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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00915525
First received: May 28, 2009
Last updated: November 13, 2015
Last verified: November 2015
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 12 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  • Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 12 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  • Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 12 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  • Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 12 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  • Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 12 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  • Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 6 ] [ 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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).

  • Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS) [ Time Frame: Week 12 Treatment Cycle 1 ] [ Designated as safety issue: No ]
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  • Percentage of Patients With a Positive Response on the 4-Point TBS [ Time Frame: Week 12 Treatment Cycle 2 ] [ Designated as safety issue: No ]
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  • Percentage of Patients With a Positive Response on the 4-Point TBS [ Time Frame: Week 12 Treatment Cycle 3 ] [ Designated as safety issue: No ]
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  • Percentage of Patients With a Positive Response on the 4-Point TBS [ Time Frame: Week 12 Treatment Cycle 4 ] [ Designated as safety issue: No ]
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  • Percentage of Patients With a Positive Response on the 4-Point TBS [ Time Frame: Week 12 Treatment Cycle 5 ] [ Designated as safety issue: No ]
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.

  • Percentage of Patients With a Positive Response on the 4-Point TBS [ Time Frame: Week 12 Treatment Cycle 6 ] [ Designated as safety issue: No ]
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.


Secondary Outcome Measures:
  • Change From Study Baseline in the Daily Average Number of Micturition Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 1 ] [ Designated as safety issue: No ]
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).

  • Change From Study Baseline in the Daily Average Number of Micturition Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 2 ] [ Designated as safety issue: No ]
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).

  • Change From Study Baseline in the Daily Average Number of Micturition Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 3 ] [ Designated as safety issue: No ]
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).

  • Change From Study Baseline in the Daily Average Number of Micturition Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 4 ] [ Designated as safety issue: No ]
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).

  • Change From Study Baseline in the Daily Average Number of Micturition Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 5 ] [ Designated as safety issue: No ]
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).

  • Change From Study Baseline in the Daily Average Number of Micturition Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 6 ] [ Designated as safety issue: No ]
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).

  • Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score [ Time Frame: Study Baseline, Week 12 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.

  • Change From Study Baseline in the I-QOL Questionnaire Total Summary Score [ Time Frame: Study Baseline, Week 12 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL

  • Change From Study Baseline in the I-QOL Questionnaire Total Summary Score [ Time Frame: Study Baseline, Week 12 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL

  • Change From Study Baseline in the I-QOL Questionnaire Total Summary Score [ Time Frame: Study Baseline, Week 12 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL

  • Change From Study Baseline in the I-QOL Questionnaire Total Summary Score [ Time Frame: Study Baseline, Week 12 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL

  • Change From Study Baseline in the I-QOL Questionnaire Total Summary Score [ Time Frame: Study Baseline, Week 12 Treatment Cycle 6 ] [ 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL

  • Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 1 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Role Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 2 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Role Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 3 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Role Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 4 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Role Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 5 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Role Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 6 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Social Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 1 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Social Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 2 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Social Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 3 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Social Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 4 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Social Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 5 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in the KHQ Social Limitations Domain [ Time Frame: Study Baseline, Week 12 Treatment Cycle 6 ] [ Designated as safety issue: No ]
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.

  • Change From Study Baseline in Daily Frequency of Urgency Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 1 ] [ Designated as safety issue: No ]
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).

  • Change From Study Baseline in Daily Frequency of Urgency Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 2 ] [ Designated as safety issue: No ]
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).

  • Change From Study Baseline in Daily Frequency of Urgency Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 3 ] [ Designated as safety issue: No ]
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).

  • Change From Study Baseline in Daily Frequency of Urgency Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 4 ] [ Designated as safety issue: No ]
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).

  • Change From Study Baseline in Daily Frequency of Urgency Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 5 ] [ Designated as safety issue: No ]
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).

  • Change From Study Baseline in Daily Frequency of Urgency Episodes [ Time Frame: Study Baseline, Week 12 Treatment Cycle 6 ] [ Designated as safety issue: No ]
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).


Enrollment: 829
Study Start Date: February 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: botulinum toxin Type A 100U
Botulinum toxin Type A 100U 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®
Experimental: botulinum toxin Type A 150U
Botulinum toxin Type A 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)

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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00915525     History of Changes
Other Study ID Numbers: 191622-096 
Study First Received: May 28, 2009
Results First Received: October 2, 2015
Last Updated: November 13, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
incobotulinumtoxinA
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

ClinicalTrials.gov processed this record on December 05, 2016