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A Reevaluation of the RIVUR trial with a Validated Risk Stratification Model

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Sources of Funding: None

Introduction

The Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial showed a 50% reduction in the risk for recurrent urinary tract infection (UTI) in children who received prophylaxis compared to placebo. This conclusion is heavily debated. We reevaluated the RIVUR data using a validated risk stratification model.

Methods

Data from all 607 children were used. We stratified the children into low, intermediate and high risk categories based on gender, circumcision status, VUR grade and bladder bowel dysfunction. Febrile or symptomatic UTI recurrence in our stratified placebo and prophylaxis groups were compared using Fisher's exact test. Kaplan-Meier curves and a log-rank test was used for time-to-event analysis.

Results

There were 389 (65%), 132 (22%) and 50 (8%) children stratified into low, intermediate and high risk categories. The rate of recurrent UTI was not significantly different in low risk children receiving either placebo or prophylaxis (Table 1). Whereas intermediate risk children receiving prophylaxis had a 20% absolute reduction in recurrence compared to placebo. Similarly, there were half as many recurrent UTIs in high risk children on prophylaxis; however this was not significant due to the small sample size. Time-to-event analysis showed no difference in recurrence between the stratified categories with placebo or prophylaxis (p=0.045).

Conclusions

The majority (65%) of the children in the RIVUR trial fell into the low risk category and do not benefit from prophylaxis, while intermediate risk children receiving prophylaxis showed a 20% absolute reduction in recurrence. These results favor an individualized approach for the optimal management of children with vesicoureteral reflux.

Funding

None

Authors
Zhan Tao (Peter) Wang
Yasaman Alam
Irene McAleer
Ahmed Ali
Josh Chamberlin
Guy Hidas
Antoine Khoury
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