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| Name | Class |
|---|---|
| Ontario Neurotrauma Foundation | OTHER |
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This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin Hydrobromide) with one standard drug (Oxybutynin Chloride) for treatment of overactive bladder in individuals with spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin Cl | Active Comparator |
| |
| Trospium Cl | Active Comparator |
| |
| Darifenacin Hydrogren Bromide (HBr) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin Cl | Drug | 15 mg qd for 3 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Incontinence Episodes | 3 days | |
| Adverse Event Reporting | Each Study Visit and Follow-up Phone Call |
| Measure | Description | Time Frame |
|---|---|---|
| Urodynamic Study | Baseline and 3 months | |
| Questionnaires | Monthly |
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Inclusion Criteria:
Male or female patients, between 18 and 75 years of age. Female patients of childbearing potential* must have a negative urine pregnancy test result on the day of Screening Visit and practice a reliable method of contraception**
*A female is considered of childbearing potential unless she is:
Postmenopausal for at least 12 months prior to study drug administration;
Without a uterus and/or both ovaries; or
Has been surgically sterilized for at least 6 months prior to study drug administration.
**Reliable methods of contraception include:
Hormonal methods or intrauterine device in use at least 30 days prior to study drug administration;
Barrier methods plus spermicidal in use at least 14 days prior to study drug administration; or
Sexual abstinence as a lifestyle.
Patients with a neurogenic bladder and detrusor overactivity secondary to a spinal cord injury.
Patients with serum creatinine within normal limits and normal renal function
Patients on a stable dose (minimum one month) of concomitant medication for Neurogenic detrusor overactivity
Patients must have adequate cognitive function to understand the requirements of the study, including completing questionnaires and signing a written Informed Consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magdy Hassouna, MD | Toronto Rehabilitation Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba, Health Sciences Centre | Winnipeg | Manitoba | R3A1R9 | Canada | ||
| Toronto Rehabilitation Institute, Lyndhurst Centre |
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| Label | URL |
|---|---|
| Ontario Neurotrauma Foundation | View source |
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| Trospium Cl | Drug | 20mg bid for 3 months |
|
|
| Darifenacin Hydrogen Bromide (HBr) | Drug | 15 mg qd for 3 months |
|
|
| Toronto |
| Ontario |
| M4G 3V9 |
| Canada |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C101207 | darifenacin |
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