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    Clinical Trial Results:
    A Phase 3, Open-label, Baseline-controlled, Multi-center, Sequential Dose-titration Study to Assess the Pharmacokinetics, Long-term Efficacy and Safety of Solifenacin Succinate Suspension in Children from 6 Months to less than 5 Years of Age with Neurogenic Detrusor Overactivity

    Summary
    EudraCT number
    		 2012-003178-22
    Trial protocol
    		 GB   NL   BE   DK  
    Global end of trial date
    18 Dec 2015

    Results information
    Results version number
    		 v2
    This version publication date
    05 Apr 2017
    First version publication date
    29 Jun 2016
    Other versions
    		 v1 , v3
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    Non-Serious Adverse Events section updated to include 2 new adverse events in updated clinical study report.

    Trial information

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    Trial identification
    Sponsor protocol code
    905-CL-074
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01981954
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe B.V.
    Sponsor organisation address
    Sylviusweg 62, Leiden, Netherlands, 2333 BE
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., astellas.resultsdisclosure@astellas.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000573-PIP02-13
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term efficacy, safety and pharmacokinetics (PK) of solifenacin succinate suspension after multiple-dose administration.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines (especially ICH E11), and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Philippines: 6
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Worldwide total number of subjects
    23
    EEA total number of subjects
    11
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    4
    Children (2-11 years)
    19
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 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).

    Pre-assignment
    Screening details
    		 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.

    Period 1
    Period 1 title
    Titration Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Solifenacin succinate
    Arm description
    		 Children aged 6 months to <5 years who received solifenacin once daily, with sequential titrated doses for 12 weeks during the Titration period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solifenacin succinate
    Investigational medicinal product code
    YM905
    Other name
    solifenacin, solifenacin succinate suspension
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    An initial dose of solifenacin (1 mg/mL) was administered on the baseline visit for children aged 6 months to <2 years and the day after the baseline visit for children aged 2 years to <5 years, then once daily for a 12-week Titration period, to determine the participant's optimal dose. Doses were calculated per weight determined at the baseline visit of this study and based on a physiologically-based pharmacokinetic (PK) model, targeting to have equivalent doses of 2.5, 5, 7.5 and 10 mg doses of solifenacin once daily in adults (referred to as PED2.5, PED5, PED7.5 and PED10). During the 12-week Titration period, the dose of solifenacin was down-titrated, up-titrated or maintained depending on the study’s titration criteria, which were based on a combination of diary endpoints, urodynamic assessments and adverse event (AE) criteria.

    Number of subjects in period 1
    		Solifenacin succinate
    Started
    23
    Treated
    23
    Completed
    22
    Not completed
    1
         Protocol Violation
    1
    Period 2
    Period 2 title
    Fixed-Dose Assessment Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Solifenacin succinate
    Arm description
    		 Children aged 6 months to <5 years who received solifenacin once daily, with a fixed dose of solifenacin once daily for 40 weeks in the Fixed-dose assessment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solifenacin succinate
    Investigational medicinal product code
    YM905
    Other name
    solifenacin, solifenacin succinate suspension
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    When a fixed and optimal dose of solifenacin was confirmed by Week 12, a participant continued on to receive solifenacin orally once daily until end of the study (Week 52).

    Number of subjects in period 2
    		Solifenacin succinate
    Started
    22
    Treated
    22
    Completed
    21
    Not completed
    1
         Lack of efficacy
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Solifenacin succinate
    Reporting group description
    		 Children aged 6 months to <5 years who received solifenacin once daily, with sequential titrated doses for 12 weeks during the Titration period.

    Reporting group values
    		 Solifenacin succinate Total
    Number of subjects
    		 23 23
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 4 4
        Children (2-11 years)
    		 19 19
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 35.3 ± 12.7 -
    Gender categorical
    Units:
        Male
    		 9 9
        Female
    		 14 14
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 13.2 ± 2.87 -
    Duration of NDO Disease
    Units: years
        median (full range (min-max))
    		 1.99 (0.13 to 4.51) -

    End points

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    End points reporting groups
    Reporting group title
    Solifenacin succinate
    Reporting group description
    		 Children aged 6 months to <5 years who received solifenacin once daily, with sequential titrated doses for 12 weeks during the Titration period.
    Reporting group title
    Solifenacin succinate
    Reporting group description
    		 Children aged 6 months to <5 years who received solifenacin once daily, with a fixed dose of solifenacin once daily for 40 weeks in the Fixed-dose assessment period.

