Data from the largest trial of its kind to date are shedding new light on the baseline clinical characteristics of children with vesicoureteral reflux (VUR).
Myra A. Carpenter, PhD, from the Department of Biostatistics, University of North Carolina, Chapel Hill, and colleagues, reported their results in an article published online June 10 in Pediatrics.
"The ideal management of children with [VUR] remains a source of debate," the researchers write. They add that in their view there is scant evidence to support many of the strategies used to manage VUR in children who have experienced 1 or 2 urinary tract infections (UTIs).
VUR is diagnosed in about a third of children who undergo imaging studies after having UTIs. It is associated with increased risk for renal scarring. However, the researchers note, scars are also seen in children who do not have VUR, and many children with higher-grade VUR never develop scarring.
Previous studies of VUR in children are limited by the lack of a placebo or observation group, according to the authors. To address that gap in knowledge, the researchers designed a new trial, the Randomized Intervention for Children with Vesicoureteral Reflux (RVUR) trial, to provide solid evidence about the use of antimicrobials to prevent recurrent UTIs in children with VUR.
The researchers recruited 607 children from 19 pediatric sites in the United States. All had experienced at least a single episode of UTI and had been diagnosed with grade 1 to 4 VUR.
The present article provides cross-sectional baseline data from the study population, including detailed clinical reports and imaging studies, as well as information provided by parents.
Among the findings so far, the authors report that most of the children enrolled are girls (558 girls, 49 boys). Ages range from 2 to 71 months, with a median age of 12 months.
About 11% of VURs were classified as grade 1, 42% as grade 2, 38% as grade 3, and 8% as grade 4.
More than 90% of the children were enrolled in the study after their first UTI.
In more than half the children (323 patients), the UTI that preceded enrollment was associated with fever and other symptoms, such as suprapubic, abdominal, or flank pain or tenderness; urinary urgency, frequency, or hesitancy; dysuria; and malodorous urine. In infants younger than 4 months, symptomology of UTI included failure to thrive, dehydration, or hypothermia.
Nearly a third of the cohort of children (197) presented with fever alone, and 86 had only other symptoms.
"Renal involvement at baseline...was uncommon with cortical defects identified in 89 (15%) children," the authors write. They identified bladder and bowel dysfunction in 71 (56%) of 126 children who were toilet-trained.
More data are expected. The researchers are following up the children for 2 years to assess recurrent febrile or symptomatic UTI, renal scarring, prophylaxis failure, antimicrobial resistance, medication adherence, and quality-of-life measures.
Supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases, the Children's Hospital of Philadelphia Clinical, and the National Center for Research Resources/National Center for Advancing Translational Sciences. The authors have disclosed no relevant financial relationships.
Pediatrics. Published online June 10, 2013. Abstract
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Cite this: Trial Sheds New Light on Vesicoureteral Reflux in Children - Medscape - Jun 11, 2013.