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Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)

Phase 2
Completed
Conditions
Autonomic Dysreflexia
Interventions
Registration Number
NCT02676154
Lead Sponsor
University of British Columbia
Brief Summary

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.

Detailed Description

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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
FesoterodineFesoterodineOpen-Label
Primary Outcome Measures
NameTimeMethod
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
Number of participants that experience a decrease in severity of autonomic dysreflexia (AD) from baseline following 12-weeks of study medication.12 weeks
Secondary Outcome Measures
NameTimeMethod
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.12 weeks
An improvement from baseline in bowel stool outcomes as reported with the Bristol Stool Scale.12 weeks
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
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 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 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 in Cerebral Blood Flow (CBF) during Urodynamics Study (UDS)12 weeks

Trial Locations

Locations (1)

University of British Columbia

🇨🇦

Vancouver, British Columbia, Canada

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