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
- Conditions
- Urinary IncontinenceOveractive Bladder
- Interventions
- Biological: botulinum toxin Type A
- Registration Number
- NCT00915525
- Lead Sponsor
- Allergan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 829
- Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description botulinum toxin Type A 100U botulinum toxin Type A Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. botulinum toxin Type A 150U botulinum toxin Type A Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
- Primary Outcome Measures
Name Time Method Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes Study Baseline, Week 12 Treatment Cycle 6 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 TBS Week 12 Treatment Cycle 6 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 Treatment Benefit Scale (TBS) Week 12 Treatment Cycle 1 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
Name Time Method Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain Study Baseline, Week 12 Treatment Cycle 1 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 Daily Frequency of Urgency Episodes Study Baseline, Week 12 Treatment Cycle 6 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 the I-QOL Questionnaire Total Summary Score Study Baseline, Week 12 Treatment Cycle 6 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 Daily Average Number of Micturition Episodes Study Baseline, Week 12 Treatment Cycle 6 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 KHQ Role Limitations Domain Study Baseline, Week 12 Treatment Cycle 6 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 Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score Study Baseline, Week 12 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 191622-095 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 KHQ Social Limitations Domain Study Baseline, Week 12 Treatment Cycle 6 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.