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

Falakaflaki 2007.

Methods
  • Study design: parallel RCT

  • Recruitment period; 2004 to 2006

  • Duration of follow‐up: 6 months

Participants
  • Country: Iran

  • Setting: single centre

  • Previous UTI, no previous prophylaxis; aged 3 months to 12 years; normal kidney function, at least one of the following: > 3 UTI/year, VUR grades 1 to 4, obstructive lesions, other anatomical abnormalities, or aged < 1 year

  • Number/VUR: treatment group 1 (66/31); treatment group 2 (66/26)

  • Mean age, range: treatment group 1 (3.8 years, 3 months to 12 years); treatment group 2 (4.4 years, 4 months to 11 years)

  • Sex (M/F): treatment group 1 (23/43); treatment group 2 (13/53)

  • Exclusion criteria: Impaired kidney function; contraindication for nitrofurantoin or TMP/SMX (e.g. G6PD deficiency); any side effects of drugs

Interventions Treatment group 1
  • TMP/SMX: 2 mg/kg/d for 6 months


Treatment group 2
  • Nitrofurantoin: 1 to 2mg/kg/d for 6 months

Outcomes
  • Repeat symptomatic UTI (culture + fever or other symptoms)

Notes
  • Included bag samples

  • Patients kept on the study after a recurrence, and changed prophylaxis type if recurrence was with a bacterial agent resistant to their allocated treatment

  • Funding source: not reported

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 Unclear risk No withdrawals or loss to follow up stated, unsure of completeness of reporting
Selective reporting (reporting bias) Low risk Primary outcome symptomatic UTI
Other bias Unclear risk Many details not reported, difficult to determine