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Randomized Controlled Trial
. 2013 Jul;132(1):e34-45.
doi: 10.1542/peds.2012-2301. Epub 2013 Jun 10.

The RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux

Myra A Carpenter  1 , Alejandro Hoberman, Tej K Mattoo, Ranjiv Mathews, Ron Keren, Russell W Chesney, Marva Moxey-Mims, Saul P Greenfield; RIVUR Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

The RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux

Myra A Carpenter et al. Pediatrics. 2013 Jul.

Abstract

Background and objective: Vesicoureteral reflux (VUR) is diagnosed in ∼30% to 40% of children who have imaging studies after urinary tract infections (UTIs). Our goal is to characterize children enrolled in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial and to compare our study cohort with those from previously published studies.

Methods: RIVUR investigators from 19 pediatric sites in the United States recruited 607 children with grade I through IV VUR. Children were enrolled after a first or second UTI. This cross-sectional report of baseline data includes extensive clinical, parental report, and imaging study results.

Results: RIVUR recruited 607 children (558 girls, 49 boys) with grade I (11%), II (42%), III (38%), or IV (8%) reflux. The median age was 12 months, and most children (91%) were enrolled after their first UTI. The UTI leading to enrollment was both febrile and symptomatic for 323 children, febrile only in 197 children, and symptomatic only in 86. Renal involvement at baseline as documented by a (99m)Tc dimercaptosuccinic acid scan was uncommon with cortical defects identified in 89 (15%) children. Bladder and bowel dysfunction was identified in 71 (56%) of 126 toilet-trained subjects assessed.

Conclusions: RIVUR is the largest prospective, randomized trial for children with primary VUR to date, comparing prophylaxis with placebo. The study sample comprises patients from 19 pediatric clinical sites in the United States, whose demographic and clinical characteristics may differ from those of children enrolled in previous trials from other countries.

Trial registration: ClinicalTrials.gov NCT00405704.

Keywords: clinical research/trials; renal scarring; urinary tract infections; vesicoureteral reflux (VUR).

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References

    1. Hoberman A, Charron M, Hickey RW, Baskin M, Kearney DH, Wald ER. Imaging studies after a first febrile urinary tract infection in young children. N Engl J Med. 2003;348(3):195–202 - PubMed
    1. Chesney RW, Carpenter MA, Moxey-Mims M, et al. members of the RIVUR Steering Committee . Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR): background commentary of RIVUR investigators. Pediatrics. 2008;122(suppl 5):S233–S239 - PMC - PubMed
    1. Keren R. Pediatrics. RIVUR trial. Introduction. Pediatrics. 2008;122(suppl 5):S231–S232 - PubMed
    1. Keren R, Carpenter MA, Hoberman A, et al. . Rationale and design issues of the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study. Pediatrics. 2008;122(suppl 5):S240–S250 - PMC - PubMed
    1. Hoberman A, Keren R. Antimicrobial prophylaxis for urinary tract infection in children. N Engl J Med. 2009;361(18):1804–1806 - PubMed

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