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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00876447
First received: April 1, 2009
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Overactive Bladder
Biological: Botulinum Toxin Type A 300U
Biological: Botulinum Toxin Type A 200U
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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 6 Treatment Cycle 1 ] [ Designated as safety issue: No ]
    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).

  • Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 6 Treatment Cycle 2 ] [ Designated as safety issue: No ]
    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).

  • Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 6 Treatment Cycle 3 ] [ Designated as safety issue: No ]
    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).

  • Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 6 Treatment Cycle 4 ] [ Designated as safety issue: No ]
    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).

  • Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 6 Treatment Cycle 5 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Study Baseline in Volume Per Void [ Time Frame: Study Baseline, Week 6 Treatment Cycle 1 ] [ Designated as safety issue: No ]
    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.

  • Change From Study Baseline in Volume Per Void [ Time Frame: Study Baseline, Week 6 Treatment Cycle 2 ] [ Designated as safety issue: No ]
    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.

  • Change From Study Baseline in Volume Per Void [ Time Frame: Study Baseline, Week 6 Treatment Cycle 3 ] [ Designated as safety issue: No ]
    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.

  • Change From Study Baseline in Volume Per Void [ Time Frame: Study Baseline, Week 6 Treatment Cycle 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Study Baseline in Volume Per Void [ Time Frame: Study Baseline, Week 6 Treatment Cycle 5 ] [ Designated as safety issue: No ]
    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.


Enrollment: 397
Study Start Date: January 2009
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT00876447

  Show 22 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00876447     History of Changes
Other Study ID Numbers: 191622-094
Study First Received: April 1, 2009
Results First Received: June 12, 2014
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014