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

Not Applicable

Recruiting

• Conditions: VUR - Vesicoureteric Reflux
• Interventions: Diagnostic Test: Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography

• Registration Number: NCT06138080
• Lead Sponsor: Turku University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-03
• Study Start: 2022-05-15
• Status Verified: 2023-04
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2030-05-15
• Study Completion: 2031-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• abnormal bladder function
• posterior uretral valves

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VUR diagnostics	Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography	-

Primary Outcome Measures

Name	Time	Method
Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux	1 day	The primary outcome measure of this study is the diagnostic accoracy of CEVUS in detecting vesicoureteral reflux compared to direct isotope cystography, expressed as the sensitivity and specificity of each method

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse effects associated with CEVUS	1 year	The secondary outcome measure of this study is the incidence and severity of adverse effects associated with CEVUS as compared to direct isotope cystography.

Trial Locations

Locations (1)

Turku University hospital; 🇫🇮 Turku, Finland