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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06138080

Enrollment

100

Registered

2023-11-18

Start date

2022-05-15

Completion date

2031-05-01

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VUR - Vesicoureteric Reflux

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.

Interventions

DIAGNOSTIC_TESTContrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography

We have no specific intervention. We investigate different diagnostic modalities of VUR.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

The radiologist and the isotope specialist are not aware of the results of previous VUR investigations.

Eligibility

Sex/Gender

ALL

Age

0 Years to 6 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Finland

Contacts

Primary ContactHanna-Reeta Viljamaa

hanna-reeta.viljamaa@tyks.fi+35823130000

Backup ContactNiklas Pakkasjärvi

niklas.pakkasjarvi@fimnet.fi+35823130000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026