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Randomized Controlled Trial
. 2023 Dec;34(12):3051-3058.
doi: 10.1007/s00192-023-05669-0. Epub 2023 Oct 18.

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

Felício Savioli Neto  1 , Helena Hachul  2 , Márcio Antônio Pereira  3 , Carlos Isaia Filho  4
Affiliations
Randomized Controlled Trial

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

Felício Savioli Neto et al. Int Urogynecol J. 2023 Dec.

Abstract

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.

Keywords: Dysuria; Methenamine; Non-antibiotic strategies; Pain; Urinary tract infections.

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Conflict of interest statement

All authors were principal investigators of their respective research centers and received a fee for including patients in the study.

Figures

Fig. 1
Fig. 1
Flow diagram of the study population. ITT intention to treat, PP per protocol
Fig. 2
Fig. 2
Investigator's evaluation of dysuria according to the Clinical Global Impression scale
See this image and copyright information in PMC

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