Urinary Incontinence
Conditions
Brief summary
This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.
Interventions
BIOLOGICALOnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall 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
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Urinary incontinence due to neurogenic detrusor overactivity * Regularly using clean intermittent catheterization to empty the bladder
Exclusion criteria
* Surgery of the spinal cord within 6 months * Diagnosis of cerebral palsy * Current or planned use of a baclofen pump * Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence * Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder * Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use * Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes | Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6 | Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Urine Volume at First Morning Catheterization | Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6 | The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. A positive change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model. |
| Percentage of Participants With Night Time Urinary Incontinence | Baseline (Day -28 to Day -1), Week 6 | Urinary incontinence was defined as involuntary loss of urine and the presence or absence of night time urinary incontinence was recorded by the participant in a bladder diary in the 2 consecutive days (normalized to a 12-hour daytime period) during the week prior to the study visit. Night time was defined as the time between going to bed to sleep for the night and waking up to start the day. The percentage of participants with night time urinary incontinence is presented in categories (0, 1, 2 nights). |
| Change From Baseline in Maximum Cystometric Capacity (MCC) | Baseline (Day -28 to Day -1) to Week 6 | The MCC was defined by urodynamics, as the volume infused before the participant felt they could no longer delay micturition (has a strong desire to void), had a leakage, or 500 mL was instilled. A positive change from Baseline indicates improvement (increase) in the maximum volume of urine the bladder holds. Least squares estimates were based on an ANCOVA model. |
| Percentage of Participants With Involuntary Detrusor Contractions (IDC) | Baseline (Day -28 to -1) and Week 6 | Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the presence of involuntary detrusor contractions upon filling. A reduction in IDCs from Baseline to Week 6 indicates improvement. |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection) | An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as any new adverse event or worsening of an existing condition after initiation of treatment. |
| Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase | Baseline (Day 1) to Week 6 | Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model. |
| Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase | Baseline (Day -28 to -1) to Week 6 | DLPP was defined as the lowest detrusor pressure at which urine leakage occurs in the absence of either a detrusor contraction or increased intra-abdominal pressure. Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates are based on an ANCOVA model. |
| Time to Participant Request for Retreatment | 48 weeks | Time from treatment on Day 1 to request for retreatment was estimated. For those participants who did not request retreatment, their data was censored using the date of their last study visit. |
| Time to Participant Qualification for Retreatment | 48 weeks | In order to qualify for retreatment, the criteria listed below must be fulfilled at the qualification for retreatment visit: Participant/parent/caregiver requests retreatment, participant has a total of at least 2 daytime urinary incontinence episodes over the 2-day bladder diary collection period, at least 12 weeks has elapsed since treatment 1 and participant has not experienced a serious treatment-related adverse event at any time. |
| Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC | Baseline (Day-28 to Day-1) to Week 6 | Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model. |
Countries
Belgium, Canada, Czechia, France, Italy, Poland, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
114 patients were enrolled and randomized into the study; 113 received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| OnabotulinumtoxinA 50 U OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified. | 39 |
| OnabotulinumtoxinA 100 U OnabotulinumtoxinA 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified. | 45 |
| OnabotulinumtoxinA 200 U OnabotulinumtoxinA 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified. | 30 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 3 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Other Miscellaneous Reasons | 1 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | OnabotulinumtoxinA 50 U | OnabotulinumtoxinA 100 U | OnabotulinumtoxinA 200 U | Total |
|---|---|---|---|---|
| Age, Continuous | 11.4 years STANDARD_DEVIATION 3.45 | 10.8 years STANDARD_DEVIATION 3.26 | 11.9 years STANDARD_DEVIATION 3.13 | 11.3 years STANDARD_DEVIATION 3.29 |
| Daily Daytime Average Frequency of Urinary Incontinence Episodes | 2.81 urinary incontinence episodes per day | 2.99 urinary incontinence episodes per day | 3.68 urinary incontinence episodes per day | 3.16 urinary incontinence episodes per day |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 3 Participants | 2 Participants | 11 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 3 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 29 Participants | 34 Participants | 22 Participants | 85 Participants |
| Sex: Female, Male Female | 19 Participants | 15 Participants | 15 Participants | 49 Participants |
| Sex: Female, Male Male | 20 Participants | 30 Participants | 15 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 45 | 0 / 30 |
| other Total, other adverse events | 27 / 38 | 33 / 45 | 23 / 30 |
| serious Total, serious adverse events | 4 / 38 | 3 / 45 | 2 / 30 |
Outcome results
Primary
Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model.
