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    Clinical Trial Results:
    Study of the efficacy and tolerance of intra-prostatic injection of botulinum toxin A in men for the treatment of symptomatic benign prostate hyperplasia.

    Summary
    EudraCT number
    		 2010-022255-37
    Trial protocol
    		 FR  
    Global end of trial date
    28 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jan 2022
    First version publication date
    15 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUBX2010/39
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01275521
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Bordeaux
    Sponsor organisation address
    12 rue Dubernat, Talence, France, 33404
    Public contact
    Dr Grégoire ROBERT, Service d'Urologie, +33 556795547, gregoire.robert@chu-bordeaux.fr
    Scientific contact
    Dr Grégoire ROBERT, Service d'Urologie, +33 556795547, gregoire.robert@chu-bordeaux.fr
    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
    21 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of intra-prostatic injection of BONT-A in men in the treatment of symptomatic BPH.
    Protection of trial subjects
    If an adverse event or a tolerance problem related to intra-prostatic injection of BONT-A occurs outside of the scheduled dates for follow-up visits, patients may consult an investigator at one of the investigating centres. These emergency consultations will be conducted in the urology department during the hours of consultation or through the out-of-hours emergency department. These consultations will be conducted to the best of the current state of medical knowledge: depending on the patient's condition, all clinical and complementary examinations necessary to take the patient's in charge may be prescribed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jan 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
    France: 127
    Worldwide total number of subjects
    127
    EEA total number of subjects
    127
    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)
    71
    From 65 to 84 years
    55
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of first inclusion: 10-jan-2011 End date of last included patient: 28-Apr-2015 9 centres (Part of the Committee for Male Mictional Disorders of the French Association of Urology (CTMH-AFU)) in France participated in the study.

    Pre-assignment
    Screening details
    		 · Patient aged 50 to 85 · Obstructive or irritative urinary symptomatology linked to a BPH · Score IPSS moderate to severe (8-19: moderate; 20-35: severe) or IPSS ≤ 7 in patient medically treated for symptomatic BPH · Increase in prostate volume on the rectal touch or ultrasound · Free consent

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BONT-A intra-prostatic injection
    Arm description
    		 Intra-prostatic injection of botulinum toxin A
    Arm type
    		 Experimental

    Investigational medicinal product name
    Botulinum toxin A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Rectal capsule
    Routes of administration
    Intraprostatic use
    Dosage and administration details
    Single dose of ofloxacin 200mg (or ceftriaxone 1g case of allergy) in accordance with the current recommendations concerning biospsies prostate. Intra-prostatic injection of 200 IU BONT-A (to be diluted in 10 cc of isotonic saline), divided into 4 injection sites, 2 in each prostatic lobe, respectively 2.5 cc each.

    Arm title
    		 Optimized medical BPH treatment
    Arm description
    		 Optimized medical BPH treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Other
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    This medical treatment can include the prescription of herbal medicine, alpha-blocker, 5 alpha reductase inhibitor, or combination of alpha-blocker and 5-alpha reductase inhibitor.

    Number of subjects in period 1
    		BONT-A intra-prostatic injection Optimized medical BPH treatment
    Started
    64
    63
    Completed
    45
    46
    Not completed
    19
    17
         Consent withdrawn by subject
    16
    12
         Other reasons
    2
    4
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BONT-A intra-prostatic injection
    Reporting group description
    		 Intra-prostatic injection of botulinum toxin A

    Reporting group title
    Optimized medical BPH treatment
    Reporting group description
    		 Optimized medical BPH treatment

    Reporting group values
    		 BONT-A intra-prostatic injection Optimized medical BPH treatment Total
    Number of subjects
    		 64 63 127
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 71
        From 65-84 years
    		 55
        85 years and over
    		 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.2 ( 7.3 ) 64.3 ( 7.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 64 63 127
    Subject analysis sets

    Subject analysis set title
    Per protocol BONT-A intra-prostatic injection
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Population analysed under treatment

    Subject analysis set title
    Per protocol Optimized medical BPH treatment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Population analysed under treatment

