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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.