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Clinical Trials/NCT06138080
NCT06138080
Recruiting
Not Applicable

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

Turku University Hospital1 site in 1 country100 target enrollmentMay 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
VUR - Vesicoureteric Reflux
Sponsor
Turku University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2022
End Date
May 1, 2031
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hanna-Reeta Viljamaa

Principal investigator

Turku University Hospital

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

Outcomes

Primary Outcomes

Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux

Time Frame: 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 Outcomes

  • Incidence and severity of adverse effects associated with CEVUS(1 year)

Study Sites (1)

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