<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/NCT04409054</url>
  </required_header>
  <id_info>
    <org_study_id>GREEN GRC_01</org_study_id>
    <nct_id>NCT04409054</nct_id>
  </id_info>
  <brief_title>The Guarding Reflex Anal, Study of the Modulation Function of Rectal Distension</brief_title>
  <official_title>The Guarding Reflex Anal, Study of the Modulation Function of Rectal Distension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gérard Amarenco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pierre and Marie Curie University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The term Guarding Reflex refers to a progressive, involuntary increase in the external&#xD;
      urethral sphincter activity during bladder filling.This is a mechanism of continence,&#xD;
      preventing from unwanted urine leakage in situation of stress.&#xD;
&#xD;
      Anal continence is essential, and any impairment of this function can have a severe impact on&#xD;
      quality of life. Anal continence at rest is mainly insured by the tone of the internal anal&#xD;
      sphincter. The external anal sphincter activity during gradually rectal filling is continuous&#xD;
      and varies according to the volume of rectal distension.&#xD;
&#xD;
      During an effort, or a cough, the increasing intra-abdominal pressure is transmitted to the&#xD;
      rectum. Increased intra-abdominal pressure during an expiratory against resistance effort&#xD;
      proportionally increases the response of the external anal sphincter. The reflex contraction&#xD;
      of the EAS is an active mechanism under spinal control, and result in a stronger contraction&#xD;
      than a voluntary one. This reflex contraction is the equivalent of &quot;Guarding Reflex&quot; and&#xD;
      provides part of the continence in situation of stress.&#xD;
&#xD;
      The main purpose of this study is to research a correlation between the ano rectal distension&#xD;
      volume and the external anal sphincter response to a stress.&#xD;
&#xD;
      Patient over eighteen years old, consulting for anorectal manometry examination in order to&#xD;
      explore anorectal disorders are included.&#xD;
&#xD;
      Age, sex, ano rectal symptoms, treatments, past history, manometrics data, area under the&#xD;
      curve for electromyography activity of the EAS and intercostal muscles during cough with a&#xD;
      Valsalva effort are recorded. Slope curve representing the EAS response to stress according&#xD;
      to the intercostal activity reflecting cough (intensity response curve) effort are&#xD;
      calculated.&#xD;
&#xD;
      The protocol consists in distending the rectum at four different volumes. For each volume,&#xD;
      the patient is asked to cough three times gradually, and perform a Valsalva effort three&#xD;
      times gradually.&#xD;
&#xD;
      Primary outcome is the difference in curve slope (intensity response curves) between empty&#xD;
      rectum and maximal tolerable volume at cough Secondary outcomes are the differences in curve&#xD;
      slope between each volume of distension at cough, and Valsalva type effort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The term Guarding Reflex refers to a progressive, involuntary increase in the external&#xD;
      urethral sphincter (EUS) activity during bladder filling. Situations increasing&#xD;
      intra-abdominal pressure, as cough, or Valsalva effort, increases this EUS activity. This is&#xD;
      a mechanism of continence, preventing from unwanted urine leakage in situation of stress.&#xD;
&#xD;
      Anal continence is essential, and any impairment of this function can have a severe impact on&#xD;
      quality of life. The anal canal is composed of the internal anal sphincter (IAS) at the top,&#xD;
      with smooth musculature and the external anal sphincter (EAS) at the bottom, with striated&#xD;
      musculature. The activity of the external anal sphincter is controlled by sympathetic and&#xD;
      somatic innervation. Anal continence at rest is mainly insured by the tone of the internal&#xD;
      anal sphincter. The external anal sphincter activity during gradually rectal filling is&#xD;
      continuous and varies according to the volume of rectal distension.&#xD;
&#xD;
      During an effort, or a cough, the increasing intra-abdominal pressure is transmitted to the&#xD;
      rectum. Increased intra-abdominal pressure during an expiratory against resistance effort&#xD;
      proportionally increases the response of the external anal sphincter. The reflex contraction&#xD;
      of the EAS is an active mechanism under spinal control, and result in a stronger contraction&#xD;
      than a voluntary one. This reflex contraction is the equivalent of &quot;Guarding Reflex&quot; and&#xD;
      provides part of the continence in situation of stress.&#xD;
&#xD;
      Previous studies focused on the search of segmental or supra segmental control of this&#xD;
      reflex. Few studies have examined factors affecting the modulation of the EAS response during&#xD;
      stress.&#xD;
&#xD;
      The main purpose of this study is to research a correlation between the ano rectal distension&#xD;
      volume and the external anal sphincter response to a stress.&#xD;
&#xD;
