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. 2012 Oct 17;2012(10):CD001321. doi: 10.1002/14651858.CD001321.pub5

Lee 2007.

Methods
  • Study design: 4 group factorial design, parallel RCT

  • Power calculation: yes

  • Intention‐to‐treat analysis: yes

Participants Inclusion criteria
  • Setting: spinal cord injuries database, predominantly community dwelling patients

  • Country: Australia

  • Spnal cord injured people with neurogenic bladder, bladder management with either indwelling urethral or suprapubic catheter, intermittent catheterization, or reflex voiding with or without a condom drainage divide, absence of complex urological or serious renal or hepatic pathology, not being prescribed antibiotics at the time of enrolment and absence of symptoms of a UTI at enrolment. Had to be willing to stop any intercurrent urinary antiseptics before entering the study,

  • Number: 305 randomised/analysed

  • Mean age: 43.5 years

  • Sex: 253 males


Exclusion criteria
  • Previous allergy to any of the test interventions

Interventions Treatment group 1
  • Methenamine hippurate: 2 g

  • Cranberry: 1600 mg


Treatment group 2
  • Methenamine hippurate: 2 g

  • Cranberry placebo


Treatment group 3
  • Cranberry: 1600 mg

  • Methenamine hippurate placebo


Control group
  • Methenamine hippurate placebo

  • Cranberry placebo

Outcomes
  • Symptomatic UTI: current criteria for treating patients in the spinal injured population

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Dynamically balanced, centralized randomisation performed externally
Allocation concealment (selection bias) Low risk External trial centre controlled, sent to pharmacy
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk States all staff and participants were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk States all staff were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All accounted for in results
Selective reporting (reporting bias) Low risk Well described
Other bias Low risk No other bias apparent, well reported study
Source of funding: Motor accidents authority and Brucia Pharmaceuticals