    Primary: Change from Baseline to Week 24 in Maximum Cystometric Capacity (MCC)

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    End point title
    		 Change from Baseline to Week 24 in Maximum Cystometric Capacity (MCC) [1]
    End point description
    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). The analysis population was the 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. Change from baseline to week 24 with and without last observation carried forward (LOCF) imputation are reported. "N" indicates the number of participants included in each analysis.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a one treatment arm study, showing statistical analysis is not possible due to system limitations.
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: mL
    arithmetic mean (standard deviation)
        Change at Week 24 [N=21]
    37 ± 35.9
        Change at Week 24 LOCF [N=22]
    35.2 ± 36.1
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12 and 52 in MCC

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12 and 52 in MCC
    End point description
    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). The analysis population was the 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. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: mL
    arithmetic mean (standard deviation)
        Week 3 [N=11]
    45.2 ± 44.8
        Week 6 [N=11]
    36.5 ± 36.6
        Week 9 [N=9]
    20.8 ± 54.7
        Week 12 [N=16]
    40.2 ± 37.9
        Week 52 [N=14]
    58.6 ± 34.1
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance
    End point description
    Bladder compliance was calculated by dividing the volume change 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: mL/cmH2O
    arithmetic mean (standard deviation)
        Week 3 [N=11]
    4.55 ± 4.3
        Week 6 [N=11]
    5.45 ± 8.45
        Week 9 [N=9]
    8.92 ± 15.69
        Week 12 [N=16]
    4.14 ± 4.2
        Week 24 [N=21]
    5.1 ± 6.82
        Week 52 [N=14]
    5.94 ± 4.24
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling
    End point description
    Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: cmH2O
    arithmetic mean (standard deviation)
        Week 3 [N=11]
    -5.2 ± 12.9
        Week 6 [N=11]
    -8.3 ± 14.8
        Week 9 [N=9]
    -8.9 ± 17.5
        Week 12 [N=16]
    -0.6 ± 23.4
        Week 24 [N=21]
    -1 ± 13.9
        Week 52 [N=14]
    -9.8 ± 19.2
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling
    End point description
    Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: cmH2O
    arithmetic mean (standard deviation)
        Week 3 [N=11]
    0.9 ± 8.4
        Week 6 [N=11]
    1.3 ± 10.4
        Week 9 [N=9]
    0.7 ± 11.1
        Week 12 [N=16]
    -4.1 ± 10.9
        Week 24 [N=21]
    -2 ± 9.4
        Week 52 [N=14]
    -2.3 ± 14.7
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling
    End point description
    Catheterized volume was measured when the bladder was emptied via catheterization 5 minutes after the end of bladder-filling. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: mL
    arithmetic mean (standard deviation)
        Week 3 [N=5]
    38.6 ± 52.6
        Week 6 [N=6]
    41.8 ± 25.5
        Week 9 [N=4]
    50.5 ± 40.5
        Week 12 [N=10]
    50.5 ± 46.6
        Week 24 [N=13]
    44 ± 29.5
        Week 52 [N=8]
    59.8 ± 27
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction >15 cmH2O

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction >15 cmH2O
    End point description
    Bladder volume as assessed by urodynamics. The analysis population was FAS. "N" indicates the number of participants with available data at each time point and excluding participants who did not have a detrusor contraction.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: mL
    arithmetic mean (standard deviation)
        Week 3 [N=4]
    47 ± 31.3
        Week 6 [N=2]
    87.4 ± 57.4
        Week 9 [N=5]
    60.8 ± 82.9
        Week 12 [N=5]
    18.7 ± 37.5
        Week 24 [N=11]
    22.9 ± 52.3
        Week 52 [N=4]
    89.2 ± 58
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure
    End point description
    Bladder volume as assessed by urodynamics. The analysis population was FAS. "N" indicates the number of participants with available data at each time point and whose pressure reached 10 cmH2O.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: mL
    arithmetic mean (standard deviation)
        Week 3 [N=8]
    31.9 ± 47.3
        Week 6 [N=8]
    47.8 ± 55.9
        Week 9 [N=6]
    31.5 ± 54.1
        Week 12 [N=14]
    30.1 ± 37.9
        Week 24 [N=17]
    28.7 ± 47.9
        Week 52 [N=10]
    49.4 ± 40.9
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure
    End point description
    Bladder volume as assessed by urodynamics. The analysis population was FAS. "N" indicates the number of participants with available data at each time point and participants whose pressure reached 20 cmH2O.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: mL
    arithmetic mean (standard deviation)
        Week 3 [N=6]
    52.4 ± 59.4
        Week 6 [N=4]
    65.5 ± 54.9
        Week 9 [N=3]
    52 ± 58
        Week 12 [N=6]
    53.9 ± 67.6
        Week 24 [N=10]
    40.1 ± 56.2
        Week 52 [N=3]
    75.4 ± 71.6
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure
    End point description
    Bladder volume as assessed by urodynamics. The analysis population was FAS. "N" indicates the number of participants with available data at each time point and participants whose pressure reached 30 cmH2O. Due to low number of participants whose pressure did not reach 30 cmH20, no data has been calculated and is denoted as "99999."
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: nL
    arithmetic mean (standard deviation)
        Week 3 [N=2]
    101.9 ± 0.2
        Week 6 [N=1]
    -2.3 ± 99999
        Week 9 [N=2]
    76 ± 120.2
        Week 12 [N=2]
    74.7 ± 54.9
        Week 24 [N=2]
    67.5 ± 118.1
        Week 52 [N=1]
    93.6 ± 99999
    No statistical analyses for this end point

    Secondary: 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

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    End point title
    		 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
    End point description
    The analysis population was FAS. "N" indicates the number of participants with available data at each time point and excluding participants who did not have a detrusor contraction.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: contractions
    arithmetic mean (standard deviation)
        Week 3 [N=11]
    -3.4 ± 3.9
        Week 6 [N=11]
    -4.2 ± 5.3
        Week 9 [N=9]
    -6 ± 6.2
        Week 12 [N=16]
    -6.8 ± 8.9
        Week 24 [N=21]
    -7 ± 8.6
        Week 52 [N=14]
    -7.2 ± 10.2
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume per Catheterization

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume per Catheterization
    End point description
    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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 36, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: mL
    arithmetic mean (standard deviation)
        Week 3 [N=19]
    20.7 ± 25.7
        Week 6 [N=18]
    23.34 ± 23.23
        Week 9 [N=19]
    24.82 ± 24.25
        Week 12 [N=19]
    37.34 ± 21.84
        Week 24 [N=19]
    33.73 ± 32.23
        Week 36 [N=18]
    44.35 ± 33.19
        Week 52 [N=17]
    41.88 ± 31.4
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV)

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV)
    End point description
    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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 36, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: mL
    arithmetic mean (standard deviation)
        Week 3 [N=19]
    29.13 ± 31.38
        Week 6 [N=18]
    30.47 ± 33.43
        Week 9 [N=19]
    28.71 ± 32.98
        Week 12 [N=19]
    42.29 ± 25.11
        Week 24 [N=19]
    40.26 ± 50.02
        Week 36 [N=18]
    61.03 ± 48.1
        Week 52 [N=17]
    44.09 ± 46.3
    No statistical analyses for this end point

    Secondary: Change from Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume

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    End point title
    		 Change from Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume
    End point description
    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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 36, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: mL
    arithmetic mean (standard deviation)
        Week 3 [N=19]
    18.34 ± 34.12
        Week 6 [N=18]
    23.14 ± 34.76
        Week 9 [N=19]
    22.76 ± 35.49
        Week 12 [N=19]
    31.53 ± 35.25
        Week 24 [N=19]
    39.37 ± 41.05
        Week 36 [N=18]
    42.5 ± 43.56
        Week 52 [N=17]
    41.15 ± 34.21
    No statistical analyses for this end point

    Secondary: 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

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    End point title
    		 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
    End point description
    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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 3, 6, 9, 12, 24, 36, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: periods
    arithmetic mean (standard deviation)
        Week 3 [N=18]
    -1.07 ± 1.44
        Week 6 [N=16]
    -1.29 ± 1.22
        Week 9 [N=16]
    -1.37 ± 1.2
        Week 12 [N=17]
    -1.22 ± 1.29
        Week 24 [N=18]
    -1.31 ± 1.35
        Week 36 [N=17]
    -1.02 ± 1.23
        Week 52 [N=15]
    -1.22 ± 1.39
    No statistical analyses for this end point

    Secondary: Incidence of Catheterizations for Each Hour of 24 Hour day at Baseline

