Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

Fundação Educacional Serra dos Órgãos

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infections

Treatments: Drug: Antibiotics; Drug: Methenamine + Methylthioninium + Acriflavine + Atropa belladona; Drug: Methenamine + Methylthioninium

Study type: Interventional

Funder types: Other

Identifiers

NCT03379389

AUCR-01-05-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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284 participants in 2 patient groups

Methenamine + Methylthioninium

Experimental group

Description:

Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days

Treatment:

Drug: Methenamine + Methylthioninium

Drug: Antibiotics

Methenamine+Methylthioninium+Acriflavine+Atropa belladona

Active Comparator group

Description:

Dosage: Methenamine (250mg) + Methylthioninium (20mg) + Acriflavine hydrochloride (15mg) + Atropa belladonna L. (15mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days

Treatment:

Drug: Methenamine + Methylthioninium + Acriflavine + Atropa belladona

Drug: Antibiotics