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A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis

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: NCT00876447
Recruitment Status : Completed
First Posted : April 6, 2009
Results First Posted : June 13, 2014
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).

Condition or disease Intervention/treatment Phase
Overactive Bladder Biological: Botulinum Toxin Type A 300U Biological: Botulinum Toxin Type A 200U Phase 3

Detailed Description:
Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the arm containing botulinum toxin Type A 300U will receive botulinum toxin Type A 200U moving forward. Also, the masking of the study is now open-label.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 397 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : January 1, 2009
Actual Primary Completion Date : June 12, 2013
Actual Study Completion Date : September 4, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
Biological: Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
Other Name: BOTOX®

Experimental: Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Biological: Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Other Name: BOTOX®




Primary Outcome Measures :
  1. Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 6 Treatment Cycle 1 ]
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

  2. Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 6 Treatment Cycle 2 ]
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

  3. Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 6 Treatment Cycle 3 ]
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

  4. Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 6 Treatment Cycle 4 ]
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

  5. Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 6 Treatment Cycle 5 ]
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).


Secondary Outcome Measures :
  1. Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score [ Time Frame: Study Baseline, Week 6 Treatment Cycle 1 ]
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.

  2. Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score [ Time Frame: Study Baseline, Week 6 Treatment Cycle 2 ]
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.

  3. Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score [ Time Frame: Study Baseline, Week 6 Treatment Cycle 3 ]
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.

  4. Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score [ Time Frame: Study Baseline, Week 6 Treatment Cycle 4 ]
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.

  5. Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score [ Time Frame: Study Baseline, Week 6 Treatment Cycle 5 ]
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.

  6. Change From Study Baseline in Volume Per Void [ Time Frame: Study Baseline, Week 6 Treatment Cycle 1 ]
    The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.

  7. Change From Study Baseline in Volume Per Void [ Time Frame: Study Baseline, Week 6 Treatment Cycle 2 ]
    The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.

  8. Change From Study Baseline in Volume Per Void [ Time Frame: Study Baseline, Week 6 Treatment Cycle 3 ]
    The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.

  9. Change From Study Baseline in Volume Per Void [ Time Frame: Study Baseline, Week 6 Treatment Cycle 4 ]
    The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.

  10. Change From Study Baseline in Volume Per Void [ Time Frame: Study Baseline, Week 6 Treatment Cycle 5 ]
    The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.



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.


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

Inclusion Criteria:

  • Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled:

    • Patient completed at least 52 weeks in the preceding study.
    • No longer than 6 months has elapsed since completion of the preceding study
    • Patient has not received any prohibited medications during any intervening period between the preceding study and this long-term study.

Exclusion Criteria:

  • History or evidence of pelvic or urologic abnormality.
  • Previous or current diagnosis of bladder or prostate cancer.

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): NCT00876447


Locations
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United States, Connecticut
Middlebury, Connecticut, United States
Australia
Randwick, Australia
Austria
Innsbruck, Austria
Belgium
Ghent, Belgium
Brazil
Rio de Janeiro, Brazil
Canada, British Columbia
Victoria, British Columbia, Canada
Czechia
Ostrava, Czechia
France
Salouel, France
Germany
Kiel, Germany
Italy
Florence, Italy
Netherlands
Amsterdam, Netherlands
New Zealand
Epsom, New Zealand
Poland
Poznan, Poland
Portugal
Porto, Portugal
Russian Federation
Moscow, Russian Federation
Singapore
Singapore, Singapore
Slovakia
Presov, Slovakia
South Africa
Pretoria, South Africa
Spain
Tenerife, Spain
Taiwan
Hualien, Taiwan
Ukraine
Kiev, Ukraine
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
Publications:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00876447    
Other Study ID Numbers: 191622-094
First Posted: April 6, 2009    Key Record Dates
Results First Posted: June 13, 2014
Last Update Posted: May 1, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
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