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    End point title
    		 Incidence of Catheterizations for Each Hour of 24 Hour day at Baseline
    End point description
    For each one hour period of the 24 hour day, the incidence of 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. The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Baseline visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with catheterization
    number (not applicable)
        06:00-07:00
    49.1
        07:00-08:00
    28.1
        08:00-09:00
    17.5
        09:00-10:00
    26.3
        10:00-11:00
    15.8
        11:00-12:00
    26.3
        12:00-13:00
    42.1
        13:00-14:00
    19.3
        14:00-15:00
    19.3
        15:00-16:00
    28.1
        16:00-17:00
    26.3
        17:00-18:00
    14
        18:00-19:00
    38.6
        19:00-20:00
    33.3
        20:00-21:00
    14
        21:00-22:00
    36.8
        22:00-23:00
    14
        23:00-00:00
    12.3
        00:00-01:00
    28.1
        01:00-02:00
    8.8
        02:00-03:00
    1.8
        03:00-04:00
    3.5
        04:00-05:00
    0
        05:00-06:00
    12.3
    No statistical analyses for this end point

    Secondary: Incidence of Catheterizations for Each Hour of 24 Hour day During Week 3

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    End point title
    		 Incidence of Catheterizations for Each Hour of 24 Hour day During Week 3
    End point description
    For each one hour period of the 24 hour day, the incidence of 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. The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 3 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with catheterization
    number (not applicable)
        06:00-07:00
    37.9
        07:00-08:00
    28.8
        08:00-09:00
    19.7
        09:00-10:00
    25.8
        10:00-11:00
    21.2
        11:00-12:00
    21.2
        12:00-13:00
    34.8
        13:00-14:00
    33.3
        14:00-15:00
    16.7
        15:00-16:00
    25.8
        16:00-17:00
    19.7
        17:00-18:00
    27.3
        18:00-19:00
    34.8
        19:00-20:00
    27.3
        20:00-21:00
    21.2
        21:00-22:00
    34.8
        22:00-23:00
    16.7
        23:00-00:00
    10.6
        00:00-01:00
    25.8
        01:00-02:00
    13.6
        02:00-03:00
    3
        03:00-04:00
    0
        04:00-05:00
    0
        05:00-06:00
    12.1
    No statistical analyses for this end point

    Secondary: Incidence of Catheterizations for Each Hour of 24 Hour day During Week 6

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    End point title
    		 Incidence of Catheterizations for Each Hour of 24 Hour day During Week 6
    End point description
    For each one hour period of the 24 hour day, the incidence of 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. The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 6 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with catheterization
    number (not applicable)
        06:00-07:00
    36.5
        07:00-08:00
    28.6
        08:00-09:00
    19
        09:00-10:00
    34.9
        10:00-11:00
    15.9
        11:00-12:00
    14.3
        12:00-13:00
    41.3
        13:00-14:00
    31.7
        14:00-15:00
    17.5
        15:00-16:00
    30.2
        16:00-17:00
    23.8
        17:00-18:00
    19
        18:00-19:00
    34.9
        19:00-20:00
    30.2
        20:00-21:00
    11.1
        21:00-22:00
    38.1
        22:00-23:00
    17.5
        23:00-00:00
    15.9
        00:00-01:00
    22.2
        01:00-02:00
    0
        02:00-03:00
    4.8
        03:00-04:00
    3.2
        04:00-05:00
    0
        05:00-06:00
    7.9
    No statistical analyses for this end point

    Secondary: Incidence of Catheterizations for Each Hour of 24 Hour day During Week 9

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    End point title
    		 Incidence of Catheterizations for Each Hour of 24 Hour day During Week 9
    End point description
    For each one hour period of the 24 hour day, the incidence of 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. The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 9 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with catheterization
    number (not applicable)
        06:00-07:00
    37.9
        07:00-08:00
    34.8
        08:00-09:00
    18.2
        09:00-10:00
    22.7
        10:00-11:00
    18.2
        11:00-12:00
    21.2
        12:00-13:00
    40.9
        13:00-14:00
    25.8
        14:00-15:00
    21.2
        15:00-16:00
    30.3
        16:00-17:00
    15.2
        17:00-18:00
    22.7
        18:00-19:00
    36.4
        19:00-20:00
    30.3
        20:00-21:00
    16.7
        21:00-22:00
    36.4
        22:00-23:00
    12.1
        23:00-00:00
    18.2
        00:00-01:00
    21.2
        01:00-02:00
    6.1
        02:00-03:00
    1.5
        03:00-04:00
    1.5
        04:00-05:00
    1.5
        05:00-06:00
    9.1
    No statistical analyses for this end point

    Secondary: Incidence of Catheterizations for Each Hour of 24 Hour day During Week 12

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    End point title
    		 Incidence of Catheterizations for Each Hour of 24 Hour day During Week 12
    End point description
    For each one hour period of the 24 hour day, the incidence of 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. The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 12 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with catheterization
    number (not applicable)
        06:00-07:00
    44.9
        07:00-08:00
    29
        08:00-09:00
    18.8
        09:00-10:00
    24.6
        10:00-11:00
    20.3
        11:00-12:00
    20.3
        12:00-13:00
    55.1
        13:00-14:00
    17.4
        14:00-15:00
    11.6
        15:00-16:00
    29
        16:00-17:00
    29
        17:00-18:00
    14.5
        18:00-19:00
    37.7
        19:00-20:00
    29
        20:00-21:00
    24.6
        21:00-22:00
    34.8
        22:00-23:00
    10.1
        23:00-00:00
    13
        00:00-01:00
    36.2
        01:00-02:00
    1.4
        02:00-03:00
    2.9
        03:00-04:00
    2.9
        04:00-05:00
    0
        05:00-06:00
    5.8
    No statistical analyses for this end point

    Secondary: Incidence of Catheterizations for Each Hour of 24 Hour day During Week 24

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    End point title
    		 Incidence of Catheterizations for Each Hour of 24 Hour day During Week 24
    End point description
    For each one hour period of the 24 hour day, the incidence of 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. The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 24 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with catheterization
    number (not applicable)
        06:00-07:00
    36.4
        07:00-08:00
    31.8
        08:00-09:00
    21.2
        09:00-10:00
    15.2
        10:00-11:00
    27.3
        11:00-12:00
    18.2
        12:00-13:00
    42.4
        13:00-14:00
    31.8
        14:00-15:00
    9.1
        15:00-16:00
    27.3
        16:00-17:00
    25.8
        17:00-18:00
    25.8
        18:00-19:00
    33.3
        19:00-20:00
    33.3
        20:00-21:00
    19.7
        21:00-22:00
    36.4
        22:00-23:00
    6.1
        23:00-00:00
    16.7
        00:00-01:00
    28.8
        01:00-02:00
    3
        02:00-03:00
    3
        03:00-04:00
    0
        04:00-05:00
    0
        05:00-06:00
    6.1
    No statistical analyses for this end point

    Secondary: Incidence of Catheterizations for Each Hour of 24 Hour day During Week 36

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    End point title
    		 Incidence of Catheterizations for Each Hour of 24 Hour day During Week 36
    End point description
    For each one hour period of the 24 hour day, the incidence of 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. The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 36 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with catheterization
    number (not applicable)
        06:00-07:00
    39.7
        07:00-08:00
    33.3
        08:00-09:00
    25.4
        09:00-10:00
    19
        10:00-11:00
    20.6
        11:00-12:00
    15.9
        12:00-13:00
    50.8
        13:00-14:00
    28.6
        14:00-15:00
    11.1
        15:00-16:00
    25.4
        16:00-17:00
    25.4
        17:00-18:00
    22.2
        18:00-19:00
    41.3
        19:00-20:00
    25.4
        20:00-21:00
    22.2
        21:00-22:00
    36.5
        22:00-23:00
    4.8
        23:00-00:00
    14.3
        00:00-01:00
    28.6
        01:00-02:00
    4.8
        02:00-03:00
    1.6
        03:00-04:00
    0
        04:00-05:00
    1.6
        05:00-06:00
    1.6
    No statistical analyses for this end point

    Secondary: Incidence of Catheterizations for Each Hour of 24 Hour day During Week 52

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    End point title
    		 Incidence of Catheterizations for Each Hour of 24 Hour day During Week 52
    End point description
    For each one hour period of the 24 hour day, the incidence of 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. The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 52 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with catheterization
    number (not applicable)
        06:00-07:00
    36.7
        07:00-08:00
    33.3
        08:00-09:00
    26.7
        09:00-10:00
    21.7
        10:00-11:00
    16.7
        11:00-12:00
    20
        12:00-13:00
    48.3
        13:00-14:00
    25
        14:00-15:00
    10
        15:00-16:00
    31.7
        16:00-17:00
    18.3
        17:00-18:00
    23.3
        18:00-19:00
    45
        19:00-20:00
    26.7
        20:00-21:00
    20
        21:00-22:00
    35
        22:00-23:00
    15
        23:00-00:00
    20
        00:00-01:00
    16.7
        01:00-02:00
    0
        02:00-03:00
    0
        03:00-04:00
    0
        04:00-05:00
    0
        05:00-06:00
    3.3
    No statistical analyses for this end point

