Clinical Trial: Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis
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 Summary: 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.
Sponsor: University of Virginia
Current Primary Outcome: Development of UTIs [ Time Frame: Through study completion, an average of 4 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The rate of reflux detected on VCUGs [ Time Frame: Through study completion, an average of 4 years ]
- Rate of resolution of hydronephrosis [ Time Frame: Through study completion, an average of 4 years ]
Original Secondary Outcome: Same as current
Information By: University of Virginia
Dates:
Date Received: June 23, 2016
Date Started: August 2016
Date Completion: June 2021
Last Updated: July 1, 2016
Last Verified: July 2016
