Trial Outcomes & Findings for A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO) (NCT NCT01981954)

NCT ID: NCT01981954

Last Updated: 2024-10-31

Results Overview

MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first), as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of expected bladder capacity \[EBC\] was reached for participants ≥ 2 years or of maximum catheterized volume \[MCV\] for participants aged 6 months to \< 2 years; the participants' bladder was emptied via catheterization).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 23 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2024-10-31

Participant Flow

Children aged 6 months to < 5 years old with neurogenic detrusor overactivity (NDO) were enrolled from Belgium (1 site), United Kingdom (1 site), Poland (2 sites), United States (1 site), the Philippines (1 site) and South Korea (2 sites).

Children who met the eligibility criteria were treated with sequential doses of solifenacin up to 12 weeks to determine each participant's optimal dose, after which a fixed dose of solifenacin was given for at least 40 weeks. A washout period was required between screening and baseline if the children were being treated with antimuscarinic agents.

Participant milestones

Measure	Solifenacin Succinate Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Titration Period STARTED	23
Titration Period Treated	23
Titration Period COMPLETED	22
Titration Period NOT COMPLETED	1
Fixed-Dose Assessment Period STARTED	22
Fixed-Dose Assessment Period Treated	22
Fixed-Dose Assessment Period COMPLETED	21
Fixed-Dose Assessment Period NOT COMPLETED	1

Reasons for withdrawal

Measure	Solifenacin Succinate Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Titration Period Protocol Deviation	1
Fixed-Dose Assessment Period Lack of Efficacy	1

Baseline Characteristics

SAF population

Baseline characteristics by cohort

Measure	Solifenacin Succinate n=23 Participants Children aged 6 months to less than 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Age, Categorical <=18 years	23 Participants n=23 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=23 Participants
Age, Categorical >=65 years	0 Participants n=23 Participants
Age, Continuous	35.3 months STANDARD_DEVIATION 12.7 • n=23 Participants
Sex: Female, Male Female	14 Participants n=23 Participants
Sex: Female, Male Male	9 Participants n=23 Participants
Weight	13.2 kg STANDARD_DEVIATION 2.87 • n=23 Participants
Duration of NDO Disease	1.99 years n=23 Participants • SAF population
Maximum Cystometric Capacity (MCC)	92.3 mL STANDARD_DEVIATION 38.2 • n=21 Participants • FAS population

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Full Analysis Set (FAS), which consisted of all participants who took at least one dose of study drug and provided both valid baseline and at least one post-baseline value for the primary efficacy endpoint.

MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first), as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of expected bladder capacity [EBC] was reached for participants ≥ 2 years or of maximum catheterized volume [MCV] for participants aged 6 months to < 2 years; the participants' bladder was emptied via catheterization).

Outcome measures

Measure	Solifenacin Succinate n=21 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)	37.0 mL Standard Deviation 35.9

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 52

Population: FAS population with available data at baseline and at each time point.

MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first) as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of EBC was reached for participants ≥ 2 years or of MCV for participants aged 6 months to < 2 years. The participants' bladder was emptied via catheterization).

Outcome measures

Measure	Solifenacin Succinate n=21 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC Week 3	45.2 mL Standard Deviation 44.8
Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC Week 6	36.5 mL Standard Deviation 36.6
Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC Week 9	23.9 mL Standard Deviation 57.6
Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC Week 12	40.2 mL Standard Deviation 37.9
Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC Week 52	58.6 mL Standard Deviation 34.1

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

Population: FAS population with available data at baseline and at each time point.

Bladder compliance gives an indication of the elasticity of the bladder wall. Bladder compliance was calculated by dividing the change in volume during the filling of the bladder by the change in detrusor pressure during that change in bladder volume using urodynamic assessments. The values for bladder volume and detrusor pressure at the beginning and end of filling were taken and used.

Outcome measures

Measure	Solifenacin Succinate n=21 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance Week 3	4.55 mL/cmH2O Standard Deviation 4.30
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance Week 12	4.14 mL/cmH2O Standard Deviation 4.20
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance Week 24	5.10 mL/cmH2O Standard Deviation 6.82
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance Week 6	5.45 mL/cmH2O Standard Deviation 8.45
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance Week 9	10.00 mL/cmH2O Standard Deviation 16.42
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance Week 52	5.94 mL/cmH2O Standard Deviation 4.24

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

Population: FAS population with available data at baseline and at each time point.

Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics.

Outcome measures

Measure	Solifenacin Succinate n=21 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling Week 3	-5.2 cmH2O Standard Deviation 12.9
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling Week 6	-8.3 cmH2O Standard Deviation 14.8
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling Week 9	-10.3 cmH2O Standard Deviation 18.2
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling Week 12	-0.6 cmH2O Standard Deviation 23.4
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling Week 24	-1.0 cmH2O Standard Deviation 13.9
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling Week 52	-9.8 cmH2O Standard Deviation 19.2

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

Population: FAS population with with available data at baseline and at each time point.

Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics.

Outcome measures

Measure	Solifenacin Succinate n=21 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling Week 3	0.9 cmH2O Standard Deviation 8.4
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling Week 6	1.3 cmH2O Standard Deviation 10.4
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling Week 9	1.2 cmH2O Standard Deviation 11.8
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling Week 12	-4.1 cmH2O Standard Deviation 10.9
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling Week 24	-2.0 cmH2O Standard Deviation 9.4
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling Week 52	-2.3 cmH2O Standard Deviation 14.7

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

Population: FAS population with available data at baseline and at each time point.

Catheterized volume was measured when the bladder was emptied via catheterization 5 minutes after the end of bladder-filling.

Outcome measures

Measure	Solifenacin Succinate n=15 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling Week 3	38.6 mL Standard Deviation 52.6
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling Week 6	41.8 mL Standard Deviation 25.5
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling Week 9	50.5 mL Standard Deviation 40.5
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling Week 12	50.5 mL Standard Deviation 46.6
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling Week 24	44.0 mL Standard Deviation 29.5
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling Week 52	59.8 mL Standard Deviation 27.0

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

Population: FAS population with data available at baseline and at each time point and excluding participants who did not have a detrusor contraction.

Bladder volume as assessed by urodynamics.

Outcome measures

Measure	Solifenacin Succinate n=21 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) Week 3	47.0 mL Standard Deviation 31.3
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) Week 6	87.4 mL Standard Deviation 57.4
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) Week 9	77.0 mL Standard Deviation 86.2
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) Week 12	18.7 mL Standard Deviation 37.5
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) Week 24	22.9 mL Standard Deviation 52.3
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) Week 52	89.2 mL Standard Deviation 58.0

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

Population: FAS population with data available at baseline and at each time point and whose pressure reached 10 cmH2O.

Bladder volume as assessed by urodynamics.

Outcome measures

Measure	Solifenacin Succinate n=19 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure Week 3	31.9 mL Standard Deviation 47.3
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure Week 6	47.8 mL Standard Deviation 55.9
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure Week 9	31.5 mL Standard Deviation 54.1
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure Week 12	30.1 mL Standard Deviation 37.9
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure Week 24	28.7 mL Standard Deviation 47.9
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure Week 52	49.4 mL Standard Deviation 40.9

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

Population: FAS population with data available at baseline and at each time point and whose pressure reached 20 cmH2O.

Bladder volume as assessed by urodynamics.

Outcome measures

Measure	Solifenacin Succinate n=13 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure Week 3	52.4 mL Standard Deviation 59.4
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure Week 6	65.5 mL Standard Deviation 54.9
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure Week 9	52.0 mL Standard Deviation 58.0
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure Week 12	53.9 mL Standard Deviation 67.6
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure Week 24	40.1 mL Standard Deviation 56.2
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure Week 52	75.4 mL Standard Deviation 71.6

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

Population: FAS population with data available at baseline and at each time point and whose pressure reached 30 cmH2O.

Bladder volume as assessed by urodynamics.

Outcome measures

Measure	Solifenacin Succinate n=7 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure Week 3	101.9 mL Standard Deviation 0.2
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure Week 6	-2.3 mL Standard Deviation NA No data has been caluclated since data were only available for one participant.
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure Week 9	76.0 mL Standard Deviation 120.2
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure Week 12	74.7 mL Standard Deviation 54.9
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure Week 24	67.5 mL Standard Deviation 118.1
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure Week 52	93.6 mL Standard Deviation NA No data has been calculated since data were only available for one participant.

