Overactive Bladder, Urinary Incontinence
Conditions
Brief summary
The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.
Interventions
BIOLOGICALbotulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
DRUGPlacebo
Placebo (normal saline) injected into detrusor on Day 1
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 85 Years
Healthy volunteers
No
Inclusion criteria
* Must be between 18-85 years old * Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago * Must weigh at least 50 kg (110 lbs) * Must be willing and able to record information regarding bladder function into a diary (provided) * Must be willing and able to complete the entire course of the study
Exclusion criteria
* Cannot currently be catheterizing as a way to control incontinence * Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Urinary Urge Incontinence Episodes | Baseline, Week 2, Week 6, Week 12 | Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Micturitions | Baseline, Week 2, Week 6, Week 12 | Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet. |
| Change in Number of Nocturia Episodes | Baseline, Week 12 | Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. |
| Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Baseline, Week 12 | Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters |
| Incontinence Quality of Life Instrument (I-QOL) | Baseline, Week 2, Week 6, Week 12 | Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented. |
Countries
Belgium, Canada, Germany, Poland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo (normal saline)injection on Day 1 into detrusor | 44 |
| BOTOX 50 U botulinum toxin Type A 50 U injection on Day 1 into detrusor | 57 |
| BOTOX 100 U botulinum toxin Type A 100 U injection on Day 1 into detrusor | 54 |
| BOTOX 150 U botulinum toxin Type A 150 U injection on Day 1 into detrusor | 49 |
| BOTOX 200 U botulinum toxin Type A 200 U injection on Day 1 into detrusor | 53 |
| BOTOX 300 U botulinum toxin Type A 300 U injection on Day 1 into detrusor | 56 |
| Total | 313 |
Baseline characteristics
| Characteristic | Placebo | BOTOX 50 U | BOTOX 100 U | BOTOX 150 U | BOTOX 200 U | BOTOX 300 U | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 45-64 years | 24 participants | 27 participants | 25 participants | 27 participants | 21 participants | 29 participants | 153 participants |
| Age, Customized <45 years | 7 participants | 9 participants | 6 participants | 8 participants | 6 participants | 6 participants | 42 participants |
| Age, Customized 65-74 years | 6 participants | 13 participants | 16 participants | 12 participants | 20 participants | 15 participants | 82 participants |
| Age, Customized >=75 years | 7 participants | 8 participants | 7 participants | 2 participants | 6 participants | 6 participants | 36 participants |
| Sex: Female, Male Female | 40 Participants | 53 Participants | 50 Participants | 47 Participants | 46 Participants | 52 Participants | 288 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 4 Participants | 2 Participants | 7 Participants | 4 Participants | 25 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 33 / — | 44 / — | 44 / — | 39 / — | 44 / — | 46 / — |
| serious Total, serious adverse events | 5 / — | 9 / — | 5 / — | 7 / — | 4 / — | 4 / — |
Outcome results
Primary
Change in Number of Urinary Urge Incontinence Episodes
Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.
Time frame: Baseline, Week 2, Week 6, Week 12
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change in Number of Urinary Urge Incontinence Episodes | Baseline | 32.5 episodes |
| Placebo | Change in Number of Urinary Urge Incontinence Episodes | Week 2 | -17.3 episodes |
| Placebo | Change in Number of Urinary Urge Incontinence Episodes | Week 6 | -18.2 episodes |
| Placebo | Change in Number of Urinary Urge Incontinence Episodes | Week 12 | -17.4 episodes |
| BOTOX 50 U | Change in Number of Urinary Urge Incontinence Episodes | Week 6 | -21.2 episodes |
| BOTOX 50 U | Change in Number of Urinary Urge Incontinence Episodes | Week 2 | -20.0 episodes |
