Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
- Conditions
- Urinary Tract Infections
- Interventions
- Registration Number
- NCT03379389
- Lead Sponsor
- Fundação Educacional Serra dos Órgãos
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 284
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methenamine + Methylthioninium Methenamine + Methylthioninium Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days Methenamine+Methylthioninium+Acriflavine+Atropa belladona Methenamine + Methylthioninium + Acriflavine + Atropa belladona 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 Methenamine+Methylthioninium+Acriflavine+Atropa belladona 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 Methenamine + Methylthioninium Antibiotics Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days
- Primary Outcome Measures
Name Time Method Urination regularity Following three days of treatment with urinary antiseptics Percentage of subjects presenting improvement in cystitis symptoms in the "Urination Regularity" domain of the UTISA at Visit 2.
- Secondary Outcome Measures
Name Time Method Total UTISA score From pretreatment to final visit, total of 6 days of treatment Evolution of total UTISA score at end of study compared to pretreatment in each treatment group
Adverse events From pretreatment to final visit, total of 6 days of treatment Incidence of study drug-related adverse events in each treatment group
Problems with Urination at Visit 3 After 6 days of treatment Evolution of UTISA domain "Problems with Urination" in each treatment Group
UTISA question # 9 At Visit 2, after 3 days of treatment Percentage of subjects with improvement in UTISA question 9 at Visit 2 in each treatment group
Blood in Urine at Visit 3 After 6 days of treatment Evolution of UTISA domain "Blood in Urine" in each treatment Group
Problems with Urination at Visit 2 After 3 days of treatment Evolution of UTISA domain "Problems with Urination" in each treatment Group
Pain Associated with UTI at Visit 3 After 6 days of treatment Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
Blood in Urine at Visit 2 After 3 days of treatment Evolution of UTISA domain "Blood in Urine" in each treatment Group
Pain Associated with UTI at Visit 2 After 3 days of treatment Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
Trial Locations
- Locations (1)
Centro Universitário Serra dos Órgãos - UNIFESO
🇧🇷Teresópolis, RJ, Brazil