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    Clinical Trial Results:
    An open, monocentric study to evaluate the urodynamic properties of a local implantation of autologous skeletal muscle-derived cells (aSMDCs) in female patients with stress urinary incontinence

    Summary
    EudraCT number
    		 2010-021867-34
    Trial protocol
    		 SI  
    Global end of trial date
    12 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2026
    First version publication date
    02 Apr 2026
    Other versions
    Summary report(s)
    		 Intrasphincteric autologous myoblast injections with electrical stimulation for stress urinary incontinence

    Trial information

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    Trial identification
    Sponsor protocol code
    IC-01-01-5-006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Innovacell Biotechnologie AG
    Sponsor organisation address
    Mitterweg 24, Innsbruck, Austria, 6020
    Public contact
    Clinical Department Innovacell , Innovacell Biotechnologie AG, office@innovacell.com
    Scientific contact
    Clinical Department Innovacell , Innovacell Biotechnologie AG, office@innovacell.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
    19 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the functional status of the urethra and particularly the urethral rhabdosphincter by means of urodynamic measures after SMDCs implantation procedure in female patients with SUI.
    Protection of trial subjects
    The rights, safety, and well-being of trial participants are the primary considerations of this clinical trial and prevail over interests of science and society. The trial is conducted in full accordance with the International Conference of Harmonisation Good Clinical Practice (GCP), the Declaration of Helsinki, and applicable national and local laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Dec 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovenia: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    34
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in a single study center. Recruitment started in December 2012 and was planned to last 7 months.

    Pre-assignment
    Screening details
    		 In total, 46 patients were screened, and 38 who received cell therapy implantation were included in the ITT set. Long-term follow up was completed by 31 patients.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 aSMDC
    Arm description
    		 All patients of the ITT set were treated with the IMP consisting of 0.2 x 10e6 autologous skeletal muscle-dericed cells are implanted in female patients with SUI.
    Arm type
    		 Experimental

    Investigational medicinal product name
    aSMDC
    Investigational medicinal product code
    Other name
    ICES13
    Pharmaceutical forms
    Implantation suspension
    Routes of administration
    Injection
    Dosage and administration details
    The IMP containing 0.2 x 10e6 aSMDC are stored in 2 ml cell transport medium. Before the implantation, 20 aliquots containing 100 µl are prepared. The IMP aliquots were single administrated by using a standardized, ultrasound-directed, transurethral injection device with electromyography (EMG) needle to validate sonographic image and correct position of needle for implantation by EMG (passive) or electrostimulation (active).

    Number of subjects in period 1 [1]
    		aSMDC
    Started
    38
    Completed
    31
    Not completed
    7
         Consent withdrawn by subject
    2
         Lost to follow-up
    5
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the overall enrolled 46 patients, 38 received treatment, and 8 patients were not eligible and not exposed to any trial treatment; the ITT set comprises 38 patients.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    aSMDC
    Reporting group description
    		 All patients of the ITT set were treated with the IMP consisting of 0.2 x 10e6 autologous skeletal muscle-dericed cells are implanted in female patients with SUI.

    Reporting group values
    		 aSMDC Total
    Number of subjects
    		 38 38
    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)
    		 31 31
        From 65-84 years
    		 7 7
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.79 ( 10.68 ) -
    Gender categorical
    Units: Subjects
        Female
    		 38 38
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    aSMDC
    Reporting group description
    		 All patients of the ITT set were treated with the IMP consisting of 0.2 x 10e6 autologous skeletal muscle-dericed cells are implanted in female patients with SUI.

    Subject analysis set title
    ES compliant participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The performance of electrical stimulation (ES) before and after the implantation of aSMDC was amended as concomitant by the sponsor (substantial amendment protocol version 4.0 (May 2013)). The Sponsor reviewed individual ES data, and allocated patients in the 2 ES sub-groups, defined as compliant and non-compliant to ES. The same methodology as described above for primary and secondary endpoints did apply, and analyses were on the ITT population, according to these two groups of patients.

