Spinal Cord Injuries Clinical Trial
Official title:
Efficacy and Tolerability of Mirabegron Compared to Oxybutynin Chloride Immediate Release for Neurogenic Detrusor Overactivity in Persons With Chronic Spinal Cord Injury: A Randomized, Double-Blind, Controlled, Cross-Over Clinical Trial
The purpose of this research study is to determine the effectiveness and safety of mirabegron compared to oxybutynin chloride immediate release (oxybutynin IR) for a condition called neurogenic detrusor overactivity in individuals with chronic spinal cord injury (SCI).
Neurogenic detrusor overactivity or "NDO" is common in people with spinal cord injury (SCI)
and is a medical condition characterized by involuntary urinary bladder contractions. These
bladder contractions can cause episodes of urinary incontinence (involuntary urine leakage)
and/or high bladder pressures that can lead to poor drainage from the kidneys and urinary
tract infections (UTIs).
Neurogenic detrusor overactivity is most commonly treated with a medication called oxybutynin
(Ditropan); however, this medication is associated with side effects such as dry mouth and
constipation. Mirabegron (Myrbetriq) is a newer medication approved by the Food and Drug
Administration for the treatment of overactive bladder that does not cause dry mouth or
constipation; however, its use in persons with SCI is investigational.
The purpose of this research study is to determine the effectiveness and safety of mirabegron
compared to oxybutynin chloride immediate release (oxybutynin IR) for neurogenic detrusor
overactivity in individuals with SCI.
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