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. 2019 Apr 1;2019(4):CD001534. doi: 10.1002/14651858.CD001534.pub4

Gucuk 2013.

Methods

  • Study design: 4‐arm RCT

  • Duration of study: May 2006 to January 2010

  • Duration of follow‐up: 12 months
Participants

  • Country: Turkey

  • Setting: single centre

  • Uncircumcised boys < 3 years with grade 1‐3 VUR after 1st febrile UTI

  • Number: group 1 (46); group 2 (45); group 3 (47); group 4 (59)

    • VUR: 99

    • Healthy boys: 117

  • Mean age ± SD (months): group 1 (19.10 ± 9.4); group 2 (19.77 ± 9.12); group 3 (20.55 ± 9.47); group 4 (18.76 ± 8.76)

  • Exclusion criteria: recently received antibiotic treatment for any reason; phimosis; balanitis; urinary tract pathology (neurogenic bladder, bladder diverticula, ureterocele); high grade VUR (III to V); allergy to sulphonamide
Interventions Group 1 (with VUR)

  • TMP/SMX: 2/10 mg/kg once/day for 12 months


Group 2 (with VUR)

  • Antibiotics: 2/10 mg/kg TMP/SMX once/day for 12 months

  • Circumcision


Group 2 (healthy boys)

  • Circumcision


Group 2 (healthy boys)

  • Observation only (no antibiotics and no circumcision)
Outcomes

  • Repeat symptomatic UTI

  • Repeat positive culture

  • Peri‐urerethral colonization

  • No data on microbial resistance
Notes

  • Circumcision was performed using the dorsal‐ventral slit technique in the operating room with adequate analgesia or sedation

  • Funding source: not reported

  • Boys with VUR were randomised into 2 groups; boys without VUR randomised into 2 groups so can't use data across all 4 groups. Boys without VUR were not given antibiotics so no data available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as randomised, method of randomisation was not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 19 boys lost to follow‐up and no data reported
Selective reporting (reporting bias) Low risk Clinically relevant outcome of repeat symptomatic UTI was reported
Other bias Unclear risk Uncertain generalisability because uncertain of the selection process for the study