    Subject analysis set title
    ES non-compliant participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The performance of electrical stimulation (ES) before and after the implantation of aSMDC was amended as concomitant by the sponsor (substantial amendment protocol version 4.0 (May 2013)). The Sponsor reviewed individual ES data, and allocated patients in the 2 ES sub-groups, defined as compliant and non-compliant to ES. The same methodology as described above for primary and secondary endpoints did apply, and analyses were on the ITT population, according to these two groups of patients.

    Primary: Change in the USP transmission ratio of Visit 2 from baseline (screening visit)

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    End point title
    		 Change in the USP transmission ratio of Visit 2 from baseline (screening visit) [1]
    End point description
    Change from baseline in the urethral stress profile (USP) measured by the transmission ratio in percent in the midurethra.
    End point type
    Primary
    End point timeframe
    Changes of USP at Visit 2 (day 90 post implantation) compared to screening visit (37 days prior implantation) in the ITT set.
    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 no control or comparator group was included, statistical analyses aimed at testing treatment effects between groups were not applicable. Instead, outcomes were assessed by comparing follow-up observations with the baseline values of the same participants in order to describe potential trends or changes over time.
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: Transmission ratio (%)
        arithmetic mean (standard deviation)
    -3.95 ( 15.01 )
    No statistical analyses for this end point

    Primary: Change in the USP transmission ratio of Visit 4 from baseline (screening visit)

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    End point title
    		 Change in the USP transmission ratio of Visit 4 from baseline (screening visit) [2]
    End point description
    Change from baseline in the urethral stress profile (USP) measured by the transmission ratio in percent in the midurethra.
    End point type
    Primary
    End point timeframe
    Changes of USP at Visit 4 (day 365 post implantation) compared to screening visit (37 days prior implantation) in the ITT set.
    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: As no control or comparator group was included, statistical analyses aimed at testing treatment effects between groups were not applicable. Instead, outcomes were assessed by comparing follow-up observations with the baseline values of the same participants in order to describe potential trends or changes over time.
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: Transmission rate (%)
        arithmetic mean (standard deviation)
    -3.87 ( 13.53 )
    No statistical analyses for this end point

    Secondary: Change of MUCP of V2 compared to baseline

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    End point title
    		 Change of MUCP of V2 compared to baseline
    End point description
    The maximum urethral closure pressure is determined through the urethral pressure profile at rest and given by the subtraction of the intravesical pressure at rest from the maximum urethral pressure at rest.
    End point type
    Secondary
    End point timeframe
    MUCP at Visit 2 (day 90 post implantation) compared to screening visit (37 days prior to implantation) in the ITT set.
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: cmH20
        arithmetic mean (standard deviation)
    -10.13 ( 19.09 )
    No statistical analyses for this end point

    Secondary: Change of MUCP of V4 compared to baseline

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    End point title
    		 Change of MUCP of V4 compared to baseline
    End point description
    The maximum urethral closure pressure is determined through the urethral pressure profile at rest and given by the subtraction of the intravesical pressure at rest from the maximum urethral pressure at rest.
    End point type
    Secondary
    End point timeframe
    MUCP at Visit 4 (day 365 post implantation) compared to screening visit (37 days prior to implantation) in the ITT set.
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: cmH20
        arithmetic mean (standard deviation)
    -9.34 ( 16.83 )
    No statistical analyses for this end point

    Secondary: Change in functional urethral length of V2 compared to baseline

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    End point title
    		 Change in functional urethral length of V2 compared to baseline
    End point description
    The functional urethral length is the part of the urethra, where the intraurethral pressure at rest is lying above the intravesical pressure at rest. The length is determined automatically trough the mechanical retraction of the catheter during USP.
    End point type
    Secondary
    End point timeframe
    Change in functional urethral length at Visit 2 (day 90 post implantation) compared to screening visit (37 days prior implantation) in the ITT set.
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: mm
        arithmetic mean (standard deviation)
    0.74 ( 7.13 )
    No statistical analyses for this end point

