Methods |
DESIGN: Randomised cross‐over trial BLINDING PROCEDURES: Not stated SAMPLE CALCULATION: No DURATION: 30 days WITHDRAWALS/DROPOUTS: 9 ITT: Not applicable GEOGRAPHICAL LOCATION: France SETTING: "11 French centres" |
Participants |
N = 106 DIAGNOSIS: Spinal cord injury ELIGIBLE: 106 ENROLLED: 106 COMPLETED: 97 AGE: 18 to 65 years GENDER: Male (63) and female (34) |
Interventions |
Novel "no‐touch" hydrophilic catheter versus participants' own hydrophilic catheter |
Outcomes |
Participant preferences |
Notes |
Reported on day 0 and then either day 15 or day 30 after use of test catheter |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
"Randomisation was stratified per center" |
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 |
Not stated |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Missing outcome data balanced in numbers between intervention group (n = 4) and control group (n = 5), with similar reasons for dropout across groups. |
Source of Funding |
Unclear risk |
Hollister France Inc. |