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Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

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ClinicalTrials.gov Identifier: NCT02825485
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Nora Kern, MD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Antenatal Hydronephrosis Post-natal Hydronephrosis Procedure: Voiding cystourethrogram Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis
Actual Study Start Date : July 27, 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Procedure: Voiding cystourethrogram
No Intervention: Observation Group
Receives no intervention



Primary Outcome Measures :
  1. Development of UTIs [ Time Frame: Through study completion, an average of 4 years ]

Secondary Outcome Measures :
  1. The rate of reflux detected on VCUGs [ Time Frame: Through study completion, an average of 4 years ]
  2. Rate of resolution of hydronephrosis [ Time Frame: Through study completion, an average of 4 years ]


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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825485


Contacts
Contact: Nora Kern, M.D. 434-924-0236 NGL2Z@virginia.edu

Locations
United States, Virginia
University of Virginia Health System, Pediatric Urology, Battle Bldg Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Nora Kern, MD         
Contact    434.924.0123      
Sponsors and Collaborators
University of Virginia

Responsible Party: Nora Kern, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT02825485     History of Changes
Other Study ID Numbers: 19030
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Hydronephrosis
Kidney Diseases
Urologic Diseases