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

Population: FAS population with data available at baseline and at each time point.

Outcome measures

Measure	Solifenacin Succinate n=21 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling Week 52	-7.2 contractions Standard Deviation 10.2
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling Week 3	-3.4 contractions Standard Deviation 3.9
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling Week 6	-4.2 contractions Standard Deviation 5.3
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling Week 9	-6.3 contractions Standard Deviation 6.6
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling Week 12	-6.8 contractions Standard Deviation 8.9
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling Week 24	-7.0 contractions Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52

Population: FAS population with data available at baseline and at each time point.

The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days were concurrent. Catheterized volumes were recorded for 2 days in a participant diary prior to each visit. Four to six catheterizations were performed every day.

Outcome measures

Measure	Solifenacin Succinate n=18 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization Week 9	25.13 mL Standard Deviation 24.91
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization Week 12	37.64 mL Standard Deviation 22.43
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization Week 24	34.38 mL Standard Deviation 33.04
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization Week 36	43.79 mL Standard Deviation 34.13
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization Week 52	40.42 mL Standard Deviation 31.83
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization Week 3	21.56 mL Standard Deviation 26.16
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization Week 6	23.93 mL Standard Deviation 23.80

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52

Population: FAS population with data available at baseline and at each time point.

The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.

Outcome measures

Measure	Solifenacin Succinate n=18 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) Week 3	30.00 mL Standard Deviation 32.06
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) Week 6	31.06 mL Standard Deviation 34.36
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) Week 9	27.31 mL Standard Deviation 33.34
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) Week 12	40.56 mL Standard Deviation 24.64
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) Week 24	40.56 mL Standard Deviation 51.45
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) Week 36	57.91 mL Standard Deviation 47.67
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) Week 52	41.69 mL Standard Deviation 46.71

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52

Population: FAS population with data available at baseline and at each time point.

The first morning catheterized volume was the volume associated with the first morning catheterization. The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.

Outcome measures

Measure	Solifenacin Succinate n=18 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume Week 3	19.47 mL Standard Deviation 34.74
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume Week 6	24.26 mL Standard Deviation 35.49
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume Week 9	23.06 mL Standard Deviation 36.50
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume Week 12	32.56 mL Standard Deviation 35.97
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume Week 24	40.58 mL Standard Deviation 41.89
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume Week 36	40.62 mL Standard Deviation 44.14
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume Week 52	39.88 mL Standard Deviation 34.91

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52

Population: FAS population with data available at baseline and at each time point.

Participants were required to have 4-6 CICs per day on a schedule fixed for the duration of the study. To calculate the number of periods between CICs with incontinence in a diary day, the diary day was divided into periods between CICs (i.e. inter-CIC periods). The hour period, rather than the exact time, of each CIC and incontinence episode was recorded in the diary. When an incontinence episode and a CIC were marked in the same hour period, the incontinence episode was counted as occurring prior to the CIC (when the bladder had not yet emptied), rather than after it (when the bladder had recently been emptied), i.e. the inter-CIC period ended with the hour in which the CIC was recorded. The mean number of periods between CICs with incontinence per 24 hours was the number of periods between CICs when incontinence occurred, divided by the total number of valid diary days.

Outcome measures

Measure	Solifenacin Succinate n=17 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours Week 3	-1.18 periods Standard Deviation 1.42
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours Week 9	-1.47 periods Standard Deviation 1.19
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours Week 12	-1.25 periods Standard Deviation 1.32
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours Week 36	-1.06 periods Standard Deviation 1.25
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours Week 52	-1.29 periods Standard Deviation 1.42
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours Week 6	-1.38 periods Standard Deviation 1.21
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours Week 24	-1.31 periods Standard Deviation 1.39

SECONDARY outcome

Timeframe: 3 days prior to Baseline visit

Population: FAS population.

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=54 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 06:00-07:00	46.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 07:00-08:00	29.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 08:00-09:00	18.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 09:00-10:00	27.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 10:00-11:00	16.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 11:00-12:00	22.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 12:00-13:00	44.4 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 13:00-14:00	20.4 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 14:00-15:00	20.4 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 15:00-16:00	24.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 16:00-17:00	27.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 17:00-18:00	14.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 18:00-19:00	40.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 19:00-20:00	31.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 20:00-21:00	13.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 21:00-22:00	38.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 22:00-23:00	14.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 23:00-00:00	13.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 00:00-01:00	24.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 01:00-02:00	9.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 02:00-03:00	1.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 03:00-04:00	3.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 04:00-05:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline 05:00-06:00	13.0 percentage of days with catheterization

SECONDARY outcome

Timeframe: 3 days prior to Week 3 visit

Population: FAS population.

