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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Allergan
- Enrollment
- 829
- Primary Endpoint
- Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
- Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain(Study Baseline, Week 12 Treatment Cycle 1)
- Change From Study Baseline in Daily Frequency of Urgency Episodes(Study Baseline, Week 12 Treatment Cycle 6)
- Change From Study Baseline in the I-QOL Questionnaire Total Summary Score(Study Baseline, Week 12 Treatment Cycle 6)
- Change From Study Baseline in the Daily Average Number of Micturition Episodes(Study Baseline, Week 12 Treatment Cycle 6)
- Change From Study Baseline in the KHQ Role Limitations Domain(Study Baseline, Week 12 Treatment Cycle 6)
- 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)
- Change From Study Baseline in the KHQ Social Limitations Domain(Study Baseline, Week 12 Treatment Cycle 6)