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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older people with overactive bladder and mild cognitive impairment.
This is a randomized placebo controlled, blinded four way cross over trial of the effect of medications used to treat overactive bladder on the cognition of older men and women with mild cognitive impairment. Each treatment phase is a week, with a weeks washout period before starting the next treatment. Cognitive testing is by way of a validated computer assisted battery of tests
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fesoterodine 4mg daily | Experimental | fesoterodine 4mg oral |
|
| Fesoterodine 8mg | Experimental | Fesoterodine 8mg in form of 2, 4mg tablets |
|
| oxybutynin | Active Comparator | oxybutynin immediate release, encapsulated 2, 5mg capsules daily |
|
| placebo capsule | Placebo Comparator | placebo capsule, 2 per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fesoterodine 4mg | Drug | 7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| continuity of attention | Continuity of Attention: Accuracy of responding in Choice Reaction Time task Percent Target Detection in Digit Vigilance task False Alarms in Digit Vigilance task | 1 and 4h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| cognitive function | includes the following domains of cognition
| 1 and 4h post last dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian S Wagg, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp | Edmonton | Alberta | T6G 2P4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23332882 | Background | Wagg A, Dale M, Tretter R, Stow B, Compion G. Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study. Eur Urol. 2013 Jul;64(1):74-81. doi: 10.1016/j.eururo.2013.01.002. Epub 2013 Jan 11. | |
| 19747069 |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
| C005419 | oxybutynin |
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|
| Oxybutynin | Drug | 5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo |
|
|
| placebo | Drug | placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes |
|
|
| fesoterodine 8mg | Drug | 2, 4mg fesoterodine capsules taken together in the morning |
|
|
| Wesnes KA, Edgar C, Tretter RN, Bolodeoku J. Exploratory pilot study assessing the risk of cognitive impairment or sedation in the elderly following single doses of solifenacin 10 mg. Expert Opin Drug Saf. 2009 Nov;8(6):615-26. doi: 10.1517/14740330903260790. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |