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)

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 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.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2016
Accession Number
AD1023989

Entities

People

  • Christopher P. Smith

Organizations

  • Baylor College of Medicine

Tags

DTIC Thesaurus Topics

  • Biological Factors
  • Chemistry
  • Health Services
  • Kidney Diseases
  • Medical Personnel
  • Peptide Growth Factors
  • Peptides
  • Proteins
  • Therapy
  • Urinary Tract

Fields of Study

  • Medicine

Readers

  • Clinical Trial Research.
  • Neurotrauma and Rehabilitation Medicine.