The Swedish reflux trial in children: I. Study design and study population characteristics.

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.

• 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
• Journal: The Journal of urology (J Urol) Vol. 184 Issue 1 Pg. 274-9 (Jul 2010) ISSN: 1527-3792 [Electronic] United States
• PMID: 20478580 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright (c) 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Technetium Tc 99m Dimercaptosuccinic Acid

Topics

• Antibiotic Prophylaxis
• Endoscopy
• Female
• Humans
• Infant
• Male
• Population Surveillance
• Prospective Studies
• Research Design
• Sweden
• Technetium Tc 99m Dimercaptosuccinic Acid
• Ultrasonography (methods)
• Urinary Tract Infections (complications, diagnosis, drug therapy)
• Urography
• Vesico-Ureteral Reflux (diagnosis, etiology, therapy)