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    Clinical Trial Results:
    The effect of clinical characterization of children with monosymptomatic nocturnal enuresis on the efficacy of desmopressin and alarm therapy.

    Summary
    EudraCT number
    		 2017-002169-23
    Trial protocol
    		 DK   BE   PL  
    Global end of trial date
    03 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jul 2023
    First version publication date
    20 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DRYCHILD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03389412
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Cecilie Siggaard Jørgensen, MD, PhD, Aarhus University Hospital , cecisi@rm.dk
    Scientific contact
    Professor Søren Rittig, DMSc, Aarhus University Hospital , rittig@clin.au.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
    02 Feb 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jan 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis in order to improve treatment efficacy. Our hypothesis is that clinical characterization by measurement of nocturnal urine production and maximal voided volumes in children with monosymptomatic nocturnal enuresis and subsequent treatment tailoring improves the response to first-line treatment approach (desmopressin and alarm treatment).
    Protection of trial subjects
    Once the informed consent form was signed, a unique patient number were assigned to each participant. In the final publication, data is handled as anonymous.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2017
    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
    China: 100
    Country: Number of subjects enrolled
    Poland: 7
    Country: Number of subjects enrolled
    Belgium: 46
    Country: Number of subjects enrolled
    Denmark: 171
    Worldwide total number of subjects
    324
    EEA total number of subjects
    224
    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)
    306
    Adolescents (12-17 years)
    18
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Most children Denmark were recruited from outside the hospital by posts on social media and newspaper advertisements. Children from Belgium and Poland were recruited from outpatient clinics, and a few children from Belgium were recruited from local schools. Children from China were recruited from outpatient clinics but without referral.

    Pre-assignment
    Screening details
    		 This was a medical assessment.

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment based on prior consideration of voiding diaries
    Arm description
    		 In this arm, treatment choice was based on voiding diaries. Children with nocturnal polyuria and normal maximum voided volume (MVV) received desmopressin treatment and children with reduced MVV and no nocturnal polyuria received an enuresis alarm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desmopressin
    Investigational medicinal product code
    H01BA02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oromucosal use
    Dosage and administration details
    The children were treated with 120 microgram/day the first two weeks. If the child was not completely dry (revaluated by the parents), the dose were increased to 240 microgram / day the rest of the study period (maximum eight weeks of treatment). The tablet was administrated one hour before bedtime.

    Arm title
    		 Random allocation of treatment
    Arm description
    		 In this arm, treatment with desmopressin or alarm was randomly allocated.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Desmopressin
    Investigational medicinal product code
    H01BA02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oromucosal use
    Dosage and administration details
    The children were treated with 120 microgram/day the first two weeks. If the child was not completely dry (revaluated by the parents), the dose were increased to 240 microgram / day the rest of the study period (maximum eight weeks of treatment). The tablet was administrated one hour before bedtime.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Investigator was not blind in the study.
    Number of subjects in period 1
    		Treatment based on prior consideration of voiding diaries Random allocation of treatment
    Started
    161
    163
    Completed voiding diaries
    150
    149
    Completed
    141
    140
    Not completed
    20
    23
         Did not complete voiding diaries
    11
    14
         Developed daytime symptoms
    1
    1
         Adherence to treatment <80%
    8
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment based on prior consideration of voiding diaries
    Reporting group description
    		 In this arm, treatment choice was based on voiding diaries. Children with nocturnal polyuria and normal maximum voided volume (MVV) received desmopressin treatment and children with reduced MVV and no nocturnal polyuria received an enuresis alarm.

    Reporting group title
    Random allocation of treatment
    Reporting group description
    		 In this arm, treatment with desmopressin or alarm was randomly allocated.

    Reporting group values
    		 Treatment based on prior consideration of voiding diaries Random allocation of treatment Total
    Number of subjects
    		 161 163 324
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 152 154 306
        Adolescents (12-17 years)
    		 9 9 18
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.1 ± 1.8 8.1 ± 1.8 -
    Gender categorical
    Units: Subjects
        Female
    		 38 54 92
        Male
    		 123 109 232
    Body mass index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 16.4 ± 2.7 16.9 ± 2.8 -

    End points

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    End points reporting groups
    Reporting group title
    Treatment based on prior consideration of voiding diaries
    Reporting group description
    		 In this arm, treatment choice was based on voiding diaries. Children with nocturnal polyuria and normal maximum voided volume (MVV) received desmopressin treatment and children with reduced MVV and no nocturnal polyuria received an enuresis alarm.

