<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/NCT02244840</url>
  </required_header>
  <id_info>
    <org_study_id>0620113700</org_study_id>
    <nct_id>NCT02244840</nct_id>
  </id_info>
  <brief_title>Anal Resting Pressure After Bidet, Compared to Sitz Bath</brief_title>
  <acronym>Bidet(2)</acronym>
  <official_title>The Effects of Electronic Bidet on Anal Resting Pressure, Compared to Conventional Sitz Bath in Normal Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coway Research and Development Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sitz bath is conventional and empirical remedy and commonly recommended for non-operative&#xD;
      treatment of various anal diseases. However, as there was no substitute for sitz bath until&#xD;
      now, the patients have to accept the inconvenience for treatment of their diseases.&#xD;
&#xD;
      Electronic bidet is used with convenience as automatic device for cleansing the perineal&#xD;
      area, especially after defecation. The similarity of contacting water to perineal area,&#xD;
      clinical use of electronic bidet has been suggested for treatment of anal diseases. However,&#xD;
      there had been few reports of clinical use of electronic bidet.&#xD;
&#xD;
      Investigators performed the study to evaluate the effects of electronic bidet on anal resting&#xD;
      pressure, compared to conventional warm sitz bath in normal healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Baseline Anorectal Manometry&#xD;
&#xD;
      The Subjects underwent a digital rectal examination and baseline anorectal manometry in the&#xD;
      lateral decubitus position using a device from Dynacompact (Menfis Biomedica Corp., Bologna,&#xD;
      Italy) using an 8 channel polyvinyl (PVC) catheter with the measuring orifices oriented&#xD;
      radially. Resting and maximal pressure in the anal canal were measured by pulling the&#xD;
      catheter out of the anorectum at a speed of 0.5 mm/sec (the 'rapid pull through' technique)&#xD;
&#xD;
      Recordings of Anal Resting Pressure on Electronic Bidet and Sitz Bath&#xD;
&#xD;
      The subjects underwent clinical experiments for recordings of anal resting pressure changes&#xD;
      using the electronic bidet and taking the sitz bath. For the measurement of effects of&#xD;
      electronic bidet on anal resting pressure, a different manometry catheter (8 spirally&#xD;
      arranged channels, 0.5 cm apart) was inserted into the anal canal placing the upper channels&#xD;
      (channels No. 1-2) with a temperature probe in the rectum and the lower channels (channel No.&#xD;
      3-8) in the anal canal. The catheter was fixed in the buttock area using waterproof tape and&#xD;
      subjects sat on a toilet equipped with an electronic bidet (Coway Corp, Seoul, Korea). After&#xD;
      anal resting pressure had stabilized at the sitting position, anal resting pressure at high&#xD;
      pressure zone (HPZ) was checked as control value to measure the change of anal resting&#xD;
      pressure. The anal high pressure zone (HPZ) was defined as the channel representing the&#xD;
      highest pressure within the anal canal for each subject. The pressures while sitting were&#xD;
      adjusted for gravity. A water flow of the electronic bidet was applied to the anus for 3&#xD;
      minute. We designed the new water flow system of the electronic bidet, which was fountain&#xD;
      type with very low force (10mN), as water falls down immediately after contacting the&#xD;
      perineal area (Fig 1A). Before applying the water flow, mist type of water particles was&#xD;
      sprayed for a few seconds for gentle contact with water first. The water used in the&#xD;
      electronic bidet was a tap water of warm temperature about 38 degree celsius. Anal resting&#xD;
      pressure at the channel of HPZ was checked at 1, 2 and 3 minutes after using the electronic&#xD;
      bidet and percentage of anal resting pressure was calculated with compared to control value&#xD;
      checked before using the electronic bidet. Maximum and minimum pressures in the HPZ during&#xD;
      application of the electronic bidet were noted.&#xD;
&#xD;
      Sitz bath was also undergone at another day. After insertion of catheter, the subjects were&#xD;
      seated on a chair with small tub filled with warm water of about 38 degree celsius and sink&#xD;
      their buttock (Fig 1B). The measurements of anal resting pressure were similar to the&#xD;
      electronic bidet. Anal resting pressures of HPZ were checked before and after using the&#xD;
      electronic bidet for 3 minutes. Maximum and minimum pressures were also checked.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anal Resting Pressure Change</measure>
    <time_frame>3 minute</time_frame>
    <description>before and after bidet/sitz bath for 3 minute</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Convenience</measure>
    <time_frame>3 minute</time_frame>
    <description>Questionnaires</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Anorectal Disorders</condition>
  <arm_group>
    <arm_group_label>Electronic bidet and sitz bath</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electronic bidet</intervention_name>
    <description>commercial electronic bidet</description>
    <arm_group_label>Electronic bidet and sitz bath</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sitz bath</intervention_name>
    <description>Conventional sitz bath</description>
    <arm_group_label>Electronic bidet and sitz bath</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  health volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anorectal disorder&#xD;
&#xD;
          -  medical comorbidities&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  history of vaginal delivery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Jongro-gu</state>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>September 20, 2014</results_first_submitted>
  <results_first_submitted_qc>September 26, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 3, 2014</results_first_posted>
  <last_update_submitted>September 26, 2014</last_update_submitted>
  <last_update_submitted_qc>September 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Kyu Joo Park</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Bidet, Sitz bath, Anal resting pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Diseases</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Electronic Bidet and Sitz Bath</title>
          <description>Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject&#xD;
Electronic bidet: commercial electronic bidet&#xD;
Sitz bath: Conventional sitz bath</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Electronic Bidet and Sitz Bath</title>
          <description>Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject&#xD;
Electronic bidet: commercial electronic bidet&#xD;
Sitz bath: Conventional sitz bath</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.0" lower_limit="22" upper_limit="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Anal Resting Pressure Change</title>
        <description>before and after bidet/sitz bath for 3 minute</description>
        <time_frame>3 minute</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electronic Bidet and Sitz Bath</title>
            <description>Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject&#xD;
Electronic bidet: commercial electronic bidet&#xD;
Sitz bath: Conventional sitz bath</description>
          </group>
        </group_list>
        <measure>
          <title>Anal Resting Pressure Change</title>
          <description>before and after bidet/sitz bath for 3 minute</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Electronic bidet</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.2" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Electronic Bidet</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.3" spread="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Sitz bath</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.1" spread="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Sitz Bathbath</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.6" spread="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Convenience</title>
        <description>Questionnaires</description>
        <time_frame>3 minute</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Electronic Bidet and Sitz Bath</title>
          <description>Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject&#xD;
Electronic bidet: commercial electronic bidet&#xD;
Sitz bath: Conventional sitz bath</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Professor</name_or_title>
      <organization>Seoul National University Hospital</organization>
      <phone>82-2-2072-2901</phone>
      <email>kjparkmd@plaza.snu.ac.kr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02244840
org study id: 0620113700
nct id: NCT02244840
lead sponsor: 
collaborator: 
has dmc: Yes
Sitz bath is conventional and empirical remedy and commonly recommended for non-operative
      treatment of various anal diseases. However, as there was no substitute for sitz bath until
      now, the patients have to accept the inconvenience for treatment of their diseases.