| BOTOX 50 U | Change in Number of Urinary Urge Incontinence Episodes | Baseline | 30.3 episodes |
| BOTOX 50 U | Change in Number of Urinary Urge Incontinence Episodes | Week 12 | -20.7 episodes |
| BOTOX 100 U | Change in Number of Urinary Urge Incontinence Episodes | Week 12 | -18.4 episodes |
| BOTOX 100 U | Change in Number of Urinary Urge Incontinence Episodes | Week 6 | -19.9 episodes |
| BOTOX 100 U | Change in Number of Urinary Urge Incontinence Episodes | Week 2 | -18.6 episodes |
| BOTOX 100 U | Change in Number of Urinary Urge Incontinence Episodes | Baseline | 27.8 episodes |
| BOTOX 150 U | Change in Number of Urinary Urge Incontinence Episodes | Baseline | 28.3 episodes |
| BOTOX 150 U | Change in Number of Urinary Urge Incontinence Episodes | Week 12 | -23.0 episodes |
| BOTOX 150 U | Change in Number of Urinary Urge Incontinence Episodes | Week 2 | -20.8 episodes |
| BOTOX 150 U | Change in Number of Urinary Urge Incontinence Episodes | Week 6 | -23.4 episodes |
| BOTOX 200 U | Change in Number of Urinary Urge Incontinence Episodes | Week 6 | -20.0 episodes |
| BOTOX 200 U | Change in Number of Urinary Urge Incontinence Episodes | Week 12 | -19.6 episodes |
| BOTOX 200 U | Change in Number of Urinary Urge Incontinence Episodes | Week 2 | -16.8 episodes |
| BOTOX 200 U | Change in Number of Urinary Urge Incontinence Episodes | Baseline | 24.1 episodes |
| BOTOX 300 U | Change in Number of Urinary Urge Incontinence Episodes | Week 2 | -18.6 episodes |
| BOTOX 300 U | Change in Number of Urinary Urge Incontinence Episodes | Week 6 | -18.8 episodes |
| BOTOX 300 U | Change in Number of Urinary Urge Incontinence Episodes | Week 12 | -19.4 episodes |
| BOTOX 300 U | Change in Number of Urinary Urge Incontinence Episodes | Baseline | 26.8 episodes |
Secondary
Change in Number of Micturitions
Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.
Time frame: Baseline, Week 2, Week 6, Week 12
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change in Number of Micturitions | Baseline | 73.3 micturitions |
| Placebo | Change in Number of Micturitions | Week 12 | -8.3 micturitions |
| Placebo | Change in Number of Micturitions | Week 6 | -9.4 micturitions |
| Placebo | Change in Number of Micturitions | Week 2 | -6.5 micturitions |
| BOTOX 50 U | Change in Number of Micturitions | Week 12 | -15.3 micturitions |
| BOTOX 50 U | Change in Number of Micturitions | Week 2 | -10.0 micturitions |
| BOTOX 50 U | Change in Number of Micturitions | Baseline | 76.3 micturitions |
| BOTOX 50 U | Change in Number of Micturitions | Week 6 | -15.2 micturitions |
| BOTOX 100 U | Change in Number of Micturitions | Baseline | 80.3 micturitions |
| BOTOX 100 U | Change in Number of Micturitions | Week 12 | -21.7 micturitions |
| BOTOX 100 U | Change in Number of Micturitions | Week 2 | -12.5 micturitions |
| BOTOX 100 U | Change in Number of Micturitions | Week 6 | -22.9 micturitions |
| BOTOX 150 U | Change in Number of Micturitions | Week 12 | -18.8 micturitions |
| BOTOX 150 U | Change in Number of Micturitions | Week 2 | -9.8 micturitions |
| BOTOX 150 U | Change in Number of Micturitions | Week 6 | -17.0 micturitions |
| BOTOX 150 U | Change in Number of Micturitions | Baseline | 76.5 micturitions |
| BOTOX 200 U | Change in Number of Micturitions | Week 6 | -18.9 micturitions |
| BOTOX 200 U | Change in Number of Micturitions | Baseline | 76.7 micturitions |
| BOTOX 200 U | Change in Number of Micturitions | Week 12 | -19.7 micturitions |
| BOTOX 200 U | Change in Number of Micturitions | Week 2 | -7.2 micturitions |
| BOTOX 300 U | Change in Number of Micturitions | Week 12 | -21.2 micturitions |
| BOTOX 300 U | Change in Number of Micturitions | Baseline | 75.6 micturitions |
| BOTOX 300 U | Change in Number of Micturitions | Week 2 | -9.2 micturitions |
| BOTOX 300 U | Change in Number of Micturitions | Week 6 | -19.9 micturitions |
Secondary
Change in Number of Nocturia Episodes
Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.
