<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04413461</url>
  </required_header>
  <id_info>
    <org_study_id>19-HPNCL-03</org_study_id>
    <nct_id>NCT04413461</nct_id>
  </id_info>
  <brief_title>Comparative Study of the Efficacy of TENS Versus Placebo in Isolated Primary Enuresis</brief_title>
  <acronym>TENS-Enuresis</acronym>
  <official_title>Efficiency of Trans-cutanéous Electrical Nerve Stimulation for Isolated Primary Enuresis : A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Lenval</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Lenval</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nocturnal enuresis is a functional urinary disorder in children. It is intermittent urinary&#xD;
      incontinence during sleep in children aged 5 years and older. It is said to be &quot;primary&quot; if&#xD;
      the child has never been clean at night for at least 6 months and &quot;isolated&quot; if there are no&#xD;
      other associated urinary symptoms, including daytime symptoms.&#xD;
&#xD;
      It is a common condition with significant repercussions, including disruption of family and&#xD;
      social life and a frequent decline in self-esteem. Without treatment, it can persist into&#xD;
      adulthood. All these reasons justify taking care of these children.&#xD;
&#xD;
      This is usually based on:&#xD;
&#xD;
      The establishment of hygienic-dietetic rules: Regular urination and before sleeping,&#xD;
      limitation of fluid intake in the evening. They are systematically implemented, whatever the&#xD;
      subsequent management Drug treatments (Desmopressin, oxybutynin). These treatments have an&#xD;
      efficiency of 60 to 70% at 6 months post treatment and sometimes have side effects.&#xD;
&#xD;
      Non-drug treatments: Night-time &quot;pee stop&quot; alarms. They have an efficiency of around 70%.&#xD;
      They are little used because they often wake up the whole family and are not reimbursed by&#xD;
      social security.&#xD;
&#xD;
      TENS (Transcutaneous Electro Neuro Stimulation) is a neuro-modulation technique which&#xD;
      consists of stimulating the nerves by means of skin electrodes in order to obtain a somatic&#xD;
      response.&#xD;
&#xD;
      In urology, it is mainly used by stimulating either the sacral region, origin of the vesical&#xD;
      innervation, or the tibial nerve. Its main indication is overactive bladder, a source of&#xD;
      discomfort and incontinence.&#xD;
&#xD;
      It is used at home, the side effects are exceptional and it does not disturb the activities&#xD;
      of the patients.&#xD;
&#xD;
      Few studies have evaluated its effectiveness in isolated primary enuresis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nocturnal enuresis is a functional urinary disorder in children. It is intermittent urinary&#xD;
      incontinence during sleep in children aged 5 years and older. It is said to be &quot;primary&quot; if&#xD;
      the child has never been clean at night for at least 6 months and &quot;isolated&quot; if there are no&#xD;
      other associated urinary symptoms, including daytime symptoms.&#xD;
&#xD;
      It is a common condition with significant repercussions, including disruption of family and&#xD;
      social life and a frequent decline in self-esteem. Without treatment, it can persist into&#xD;
      adulthood.&#xD;
&#xD;
      All these reasons justify taking care of these children.&#xD;
&#xD;
      This is usually based on:&#xD;
&#xD;
      The establishment of hygienic-dietetic rules: Regular urination and before sleeping,&#xD;
      limitation of fluid intake in the evening. They are systematically implemented, whatever the&#xD;
      subsequent management Drug treatments (Desmopressin, oxybutynin). These treatments have an&#xD;
      efficiency of 60 to 70% at 6 months post treatment and sometimes have side effects.&#xD;
&#xD;
      Non-drug treatments: Night-time &quot;pee stop&quot; alarms. They have an efficiency of around 70%.&#xD;
      They are little used because they often wake up the whole family and are not reimbursed by&#xD;
      social security.&#xD;
&#xD;
      TENS (Transcutaneous Electro Neuro Stimulation) is a neuro-modulation technique which&#xD;
      consists of stimulating the nerves by means of skin electrodes in order to obtain a somatic&#xD;
      response.&#xD;
&#xD;
      In urology, it is mainly used by stimulating either the sacral region, origin of the vesical&#xD;
      innervation, or the tibial nerve. Its main indication is overactive bladder, a source of&#xD;
      discomfort and incontinence.&#xD;
&#xD;
      It is used at home, the side effects are exceptional and it does not disturb the activities&#xD;
