Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

Not Applicable

Terminated

• Conditions: Antenatal Hydronephrosis; Post-natal Hydronephrosis
• Interventions: Procedure: Voiding cystourethrogram

• Registration Number: NCT02825485
• Lead Sponsor: University of Virginia

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Study Start: 2016-07-27
• Primary Completion: 2019-05-24
• Study Completion: 2019-05-24
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patients with a history of antenatal hydronephrosis who have a post-natal ultrasound demonstrating hydronephrosis alone and no other abnormalities

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Voiding cystourethrogram	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.

Primary Outcome Measures

Name	Time	Method
Development of UTIs	Through study completion, an average of 4 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Virginia Health System, Pediatric Urology, Battle Bldg; 🇺🇸 Charlottesville, Virginia, United States