Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundação Educacional Serra dos Órgãos
• Collaborator: Laboratório Gross S.A.
• Treatments: Acriflavine; Anti-Bacterial Agents; Methenamine; Methenamine hippurate; Methenamine mandelate; Methylene Blue

Criteria

Inclusion Criteria:

• Patients of both sexes, age ≥18

• Clinical diagnosis of recurrent cystitis (≥ 2 episodes in the past 6 months)

• Female subject of reproductive age not pregnant, agrees to use birth control during study period

• Subject has read, understood, signed and dated informed consent document

Exclusion Criteria:

• History of nephritis or kidney stones

• History of hepatic or gastrointestinal disease

• Diabetes

• Glaucoma

• Female subjects: pregnancy or breastfeeding

• History of anatomical alterations contributing to recurring cystitis on imaging exams

• Hypersensitivity to any component of study drug