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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: Single blind (trial nurse) SAMPLE CALCULATION: Yes DURATION: 1 day WITHDRAWALS/DROPOUTS: 1 ITT: Not applicable GEOGRAPHICAL LOCATION: Three trial sites in Germany SETTING: Not stated
Participants N = 37 DIAGNOSIS: Spinal cord injury ELIGIBLE: 37 ENROLLED: 37 COMPLETED: 36 AGE: Adults GENDER: Male
Interventions Short length male hydrophilic‐coated catheter (activated) versus standard length male hydrophilic‐coated catheter (activated)
Outcomes Residual urine and user satisfaction
Notes Two observations of visible bleeding on test catheter
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Crossover design, randomized in permuted blocks"
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) All outcomes Low risk No blinding of participants, but risk of performance bias considered low as cross‐over trial. Blinding of trial nurse throughout all measurement procedures.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Participant‐reported outcome ‐ risk of detection bias unclear
Incomplete outcome data (attrition bias) All outcomes Unclear risk 1 withdrawal reported because the participant "did not consider the 'test' catheter material flexible enough"
Source of Funding Unclear risk Coloplast A/S.