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=63 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 06:00-07:00	36.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 07:00-08:00	30.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 12:00-13:00	36.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 13:00-14:00	34.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 14:00-15:00	15.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 15:00-16:00	23.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 16:00-17:00	20.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 17:00-18:00	28.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 18:00-19:00	36.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 19:00-20:00	25.4 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 20:00-21:00	20.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 21:00-22:00	36.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 22:00-23:00	17.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 23:00-00:00	9.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 00:00-01:00	25.4 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 01:00-02:00	12.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 02:00-03:00	3.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 03:00-04:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 04:00-05:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 05:00-06:00	11.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 08:00-09:00	20.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 09:00-10:00	27.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 10:00-11:00	20.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 11:00-12:00	19.0 percentage of days with catheterization

SECONDARY outcome

Timeframe: 3 days prior to Week 6 visit

Population: FAS population.

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=60 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 12:00-13:00	43.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 13:00-14:00	33.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 14:00-15:00	15.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 15:00-16:00	30.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 16:00-17:00	25.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 17:00-18:00	20.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 18:00-19:00	35.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 06:00-07:00	35.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 07:00-08:00	30.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 08:00-09:00	20.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 09:00-10:00	36.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 10:00-11:00	15.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 11:00-12:00	11.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 19:00-20:00	28.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 20:00-21:00	11.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 21:00-22:00	40.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 22:00-23:00	18.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 23:00-00:00	16.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 00:00-01:00	18.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 01:00-02:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 02:00-03:00	5.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 03:00-04:00	3.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 04:00-05:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 05:00-06:00	6.7 percentage of days with catheterization

SECONDARY outcome

Timeframe: 3 days prior to Week 9 visit

Population: FAS population.

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=63 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 06:00-07:00	34.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 07:00-08:00	36.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 08:00-09:00	19.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 09:00-10:00	23.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 10:00-11:00	17.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 11:00-12:00	19.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 12:00-13:00	42.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 13:00-14:00	27.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 14:00-15:00	17.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 15:00-16:00	31.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 16:00-17:00	15.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 17:00-18:00	23.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 18:00-19:00	38.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 19:00-20:00	27.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 20:00-21:00	17.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 21:00-22:00	38.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 22:00-23:00	12.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 23:00-00:00	19.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 00:00-01:00	19.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 01:00-02:00	4.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 02:00-03:00	1.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 03:00-04:00	1.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 04:00-05:00	1.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 05:00-06:00	9.5 percentage of days with catheterization

SECONDARY outcome

Timeframe: 3 days prior to Week 12 visit

Population: FAS population.

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=63 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 06:00-07:00	39.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 07:00-08:00	31.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 08:00-09:00	20.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 09:00-10:00	27.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 10:00-11:00	19.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 11:00-12:00	15.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 12:00-13:00	58.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 13:00-14:00	19.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 14:00-15:00	12.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 15:00-16:00	22.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 16:00-17:00	31.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 17:00-18:00	15.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 18:00-19:00	41.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 19:00-20:00	22.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 20:00-21:00	27.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 21:00-22:00	38.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 22:00-23:00	11.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 23:00-00:00	14.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 00:00-01:00	30.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 01:00-02:00	1.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 02:00-03:00	3.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 03:00-04:00	3.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 04:00-05:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 05:00-06:00	6.3 percentage of days with catheterization

SECONDARY outcome

Timeframe: 3 days prior to Week 24 visit

Population: FAS population.

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=63 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 15:00-16:00	23.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 16:00-17:00	27.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 17:00-18:00	27.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 18:00-19:00	34.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 19:00-20:00	30.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 20:00-21:00	20.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 21:00-22:00	38.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 22:00-23:00	6.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 23:00-00:00	17.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 00:00-01:00	25.4 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 04:00-05:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 05:00-06:00	6.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 06:00-07:00	33.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 07:00-08:00	33.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 08:00-09:00	22.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 09:00-10:00	15.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 10:00-11:00	23.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 11:00-12:00	19.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 12:00-13:00	44.4 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 13:00-14:00	33.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 14:00-15:00	9.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 01:00-02:00	3.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 02:00-03:00	3.2 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 03:00-04:00	0 percentage of days with catheterization

SECONDARY outcome

Timeframe: 3 days prior to Week 36 visit

Population: FAS population.

