VUR - Vesicoureteric RefluxNCT06138080
Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
A study testing Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography in people with VUR - Vesicoureteric Reflux, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 6 years
- Conditions the study is for
- VUR - Vesicoureteric Reflux
- What is being tested?
- Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 15 May 2022to 1 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- under 6 years old patients who have had at least 2 culture positive urinary tract infections
Who cannot join
- abnormal bladder function
- posterior uretral valves
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Turku University hospital
Turku, 20521
Hanna-Reeta Viljamaa, hanna-reeta.viljamaa@tyks.fi
About this study
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.
- Conditions
- VUR - Vesicoureteric Reflux
- Being tested
- Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography
- Medical subject headings
- Vesico-Ureteral Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystographyDiagnostic test
We have no specific intervention. We investigate different diagnostic modalities of VUR.
| Study group | Role | What they receive |
|---|---|---|
| VUR diagnostics | Other | Not described Receives: Diagnostic Test: Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 May 2022
- Primary completion15 May 2030 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VUR - Vesicoureteric RefluxStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hanna-Reeta Viljamaa, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138080
- Sponsor's protocol ID
- 1111
- Status last verified
- Apr 2023
- First submitted
- 3 Oct 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
- ClinicalTrials.gov ID
- NCT06138080
- Acronym / sponsor ID
- 1111
- Conditions
- VUR - Vesicoureteric Reflux
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 May 2030 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VUR diagnostics | Other | Diagnostic Test: Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography |
Who may qualify
- Ages
- 0 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- under 6 years old patients who have had at least 2 culture positive urinary tract infections
Key exclusion criteria (2 listed)
- abnormal bladder function
- posterior uretral valves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystographyWe have no specific intervention. We investigate different diagnostic modalities of VUR. | Diagnostic test | VUR diagnostics |
Primary outcome
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 secondary outcome
Incidence and severity of adverse effects associated with CEVUS
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced voiding ultrasonography (CEVUS), Direct isotope cystography in people with VUR - Vesicoureteric Reflux, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna-Reeta Viljamaa (+35823130000, hanna-reeta.viljamaa@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.