Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2021
CompletedStudy Start
First participant enrolled
May 15, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2031
November 18, 2023
April 1, 2023
8 years
October 3, 2021
November 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux
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
1 day
Secondary Outcomes (1)
Incidence and severity of adverse effects associated with CEVUS
1 year
Study Arms (1)
VUR diagnostics
OTHERInterventions
We have no specific intervention. We investigate different diagnostic modalities of VUR.
Eligibility Criteria
You may qualify if:
- under 6 years old patients who have had at least 2 culture positive urinary tract infections
You may not qualify if:
- abnormal bladder function
- posterior uretral valves
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Turku University hospital
Turku, 20521, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- The radiologist and the isotope specialist are not aware of the results of previous VUR investigations.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 3, 2021
First Posted
November 18, 2023
Study Start
May 15, 2022
Primary Completion (Estimated)
May 15, 2030
Study Completion (Estimated)
May 1, 2031
Last Updated
November 18, 2023
Record last verified: 2023-04