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. 2017 Aug 8;2017(8):CD006008. doi: 10.1002/14651858.CD006008.pub4
Methods DESIGN: Randomised controlled trial BLINDING PROCEDURES: Not stated SAMPLE CALCULATION: No (feasibility trial) DURATION: 24 hours FOLLOW‐UP: 3 urine samples for C&S in 24 hours WITHDRAWALS/DROPOUTS: No ITT: Not stated GEOGRAPHICAL LOCATION: Canada SETTING: ICU
Participants N =11 DIAGNOSIS: Neurogenic bladder due to recent spinal cord injury ELIGIBLE: 53 ENROLLED: 11 COMPLETED: 11 AGE: Adults GENDER: Male
Interventions Uncoated, pre‐lubricated catheter with an integrated bag with an uncoated, non‐lubricated catheter, aseptic technique both arms
Outcomes 3 urine samples for culture over a 24‐hour period + meatal swabs
Notes No difference between groups but sample too small and time frame too short to make any inferences
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) All outcomes Low risk No blinding, but the review authors judge that the outcome and outcome measurement are not likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias) All outcomes Low risk No missing outcome data
Source of Funding Unclear risk Not stated.