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

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ClinicalTrials.gov Identifier: NCT00910845
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE May 28, 2009
First Posted Date  ICMJE June 1, 2009
Results First Submitted Date  ICMJE January 29, 2013
Results First Posted Date  ICMJE March 5, 2013
Last Update Posted Date March 5, 2013
Study Start Date  ICMJE September 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Change From Baseline in Number of Daily Episodes of Urinary Incontinence [ Time Frame: Baseline, Week 12 ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
Number of Episodes of Urinary Incontinence [ Time Frame: Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
  • Change From Baseline in Number of Daily Micturition Episodes [ Time Frame: Baseline, Week 12 ]
    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 ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
  • Number of micturition episodes [ Time Frame: Week 12 ]
  • Volume Voided per micturition [ Time Frame: Week 12 ]
  • Treatment Benefit Scale [ Time Frame: Week 12 ]
  • Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) [ Time Frame: Week 12 ]
  • King's Health Questionnaire [ Time Frame: Week 12 ]
  • Number of Urgency episodes [ Time Frame: Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Official Title  ICMJE Not Provided
Brief Summary 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.
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 Overactive Bladder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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).
    Intervention: Biological: onabotulinumtoxinA
  • 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).
    Interventions:
    • Biological: onabotulinumtoxinA
    • Drug: normal saline
Publications *

*   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: December 7, 2011)
557
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2009)
534
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00910845
Other Study ID Numbers  ICMJE 191622-095
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 January 2013

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