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 |