Time frame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Population: mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Missing data are imputed up to Week 6 using Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| OnabotulinumtoxinA 50 U | Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes | -1.30 urinary incontinence episodes per day | Standard Error 0.205 |
| OnabotulinumtoxinA 100 U | Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes | -1.30 urinary incontinence episodes per day | Standard Error 0.189 |
| OnabotulinumtoxinA 200 U | Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes | -1.34 urinary incontinence episodes per day | Standard Error 0.245 |
p-value: 0.994995% CI: [-0.549, 0.545]ANCOVA
p-value: 0.912395% CI: [-0.673, 0.602]ANCOVA
Secondary
Change From Baseline in Average Urine Volume at First Morning Catheterization
The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. A positive change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Time frame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Population: mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| OnabotulinumtoxinA 50 U | Change From Baseline in Average Urine Volume at First Morning Catheterization | 21.93 milliliters (mL) | Standard Error 14.676 |
| OnabotulinumtoxinA 100 U | Change From Baseline in Average Urine Volume at First Morning Catheterization | 34.90 milliliters (mL) | Standard Error 13.58 |
| OnabotulinumtoxinA 200 U | Change From Baseline in Average Urine Volume at First Morning Catheterization | 87.49 milliliters (mL) | Standard Error 17.808 |
p-value: 0.511795% CI: [-26.12, 52.064]ANCOVA
p-value: 0.005595% CI: [19.711, 111.421]ANCOVA
Secondary
Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase
DLPP was defined as the lowest detrusor pressure at which urine leakage occurs in the absence of either a detrusor contraction or increased intra-abdominal pressure. Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates are based on an ANCOVA model.
Time frame: Baseline (Day -28 to -1) to Week 6
Population: mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Only participants who experienced a leak during urodynamics are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OnabotulinumtoxinA 50 U | Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase | 9.50 cm H2O | Standard Deviation 2.121 |
| OnabotulinumtoxinA 100 U | Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase | -39.00 cm H2O | Standard Deviation 0 |
| OnabotulinumtoxinA 200 U | Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase | 12.00 cm H2O | Standard Deviation 0 |
Secondary
Change From Baseline in Maximum Cystometric Capacity (MCC)
The MCC was defined by urodynamics, as the volume infused before the participant felt they could no longer delay micturition (has a strong desire to void), had a leakage, or 500 mL was instilled. A positive change from Baseline indicates improvement (increase) in the maximum volume of urine the bladder holds. Least squares estimates were based on an ANCOVA model.
Time frame: Baseline (Day -28 to Day -1) to Week 6
Population: mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| OnabotulinumtoxinA 50 U | Change From Baseline in Maximum Cystometric Capacity (MCC) | 62.06 mL | Standard Error 14.339 |
| OnabotulinumtoxinA 100 U | Change From Baseline in Maximum Cystometric Capacity (MCC) | 48.57 mL | Standard Error 13.549 |
| OnabotulinumtoxinA 200 U | Change From Baseline in Maximum Cystometric Capacity (MCC) | 63.55 mL | Standard Error 17.363 |
p-value: 0.494895% CI: [-52.605, 25.626]ANCOVA
p-value: 0.947195% CI: [-43.012, 45.991]ANCOVA
Secondary
Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Time frame: Baseline (Day-28 to Day-1) to Week 6
Population: mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Only participants who experienced an IDC are included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| OnabotulinumtoxinA 50 U | Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC | -7.64 centimeters of water (cm H2O) | Standard Error 5.301 |
| OnabotulinumtoxinA 100 U | Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC | -12.13 centimeters of water (cm H2O) | Standard Error 5.573 |
| OnabotulinumtoxinA 200 U | Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC | -5.46 centimeters of water (cm H2O) | Standard Error 8.267 |
p-value: 0.552495% CI: [-19.648, 10.669]ANCOVA
p-value: 0.831395% CI: [-18.427, 22.795]ANCOVA
Secondary
Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Time frame: Baseline (Day 1) to Week 6
Population: mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| OnabotulinumtoxinA 50 U | Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase | -12.88 cm H2O | Standard Error 3.793 |
| OnabotulinumtoxinA 100 U | Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase | -20.09 cm H2O | Standard Error 3.632 |
| OnabotulinumtoxinA 200 U | Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase | -27.31 cm H2O | Standard Error 4.557 |
p-value: 0.173795% CI: [-17.653, 3.238]ANCOVA
p-value: 0.015795% CI: [-26.061, -2.793]ANCOVA
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAE)
An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as any new adverse event or worsening of an existing condition after initiation of treatment.
