Skip to main content
. 2017 Aug 8;2017(8):CD006008. doi: 10.1002/14651858.CD006008.pub4
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)