      of the patients.&#xD;
&#xD;
      Main objective is to compare the effectiveness of treatment with TENS versus TENS sham&#xD;
      procedure (placebo) in isolated primary enuresis, one month after the end of treatment in&#xD;
      patients from 5 to 17 years old The effectiveness will be evaluated by the evolution of the&#xD;
      number of wet nights&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 13, 2021</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>effectiveness of treatment with Transcutaneous Electro Neuro Stimulation (TENS) versus TENS sham procedure at 1 month post treatment</measure>
    <time_frame>at 2 months</time_frame>
    <description>The effectiveness will be evaluated by the evolution of the number of wet nights.&#xD;
Measure of number of wet nights per week at baseline before treatment by TENS and at 1 month after the end of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>effectiveness of treatment with TENS versus TENS sham procedure at 1 month</measure>
    <time_frame>at 1 month</time_frame>
    <description>measure of number of wet nights per week at the end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life during treatment</measure>
    <time_frame>at baseline and at 1 month and at 2 month</time_frame>
    <description>measure of quality of life with the Pediatric Quality of Life Inventory (Peds QL) questionnaire.&#xD;
The Pediatric Quality of Life Inventory (PedsQL) is a 23-items generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18.&#xD;
For ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life). The minimum value is 0 and maximum is 100.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Enuresis, Nocturnal</condition>
  <arm_group>
    <arm_group_label>TENS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>TENS Sham</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TENS</intervention_name>
    <description>Transcutaneous Electro Neuro Stimulation</description>
    <arm_group_label>TENS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TENS Sham</intervention_name>
    <description>placebo of Transcutaneous Electro Neuro Stimulation : similar device without electro stimulation</description>
    <arm_group_label>TENS Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children 5 to 17 years old&#xD;
&#xD;
          -  Medium or severe isolated primary enuresis (more than 1 episode per week)&#xD;
&#xD;
          -  Never treated or in failure of previous treatment (with treatment discontinuation for&#xD;
             at least 1 month)&#xD;
&#xD;
          -  Affiliation to a social security scheme&#xD;
&#xD;
          -  Good understanding of the protocol&#xD;
&#xD;
          -  Signature of informed consent by a parent or the legal representative of parental&#xD;
             authority&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Other pathologies which can influence urination behavior (Daytime urinary disorders)&#xD;
&#xD;
          -  Treatment in progress which can modify voiding behavior&#xD;
&#xD;
          -  TENS treatment in progress for another pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ronny Bensaid, MD</last_name>
    <phone>0492030303</phone>
    <email>bensaid.r@pediatrie-chulenval-nice.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CH de Cannes</name>
      <address>
        <city>Cannes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Muriel MARTINEZ OZENDA</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH de GRASSE</name>
      <address>
        <city>Grasse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Joel NGUYEN, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Camille FAUDEUX</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Pédiatrique de Nice CHU Lenval</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ronny Bensaid, MD</last_name>
      <phone>0492030303</phone>
      <email>bensaid.r@pediatrie-chulenval-nice.fr</email>
    </contact>
    <contact_backup>
      <last_name>Dominique Donzeau</last_name>
      <email>donzeau.d@chu-nice.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Ronny Bensaid, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Nocturnal Enuresis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04413461
org study id: 19-HPNCL-03
nct id: NCT04413461
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Nocturnal enuresis is a functional urinary disorder in children. It is intermittent urinary
      incontinence during sleep in children aged 5 years and older. It is said to be "primary" if
      the child has never been clean at night for at least 6 months and "isolated" if there are no
      other associated urinary symptoms, including daytime symptoms.

