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

Mendoza 1971.

Methods Study design: double‐blind, randomized controlled study
Study dates: not reported
Setting: all participants hospitalized and examined daily
Country: USA
Participants Inclusion criteria: not reported
Exclusion criteria: severe renal impairment, active severe cystitis, or known allergy to the active drug used
Sample size: 2 trials of men were studied. In each trial, 30 participants were treated with an active drug and 30 with a placebo
Age: not reported
Sex: men
Interventions Trial A
Group 1 (n = 30): sulphamethoxypyridazine‐pyridazine, initial dose 1 g, and then 0.5 g, daily for 3 days
Group 2 (n = 30): placebo
Trial B
Group 3 (n = 30): demeclocycline hydrochloride 150 mg 4 times a day for 4 days
Group 4 (n = 30): placebo
Outcomes Bacteriuria
How measured: positive culture indicating presence of an organism usually considered pathogenic
Time points measured: prior to cystoscopic examination and 1, 3, and 4 days after instrumentation each participant had a urine culture
Time points reported: not reported
Outcomes: in trial A, no statistically significant difference in any category between participants in terms of bacteriuria. In trial B, more cultures remained negative after demeclocycline hydrochloride than after placebo (20/22 vs 11/21). For participants who were initially totally asymptomatic, i.e. had no abnormal clinical symptoms or laboratory findings. In trial A, 6/8 participants in placebo group and 1/11 participants in treatment group had bacteriuria. In trial B, 4/9 participants in placebo group and 0 participants in treatment group 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: "Active drugs and placebos were administered in capsule form, coded and assigned randomly to patients."
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 Low risk Quote: "Active drugs and placebos were administered in capsule form, coded and assigned randomly to participants, participants and personnel were likely to be blinded."
Comment: blinding of participants and personnel performed adequately.
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.