    Secondary: Change in functional urethral length of V4 compared to baseline

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    End point title
    		 Change in functional urethral length of V4 compared to baseline
    End point description
    The functional urethral length is the part of the urethra, where the intraurethral pressure at rest is lying above the intravesical pressure at rest. The length is determined automatically trough the mechanical retraction of the catheter during USP.
    End point type
    Secondary
    End point timeframe
    Change in functional urethral length at Visit 4 (day 365 post implantation) compared to screening visit (37 days prior implantation) in the ITT set.
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: mm
        arithmetic mean (standard deviation)
    -0.29 ( 6.89 )
    No statistical analyses for this end point

    Secondary: Change of AUC of the urethral pressure curve at rest of V2 compared to baseline

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    End point title
    		 Change of AUC of the urethral pressure curve at rest of V2 compared to baseline
    End point description
    This value corresponds to the area under the curve of the urethral pressure profile at rest, depending on the maximum urethral closure pressure and the functional urethral length.
    End point type
    Secondary
    End point timeframe
    Absolute change in area under the curve of the urethral closure pressure (cm^2 H2O) of Visit 2 (day 90 post implantation) compared to screening visit (37 days prior implantation) in the ITT set.
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: cm^2 H20
        arithmetic mean (standard deviation)
    -35.26 ( 48.31 )
    No statistical analyses for this end point

    Secondary: Change of AUC of the urethral pressure curve at rest of V4 compared to baseline

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    End point title
    		 Change of AUC of the urethral pressure curve at rest of V4 compared to baseline
    End point description
    This value corresponds to the area under the curve of the urethral pressure profile at rest, depending on the maximum urethral closure pressure and the functional urethral length.
    End point type
    Secondary
    End point timeframe
    Absolute change in area under the curve of the urethral closure pressure (cm^2 H2O) of Visit 4 (day 365 post implantation) compared to screening visit (37 days prior implantation) in the ITT set.
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: cm^2 H2O
        arithmetic mean (standard deviation)
    -46.45 ( 47.94 )
    No statistical analyses for this end point

    Secondary: Incontinence Episode Frequency Reduction >=75% (V4 compared to baseline)

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    End point title
    		 Incontinence Episode Frequency Reduction >=75% (V4 compared to baseline)
    End point description
    The Incontinence Episodes Frequency (IEF) is calculated as number of iincontinence episodes that occurred during 7 days preceding a visit.
    End point type
    Secondary
    End point timeframe
    Frequency of response measured as a reduction of the frequency of incontinence episodes by more than 75% under treatment from V4 (365 days post implantation) compared to screening visit 8 (37 days prior implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    37
    Units: Number of Patients
    13
    No statistical analyses for this end point

    Secondary: Incontinence Episode Frequency Reduction >=90% (V4 compared to baseline)

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    End point title
    		 Incontinence Episode Frequency Reduction >=90% (V4 compared to baseline)
    End point description
    The Incontinence Episodes Frequency (IEF) is calculated as number of iincontinence episodes that occurred during 7 days preceding a visit.
    End point type
    Secondary
    End point timeframe
    Frequency of response measured as a reduction of the frequency of incontinence episodes by more than 90% under treatment from V4 (365 days post implantation) compared to screening visit 8 (37 days prior implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    37
    Units: Number of Patients
    11
    No statistical analyses for this end point

    Secondary: Change of visual analogue scale (VAS) of Visit 4 from baseline

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    End point title
    		 Change of visual analogue scale (VAS) of Visit 4 from baseline
    End point description
    The individual perception of UI complaints will be evaluated by each patient using a standardized VAS. The VAS is an instrument that measures a characteristic or attitude believed to range across a continuum of values and cannot easily be directly measured. It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient should mark the VAS with a vertical line representing his or her perception of the individual UI status. In the study, the two endpoints of the VAS are defined as "no complaints at all" (0 cm) and "worst complaints imaginable" (10 cm).
    End point type
    Secondary
    End point timeframe
    Changes of visual analogue scale (VAS) from Visit 4 (365 days post implantation) compared to screening visit (37 day prior to implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: cm
        arithmetic mean (standard deviation)
    -1.83 ( 2.55 )
    No statistical analyses for this end point