Time frame: First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)
Population: Safety population included participants who underwent treatment procedure and received study drug on randomization/Day 1, except those who received less dose due to 6 U/kg weight cap, were allocated to nearest dose group based on the actual dose received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OnabotulinumtoxinA 50 U | Number of Participants With Treatment Emergent Adverse Events (TEAE) | 27 Participants |
| OnabotulinumtoxinA 100 U | Number of Participants With Treatment Emergent Adverse Events (TEAE) | 33 Participants |
| OnabotulinumtoxinA 200 U | Number of Participants With Treatment Emergent Adverse Events (TEAE) | 23 Participants |
Secondary
Percentage of Participants With Involuntary Detrusor Contractions (IDC)
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the presence of involuntary detrusor contractions upon filling. A reduction in IDCs from Baseline to Week 6 indicates improvement.
Time frame: Baseline (Day -28 to -1) and Week 6
Population: mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OnabotulinumtoxinA 50 U | Percentage of Participants With Involuntary Detrusor Contractions (IDC) | Baseline | 94.4 percentage of participants |
| OnabotulinumtoxinA 50 U | Percentage of Participants With Involuntary Detrusor Contractions (IDC) | Week 6 | 61.8 percentage of participants |
| OnabotulinumtoxinA 100 U | Percentage of Participants With Involuntary Detrusor Contractions (IDC) | Baseline | 88.1 percentage of participants |
| OnabotulinumtoxinA 100 U | Percentage of Participants With Involuntary Detrusor Contractions (IDC) | Week 6 | 44.7 percentage of participants |
| OnabotulinumtoxinA 200 U | Percentage of Participants With Involuntary Detrusor Contractions (IDC) | Baseline | 92.6 percentage of participants |
| OnabotulinumtoxinA 200 U | Percentage of Participants With Involuntary Detrusor Contractions (IDC) | Week 6 | 46.4 percentage of participants |
Comparison: Week 6p-value: 0.202795% CI: [0.45, 1.14]Cochran-Mantel-Haenszel
Comparison: Week 6p-value: 0.156495% CI: [0.4, 1.21]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Night Time Urinary Incontinence
Urinary incontinence was defined as involuntary loss of urine and the presence or absence of night time urinary incontinence was recorded by the participant in a bladder diary in the 2 consecutive days (normalized to a 12-hour daytime period) during the week prior to the study visit. Night time was defined as the time between going to bed to sleep for the night and waking up to start the day. The percentage of participants with night time urinary incontinence is presented in categories (0, 1, 2 nights).
