📃 Paper Title: The Swedish reflux trial in children: III. Urinary tract infection pattern
🧍 Author: Per Brandström
🕒 Year: 2010
📚 Journal: Journal of Urology
🌎 Country: Sweden
ㅤContext to the study:
Can you tell me about a study that evaluated the benefits of active treatment with either antibiotic prophylaxis or endoscopic treatment in children with Vesicoureteral Reflux?
ㅤ✅ Take-home message of study:
In girls with grade III-IV vesicoureteral reflux (VUR) antibiotic prophylaxis and endoscopic treatment decreased the febrile urinary tract infection (UTI) recurrence rate compared to surveillance. Reflux severity at study entry did not predict recurrence.
Boys with dilating VUR who were older than 1 year old showed few recurrences and did not benefit from active treatment.
ㅤ Multicentre, three-arm randomised controlled trial (i.e. antibiotic prophylaxis, endoscopic treatment, surveillance)
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Study participants:
203 children (128 girls and 75 boys)
Age; 1 to younger than 2 years
Grade III-IV VUR
Exclusion criteria: previous urogenital surgery, malformation (except duplication), known neurological disease, stone disease, glomerular filtration rate less than 70 ml per minute per 1.73 m2, split renal function below 15% or suspected noncompliance.
Children were randomly assigned to prophylaxis (69), endoscopic treatment (66) or surveillance (68).
Ultrasound, voiding cystourethrography (VCU) and DMSA scintigraphy were performed before randomisation. At 2-year followup VCU and DMSA scans were done at a median age of 3.8 years.
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Key study outcomes:
Main end point variables were recurrent febrile UTI, VUR status and renal damage on DMSA scintigraphy at 2 years
A total of 67 febrile recurrences in 42 girls and a total of 8 in 7 boys was observed (p=0.0002).
In the prophylaxis group febrile recurrence was seen in 8 of 43 girls (19%) with trimethoprim resistant bacteria in 7.
In the endoscopic group 10 of 43 girls (23%) had recurrence, including 5 with resistance to trimethoprim.
In the surveillance group 24 of 42 girls (57%) had recurrence with trimethoprim resistant bacteria in 9 (p<0.0001).
In girls there was no difference between the prophylaxis and endoscopic groups (p = 0.53).
In boys there were few recurrences with no differences between treatment groups (p = 0.28).
In girls median time to the first recurrence was 589 days in the prophylaxis, 380 days in the endoscopic therapy and 96 days in the surveillance (p <0.0001).
There was an association between VUR grade at 2 years and the recurrence rate in girls, with more UTIs in those with higher grade VUR (p = 0.0095)
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Study Limitations:
The study was not placebo controlled, which may have caused the bias of families or health professionals being extra observant about recurrence in the surveillance group on no active treatment.
The study only included children between the ages of 1 and 2 with dilating VUR, so the findings may not be generalisable to other paediatric populations.
Long term outcomes are uncertain of the 3 intervention modalities.
Lack of drug compliance monitoring.
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