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 vesicoureteral reflux.

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. The RIVUR Study is designed to determine whether daily preventative treatment with an 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 VUR.

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.

Web cast: Urinary Tract Infection and Vesicoureteral Reflux: Are We Doing Enough or Too Much?
Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Web site
RIVUR Frequently Asked Questions
List of Institutions Participating in the National Study
RIVUR study on ClinicalTrials.gov

Eligibility

• At least 2 months of age, but less than 6 years old
• Diagnosed with first urinary tract infection (UTI) with either fever or associated symptoms within 10 weeks
• Treated for the first UTI for at least 7 days with an effective antibiotic
• Diagnosed with Vesicoureteral Reflux (VUR) grade I-IV, but not have grade V VUR
• No history of other renal injury or serious disease
• No history of medical conditions that could interfere with response to study medication
• No allergies to sulfa medications, including Trimethoprim-Sulfamethoxazole, nor can there be a family history of serious anaphylactic reaction to sulfa medications
• 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.

Additional Resources

Urinary Tract Infections in Children (PDF)
Vesicoureteral Reflux (UrologyHealth.org)
Vesicoureteral Reflux (National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC))
The Management of Primary Vesicoureteral Reflux in Children (PDF)

Assisted UTI Imaging Clinical Service

To facilitate scheduling of recommended tests (VCUG, ultrasound) for children with their first UTI, 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 with the radiology department, and provide families with directions to the imaging center at Children's Hospital in Oakland. Results will be sent directly to the child’s primary care provider.

Previous Related Publications

Does Early Treatment of Urinary Tract Infection Prevent Renal Damage? (PDF)
Does This Child Have a Urinary Tract Infection? (PDF)
Imaging Studies after a First Febrile Urinary Tract Infection in Young Children (New England Journal of Medicine) (PDF)
Normal Dimercaptosuccinic Acid Scintigraphy Makes Voiding Cystourethrography Unnecessary after Urinary Tract Infection (PDF)
Oral Versus Initial Intravenous Therapy for Urinary Tract Infections in
Young Febrile Children (PDF)
Recurrent Urinary Tract Infections in Children: Risk Factors and Association With Propylactic Antimicrobials (PDF)
Conventional Management of VUR in Children Questioned (PDF)

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