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. 2017 Aug 8;2017(8):CD006008. doi: 10.1002/14651858.CD006008.pub4
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.