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. 2017 Aug 8;2017(8):CD006008. doi: 10.1002/14651858.CD006008.pub4
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