Overactive Bladder, Urinary Incontinence
Conditions
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.
Interventions
BIOLOGICALbotulinum 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.
Sponsors
Allergan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 12 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 191622-096 (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) | 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. |
| Percentage of Patients With a Positive Response on the 4-Point TBS | Week 12 Treatment Cycle 2 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 the KHQ Role Limitations Domain | Study Baseline, Week 12 Treatment Cycle 2 | 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 Daily Average Number of Micturition Episodes | Study Baseline, Week 12 Treatment Cycle 1 | 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 Daily Frequency of Urgency Episodes | Study Baseline, Week 12 Treatment Cycle 1 | 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 KHQ Social Limitations Domain | Study Baseline, Week 12 Treatment Cycle 1 | 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 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 I-QOL Questionnaire Total Summary Score | Study Baseline, Week 12 Treatment Cycle 2 | 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 |
Countries
Belgium, Canada, Czechia, Germany, Poland, Russia, United Kingdom, United States
Participant flow
Recruitment details
This was a long-term follow-up study that enrolled patients after participation in the preceding studies 191622-095 (NCT00910845) and 191622-520 (NCT00910520). A total of 829 patients received at least 1 BOTOX treatment in Study 191622-096 or in the preceding studies.
Pre-assignment details
Following a planned interim analysis, the protocol was amended to remove the option to escalate to the 150U dose. The dose groups reflect the highest dose received (i.e. 100U BOTOX includes patients who only received 100U throughout the study and 150U BOTOX includes patients who received at least 1 dose of 150U at any time during the study).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 543 |
| 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. | 286 |
| Total | 829 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 29 | 13 |
| Overall Study | Lack of Efficacy | 15 | 32 |
| Overall Study | Lost to Follow-up | 27 | 16 |
| Overall Study | Missing | 12 | 1 |
| Overall Study | Non-Compliance | 3 | 1 |
| Overall Study | Other Reason | 35 | 12 |
| Overall Study | Patient Moved | 15 | 9 |
| Overall Study | Pregnancy | 2 | 0 |
| Overall Study | Protocol Violation | 9 | 4 |
| Overall Study | Retreat Request >Wk 144 (exclusionary) | 4 | 5 |
| Overall Study | Site Closed | 27 | 9 |
| Overall Study | Study Burden | 28 | 12 |
| Overall Study | Withdrawal by Subject | 59 | 21 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A 100U | Botulinum Toxin Type A 150U | Total |
|---|---|---|---|
| Age, Customized 40 to 64 years | 276 Participants | 147 Participants | 423 Participants |
| Age, Customized <40 years | 39 Participants | 23 Participants | 62 Participants |
| Age, Customized 65 to 74 years | 156 Participants | 74 Participants | 230 Participants |
| Age, Customized ≥75 years | 72 Participants | 42 Participants | 114 Participants |
| Sex: Female, Male Female | 493 Participants | 256 Participants | 749 Participants |
| Sex: Female, Male Male | 50 Participants | 30 Participants | 80 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 297 / 829 | 204 / 608 | 28 / 116 | 135 / 388 | 50 / 179 | 86 / 273 | 34 / 131 | 53 / 185 | 35 / 88 | 43 / 139 | 10 / 50 | 37 / 93 | 16 / 27 | 21 / 69 | 9 / 11 | 18 / 48 | 6 / 7 | 14 / 37 | 1 / 2 | 12 / 20 | 1 / 5 | 2 / 2 |
| serious Total, serious adverse events | 71 / 829 | 62 / 608 | 7 / 116 | 32 / 388 | 13 / 179 | 18 / 273 | 8 / 131 | 15 / 185 | 4 / 88 | 8 / 139 | 3 / 50 | 3 / 93 | 0 / 27 | 4 / 69 | 0 / 11 | 0 / 48 | 0 / 7 | 1 / 37 | 1 / 2 | 2 / 20 | 1 / 5 | 0 / 2 |
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 191622-096 (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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 5.55 Incontinence Episodes | Standard Deviation 3.617 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle1 (N=812) | -3.26 Incontinence Episodes | Standard Deviation 3.439 |
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 191622-096 (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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 5.70 Incontinence Episodes | Standard Deviation 3.685 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108) | -3.64 Incontinence Episodes | Standard Deviation 3.402 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 5.66 Incontinence Episodes | Standard Deviation 3.798 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108) | -3.05 Incontinence Episodes | Standard Deviation 3.69 |
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 191622-096 (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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 5.65 Incontinence Episodes | Standard Deviation 3.38 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170) | -3.82 Incontinence Episodes | Standard Deviation 3.341 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 6.30 Incontinence Episodes | Standard Deviation 4.28 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170) | -3.46 Incontinence Episodes | Standard Deviation 3.771 |
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 191622-096 (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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 5.78 Incontinence Episodes | Standard Deviation 3.463 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122) | -3.48 Incontinence Episodes | Standard Deviation 3.733 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 6.19 Incontinence Episodes | Standard Deviation 4.14 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122) | -3.32 Incontinence Episodes | Standard Deviation 3.972 |
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 191622-096 (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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 5.47 Incontinence Episodes | Standard Deviation 3.283 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85) | -3.34 Incontinence Episodes | Standard Deviation 3.791 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 6.43 Incontinence Episodes | Standard Deviation 3.622 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85) | -3.58 Incontinence Episodes | Standard Deviation 3.266 |
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 191622-096 (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).