Time frame: Baseline, Week 12
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change in Number of Nocturia Episodes | Baseline | 12.3 episodes |
| Placebo | Change in Number of Nocturia Episodes | Week 12 | -0.3 episodes |
| BOTOX 50 U | Change in Number of Nocturia Episodes | Baseline | 12.2 episodes |
| BOTOX 50 U | Change in Number of Nocturia Episodes | Week 12 | -2.5 episodes |
| BOTOX 100 U | Change in Number of Nocturia Episodes | Baseline | 13.9 episodes |
| BOTOX 100 U | Change in Number of Nocturia Episodes | Week 12 | -4.1 episodes |
| BOTOX 150 U | Change in Number of Nocturia Episodes | Baseline | 17.9 episodes |
| BOTOX 150 U | Change in Number of Nocturia Episodes | Week 12 | -6.5 episodes |
| BOTOX 200 U | Change in Number of Nocturia Episodes | Baseline | 12.2 episodes |
| BOTOX 200 U | Change in Number of Nocturia Episodes | Week 12 | -3.8 episodes |
| BOTOX 300 U | Change in Number of Nocturia Episodes | Baseline | 14.9 episodes |
| BOTOX 300 U | Change in Number of Nocturia Episodes | Week 12 | -7.0 episodes |
Secondary
Incontinence Quality of Life Instrument (I-QOL)
Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.
Time frame: Baseline, Week 2, Week 6, Week 12
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Incontinence Quality of Life Instrument (I-QOL) | Baseline | 35.9 Units on a scale |
| Placebo | Incontinence Quality of Life Instrument (I-QOL) | Week 2 | 14.8 Units on a scale |
| Placebo | Incontinence Quality of Life Instrument (I-QOL) | Week 6 | 16.3 Units on a scale |
| Placebo | Incontinence Quality of Life Instrument (I-QOL) | Week 12 | 17.9 Units on a scale |
| BOTOX 50 U | Incontinence Quality of Life Instrument (I-QOL) | Week 6 | 30.6 Units on a scale |
| BOTOX 50 U | Incontinence Quality of Life Instrument (I-QOL) | Week 2 | 21.1 Units on a scale |
| BOTOX 50 U | Incontinence Quality of Life Instrument (I-QOL) | Baseline | 32.3 Units on a scale |
| BOTOX 50 U | Incontinence Quality of Life Instrument (I-QOL) | Week 12 | 29.8 Units on a scale |
| BOTOX 100 U | Incontinence Quality of Life Instrument (I-QOL) | Week 12 | 32.9 Units on a scale |
| BOTOX 100 U | Incontinence Quality of Life Instrument (I-QOL) | Week 6 | 32.1 Units on a scale |
| BOTOX 100 U | Incontinence Quality of Life Instrument (I-QOL) | Week 2 | 28.1 Units on a scale |
| BOTOX 100 U | Incontinence Quality of Life Instrument (I-QOL) | Baseline | 34.3 Units on a scale |
| BOTOX 150 U | Incontinence Quality of Life Instrument (I-QOL) | Baseline | 30.5 Units on a scale |
| BOTOX 150 U | Incontinence Quality of Life Instrument (I-QOL) | Week 12 | 35.2 Units on a scale |
| BOTOX 150 U | Incontinence Quality of Life Instrument (I-QOL) | Week 2 | 29.5 Units on a scale |
| BOTOX 150 U | Incontinence Quality of Life Instrument (I-QOL) | Week 6 | 37.2 Units on a scale |
| BOTOX 200 U | Incontinence Quality of Life Instrument (I-QOL) | Week 6 | 34.5 Units on a scale |
| BOTOX 200 U | Incontinence Quality of Life Instrument (I-QOL) | Week 12 | 37.1 Units on a scale |
| BOTOX 200 U | Incontinence Quality of Life Instrument (I-QOL) | Week 2 | 26.7 Units on a scale |
| BOTOX 200 U | Incontinence Quality of Life Instrument (I-QOL) | Baseline | 32.0 Units on a scale |
| BOTOX 300 U | Incontinence Quality of Life Instrument (I-QOL) | Week 2 | 31.6 Units on a scale |
| BOTOX 300 U | Incontinence Quality of Life Instrument (I-QOL) | Week 6 | 41.6 Units on a scale |
| BOTOX 300 U | Incontinence Quality of Life Instrument (I-QOL) | Week 12 | 39.7 Units on a scale |
| BOTOX 300 U | Incontinence Quality of Life Instrument (I-QOL) | Baseline | 34.5 Units on a scale |
Secondary
Maximum Cystometric Capacity (MCC) by Urodynamic Measurements
Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters
Time frame: Baseline, Week 12
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Baseline | 267.1 milliliters |
| Placebo | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Week 12 | 49.5 milliliters |
| BOTOX 50 U | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Baseline | 262.9 milliliters |
| BOTOX 50 U | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Week 12 | 50.0 milliliters |
| BOTOX 100 U | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Baseline | 255.0 milliliters |
| BOTOX 100 U | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Week 12 | 71.0 milliliters |
| BOTOX 150 U | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Baseline | 258.4 milliliters |
| BOTOX 150 U | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Week 12 | 101.7 milliliters |
| BOTOX 200 U | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Baseline | 280.1 milliliters |