    Secondary: Incidence of Incontinence for Each Hour of 24 Hour day at Baseline

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    End point title
    		 Incidence of Incontinence for Each Hour of 24 Hour day at Baseline
    End point description
    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 incidence of 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.The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Baseline visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with incontinence
    number (not applicable)
        06:00-07:00
    31.6
        07:00-08:00
    26.3
        08:00-09:00
    15.8
        09:00-10:00
    35.1
        10:00-11:00
    24.6
        11:00-12:00
    26.3
        12:00-13:00
    33.3
        13:00-14:00
    31.6
        14:00-15:00
    24.6
        15:00-16:00
    35.1
        16:00-17:00
    35.1
        17:00-18:00
    22.8
        18:00-19:00
    22.8
        19:00-20:00
    33.3
        20:00-21:00
    15.8
        21:00-22:00
    33.3
        22:00-23:00
    14
        23:00-00:00
    8.8
        00:00-01:00
    12.3
        01:00-02:00
    5.3
        02:00-03:00
    1.8
        03:00-04:00
    1.8
        04:00-05:00
    1.8
        05:00-06:00
    7
    No statistical analyses for this end point

    Secondary: Incidence of Incontinence for Each Hour of 24 Hour day During Week 3

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    End point title
    		 Incidence of Incontinence for Each Hour of 24 Hour day During Week 3
    End point description
    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 incidence of 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.The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 3 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with incontinence
    number (not applicable)
        06:00-07:00
    19.7
        07:00-08:00
    24.2
        08:00-09:00
    10.6
        09:00-10:00
    21.2
        10:00-11:00
    22.7
        11:00-12:00
    16.7
        12:00-13:00
    15.2
        13:00-14:00
    15.2
        14:00-15:00
    21.2
        15:00-16:00
    22.7
        16:00-17:00
    15.2
        17:00-18:00
    19.7
        18:00-19:00
    13.6
        19:00-20:00
    28.8
        20:00-21:00
    19.7
        21:00-22:00
    18.2
        22:00-23:00
    3
        23:00-00:00
    9.1
        00:00-01:00
    4.5
        01:00-02:00
    4.5
        02:00-03:00
    1.5
        03:00-04:00
    1.5
        04:00-05:00
    0
        05:00-06:00
    10.6
    No statistical analyses for this end point

    Secondary: Incidence of Incontinence for Each Hour of 24 Hour day During Week 6

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    End point title
    		 Incidence of Incontinence for Each Hour of 24 Hour day During Week 6
    End point description
    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 incidence of 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.The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior Week 6 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with incontinence
    number (not applicable)
        06:00-07:00
    27
        07:00-08:00
    17.5
        08:00-09:00
    11.1
        09:00-10:00
    11.1
        10:00-11:00
    20.6
        11:00-12:00
    22.2
        12:00-13:00
    12.7
        13:00-14:00
    6.3
        14:00-15:00
    14.3
        15:00-16:00
    27
        16:00-17:00
    20.6
        17:00-18:00
    22.2
        18:00-19:00
    15.9
        19:00-20:00
    27
        20:00-21:00
    9.5
        21:00-22:00
    22.2
        22:00-23:00
    4.8
        23:00-00:00
    4.8
        00:00-01:00
    1.6
        01:00-02:00
    0
        02:00-03:00
    3.2
        03:00-04:00
    1.6
        04:00-05:00
    3.2
        05:00-06:00
    4.8
    No statistical analyses for this end point

    Secondary: Incidence of Incontinence for Each Hour of 24 Hour day During Week 9

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    End point title
    		 Incidence of Incontinence for Each Hour of 24 Hour day During Week 9
    End point description
    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 incidence of 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.The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 9 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with incontinence
    number (not applicable)
        06:00-07:00
    18.2
        07:00-08:00
    19.7
        08:00-09:00
    9.1
        09:00-10:00
    9.1
        10:00-11:00
    25.8
        11:00-12:00
    24.2
        12:00-13:00
    10.6
        13:00-14:00
    10.6
        14:00-15:00
    15.2
        15:00-16:00
    21.2
        16:00-17:00
    19.7
        17:00-18:00
    19.7
        18:00-19:00
    10.6
        19:00-20:00
    19.7
        20:00-21:00
    13.6
        21:00-22:00
    10.6
        22:00-23:00
    6.1
        23:00-00:00
    4.5
        00:00-01:00
    3
        01:00-02:00
    3
        02:00-03:00
    1.5
        03:00-04:00
    3
        04:00-05:00
    1.5
        05:00-06:00
    9.1
    No statistical analyses for this end point

