Methods |
DESIGN: Randomised controlled trial BLINDING PROCEDURES: Not clear SAMPLE CALCULATION: No DURATION: 28 days FOLLOW‐UP: Daily urine dipslides WITHDRAWALS/DROPOUTS: 11 ITT: Not stated GEOGRAPHICAL LOCATION: USA SETTING: Rehabilitation Hospital |
Participants |
N = 46 DIAGNOSIS: Neurogenic bladder due to recent spinal cord injury ELIGIBLE: 58 ENROLLED: 46 COMPLETED: 35 AGE: Adults GENDER: Male |
Interventions |
Sterile vs clean technique (also Single Use vs Multiple Use) catheterisation kit and sterile single‐use catheter, meatus cleansed with povidone iodine. Clean technique: sterile catheter reused for one day after being washed with soap and water, non‐sterile gloves and container (uncoated, non‐lubricated catheters) |
Outcomes |
Ddaily urine dipslides + symptomatic UTI |
Notes |
No statistically significant differences between urine cultures or Sx UTI; weeks to onset of UTI was 1.1 (0.87) for treatment and 1.2 (1.0) for control. Number of days in trial varied from 1 to 28 with only nine participants completing more than twenty days. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
"46 patients were assigned randomly" |
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. UTI determined by lab results and participant symptoms |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Withdrawals were evenly balanced between groups |
Source of Funding |
Low risk |
American Association of Spinal Cord Injury Nurses; Rehabilitation Institute Foundation US |