Cessation of vesicoureteral reflux for 5 years in infants and children allocated to medical treatment. The International Reflux Study in Children.

A total of 401 children with severe vesicoureteral reflux (97 with grade III and 304 with grade IV) was entered into the European branch of the International Reflux Study in Children. Of these patients 37 with grade III and 43 with grade IV reflux were allocated to medical treatment as a sideline group because the reflux grade III or IV had improved to grade II or I, or it had disappeared during the preceding 2 to 6 months (median 4). Of the remaining 321 patients with persistent grade III or IV reflux 158 were randomly allocated to medical treatment of whom 3 switched to surgery. We report on 235 children treated medically (155 random medical and 80 sideline), of whom 88% had a complete 5-year followup with x-ray and/or isotope voiding cystourethrography at 6, 18, 30 and 54 months. Seven children dropped out of the study after a followup of 6 months or less, including 6 with persistent vesicoureteral reflux. Cessation of vesicoureteral reflux was observed significantly more often in children with unilateral (40 of 74, 54%) than with bilateral (18 of 154, 12%) reflux (p < 0.001). No significant difference between grades III and IV was noted. Vesicoureteral reflux ceased in 25 of 153 children (16%) from the random medical group and in 32 of 75 children (43%) in the sideline group. Of 194 children with vesicoureteral reflux detected for the first time at entry reflux resolved in 55 (28%). In only 2 of 34 children (6%) in whom vesicoureteral reflux was detected more than 1 year before entry did reflux resolve after 5 years. Among the children in whom vesicoureteral reflux either disappeared, diminished or remained unchanged the proportion with urinary tract infection recurrences was almost the same.

RCT Entities:   Population Interventions Outcomes