Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-27

Study Completion Date

2019-05-24

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.

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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.

Conditions

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Antenatal Hydronephrosis Post-natal Hydronephrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control Group

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.

Group Type OTHER

Voiding cystourethrogram

Intervention Type PROCEDURE

Observation Group

Receives no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Voiding cystourethrogram

Intervention Type PROCEDURE

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

Minimum Eligible Age

0 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No