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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: SAMPLE CALCULATION: Yes DURATION: 1 week for each of 4 arms WITHDRAWALS/DROPOUTS: None ITT: Not applicable GEOGRAPHICAL LOCATION: UK SETTING: 7 test centres run by continence nurse specialists
Participants N = 61 DIAGNOSIS: not stated ELIGIBLE: Not stated ENROLLED: 61 COMPLETED: 61 AGE: Adults GENDER: Male
Interventions Comparison of 4 hydrophilic‐coated catheters (not activated, water added by user)
Outcomes Smoothness of catheter removal, severity of sticking and user‐reported satisfaction and ease of use
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomisation in Latin squares"
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 Low risk Participant‐reported outcome, but risk of detection bias considered low as cross‐over trial
Incomplete outcome data (attrition bias) All outcomes Unclear risk Not stated
Source of Funding Low risk Continence Product Evaluation Network.