigators recruit 100 under 6 years old patients who have had at least 2 culture positive urinary tract infections. Exluding criteria are abnormal bladder function and posterior uretral valves. The investigators perform direct isotope cystography and contrast enhanced voiding urosonography during the same day to diagnose and grade VUR. The investigators use standardized volume and speed of bladder filling. The examinations are done by a radiologist and an isotope specialist and they are blinded to the result of the other examination.

Interventions

Diagnostic test Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography
We have no specific intervention. We investigate different diagnostic modalities of VUR.

Primary outcome measures

Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux [Time frame: 1 day]

Secondary outcome measures (1)

Incidence and severity of adverse effects associated with CEVUS [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

under 6 years old patients who have had at least 2 culture positive urinary tract infections

Exclusion criteria

abnormal bladder function
posterior uretral valves

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Diagnostic

Study locations

Finland · 1 center

Turku University hospital — Turku

Identifiers

NCT: NCT06138080 · 1111

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