The Swedish reflux trial: review of a randomized, controlled trial in children with dilating vesicoureteral reflux.

OBJECTIVES

To evaluate prophylaxis and endoscopic injection for children with dilating vesicoureteral reflux (VUR) compared to surveillance, regarding urinary tract infection (UTI) recurrence, new renal damage, VUR outcome, and impact of lower urinary tract (LUT) dysfunction on these outcomes.

PATIENTS AND METHODS

203 children (128 girls and 75 boys), aged 1 to <2 years, with VUR grade III or IV were randomized to antibiotic prophylaxis (n = 69), endoscopic injection (n = 66) or surveillance (n = 68). Voiding cystourethrography, dimercaptosuccinic acid scintigraphy and optional LUT function assessment were performed before randomization and after 2 years.

RESULTS

There were 67 febrile UTIs in 42 girls and 8 in 7 boys (p = 0.0001). In girls, recurrence rate was 19% on prophylaxis, 23% with endoscopic treatment and 57% on surveillance (p = 0.0002). In boys, there was no difference between treatment groups. New damage was seen in 13 girls: 8 on surveillance, 5 in the endoscopic group and none on prophylaxis (p = 0.0155), and in 2 boys. In 13 children with no or non-dilating VUR after 1 injection, dilating VUR reappeared at the 2-year follow up. LUT dysfunction at follow up was associated with persistence of VUR.

CONCLUSION

In girls, prophylaxis reduced the rate of UTI recurrence and new renal damage, and endoscopic injection the rate of UTI recurrence. Boys did not benefit from active treatment.