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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: 12 months FOLLOW‐UP: Urine C&S every 3 months WITHDRAWALS/DROPOUTS: 13 ITT: Not stated GEOGRAPHICAL LOCATION: 3 sites in USA SETTING: Community
Participants N = 62 DIAGNOSIS: Neurogenic bladder (cause not stated) ELIGIBLE: Not stated ENROLLED: 62 COMPLETED: 49 AGE: Adults GENDER: Male
Interventions Hydrophilic‐coated (not activated) (Lofric) single‐use catheter with an uncoated, non‐lubricated (water added by user) multiple‐use catheter. Reuse time 24 hours.
Outcomes UTI; pyuria; haematuria.
Notes UTI defined as 10x5 CFU/mL + at least one clinical symptom (fever, chills, malodorous urine, increased spasticity, malaise). Catheter cleaning not described; used 1 reused catheter per day. No statistically significant group differences were noted; unclear how long participants were using IC before entering trial; pre trial UTI based on participant recall.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomised fashion"
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 Unclear risk Withdrawal rate greater in the experimental arm (8 vs 5). "Two patients per group related to the type of catheter used"
Source of Funding Unclear risk Astro Tech AB