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. 2017 Aug 8;2017(8):CD006008. doi: 10.1002/14651858.CD006008.pub4
Methods DESIGN: Randomised controlled cross‐over trial with each arm 6 months BLINDING PROCEDURES: Not stated SAMPLE CALCULATION: No DURATION: 6 months FOLLOW‐UP: Monthly WITHDRAWALS/DROPOUTS: Nil ITT: Not applicable GEOGRAPHICAL LOCATION: Canada SETTING: Community
Participants N = 30 DIAGNOSIS: Neurogenic bladder due to spina bifida ELIGIBLE: Unknown ENROLLED: 30 COMPLETED: 30 AGE: Children GENDER: 15 male, 15 female
Interventions SINGLE VS MULTI USE:sterile single‐use PVC or reused PVC (uncoated, non‐lubricated catheters)
Outcomes Bacteriuria > 10x3 CFU/mL obtained monthly; no difference between groups.
Notes Symptomatic UTI defined as + symptoms; catheters washed with liquid soap and water, air dried and reused (does not indicate length of reuse); several participants took prophylactic antibiotics.
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 Low risk "Both lab technologists were blind to the arm of the crossover design"
Incomplete outcome data (attrition bias) All outcomes Low risk No incomplete data
Source of Funding Unclear risk Spina Bifida Association of Northern & Southern Alberta and Canada, Baxter Corporation,Canadian Hospital Suppliers, Congdon's Aids to Daily Living, Glenrose Rehabilitation Hospital, Lever Soap, Mentor Corporation, Northern Alberta Urology Foundation,