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

Si 1997.

Methods Study design: randomized controlled study
Study dates: January 1990 to December 1994
Setting: not reported
Country: China
Participants Inclusion criteria: not reported
Exclusion criteria: not reported
Sample size: 252 cystoscopes performed on 206 participants
Age: not reported
Sex: 140 men, 61 women
Interventions Group 1 (n = 64): simple cystoscopy examination without other manipulation. No antibiotic
Group 2 (n = 52): simple cystoscopy examination without other manipulation. Norfloxacin 400 mg 2 hours before cystoscopy, then 200 mg twice after cystoscopy, interval 6 hours
Group 3 (n = 41): cystoscopy examination with manipulations, e.g. biopsy. No antibiotic
Group 4 (n = 44): cystoscopy examination with manipulations, e.g. biopsy. Norfloxacin, 400 mg 2 hours before cystoscopy, then 200 mg twice after cystoscopy, interval 6 hours
Outcomes Bacteriuria
How measured: positive urine cultures ≥ 105 CFU/mL or > 5 white blood cells/high power field in microscope
Time points measured: urine cultures before cystoscopy and 3 days after procedure
Time points reported: not reported
Outcomes: 3/64 participants in group 1, 2/52 in group 2, 7/41 in group 3, and 2/41 in group 4 had bacteriuria
Funding sources No information about funding
Declarations of interest No information about conflict and interest
Notes No email address available for contacting the corresponding author for further information.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients were randomly assigned into groups."
Comment: method for generation of random sequence not given.
Allocation concealment (selection bias) Unclear risk Comment: no information regarding the concealment of randomization.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Participants in the treatment group received 400mg norfloxacin, while the control group received no antibiotic."
Comment: participants in control group did not receive antibiotics, while participants in treatment group received antibiotics. Unlikely that participants and personnel were blinded to the intervention.
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Unclear risk Comment: subjective outcomes of systemic and localized symptoms after cystoscopy; adverse events not reported.
Blinding of outcome assessment (detection bias) 
 Objective outcomes Low risk Comment: bacteriuria evaluated by urine culture was regarded as the primary outcome, the result was obtained from laboratory. Detection bias for this outcome was unlikely to be influenced by the unblinded design.
Incomplete outcome data (attrition bias) 
 Systemic UTI Unclear risk Comment: outcome not reported.
Incomplete outcome data (attrition bias) 
 Symptomatic UTI Unclear risk Comment: outcome not reported (bacteriuria was reported, but without differentiating whether participants had symptoms or not).
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 Unclear risk Comment: outcome not reported.
Incomplete outcome data (attrition bias) 
 Asymptomatic bacteriuria Unclear risk Comment: outcome not reported (bacteriuria was reported, but without differentiating whether participants had symptoms or not).
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.