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

November 13, 2023 updated by: Hanna-Reeta Viljamaa, Turku University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: VUR diagnostics
Diagnostic test: Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography
We have no specific intervention. We investigate different diagnostic modalities of VUR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2022

Primary Completion (Estimated)

May 15, 2030

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

October 3, 2021

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Estimated)

November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1111 (Prima Psychiatry internal research fund)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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