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    Clinical Trial Results:
    The effect of intravesical Lidocaine solution versus placebo as anesthesia prior to intravesical injection of onabotulinum toxin A. A randomized, double-blind, placebo controlled cross-over study

    Summary
    EudraCT number
    		 2021-000559-38
    Trial protocol
    		 DK  
    Global end of trial date
    10 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2025
    First version publication date
    13 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BTXA2021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05415865
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev and Gentofte Hospital
    Sponsor organisation address
    Borgmester Ib Juuls Vej 1, 16. etage, Herlev, Denmark, 2730
    Public contact
    Department of Obstetrics and Gynecology , Herlev and Gentofte University Hospital, Department of Obstetrics and Gynecology, +45 38681406, niels.klarskov@regionh.dk
    Scientific contact
    Department of Obstetrics and Gynecology , Herlev and Gentofte University Hospital, Department of Obstetrics and Gynecology, +45 38681406, niels.klarskov@regionh.dk
    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
    01 Sep 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of intravesical alkalinised lidocaine as an anaesthetic treatment on procedural pain duringintradetrusor onabotulinumtoxinA injections for overactive bladder.
    Protection of trial subjects
    A follow up call one week was conducted, where patients were asked about adverse effects and experience with the treatment.
    Background therapy
    		 Intradetrusor onabotulinumtoxinA injections
    Evidence for comparator
    		 Alkalinized lidocaine was not previously compared to placebo (saline).
    Actual start date of recruitment
    15 Nov 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    16
    From 65 to 84 years
    32
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Women aged ≥18 years referred for treatment with onabotulinumtoxinA injections due to complaints of OAB symptoms. Patients should accept to receive BTX-A injections in an outpatient clinic without the option of sedation.

    Pre-assignment
    Screening details
    		 60 women scheduled for BTX-A treatment between September 2022 and May 2023 were screened. Of these, 50 signed informed consent, met eligibility criteria and completed the first treatment period.

    Period 1
    Period 1 title
    First onabotulinumtoxinA inj. in trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All personnel involved in enrolment, randomisation, medication administration, and outcome assessment remained blinded until the outcomes were analysed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Alkalinized lidocaine
    Arm description
    		 Patients were randomly assigned (1:1) to receive either alkalinized lidocaine or placebo during the first treatment period. In the second treatment period, patients received the alternate treatment, with a maintained double-blind protocol and all procedures consistent with those in the first treatment period
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lidokain SAD
    Investigational medicinal product code
    Other name
    LIDOCAINE HYDROCHLORIDE
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravesical use
    Dosage and administration details
    Lidocaine hydrochloride20 mg/mL, 20 mL was mixed with sodium hydrogen carbonate 1 mmoL/mL,10 mL; and sodium chloride 9 g/L, 10 mL. The buffer was instilled in the bladder with a Luer lock catheter.

    Investigational medicinal product name
    Natriumbikarbonat SAD
    Investigational medicinal product code
    Other name
    SODIUM HYDROGEN CARBONATE
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravesical use
    Dosage and administration details
    Lidocaine hydrochloride20 mg/mL, 20 mL was mixed with sodium hydrogen carbonate 1 mmoL/mL,10 mL; and sodium chloride 9 g/L, 10 mL. The buffer was instilled in the bladder with a Luer lock catheter.

    Arm title
    		 Placebo
    Arm description
    		 Patients were randomly assigned (1:1) to receive either alkalinized lidocaine or placebo during the first treatment period. In the second treatment period, patients received the alternate treatment, with a maintained double-blind protocol and all procedures consistent with those in the first treatment period less
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium chloride, NaCl SAD 9 g/l
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravesical use
    Dosage and administration details
    Sodium chloride 9 g/L, 20 mL; sodium chloride9 g/L, 10 mL; and sodium chloride 9 g/L, 10 mL instilled in the bladder with Luer Lock catheter

    Number of subjects in period 1
    		Alkalinized lidocaine Placebo
    Started
    25
    25
    Completed
    25
    25
    Period 2
    Period 2 title
    Second onabotulinumtoxinA inj in trial
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All personnel involved in enrolment, randomisation, medication administration, and outcome assessment remained blinded until the outcomes were analysed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Alkalinized lidocaine
    Arm description
    		 Patients were randomly assigned (1:1) to receive either alkalinized lidocaine or placebo during the first treatment period. In the second treatment period, patients received the alternate treatment, with a maintained double-blind protocol and all procedures consistent with those in the first treatment period
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lidokain SAD
    Investigational medicinal product code
    Other name
    LIDOCAINE HYDROCHLORIDE
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravesical use
    Dosage and administration details
    Lidocaine hydrochloride20 mg/mL, 20 mL was mixed with sodium hydrogen carbonate 1 mmoL/mL,10 mL; and sodium chloride 9 g/L, 10 mL. The buffer was instilled in the bladder with a Luer lock catheter.