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=60 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 06:00-07:00	36.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 07:00-08:00	35.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 08:00-09:00	26.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 09:00-10:00	20.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 10:00-11:00	16.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 11:00-12:00	16.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 12:00-13:00	53.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 13:00-14:00	30.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 14:00-15:00	8.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 15:00-16:00	25.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 16:00-17:00	26.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 17:00-18:00	23.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 18:00-19:00	43.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 19:00-20:00	21.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 20:00-21:00	23.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 21:00-22:00	38.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 22:00-23:00	5.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 23:00-00:00	15.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 00:00-01:00	25.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 01:00-02:00	5.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 02:00-03:00	1.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 03:00-04:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 04:00-05:00	1.7 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 05:00-06:00	1.7 percentage of days with catheterization

SECONDARY outcome

Timeframe: 3 days prior to Week 52 visit

Population: FAS population.

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all subjects. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=57 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 06:00-07:00	35.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 07:00-08:00	33.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 08:00-09:00	28.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 09:00-10:00	22.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 10:00-11:00	15.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 11:00-12:00	17.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 12:00-13:00	50.9 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 13:00-14:00	26.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 14:00-15:00	10.5 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 15:00-16:00	28.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 16:00-17:00	19.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 17:00-18:00	24.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 18:00-19:00	45.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 19:00-20:00	24.6 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 20:00-21:00	21.1 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 21:00-22:00	36.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 22:00-23:00	15.8 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 23:00-00:00	19.3 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 00:00-01:00	14.0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 01:00-02:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 02:00-03:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 03:00-04:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 04:00-05:00	0 percentage of days with catheterization
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 05:00-06:00	3.5 percentage of days with catheterization

SECONDARY outcome

Timeframe: 3 days prior to Baseline visit

Population: FAS population.

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=54 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 06:00-07:00	27.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 07:00-08:00	27.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 08:00-09:00	16.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 09:00-10:00	37.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 10:00-11:00	25.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 11:00-12:00	22.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 12:00-13:00	35.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 13:00-14:00	33.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 14:00-15:00	25.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 15:00-16:00	31.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 16:00-17:00	37.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 17:00-18:00	24.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 18:00-19:00	24.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 19:00-20:00	31.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 20:00-21:00	14.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 21:00-22:00	35.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 22:00-23:00	14.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 23:00-00:00	9.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 00:00-01:00	13.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 01:00-02:00	5.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 02:00-03:00	1.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 03:00-04:00	1.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 04:00-05:00	1.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline 05:00-06:00	7.4 percentage of days with incontinence

SECONDARY outcome

Timeframe: 3 days prior to Week 3 visit

Population: FAS population.

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=63 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 06:00-07:00	17.5 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 07:00-08:00	25.4 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 08:00-09:00	11.1 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 09:00-10:00	22.2 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 10:00-11:00	22.2 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 11:00-12:00	14.3 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 00:00-01:00	4.8 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 01:00-02:00	3.2 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 02:00-03:00	1.6 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 03:00-04:00	1.6 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 04:00-05:00	0 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 05:00-06:00	9.5 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 12:00-13:00	15.9 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 13:00-14:00	15.9 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 14:00-15:00	20.6 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 15:00-16:00	20.6 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 16:00-17:00	15.9 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 17:00-18:00	20.6 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 18:00-19:00	14.3 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 19:00-20:00	27.0 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 20:00-21:00	19.0 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 21:00-22:00	19.0 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 22:00-23:00	3.2 percentage of days with incontinence
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 23:00-00:00	7.9 percentage of days with incontinence

SECONDARY outcome

Timeframe: 3 days prior to Week 6 visit

Population: FAS population.

