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Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00910520
First received: May 28, 2009
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.


Condition Intervention Phase
Overactive Bladder
 Biological: onabotulinumtoxinA
Drug: 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:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Number of Daily Episodes of Urinary Incontinence [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).


Secondary Outcome Measures:
  • Change From Baseline in Number of Daily Micturition Episodes [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).

  • Change From Baseline in Volume Voided Per Micturition [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).


Enrollment: 548
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: onabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
 Biological: onabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).
Other Names:
  • BOTOX®
  • botulinum toxin Type A
placebo/onabotulinumtoxinA
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
 Biological: onabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Drug: normal saline
Normal saline (placebo) injected into the detrusor at Day 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
  • Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

  • Overactive Bladder caused by neurological condition
  • Patient has predominance of stress incontinence
  • History or evidence of pelvic or urological abnormality
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910520

Locations
United States, California
Laguna Hills, California, United States
Belgium
Gent, Belgium
Czech Republic
Prague, Czech Republic
Germany
Tubingen, Germany
Poland
Warsaw, Poland
Russian Federation
Moscow, Russian Federation
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00910520     History of Changes
Other Study ID Numbers: 191622-520
Study First Received: May 28, 2009
Results First Received: January 29, 2013
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Botulinum Toxins, Type A
 Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013