Intervention
urinary bacterial infection
Group 1 received the investigational drug, consisting of the combination of methenamine 250 mg and methylthioninium chloride 20 mg (EMS, Hortolândia, Brazil), two tablets by oral route every 8 h for 3 days. Group 2 received the comparator, consisting of phenazopyridine hydrochloride 100 mg (Pyridium®, Zodiac), two pills via the oral route every 8 h for 3 days.Laboratory tests were carried out at the beginning and the end of the study and comprised blood count, biochemistry, urine analysis, and urine culture with antibiogram. Participants had two visits to the research center: V1 (beginning of treatment) and V2 (4 days ± 1). Adjuvant therapy was acceptable in the case of urinary bacterial infection confirmed by urine culture, with ciprofloxacin 250 mg (Proflox®; EMS) twice a day for 3 days, given at V2, and two extra visits were required: V3 (7 days ± 1) and V4 (12 ± 1). Those who used an analgesic during the study were excluded from the trial, and their data were analyzed only for safety.