<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/NCT04482426</url>
  </required_header>
  <id_info>
    <org_study_id>CGH-P102071</org_study_id>
    <nct_id>NCT04482426</nct_id>
  </id_info>
  <brief_title>Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor Function</brief_title>
  <acronym>PFMF</acronym>
  <official_title>Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cathay General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cathay General Hospital</source>
  <brief_summary>
    <textblock>
      The study aimed to explore and quantify functional and electrical activities in different&#xD;
      pelvic floor muscle groups, to differentiate the electrophysiological role in different&#xD;
      pelvic floor muscle groups relating to pelvic floor dysfunction or disorders, and further to&#xD;
      develop treatment strategies for different pelvic floor muscle groups in different female&#xD;
      pelvic disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Female pelvic floor disorders including sexual dysfunction, urinary incontinence, fecal&#xD;
      incontinence, and pelvic organ prolapse are relating to the function of pelvic floor&#xD;
      structures. Essential components responsible for pelvic floor function include bony,&#xD;
      muscular, and fascial structures of the pelvis. Among above components, pelvic floor muscles,&#xD;
      either the superficial or deep group, are considered crucial in maintaining the morphology&#xD;
      and functional integrity of the pelvic floor.&#xD;
&#xD;
      Inspection and digital examination incorporating Oxford grading system during pelvic&#xD;
      examinations are the most convenient and commonly methods applied to evaluate the function of&#xD;
      pelvic floor muscles. Nevertheless, both methods cannot provide quantitative information of&#xD;
      pelvic floor muscle contraction. With the introduction of pelvic floor manometry and&#xD;
      electrophysiological testing, quantification of pelvic floor muscle contractions can be&#xD;
      expected.&#xD;
&#xD;
      The study aimed to explore and quantify functional and electrical activities in different&#xD;
      pelvic floor muscle groups, to differentiate the electrophysiological role in different&#xD;
      pelvic floor muscle groups relating to pelvic floor dysfunction or disorders, and further to&#xD;
      develop treatment strategies for different pelvic floor muscle groups in different female&#xD;
      pelvic disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 25, 2014</start_date>
  <completion_date type="Actual">August 11, 2017</completion_date>
  <primary_completion_date type="Actual">August 29, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Contraction of pelvic floor muscle</measure>
    <time_frame>Baseline</time_frame>
    <description>Chart review</description>
  </primary_outcome>
  <enrollment type="Actual">112</enrollment>
  <condition>Pelvic Floor</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Women with pelvic floor dysfunction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with pelvic floor dysfuntion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Women with histories of diabetes, cerebrovascular diseases, neurological diseases,&#xD;
             degenerative muscular diseases, or autoimmune connective tissue diseases。&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cathay General Hospital</investigator_affiliation>
    <investigator_full_name>Wen-Chen Huang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04482426
org study id: CGH-P102071
nct id: NCT04482426
lead sponsor: 
The study aimed to explore and quantify functional and electrical activities in different
      pelvic floor muscle groups, to differentiate the electrophysiological role in different
      pelvic floor muscle groups relating to pelvic floor dysfunction or disorders, and further to
      develop treatment strategies for different pelvic floor muscle groups in different female
      pelvic disorders.
Female pelvic floor disorders including sexual dysfunction, urinary incontinence, fecal
      incontinence, and pelvic organ prolapse are relating to the function of pelvic floor
      structures. Essential components responsible for pelvic floor function include bony,
      muscular, and fascial structures of the pelvis. Among above components, pelvic floor muscles,
      either the superficial or deep group, are considered crucial in maintaining the morphology
      and functional integrity of the pelvic floor.

      Inspection and digital examination incorporating Oxford grading system during pelvic
      examinations are the most convenient and commonly methods applied to evaluate the function of
      pelvic floor muscles. Nevertheless, both methods cannot provide quantitative information of
      pelvic floor muscle contraction. With the introduction of pelvic floor manometry and
      electrophysiological testing, quantification of pelvic floor muscle contractions can be
      expected.

      The study aimed to explore and quantify functional and electrical activities in different
      pelvic floor muscle groups, to differentiate the electrophysiological role in different
      pelvic floor muscle groups relating to pelvic floor dysfunction or disorders, and further to
      develop treatment strategies for different pelvic floor muscle groups in different female
      pelvic disorders.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Contraction of pelvic floor muscle
time frame: Baseline
description: Chart review
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cathay General Hospital
investigator full name: Wen-Chen Huang
investigator title: Professor