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

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).

The inclusion criteria include, but are not limited to, the following:

• Male or female, 18 - 60 years of age
• Chronic traumatic SCI at or above T6 spinal segment and >1 year post injury
• Documented presence of AD and NDO during UDS
• Hand function sufficient to perform CIC or a committed caregiver to provide CIC for management of urinary bladder drainage
• Patients must have documented two weeks of bladder and bowel history prior to their baseline visit
• Willing and able to comply with all clinic visits and study-related procedures
• Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
• Women of childbearing potential must not be intended to become pregnant, currently pregnant, or lactating. The following conditions apply:
• Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.
• Women of childbearign potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
• Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment
• Must Provide Informed Consent

The exclusion criteria include, but are not limited to, the following:

• Presence of severe acute medical issue that in the investigator's judgement would adversely affect the patient's participation in the study
• A hypersensitivity to tolterodine (available as Detrol, Detrol LA), soya, peanuts, or lactose
• Recent treatment with intravesical OnabotulinumtoxinA (within 9 months of the baseline visit)
• Recent treatment with other anticholinergics medications (within 3 weeks of the baseline visit)
• Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the patient to participate in this study
• Patient is a member of the investigational team or his /her immediate family