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

NCT ID: NCT06138080

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2031-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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VUR - Vesicoureteric Reflux

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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

Study Groups

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VUR diagnostics

Group Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hanna-Reeta Viljamaa

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Turku University hospital

Turku, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Hanna-Reeta Viljamaa

Role: CONTACT

+35823130000

Niklas PakkasjÀrvi

Role: CONTACT

+35823130000

Facility Contacts

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Hanna-Reeta Viljamaa

Role: primary

Other Identifiers

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1111

Identifier Type: -

Identifier Source: org_study_id

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