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 |