| BOTOX 200 U | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Week 12 | 91.5 milliliters |
| BOTOX 300 U | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Baseline | 271.7 milliliters |
| BOTOX 300 U | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Week 12 | 130.8 milliliters |
Post Hoc
Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes
Measured by the 7 day diary preceding each visit. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.
Time frame: Baseline, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 6 | 18.2 Percentage of patients |
| Placebo | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 24 | 13.6 Percentage of patients |
| Placebo | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 12 | 15.9 Percentage of patients |
| Placebo | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 36 | 11.4 Percentage of patients |
| Placebo | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 2 | 11.4 Percentage of patients |
| Placebo | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 30 | 18.2 Percentage of patients |
| Placebo | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 18 | 13.6 Percentage of patients |
| BOTOX 50 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 18 | 26.3 Percentage of patients |
| BOTOX 50 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 24 | 28.1 Percentage of patients |
| BOTOX 50 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 36 | 15.8 Percentage of patients |
| BOTOX 50 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 6 | 24.6 Percentage of patients |
| BOTOX 50 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 30 | 21.1 Percentage of patients |
| BOTOX 50 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 12 | 29.8 Percentage of patients |
| BOTOX 50 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 2 | 12.3 Percentage of patients |
| BOTOX 100 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 2 | 27.8 Percentage of patients |
| BOTOX 100 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 12 | 37.0 Percentage of patients |
| BOTOX 100 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 18 | 38.9 Percentage of patients |
| BOTOX 100 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 36 | 33.3 Percentage of patients |
| BOTOX 100 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 30 | 35.2 Percentage of patients |
| BOTOX 100 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 24 | 27.8 Percentage of patients |
| BOTOX 100 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 6 | 44.4 Percentage of patients |
| BOTOX 150 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 6 | 49.0 Percentage of patients |
| BOTOX 150 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 2 | 26.5 Percentage of patients |
| BOTOX 150 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 12 | 40.8 Percentage of patients |
| BOTOX 150 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 18 | 44.9 Percentage of patients |
| BOTOX 150 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 24 | 42.9 Percentage of patients |
| BOTOX 150 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 30 | 28.6 Percentage of patients |
| BOTOX 150 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 36 | 36.7 Percentage of patients |
| BOTOX 200 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 30 | 41.5 Percentage of patients |
| BOTOX 200 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 12 | 50.9 Percentage of patients |
| BOTOX 200 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 24 | 54.7 Percentage of patients |
| BOTOX 200 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 2 | 28.3 Percentage of patients |
| BOTOX 200 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 6 | 49.1 Percentage of patients |
| BOTOX 200 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 18 | 39.6 Percentage of patients |
| BOTOX 200 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 36 | 32.1 Percentage of patients |
| BOTOX 300 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 12 | 57.1 Percentage of patients |
| BOTOX 300 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 24 | 53.6 Percentage of patients |
| BOTOX 300 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 6 | 55.4 Percentage of patients |
| BOTOX 300 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 30 | 46.4 Percentage of patients |
| BOTOX 300 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 2 | 44.6 Percentage of patients |
| BOTOX 300 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 18 | 46.4 Percentage of patients |
| BOTOX 300 U | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Week 36 | 42.9 Percentage of patients |