    Subject analysis set title
    Intention-to-treat BONT-A intra-prostatic injection
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Population analysed by intention-to-treat

    Subject analysis set title
    Intention-to-treat Optimized medical BPH treatment
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Population analysed in intention-to-treat

    Subject analysis sets values
    		 Per protocol BONT-A intra-prostatic injection Per protocol Optimized medical BPH treatment Intention-to-treat BONT-A intra-prostatic injection Intention-to-treat Optimized medical BPH treatment
    Number of subjects
    44
    60
    64
    63
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65.2 ( 7.3 )
    64.3 ( 7.6 )
    65.2 ( 7.3 )
    64.3 ( 7.6 )
    Gender categorical
    Units: Subjects
        Female
    0
    0
    0
    0
        Male
    44
    60
    64
    63

    End points

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    End points reporting groups
    Reporting group title
    BONT-A intra-prostatic injection
    Reporting group description
    		 Intra-prostatic injection of botulinum toxin A

    Reporting group title
    Optimized medical BPH treatment
    Reporting group description
    		 Optimized medical BPH treatment

    Subject analysis set title
    Per protocol BONT-A intra-prostatic injection
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Population analysed under treatment

    Subject analysis set title
    Per protocol Optimized medical BPH treatment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Population analysed under treatment

    Subject analysis set title
    Intention-to-treat BONT-A intra-prostatic injection
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Population analysed by intention-to-treat

    Subject analysis set title
    Intention-to-treat Optimized medical BPH treatment
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Population analysed in intention-to-treat

    Primary: Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score)

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    End point title
    		 Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score)
    End point description
    Evaluation of the patient's urinary symptomatology by Internation Prostate Symptom Score (IPSS) self-assessment questionnaire with questions 1-7 assessing obstructive and irritative symptoms related to BPH (8-19 moderate, 20-35 severe)
    End point type
    Primary
    End point timeframe
    At 4 months after the study inclusion
    End point values
    		 Per protocol BONT-A intra-prostatic injection Per protocol Optimized medical BPH treatment
    Number of subjects analysed
    44
    60
    Units: score
        arithmetic mean (standard deviation)
    12.3 ( 7.4 )
    12.0 ( 6.9 )
    Statistical analysis title
    		 Difference in mean IPSS score [0-35]
    Statistical analysis description
    The analysis use the multiple imputation strategy with adjustment for exposure to 5 alpha-reductase inhibitor (ARI) treatment and IPSS score at M0
    Comparison groups
    Per protocol Optimized medical BPH treatment v Per protocol BONT-A intra-prostatic injection
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.14
         upper limit
    		 2.11

    Secondary: IPSS question 8 (score 0 to 6)

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    End point title
    		 IPSS question 8 (score 0 to 6)
    End point description
    End point type
    Secondary
    End point timeframe
    At 4 months.
    End point values
    		 Intention-to-treat BONT-A intra-prostatic injection Intention-to-treat Optimized medical BPH treatment
    Number of subjects analysed
    58
    53
    Units: scores
        arithmetic mean (standard deviation)
    3.1 ( 1.4 )
    3.1 ( 1.4 )
    Statistical analysis title
    		 Treatment effect allocated by randomisation
    Statistical analysis description
    Results of the intention-to-treat analysis of the IPSS score at question 8 at M4, with adjustment for the stratification variable of randomisation and the IPSS score at question 8 at M0
    Comparison groups
    Intention-to-treat BONT-A intra-prostatic injection v Intention-to-treat Optimized medical BPH treatment
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0658
    Method
    		 Regression, Linear
    Parameter type
    		 Slope
    Point estimate
    -0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.97
         upper limit
    		 0.03

