Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

Conditions
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Antenatal Hydronephrosis, Post-natal Hydronephrosis

Intervention / Treatment
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* Procedure: Voiding cystourethrogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a history of antenatal hydronephrosis who have a post-natal ultrasound demonstrating hydronephrosis alone and no other abnormalities Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>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. | Procedure: Voiding cystourethrogram<br> <br> |
| No Intervention: Observation Group<br>Receives no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of UTIs |  | Through study completion, an average of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of reflux detected on VCUGs |  | Through study completion, an average of 4 years | 
| Rate of resolution of hydronephrosis |  | Through study completion, an average of 4 years |