Urinary Tract Infections
Conditions
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.
Interventions
DRUGMethenamine + Methylthioninium
Methenamine + Methylthioninium
DRUGMethenamine + Methylthioninium + Acriflavine + Atropa belladona
Methenamine + Methylthioninium + Acriflavine + Atropa belladona
DRUGAntibiotics
Antibiotics based on individual subjects urine culture / antibiogram
Sponsors
Fundação Educacional Serra dos Órgãos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 2 | After 3 days of treatment | Evolution of UTISA domain Problems with Urination 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 |
| 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 |
| 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 |
| Blood in Urine at Visit 3 | After 6 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 |
Countries
Brazil
Outcome results
None listed