    Secondary: Measurement of urine flowmetry Qmax

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    End point title
    		 Measurement of urine flowmetry Qmax
    End point description
    This endpoint is analysed only in patients with a urine volume ≥ 80mL at visit M4
    End point type
    Secondary
    End point timeframe
    At 4 months
    End point values
    		 Intention-to-treat BONT-A intra-prostatic injection Intention-to-treat Optimized medical BPH treatment
    Number of subjects analysed
    46
    41
    Units: millilitre(s)/seconds
        arithmetic mean (standard deviation)
    12.9 ( 8.2 )
    12.2 ( 6.0 )
    Statistical analysis title
    		 Treatment effect allocated by randomisation
    Statistical analysis description
    Results of intention-to-treat analysis of Qmax (in mL/s) at M4, with adjustment for the stratification variable of randomisation and Qmax measurement at M0
    Comparison groups
    Intention-to-treat BONT-A intra-prostatic injection v Intention-to-treat Optimized medical BPH treatment
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4529
    Method
    		 Regression, Linear
    Parameter type
    		 Slope
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.66
         upper limit
    		 3.69

    Secondary: Measurement of post-void residual

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    End point title
    		 Measurement of post-void residual
    End point description
    Measurement of post-void residual assessed by suprapubic ultrasound or urinary catheterization evacuator
    End point type
    Secondary
    End point timeframe
    At 4 months
    End point values
    		 Intention-to-treat BONT-A intra-prostatic injection Intention-to-treat Optimized medical BPH treatment
    Number of subjects analysed
    54
    52
    Units: millilitre(s)
        arithmetic mean (standard deviation)
    59.7 ( 77.2 )
    70.3 ( 95.5 )
    Statistical analysis title
    		 Treatment effect allocated by randomisation
    Statistical analysis description
    Results of intention-to-treat analysis of post-void residual measurements (in mL) at M4, with adjustment for the stratification variable of randomisation
    Comparison groups
    Intention-to-treat BONT-A intra-prostatic injection v Intention-to-treat Optimized medical BPH treatment
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5207
    Method
    		 Regression, Linear
    Parameter type
    		 Slope
    Point estimate
    -10.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.07
         upper limit
    		 22.45

    Secondary: Measurement of prostate volume

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    End point title
    		 Measurement of prostate volume
    End point description
    Measurement of prostate volume assessed by endorectal ultrasound
    End point type
    Secondary
    End point timeframe
    At 4 months
    End point values
    		 Intention-to-treat BONT-A intra-prostatic injection Intention-to-treat Optimized medical BPH treatment
    Number of subjects analysed
    57
    50
    Units: millilitre(s)
        arithmetic mean (standard deviation)
    58.4 ( 31.4 )
    51.8 ( 30.2 )
    Statistical analysis title
    		 Treatment effect allocated by randomisation
    Statistical analysis description
    Results of intention-to-treat analysis of prostate volume measurements (in mL) at M4, with adjustment for the stratification variable of randomisation
    Comparison groups
    Intention-to-treat BONT-A intra-prostatic injection v Intention-to-treat Optimized medical BPH treatment
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2686
    Method
    		 Regression, Linear
    Parameter type
    		 Slope
    Point estimate
    6.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.21
         upper limit
    		 18.53

    Secondary: Evaluation of erectile function using the IIEF-5 self-assessment questionnaire (score from 0 to 24)

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    End point title
    		 Evaluation of erectile function using the IIEF-5 self-assessment questionnaire (score from 0 to 24)
    End point description
    Evaluation of erectile function using the International Index of Erectile Dysfunction score (IIEF-5) self-assessment questionnaire (score from 0 to 24)
    End point type
    Secondary
    End point timeframe
    At 4 months
    End point values
    		 Intention-to-treat BONT-A intra-prostatic injection Intention-to-treat Optimized medical BPH treatment
    Number of subjects analysed
    58
    53
    Units: scores
        arithmetic mean (standard deviation)
    14.9 ( 8.3 )
    14.1 ( 7.7 )
    Statistical analysis title
    		 Treatment effect allocated by randomisation
    Statistical analysis description
    Results of ITT analysis of IIEF-5 score at M4, with adjustment for randomisation stratification variable
    Comparison groups
    Intention-to-treat Optimized medical BPH treatment v Intention-to-treat BONT-A intra-prostatic injection
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5438
    Method
    		 Regression, Linear
    Parameter type
    		 Slope
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.04
         upper limit
    		 3.85