    Secondary: Incidence of Incontinence for Each Hour of 24 Hour day During Week 12

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    End point title
    		 Incidence of Incontinence for Each Hour of 24 Hour day During Week 12
    End point description
    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 incidence of 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.The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 12 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with incontinence
    number (not applicable)
        06:00-07:00
    23.2
        07:00-08:00
    10.1
        08:00-09:00
    8.7
        09:00-10:00
    26.1
        10:00-11:00
    20.3
        11:00-12:00
    23.2
        12:00-13:00
    23.2
        13:00-14:00
    4.3
        14:00-15:00
    8.7
        15:00-16:00
    31.9
        16:00-17:00
    11.6
        17:00-18:00
    15.9
        18:00-19:00
    15.9
        19:00-20:00
    23.2
        20:00-21:00
    11.6
        21:00-22:00
    10.1
        22:00-23:00
    8.7
        23:00-00:00
    5.8
        00:00-01:00
    7.2
        01:00-02:00
    1.4
        02:00-03:00
    1.4
        03:00-04:00
    1.4
        04:00-05:00
    0
        05:00-06:00
    7.2
    No statistical analyses for this end point

    Secondary: Incidence of Incontinence for Each Hour of 24 Hour day During Week 24

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    End point title
    		 Incidence of Incontinence for Each Hour of 24 Hour day During Week 24
    End point description
    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 incidence of 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.The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 24 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with incontinence
    number (not applicable)
        06:00-07:00
    27.3
        07:00-08:00
    13.6
        08:00-09:00
    7.6
        09:00-10:00
    15.2
        10:00-11:00
    31.8
        11:00-12:00
    22.7
        12:00-13:00
    10.6
        13:00-14:00
    10.6
        14:00-15:00
    9.1
        15:00-16:00
    25.8
        16:00-17:00
    13.6
        17:00-18:00
    28.8
        18:00-19:00
    16.7
        19:00-20:00
    22.7
        20:00-21:00
    15.2
        21:00-22:00
    7.6
        22:00-23:00
    7.6
        23:00-00:00
    6.1
        00:00-01:00
    4.5
        01:00-02:00
    3
        02:00-03:00
    1.5
        03:00-04:00
    0
        04:00-05:00
    0
        05:00-06:00
    4.5
    No statistical analyses for this end point

    Secondary: Incidence of Incontinence for Each Hour of 24 Hour day During Week 36

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    End point title
    		 Incidence of Incontinence for Each Hour of 24 Hour day During Week 36
    End point description
    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 incidence of 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.The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 36 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with incontinence
    number (not applicable)
        06:00-07:00
    28.6
        07:00-08:00
    12.7
        08:00-09:00
    11.1
        09:00-10:00
    17.5
        10:00-11:00
    22.2
        11:00-12:00
    19
        12:00-13:00
    20.6
        13:00-14:00
    12.7
        14:00-15:00
    12.7
        15:00-16:00
    31.7
        16:00-17:00
    11.1
        17:00-18:00
    15.9
        18:00-19:00
    11.1
        19:00-20:00
    33.3
        20:00-21:00
    20.6
        21:00-22:00
    17.5
        22:00-23:00
    4.8
        23:00-00:00
    11.1
        00:00-01:00
    7.9
        01:00-02:00
    3.2
        02:00-03:00
    0
        03:00-04:00
    1.6
        04:00-05:00
    1.6
        05:00-06:00
    4.8
    No statistical analyses for this end point

    Secondary: Incidence of Incontinence for Each Hour of 24 Hour day During Week 52

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    End point title
    		 Incidence of Incontinence for Each Hour of 24 Hour day During Week 52
    End point description
    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 incidence of 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.The analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    3 days prior to Week 52 visit
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: percentage of days with incontinence
    number (not applicable)
        06:00-07:00
    18.3
        07:00-08:00
    20
        08:00-09:00
    16.7
        09:00-10:00
    13.3
        10:00-11:00
    25
        11:00-12:00
    35
        12:00-13:00
    16.7
        13:00-14:00
    8.3
        14:00-15:00
    11.7
        15:00-16:00
    33.3
        16:00-17:00
    16.7
        17:00-18:00
    21.7
        18:00-19:00
    18.3
        19:00-20:00
    23.3
        20:00-21:00
    16.7
        21:00-22:00
    20
        22:00-23:00
    1.7
        23:00-00:00
    3.3
        00:00-01:00
    6.7
        01:00-02:00
    3.3
        02:00-03:00
    3.3
        03:00-04:00
    1.7
        04:00-05:00
    5
        05:00-06:00
    3.3
    No statistical analyses for this end point

    Secondary: 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

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    End point title
    		 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
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=21]
    -1.7 ± 18.7
        Week 52 [N=16]
    10.9 ± 18.5
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Physical Abilities Score

