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. 2017 Aug 8;2017(8):CD006008. doi: 10.1002/14651858.CD006008.pub4
Methods DESIGN: Randomised controlled cross‐over trial. BLINDING PROCEDURES: Not stated SAMPLE CALCULATION: No DURATION: Each arm was 4 months FOLLOW‐UP: Weekly home visit for urine for C&S, catheter count, medication use and symptoms or signs of UTI WITHDRAWALS/DROPOUTS: None ITT: Not applicable GEOGRAPHICAL LOCATION: USA SETTING: Community
Participants N = 10 DIAGNOSIS: Neurogenic bladder due to spina bifida ELIGIBLE: 12 ENROLLED:10 COMPLETED: 10 AGE: Children GENDER: 4 male, 6 female
Interventions Single vs multiuse Uncoated catheter, non‐lubricated and clean technique both arms
Outcomes UTI weekly urine for C&S x 4 months
Notes UTI defined as + or > than 10x4 CFU/mL plus symptoms (fever, pain, change in continence, change in colour or odour of urine); No differences between groups (2 Sx UTI each). SS too small to draw any conclusions about effectiveness. Catheter cleaning: PVC rinsed with tap water, air dried. At end of day catheters were boiled x 3 minutes, air dried and stored in clean bag.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomised"
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 whether laboratory technician was blinded to catheter
Incomplete outcome data (attrition bias) All outcomes Low risk Minimal missing data
Source of Funding Unclear risk Mentor Corporation US