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 |