    Secondary: Evaluation of urinary continence by ICS 1 scores (score from 0 to 23)

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    End point title
    		 Evaluation of urinary continence by ICS 1 scores (score from 0 to 23)
    End point description
    Evaluation of urinary continence by Internation Continence Society Score 1 (ICS 1) (score from 0 to 23)
    End point type
    Secondary
    End point timeframe
    At 4 months
    End point values
    		 Intention-to-treat BONT-A intra-prostatic injection Intention-to-treat Optimized medical BPH treatment
    Number of subjects analysed
    58
    53
    Units: scores
        arithmetic mean (standard deviation)
    1.1 ( 2.2 )
    0.6 ( 1.5 )
    Statistical analysis title
    		 Treatment effect allocated by randomisation
    Statistical analysis description
    Results of intention-to-treat analysis of ICS1 score at M4, with adjustment for randomisation stratification variable and ICS1 score at M0
    Comparison groups
    Intention-to-treat BONT-A intra-prostatic injection v Intention-to-treat Optimized medical BPH treatment
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.789
    Method
    		 Regression, Linear
    Parameter type
    		 Slope
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.49

    Secondary: Evaluation of urinary continence by ICS 2 scores (score from 0 to 12)

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    End point title
    		 Evaluation of urinary continence by ICS 2 scores (score from 0 to 12)
    End point description
    End point type
    Secondary
    End point timeframe
    At 4 months
    End point values
    		 Intention-to-treat BONT-A intra-prostatic injection Intention-to-treat Optimized medical BPH treatment
    Number of subjects analysed
    58
    53
    Units: scores
        arithmetic mean (standard deviation)
    1.2 ( 2.4 )
    0.7 ( 1.9 )
    Statistical analysis title
    		 Effect of treatment allocated by randomisation
    Statistical analysis description
    Results of intention-to-treat analysis of ICS2 score at M4, with adjustment for randomisation stratification variable and ICS2 score at M0
    Comparison groups
    Intention-to-treat BONT-A intra-prostatic injection v Intention-to-treat Optimized medical BPH treatment
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4458
    Method
    		 Regression, Linear
    Parameter type
    		 Slope
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.83

    Secondary: Need for surgical intervention

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    End point title
    		 Need for surgical intervention
    End point description
    End point type
    Secondary
    End point timeframe
    At 4 months
    End point values
    		 Per protocol BONT-A intra-prostatic injection Per protocol Optimized medical BPH treatment
    Number of subjects analysed
    44
    60
    Units: percent
    number (not applicable)
        Yes
    4.5
    8.3
        No
    95.5
    91.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study
    Adverse event reporting additional description
    These adverse events described by PT occurred during follow-up (before and after M4)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    BONT-A intra-prostatic injection
    Reporting group description
    		 -

    Reporting group title
    Optimized medical BPH treatment
    Reporting group description
    		 -

