Goh 1982.
Methods |
Study design: randomized controlled trial Study dates: not reported Setting: not reported Country: Singapore |
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Participants |
Inclusion criteria: attending for check cystoscopy for previous bladder neoplasms, or for primary investigation of haematuria Exclusion criteria: not reported Sample size: 420 participants randomized and 31 participants had bacteriuria present at cystoscopy and were excluded. Age (years): mean control group: 66.5 (SD 15.64); mean treatment group: 63.2 (SD 14.43) Sex: not reported |
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Interventions |
Trial A Group 1 (n = 111): no antibiotic prophylaxis Group 2 (n = 93): 2 tablets each containing trimethoprim 80 mg + sulphamethoxazole 400 mg twice daily for 2 days after cystoscopy Trial B Group 3 (n = 95): no antibiotic prophylaxis Group 4 (n = 90): 1 tablet containing trimethoprim 160 mg + sulphamethoxazole 800 mg, taken once after cystoscopy |
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Outcomes |
[Bacteriuria] How measured: urine samples with count of organisms > 105 CFU/mL Time points measured: midstream urine samples 5 days after cystoscopy Time points reported: not reported Outcomes: trial A: control group: 34/111 participants had bacteriuria after cystoscopy; treatment group: 5/93 had bacteriuria after cystoscopy; trial B: control group: 17/95 had bacteriuria after cystoscopy; treatment group: 5/90 had bacteriuria after cystoscopy |
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Funding sources | No information about funding | |
Declarations of interest | No information about conflict and interest | |
Notes | 1 participant developed Escherichia coli septicaemia, an incidence of 0.2%, from the trial B control group with no existing bacteriuria. No email address available for contacting the corresponding author for further information. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "In both trials patients were randomly allocated into a control group and a study group." Comment: method for generation of random sequence not given. |
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 study group took a standard preparation of co‐trimoxazole, two tablets each containing trimethoprim 80 mg and sulphamethoxazole 400 mg twice daily for two days post‐cystoscopy. The control group received no antibiotics." Comment: participants in the control group were not administered antibiotic prophylaxis, while the treatment group receive tablets. Unlikely that participants and personnel were blinded to the intervention. |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: 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 primary outcome. Result 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. |