children ages 1-12 with bilateral grade III-V VUR were randomized
to medical vs. surgical management.1
were followed with imaging (IVP, VCUG, and DMSA) and renal functional
assessment (GFR) at baseline and at 4 years, with GFR measurements
at 10 years follow-up as well.
outcomes reported were mean percentage change in GFR at 4 years.
Secondary outcomes included somatic growth, blood pressure, recurrent
UTI, renal growth, and renal scarring.
GFR at enrollment was 72.4 mL/min and 71.7 mL/min for the medical
and surgical groups respectively. All patients enrolled
had some evidence of renal scarring at enrollment; approximately
70% had more than mild scarring.
percentage change in GFR was -2.4% in the medical group and 4.7%
in the surgical group with a difference of 7.1% [95% CI (-6.4
risk for recurrent UTI was 1.69 [95% CI 0.74-3.86.]. RR for development
of ESRD was 0.88 [95% CI 0.14-5.73]. Both results were not significant.
authors state that in order for a 7% difference to be statistically
significant, 90 children in each group would have needed to be enrolled
to achieve a 90% power. Thus, this study was underpowered.
study selected only patients with severe bilateral reflux, and
in this group of patients, surgery was not shown to be more effective
than medical management.