Skip to Main Content
Phase III

OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients

  • Study HIC#:1409014633
  • Last Updated:07/15/2021

This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to overactive bladder in pediatric patients between the ages of 12 to 17 years who have not been adequately managed with anticholinergics.

  • Age12 years - 17 years
  • GenderBoth
  • Start Date01/02/2015
  • End Date12/31/2018

Trial Purpose and Description

To evaluate the safety and efficacy of BOTOX for the treatment of urinary incontinence due to overactive bladder (OAB) in patients 12 to 17 years of age who have not been adequately managed with anticholinergic therapy. To evaluate the safety and efficacy of repeated BOTOX treatments in this patient population

Eligibility Criteria

Criteria

Inclusion Criteria:

  • Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
  • OAB symptoms not adequately managed by 1 or more anticholinergic agents

Exclusion Criteria:

  • OAB caused by a neurological condition
  • Use of anticholinergics or other medications to treat OAB symptoms within 7 days
  • Current use of indwelling catheter or clean intermittent catheterization to empty the bladder
  • Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
  • Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

Sub-Investigator

For more information about this study, contact:

Or contact the Help us Discover team on: