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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort of children with isolated nocturnal enuresis : a study of the safety of Minirinmelt in actual prescription</titl>
      <IDNo>FRESH-PEF185-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="FERRING SAS" role="">Martine MONDIET</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort of children with isolated nocturnal enuresis : a study of the safety of Minirinmelt in actual prescription            </titl>
      <altTitl>
                    MENUI                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF185-en            </IDNo>
      <IDNo agency="PEF">
                    185                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF185                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Philippe NIEZ                                                                                </AuthEnty>
      <AuthEnty affiliation="FERRING SAS">
        <ExtLink title="SIREN" URI="322624735" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            FERRING SAS                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            FERRING SAS                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="FERRING SAS" email="philippe.niez@ferring.com">
                    Philippe;NIEZ
                                            <ExtLink title="SIREN" URI="322624735" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    desmopressin</keyword>
      <keyword vocab="" vocabURI="">
                    Minirin® tablet</keyword>
      <keyword vocab="" vocabURI="">
                    Minirinmelt®</keyword>
      <topcClas vocab="health theme">
                        Endocrinology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D004704"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Paediatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D010372"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Andrology and urology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/7341b8bd-fcb0-44c1-9ca9-8752b542ed59"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/d90d8dbf-c4b3-46c0-bf2c-55a4a3d9ba8b"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D033441"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D014572"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Nocturnal enuresis                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Show that the two oral forms (tablet and lyophilisate) of desmopressin have a similar safety profile and in particular in terms of frequency of the symptoms of alarms of an intoxication via water, in actual prescription situations, i.e. at general practitioners.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2007-01-01"/>
      <collDate event="end" date="2010-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </universe>
      <universe clusion="I">Criteria for inclusion:             -patient having an isolated nocturnal enuresis, defined by the number of wet nights per week,             -patient aged 6 to 18 years,             -patient in which the family doctor has decided to prescribe a treatment via desmopressin, or      Minirin® tablets or Minirinmelt® lyophilisate.                     </universe>
      <universe clusion="E">patient who has already received prior treatment via desmopressin regardless of its form,-patient who has a treatment in progress via desmopressin,-patient participating in a therapeutic study.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Quality of life/health perception
Others</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>750</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
