Methods |
DESIGN: Randomised controlled cross‐over trial BLINDING PROCEDURES: Not stated SAMPLE CALCULATION: No DURATION: 3 weeks each arm FOLLOW‐UP: 3 weeks WITHDRAWALS/DROPOUTS: Not clear ITT: Not applicable GEOGRAPHICAL LOCATION: Denmark SETTING: Community |
Participants |
N = 32 DIAGNOSIS: Retention due to BPH ELIGIBLE: Not stated ENROLLED: 43 COMPLETED: 32 AGE: Adults GENDER: Male |
Interventions |
Hydrophilic‐coated (not activated) (Lofric) single‐use catheter with an uncoated, non‐lubricated (water added by user) multiple‐use catheter x 3 weeks each |
Outcomes |
Urine for C&S at baseline and each 3 week point; haematuria; responses to catheter use questionnaire |
Notes |
UTI defined as > 10 x 4 CFU/mL. No differences between groups in questionnaire response, bacteriuria or haematuria but short follow‐up and small sample size. Unable to use data in Table of Comparisons because of cross‐over design and no mid‐point data. |
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 |
Unclear risk |
Participant‐reported outcome ‐ risk of detection bias unclear |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
Unclear number of participants included but not completed |
Source of Funding |
Unclear risk |
Kirudan A/S (products) |