Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

University of Virginia

Status: Terminated

Conditions: Post-natal Hydronephrosis; Antenatal Hydronephrosis

Treatments: Procedure: Voiding cystourethrogram

Study type: Interventional

Funder types: Other

Identifiers

NCT02825485

19030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: Under 5 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Control Group

Other group

Description:

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.

Treatment:

Procedure: Voiding cystourethrogram

Observation Group

No Intervention group

Description:

Receives no intervention