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    End point title
    		 Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Physical Abilities Score
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=21]
    2.59 ± 18.33
        Week 52 [N=16]
    9.24 ± 25.61
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Growth and Development Score

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    End point title
    		 Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Growth and Development Score
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=21]
    -0.48 ± 12.03
        Week 52 [N=16]
    3.44 ± 13.51
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Pain Score

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    End point title
    		 Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Pain Score
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=19]
    -5.26 ± 32.63
        Week 52 [N=16]
    -0.78 ± 20.65
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Temperament and Moods Score

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    End point title
    		 Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Temperament and Moods Score
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=19]
    -2.41 ± 15.79
        Week 52 [N=16]
    -1.56 ± 15.58
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Behaviour Score

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    End point title
    		 Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Behaviour Score
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=18]
    -1.6 ± 8.01
        Week 52 [N=14]
    -0.35 ± 6.68
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 and 52 in ITQoL SF-47 – General Health Score

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    End point title
    		 Change from Baseline to Week 24 and 52 in ITQoL SF-47 – General Health Score
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=18]
    -0.32 ± 20.75
        Week 52 [N=14]
    3.57 ± 16.92
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Change in Health Score

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    End point title
    		 Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Change in Health Score
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=18]
    1.39 ± 23.44
        Week 52 [N=14]
    7.14 ± 20.64
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Parent-Emotional Impact Score

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    End point title
    		 Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Parent-Emotional Impact Score
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=18]
    -1.74 ± 24.04
        Week 52 [N=14]
    5.36 ± 27.17
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Parent-Time Impact Score

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    End point title
    		 Change from Baseline to Week 24 and 52 in ITQoL SF-47 – Parent-Time Impact Score
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    2
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=17]
    15.2 ± 26.6
        Week 52 [N=14]
    6.5 ± 23.6
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 24 and 52 in ITQoL SF-47 – Family Cohesion Impact Score

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    End point title
    		 Change from baseline to Week 24 and 52 in ITQoL SF-47 – Family Cohesion Impact Score
    End point description
    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). Before calculating a scale, the value of each item is coded so that it ranges from 0 (worst possible) to 100 (best possible). 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. The analysis population was FAS. "N" indicates the number of participants with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 24, 52
    End point values
    		 Solifenacin succinate
    Number of subjects analysed
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 24 [N=17]
    1.5 ± 16.7
        Week 52 {N=14]
    -5 ± 17.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug to last dose of study drug (up to 54 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Solifenacin succinate
    Reporting group description
    		 Children aged 6 months to less than 5 years who received solifenacin once daily for 52 weeks.

    Serious adverse events
    		 Solifenacin succinate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 23 (13.04%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Teratoma
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Solifenacin succinate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 23 (47.83%)
    Investigations
    Bacterial test positive
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Joint dislocation
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    3
    Dry mouth
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Enteritis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    4 / 23 (17.39%)
         occurrences all number
    4
    Otitis media
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Urinary tract infection bacterial
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    3
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2014
    Changes summarized: ● Change in the planned study period: the duration of the study was increased from 4Q2014 to 3Q2015. Recruitment timeframe was extended to include children under the age of 2 years. ● Change in the dosing rationale: the model used to select the drug dose was updated to a PBPK model to account for age-related physiological changes in clearance and distribution processes. ● Adjustment in the automated dose volume: the volume of medication was adjusted at visit 7 and 8 if any change in weight placed the patient in a new category. The dose volume was adjusted to ensure that patients were being treated effectively as weight in young infants could have increased substantially during the study. ● Added optional unscheduled urodynamic evaluation: new unscheduled urodynamic assessment was permitted 3 weeks after visit 6 (week 12). This evaluation allowed the investigator to confirm that the balance of efficacy and symptoms of intolerability had been established for patients who have had their dose adjusted at visit 6. ● Revised calculation of baseline mean QT interval corrected for heart rate by Bazett’s formula (QTcB): new calculations included the averages of the QTcB mean from visit 1 and 2. Previous calculations used only the QTcB mean from visit 2. This revision was done as statistical analysis of the intra-patient variation in baseline QTcB between visit 1 and visit 2 showed that a more precise estimate of QTcB could be obtained using the measurements from both visits. ● Addition of medical assessment of safety profile of children: New assessment used descriptive statistics rather than formal statistics comparisons given that only a small number of patients under the age of 2 years enrolled. ● Change in the lower age range of patients: the lower age limit was decreased from 2 years to 6 months. The inclusion of children from 6 months of age aligns the study with the approved PIP for solifenacin (EMEA-000573-PIP01-09).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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