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 |