| 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 |