Methods |
DESIGN: Randomised controlled trial BLINDING PROCEDURES: Unclear SAMPLE CALCULATION: No DURATION: 4 months FOLLOW‐UP: Urine culture every 3 weeks for 4 months (5 samples) WITHDRAWALS/DROPOUTS: 0 ITT: Not stated GEOGRAPHICAL LOCATION: Brazil SETTING: General School Hospital |
Participants |
N = 20 DIAGNOSIS: Variable, mielomeningocele most common (25%) ELIGIBLE: Not stated ENROLLED: 20 COMPLETED: 20 AGE: Mixed adults and children 2‐79 years (mean not stated) GENDER: 12 male and 8 female |
Interventions |
Other strategies designed to reduce infection: Gentamycin cream (0.1%) versus lidocaine jelly used as separate lubricant for IC |
Outcomes |
Number of episodes of asymptomatic bacteriuria (>= 100,000 CFU/mL) , number of participants with symptomatic UTI |
Notes |
Repeated measures of asymptomatic bacteriuria reported for each participant. Final measure used in table of results. Asymptomatic bacteriuria similar in both groups 8/10 in gentamycin group 6/10 in lidocaine group. 1/10 developed symptomatic UTI in gentamycin group, 2/10 in Lidocaine 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 |
Low risk |
No missing outcome data |
Source of Funding |
Unclear risk |
Not stated |