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


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.
Brandström
Per
P
Pediatric Uro-Nephrologic Center, Queen Silvia Children's Hospital, University of Gothenburg, Göteborg, Sweden.
Esbjörner
Elisabeth
E
Herthelius
Maria
M
Holmdahl
Gundela
G
Läckgren
Göran
G
Nevéus
Tryggve
T
Sillén
Ulla
U
Sixt
Rune
R
Sjöberg
Ingrid
I
Stokland
Eira
E
Jodal
Ulf
U
Hansson
Sverker
S
D019072:Antibiotic Prophylaxis; D004724:Endoscopy; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011159:Population Surveillance; D011446:Prospective Studies; D012107:Research Design; D013548:Sweden; D019783:Technetium Tc 99m Dimercaptosuccinic Acid; D014463:Ultrasonography / Q000379:methods; D014552:Urinary Tract Infections / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D014567:Urography; D014718:Vesico-Ureteral Reflux / Q000175:diagnosis* / Q000209:etiology / Q000628:therapy*
D019783:Technetium Tc 99m Dimercaptosuccinic Acid