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The Swedish Reflux Trial in Children: I. Study Design and Study Population Characteristics.

Journal article
Authors Per Brandström
Elisabeth Esbjörner
Maria Herthelius
Gundela Holmdahl
Göran Läckgren
Tryggve Nevéus
Ulla Sillén
Rune Sixt
Ingrid Sjöberg
Eira Stokland
Ulf Jodal
Sverker Hansson
Published in The Journal of urology
Volume 184
Issue 1
Pages 274-279
ISSN 1527-3792
Publication year 2010
Published at Institute of Clinical Sciences, Department of Pediatrics
Pages 274-279
Language en
Links dx.doi.org/10.1016/j.juro.2010.01.0...
Subject categories Pediatrics, Pediatric surgery, Urology and andrology

Abstract

PURPOSE: We compared the rates of febrile urinary tract infection, kidney damage and reflux resolution in children with vesicoureteral reflux treated in 3 ways, including antibiotic prophylaxis, endoscopic therapy and surveillance with antibiotics only for symptomatic urinary tract infection. MATERIALS AND METHODS: Children 1 to younger than 2 years with grade III-IV reflux were recruited into this prospective, open, randomized, controlled, multicenter study and followed for 2 years after randomization. The main study end points were recurrent febrile urinary tract infection, renal status on dimercapto-succinic acid scintigraphy and reflux status. Outcomes were analyzed by the intent to treat principle. RESULTS: During a 6-year period 128 girls and 75 boys entered the study. In 96% of cases reflux was detected after urinary tract infection. The randomization procedure was successful and resulted in 3 groups matched for relevant factors. Recruitment was slower than anticipated but after patients were entered adherence to the protocol was good. Of the children 93% were followed for the intended 2 years without a treatment arm change. All except 2 patients completed 2-year followup scintigraphy. CONCLUSIONS: Recruitment was difficult but a substantial number of children were entered and randomly assigned to 3 groups with similar basic characteristics. Good adherence to the protocol made it possible to address the central study questions.

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