A Double Blind, Randomized Study of Safety and Efficacy of OnabotulinumtoxinA (OnaBoNT A) versus Oral Oxybutynin in SCI Patients with NDO (11 09 10 04)
Technical Report,30 Sep 2015,29 Sep 2016
Baylor College of Medicine Houston United States
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The purpose is to evaluate the safety and efficacy of 200 U OnaBoNT-A injected into the detrusor versus oral oxybutynin for the treatment of urinary incontinence UI caused by neurogenic detrusor overactivity NDO in spinal cord injured volunteers and 2 To determine the potential role of urine biomarkers as patient selection and surrogate endpoints of treatment outcome predictors. Thirty-six patients will be randomized to two treatment groups. The first patient was enrolled to the study at The Institute of Rehabilitation and Research TIRR on June 17, 2016. A total of three patients have been consented to date at TIRR with one being a screen failure. Two are continuing on protocol with each having been injected with the study drug. Enrollment is continuing. The study was closed at the Michael E. DeBakey Veterans Affairs Medical Center Houston in July 2016 due to lack of accrual.