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

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.

Key Words: kidney, vesico-ureteral reflux, urinary tract infection, disease recurrence, disease progression

Abbreviations and Acronyms: DMSA, ^99mtechnetium-dimercapto-succinic acid, RCT, randomized, controlled trial, UTI, urinary tract infection, VCU, voiding cystourethrography, VUR, vesicoureteral reflux