Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Number of Participants With Treatment Emergent Adverse Events |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. |
From the first dose of study drug until the last dose, up to 147 weeks |
|
| Primary |
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1 |
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle. |
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1 |
|
| Secondary |
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes |
Micturition was defined as toilet voids recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime micturition episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle. |
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1 |
|
| Secondary |
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes |
Participants recorded daytime urgency episodes in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime urgency episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle. |
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1 |
|
| Secondary |
Percentage of Participants With Night Time Urinary Incontinence |
Urinary incontinence was defined as involuntary loss of urine. Participants recorded night time urinary incontinence episodes in a bladder diary during 2 consecutive days in the week prior to the study visit. Night time is defined as the time between going to bed to sleep for the night and waking up to start the next day. The number of daily night time urinary incontinence episodes were averaged during the 2-day period. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle. |
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1 |
|
| Secondary |
Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL) |
The volume per micturition was derived from the total urine volume voided over 1 daytime period during the 2-day bladder diary collection period divided by the number of voids in the same daytime period. Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle. |
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1 |
|
| Secondary |
Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ) |
The PinQ is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time) and a total sum score is calculated (from 0 to 80), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement. |
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1 |
|
| Secondary |
Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee" |
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement. |
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1 |
|
| Secondary |
Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself" |
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement. |
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1 |
|
| Secondary |
Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems" |
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement. |
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1 |
|
| Secondary |
Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale |
The Modified Treatment Benefit Scale (Modified TBS) is a single-item scale designed to assess the change in the participant's overactive bladder (OAB) condition following treatment. The participant's current condition (urinary problems, urinary incontinence) is compared to their condition prior to receipt of any study treatment by selection of "greatly improved", "improved", "not changed" or "worsened". Participants who selected "greatly improved" or "improved" were considered to have a positive treatment response. |
At Week 12 in Treatment Cycle 1 |
|
| Secondary |
Time to Participant's First Request for Retreatment |
The time from the day of BOTOX treatment to the request for the subsequent treatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not request retreatment were treated as censored at the time of their last study visit or study exit. |
From the day of BOTOX treatment in Treatment Cycle 1 to the request for subsequent treatment |
|
| Secondary |
Time to Participant's Qualification for Retreatment |
The time from the day of BOTOX treatment to the qualification for retreatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not qualify for retreatment were treated as censored at the time of their last study visit or study exit. |
From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatment |
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