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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379389
• Other study ID #: AUCR-01-05-17
• Status: Completed
• Phase: Phase 4
• Start date: March 31, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: November 2021
• Source: Fundação Educacional Serra dos Órgãos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Urinary Tract Infections

Intervention

Drug:
• Methenamine + Methylthioninium
Methenamine + Methylthioninium
• Methenamine + Methylthioninium + Acriflavine + Atropa belladona
Methenamine + Methylthioninium + Acriflavine + Atropa belladona
• Antibiotics
Antibiotics based on individual subjects urine culture / antibiogram

Locations

Country	Name	City	State
Brazil	Centro Universitário Serra dos Órgãos - UNIFESO	Teresópolis	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Fundação Educacional Serra dos Órgãos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urination regularity	Percentage of subjects presenting improvement in cystitis symptoms in the "Urination Regularity" domain of the UTISA at Visit 2.	Following three days of treatment with urinary antiseptics
Secondary	Total UTISA score	Evolution of total UTISA score at end of study compared to pretreatment in each treatment group	From pretreatment to final visit, total of 6 days of treatment
Secondary	UTISA question # 9	Percentage of subjects with improvement in UTISA question 9 at Visit 2 in each treatment group	At Visit 2, after 3 days of treatment
Secondary	Adverse events	Incidence of study drug-related adverse events in each treatment group	From pretreatment to final visit, total of 6 days of treatment
Secondary	Problems with Urination at Visit 2	Evolution of UTISA domain "Problems with Urination" in each treatment Group	After 3 days of treatment
Secondary	Problems with Urination at Visit 3	Evolution of UTISA domain "Problems with Urination" in each treatment Group	After 6 days of treatment
Secondary	Pain Associated with UTI at Visit 2	Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group	After 3 days of treatment
Secondary	Pain Associated with UTI at Visit 3	Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group	After 6 days of treatment
Secondary	Blood in Urine at Visit 2	Evolution of UTISA domain "Blood in Urine" in each treatment Group	After 3 days of treatment
Secondary	Blood in Urine at Visit 3	Evolution of UTISA domain "Blood in Urine" in each treatment Group	After 6 days of treatment