    Reporting group title
    Random allocation of treatment
    Reporting group description
    		 In this arm, treatment with desmopressin or alarm was randomly allocated.

    Primary: The number of children who responded to the treatment

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    End point title
    		 The number of children who responded to the treatment
    End point description
    Defined by the International Children's Continence Society as a ≥ 50% reduction in number of wet nights per week and based on voiding diaries.
    End point type
    Primary
    End point timeframe
    Measured at the end of treatment.
    End point values
    		 Treatment based on prior consideration of voiding diaries Random allocation of treatment
    Number of subjects analysed
    141
    140
    Units: Number of children
    104
    85
    Statistical analysis title
    		 Generalized linear regression model
    Statistical analysis description
    Generalized linear regression model with log link function that adjusted the standard errors for the center as clusters.
    Comparison groups
    Treatment based on prior consideration of voiding diaries v Random allocation of treatment
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Risk ratio (RR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Primary: The number of children achieving complete dryness (complete responders)

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    End point title
    		 The number of children achieving complete dryness (complete responders)
    End point description
    End point type
    Primary
    End point timeframe
    Measured at the end of treatment.
    End point values
    		 Treatment based on prior consideration of voiding diaries Random allocation of treatment
    Number of subjects analysed
    141
    140
    Units: Number of children
    72
    59
    Statistical analysis title
    		 Generalized linear regression model
    Statistical analysis description
    Generalized linear regression model with log link function that adjusted the standard errors for the center as clusters.
    Comparison groups
    Random allocation of treatment v Treatment based on prior consideration of voiding diaries
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Risk ratio (RR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: The reduction in wet nights

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    End point title
    		 The reduction in wet nights
    End point description
    End point type
    Secondary
    End point timeframe
    Measured at the end of treatment.
    End point values
    		 Treatment based on prior consideration of voiding diaries Random allocation of treatment
    Number of subjects analysed
    141
    140
    Units: Wet nights/week
        arithmetic mean (standard deviation)
    4.1 ± 2.7
    3.4 ± 2.8
    Statistical analysis title
    		 Mixed model with center as random effect
    Comparison groups
    Treatment based on prior consideration of voiding diaries v Random allocation of treatment
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events and reaction were reported between the first dose administration of trial medication / start of alarm treatment and the last trial related activity.
    Adverse event reporting additional description
    Events occurring within a period of 30 days following the last intake of trial medication were also handled as such if spontaneously reported to the investigator. At all clinical visits, the children and parents were asked about adverse events and reactions, and the families were at all-time able to contact the investigators to report any.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Subjects treated with Desmopressin
    Reporting group description
    		 -

    Reporting group title
    Subjects treated with an enuresis alarm
    Reporting group description
    		 -

    Serious adverse events
    		 Subjects treated with Desmopressin Subjects treated with an enuresis alarm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 155 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Urinary tract infection bacterial
    Additional description: Hospitalisation
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 155 (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: 5%
    Non-serious adverse events
    		 Subjects treated with Desmopressin Subjects treated with an enuresis alarm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 146 (1.37%)
    6 / 155 (3.87%)
    Cardiac disorders
    Coarctation of the aorta
    Additional description: No relation to the study, but was discovered during the study period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 155 (0.65%)
         occurrences all number
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 146 (1.37%)
    1 / 155 (0.65%)
         occurrences all number
    2
    1
    Skin and subcutaneous tissue disorders
    Rash
    Additional description: Rash along the cord
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 155 (0.65%)
         occurrences all number
    0
    1
    Infections and infestations
    Cold and fever
         subjects affected / exposed
    0 / 146 (0.00%)
    2 / 155 (1.29%)
         occurrences all number
    0
    2
    Product issues
    Entangled in the wire
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 155 (0.65%)
         occurrences all number
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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