Accession Number:

AD1041778

Title:

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)

Descriptive Note:

Technical Report,30 Sep 2016,29 Sep 2017

Corporate Author:

Baylor College of Medicine Houston United States

Personal Author(s):

Report Date:

2017-10-01

Pagination or Media Count:

252.0

Abstract:

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 over activity 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 thirteen patients have been consented to date at TIRR. Three have completed the study. Three 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.

Subject Categories:

  • Medicine and Medical Research
  • Anatomy and Physiology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE