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Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

Primary Purpose

Antenatal Hydronephrosis, Post-natal Hydronephrosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Voiding cystourethrogram
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Antenatal Hydronephrosis

Eligibility Criteria

0 Months - 5 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University of Virginia Health System, Pediatric Urology, Battle Bldg

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Control Group

Observation Group

Arm 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.

Receives no intervention

Outcomes

Primary Outcome Measures

Development of UTIs

Secondary Outcome Measures

The rate of reflux detected on VCUGs
Rate of resolution of hydronephrosis

Full Information

First Posted
June 23, 2016
Last Updated
September 29, 2021
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02825485
Brief Title
Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis
Official Title
Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Study Start Date
July 27, 2016 (Actual)
Primary Completion Date
May 24, 2019 (Actual)
Study Completion Date
May 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antenatal Hydronephrosis, Post-natal Hydronephrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm 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.
Arm Title
Observation Group
Arm Type
No Intervention
Arm Description
Receives no intervention
Intervention Type
Procedure
Intervention Name(s)
Voiding cystourethrogram
Primary Outcome Measure Information:
Title
Development of UTIs
Time Frame
Through study completion, an average of 4 years
Secondary Outcome Measure Information:
Title
The rate of reflux detected on VCUGs
Time Frame
Through study completion, an average of 4 years
Title
Rate of resolution of hydronephrosis
Time Frame
Through study completion, an average of 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Virginia Health System, Pediatric Urology, Battle Bldg
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

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