Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00915525
First received: May 28, 2009
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Overactive Bladder
Urinary Incontinence
Biological: botulinum toxin Type A
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Episodes of Urinary Incontinence [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients with a Positive Response on the 4-Point Treatment Benefit Scale [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of micturition episodes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Volume Voided per micturition [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Urinary Incontinence-Specific Quality of Life Questionnaire Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • King's Health Questionnaire Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Urgency episodes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 839
Study Start Date: February 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: botulinum toxin Type A
Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Biological: botulinum toxin Type A
Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Other Name: BOTOX®

  Eligibility

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

Inclusion Criteria:

  • Participation in preceding study 191622-095 or 191622-520

Exclusion Criteria:

  • Females who are pregnant, nursing or planning a pregnancy
  • Patient has any condition or situation which, in the Investigators opinion, would put the patient at risk from continuing treatment with botulinum toxin Type A
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915525

Locations
United States, California
Newport Beach, California, United States
Belgium
Gent, Belgium
Canada, British Columbia
Victoria, British Columbia, Canada
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: NCT00915525     History of Changes
Other Study ID Numbers: 191622-096
Study First Received: May 28, 2009
Last Updated: October 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
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 August 19, 2014