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| ID | Type | Description | Link |
|---|---|---|---|
| WI207218 | Other Grant/Funding Number | Pfizer Canada Inc |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| International Collaboration on Repair Discoveries | OTHER |
| Vancouver Coastal Health | OTHER_GOV |
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This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD) in patients with spinal cord injuries (SCI). The goal of the study is to examine the effect of increasing daily use of fesoterodine on episodes of high blood pressure triggered by urinary bladder contractions.
This is a Phase 2, open-label exploratory study investigating the efficacy of fesoterodine for treatment of adult patients with spinal cord injuries (SCI) with autonomic dysreflexia (AD) triggered by neurogenic detrusor overactivity (NDO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fesoterodine | Other | Open-Label |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fesoterodine | Drug | 4mg, oral, once daily for 12 weeks; dose adjustments may be permitted. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that experience a decrease in severity of autonomic dysreflexia (AD) from baseline following 12-weeks of study medication. | 12 weeks | |
| Number of participants that experience a decrease in the severity of spontaneously occurring episode of Autonomic Dysreflexia (AD) during the 24 hour Ambulatory Blood Pressure Monitoring (24hr ABPM) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that experience a decrease in the frequency of autonomic dysreflexia (AD) episodes from baseline following 12-weeks of study medication. | 12 weeks | |
| Number of participants that experience an improvement from baseline of self-reported severity and frequency of AD as reported with the Autonomic Dysreflexia Health Related-Quality of Life (AD HR-QoL) questionnaire and reflected by a decrease in score. |
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The inclusion criteria include, but are not limited to, the following:
The exclusion criteria include, but are not limited to, the following:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Krassioukov, MD,PhD,FRCPC | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30467135 | Derived | Walter M, Ramirez AL, Lee AH, Rapoport D, Kavanagh A, Krassioukov AV. Protocol for a phase II, open-label exploratory study investigating the efficacy of fesoterodine for treatment of adult patients with spinal cord injury suffering from neurogenic detrusor overactivity for amelioration of autonomic dysreflexia. BMJ Open. 2018 Nov 21;8(11):e024084. doi: 10.1136/bmjopen-2018-024084. |
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Data collected during the study will be used by the investigator to communicate results of the study to the research community. Data will mostly be communicated as a pooled data set; in the event that individual participant data is communicated, it will be represented with the unique study identifier which does not identify the individual participant.
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| ID | Term |
|---|---|
| D020211 | Autonomic Dysreflexia |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D013118 | Spinal Cord Diseases |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
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| 12 weeks |
| An improvement from baseline of self-reported bladder incontinence as reported with the Incontinence Quality of Life (I-QoL) questionnaire and reflected with an increase in score. | 12 weeks |
| An improvement from baseline of cognitive function as evaluated with the Montreal Cognitive Assessment scale (MoCA) and reflected with a total score at or greater than 26. | 12 weeks |
| An improvement from baseline in bowel stool outcomes as reported with the Bristol Stool Scale. | 12 weeks |
| An Improvement from baseline in the ability of the bladder to stretch in response to filling of the bladder as indicated by Urodynamics Study (UDS) parameters of bladder volume and pressure on the detrusor muscle.. | 12 weeks |
| An improvement from baseline in Cerebral Blood Flow (CBF) during Urodynamics Study (UDS) | 12 weeks |
| D002493 | Central Nervous System Diseases |
| D014947 | Wounds and Injuries |