    Serious adverse events
    		 BONT-A intra-prostatic injection Optimized medical BPH treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 64 (28.13%)
    15 / 63 (23.81%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of prostate (10001186)
    Additional description: Adenocarcinoma of prostate (10001186)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplasia (10028532)
    Additional description: Myelodysplasia (10028532)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung (10041826)
    Additional description: Squamous cell carcinoma of lung (10041826)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Critical limb ischemia (10058069)
    Additional description: Critical limb ischemia (10058069)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension (10021097)
    Additional description: Hypotension (10021097)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Anoplasty (10068132)
    Additional description: Anoplasty (10068132)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic diet (10064725)
    Additional description: Diabetic diet (10064725)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospitalisation (10054112)
    Additional description: Hospitalisation (10054112)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia hiatus repair (10019915)
    Additional description: Hernia hiatus repair (10019915)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee prosthesis insertion (10050155)
    Additional description: Knee prosthesis insertion (10050155)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laser prostatectomy (10023925)
    Additional description: Laser prostatectomy (10023925)
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate adenoma removal (10065313)
    Additional description: Prostate adenoma removal (10065313)
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of foreign body (10062102)
    Additional description: Removal of foreign body (10062102)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toe amputation (10043913)
    Additional description: Toe amputation (10043913)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral prostatectomy (10044445)
    Additional description: Transurethral prostatectomy (10044445)
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia (10003549)
    Additional description: Asthenia (10003549)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst (10011732)
    Additional description: Cyst (10011732)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acute prostatitis (10001021)
    Additional description: Acute prostatitis (10001021)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erection decreased (10015117)
    Additional description: Erection decreased (10015117)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis (10036978)
    Additional description: Prostatitis (10036978)
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis (10015090)
    Additional description: Epistaxis (10015090)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression (10012378)
    Additional description: Depression (10012378)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression (10057840)
    Additional description: Major depression (10057840)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Biopsy of prostate (10004825)
    Additional description: Biopsy of prostate (10004825)
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased (10005470)
    Additional description: Blood creatine phosphokinase increased (10005470)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    AFib (10001452)
    Additional description: AFib (10001452)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia (10047302)
    Additional description: Ventricular tachycardia (10047302)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis (10007687)
    Additional description: Carotid artery stenosis (10007687)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia (10016288)
    Additional description: Febrile neutropenia (10016288)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia (10029354)
    Additional description: Neutropenia (10029354)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye haemorrhage (10015926)
    Additional description: Eye haemorrhage (10015926)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pyrosis (10037676)
    Additional description: Pyrosis (10037676)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectorrhagia (10063014)
    Additional description: Rectorrhagia (10063014)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria (10018867)
    Additional description: Haematuria (10018867)
         subjects affected / exposed
    3 / 64 (4.69%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic (10038419)
    Additional description: Renal colic (10038419)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention (10046555)
    Additional description: Urinary retention (10046555)
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis (10002556)
    Additional description: Ankylosing spondylitis (10002556)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's contracture (10013872)
    Additional description: Dupuytren's contracture (10013872)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 BONT-A intra-prostatic injection Optimized medical BPH treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 64 (51.56%)
    28 / 63 (44.44%)
    Vascular disorders
    Essential hypertension (10015488)
    Additional description: Essential hypertension (10015488)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Hypotension (10021097)
    Additional description: Hypotension (10021097)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Peripheral obliterative arteriopathy (10072121)
    Additional description: Peripheral obliterative arteriopathy (10072121)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Bladder tumour resection (10005085)
    Additional description: Bladder tumour resection (10005085)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia (10003549)
    Additional description: Asthenia (10003549)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Fatigue (10016256)
    Additional description: Fatigue (10016256)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Nodule (10054107)
    Additional description: Nodule (10054107)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Pyrexia (10037660)
    Additional description: Pyrexia (10037660)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy (10001738)
    Additional description: Allergy (10001738)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Anejaculation (10073936)
    Additional description: Anejaculation (10073936)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Ejaculation failure (10014328)
    Additional description: Ejaculation failure (10014328)
         subjects affected / exposed
    1 / 64 (1.56%)
