Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)

Last updated: April 17, 2019
Sponsor: Allergan
Overall Status: Completed

Phase

3

Condition

Multiple Sclerosis

Enuresis

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT01600716
191622-117
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 3 episodes of urinary incontinence over a 3-day period

  • History of Multiple Sclerosis (MS)

  • Urinary incontinence not adequately controlled by anticholinergic medication

Exclusion

Exclusion Criteria:

  • Current use of intermittent catheter or indwelling catheter to manage urinaryincontinence

  • Previous or current botulinum toxin therapy of any serotype for any urologicalcondition

  • Previous or current botulinum toxin therapy of any serotype for any non-urologicalcondition within the last 12 weeks

  • Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic LateralSclerosis

Study Design

Total Participants: 144
Study Start date:
June 13, 2012
Estimated Completion Date:
March 27, 2015

Connect with a study center

  • Liege,
    Belgium

    Site Not Available

  • Victoria, British Columbia
    Canada

    Site Not Available

  • Kitchener, Ontario
    Canada

    Site Not Available

  • Olomouc,
    Czechia

    Site Not Available

  • Garches,
    France

    Site Not Available

  • Marseille,
    France

    Site Not Available

  • Warsaw,
    Poland

    Site Not Available

  • empty

    Wroclaw,
    Poland

    Site Not Available

  • Porto,
    Portugal

    Site Not Available

  • empty

    Moscow,
    Russian Federation

    Site Not Available

  • St. Petersburg,
    Russian Federation

    Site Not Available

  • Mountlake Terrace, Washington
    United States

    Site Not Available

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