Efficacy of methenamine with methylthioninium in the treatment of dysuria: a randomized clinical study.

INTRODUCTION AND HYPOTHESIS: Dysuria is a common symptom present in several urological and gynecological conditions. Management relies on the underlying disease but may require additional symptomatic treatment. This study evaluated the combination of methenamine 250 mg and methylthioninium chloride 20 mg in the treatment of dysuria versus phenazopyridine. METHODS: This was a multicenter, single-blind, randomized, superiority clinical trial, including individuals over 18 with dysuria and a score ≥ 5 points on the pre-treatment categorical scale for pain. The primary outcome was the proportion of participants presenting excellent clinical response within 24 h after treatment. Improvement up to 72 h, time to reach improvement, sustained healing, investigators' opinion, and safety were also evaluated. RESULTS: Three hundred and fifteen participants were evaluated. Demographic characteristics and symptoms of dysuria were comparable between groups at baseline. The difference in the excellent response rate between treatments within 24 h was 12.7% (95% CI 6.16, 19.21) for pain, 9.4% (95% CI 3.32, 15.39) for burning, and 12.7% (95% CI 6.37, 18.99) for burning on urination, all in favor of the test drug, which was also superior from 36 to 48 h. Treatments were similar concerning time to reach the absence of symptoms and in the percentage of participants with sustained healing after 72 h. CONCLUSIONS: The association of methenamine with methylthioninium is superior to phenazopyridine in the treatment of dysuria.

Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 microg and ethinylestradiol 15 microg (Minesse).

OBJECTIVE: A prospective, open-label, noncomparative, multicenter study was carried out in 163 women aged 18-39 (mean 25+/-5 years), who used an ultra-low-dose oral contraceptive pill (OCP) containing gestodene (GTD) 60 mug/ethinylestradiol (EE) 15 mug for 6 months. The objective of the study was to evaluate the acceptability, safety, bleeding patterns and premenstrual symptomatology in these women. METHODS: Patients used the OCP from Days 1-24, followed by a 4-day pill-free interval from Days 25-28 of the menstrual cycle. Physical and gynecological examinations were carried out at baseline and after 3 and 6 months, at which time blood pressure, weight, hemoglobin, hematocrit, SGOT, SGPT and urinalysis were also assessed. The Moos Menstrual Distress Questionnaire (MDQ) was completed on three consecutive days (Days 25-27 of the cycle) at baseline and at the end of the third and sixth cycles. Patients kept a menstrual diary throughout the study. RESULTS: A total of 146 women completed the study. Ten women discontinued because of adverse events and one undesired pregnancy occurred during treatment. No adverse metabolic effects were observed. The adverse event most frequently reported was breakthrough bleeding, which diminished, however, as the time of OC use increased. Cycle length and duration of bleeding decreased significantly with OC use (p<.01 and p<.05, respectively, after 6 months). Intensity of menstrual bleeding tended to decrease with OC use, but this difference was not statistically significant. Systolic and diastolic blood pressure were significantly lower after 6 months of OC use compared to baseline (p<.02). No alterations were recorded in body weight or laboratory evaluations. Statistically significant changes were found both in the total MDQ score and in several of the factors evaluated, and patients showed a statistically significant improvement in well-being with respect to premenstrual complaints and symptoms. CONCLUSION: This OC regimen is safe, well-accepted and well-tolerated, affects menstrual patterns beneficially by reducing both the intensity and duration of bleeding, provides good cycle control and improves premenstrual symptomatology.