Overactive Bladder
Conditions
Brief summary
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.
Interventions
BIOLOGICALonabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).
DRUGnormal saline
Normal saline (placebo) injected into the detrusor at 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 No maximum
Healthy volunteers
No
Inclusion criteria
* Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months * Inadequate response or limiting side effects with anticholinergics for the treatment of OAB
Exclusion criteria
* Overactive Bladder caused by neurological condition * Patient has predominance of stress incontinence * History or evidence of pelvic or urological abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Daily Episodes of Urinary Incontinence | Baseline, Week 12 | A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Daily Micturition Episodes | Baseline, Week 12 | The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement). |
| Change From Baseline in Volume Voided Per Micturition | Baseline, Week 12 | The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement). |
Countries
Belgium, Czechia, Germany, Poland, Russia, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| onabotulinumtoxinA OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). | 277 |
| Placebo/onabotulinumtoxinA Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable). | 271 |
| Total | 548 |
Baseline characteristics
| Characteristic | onabotulinumtoxinA | Placebo/onabotulinumtoxinA | Total |
|---|---|---|---|
| Age, Customized < 40 years | 38 Participants | 24 Participants | 62 Participants |
| Age, Customized ≥ 75 years | 42 Participants | 35 Participants | 77 Participants |
| Age, Customized Between 40 and 64 years | 115 Participants | 139 Participants | 254 Participants |
| Age, Customized Between 65 and 74 years | 82 Participants | 73 Participants | 155 Participants |
| Sex: Female, Male Female | 244 Participants | 229 Participants | 473 Participants |
| Sex: Female, Male Male | 33 Participants | 42 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 115 / 274 | 47 / 270 |
| serious Total, serious adverse events | 17 / 274 | 15 / 270 |
Outcome results
Primary
Change From Baseline in Number of Daily Episodes of Urinary Incontinence
A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Time frame: Baseline, Week 12
Population: Intent-to-treat population included all randomized patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| onabotulinumtoxinA | Change From Baseline in Number of Daily Episodes of Urinary Incontinence | Baseline | 5.52 Incontinence episodes | Standard Deviation 3.753 |
| onabotulinumtoxinA | Change From Baseline in Number of Daily Episodes of Urinary Incontinence | Change from Baseline at Week 12 | -2.95 Incontinence episodes | Standard Deviation 3.576 |
| Placebo/onabotulinumtoxinA | Change From Baseline in Number of Daily Episodes of Urinary Incontinence | Baseline | 5.70 Incontinence episodes | Standard Deviation 3.858 |
| Placebo/onabotulinumtoxinA | Change From Baseline in Number of Daily Episodes of Urinary Incontinence | Change from Baseline at Week 12 | -1.03 Incontinence episodes | Standard Deviation 3.004 |
Secondary
Change From Baseline in Number of Daily Micturition Episodes
The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).
Time frame: Baseline, Week 12
Population: Intent-to-treat population included all randomized patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| onabotulinumtoxinA | Change From Baseline in Number of Daily Micturition Episodes | Baseline | 12.01 micturition episodes | Standard Deviation 4.007 |
| onabotulinumtoxinA | Change From Baseline in Number of Daily Micturition Episodes | Change from Baseline at Week 12 | -2.56 micturition episodes | Standard Deviation 3.351 |
| Placebo/onabotulinumtoxinA | Change From Baseline in Number of Daily Micturition Episodes | Baseline | 11.77 micturition episodes | Standard Deviation 3.648 |
| Placebo/onabotulinumtoxinA | Change From Baseline in Number of Daily Micturition Episodes | Change from Baseline at Week 12 | -0.83 micturition episodes | Standard Deviation 2.523 |
Secondary
Change From Baseline in Volume Voided Per Micturition
The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).
Time frame: Baseline, Week 12
Population: Intent-to-treat population included all randomized patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| onabotulinumtoxinA | Change From Baseline in Volume Voided Per Micturition | Baseline | 144.2 milliliters | Standard Deviation 57.54 |
| onabotulinumtoxinA | Change From Baseline in Volume Voided Per Micturition | Change from Baseline at Week 12 | 43.0 milliliters | Standard Deviation 65.27 |
| Placebo/onabotulinumtoxinA | Change From Baseline in Volume Voided Per Micturition | Baseline | 152.5 milliliters | Standard Deviation 59.27 |
| Placebo/onabotulinumtoxinA | Change From Baseline in Volume Voided Per Micturition | Change from Baseline at Week 12 | 12.6 milliliters | Standard Deviation 52.01 |