| 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. |