Overactive Bladder
Conditions
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).
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.
Interventions
BIOLOGICALBotulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years.
BIOLOGICALBotulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | 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. |
| Change From Study Baseline in Volume Per Void | 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. |
Countries
Australia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Netherlands, New Zealand, Poland, Portugal, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
This was a long-term follow-up study that enrolled patients after participation in Study 191622-515 or 191622-516. A total of 397 patients were enrolled and 388 patients received at least 1 BOTOX treatment in study 191622-094 or in the preceding studies.
Pre-assignment details
The protocol was amended to remove the 300 U dose. Patients ongoing in the study who were treated with 300 U BOTOX prior to the amendment were assigned to 200 U BOTOX for all subsequent treatments. Participant Flow and Baseline Characteristics are based on the first BOTOX dose that patients received.
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A 300U Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years. | 185 |
| Botulinum Toxin Type A 200U Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years. | 203 |
| Total | 388 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 8 |
| Overall Study | Lack of Efficacy | 5 | 3 |
| Overall Study | Lost to Follow-up | 6 | 15 |
| Overall Study | Other miscellaneous reasons | 3 | 8 |
| Overall Study | Personal reasons | 30 | 28 |
| Overall Study | Pregnancy | 4 | 2 |
| Overall Study | Protocol Violation | 9 | 3 |
| Overall Study | Site closure | 19 | 14 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A 300U | Botulinum Toxin Type A 200U | Total |
|---|---|---|---|
| Age, Customized ≥40 to 64 years | 116 Participants | 135 Participants | 251 Participants |
| Age, Customized <40 years | 55 Participants | 57 Participants | 112 Participants |
| Age, Customized ≥65 to 74 years | 14 Participants | 10 Participants | 24 Participants |
| Age, Customized ≥75 years | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 116 Participants | 118 Participants | 234 Participants |
| Sex: Female, Male Male | 69 Participants | 85 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 154 / 185 | 170 / 203 | 126 / 163 | 147 / 187 | 89 / 119 | 123 / 175 | 51 / 69 | 109 / 153 | 19 / 34 | 72 / 110 | 8 / 16 | 46 / 70 | 3 / 8 | 28 / 48 | 0 / 0 | 23 / 36 | 0 / 0 | 13 / 22 | 0 / 0 | 5 / 11 | 0 / 0 | 3 / 5 | 0 / 0 | 1 / 2 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 28 / 185 | 35 / 203 | 26 / 163 | 21 / 187 | 20 / 119 | 19 / 175 | 11 / 69 | 20 / 153 | 5 / 34 | 11 / 110 | 0 / 16 | 9 / 70 | 0 / 8 | 6 / 48 | 0 / 0 | 0 / 36 | 0 / 0 | 2 / 22 | 0 / 0 | 1 / 11 | 0 / 0 | 0 / 5 | 0 / 0 | 0 / 2 | 0 / 0 | 0 / 1 |
Outcome results
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
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).
Time frame: Study Baseline, Week 6 Treatment Cycle 1
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 4.4 Incontinence Episodes | Standard Deviation 2.54 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 6 Tmt Cycle1 (N=176, 195) | -3.4 Incontinence Episodes | Standard Deviation 3.16 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 4.5 Incontinence Episodes | Standard Deviation 2.64 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 6 Tmt Cycle1 (N=176, 195) | -3.2 Incontinence Episodes | Standard Deviation 2.69 |
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
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).
Time frame: Study Baseline, Week 6 Treatment Cycle 2
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline | 4.5 Incontinence Episodes | Standard Deviation 2.62 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 6 Tmt Cycle2 (N=153, 175) | -3.5 Incontinence Episodes | Standard Deviation 3.13 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline | 4.6 Incontinence Episodes | Standard Deviation 2.71 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 6 Tmt Cycle2 (N=153, 175) | -3.3 Incontinence Episodes | Standard Deviation 2.85 |
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
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).