Time frame: Study Baseline, Week 12 Treatment Cycle 6
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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 5.65 Incontinence Episodes | Standard Deviation 3.238 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48) | -3.05 Incontinence Episodes | Standard Deviation 3.493 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline (BL) | 7.17 Incontinence Episodes | Standard Deviation 4.223 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48) | -3.12 Incontinence Episodes | Standard Deviation 3.753 |
Primary
Percentage of Patients With a Positive Response on the 4-Point TBS
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.
Time frame: Week 12 Treatment Cycle 6
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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 100U | Percentage of Patients With a Positive Response on the 4-Point TBS | 80.9 Percentage of Patients |
| Botulinum Toxin Type A 150U | Percentage of Patients With a Positive Response on the 4-Point TBS | 81.3 Percentage of Patients |
Primary
Percentage of Patients With a Positive Response on the 4-Point TBS
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.
Time frame: Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 100U | Percentage of Patients With a Positive Response on the 4-Point TBS | 81.3 Percentage of Patients |
| Botulinum Toxin Type A 150U | Percentage of Patients With a Positive Response on the 4-Point TBS | 71.8 Percentage of Patients |
Primary
Percentage of Patients With a Positive Response on the 4-Point TBS
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.
Time frame: Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 100U | Percentage of Patients With a Positive Response on the 4-Point TBS | 82.1 Percentage of Patients |
| Botulinum Toxin Type A 150U | Percentage of Patients With a Positive Response on the 4-Point TBS | 71.1 Percentage of Patients |
Primary
Percentage of Patients With a Positive Response on the 4-Point TBS
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.
Time frame: Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 100U | Percentage of Patients With a Positive Response on the 4-Point TBS | 78.3 Percentage of Patients |
| Botulinum Toxin Type A 150U | Percentage of Patients With a Positive Response on the 4-Point TBS | 81.3 Percentage of Patients |
Primary
Percentage of Patients With a Positive Response on the 4-Point TBS
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.
Time frame: Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 100U | Percentage of Patients With a Positive Response on the 4-Point TBS | 83.2 Percentage of Patients |
| Botulinum Toxin Type A 150U | Percentage of Patients With a Positive Response on the 4-Point TBS | 81.4 Percentage of Patients |
Primary
Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)
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.
Time frame: Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 100U | Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS) | 74.0 Percentage of Patients |
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
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).
Time frame: Study Baseline, Week 12 Treatment Cycle 6
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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 8.98 Number of Episodes | Standard Deviation 4.059 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48) | -3.95 Number of Episodes | Standard Deviation 4.662 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 8.84 Number of Episodes | Standard Deviation 3.629 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48) | -2.64 Number of Episodes | Standard Deviation 4.112 |
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 8.55 Number of Episodes | Standard Deviation 4.206 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle1 (N=812) | -3.81 Number of Episodes | Standard Deviation 4.031 |
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 8.63 Number of Episodes | Standard Deviation 4.188 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108) | -4.07 Number of Episodes | Standard Deviation 4.046 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 9.09 Number of Episodes | Standard Deviation 4.764 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108) | -3.96 Number of Episodes | Standard Deviation 4.519 |
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 8.62 Number of Episodes | Standard Deviation 4.055 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170) | -4.22 Number of Episodes | Standard Deviation 4.12 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 9.28 Number of Episodes | Standard Deviation 4.552 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170) | -3.86 Number of Episodes | Standard Deviation 4.332 |
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 8.65 Number of Episodes | Standard Deviation 3.951 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122) | -3.92 Number of Episodes | Standard Deviation 4.341 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 8.98 Number of Episodes | Standard Deviation 4.241 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122) | -3.50 Number of Episodes | Standard Deviation 3.916 |
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 8.67 Number of Episodes | Standard Deviation 3.961 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85) | -4.11 Number of Episodes | Standard Deviation 4.549 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Study Baseline (BL) | 8.89 Number of Episodes | Standard Deviation 3.341 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in Daily Frequency of Urgency Episodes | Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85) | -3.56 Number of Episodes | Standard Deviation 3.576 |
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
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).
