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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VUR diagnostics | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography | Diagnostic Test | We have no specific intervention. We investigate different diagnostic modalities of VUR. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse effects associated with CEVUS | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna-Reeta Viljamaa | Contact | +35823130000 | hanna-reeta.viljamaa@tyks.fi | |
| Niklas Pakkasjärvi | Contact | +35823130000 | niklas.pakkasjarvi@fimnet.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University hospital | Recruiting | Turku | 20521 | Finland |
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The radiologist and the isotope specialist are not aware of the results of previous VUR investigations.
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| ID | Term |
|---|---|
| D014718 | Vesico-Ureteral Reflux |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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