Time frame: Study Baseline, Week 6 Treatment Cycle 3
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline | 4.4 Incontinence Episodes | Standard Deviation 2.33 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 6 Tmt Cycle3 (N=109, 164) | -3.3 Incontinence Episodes | Standard Deviation 2.39 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline | 4.6 Incontinence Episodes | Standard Deviation 2.65 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 6 Tmt Cycle3 (N=109, 164) | -3.5 Incontinence Episodes | Standard Deviation 2.96 |
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
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).
Time frame: Study Baseline, Week 6 Treatment Cycle 4
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline | 4.4 Incontinence Episodes | Standard Deviation 2.13 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 6 Tmt Cycle4 (N=62, 141) | -3.4 Incontinence Episodes | Standard Deviation 2.57 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline | 4.4 Incontinence Episodes | Standard Deviation 2.57 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 6 Tmt Cycle4 (N=62, 141) | -3.5 Incontinence Episodes | Standard Deviation 2.61 |
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
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).
Time frame: Study Baseline, Week 6 Treatment Cycle 5
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline | 4.1 Incontinence Episodes | Standard Deviation 2.34 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 6 Tmt Cycle5 (N=29, 99) | -3.7 Incontinence Episodes | Standard Deviation 2.82 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline | 4.6 Incontinence Episodes | Standard Deviation 2.57 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 6 Tmt Cycle5 (N=29, 99) | -3.6 Incontinence Episodes | Standard Deviation 2.27 |
Secondary
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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.
Time frame: Study Baseline, Week 6 Treatment Cycle 1
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline | 33.9 Scores on a Scale | Standard Deviation 18.19 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Chg from Study BL at Wk 6 Tmt Cycle1 (N=180, 199) | 32.3 Scores on a Scale | Standard Deviation 26.07 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline | 34.4 Scores on a Scale | Standard Deviation 18.18 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Chg from Study BL at Wk 6 Tmt Cycle1 (N=180, 199) | 30.3 Scores on a Scale | Standard Deviation 26.37 |
Secondary
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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.
Time frame: Study Baseline, Week 6 Treatment Cycle 2
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline | 33.3 Scores on a Scale | Standard Deviation 18.17 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Chg from Study BL at Wk 6 Tmt Cycle2 (N=157, 178) | 31.4 Scores on a Scale | Standard Deviation 27.73 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline | 33.8 Scores on a Scale | Standard Deviation 18.17 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Chg from Study BL at Wk 6 Tmt Cycle2 (N=157, 178) | 33.5 Scores on a Scale | Standard Deviation 26.23 |
Secondary
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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.
Time frame: Study Baseline, Week 6 Treatment Cycle 3
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline | 32.5 Scores on a Scale | Standard Deviation 17.83 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Chg from Study BL at Wk 6 Tmt Cycle3 (N=114, 164) | 28.8 Scores on a Scale | Standard Deviation 28.96 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline | 34.8 Scores on a Scale | Standard Deviation 18.95 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Chg from Study BL at Wk 6 Tmt Cycle3 (N=114, 164) | 30.4 Scores on a Scale | Standard Deviation 29.25 |
Secondary
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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.
Time frame: Study Baseline, Week 6 Treatment Cycle 4
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline | 27.9 Scores on a Scale | Standard Deviation 16.66 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Chg from Study BL at Wk 6 Tmt Cycle4 (N=63, 147) | 30.4 Scores on a Scale | Standard Deviation 31.77 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline | 35.5 Scores on a Scale | Standard Deviation 17.7 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Chg from Study BL at Wk 6 Tmt Cycle4 (N=63, 147) | 30.1 Scores on a Scale | Standard Deviation 26.07 |
Secondary
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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.
Time frame: Study Baseline, Week 6 Treatment Cycle 5
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline | 32.0 Scores on a Scale | Standard Deviation 16.13 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Chg from Study BL at Wk 6 Tmt Cycle5 (N=28, 100) | 36.6 Scores on a Scale | Standard Deviation 28.28 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline | 33.0 Scores on a Scale | Standard Deviation 19.61 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Chg from Study BL at Wk 6 Tmt Cycle5 (N=28, 100) | 27.1 Scores on a Scale | Standard Deviation 24.54 |
Secondary
Change From Study Baseline in Volume Per Void
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.
