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. 2017 Aug 8;2017(8):CD006008. doi: 10.1002/14651858.CD006008.pub4
Methods DESIGN: Randomised controlled trial BLINDING PROCEDURES: Non‐blinded SAMPLE CALCULATION: Yes DURATION: 12 months WITHDRAWALS/DROPOUTS: 11 ITT: Not stated GEOGRAPHICAL LOCATION: North America SETTING: Community
Participants N = 56 DIAGNOSIS: Spinal cord injury for >6 months with >1 UTI ELIGIBLE: Not stated ENROLLED: 56 COMPLETED: 45 AGE: Adults GENDER: 29 male, 16 female
Interventions Hydrophilic‐coated catheter, not activated, water added by user versus uncoated catheter, non‐lubricated, single use both arms
Outcomes Symptomatic UTI, treatment with antibiotics
Notes No difference in incidence of bacteriuria or symptomatic UTIs between treatment and control groups. Significantly less UTIs treated with antibiotics in treatment group.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated. More women in the control group, significantly more tetraplegic participants in the control group.
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 Unblinded. Monthly self‐report of UTI symptoms together with urine sampling used to determine presence of UTI. Use of antibiotics determined by participant's clinician (independent of research trial).
Incomplete outcome data (attrition bias) All outcomes Low risk Missing outcome data balanced in numbers between intervention group (n = 6) and control group (n = 5), with similar reasons for missing data across groups.
Source of Funding Low risk National Institute on Disability and Rehabilitation Research US