OnaBoNT-A vs Oxybutynin for Bladder Overactivity in SCI Patients (Veterans) (H-26296)
A Double-Blind, Randomized Study of the Safety and Efficacy of OnabotulinumtoxinA (OnaBoNT-A) Versus Oral Oxybutynin in Spinal Cord Injured Veterans With Neurogenic Detrusor Overactivity (Protocol Number 11-09-10-04)
Overactive bladder is a condition associated with symptoms of feeling the urge to urinate, urinating often, and may or may not be accompanied by leakage of urine. A patient who has a spinal cord injury (SCI) often suffers from an overactive bladder which often leads to urinary incontinence (UI - an unwanted leakage of urine). This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when injected into the bladder for the treatment of UI and if it works better than a drug that is taken by mouth. The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or placebo bladder injection and oxybutynin ER (like Ditropan) capsule once a day. Placebo contains no active medicine. Participation in this study will be about 24 weeks and involve 5 visits to the clinic.
For more information: http://clinicaltrials.gov/ct2/show/NCT01050114