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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methenamine + Methylthioninium | Experimental | Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days |
|
| Methenamine+Methylthioninium+Acriflavine+Atropa belladona | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methenamine + Methylthioninium | Drug | Methenamine + Methylthioninium |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| UTISA question # 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| carlos p nunes, MD | Fundação Educacional Serra dos Órgãos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Universitário Serra dos Órgãos - UNIFESO | Teresópolis | Rio de Janeiro | 25964004 | Brazil |
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| Methenamine + Methylthioninium + Acriflavine + Atropa belladona | Drug | Methenamine + Methylthioninium + Acriflavine + Atropa belladona |
|
|
| Antibiotics | Drug | Antibiotics based on individual subjects urine culture / antibiogram |
|
|
Percentage of subjects with improvement in UTISA question 9 at Visit 2 in each treatment group
| At Visit 2, after 3 days of treatment |
| Adverse events | Incidence of study drug-related adverse events in each treatment group | 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 | After 3 days of treatment |
| Problems with Urination at Visit 3 | Evolution of UTISA domain "Problems with Urination" in each treatment Group | After 6 days of treatment |
| Pain Associated with UTI at Visit 2 | Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group | After 3 days of treatment |
| Pain Associated with UTI at Visit 3 | Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group | After 6 days of treatment |
| Blood in Urine at Visit 2 | Evolution of UTISA domain "Blood in Urine" in each treatment Group | After 3 days of treatment |
| Blood in Urine at Visit 3 | Evolution of UTISA domain "Blood in Urine" in each treatment Group | After 6 days of treatment |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D008709 | Methenamine |
| D008751 | Methylene Blue |
| D000167 | Acriflavine |
| D000900 | Anti-Bacterial Agents |
| D000890 | Anti-Infective Agents |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000609 | Aminoacridines |
| D000166 | Acridines |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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