A Phase 4 interventional study of Methenamine + Methylthioninium and Methenamine + Methylthioninium + Acriflavine + Atropa belladona in Urinary Tract Infections, sponsored by Fundação Educacional Serra dos Órgãos. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-14.
Sponsored by Fundação Educacional Serra dos Órgãos · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days
Drug: Methenamine + Methylthioninium · Drug: Antibiotics
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
Drug: Methenamine + Methylthioninium + Acriflavine + Atropa belladona · Drug: Antibiotics
Methenamine + Methylthioninium
Also known as: methenamine + methylene blue
Methenamine + Methylthioninium + Acriflavine + Atropa belladona
Also known as: methenamine + methylene blue + acriflavine + A. belladona
Antibiotics based on individual subjects urine culture / antibiogram
Also known as: Antimicrobials
Urination regularity
Percentage of subjects presenting improvement in cystitis symptoms in the "Urination Regularity" domain of the UTISA at Visit 2.
Time frame: Following three days of treatment with urinary antiseptics
Total UTISA score
Evolution of total UTISA score at end of study compared to pretreatment in each treatment group
Time frame: From pretreatment to final visit, total of 6 days of treatment
UTISA question # 9
Percentage of subjects with improvement in UTISA question 9 at Visit 2 in each treatment group
Time frame: At Visit 2, after 3 days of treatment
Adverse events
Incidence of study drug-related adverse events in each treatment group
Time frame: From pretreatment to final visit, total of 6 days of treatment
Problems with Urination at Visit 2
Evolution of UTISA domain "Problems with Urination" in each treatment Group
Time frame: After 3 days of treatment
Problems with Urination at Visit 3
Evolution of UTISA domain "Problems with Urination" in each treatment Group
Time frame: After 6 days of treatment
Pain Associated with UTI at Visit 2
Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
Time frame: After 3 days of treatment
Pain Associated with UTI at Visit 3
Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
Time frame: After 6 days of treatment
Blood in Urine at Visit 2
Evolution of UTISA domain "Blood in Urine" in each treatment Group
Time frame: After 3 days of treatment
Blood in Urine at Visit 3
Evolution of UTISA domain "Blood in Urine" in each treatment Group
Time frame: After 6 days of treatment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundação Educacional Serra dos Órgãos