Methods | DESIGN: Randomised controlled trial BLINDING PROCEDURES: Not stated SAMPLE CALCULATION: Yes DURATION: 12 months FOLLOW‐UP: Baseline, day 15 then monthly x 12 months WITHDRAWALS/DROPOUTS: 66 ITT: Not stated GEOGRAPHICAL LOCATION: Europe SETTING: Rehabilitation and community | |
Participants | N =123 DIAGNOSIS: Neurogenic bladder due to spinal cord injury < 6 months ELIGIBLE: Unknown ENROLLED: 123 COMPLETED: 57 AGE: Adults GENDER: Male |
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Interventions | Hydrophilic‐coated catheter, activated versus uncoated catheter, non‐lubricated (single use both arms); assessed at Day 15 then monthly x 12 m. | |
Outcomes | Primary: UTI Secondary: haematuria strictures, convenience; 82% PVC had UTI; 64% Speedicath; no difference in haematuria. | |
Notes | UTI described as "clinical infection with Sx of UTI and for which treatment was prescribed", however, lab analyses did not differ between groups. significant challenges in retaining participants illustrating the difficulty of conducting trials in this group. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomised in two groups" |
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 | Low risk | Not stated, but outcome not likely to be influenced by a lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | High risk | Outcome data accounted for descriptively. However, larger numbers of dropouts in intervention group. This has not been accounted for in the analysis, which does not appear to be intention‐to‐treat. |
Source of Funding | Unclear risk | Not stated. |