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Trial record 1 of 1 for:    Allergan GMA-OAB-113
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OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder (COMFORT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01945489
First Posted: September 18, 2013
Last Update Posted: November 6, 2017
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.
Information provided by (Responsible Party):
Allergan
  Purpose
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

Condition Intervention Phase
Overactive Bladder Biological: onabotulinumtoxinA Drug: Normal saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes [ Time Frame: Baseline, Week 12 ]
    Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.

  • Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence [ Time Frame: Baseline, Week 12 ]
    Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.


Secondary Outcome Measures:
  • Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores [ Time Frame: Baseline, Week 12 ]
    The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening.

  • Change From Baseline in the Daily Average Number of Micturition Episodes [ Time Frame: Baseline, Week 12 ]
    The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

  • Change From Baseline in the Daily Average Number of Urgency Episodes [ Time Frame: Baseline, Week 12 ]
    The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

  • Change From Baseline in the Daily Average Number of Nocturia Episodes [ Time Frame: Baseline, Week 12 ]
    Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from Baseline indicates an improvement and a positive number change from baseline indicates a worsening.


Enrollment: 254
Actual Study Start Date: October 28, 2013
Study Completion Date: January 5, 2017
Primary Completion Date: May 24, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OnabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Biological: onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Placebo/OnabotulinumtoxinA
Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Biological: onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Drug: Normal saline
Normal saline (placebo) injected into the detrusor.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.

Exclusion Criteria:

  • Symptoms of OAB due to a neurological reason
  • Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
  • Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
  • Use of botulinum toxin therapy of any serotype for any urological condition
  • Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
  • History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
  • Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945489


  Show 40 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Tamer Aboushwareb Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01945489     History of Changes
Other Study ID Numbers: GMA-OAB-113
First Submitted: September 16, 2013
First Posted: September 18, 2013
Results First Submitted: July 25, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents