Antenatal HydronephrosisNCT02825485
Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis
A study testing Voiding cystourethrogram in people with Antenatal Hydronephrosis and Post-natal Hydronephrosis, run by University of Virginia at 1 site in United States.
Trial summary
It has previously been found that there is no correlation between degree of hydronephrosis and presence of reflux; however this is oftentimes the criteria physicians use to obtain a VCUG. Read more about this study
- Who is it for?
- Ages 0 months to 5 years
- Conditions the study is for
- Antenatal Hydronephrosis, Post-natal Hydronephrosis
- What is being tested?
- Voiding cystourethrogram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2016to 24 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with a history of antenatal hydronephrosis who have a post-natal ultrasound demonstrating hydronephrosis alone and no other abnormalities
Who cannot join
- Patients with a post-natal ultrasound demonstrating bilateral hydronephrosis
- Patients with a history of posterior urethral valve or when a valve is suspected
- Patients who have hydronephrosis on ultrasound as well as other findings including duplication, hydroureter, dysmorphic kidneys, or bladder abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System, Pediatric Urology, Battle Bldg
Charlottesville, Virginia, 22908
About this study
It has previously been found that there is no correlation between degree of hydronephrosis and presence of reflux; however this is oftentimes the criteria physicians use to obtain a VCUG.
Read the detailed description
Investigators conducted a previous retrospective study to evaluate other possible findings on ultrasound that may better predict reflux. Investigators found that if a postnatal ultrasound showed any of the three findings of hydroureter, duplication or dysmorphic kidney, then the odds ratio of detecting reflux was 8.07 (95%CI 3.86, 16.87). The purpose of this study is to perform a randomized prospective study to validate this retrospective study. Investigators hypothesis is that patients with hydronephrosis alone will be more likely to have negative VCUG studies; hence obtaining a VCUG for this indication may not be warranted.
- Being tested
- Voiding cystourethrogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voiding cystourethrogramProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | The control patients will be the patients with antenatal hydronephrosis who get a routine VCUG to evaluate for vesicoureteral reflux, as part of routine care. Receives: Procedure: Voiding cystourethrogram |
| Observation Group | No intervention | Receives no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of UTIs
Measured: Through study completion, an average of 4 years
Secondary outcomes (2)
The rate of reflux detected on VCUGs
Measured: Through study completion, an average of 4 years
Rate of resolution of hydronephrosis
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start27 Jul 2016
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antenatal HydronephrosisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Kern, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825485
- Sponsor's protocol ID
- 19030
- Status last verified
- Sep 2021
- First submitted
- 23 Jun 2016
- Last updated
- 30 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis
- ClinicalTrials.gov ID
- NCT02825485
- Acronym / sponsor ID
- 19030
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 7 Jul 2016 (estimated)
- 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.
It has previously been found that there is no correlation between degree of hydronephrosis and presence of reflux; however this is oftentimes the criteria physicians use to obtain a VCUG.
Detailed description
Investigators conducted a previous retrospective study to evaluate other possible findings on ultrasound that may better predict reflux. Investigators found that if a postnatal ultrasound showed any of the three findings of hydroureter, duplication or dysmorphic kidney, then the odds ratio of detecting reflux was 8.07 (95%CI 3.86, 16.87). The purpose of this study is to perform a randomized prospective study to validate this retrospective study. Investigators hypothesis is that patients with hydronephrosis alone will be more likely to have negative VCUG studies; hence obtaining a VCUG for this indication may not be warranted.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Procedure: Voiding cystourethrogramThe control patients will be the patients with antenatal hydronephrosis who get a routine VCUG to evaluate for vesicoureteral reflux, as part of routine care. |
| Observation Group | No intervention | –Receives no intervention |
Who may qualify
- Ages
- 0 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with a history of antenatal hydronephrosis who have a post-natal ultrasound demonstrating hydronephrosis alone and no other abnormalities
Key exclusion criteria (3 listed)
- Patients with a post-natal ultrasound demonstrating bilateral hydronephrosis
- Patients with a history of posterior urethral valve or when a valve is suspected
- Patients who have hydronephrosis on ultrasound as well as other findings including duplication, hydroureter, dysmorphic kidneys, or bladder abnormalities
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 |
|---|---|---|
| Voiding cystourethrogram | Procedure or surgery | Control Group |
Primary outcome
Development of UTIs
Time frame: Through study completion, an average of 4 years
2 secondary outcomes
The rate of reflux detected on VCUGs
Time frame: Through study completion, an average of 4 years
Rate of resolution of hydronephrosis
Time frame: Through study completion, an average of 4 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voiding cystourethrogram in people with Antenatal Hydronephrosis and Post-natal Hydronephrosis, run by University of Virginia at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 30 Sep 2021. 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 United States. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of UTIs (time frame: Through study completion, an average of 4 years). 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 30 Sep 2021.