Primary outcome
dysuria, pain
Groups 1 and 2 showed statistically significant improvement in the three symptomatic components of dysuria within 24 h of treatment evaluated with the categorical scale. They were 15.19% in group 1 without pain, 12.03% without burning, and 15.19% without burning on urination versus 3.21%, 3.21%, and 2.56% in group 2 respectively (Table Evaluation of dysuria: pain, burning, and burning on urination within 24 hIn group 1, 16% of participants presented excellent clinical response for pain within 24 h, versus 3.31% in group 2. The difference between groups was 12.69% (95% CI 6.16, 19.21%). In the evaluation of burning, 12.67% of group 1 showed excellent clinical response, versus 3.31% in group 2, a difference of 9.36% (95% CI 3.32, 15.39%). 15.33% of group 1 showed an excellent clinical response in burning on urination versus 2.65% in group 2, a difference of 12.68% (95% CI 6.37, 18.99%). As the lower limit of 95% CI of the difference in the excellent response between the two treatments was greater than 1.85% in all components of dysuria, the test drug was superior to the comparator.The evaluation of primary outcome in the per protocol (PP) population showed similar results for the three components: pain (95% CI 6.63%, 20.66%), burning (95% CI 3.54%, 16.55%), and burning on urination (95% CI 6.87%, 20.43%).