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

May 15, 2012
May 11, 2016
June 2012
April 2014   (final data collection date for primary outcome measure)
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).
Number of Urinary Incontinence Episodes [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01600716 on ClinicalTrials.gov Archive Site
  • 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.
  • Maximum Cystometric Capacity (MCC) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Incontinence Quality of Life Instrument (I-QOL) Total Summary Score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
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.
Not Provided
 
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)
Not Provided
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Urinary Incontinence
  • Multiple Sclerosis
  • Neurogenic Bladder
  • 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.
  • 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.
    Intervention: Biological: OnabotulinumtoxinA
  • 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.
    Interventions:
    • Biological: OnabotulinumtoxinA
    • Drug: Placebo (Normal Saline)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
March 2015
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Czech Republic,   France,   Poland,   Portugal,   Russian Federation
 
NCT01600716
191622-117
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP