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. 2017 Aug 8;2017(8):CD006008. doi: 10.1002/14651858.CD006008.pub4
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
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