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A Research Study for Patients With Overactive Bladder

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: NCT00168454
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : February 11, 2010
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

Condition or disease Intervention/treatment Phase
Overactive Bladder Urinary Incontinence Biological: botulinum toxin Type A Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo (normal saline) injected into detrusor on Day 1
 Drug: Placebo
Placebo (normal saline) injected into detrusor on Day 1
Experimental: BOTOX 50 U
botulinum toxin Type A 50 U injected into detrusor on Day 1
 Biological: botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
Other Name: BOTOX®
Experimental: BOTOX 100 U
botulinum toxin Type A 100 U injected into detrusor on Day 1
 Biological: botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
Other Name: BOTOX®
Experimental: BOTOX 150 U
botulinum toxin Type A 150 U injected into detrusor on Day 1
 Biological: botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
Other Name: BOTOX®
Experimental: BOTOX 200 U
botulinum toxin Type A 200 U injected into detrusor on Day 1
 Biological: botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
Other Name: BOTOX®
Experimental: BOTOX 300 U
botulinum toxin Type A 300 U injected into detrusor on Day 1
 Biological: botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
Other Name: BOTOX®


Outcome Measures
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Primary Outcome Measures :
  1. Change in Number of Urinary Urge Incontinence Episodes [ Time Frame: Baseline, Week 2, Week 6, Week 12 ]
    Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.


Secondary Outcome Measures :
  1. Change in Number of Micturitions [ Time Frame: Baseline, Week 2, Week 6, Week 12 ]
    Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.

  2. Change in Number of Nocturia Episodes [ Time Frame: Baseline, Week 12 ]
    Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.

  3. Maximum Cystometric Capacity (MCC) by Urodynamic Measurements [ Time Frame: Baseline, Week 12 ]
    Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters

  4. Incontinence Quality of Life Instrument (I-QOL) [ Time Frame: Baseline, Week 2, Week 6, Week 12 ]
    Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be between 18-85 years old
  • Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
  • Must weigh at least 50 kg (110 lbs)
  • Must be willing and able to record information regarding bladder function into a diary (provided)
  • Must be willing and able to complete the entire course of the study

Exclusion Criteria:

  • Cannot currently be catheterizing as a way to control incontinence
  • Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition
Contacts and Locations
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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): NCT00168454


Locations
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United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
Belgium
Ghent, Belgium
Canada, British Columbia
Victoria, British Columbia, Canada
Germany
Berlin, Germany
Poland
Warsaw, Poland
United Kingdom
Sheffield, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00168454    
Other Study ID Numbers: 191622-077
First Posted: September 15, 2005    Key Record Dates
Results First Posted: February 11, 2010
Last Update Posted: November 6, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Urinary Bladder Diseases
Botulinum Toxins
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