Methods | DESIGN: Randomised controlled trial BLINDING PROCEDURES: Not stated SAMPLE CALCULATION: No DURATION: 8 weeks FOLLOW‐UP: Weekly urine C&S and microscopy x 8 weeks. WITHDRAWALS/DROPOUTS: 3 ITT: Not stated GEOGRAPHICAL LOCATION: USA SETTING: community | |
Participants | N = 33 DIAGNOSIS: Neurogenic bladder due to spinal cord injury, Hinman syndrome, spinal dysraphism; ELIGIBLE: Not stated ENROLLED: 33 COMPLETED: 30 AGE: Children GENDER: Male |
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Interventions | Hydrophilic‐coated (not activated) (Lofric) single‐use catheter with an uncoated, non‐lubricated (water added by user) multiple‐use catheter. Method of cleaning catheter and length of reuse not described. | |
Outcomes | UTI Haematuria > 3 RBC per HPF; VAS for satisfaction; | |
Notes | UTI defined as 10x5 CFU/mL + Sx (not defined); participants with positive cultures were treated and re‐entered into the trial; no diff in bacteriuria b/w groups; haematuria lower in Lofric group but SS too small to draw conclusions and groups included gastric augmentation as well. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "assigned" |
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 | Not stated whether laboratory technician was blinded to catheter |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 participants did not complete the trial, 2 in one arm and 1 in the other. Reasons for missing data unlikely to be related to outcome. |
Source of Funding | Unclear risk | Not stated |