    Secondary: Incontinence Quality of Life (I-QoL) (V4 compared to screening)

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    End point title
    		 Incontinence Quality of Life (I-QoL) (V4 compared to screening)
    End point description
    The patients' health-related QoL is assessed using the urinary I-QoL scale with 22-items specific to people with stress and mixed types of UI. It includes general questions on eliciting all areas of concern and specific probes into hypothesized areas of impact: social life, family life, job/work, intimate relationships, activities of daily life, household activities recreation and travel, mental health, physical health, and anxiety/depression.
    End point type
    Secondary
    End point timeframe
    Change of Patient's assessment based on the Quality of Life questionnaire (QoL) lifestyle score of V4 (365 days post implantation) compared to baseline (screening visit 37 days prior to implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: Total I-QoL score
        arithmetic mean (standard deviation)
    29.88 ( 25.66 )
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: very much improved

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    End point title
    		 Clinical Global Impression (CGI) improvement: very much improved
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V4 (365 days post implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    37
    Units: Number of Patients
    15
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: much improved

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    End point title
    		 Clinical Global Impression (CGI) improvement: much improved
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V4 (365 days post implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    37
    Units: Number of Patients
    9
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: minimally improved

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    End point title
    		 Clinical Global Impression (CGI) improvement: minimally improved
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V4 (365 days post implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    37
    Units: Number of Patients
    7
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: no change

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    End point title
    		 Clinical Global Impression (CGI) improvement: no change
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V4 (365 days post implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    37
    Units: Number of Patients
    5
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: minimally worse

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    End point title
    		 Clinical Global Impression (CGI) improvement: minimally worse
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V4 (365 days post implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    37
    Units: Number of Patients
    1
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: much worse

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    End point title
    		 Clinical Global Impression (CGI) improvement: much worse
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V4 (365 days post implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    37
    Units: Number of Patients
    0
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: very much worse

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    End point title
    		 Clinical Global Impression (CGI) improvement: very much worse
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V4 (365 days post implantation).
    End point values
    		 aSMDC
    Number of subjects analysed
    37
    Units: Number of Patients
    0
    No statistical analyses for this end point

    Secondary: USP transmission ratio at visit 4 (ES vs. no ES)

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    End point title
    		 USP transmission ratio at visit 4 (ES vs. no ES)
    End point description
    End point type
    Secondary
    End point timeframe
    Transmission ratio at V4 (365 days post-implantation),
    End point values
    		 ES compliant participants ES non-compliant participants
    Number of subjects analysed
    25
    12
    Units: Transmission ratio (%)
        arithmetic mean (standard deviation)
    81.0 ( 8.1 )
    71.4 ( 10.7 )
    Statistical analysis title
    		 ES vs. no ES
    Comparison groups
    ES non-compliant participants v ES compliant participants
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 2.5%

    Secondary: Change in the USP transmission ratio of Visit 4 to baseline (ES vs. no ES)

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    End point title
    		 Change in the USP transmission ratio of Visit 4 to baseline (ES vs. no ES)
    End point description
    End point type
    Secondary
    End point timeframe
    Changes of USP at Visit 4 (day 365 post implantation) compared to screening visit (37 days prior implantation).
    End point values
    		 ES compliant participants ES non-compliant participants
    Number of subjects analysed
    25
    12
    Units: Transmission ratio (%)
        arithmetic mean (standard deviation)
    -2.28 ( 12.77 )
    -6.92 ( 14.92 )
    Statistical analysis title
    		 ES vs. no ES
    Comparison groups
    ES compliant participants v ES non-compliant participants
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.322
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 2.5%

