Research

Vesicoureteral Reflux (VUR) NIH Clinical Trial

Purpose

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 (UTIs) and renal scarring in children with VUR.

Study Description

VUR is a condition in which urine goes up from the bladder into the ureters during urination. VUR is found in 30 percent to 40 percent of children who had a UTI, and is thought to increase the risk of kidney damage when children have recurrent UTIs. Currently, children are treated with a small daily dose of antibiotics (often for several years) in hope of preventing recurrent UTIs and kidney damage. This practice has been based on information provided by a study during the 1980s in children with severe VUR who received prophylactic antibiotics or surgery; an observation group was not included in that study. There have been no well-designed research studies to show that this practice is necessary in all children with VUR.

The RIVUR Study (Randomized Intervention for Children with Vesicoureteral Reflux) is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. It will be conducted in 15 specialty clinics across the United States and Canada.

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 two years, and be closely monitored for UTIs 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.

Eligibility Criteria

At least 2 months of age, but less than 6 years old
First or second UTI with fever or symptoms within 16 weeks
Treated for the first UTI for at least 7 days with an effective antibiotic
VUR grade I-IV
No history of other renal injury or serious disease
No allergies to sulfa medications, including trimethoprim-sulfamethoxazole
Meet a few additional eligibility requirements

Enroll

For more information or to enroll, contact Alejandro Hoberman, MD, Chief, Division of General Academic Pediatrics, at 412-999-3277.

Toolkit for Physicians

How to refer your next patient with UTI/VUR:

Call Dr. Hoberman at 412-999-3277 (EARS)
Refer parents to RIVUR study materials.
Provide parents with RIVUR Study Introduction (PDF).
Provide parents with Assisted Imaging Service information.

Demonstration Video about VUR

RIVUR study materials for parents

RIVUR Consent Form (PDF)
RIVUR Parent Brochure (PDF)
Parent Video- Questions about the Study
Parent Video- Questions about VUR
Ultrasound Procedure (PDF)
Voiding Cystourethrogram (VCUG) Procedure (PDF)
DMSA Procedure (PDF)
Directions to Oakland Medical Building (PDF)

Assisted UTI Imaging Clinical Service

To facilitate scheduling of recommended tests (VCUG, DMSA, ultrasound) Pittsburgh area primary care providers have the opportunity to take advantage of a new service at Children's Hospital. Area practitioners can contact the Assisted Imaging Service at 412-692-5271, or call Dr. Hoberman at 412-999-3277. A staff member of the Children’s Hospital of Pittsburgh of UPMC RIVUR team will schedule the tests and provide directions to the imaging center at Children's Hospital in Oakland. Results will be sent directly to the child’s primary care provider.