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, |