A Double-Blind, Randomized Study of Safety and Efficacy of OnabotulinumtoxinA (OnaBoNT-A) Versus Oral Oxybutynin in SCI Patients with NDO

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 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.

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Document Details

Document Type
Technical Report
Publication Date
Dec 01, 2018
Accession Number
AD1095085

Entities

People

  • Christopher P. Smith

Organizations

  • Baylor College of Medicine

Tags

DTIC Thesaurus Topics

  • Alkynes
  • Biological Factors
  • Biological Markers
  • Biomedical Research
  • Data Sets
  • Department Of Defense
  • Electronic Mail
  • Growth Factors
  • Health Services
  • Institutional Review Board
  • Medical Personnel
  • Proteins
  • Quality Of Life
  • Rehabilitation
  • Side Effects
  • Spinal Cord
  • Standards

Fields of Study

  • Medicine

Readers

  • Clinical Trial Research.
  • Neurotrauma and Rehabilitation Medicine.