Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 06 18:16:06 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA