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

Waites 2004.

Methods
  • Study design: parallel RCT

  • Power calculations: no

  • Intention‐to‐treat analysis: no

Participants Inclusion criteria
  • Setting: single centre

  • Country: USA

  • Community residing men and women at least one year post spinal cord injury, age 16 years or older, neurogenic bladder managed by clean intermittent catheterization or external collection device, no systemic antimicrobials or urinary acidifying agents taken within 7 days, no current fever and chills suggestive of acute symptomatic UTI, and agreement not to ingest and cranberry‐containing products whilst participation in the clinical study. Baseline urine culture demonstrating at least 105 cfu/mL

  • Number: 74 randomised; 48 analysed

Interventions Treatment group
  • Concentrated cranberry extract: 2 g in capsule form


Control group
  • Placebo capsule


Duration of treatment: 6 months
Outcomes
  • Baseline urinalysis and cultures were performed at the time of the initial clinic visit and monthly for 6 months

Notes
  • Microbiologic data were evaluated using analysis of variance with repeated measures.

  • Method of obtaining urine sample

    • CSU or clean catch

  • Definition of bacteriuria

    • ≥ 100,000/mL

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details about random sequence methods were reported
Allocation concealment (selection bias) Unclear risk Uncertain of the process of treatment allocation, no details were reported
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Patients and clinicians were blind to treatment allocation
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Probably likely that microbiology staff assessing culture results were blind to treatment, but this wasn't stated
Incomplete outcome data (attrition bias) 
 All outcomes High risk 26 withdrawals out of 74 participants had no data on outcomes
Selective reporting (reporting bias) Low risk The primary outcome was symptomatic UTI which is appropriate
Other bias Unclear risk Few details on how patients were identified, possible selection bias
Source of funding: NS, but Cranberry capsules were provided by Aim This Way, Cambridge, Massachusetts.