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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 DURATION: 4 days FOLLOW‐UP: WITHDRAWALS/DROPOUTS: 10 ITT: Not stated GEOGRAPHICAL LOCATION: SETTING: Rehabilitation
Participants N = 30 DIAGNOSIS: Neurogenic bladder due to recent spinal cord injury or stroke ELIGIBLE: Unknown ENROLLED: 30 COMPLETED: 20 AGE: Adults GENDER: Not stated
Interventions Uncoated, pre‐lubricated catheter with an integrated bag with an uncoated, non‐lubricated catheter, aseptic technique both arms
Outcomes UTI >10x5 CFU/mL + symptoms (fever, CV or SP tenderness)
Notes Data only collected for 4 days
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomly assigned"
Allocation concealment (selection bias) Low risk "blind selection of a marked piece of paper from a box prepared for the particular service"
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 Outcome data is not reported for the missing participants but there were the same number of participants with incomplete data in each arm.
Source of Funding Unclear risk Bard Inc.