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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 possible to blind participants. SAMPLE CALCULATION: Yes DURATION: 48 weeks (24 weeks each arm) WITHDRAWALS/DROPOUTS: 24 ITT: Not applicable GEOGRAPHICAL LOCATION: 4 sites in Western Canada SETTING: Paediatric clinic
Participants N = 46 DIAGNOSIS: Spina bifida ELIGIBLE: Not stated ENROLLED: 70 COMPLETED: 46 AGE: Children GENDER: 21 male, 25 female
Interventions Hydrophilic‐coated (not activated) single‐use catheter with an uncoated, non‐lubricated (water added by user) multiple‐use catheter
Outcomes Symptomatic UTI, antimicrobial use, haematuria, days of missed activities, user‐reported satisfaction
Notes Hydrophilic catheters do not appear to reduce febrile UTI or antibiotic use in community‐dwelling children using CIC.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 'Computer generated list into random blocks of 8'
Allocation concealment (selection bias) Low risk 'Sealed opaque envelopes'
Blinding of participants and personnel (performance bias) All outcomes Low risk 'Not possible to blind subjects to product. All data was entered by an impartial technician.'
Blinding of outcome assessment (detection bias) All outcomes Low risk Risk of detection bias considered low as cross‐over trial.
Incomplete outcome data (attrition bias) All outcomes High risk 24 participants dropped out
Source of Funding Unclear risk Glenrose Rehabilitation Hospital, Spina Bifida Association of Northern Alberta, Northern Alberta Urology Foundation Canada, Coloplast A/S (products)