Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

Antenatal Hydronephrosis Clinical Trial

Official title:

Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02825485
• Other study ID #: 19030
• Status: Terminated
• Phase: N/A
• Start date: July 27, 2016
• Est. completion date: May 24, 2019

Study information

• Verified date: September 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Antenatal Hydronephrosis
• Hydronephrosis
• Post-natal Hydronephrosis

Intervention

Procedure:
• Voiding cystourethrogram

Locations

Country	Name	City	State
United States	University of Virginia Health System, Pediatric Urology, Battle Bldg	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of UTIs		Through study completion, an average of 4 years
Secondary	The rate of reflux detected on VCUGs		Through study completion, an average of 4 years
Secondary	Rate of resolution of hydronephrosis		Through study completion, an average of 4 years