      It is a common condition with significant repercussions, including disruption of family and
      social life and a frequent decline in self-esteem. Without treatment, it can persist into
      adulthood. All these reasons justify taking care of these children.

      This is usually based on:

      The establishment of hygienic-dietetic rules: Regular urination and before sleeping,
      limitation of fluid intake in the evening. They are systematically implemented, whatever the
      subsequent management Drug treatments (Desmopressin, oxybutynin). These treatments have an
      efficiency of 60 to 70% at 6 months post treatment and sometimes have side effects.

      Non-drug treatments: Night-time "pee stop" alarms. They have an efficiency of around 70%.
      They are little used because they often wake up the whole family and are not reimbursed by
      social security.

      TENS (Transcutaneous Electro Neuro Stimulation) is a neuro-modulation technique which
      consists of stimulating the nerves by means of skin electrodes in order to obtain a somatic
      response.

      In urology, it is mainly used by stimulating either the sacral region, origin of the vesical
      innervation, or the tibial nerve. Its main indication is overactive bladder, a source of
      discomfort and incontinence.

      It is used at home, the side effects are exceptional and it does not disturb the activities
      of the patients.

      Few studies have evaluated its effectiveness in isolated primary enuresis.
Nocturnal enuresis is a functional urinary disorder in children. It is intermittent urinary
      incontinence during sleep in children aged 5 years and older. It is said to be "primary" if
      the child has never been clean at night for at least 6 months and "isolated" if there are no
      other associated urinary symptoms, including daytime symptoms.

      It is a common condition with significant repercussions, including disruption of family and
      social life and a frequent decline in self-esteem. Without treatment, it can persist into
      adulthood.

      All these reasons justify taking care of these children.

      This is usually based on:

      The establishment of hygienic-dietetic rules: Regular urination and before sleeping,
      limitation of fluid intake in the evening. They are systematically implemented, whatever the
      subsequent management Drug treatments (Desmopressin, oxybutynin). These treatments have an
      efficiency of 60 to 70% at 6 months post treatment and sometimes have side effects.

      Non-drug treatments: Night-time "pee stop" alarms. They have an efficiency of around 70%.
      They are little used because they often wake up the whole family and are not reimbursed by
      social security.

      TENS (Transcutaneous Electro Neuro Stimulation) is a neuro-modulation technique which
      consists of stimulating the nerves by means of skin electrodes in order to obtain a somatic
      response.

      In urology, it is mainly used by stimulating either the sacral region, origin of the vesical
      innervation, or the tibial nerve. Its main indication is overactive bladder, a source of
      discomfort and incontinence.

      It is used at home, the side effects are exceptional and it does not disturb the activities
      of the patients.

      Main objective is to compare the effectiveness of treatment with TENS versus TENS sham
      procedure (placebo) in isolated primary enuresis, one month after the end of treatment in
      patients from 5 to 17 years old The effectiveness will be evaluated by the evolution of the
      number of wet nights
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: effectiveness of treatment with Transcutaneous Electro Neuro Stimulation (TENS) versus TENS sham procedure at 1 month post treatment
time frame: at 2 months
description: The effectiveness will be evaluated by the evolution of the number of wet nights.
Measure of number of wet nights per week at baseline before treatment by TENS and at 1 month after the end of treatment
measure: effectiveness of treatment with TENS versus TENS sham procedure at 1 month
time frame: at 1 month
description: measure of number of wet nights per week at the end of treatment
measure: quality of life during treatment
time frame: at baseline and at 1 month and at 2 month
description: measure of quality of life with the Pediatric Quality of Life Inventory (Peds QL) questionnaire.
The Pediatric Quality of Life Inventory (PedsQL) is a 23-items generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18.
For ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life). The minimum value is 0 and maximum is 100.
arm group label: TENS
arm group type: Experimental
arm group label: TENS Sham
arm group type: Placebo Comparator
intervention type: Other
intervention name: TENS
description: Transcutaneous Electro Neuro Stimulation
arm group label: TENS
intervention type: Other
intervention name: TENS Sham
description: placebo of Transcutaneous Electro Neuro Stimulation : similar device without electro stimulation
arm group label: TENS Sham
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
last name: Ronny Bensaid, MD
phone: 0492030303
email: bensaid.r@pediatrie-chulenval-nice.fr
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Enuresis
mesh term: Urinary Incontinence
mesh term: Nocturnal Enuresis