NCT03379389

Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Fundação Educacional Serra dos Órgãos · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Methenamine + Methylthioninium	Methenamine + Methylthioninium
DRUG	Methenamine + Methylthioninium + Acriflavine + Atropa belladona	Methenamine + Methylthioninium + Acriflavine + Atropa belladona
DRUG	Antibiotics	Antibiotics based on individual subjects urine culture / antibiogram

Timeline

• Start date: 2018-03-31
• Primary completion: 2019-05-01
• Completion: 2021-06-01
• First posted: 2017-12-20
• Last updated: 2021-12-14

Locations

1 site across 1 country: Brazil