    6 / 63 (9.52%)
         occurrences all number
    1
    6
    Ejaculation disorder (10014326)
    Additional description: Ejaculation disorder (10014326)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Erection decreased (10015117)
    Additional description: Erection decreased (10015117)
         subjects affected / exposed
    1 / 64 (1.56%)
    4 / 63 (6.35%)
         occurrences all number
    1
    4
    Gynaecomastia (10018800)
    Additional description: Gynaecomastia (10018800)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Haemospermia (10019025)
    Additional description: Haemospermia (10019025)
         subjects affected / exposed
    5 / 64 (7.81%)
    0 / 63 (0.00%)
         occurrences all number
    5
    0
    Painful ejaculation (10072353)
    Additional description: Painful ejaculation (10072353)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Prostatitis (10036978)
    Additional description: Prostatitis (10036978)
         subjects affected / exposed
    5 / 64 (7.81%)
    1 / 63 (1.59%)
         occurrences all number
    5
    1
    Retrograde ejaculation (10038967)
    Additional description: Retrograde ejaculation (10038967)
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    Testicular pain (10043345)
    Additional description: Testicular pain (10043345)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Libido decreased (10024419)
    Additional description: Libido decreased (10024419)
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 63 (4.76%)
         occurrences all number
    2
    3
    Insomnia (10022437)
    Additional description: Insomnia (10022437)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Elevated prostate specific antigen [PSA] (10014484)
    Additional description: Elevated prostate specific antigen [PSA] (10014484)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Prostate specific antigen increased (10036931)
    Additional description: Prostate specific antigen increased (10036931)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Semen volume decreased (10039944)
    Additional description: Semen volume decreased (10039944)
         subjects affected / exposed
    0 / 64 (0.00%)
    3 / 63 (4.76%)
         occurrences all number
    0
    3
    Congenital, familial and genetic disorders
    Hydrocele (10020488)
    Additional description: Hydrocele (10020488)
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Arrhythmia (10003119)
    Additional description: Arrhythmia (10003119)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Bradycardia (10006093)
    Additional description: Bradycardia (10006093)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Palpitation (10033556)
    Additional description: Palpitation (10033556)
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    3
    Nervous system disorders
    Dizziness (10013573)
    Additional description: Dizziness (10013573)
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Headache (10019211)
    Additional description: Headache (10019211)
         subjects affected / exposed
    1 / 64 (1.56%)
    3 / 63 (4.76%)
         occurrences all number
    1
    3
    Parasthesia (10033922)
    Additional description: Parasthesia (10033922)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Syncope vasovagal (10042777)
    Additional description: Syncope vasovagal (10042777)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Eye disorders
    Eye allergy (10015907)
    Additional description: Eye allergy (10015907)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Digestion impaired (10012980)
    Additional description: Digestion impaired (10012980)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Dryness oral (10013794)
    Additional description: Dryness oral (10013794)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Haemorrhoids (10019022)
    Additional description: Haemorrhoids (10019022)
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    2
    1
    Nausea (10028813)
    Additional description: Nausea (10028813)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Urticaria (10046735)
    Additional description: Urticaria (10046735)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Bladder pain (10005063)
    Additional description: Bladder pain (10005063)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Burning micturition (10006779)
    Additional description: Burning micturition (10006779)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Dysuria (10013990)
    Additional description: Dysuria (10013990)
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Haematuria (10018867)
    Additional description: Haematuria (10018867)
         subjects affected / exposed
    6 / 64 (9.38%)
    0 / 63 (0.00%)
         occurrences all number
    7
    0
    Renal colic (10038419)
    Additional description: Renal colic (10038419)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Urinary tract disorder (10046566)
    Additional description: Urinary tract disorder (10046566)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence (10046543)
    Additional description: Urinary incontinence (10046543)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Urinary retention (10046555)
    Additional description: Urinary retention (10046555)
         subjects affected / exposed
    5 / 64 (7.81%)
    0 / 63 (0.00%)
         occurrences all number
    5
    0
    Musculoskeletal and connective tissue disorders
    Degenerative joint disease (10049491)
    Additional description: Degenerative joint disease (10049491)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Rhinitis (10039083)
    Additional description: Rhinitis (10039083)
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    Sinusitis (10040753)
    Additional description: Sinusitis (10040753)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Urinary infection (10046544)
    Additional description: Urinary infection (10046544)
         subjects affected / exposed
    5 / 64 (7.81%)
    0 / 63 (0.00%)
         occurrences all number
    5
    0
    Viral infection (10047461)
    Additional description: Viral infection (10047461)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Gout (10018627)
    Additional description: Gout (10018627)
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    NIDDM (10029402)
    Additional description: NIDDM (10029402)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2011
    Change in the treatment in case of allergy, modification of the flow-chart.
    27 Jul 2011
    Change of recrutment terms.
    25 Jan 2012
    Extension, changes related to vigilance.
    19 Dec 2012
    Extension.

    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/29383480
    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.

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