    Secondary: Change of IEF of Visit 4 to baseline (ES vs. no ES)

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    End point title
    		 Change of IEF of Visit 4 to baseline (ES vs. no ES)
    End point description
    The frequencies of incontinence episodes were documented by a bowel diary that was completed by the patient. The Incontinence Episodes Frequency (IEF) is calculated as number of incontinence episodes that occurred during 7 days preceding a visit.
    End point type
    Secondary
    End point timeframe
    Changes in IEF at V4 (365 days post implantation) compared to baseline (screening visit).
    End point values
    		 ES compliant participants ES non-compliant participants
    Number of subjects analysed
    25
    12
    Units: IEF change
        arithmetic mean (standard deviation)
    -18.24 ( 22.50 )
    -9.38 ( 15.76 )
    Statistical analysis title
    		 ES vs. no ES
    Comparison groups
    ES compliant participants v ES non-compliant participants
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.208
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change of visual analogue scale (VAS) of Visit 4 to baseline (ES vs. no ES)

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    End point title
    		 Change of visual analogue scale (VAS) of Visit 4 to baseline (ES vs. no ES)
    End point description
    The individual perception of UI complaints will be evaluated by each patient using a standardized VAS. The VAS is an instrument that measures a characteristic or attitude believed to range across a continuum of values and cannot easily be directly measured. It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient should mark the VAS with a vertical line representing his or her perception of the individual UI status. In the study, the two endpoints of the VAS are defined as "no complaints at all" (0 cm) and "worst complaints imaginable" (10 cm).
    End point type
    Secondary
    End point timeframe
    Changes of visual analogue scale (VAS) from Visit 4 (365 days post implantation) compared to baseline (screening visit, 37 days prior implantation).
    End point values
    		 ES compliant participants ES non-compliant participants
    Number of subjects analysed
    25
    12
    Units: cm
        arithmetic mean (standard deviation)
    -1.81 ( 2.76 )
    -1.86 ( 2.14 )
    Statistical analysis title
    		 ES vs. no ES
    Comparison groups
    ES compliant participants v ES non-compliant participants
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.954
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Incontinence Quality of Life (I-QoL) V4 compared to baseline (ES vs. no ES)

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    End point title
    		 Incontinence Quality of Life (I-QoL) V4 compared to baseline (ES vs. no ES)
    End point description
    The patients' health-related QoL is assessed using the urinary I-QoL scale with 22-items specific to people with stress and mixed types of UI. It includes general questions on eliciting all areas of concern and specific probes into hypothesized areas of impact: social life, family life, job/work, intimate relationships, activities of daily life, household activities recreation and travel, mental health, physical health, and anxiety/depression.
    End point type
    Secondary
    End point timeframe
    Change of Patient's assessment based on the Quality of Life questionnaire (QoL) lifestyle score of V4 (365 days post implantation) compared to screening (37 days prior implantation).
    End point values
    		 ES compliant participants ES non-compliant participants
    Number of subjects analysed
    25
    13
    Units: I-QoL total score
        arithmetic mean (standard deviation)
    35.70 ( 24.34 )
    19.14 ( 25.44 )
    Statistical analysis title
    		 ES vs. no ES
    Comparison groups
    ES compliant participants v ES non-compliant participants
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.06
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change of IEF of Visit 4 from baseline

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    End point title
    		 Change of IEF of Visit 4 from baseline
    End point description
    The frequencies of incontinence episodes were documented by a bowel diary that was completed by the patient. The Incontinence Episodes Frequency (IEF) is calculated as number of incontinence episodes that occurred during 7 days preceding a visit.
    End point type
    Secondary
    End point timeframe
    Changes in IEF at V4 (365 days post implantation) compared to baseline (screening visit).
    End point values
    		 aSMDC
    Number of subjects analysed
    38
    Units: IEF change
        arithmetic mean (standard deviation)
    -15.51 ( 20.72 )
    No statistical analyses for this end point

