Skip to main content
. 2019 Apr 1;2019(4):CD001534. doi: 10.1002/14651858.CD001534.pub4

Stansfeld 1975.

Methods
  • Study design: RCT

  • Study recruitment period; 1969

  • Follow‐up: to 6 months

Participants
  • Country: UK

  • Setting: single centre

  • Children with active UTI (first or recurrent) Initial UTI defined as two or more consecutive, significant and consistent urine cultures accompanied by pyuria

  • Number: treatment group (21); control group (24)

  • Age range: 6 months to 14 years

  • Sex (M/F): 3/42

  • VUR: 10

  • Exclusion criteria: neonates; children with impaired drainage due to obstruction or bladder paralysis

Interventions Cotrimoxazole given for 2 weeks and then randomised to treatment or control
Treatment group
  • Cotrimoxazole: given for 6 months, no dosage stated


Control group
  • Placebo tablets for 6 months

Outcomes
  • Number of repeat positive cultures

Notes
  • Urine samples screened at each visit

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sequence generated and held in pharmacy, independent to investigators
Allocation concealment (selection bias) Low risk Clinician unable to manipulate allocation
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk States double blinding and used a placebo
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Loss to follow‐up detailed
Selective reporting (reporting bias) High risk Primary outcome positive culture, not symptomatic UTI
Other bias Unclear risk Many methods poorly reported

CFU ‐ colony forming units; CRP ‐ C‐reactive protein; ESR‐ erythrocyte sedimentation rate; DMSA ‐ 99Tc‐dimercaptosuccinic acid; G6PD ‐ glucose‐6‐phosphate dehydrogenase; M/F ‐ male/female; MSU ‐ midstream urine; RCT ‐ randomised controlled trial; SD ‐ standard deviation; SE ‐ standard error; SMX ‐ sulfamethoxazole; TMP ‐ trimethoprim; UTI ‐ urinary tract infection; VUR ‐ vesicoureteric reflux