      Patient over eighteen years old, consulting for anorectal manometry examination in order to&#xD;
      explore anorectal disorders are included.&#xD;
&#xD;
      Age, sex, ano rectal symptoms, treatments, past history, manometrics data, area under the&#xD;
      curve for electromyography activity of the EAS and intercostal muscles during cough with a&#xD;
      Valsalva effort are recorded. Slope curve representing the EAS response to stress according&#xD;
      to the intercostal activity reflecting cough (intensity response curve) effort are&#xD;
      calculated.&#xD;
&#xD;
      The protocol consists in distending the rectum at four different volumes : empty rectum,&#xD;
      volume for first sensation of filling, volume for desire to defecate and maximal tolerable&#xD;
      volume. For each volume, the patient is asked to cough three times gradually, and perform a&#xD;
      Valsalva effort three times gradually.&#xD;
&#xD;
      Primary outcome is the difference in curve slope (intensity response curves) between empty&#xD;
      rectum and maximal tolerable volume at cough&#xD;
&#xD;
      Secondary outcomes are the differences in curve slope between each volume of distension at&#xD;
      cough, and the differences in curve slope between each volume of distension at Valsalva type&#xD;
      effort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 2, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in curve slope between empty rectum and maximal tolerable volume at cough</measure>
    <time_frame>1 day</time_frame>
    <description>The area under the curve of EAS response to stress is recorded three times (at each cough effort) for each volume of distension. Curve representing the intensity response is build for each volume of rectal distension. Then, the curve slopes are compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in curve slope between each volume of distension at cough</measure>
    <time_frame>1 day</time_frame>
    <description>The area under the curve of EAS response to stress is recorded three times (at each cough effort) for each volume of distension. Curve representing the intensity response is build for each volume of rectal distension. Then, the curve slopes are compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in curve slope between each volume of distension at Valsalva type effort.</measure>
    <time_frame>1 day</time_frame>
    <description>The area under the curve of EAS response to stress is recorded three times (at each Valsalva type effort) for each volume of distension. Curve representing the intensity response is build for each volume of rectal distension. Then, the curve slopes are compared.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Anorectal Disorder</condition>
  <arm_group>
    <arm_group_label>Patients undergoing the cough and Valsalva protocol</arm_group_label>
    <description>Patients over 18 years old, consulting in neuro urology departement, undergoing ano rectal manometry in order to explore ano rectal disorders</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cough and Valsalva effort</intervention_name>
    <description>Three increasingly cough effort and three Valsalva type effort at four different volumes of rectal distension (empty rectum, volume for a first sensation of filling, volume for desire to defecate and maximal tolerable volume) while recording the external anal sphincter activity</description>
    <arm_group_label>Patients undergoing the cough and Valsalva protocol</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients over eighteen years old consulting in the neuro urology departement for ano&#xD;
        rectal disorders, undergoing ano rectal manometry examination&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years old&#xD;
&#xD;
          -  Ano rectal disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand simple orders&#xD;
&#xD;
          -  Anal hypotonia&#xD;
&#xD;
          -  Peripheral neurological disorder&#xD;
&#xD;
          -  Anal incontinence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gérard Amarenco, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sorbonne Université, GRC 001, GREEN, AP-HP,Hôpital Tenon, Paris, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of neuro-urology, hôpital Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>February 17, 2022</last_update_submitted>
  <last_update_submitted_qc>February 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Pierre and Marie Curie University</investigator_affiliation>
    <investigator_full_name>Gérard Amarenco</investigator_full_name>
    <investigator_title>Head of Neuro-Urology department, Tenon Hospital</investigator_title>
  </responsible_party>
  <keyword>Anal Canal</keyword>
  <keyword>Reflex</keyword>
  <keyword>Anorectal Manometry</keyword>
  <keyword>Fecal incontinence</keyword>
  <keyword>Electromyography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04409054
org study id: GREEN GRC_01
nct id: NCT04409054
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The term Guarding Reflex refers to a progressive, involuntary increase in the external
      urethral sphincter activity during bladder filling.This is a mechanism of continence,
      preventing from unwanted urine leakage in situation of stress.

