An interventional study of Voiding cystourethrogram in Antenatal Hydronephrosis and Post-natal Hydronephrosis, sponsored by University of Virginia. Terminated at 1 site in United States. Open to participants aged 0 Months to 5 Years. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by University of Virginia · Not applicable, Interventional, and Diagnostic
Among 12 studies in Hydronephrosis with a site in United States — none open to participants now, 1 under way, none of them phase 3. Hydronephrosis · United States.
Among the 12 studies in Hydronephrosis with a site in United States, this one is one of 2 that started in 2016, is one of 5 with no phase, and was the 8th registered.
55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.
This study's enrollment of 24 is below the median of 100 across 23 interventional studies indexed under Hydronephrosis.
Browse Hydronephrosis studies →None of the 12 studies in Hydronephrosis with a site in United States is open now.
Of the 5 Hydronephrosis studies recruiting now, 3 (60%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 0 Months to 5 Years · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2016.
Median enrollment 24 across the 7 interventional studies, 97 across the 5 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
None of the 12 has an industry lead sponsor. The 10 most frequent:
University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
University of Virginia has 1 study filed under Hydronephrosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Hydronephrosis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Receives no intervention
Development of UTIs
Time frame: Through study completion, an average of 4 years
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
Ran from Jul 2016 to primary completion in May 2019, 33 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.