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   43873   clinical trials with a EudraCT protocol, of which   7292   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 Double blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients with Stress Urinary Incontinence

    Summary
    EudraCT number
    		 2011-003599-35
    Trial protocol
    		 DE   GB   BE   NL  
    Global end of trial date
    29 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2018
    First version publication date
    01 Apr 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    10-019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01382602
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cook MyoSite Incorporated
    Sponsor organisation address
    105 Delta Drive, Pittsburgh, United States, 15238
    Public contact
    Maja Skytte Jensen, William Cook Europe ApS, +45 56868686, DNK-Clinical-Studies@CookMedical.com
    Scientific contact
    Ron Jankowski, PhD, Cook MyoSite Incorporated, +1 412-963-7380, Ron.Jankowski@CookMyosite.com
    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
    18 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the safety and efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared with placebo control in women with stress urinary incontinence (SUI).
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, including the International Council for Harmonization (ICH) Guideline for Good Clinical Practice and applicable regulations in Canada and Europe where the study took place.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Nov 2011
    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
    United Kingdom: 1
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Canada: 140
    Worldwide total number of subjects
    143
    EEA total number of subjects
    3
    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)
    125
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were screened and enrolled at 10 sites globally; 8 sites in Canada, 1 site in Germany, and 1 site in United Kingdom.

    Pre-assignment
    Screening details
    		 227 subjects consented to study participation and were screened for eligibility, of whom 150 subjects were enrolled (underwent biopsy procedure) and 143 subjects underwent at least 1 study treatment of AMDC-USR (93 subjects) or placebo (50 subjects). Analysis population is based on 143 subjects that underwent at least 1 study treatment.

    Period 1
    Period 1 title
    Blinded Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AMDC-USR
    Arm description
    		 Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment. Analysis population is based on subjects that received at least 1 treatment of AMDC-USR at the 12 months follow-up.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMDC-USR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received open-label AMDC-USR treatment were followed for 2 years after initial AMDC-USR treatment. Analysis population is based on subjects that received at least 1 treatment of placebo at the 12 months follow-up.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 or 2 treatments of placebo delivered via transurethral instrasphincteric injection.

    Number of subjects in period 1
    		AMDC-USR Placebo
    Started
    93
    50
    Completed
    93
    50

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    AMDC-USR
    Reporting group description
    		 Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment. Analysis population is based on subjects that received at least 1 treatment of AMDC-USR at the 12 months follow-up.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received open-label AMDC-USR treatment were followed for 2 years after initial AMDC-USR treatment. Analysis population is based on subjects that received at least 1 treatment of placebo at the 12 months follow-up.

    Reporting group values
    		 AMDC-USR Placebo Total
    Number of subjects
    		 93 50 143
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 82 43 125
        From 65-84 years
    		 11 7 18
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.4 ( 11.1 ) 51.7 ( 9.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 93 50 143
        Male
    		 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    AMDC-USR
    Reporting group description
    		 Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment. Analysis population is based on subjects that received at least 1 treatment of AMDC-USR at the 12 months follow-up.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received open-label AMDC-USR treatment were followed for 2 years after initial AMDC-USR treatment. Analysis population is based on subjects that received at least 1 treatment of placebo at the 12 months follow-up.

    Primary: Responder Rate (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months

    		 Close Top of page
    End point title
    		 Responder Rate (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months
    End point description
    A composite primary endpoint of responder rate was used, where a subject was considered a responder if she had ≥ 50 % reduction from baseline in stress Incontinence Episode Frequency (stress IEF; reported stress leaks from 3-day diary) or ≥ 50 % reduction in leakage from baseline as determined by either the in-office pad weight test or the 24-hour pad weight test.
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 AMDC-USR Placebo
    Number of subjects analysed
    91
    50
    Units: Percentage of Subjects
        number (confidence interval 95%)
    82 (73 to 90)
    90 (78 to 97)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    AMDC-USR v Placebo
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05 [1]
    Method
    		 t-test, 1-sided
    Confidence interval
    Notes
    [1] - Enrollment was halted early due to limitations in study design related to the primary efficacy endpoint. Therefore, official p-value for primary endpoint was not calculated.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were monitored from consent through study exit. Reporting groups were based on adverse events that occurred between initial blinded injection treatment and unblinding of subjects after 12-months follow-up.
    Adverse event reporting additional description
    Adverse events that occurred between initial blinded injection and unblinding of subjects after 12-months follow-up were compared between AMDC-USR and Placebo groups. No deaths, SAEs, or discontinuation of a subject due to adverse events were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    AMDC-USR
    Reporting group description
    		 Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. Analysis population is based on subjects that received at least 1 treatment of AMDC-USR at the 12 months follow-up.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. Analysis population is based on subjects that received at least 1 treatment of placebo at the 12 months follow-up.

    Serious adverse events
    		 AMDC-USR Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AMDC-USR Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 93 (34.41%)
    13 / 50 (26.00%)
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    5 / 93 (5.38%)
    1 / 50 (2.00%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 93 (8.60%)
    0 / 50 (0.00%)
         occurrences all number
    8
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    5 / 93 (5.38%)
    3 / 50 (6.00%)
         occurrences all number
    6
    3
    Pollakiuria
         subjects affected / exposed
    2 / 93 (2.15%)
    4 / 50 (8.00%)
         occurrences all number
    2
    4
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    12 / 93 (12.90%)
    5 / 50 (10.00%)
         occurrences all number
    18
    5

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2011
    Amendment 01 to protocol for use in Canada.
    21 Feb 2012
    Substantial Amendment 01, to protocol for use in United Kingdom.
    04 Jul 2012
    Amendment during CTA review, to protocol for use in Germany.
    04 Sep 2012
    Substantial Amendment 02, to protocol for use in United Kingdom.
    15 Oct 2012
    Substantial Amendment 02, to protocol for use in Germany.
    02 Jan 2013
    Amendment 02 to protocol for use in Canada.
    09 Aug 2013
    Substantial Amendment 03, to protocol for use in United Kingdom.
    04 Mar 2014
    Substantial Amendment 04, to protocol for use in United Kingdom.
    04 Mar 2014
    Substantial Amendment 03, to protocol for use in Germany.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    05 May 2014
    Planned study enrollment was 246 subjects; due to limitations in study design related to the primary efficacy endpoint, enrollment was halted early after 150 subjects.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Planned study enrollment was 246 patients; due to limitations in study design related to the primary efficacy endpoint, enrollment was halted at 150 subjects.
    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 07 09:40:20 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA