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 |