      Electronic bidet is used with convenience as automatic device for cleansing the perineal
      area, especially after defecation. The similarity of contacting water to perineal area,
      clinical use of electronic bidet has been suggested for treatment of anal diseases. However,
      there had been few reports of clinical use of electronic bidet.

      Investigators performed the study to evaluate the effects of electronic bidet on anal resting
      pressure, compared to conventional warm sitz bath in normal healthy volunteers.
Baseline Anorectal Manometry

      The Subjects underwent a digital rectal examination and baseline anorectal manometry in the
      lateral decubitus position using a device from Dynacompact (Menfis Biomedica Corp., Bologna,
      Italy) using an 8 channel polyvinyl (PVC) catheter with the measuring orifices oriented
      radially. Resting and maximal pressure in the anal canal were measured by pulling the
      catheter out of the anorectum at a speed of 0.5 mm/sec (the 'rapid pull through' technique)

      Recordings of Anal Resting Pressure on Electronic Bidet and Sitz Bath

      The subjects underwent clinical experiments for recordings of anal resting pressure changes
      using the electronic bidet and taking the sitz bath. For the measurement of effects of
      electronic bidet on anal resting pressure, a different manometry catheter (8 spirally
      arranged channels, 0.5 cm apart) was inserted into the anal canal placing the upper channels
      (channels No. 1-2) with a temperature probe in the rectum and the lower channels (channel No.
      3-8) in the anal canal. The catheter was fixed in the buttock area using waterproof tape and
      subjects sat on a toilet equipped with an electronic bidet (Coway Corp, Seoul, Korea). After
      anal resting pressure had stabilized at the sitting position, anal resting pressure at high
      pressure zone (HPZ) was checked as control value to measure the change of anal resting
      pressure. The anal high pressure zone (HPZ) was defined as the channel representing the
      highest pressure within the anal canal for each subject. The pressures while sitting were
      adjusted for gravity. A water flow of the electronic bidet was applied to the anus for 3
      minute. We designed the new water flow system of the electronic bidet, which was fountain
      type with very low force (10mN), as water falls down immediately after contacting the
      perineal area (Fig 1A). Before applying the water flow, mist type of water particles was
      sprayed for a few seconds for gentle contact with water first. The water used in the
      electronic bidet was a tap water of warm temperature about 38 degree celsius. Anal resting
      pressure at the channel of HPZ was checked at 1, 2 and 3 minutes after using the electronic
      bidet and percentage of anal resting pressure was calculated with compared to control value
      checked before using the electronic bidet. Maximum and minimum pressures in the HPZ during
      application of the electronic bidet were noted.

      Sitz bath was also undergone at another day. After insertion of catheter, the subjects were
      seated on a chair with small tub filled with warm water of about 38 degree celsius and sink
      their buttock (Fig 1B). The measurements of anal resting pressure were similar to the
      electronic bidet. Anal resting pressures of HPZ were checked before and after using the
      electronic bidet for 3 minutes. Maximum and minimum pressures were also checked.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anal Resting Pressure Change
time frame: 3 minute
description: before and after bidet/sitz bath for 3 minute
measure: Convenience
time frame: 3 minute
description: Questionnaires
arm group label: Electronic bidet and sitz bath
arm group type: Experimental
description: Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject
intervention type: Device
intervention name: Electronic bidet
description: commercial electronic bidet
arm group label: Electronic bidet and sitz bath
intervention type: Device
intervention name: Sitz bath
description: Conventional sitz bath
arm group label: Electronic bidet and sitz bath
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Kyu Joo Park
investigator title: Professor
mesh term: Rectal Diseases
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 