Time frame: Study Baseline, Week 12 Treatment Cycle 6
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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 11.85 Number of Episodes | Standard Deviation 3.377 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48) | -2.76 Number of Episodes | Standard Deviation 3.153 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 11.81 Number of Episodes | Standard Deviation 2.99 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48) | -2.66 Number of Episodes | Standard Deviation 3.351 |
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 11.55 Number of Episodes | Standard Deviation 3.261 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85) | -2.85 Number of Episodes | Standard Deviation 3.181 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 11.79 Number of Episodes | Standard Deviation 2.77 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85) | -3.19 Number of Episodes | Standard Deviation 2.772 |
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 11.70 Number of Episodes | Standard Deviation 3.584 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle1 (N=812) | -2.56 Number of Episodes | Standard Deviation 2.887 |
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 11.83 Number of Episodes | Standard Deviation 3.634 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108) | -2.89 Number of Episodes | Standard Deviation 3.037 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 11.48 Number of Episodes | Standard Deviation 3.912 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108) | -2.31 Number of Episodes | Standard Deviation 3.293 |
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 11.65 Number of Episodes | Standard Deviation 3.553 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170) | -2.86 Number of Episodes | Standard Deviation 3.058 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 12.22 Number of Episodes | Standard Deviation 3.76 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170) | -3.01 Number of Episodes | Standard Deviation 3.217 |
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
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).
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 11.68 Number of Episodes | Standard Deviation 3.456 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122) | -2.69 Number of Episodes | Standard Deviation 3.485 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Study Baseline (BL) | 11.82 Number of Episodes | Standard Deviation 3.442 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the Daily Average Number of Micturition Episodes | Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122) | -2.78 Number of Episodes | Standard Deviation 2.882 |
Secondary
Change From Study Baseline in the I-QOL Questionnaire 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Study Baseline (BL) | 31.2 Scores on a Scale | Standard Deviation 17.49 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle5 (N=178, 86) | 28.1 Scores on a Scale | Standard Deviation 23.75 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Study Baseline (BL) | 31.9 Scores on a Scale | Standard Deviation 20.3 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle5 (N=178, 86) | 19.5 Scores on a Scale | Standard Deviation 21.43 |
Secondary
Change From Study Baseline in the I-QOL Questionnaire 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Time frame: Study Baseline, Week 12 Treatment Cycle 6
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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Study Baseline (BL) | 30.3 Scores on a Scale | Standard Deviation 17.87 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle5 (N=178, 86) | 22.6 Scores on a Scale | Standard Deviation 24.99 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Study Baseline (BL) | 30.2 Scores on a Scale | Standard Deviation 20.28 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle5 (N=178, 86) | 18.3 Scores on a Scale | Standard Deviation 14.91 |
Secondary
Change From Study Baseline in the I-QOL Questionnaire 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Study Baseline (BL) | 33.8 Scores on a Scale | Standard Deviation 18.72 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle2 (N=586, 109) | 28.6 Scores on a Scale | Standard Deviation 24.38 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Study Baseline (BL) | 32.8 Scores on a Scale | Standard Deviation 17.91 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle2 (N=586, 109) | 21.6 Scores on a Scale | Standard Deviation 23.71 |
Secondary
Change From Study Baseline in the I-QOL Questionnaire 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Study Baseline (BL) | 33.8 Scores on a Scale | Standard Deviation 18.21 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle3 (N=371, 173) | 27.6 Scores on a Scale | Standard Deviation 22.39 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Study Baseline (BL) | 31.9 Scores on a Scale | Standard Deviation 18.17 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle3 (N=371, 173) | 23.7 Scores on a Scale | Standard Deviation 25.68 |
Secondary
Change From Study Baseline in the I-QOL Questionnaire 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Study Baseline (BL) | 31.4 Scores on a Scale | Standard Deviation 17.32 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 124) | 27.3 Scores on a Scale | Standard Deviation 24.9 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Study Baseline (BL) | 32.5 Scores on a Scale | Standard Deviation 19.36 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the I-QOL Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 124) | 20.3 Scores on a Scale | Standard Deviation 22.63 |
Secondary
Change From Study Baseline in the KHQ Role Limitations Domain
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.
