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