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    Clinical Trial Results:
    A 12 week, multi centre, open label study to evaluate the effect of fesoterodine flexible dosing regimen on the sexual function of women with overactive bladder.

    Summary
    EudraCT number
    		 2010-023851-27
    Trial protocol
    		 GB  
    Global end of trial date
    17 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Oct 2018
    First version publication date
    13 Oct 2018
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    AMRPhD1
    Additional study identifiers
    ISRCTN number
    		 ISRCTN40720691
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College Hospital NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 9RS
    Public contact
    Angela Rantell, King’s College Hospital NHS Foundation Trust, 0044 0203299 3568, angela.rantell@nhs.net
    Scientific contact
    Angela Rantell, King’s College Hospital NHS Foundation Trust, 0044 0203299 3568, angela.rantell@nhs.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the impact on sexual function, after 12 weeks flexible dose fesoterodine in women with OAB compared to baseline.
    Protection of trial subjects
    At the screening visit the following were performed • Weight, medical history (including any medication and non-drug treatment) and demographn. • Sitting blood pressure and pulse. • Physical examination. • Urine dipstick test w to exclude blood and infection and Urine pregnancy test for women of child bearing potential.
    Background therapy
    		 none
    Evidence for comparator
    		 No comparator.
    Actual start date of recruitment
    01 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    28
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from four clinical sites within the United Kingdom between 12/10/2012 and 10/06/2016.

    Pre-assignment
    Screening details
    		 1. Female outpatients aged 18 – 80 years. 2. Overactive bladder symptoms (subject reported) for ≥3 months prior to screening visit according to ICS guidelines. 3. Mean number of Urgency episodes ≥3 per 24 hours as verified by the screening bladder diary prior to baseline / Visit 2. 4. Sexually active Able and willing to complete the micturition

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Full study
    Arm description
    		 This was a multi-centre open label study which aimed to enter 132 female subjects with OAB symptoms. Sexual function and efficacy assessments was evaluated via 3-day bladder diaries, questionnaires (KHQ, PISQ-12, SQoL, PAC-QoL, SAGA, PPBC) and urodynamics. Tolerability and safety was evaluated at every visit with recording of adverse events.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fesoteradine
    Investigational medicinal product code
    Other name
    TOVIAZ
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4mg daily for 28 days then option to either continue on same dose or dose escalate to 8mg for the next 56 days

    Number of subjects in period 1
    		Full study
    Started
    30
    Completed
    20
    Not completed
    10
         Consent withdrawn by subject
    4
         Physician decision
    1
         Pregnancy
    1
         Failed screening
    2
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 30 30
    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)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 28 28
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 30 30
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Full study
    Reporting group description
    		 This was a multi-centre open label study which aimed to enter 132 female subjects with OAB symptoms. Sexual function and efficacy assessments was evaluated via 3-day bladder diaries, questionnaires (KHQ, PISQ-12, SQoL, PAC-QoL, SAGA, PPBC) and urodynamics. Tolerability and safety was evaluated at every visit with recording of adverse events.

    Primary: PISQ-12

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    End point title
    		 PISQ-12 [1]
    End point description
    Change in item scores of the Pelvic Organ Prolapse. Prolapse and Incontinence Sexual Quality of Life Questionnaire (PISQ-12), PISQ-12 is a self administered questionnaire consisting of 12 items.
    End point type
    Primary
    End point timeframe
    From initial IMP dosing until 12 weeks post dose.
    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: Please see attached document for full results
    End point values
    		 Full study
    Number of subjects analysed
    20
    Units: questionnaire score
        number (not applicable)
    20
    Attachments
    		 RESULTS
    No statistical analyses for this end point

    Primary: Paired T-Test SQOL-F Total Score

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    End point title
    		 Paired T-Test SQOL-F Total Score [2]
    End point description
    End point type
    Primary
    End point timeframe
    From commencement of IMP to 12 weeks post.
    Notes
    [2] - 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: Please see attached document for full results
    End point values
    		 Full study
    Number of subjects analysed
    20
    Units: Questionnaire score
        number (not applicable)
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until Week 24 post commencement of dosing.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Whole Trial
    Reporting group description
    		 All participants

    Serious adverse events
    		 Whole Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 28 (3.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Whole Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 28 (60.71%)
    General disorders and administration site conditions
    Dry mouth
         subjects affected / exposed
    10 / 28 (35.71%)
         occurrences all number
    10
    Ear and labyrinth disorders
    Labrynthitis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Eye disorders
    Blurred Vision
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Gastrointestinal disorders
    Bloating
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    chest infection
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Sep 2013
    Amendment to change IMP supply from clinical trial supplies to commercial stock.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24369895
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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