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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II, Open-Label Exploratory Study Investigating the Efficacy of Toviaz for Treatment of Adult Patients With Spinal Cord Injury With Neurogenic Detrusor Overactivity for Amelioration of

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 Summary: 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).
Sponsor: University of British Columbia

Current Primary Outcome: Number of participants that experience a decrease in severity of autonomic dysreflexia (AD) from baseline following 12-weeks of study medication. [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants that experience a decrease in the frequency of autonomic dysreflexia (AD) episodes from baseline following 12-weeks of study medication. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 12 weeks ]
  • An improvement from baseline in bowel stool outcomes as reported with the Bristol Stool Scale. [ Time Frame: 12 weeks ]
  • An Improvement from baseline in the ability of the bladder to stretch in response to filling of the bladder as indicated by urodynamic studies (UDS) parameters of bladder volume and pressure on the detrusor muscle.. [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: University of British Columbia

Dates:
Date Received: January 27, 2016
Date Started: February 2016
Date Completion: October 2017
Last Updated: November 1, 2016
Last Verified: November 2016