Randomized Intervention in Children with VesicoUreteral Reflux

Clinical Centers
Study Design
Randomized, double-masked controlled clinical trial
The purpose of this study is to learn whether all children with vesicoureteral reflux (VUR) should be treated with antibiotics. The study will tell us if prophylactic antibiotic treatment prevents urinary tract infections and renal scarring in children with VUR. More information at ClinicalTrials.gov.

Vesicoureteral reflux (VUR) is a condition in which urine goes up from the bladder into the ureters during urination. VUR is found in 30-50% of children who have had a urinary tract infection (UTI), and is thought to increase the risk of kidney damage when children have recurrent UTIs. Currently, many children who are found to have VUR after a UTI are treated with a small daily dose of antibiotics (often for several years) in hope of preventing recurrent UTIs and kidney damage. However, there have been no well-designed research studies to show that this practice is necessary in all children with vesicoureteral reflux.

The RIVUR Study is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. It will be conducted in 15 specialty clinics across the U.S. and Canada. The RIVUR Study is designed to determine whether daily preventative treatment with a common antimicrobial medication (trimethoprim/sulfamethoxazole, TMP/SMZ), in the setting of prompt evaluation and treatment of UTI, is superior to placebo in preventing recurrence UTI and/or the occurrence of, or worsening, of renal scarring in children with vesicoureteral reflux.

Children participating in the RIVUR Study will be randomly assigned to one of two treatment groups. One group will receive the active antimicrobial medication. The other group will receive a placebo, a liquid that looks and tastes exactly like the active medication, but contains no medicine. All children in the RIVUR study will continue in the study for 2 years, and be closely monitored for urinary infections and kidney health. The study team will provide participant families with educational materials about VUR and UTIs, and will stay in close contact through phone calls and study visits.

The RIVUR Study has the potential to help us understand how to provide the best care for the tens of thousands of children who are diagnosed each year with VUR and UTI.