Blackard 1972.
Methods |
Study design: parallel‐group, double‐blind randomized trial Study dates: 1 January 1969 to 31 December 1969 Setting: 1 hospital Country: USA |
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Participants |
Inclusion criteria: no fever or clinical UTI; required no antibacterial agents during the preceding 2 weeks; no retention type urethral catheter; no need for immediate operation; no allergy to sulphonamide Exclusion criteria: not available Sample size: 75 men Age (years): overall median 74 (44–82) Sex: all men |
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Interventions |
Group 1 (n = 37): placebo, oral, started 2 days before cystoscopy and maintained 10 days following cystoscopy Group 2 (n = 38): sulphamethoxazole 500 mg + phenazopyridine 100 mg, oral, started 2 days before cystoscopy and maintained 10 days following cystoscopy |
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Outcomes |
Systemic UTI How measured: body temperature ≥ 38 °C Time points measured: within 10 days after cystoscopy Time points reported: within 10 days after cystoscopy Outcomes: placebo group: 0/37 participants had fever 1 day after cystoscopy, and 5/37 had fever within 2–10 days after cystoscopy; treatment group: 4/38 had fever 1 day after cystoscopy, and 5/38 had fever within 2–10 days after cystoscopy Bacteriuria How measured: urine culture yielded > 104 CFU/mL Time points measured: within 10 days after cystoscopy Time points reported: within 10 days after cystoscopy Outcomes: placebo group: 17/37 participants had bacteriuria 1 day after cystoscopy, and 14/37 had bacteriuria within 2–10 days after cystoscopy; treatment group: 6/38 had bacteriuria 1 day after cystoscopy, and 5/38 had bacteriuria within 2–10 days after cystoscopy Minor adverse events How measured: decided by physician Time points measured: within 10 days after cystoscopy Time points reported: within 10 days after cystoscopy Outcomes: treatment group: 1 participants had drug eruption and 2 participants had sulphonamide crystals in the urine 1 day after cystoscopy |
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Funding sources | No information about funding | |
Declarations of interest | No information about conflict and interest | |
Notes | For participants with sterile urine before cystoscopy, in the placebo group, 7/27 had bacteriuria 1 day after cystoscopy, and 6/27 had bacteriuria within 2–10 days after cystoscopy. In the treatment group, 3/27 had bacteriuria 1 day after cystoscopy, and 3/27 had bacteriuria within 2–10 days after cystoscopy Localized symptom How measured: burning or painful urination usually accompanied by frequency and urgency Time points measured: within 10 days after cystoscopy Time points reported: within 10 days after cystoscopy Outcomes: placebo group: 16/37 participants had localized symptom 1 day after cystoscopy, and 9/37 had localized symptom within 2–10 days after cystoscopy; treatment group: 16/38 had localized symptom 1 day after cystoscopy, and 11/38 had localized symptom within 2–10 days after cystoscopy 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: "Drugs were randomly assigned and administered in a double‐blind fashion." 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 | Low risk | Quote: "Drugs and placebo looked like the same and they were randomly assigned to participants, principle investigator and participants were not able to identify the active drugs or placebo." Comment: treatment providers and participants adequately blinded. |
Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Quote: "Drugs were randomly assigned and administered in a double‐blind fashion." Comment: double‐blind study, and this probably done. |
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: "In the placebo group, none of 37 had fever 1 day after cystoscopy, and 5 out of 37 had fever within 2 to 10 days after cystoscopy. in the treatment group, 4 out of 38 had fever 1 day after cystoscopy, and 5 out of 38 had fever within 2 to 10 days after cystoscopy (rephrased from table)." Comment: 75/75 randomized participants (37 participants in the control arm, 38 participants in the intervention arm) were included for analysis of this outcome. |
Incomplete outcome data (attrition bias) Symptomatic UTI | Low risk | Quote: "In the placebo group, 17 out of 37 had bacteriuria 1 day after cystoscopy, and 14 out of 37 had bacteriuria within 2 to 10 days after cystoscopy. In the treatment group, 6 out of 38 had bacteriuria 1 day after cystoscopy, and 5 out of 38 had bacteriuria within 2 to 10 days after cystoscopy (rephrased from table)." Comment: 75/75 randomized participants (37 participants in control arm, 38 participants in intervention arm) were included for analysis of this outcome. |
Incomplete outcome data (attrition bias) Serious adverse events | Low risk | Quote: "In the treatment group, 1 participants had drug eruption and 2 participants had sulfenamide crystals in the urine 1 day after cystoscopy (rephrased from table)." Comment: 75/75 randomized participants (37 participants in control arm, 38 participants in intervention arm) were included for analysis of this outcome. |
Incomplete outcome data (attrition bias) Minor adverse events | Low risk | Quote: "In the treatment group, 1 participants had drug eruption and 2 participants had sulfenamide crystals in the urine 1 day after cystoscopy (rephrased from table)." Comment: 75/75 randomized participants (37 participants in control arm, 38 participants in intervention arm) were included for analysis of this outcome. |
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. |