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. 2017 Aug 8;2017(8):CD006008. doi: 10.1002/14651858.CD006008.pub4
Methods DESIGN: Randomised controlled cross‐over trial BLINDING PROCEDURES: No SAMPLE CALCULATION: No DURATION: 6 weeks WITHDRAWALS/DROPOUTS: 11 ITT: Not applicable GEOGRAPHICAL LOCATION: Turkey SETTING: Hospital clinic
Participants N = 25 DIAGNOSIS: Spinal cord injury ELIGIBLE: 25 ENROLLED: 21 COMPLETED: 10 (all three arms) AGE: Adults GENDER: Male
Interventions One uncoated (not lubricated), one pre‐lubricated with integrated bag and one hydrophilic coated (water added by user)
Outcomes Urethral cytology, urine culture, user satisfaction
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Sequence generated by table of random numbers"
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 "Urethral cytology samples were taken by a blinded doctor"
Incomplete outcome data (attrition bias) All outcomes Unclear risk Missing data on one or more catheters from 15 participants ‐ 9 participants gave non‐approval of catheter as the reason (2 gel‐lubricated catheter, 5 PVC catheter, 2 hydrophilic catheter)
Source of Funding Low risk No funding