Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02825485

Enrollment

Registered

2016-07-07

Start date

2016-07-27

Completion date

2019-05-24

Last updated

2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antenatal Hydronephrosis, Post-natal Hydronephrosis

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.

Interventions

PROCEDUREVoiding cystourethrogram

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

0 Months to 5 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Development of UTIs	Through study completion, an average of 4 years

Secondary

Measure	Time frame
Rate of resolution of hydronephrosis	Through study completion, an average of 4 years
The rate of reflux detected on VCUGs	Through study completion, an average of 4 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026