    Investigational medicinal product name
    Natriumbikarbonat SAD
    Investigational medicinal product code
    Other name
    SODIUM HYDROGEN CARBONATE
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravesical use
    Dosage and administration details
    Lidocaine hydrochloride20 mg/mL, 20 mL was mixed with sodium hydrogen carbonate 1 mmoL/mL,10 mL; and sodium chloride 9 g/L, 10 mL. The buffer was instilled in the bladder with a Luer lock catheter.

    Arm title
    		 Placebo
    Arm description
    		 Patients were randomly assigned (1:1) to receive either alkalinized lidocaine or placebo during the first treatment period. In the second treatment period, patients received the alternate treatment, with a maintained double-blind protocol and all procedures consistent with those in the first treatment period less
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium chloride, NaCl SAD 9 g/l
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravesical use
    Dosage and administration details
    Sodium chloride 9 g/L, 20 mL; sodium chloride9 g/L, 10 mL; and sodium chloride 9 g/L, 10 mL instilled in the bladder with Luer Lock catheter

    Number of subjects in period 2
    		Alkalinized lidocaine Placebo
    Started
    25
    25
    Completed
    21
    20
    Not completed
    4
    5
         Consent withdrawn by subject
    -
    1
         Changed protocl
    -
    2
         Received Myobloc
    -
    1
         Changed protocol
    2
    -
         Other healthcare issues
    1
    -
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    First onabotulinumtoxinA inj. in trial
    Reporting group description
    		 -

    Reporting group values
    		 First onabotulinumtoxinA inj. in trial Total
    Number of subjects
    		 50 50
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 73 (63 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 50 50
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Alkalinized lidocaine
    Reporting group description
    		 Patients were randomly assigned (1:1) to receive either alkalinized lidocaine or placebo during the first treatment period. In the second treatment period, patients received the alternate treatment, with a maintained double-blind protocol and all procedures consistent with those in the first treatment period

    Reporting group title
    Placebo
    Reporting group description
    		 Patients were randomly assigned (1:1) to receive either alkalinized lidocaine or placebo during the first treatment period. In the second treatment period, patients received the alternate treatment, with a maintained double-blind protocol and all procedures consistent with those in the first treatment period less
    Reporting group title
    Alkalinized lidocaine
    Reporting group description
    		 Patients were randomly assigned (1:1) to receive either alkalinized lidocaine or placebo during the first treatment period. In the second treatment period, patients received the alternate treatment, with a maintained double-blind protocol and all procedures consistent with those in the first treatment period

    Reporting group title
    Placebo
    Reporting group description
    		 Patients were randomly assigned (1:1) to receive either alkalinized lidocaine or placebo during the first treatment period. In the second treatment period, patients received the alternate treatment, with a maintained double-blind protocol and all procedures consistent with those in the first treatment period less

    Primary: Visual analogue scale (VAS) score

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    End point title
    		 Visual analogue scale (VAS) score
    End point description
    End point type
    Primary
    End point timeframe
    Maximum pain score reported using the 100-mm visual analogue scale (VAS) score immediately after BTX-A injections
    End point values
    		 Alkalinized lidocaine Placebo Alkalinized lidocaine Placebo
    Number of subjects analysed
    25
    25
    21
    20
    Units: millimetre(s)
        least squares mean (confidence interval 95%)
    21.3 (14.7 to 27.8)
    41.6 (35 to 48.1)
    21.3 (14.7 to 27.8)
    41.6 (35 to 48.1)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    The difference in VAS pain scores between alkalinized lidocaine and placebo treatments was calculated using repeated measures analysis of covariance (ANCOVA )
    Comparison groups
    Alkalinized lidocaine v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean

    Secondary: 5- point satisfaction score

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    End point title
    		 5- point satisfaction score
    End point description
    End point type
    Secondary
    End point timeframe
    One week after each BTX-A treatment, a follow-up call was scheduled asking the patients about their satisfaction with the BTX-A treatment using a 5-point Likert scale.
    End point values
    		 Alkalinized lidocaine Placebo Alkalinized lidocaine Placebo
    Number of subjects analysed
    25
    25
    21
    20
    Units: Ordinal
    median (full range (min-max))
        5- point satisfaction scale score
    5 (3 to 5)
    5 (2 to 5)
    5 (3 to 5)
    5 (2 to 5)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    Wilcoxon signed-rank test was used to compare 5-point satisfaction score.
    Comparison groups
    Alkalinized lidocaine v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Urinary tract infection

