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. 2019 Feb 21;2019(2):CD012305. doi: 10.1002/14651858.CD012305.pub2

Cam 2009.

Methods Study design: parallel‐group, prospective randomized trial
Study dates: not available
Setting: 1 hospital
Country: Turkey
Participants Inclusion criteria: people undergoing diagnostic cystoscopy for check‐up of a superficial bladder tumour; people with subsequent incidental interventions, including punch biopsy and transurethral resection of a small bladder tumour; people with initial negative urine cultures
Exclusion criteria: used antibiotics for any reason during last month. Moreover, people requiring antibiotic prophylaxis for infective endocarditis or those with positive urine cultures were excluded
Sample size: 200 participants randomized
Age (years): mean control group: 56.3 (SD 5.4); mean prophylaxis group: 58.9 (SD 5.2)
Sex: control group: 59 men and 41 women; prophylaxis group: 62 men and 38 women
Interventions Group 1 (n = 100): antibiotic prophylaxis, intravenous, single dose 1 g, at the time of induction of anaesthesia
Group 2 (n = 100): no antibiotic prophylaxis
Outcomes Systemic UTI
How measured: participants had a follow‐up visit at the first month after cystoscopy; clinical parameters including fever, dysuria, and frequency evaluated
Time points measured: within 30 days after cystoscopy
Time points reported: within 30 days after cystoscopy
Outcomes: no fever or any other severe symptom was detected in any participant
Localized UTI
How measured: participants with positive urine cultures had complaints of dysuria and frequency
Time points measured: urine culture tested 1 day after cystoscopy
Time points reported: not available
Outcomes: placebo group: 1/100 had localized symptom and positive urine culture 1 day after cystoscopy; treatment group: 1/100 had localized symptom and positive urine culture 1 day after cystoscopy
Asymptomatic bacteriuria
How measured: participants with positive urine culture and no symptoms
Time points measured: urine culture tested 1 day after cystoscopy
Time points reported: not reported
Outcomes: control group: 1/100 had asymptomatic bacteriuria; treatment group: 0/100 had asymptomatic bacteriuria
Funding sources No information about funding
Declarations of interest No information about conflict and interest
Notes Used rigid cystoscopes. 2 participants, 1 from each group, had dysuria without associated positive culture results.
We tried to contact corresponding author about allocation concealment, but we received no response.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed using tables of random numbers and using a block randomization."
Comment: random sequence generation performed adequately.
Allocation concealment (selection bias) Unclear risk Comment: no information regarding concealment of randomization.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "The first group received no antibiotic prophylaxis, the second group had a single dose of intravenous cefoperazone (1 g)."
Comment: participants in control group were not administered antibiotic prophylaxis, while the treatment group received intravenously antibiotic prophylaxis. Unlikely that participants and personnel were blinded to the intervention.
Blinding of outcome assessment (detection bias) 
 Subjective outcomes High risk Quote: "The first group received no antibiotic prophylaxis, the second group had a single dose of intravenous cefoperazone (1 g)."
Comment: participants were not blinded to their treatment. Risk of detection bias for systemic UTI, localized UTI and asymptomatic bacteriuria was high.
Blinding of outcome assessment (detection bias) 
 Objective outcomes Unclear risk Comment: not applicable, since the objective outcome of drug resistance was not reported.
Incomplete outcome data (attrition bias) 
 Systemic UTI Low risk Quote: "No statistical difference was detected regarding age and gender between the groups, two groups were similar with regard to the distribution of cystoscopy indications."
Comment: 200/200 randomized participants (100 participants in each arm) were included for analysis of this outcome.
Incomplete outcome data (attrition bias) 
 Symptomatic UTI Low risk Quote: "No statistical difference was detected regarding age and gender between the groups, two groups were similar with regard to the distribution of cystoscopy indications."
Comment: 200/200 randomized participants (100 participants in each arm) were included for analysis of this outcome.
Incomplete outcome data (attrition bias) 
 Serious adverse events Unclear risk Comment: outcome not reported.
Incomplete outcome data (attrition bias) 
 Minor adverse events Unclear risk Comment: outcome not reported.
Incomplete outcome data (attrition bias) 
 Localized UTI Low risk Quote: "No statistical difference was detected regarding age and gender between the groups, two groups were similar with regard to the distribution of cystoscopy indications."
Comment: 200/200 randomized participants (100 participants in each arm) were included for analysis of this outcome.
Incomplete outcome data (attrition bias) 
 Asymptomatic bacteriuria Low risk Quote: "No statistical difference was detected regarding age and gender between the groups, two groups were similar with regard to the distribution of cystoscopy indications."
Comment: 200/200 randomized participants (100 participants in each arm) were included for analysis of this outcome.
Incomplete outcome data (attrition bias) 
 Bacterial resistance Unclear risk Comment: outcome not reported.
Selective reporting (reporting bias) Unclear risk Comment: data reported on all outcomes specified in methods section, but there was no access to trial protocol/registration to further assess selective reporting.
Other bias Low risk Comment: no other bias detected.