Actively Recruiting
Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
Led by Turku University Hospital · Updated on 2023-11-18
100
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
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 other's 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.
CONDITIONS
Brief Title
Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Under 6 years old
- At least 2 culture positive urinary tract infections
You will not qualify if you...
- Abnormal bladder function
- Posterior urethral valves
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo diagnostic tests including contrast-enhanced voiding ultrasonography and direct isotope cystography to detect vesicoureteral reflux.
1 visit (in-person)
Duration - 1 year
Participants are observed for any adverse effects associated with the diagnostic procedures.
Follow-up visits as needed over 1 year
Trial Site Locations
Total: 1 location
1
Turku University hospital
Turku, Finland, 20521
Actively Recruiting
Research Team
H
Hanna-Reeta Viljamaa
N
Niklas Pakkasjärvi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Frequently Asked Questions
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