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. |