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    End point title
    		 Urinary tract infection
    End point description
    End point type
    Secondary
    End point timeframe
    Urinary tract infection (UTI) one week after each BTX-A treatment
    End point values
    		 Alkalinized lidocaine Placebo Alkalinized lidocaine Placebo
    Number of subjects analysed
    25
    25
    21
    20
    Units: Number
    5
    2
    5
    2
    Statistical analysis title
    		 McNemars test
    Statistical analysis description
    McNemars test was used to compare the UTI rate in intervention and placebo group.
    Comparison groups
    Alkalinized lidocaine v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mcnemar
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Hematuria

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    End point title
    		 Hematuria
    End point description
    End point type
    Secondary
    End point timeframe
    Hematuria during or within one week after each BTX-A treatment
    End point values
    		 Alkalinized lidocaine Placebo Alkalinized lidocaine Placebo
    Number of subjects analysed
    25
    25
    21
    20
    Units: Frequency
    4
    2
    4
    2
    Statistical analysis title
    		 McNemars test
    Statistical analysis description
    McNemars test was used to compare hematuria in the intervention and placebo group.
    Comparison groups
    Alkalinized lidocaine v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mcnemar
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
    Variability estimate
    Standard deviation

    Secondary: Clean intermittent catherization (CIC)

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    End point title
    		 Clean intermittent catherization (CIC)
    End point description
    End point type
    Secondary
    End point timeframe
    Post-void residuals requiring clean intermittent catherization (CIC) within one week after BTX-A treatment
    End point values
    		 Alkalinized lidocaine Placebo Alkalinized lidocaine Placebo
    Number of subjects analysed
    25
    25
    21
    20
    Units: Frequency
    1
    0
    0
    0
    Statistical analysis title
    		 McNemars test
    Statistical analysis description
    McNemars test was used to compare CIC risk in intervention and placebo group.
    Comparison groups
    Alkalinized lidocaine v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mcnemar
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were registered on-site during BTX-A treatments or during follow-up calls one week after each BTX-A treatment. Patients were asked about specific adverse events (urinary retention, UTI, hematuria).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Alkalinized lidocaine
    Reporting group description
    		 Intervention

    Reporting group title
    Placebo
    Reporting group description
    		 Adverse events were registered on-site during BTX-A treatments or during follow-up calls one week after each BTX-A treatment. Patients were asked about specific adverse events (urinary retention, UTI, hematuria).

    Serious adverse events
    		 Alkalinized lidocaine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 45 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Alkalinized lidocaine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 48 (45.83%)
    23 / 45 (51.11%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Headache
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Vaginal bleeding
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    7 / 48 (14.58%)
    7 / 45 (15.56%)
         occurrences all number
    7
    7
    Bladder pain
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Pelvic pain
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 45 (6.67%)
         occurrences all number
    1
    3
    Pollakiuria
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    0
    2
    Asymptomatic urinary tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Urgency urinary incontinence
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Urethral bleeding
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    hematuria
         subjects affected / exposed
    5 / 48 (10.42%)
    2 / 45 (4.44%)
         occurrences all number
    5
    2
    Urinary retention
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    UTI
         subjects affected / exposed
    5 / 48 (10.42%)
    2 / 45 (4.44%)
         occurrences all number
    5
    2
    Infections and infestations
    Fever
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jan 2023
    We requested a protocol amendment after enrolling the firstthree patients in the trial because the treating nurse observed a milky white appearance in the trial medication after mixing. Our initial protocol followed the same solution administered in a previous RCT by, which comprised 20 mL of 2% lidocaine hydrochloride with 10 mL of 8.4% sodium bicarbonate. As a result, the trial was halted due to the compromised double-blind conditions. We consulted the Capital Region of Denmark’s unit for pharmaceutical advice. The unit stated that the mixture of lidocaine hydrochloride 20 mg/mL and sodium hydrogen carbonate 1 mmol/mL was unstable and could precipitate. This could lead to reduced anesthetic effect compared to anticipated results. Additionally, the solution could potentially irritate the bladder mucosa. The hospital pharmacy conducted new analyses and recommended dissolving the mixture in 10 mL of sodium chloride (9 g/L). This prevented the milky white appearance or precipitation of the trial medication. Amendment approval for 10 mL sodium chloride was obtained from the Danish Research Ethics Committees and the Danish Medicines Agency. The trial was resumed in January 2023

    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
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