Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01600716
Recruitment Status : Completed
First Posted : May 17, 2012
Results First Posted : March 22, 2016
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE May 15, 2012
First Posted Date  ICMJE May 17, 2012
Results First Submitted Date  ICMJE February 17, 2016
Results First Posted Date  ICMJE March 22, 2016
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE June 13, 2012
Actual Primary Completion Date April 4, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes [ Time Frame: Baseline, Week 6 ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2012)
Number of Urinary Incontinence Episodes [ Time Frame: Week 6 ]
Change History Complete list of historical versions of study NCT01600716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
  • Change From Baseline in Maximum Cystometric Capacity (MCC) [ Time Frame: Baseline, Week 6 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2012)
  • Maximum Cystometric Capacity (MCC) [ Time Frame: Week 6 ]
  • Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) [ Time Frame: Week 6 ]
  • Incontinence Quality of Life Instrument (I-QOL) Total Summary Score [ Time Frame: Week 6 ]
Current Other Pre-specified Outcome Measures
 (submitted: May 11, 2016)
Duration of Treatment Effect Through Week 52 [ Time Frame: Up to 52 Weeks ]
The duration of treatment effect is the time to patient request for retreatment.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE Not Provided
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Urinary Incontinence
  • Multiple Sclerosis
  • Neurogenic Bladder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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)
Publications * Tullman M, Chartier-Kastler E, Kohan A, Keppenne V, Brucker BM, Egerdie B, Mandle M, Nicandro JP, Jenkins B, Denys P. Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS. Neurology. 2018 Aug 14;91(7):e657-e665. doi: 10.1212/WNL.0000000000005991. Epub 2018 Jul 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2016)
144
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2012)
184
Actual Study Completion Date  ICMJE March 27, 2015
Actual Primary Completion Date April 4, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   France,   Poland,   Portugal,   Russian Federation,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01600716
Other Study ID Numbers  ICMJE 191622-117
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date April 2019

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