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) |