| Methods | DESIGN: Randomised controlled trial BLINDING PROCEDURES: Not stated SAMPLE CALCULATION: No DURATION: Unclear FOLLOW‐UP: Unclear WITHDRAWALS/DROPOUTS: Not stated ITT: Not applicable GEOGRAPHICAL LOCATION: USA SETTING: Rehabiltiation | |
| Participants | N = 29 DIAGNOSIS: Neurogenic bladder due to spinal cord injury ELIGIBLE: Unknown ENROLLED: 29 COMPLETED: Not stated AGE: Adults GENDER: 16 male, 13 female | |
| Interventions | Single‐use uncoated, pre‐lubricated catheter with an integrated bag (sterile) versus multiple‐use uncoated, non‐lubricated catheter (CLEAN) | |
| Outcomes | UTI Urine for C&S collected weekly ‐ unclear on trial time frame or endpoint. | |
| Notes | UTI as defined by NIDRR (1992); higher % of UTI in closed system (42% vs 29%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| 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 | Not stated, but does not appear to be any missing outcome data |
| Source of Funding | Unclear risk | Medical Marketing Group Inc. US |