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=60 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 08:00-09:00	11.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 09:00-10:00	11.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 10:00-11:00	20.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 11:00-12:00	20.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 12:00-13:00	13.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 13:00-14:00	6.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 14:00-15:00	11.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 15:00-16:00	26.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 16:00-17:00	21.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 17:00-18:00	23.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 18:00-19:00	15.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 19:00-20:00	25.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 20:00-21:00	10.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 21:00-22:00	23.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 22:00-23:00	5.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 23:00-00:00	5.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 00:00-01:00	0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 01:00-02:00	0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 02:00-03:00	3.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 03:00-04:00	1.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 04:00-05:00	3.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 05:00-06:00	5.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 06:00-07:00	25.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 07:00-08:00	18.3 percentage of days with incontinence

SECONDARY outcome

Timeframe: 3 days prior to Week 9 visit

Population: FAS population.

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=63 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 06:00-07:00	14.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 07:00-08:00	20.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 08:00-09:00	9.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 09:00-10:00	9.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 10:00-11:00	25.4 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 11:00-12:00	22.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 12:00-13:00	11.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 13:00-14:00	11.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 14:00-15:00	12.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 15:00-16:00	22.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 16:00-17:00	20.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 17:00-18:00	20.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 18:00-19:00	11.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 19:00-20:00	15.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 20:00-21:00	14.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 21:00-22:00	11.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 22:00-23:00	6.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 23:00-00:00	4.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 00:00-01:00	1.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 01:00-02:00	3.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 02:00-03:00	1.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 03:00-04:00	3.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 04:00-05:00	1.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 05:00-06:00	9.5 percentage of days with incontinence

SECONDARY outcome

Timeframe: 3 days prior to Week 12 visit

Population: FAS population

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=63 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 06:00-07:00	17.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 07:00-08:00	11.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 08:00-09:00	9.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 09:00-10:00	28.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 10:00-11:00	22.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 11:00-12:00	23.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 12:00-13:00	25.4 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 13:00-14:00	4.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 14:00-15:00	9.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 15:00-16:00	28.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 16:00-17:00	12.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 17:00-18:00	17.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 18:00-19:00	17.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 19:00-20:00	17.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 20:00-21:00	12.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 03:00-04:00	1.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 04:00-05:00	0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 05:00-06:00	7.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 21:00-22:00	11.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 22:00-23:00	9.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 23:00-00:00	6.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 00:00-01:00	4.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 01:00-02:00	1.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 02:00-03:00	1.6 percentage of days with incontinence

SECONDARY outcome

Timeframe: 3 days prior to Week 24 visit

Population: FAS population.

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=63 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 08:00-09:00	7.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 09:00-10:00	15.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 10:00-11:00	31.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 11:00-12:00	23.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 06:00-07:00	25.4 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 07:00-08:00	14.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 12:00-13:00	11.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 13:00-14:00	11.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 14:00-15:00	9.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 15:00-16:00	25.4 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 16:00-17:00	14.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 17:00-18:00	30.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 18:00-19:00	17.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 19:00-20:00	19.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 20:00-21:00	15.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 21:00-22:00	7.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 22:00-23:00	7.9 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 23:00-00:00	6.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 00:00-01:00	3.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 01:00-02:00	3.2 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 02:00-03:00	1.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 03:00-04:00	0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 04:00-05:00	0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 05:00-06:00	4.8 percentage of days with incontinence

SECONDARY outcome

Timeframe: 3 days prior to Week 36 visit

Population: FAS population.

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=60 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 06:00-07:00	25.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 07:00-08:00	13.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 12:00-13:00	21.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 13:00-14:00	13.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 14:00-15:00	11.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 15:00-16:00	31.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 16:00-17:00	11.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 17:00-18:00	16.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 18:00-19:00	11.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 19:00-20:00	30.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 20:00-21:00	21.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 21:00-22:00	18.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 22:00-23:00	5.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 23:00-00:00	11.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 00:00-01:00	6.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 03:00-04:00	1.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 04:00-05:00	1.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 05:00-06:00	5.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 08:00-09:00	11.7 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 09:00-10:00	18.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 10:00-11:00	20.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 11:00-12:00	20.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 01:00-02:00	3.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 02:00-03:00	0 percentage of days with incontinence

SECONDARY outcome

Timeframe: 3 days prior to Week 52 visit

Population: FAS population.

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.