Time frame: Study Baseline, Week 12 Treatment Cycle 6
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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Role Limitations Domain | Study Baseline (BL) | 66.4 Scores on a Scale | Standard Deviation 30 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle6 (N=134, 48) | -24.8 Scores on a Scale | Standard Deviation 38.93 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Role Limitations Domain | Study Baseline (BL) | 60.3 Scores on a Scale | Standard Deviation 33.15 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle6 (N=134, 48) | -22.9 Scores on a Scale | Standard Deviation 25.64 |
Secondary
Change From Study Baseline in the KHQ Role Limitations Domain
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.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Role Limitations Domain | Study Baseline (BL) | 64.5 Scores on a Scale | Standard Deviation 28.51 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle2 (N=585, 109) | -32.1 Scores on a Scale | Standard Deviation 34.29 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Role Limitations Domain | Study Baseline (BL) | 66.2 Scores on a Scale | Standard Deviation 30.15 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle2 (N=585, 109) | -29.2 Scores on a Scale | Standard Deviation 35.94 |
Secondary
Change From Study Baseline in the KHQ Role Limitations Domain
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.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Role Limitations Domain | Study Baseline (BL) | 64.7 Scores on a Scale | Standard Deviation 28.36 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle3 (N=373, 171) | -29.7 Scores on a Scale | Standard Deviation 33.47 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Role Limitations Domain | Study Baseline (BL) | 63.4 Scores on a Scale | Standard Deviation 30.41 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle3 (N=373, 171) | -27.9 Scores on a Scale | Standard Deviation 34.57 |
Secondary
Change From Study Baseline in the KHQ Role Limitations Domain
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.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Role Limitations Domain | Study Baseline (BL) | 66.3 Scores on a Scale | Standard Deviation 27.65 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 123) | -30.9 Scores on a Scale | Standard Deviation 33.82 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Role Limitations Domain | Study Baseline (BL) | 62.3 Scores on a Scale | Standard Deviation 31.17 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 123) | -23.4 Scores on a Scale | Standard Deviation 33.05 |
Secondary
Change From Study Baseline in the KHQ Role Limitations Domain
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.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Role Limitations Domain | Study Baseline (BL) | 65.4 Scores on a Scale | Standard Deviation 29.15 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle5 (N=179, 85) | -30.8 Scores on a Scale | Standard Deviation 35.13 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Role Limitations Domain | Study Baseline (BL) | 62.6 Scores on a Scale | Standard Deviation 31.84 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle5 (N=179, 85) | -26.3 Scores on a Scale | Standard Deviation 28.45 |
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
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.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 43.1 Scores on a Scale | Standard Deviation 30.79 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle1 (N=813) | -18.4 Scores on a Scale | Standard Deviation 29.46 |
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
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.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 43.0 Scores on a Scale | Standard Deviation 30.96 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle2 (N=585, 109) | -20.0 Scores on a Scale | Standard Deviation 29.12 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 48.4 Scores on a Scale | Standard Deviation 30.12 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle2 (N=585, 109) | -19.0 Scores on a Scale | Standard Deviation 28.55 |
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
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.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 42.8 Scores on a Scale | Standard Deviation 31.02 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle3 (N=373, 171) | -17.9 Scores on a Scale | Standard Deviation 29.26 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 45.4 Scores on a Scale | Standard Deviation 31.38 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle3 (N=373, 171) | -19.2 Scores on a Scale | Standard Deviation 28.31 |
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
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.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 44.7 Scores on a Scale | Standard Deviation 31.86 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 123) | -19.8 Scores on a Scale | Standard Deviation 31.26 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 43.2 Scores on a Scale | Standard Deviation 30.46 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 123) | -16.1 Scores on a Scale | Standard Deviation 23.17 |
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
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.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 44.4 Scores on a Scale | Standard Deviation 31.39 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle5 (N=179, 85) | -21.7 Scores on a Scale | Standard Deviation 28.47 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 43.4 Scores on a Scale | Standard Deviation 32.89 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle5 (N=179, 85) | -15.7 Scores on a Scale | Standard Deviation 24.52 |
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
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.
Time frame: Study Baseline, Week 12 Treatment Cycle 6
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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 46.7 Scores on a Scale | Standard Deviation 32.72 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle6 (N=134, 48) | -17.0 Scores on a Scale | Standard Deviation 33.59 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Social Limitations Domain | Study Baseline (BL) | 43.3 Scores on a Scale | Standard Deviation 32.56 |
| Botulinum Toxin Type A 150U | Change From Study Baseline in the KHQ Social Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle6 (N=134, 48) | -17.6 Scores on a Scale | Standard Deviation 24.43 |
Secondary
Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain
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.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain | Study Baseline (BL) | 64.3 Scores on a Scale | Standard Deviation 28.77 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain | Chg from Study BL at Wk 12 Tmt Cycle1 (N=813) | -28.5 Scores on a Scale | Standard Deviation 34.32 |
Secondary
Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire 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 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.
Time frame: Study Baseline, Week 12 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 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score | Study Baseline (BL) | 34.3 Scores on a Scale | Standard Deviation 18.58 |
| Botulinum Toxin Type A 100U | Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score | Chg from Study BL at Wk 12 Tmt Cycle1 (N=810) | 26.0 Scores on a Scale | Standard Deviation 24.84 |