Time frame: Study Baseline, Week 6 Treatment Cycle 1
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in Volume Per Void | Chg from Study BL at Wk 6 Tmt Cycle1 (N=168, 186) | 133.8 Milliliters (mL) | Standard Deviation 137.23 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in Volume Per Void | Study Baseline | 147.3 Milliliters (mL) | Standard Deviation 90.15 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in Volume Per Void | Study Baseline | 154.2 Milliliters (mL) | Standard Deviation 96.54 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in Volume Per Void | Chg from Study BL at Wk 6 Tmt Cycle1 (N=168, 186) | 133.2 Milliliters (mL) | Standard Deviation 128.19 |
Secondary
Change From Study Baseline in Volume Per Void
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.
Time frame: Study Baseline, Week 6 Treatment Cycle 2
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in Volume Per Void | Study Baseline | 149.8 Milliliters (mL) | Standard Deviation 91.03 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in Volume Per Void | Chg from Study BL at Wk 6 Tmt Cycle2 (N=146, 168) | 148.0 Milliliters (mL) | Standard Deviation 134.45 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in Volume Per Void | Study Baseline | 151.9 Milliliters (mL) | Standard Deviation 95.22 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in Volume Per Void | Chg from Study BL at Wk 6 Tmt Cycle2 (N=146, 168) | 135.1 Milliliters (mL) | Standard Deviation 127.62 |
Secondary
Change From Study Baseline in Volume Per Void
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.
Time frame: Study Baseline, Week 6 Treatment Cycle 3
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in Volume Per Void | Study Baseline | 155.0 Milliliters (mL) | Standard Deviation 90.7 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in Volume Per Void | Chg from Study BL at Wk 6 Tmt Cycle3 (N=105, 158) | 166.9 Milliliters (mL) | Standard Deviation 133.59 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in Volume Per Void | Chg from Study BL at Wk 6 Tmt Cycle3 (N=105, 158) | 157.5 Milliliters (mL) | Standard Deviation 129.81 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in Volume Per Void | Study Baseline | 149.6 Milliliters (mL) | Standard Deviation 91.12 |
Secondary
Change From Study Baseline in Volume Per Void
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.
Time frame: Study Baseline, Week 6 Treatment Cycle 4
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in Volume Per Void | Study Baseline | 159.7 Milliliters (mL) | Standard Deviation 89.37 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in Volume Per Void | Chg from Study BL at Wk 6 Tmt Cycle4 (N=61, 135) | 170.8 Milliliters (mL) | Standard Deviation 128.26 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in Volume Per Void | Study Baseline | 151.7 Milliliters (mL) | Standard Deviation 93.65 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in Volume Per Void | Chg from Study BL at Wk 6 Tmt Cycle4 (N=61, 135) | 147.3 Milliliters (mL) | Standard Deviation 122.09 |
Secondary
Change From Study Baseline in Volume Per Void
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.
Time frame: Study Baseline, Week 6 Treatment Cycle 5
Population: BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300U | Change From Study Baseline in Volume Per Void | Study Baseline | 182.7 Milliliters (mL) | Standard Deviation 85.03 |
| Botulinum Toxin Type A 300U | Change From Study Baseline in Volume Per Void | Chg from Study BL at Wk 6 Tmt Cycle5 (N=28, 95) | 163.5 Milliliters (mL) | Standard Deviation 106.44 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in Volume Per Void | Study Baseline | 140.8 Milliliters (mL) | Standard Deviation 91.32 |
| Botulinum Toxin Type A 200U | Change From Study Baseline in Volume Per Void | Chg from Study BL at Wk 6 Tmt Cycle5 (N=28, 95) | 160.2 Milliliters (mL) | Standard Deviation 119.4 |