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NCT Number: NCT06138080

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

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.

Recruiting

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Key information

Age range

0 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku University hospital

Turku, 20521, Finland

Location status: Recruiting

Location contact

Hanna-Reeta Viljamaa

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. 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

  1. Incidence and severity of adverse effects associated with CEVUS

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna-Reeta Viljamaa

CONTACT

[email protected]

+35823130000

Niklas Pakkasjärvi

CONTACT

[email protected]

+35823130000

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2030
Study completion
2031
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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