Methods |
DESIGN: Randomised controlled trial ALLOCATION: By third party using sealed opaque envelopes. BLINDING PROCEDURES: Data entry blinded SAMPLE CALCULATION: Yes DURATION: Up to 12 months FOLLOW‐UP: Weekly urinalysis WITHDRAWALS/DROPOUTS: None ITT: Yes GEOGRAPHICAL LOCATION: Canada SETTING: Rehabilitation Hospital |
Participants |
N = 36 DIAGNOSIS: Neurogenic bladder due to recent high spinal cord injury; neurogenic bladder. ELIGIBLE: 50 ENROLLED: 36 COMPLETED: 36 AGE: Adults GENDER: 28 male, 8 female |
Interventions |
Sterile technique vs clean technique Sterile single‐use PVC catheter with sterile technique or sterile single‐use PVC catheter with clean technique (clean gloves, clean container, non‐sterile wipes for cleansing pre catheterisation) (uncoated, non‐lubricated both arms) |
Outcomes |
Days to onset of symptomatic UTI |
Notes |
UTI defined as >= 10x5 CFU/mL, pyuria + accompanying symptoms; no difference between groups. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"Computer generated random numbers" |
Allocation concealment (selection bias) |
Low risk |
"Sealed brown envelopes" |
Blinding of participants and personnel (performance bias) All outcomes |
Unclear risk |
"It was not possible to blind nursing staff" |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
"laboratory was blinded to subject allocation" |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
No incomplete data |
Source of Funding |
Low risk |
Glenrose Rehabilitation Hospital; Small Faculties Grant University of Alberta |