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