Outcome measures

Measure	Solifenacin Succinate n=57 Days Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 06:00-07:00	19.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 07:00-08:00	19.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 08:00-09:00	17.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 09:00-10:00	14.0 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 10:00-11:00	24.6 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 11:00-12:00	33.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 12:00-13:00	17.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 13:00-14:00	8.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 14:00-15:00	12.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 16:00-17:00	17.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 17:00-18:00	22.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 18:00-19:00	19.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 20:00-21:00	17.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 21:00-22:00	21.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 22:00-23:00	1.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 03:00-04:00	1.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 04:00-05:00	5.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 05:00-06:00	3.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 15:00-16:00	29.8 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 19:00-20:00	21.1 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 23:00-00:00	3.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 00:00-01:00	5.3 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 01:00-02:00	3.5 percentage of days with incontinence
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 02:00-03:00	3.5 percentage of days with incontinence

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with available data at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=20 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score Week 24	-1.8 units on a scale Standard Deviation 19.2
Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score Week 52	9.0 units on a scale Standard Deviation 17.4

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with data available at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=20 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score Week 52	3.93 units on a scale Standard Deviation 14.81
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score Week 24	2.17 units on a scale Standard Deviation 18.70

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with data available at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=20 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score Week 24	-1.50 units on a scale Standard Deviation 11.37
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score Week 52	2.33 units on a scale Standard Deviation 13.21

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with data available at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=19 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score Week 24	-3.47 units on a scale Standard Deviation 32.60
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score Week 52	-0.83 units on a scale Standard Deviation 21.37

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with data available at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=19 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score Week 24	-1.85 units on a scale Standard Deviation 16.06
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score Week 52	-1.11 units on a scale Standard Deviation 16.02

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with data available at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=18 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score Week 24	-1.69 units on a scale Standard Deviation 8.24
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score Week 52	-0.06 units on a scale Standard Deviation 6.86

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with data available at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=18 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score Week 24	0.39 units on a scale Standard Deviation 21.16
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score Week 52	4.29 units on a scale Standard Deviation 17.39

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with data available at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=18 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score Week 24	0.00 units on a scale Standard Deviation 23.39
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score Week 52	5.77 units on a scale Standard Deviation 20.80

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with data available at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=18 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score Week 24	-3.31 units on a scale Standard Deviation 23.81
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score Week 52	4.81 units on a scale Standard Deviation 28.20

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with data available at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=18 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score Week 52	7.1 units on a scale Standard Deviation 24.5
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score Week 24	15.2 units on a scale Standard Deviation 26.6

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 52

Population: FAS population with data available at baseline and at each time point.

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).

Outcome measures

Measure	Solifenacin Succinate n=18 Participants Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score Week 24	1.5 units on a scale Standard Deviation 16.7
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score Week 52	-4.2 units on a scale Standard Deviation 17.7

Adverse Events

Solifenacin Succinate

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Solifenacin Succinate n=23 participants at risk Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Teratoma	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Gastrointestinal disorders Vomiting	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Pharyngitis	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Urinary tract infection	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)

Other adverse events

Measure	Solifenacin Succinate n=23 participants at risk Children aged 6 months to \< 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Gastrointestinal disorders Constipation	13.0% 3/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Gastrointestinal disorders Dental caries	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Gastrointestinal disorders Diarrhoea	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Gastrointestinal disorders Dry mouth	8.7% 2/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Gastrointestinal disorders Enteritis	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Gastrointestinal disorders Vomiting	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
General disorders Pyrexia	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Bronchitis	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Escherichia urinary tract infection	8.7% 2/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Gastroenteritis	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Nasopharyngitis	17.4% 4/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Otitis media	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Respiratory tract infection	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Tonsillitis	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Upper respiratory tract infection	13.0% 3/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Urinary tract infection	8.7% 2/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Urinary tract infection bacterial	13.0% 3/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Infections and infestations Urinary tract infection enterococcal	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Injury, poisoning and procedural complications Burns second degree	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Injury, poisoning and procedural complications Joint dislocation	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Investigations Bacterial test positive	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)
Skin and subcutaneous tissue disorders Decubitus ulcer	4.3% 1/23 • From first dose of study drug to last dose of study drug (up to 54 weeks)

Additional Information

Medical Director

Astellas Pharma Europe B.V.

Phone: +31 (0) 715455050

Email: astellas.resultsdisclosure@astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript sixty (60) days prior to publication for review and comment.
• Publication restrictions are in place

Restriction type: OTHER