    Secondary: Change of AUC of the urethral pressure curve (ES vs. no ES)

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    End point title
    		 Change of AUC of the urethral pressure curve (ES vs. no ES)
    End point description
    This value corresponds to the area under the curve of the urethral pressure profile at rest, depending on the maximum urethral closure pressure and the functional urethral length.
    End point type
    Secondary
    End point timeframe
    Absolute change in area under the curve of the urethral closure pressure (cm^2 H2O) at Visit 4 (day 365 post implantation) compared to screening visit (37 days prior to implantation).
    End point values
    		 ES compliant participants ES non-compliant participants
    Number of subjects analysed
    25
    13
    Units: cm^2 H20
        arithmetic mean (standard deviation)
    -32.6 ( 47 )
    -73.1 ( 38.7 )
    No statistical analyses for this end point

    Secondary: Maximum urethral closure pressure at V4 (ES vs. no ES)

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    End point title
    		 Maximum urethral closure pressure at V4 (ES vs. no ES)
    End point description
    The maximum urethral closure pressure is determined through the urethral pressure profile at rest and given by the subtraction of the intravesical pressure at rest from the maximum urethral pressure at rest.
    End point type
    Secondary
    End point timeframe
    MUCP at Visit 4 (d365 days post implantation)
    End point values
    		 ES compliant participants ES non-compliant participants
    Number of subjects analysed
    25
    13
    Units: cm H20
        median (standard deviation)
    47.6 ( 17.65 )
    42.5 ( 16 )
    No statistical analyses for this end point

    Secondary: Functional urethral length at Visit 4 (ES vs. no ES)

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    End point title
    		 Functional urethral length at Visit 4 (ES vs. no ES)
    End point description
    The functional urethral length is the part of the urethra, where the intraurethral pressure at rest is lying above the intravesical pressure at rest. The length is determined automatically trough the mechanical retraction of the catheter during USP.
    End point type
    Secondary
    End point timeframe
    Functional urethral length at Visit 4 (365 days post implantation)
    End point values
    		 ES compliant participants ES non-compliant participants
    Number of subjects analysed
    25
    13
    Units: mm
        arithmetic mean (standard deviation)
    31.5 ( 6.8 )
    27.9 ( 5.4 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    December 2012 - August 2015
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    aSMDC
    Reporting group description
    		 -

    Serious adverse events
    		 aSMDC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 38 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 aSMDC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 38 (44.74%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Vascular disorders
    All PT's in this SOC
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Surgical and medical procedures
    Obesity surgery
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Menometrorrhagia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Ligmanet sprain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Nervous system disorders
    All PT's in this SOC
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Gastrointestinal disorders
    Mouth ulceration
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Renal and urinary disorders
    All PT's in this SOC
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Infections and infestations
    All PT's in this SOC
         subjects affected / exposed
    9 / 38 (23.68%)
         occurrences all number
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 May 2012
    - The sponsor made decision to replace the initial CRO - One primary endpoint “Change from - baseline in the Valsalva Leak Point Pressure” was added because this is an important parameter to describe urethral closure function and yields important information on the function and activity of the external urethral sphincter. - The study duration per patient was extended and is 13 months. An assessment of 12 months with interim analysis at 3 months appeared the most appropriate to increase probability of detecting any pre-post difference. - The definition of response in liaison with IEF scores was modified from 50% and 75% to 75% and 90%.
    06 May 2013
    Addition of pelvic floor electrical stimulation as concomitant treatment all new patients enrolled into the study for 4 weeks after screening and prior to the cell implantation and 4 weeks starting immediately after cell implantation.
    20 Dec 2013
    Valsalva Leak-Point Pressure (VLLP) measure was considered as not appropriate further to the interim data reviews occurred on 24SEP2013 and 19DEC2013. The sponsor decided to skip this test from the primary endpoint and so at Visit 4 for all patients.
    17 Mar 2014
    An additional follow-up period was directly integrated into the current study instead of a separate follow up study.

    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/34355391
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