[2823.9] Results from the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Trial
Alejandro Hoberman, Saul P. Greenfield, Tej K. Mattoo, Ron Keren, Ranjiv Mathews, Hans G. Pohl, Bradley P. Kropp, Caleb P. Nelson, Marva Moxey-Mims, Russell W. Chesney, Myra A. Carpenter. Pediatrics, University of Pittsburgh, Pittsburgh, PA; Pediatric Urology, Women and Children's Hospital of Buffalo, Buffalo, NY; Pediatric Nephrology and Hypertension, Wayne State University School of Medicine, Detroit, MI; General Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA; Pediatric Urology, Johns Hopkins School of Medicine, Baltimore, MD; Urology, Children's National Medical Center, Washington, DC; Pediatric Urology, University of Oklahoma, Oklahoma City, OK; Urology, Children's Hospital of Boston, Boston, MA; Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; Pediatrics, Le Bonheur Children's Hospital, Memphis, TN; Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.
BACKGROUND: Vesicoureteral reflux (VUR) is diagnosed in approximately 30-40% of children who undergo voiding cystourethrograms following urinary tract infection (UTI). The associations between VUR, febrile UTI and renal scarring are complex with evidence that severity of VUR directly correlates with renal scarring, but scars also occur in children without VUR.
OBJECTIVE: The RIVUR trial was designed to determine if 2-year antimicrobial prophylaxis with trimethoprim-sulfamethoxazole 1) prevents febrile and/or symptomatic UTI (F/SUTI), 2) decreases the likelihood of long-term renal scarring, and 3) contributes to the emergence of bacterial resistance.
DESIGN/METHODS: Children (aged 2-71 months) with grades I-IV VUR were recruited from 19 pediatric sites in the U.S. following a first or second F/SUTI. We sought baseline sonography and VCUG within 16 weeks after the index UTI and DMSA renal scans within 2 weeks of randomization and no more than 16 weeks after the index UTI. VCUG (2-year) and DMSA (1 & 2-year) scans were also collected in follow-up. F/SUTI and renal scarring were determined by masked experts using standardized methods and definitions.
RESULTS: RIVUR recruited 607 children (558 girls, 49 boys) with grade I (11%), II (42%), III (38%) or IV (8%) VUR. The median age was 12 months. The index UTI was the first UTI in 554 children; and was both febrile and symptomatic for 325 children, febrile only in 196 children and symptomatic only in 86. Baseline DMSA scans rarely showed cortical defects (89/607, 15%). Bladder and bowel dysfunction was identified in 56% (71/126) of toilet-trained children assessed. Outcome results will be presented at the meeting.
CONCLUSIONS: RIVUR is the largest prospective, randomized trial for children with primary VUR to date, comparing prophylaxis with placebo. Strengths of the study include the multisite randomized double-blind design, large sample size, and rigorous classification of outcomes. As noted in the 2011 American Academy of Pediatrics Clinical Practice Guidelines for Urinary Tract Infection, the RIVUR trial will provide important data on the effects of antimicrobial prophylaxis on UTI and renal scarring in children with VUR.
Session: Platform Session: Late Breakers (3:30 PM - 5:45 PM)
Date/Time: Sunday, May 4, 2014 - 5:30 PM
Room: West 201 - Vancouver Convention Centre
Course Code: 2823