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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01600716
First received: May 15, 2012
Last updated: May 11, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Urinary Incontinence
Multiple Sclerosis
Neurogenic Bladder
Biological: OnabotulinumtoxinA
Drug: Placebo (Normal Saline)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).


Secondary Outcome Measures:
  • Change From Baseline in Maximum Cystometric Capacity (MCC) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds.

  • Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure.

  • Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening.


Other Outcome Measures:
  • Duration of Treatment Effect Through Week 52 [ Time Frame: Up to 52 Weeks ] [ Designated as safety issue: No ]
    The duration of treatment effect is the time to patient request for retreatment.


Enrollment: 144
Study Start Date: June 2012
Study Completion Date: March 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OnabotulinumtoxinA
OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA 100 U injection.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Placebo (Normal Saline)
Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Drug: Placebo (Normal Saline)
Placebo (normal saline) is administered into the detrusor at Day 1.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Criteria:

  • Current use of intermittent catheter or indwelling catheter to manage urinary incontinence
  • Previous or current botulinum toxin therapy of any serotype for any urological condition
  • Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks
  • Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600716

Locations
United States, Washington
Mountlake Terrace, Washington, United States
Belgium
Liege, Belgium
Canada, British Columbia
Victoria, British Columbia, Canada
Canada, Ontario
Kitchener, Ontario, Canada
Czech Republic
Olomouc, Czech Republic
France
Garches, France
Marseille, France
Poland
Warsaw, Poland
Portugal
Porto, Portugal
Russian Federation
St. Petersburg, Russian Federation
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01600716     History of Changes
Other Study ID Numbers: 191622-117 
Study First Received: May 15, 2012
Results First Received: February 17, 2016
Last Updated: May 11, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Urinary Incontinence
Enuresis
Urinary Bladder, Neurogenic
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Neurologic Manifestations
Urinary Bladder Diseases
Botulinum Toxins
Botulinum Toxins, Type A
AbobotulinumtoxinA
OnabotulinumtoxinA
IncobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 24, 2016