<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/NCT04416152</url>
  </required_header>
  <id_info>
    <org_study_id>109045-F</org_study_id>
    <nct_id>NCT04416152</nct_id>
  </id_info>
  <brief_title>Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function</brief_title>
  <official_title>Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      To get the impact of pelvic floor reconstruction surgery on lower urinary tract symptoms,&#xD;
      psychological distress and sexual function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the women's bladder function questionnaire of UDI-6</measure>
    <time_frame>10 years</time_frame>
    <description>Change of UDI-6 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the women's bladder function questionnaire of IIQ-7</measure>
    <time_frame>10 years</time_frame>
    <description>Change of IIQ-7 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of psychosomatic score</measure>
    <time_frame>1 year</time_frame>
    <description>Change of psychosomatic score between baseline and after pelvic reconstruction surgery, and higher scores mean a or worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Overactive Bladder Symptom Score</measure>
    <time_frame>1 year</time_frame>
    <description>Change of OABSS score between baseline and after pelvic reconstruction surgery. Score values 0-15, and higher scores mean a or worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of FSFI score</measure>
    <time_frame>1 year</time_frame>
    <description>Change of FSFI score between baseline and after pelvic reconstruction surgery. higher scores mean a or worse outcome.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pelvic reconstruction surgery</intervention_name>
    <description>Pelvic reconstruction surgeries, such as anterior/posterior colporrhaphy, sacrospinous ligament fixation, transvaginal mesh repair and sacrocolpopexy.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with pelvic organ prolapse, who will undergo or had undergo pelvic reconstruction&#xD;
        surgeries.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with pelvic organ prolapse, who will undergo pelvic reconstruction surgery&#xD;
&#xD;
          -  Women who had undergone pelvic reconstruction surgeries in our hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sheng-Mou Hsiao, MD</last_name>
    <phone>+886289667000</phone>
    <phone_ext>1818</phone_ext>
    <email>smhsiao2@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei</state>
        <zip>22050</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sheng-Mou Hsiao, M.D.</last_name>
      <phone>+886-2-89667000</phone>
      <phone_ext>1818</phone_ext>
      <email>smhsiao2@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Far Eastern Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Sheng-Mou Hsiao</investigator_full_name>
    <investigator_title>Chief, Department of Obstetrics &amp; Gynecology, Far Eastern Memorial Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</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/NCT04416152
org study id: 109045-F
nct id: NCT04416152
lead sponsor: 
is fda regulated drug: No
To get the impact of pelvic floor reconstruction surgery on lower urinary tract symptoms,
      psychological distress and sexual function.
observational model: Case-Only
time perspective: Other
measure: the women's bladder function questionnaire of UDI-6
time frame: 10 years
description: Change of UDI-6 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.
measure: the women's bladder function questionnaire of IIQ-7
time frame: 10 years
description: Change of IIQ-7 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.
measure: Change of psychosomatic score
time frame: 1 year
description: Change of psychosomatic score between baseline and after pelvic reconstruction surgery, and higher scores mean a or worse outcome.
measure: Change of Overactive Bladder Symptom Score
time frame: 1 year
description: Change of OABSS score between baseline and after pelvic reconstruction surgery. Score values 0-15, and higher scores mean a or worse outcome.
measure: Change of FSFI score
time frame: 1 year
description: Change of FSFI score between baseline and after pelvic reconstruction surgery. higher scores mean a or worse outcome.
intervention type: Procedure
intervention name: Pelvic reconstruction surgery
description: Pelvic reconstruction surgeries, such as anterior/posterior colporrhaphy, sacrospinous ligament fixation, transvaginal mesh repair and sacrocolpopexy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Sheng-Mou Hsiao, MD
phone: +886289667000
phone ext: 1818
email: smhsiao2@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Sheng-Mou Hsiao
investigator title: Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
mesh term: Lower Urinary Tract Symptoms