      Anal continence is essential, and any impairment of this function can have a severe impact on
      quality of life. Anal continence at rest is mainly insured by the tone of the internal anal
      sphincter. The external anal sphincter activity during gradually rectal filling is continuous
      and varies according to the volume of rectal distension.

      During an effort, or a cough, the increasing intra-abdominal pressure is transmitted to the
      rectum. Increased intra-abdominal pressure during an expiratory against resistance effort
      proportionally increases the response of the external anal sphincter. The reflex contraction
      of the EAS is an active mechanism under spinal control, and result in a stronger contraction
      than a voluntary one. This reflex contraction is the equivalent of "Guarding Reflex" and
      provides part of the continence in situation of stress.

      The main purpose of this study is to research a correlation between the ano rectal distension
      volume and the external anal sphincter response to a stress.

      Patient over eighteen years old, consulting for anorectal manometry examination in order to
      explore anorectal disorders are included.

      Age, sex, ano rectal symptoms, treatments, past history, manometrics data, area under the
      curve for electromyography activity of the EAS and intercostal muscles during cough with a
      Valsalva effort are recorded. Slope curve representing the EAS response to stress according
      to the intercostal activity reflecting cough (intensity response curve) effort are
      calculated.

      The protocol consists in distending the rectum at four different volumes. For each volume,
      the patient is asked to cough three times gradually, and perform a Valsalva effort three
      times gradually.

      Primary outcome is the difference in curve slope (intensity response curves) between empty
      rectum and maximal tolerable volume at cough Secondary outcomes are the differences in curve
      slope between each volume of distension at cough, and Valsalva type effort.
The term Guarding Reflex refers to a progressive, involuntary increase in the external
      urethral sphincter (EUS) activity during bladder filling. Situations increasing
      intra-abdominal pressure, as cough, or Valsalva effort, increases this EUS activity. This is
      a mechanism of continence, preventing from unwanted urine leakage in situation of stress.

      Anal continence is essential, and any impairment of this function can have a severe impact on
      quality of life. The anal canal is composed of the internal anal sphincter (IAS) at the top,
      with smooth musculature and the external anal sphincter (EAS) at the bottom, with striated
      musculature. The activity of the external anal sphincter is controlled by sympathetic and
      somatic innervation. Anal continence at rest is mainly insured by the tone of the internal
      anal sphincter. The external anal sphincter activity during gradually rectal filling is
      continuous and varies according to the volume of rectal distension.

      During an effort, or a cough, the increasing intra-abdominal pressure is transmitted to the
      rectum. Increased intra-abdominal pressure during an expiratory against resistance effort
      proportionally increases the response of the external anal sphincter. The reflex contraction
      of the EAS is an active mechanism under spinal control, and result in a stronger contraction
      than a voluntary one. This reflex contraction is the equivalent of "Guarding Reflex" and
      provides part of the continence in situation of stress.

      Previous studies focused on the search of segmental or supra segmental control of this
      reflex. Few studies have examined factors affecting the modulation of the EAS response during
      stress.

      The main purpose of this study is to research a correlation between the ano rectal distension
      volume and the external anal sphincter response to a stress.

      Patient over eighteen years old, consulting for anorectal manometry examination in order to
      explore anorectal disorders are included.

      Age, sex, ano rectal symptoms, treatments, past history, manometrics data, area under the
      curve for electromyography activity of the EAS and intercostal muscles during cough with a
      Valsalva effort are recorded. Slope curve representing the EAS response to stress according
      to the intercostal activity reflecting cough (intensity response curve) effort are
      calculated.

      The protocol consists in distending the rectum at four different volumes : empty rectum,
      volume for first sensation of filling, volume for desire to defecate and maximal tolerable
      volume. For each volume, the patient is asked to cough three times gradually, and perform a
      Valsalva effort three times gradually.

      Primary outcome is the difference in curve slope (intensity response curves) between empty
      rectum and maximal tolerable volume at cough

      Secondary outcomes are the differences in curve slope between each volume of distension at
      cough, and the differences in curve slope between each volume of distension at Valsalva type
      effort.
observational model: Cohort
time perspective: Prospective
measure: Difference in curve slope between empty rectum and maximal tolerable volume at cough
time frame: 1 day
description: The area under the curve of EAS response to stress is recorded three times (at each cough effort) for each volume of distension. Curve representing the intensity response is build for each volume of rectal distension. Then, the curve slopes are compared.
measure: Difference in curve slope between each volume of distension at cough
time frame: 1 day
description: The area under the curve of EAS response to stress is recorded three times (at each cough effort) for each volume of distension. Curve representing the intensity response is build for each volume of rectal distension. Then, the curve slopes are compared.
measure: Difference in curve slope between each volume of distension at Valsalva type effort.
time frame: 1 day
description: The area under the curve of EAS response to stress is recorded three times (at each Valsalva type effort) for each volume of distension. Curve representing the intensity response is build for each volume of rectal distension. Then, the curve slopes are compared.
arm group label: Patients undergoing the cough and Valsalva protocol
description: Patients over 18 years old, consulting in neuro urology departement, undergoing ano rectal manometry in order to explore ano rectal disorders
intervention type: Other
intervention name: Cough and Valsalva effort
description: Three increasingly cough effort and three Valsalva type effort at four different volumes of rectal distension (empty rectum, volume for a first sensation of filling, volume for desire to defecate and maximal tolerable volume) while recording the external anal sphincter activity
arm group label: Patients undergoing the cough and Valsalva protocol
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gérard Amarenco, PhD
role: Principal Investigator
affiliation: Sorbonne Université, GRC 001, GREEN, AP-HP,Hôpital Tenon, Paris, France
facility: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Pierre and Marie Curie University
investigator full name: Gérard Amarenco
investigator title: Head of Neuro-Urology department, Tenon Hospital
mesh term: Rectal Diseases
sharing ipd: Undecided