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The RIVUR trial: a factual interpretation of our data
Tej K Mattoo1, Myra A Carpenter, Marva Moxey-Mims
1Division of Pediatric Nephrology and Hypertension, Children's Hospital of Michigan, Wayne State University School of Medicine, 3901 Beaubien Blvd, Detroit, MI, 48201, USA, tmattoo@med.wayne.edu.
Insights
Antimicrobial prophylaxis significantly reduced urinary tract infection (UTI) recurrences in children with vesicoureteral reflux (VUR). The RIVUR trial suggests a shift towards selective prophylaxis rather than no prophylaxis for these patients.
Area of Science:
- Pediatric Nephrology
- Infectious Diseases
- Clinical Trials
Background:
- Vesicoureteral reflux (VUR) is a significant risk factor for recurrent urinary tract infections (UTIs) and potential renal scarring in children.
- The RIVUR trial, a large randomized, placebo-controlled study, investigated antimicrobial prophylaxis in 607 children (aged 2-72 months) with VUR.
- Key patient demographics included a median age of 12 months, 92% female, and 86% with a febrile index UTI.
Discussion:
- Trimethoprim/sulfamethoxazole demonstrated a 50% reduction in UTI recurrences compared to placebo.
- No significant difference in renal scarring was observed between prophylaxis and placebo groups in the RIVUR trial.
- The study's design limitations mean it was not powered to definitively assess prophylaxis's role in preventing renal scarring.
Key Insights:
- Antimicrobial prophylaxis is effective in reducing UTI recurrence in children with VUR.
- The debate on VUR management should evolve from 'no prophylaxis' to 'selective prophylaxis'.
- Bladder bowel dysfunction was noted in 56% of toilet-trained children, a factor potentially influencing UTI risk.
Outlook:
- Further research is needed to refine criteria for selective antimicrobial prophylaxis in VUR.
- Long-term outcomes regarding renal scarring require continued investigation in children with VUR.
- Understanding the interplay between VUR, UTI, and bladder bowel dysfunction is crucial for optimal patient management.
Abstract:
Vesicoureteral reflux (VUR) increases the risk of urinary tract infection (UTI) and renal scarring. Many prospective studies have evaluated the role of antimicrobial prophylaxis in the prevention of recurrent UTI and renal scarring in children with VUR. Of these, the RIVUR trial was the largest, randomized, placebo-controlled, double blind, multicenter study, involving 607 children aged 2-72 months with grade I-IV VUR and a first or second symptomatic UTI. The median age of children in the RIVUR trial was 12 months, 92% were female, 91% were randomized after a first UTI, 86% had a febrile index UTI, and 71 (56%) of 126 toilet-trained children had bladder bowel dysfunction. Trimethoprim/sulfamethoxazole reduced the risk of UTI recurrences by 50% (hazard ratio 0.50; 95% confidence interval 0.34-0.74) as compared to placebo. No significant difference was seen in renal scarring between the two groups. However, this does not invalidate the role of prophylaxis in preventing renal scars because RIVUR and other recent prospective studies were not designed to address renal scarring as a primary study endpoint. In view of the RIVUR Trial and other studies that showed similar results, albeit in selected groups of patients, the debate on antimicrobial prophylaxis should shift from "no prophylaxis" to "selective prophylaxis" in children with VUR.
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