Time frame: Baseline (Day -28 to Day -1), Week 6
Population: mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OnabotulinumtoxinA 50 U | Percentage of Participants With Night Time Urinary Incontinence | Baseline (BL): 0 nights of incontinence | 0.0 percentage of participants |
| OnabotulinumtoxinA 50 U | Percentage of Participants With Night Time Urinary Incontinence | BL: 1 night of incontinence | 13.2 percentage of participants |
| OnabotulinumtoxinA 50 U | Percentage of Participants With Night Time Urinary Incontinence | BL: 2 nights of incontinence | 86.8 percentage of participants |
| OnabotulinumtoxinA 50 U | Percentage of Participants With Night Time Urinary Incontinence | Week 6: 0 nights of incontinence | 30.6 percentage of participants |
| OnabotulinumtoxinA 50 U | Percentage of Participants With Night Time Urinary Incontinence | Week 6: 1 night of incontinence | 16.7 percentage of participants |
| OnabotulinumtoxinA 50 U | Percentage of Participants With Night Time Urinary Incontinence | Week 6: 2 nights of incontinence | 52.8 percentage of participants |
| OnabotulinumtoxinA 100 U | Percentage of Participants With Night Time Urinary Incontinence | Week 6: 2 nights of incontinence | 51.2 percentage of participants |
| OnabotulinumtoxinA 100 U | Percentage of Participants With Night Time Urinary Incontinence | Baseline (BL): 0 nights of incontinence | 13.3 percentage of participants |
| OnabotulinumtoxinA 100 U | Percentage of Participants With Night Time Urinary Incontinence | Week 6: 0 nights of incontinence | 32.6 percentage of participants |
| OnabotulinumtoxinA 100 U | Percentage of Participants With Night Time Urinary Incontinence | Week 6: 1 night of incontinence | 16.3 percentage of participants |
| OnabotulinumtoxinA 100 U | Percentage of Participants With Night Time Urinary Incontinence | BL: 1 night of incontinence | 2.2 percentage of participants |
| OnabotulinumtoxinA 100 U | Percentage of Participants With Night Time Urinary Incontinence | BL: 2 nights of incontinence | 84.4 percentage of participants |
| OnabotulinumtoxinA 200 U | Percentage of Participants With Night Time Urinary Incontinence | BL: 1 night of incontinence | 14.3 percentage of participants |
| OnabotulinumtoxinA 200 U | Percentage of Participants With Night Time Urinary Incontinence | BL: 2 nights of incontinence | 82.1 percentage of participants |
| OnabotulinumtoxinA 200 U | Percentage of Participants With Night Time Urinary Incontinence | Week 6: 2 nights of incontinence | 42.9 percentage of participants |
| OnabotulinumtoxinA 200 U | Percentage of Participants With Night Time Urinary Incontinence | Week 6: 0 nights of incontinence | 28.6 percentage of participants |
| OnabotulinumtoxinA 200 U | Percentage of Participants With Night Time Urinary Incontinence | Baseline (BL): 0 nights of incontinence | 3.6 percentage of participants |
| OnabotulinumtoxinA 200 U | Percentage of Participants With Night Time Urinary Incontinence | Week 6: 1 night of incontinence | 28.6 percentage of participants |
Secondary
Time to Participant Qualification for Retreatment
In order to qualify for retreatment, the criteria listed below must be fulfilled at the qualification for retreatment visit: Participant/parent/caregiver requests retreatment, participant has a total of at least 2 daytime urinary incontinence episodes over the 2-day bladder diary collection period, at least 12 weeks has elapsed since treatment 1 and participant has not experienced a serious treatment-related adverse event at any time.
Time frame: 48 weeks
Population: mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OnabotulinumtoxinA 50 U | Time to Participant Qualification for Retreatment | 35.0 weeks |
| OnabotulinumtoxinA 100 U | Time to Participant Qualification for Retreatment | 25.0 weeks |
| OnabotulinumtoxinA 200 U | Time to Participant Qualification for Retreatment | 29.6 weeks |
Secondary
Time to Participant Request for Retreatment
Time from treatment on Day 1 to request for retreatment was estimated. For those participants who did not request retreatment, their data was censored using the date of their last study visit.
Time frame: 48 weeks
Population: mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OnabotulinumtoxinA 50 U | Time to Participant Request for Retreatment | 30.6 weeks |
| OnabotulinumtoxinA 100 U | Time to Participant Request for Retreatment | 24.1 weeks |
| OnabotulinumtoxinA 200 U | Time to Participant Request for Retreatment | 29.6 weeks |