Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

Urinary Tract Infections Clinical Trial

Official title: Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

Status Completed

Clinical Trial Summary

This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). Subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for three days, followed by three days of antibiotic therapy as determined by urine culture and antibiogram. This study aims to assess the efficacy and safety of each treatment.

Clinical Trial Description

This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). After initial evaluations including urine culture and antibiogram, a total of 284 subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for six days. After three days of treatment, subjects will return to the study center and antibiotic therapy based on the results of the urine culture and antibiogram will be initiated for each subject, to be continued for the remaining three days of the treatment period. Efficacy assessments will include the UTISA (Urinary Tract Infection Symptoms Assessment Questionnaire) together with a global assessment by the investigator. Safety assessments will include monitoring of adverse events and laboratory tests carried out at each of the three study visits. ;

Related Conditions & MeSH terms

• Cystitis
• Urinary Tract Infections

• NCT number: NCT03379389
• Study type: Interventional
• Source: Fundação Educacional Serra dos Órgãos
• Status: Completed
• Phase: Phase 4
• Start date: March 31, 2018
• Completion date: June 1, 2021