<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/NCT01683890</url>
  </required_header>
  <id_info>
    <org_study_id>SBSFSH</org_study_id>
    <nct_id>NCT01683890</nct_id>
  </id_info>
  <brief_title>Study on Bladder and Sexual Function Change After Simple Hysterectomy</brief_title>
  <official_title>Incidence and Pattern of Overactive Bladder Symptoms Occurring After Hysterectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the incidence and pattern of bladder symptoms and sexual function change occuring&#xD;
      after simple hysterectomy and to analyze the influence of bladder symptoms and sexual&#xD;
      function change on quality of life of patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</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>Incidence of bladder symptoms</measure>
    <time_frame>within 6 months after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pattern change of bladder symptoms after surgery</measure>
    <time_frame>Baseline and within 6 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual function change</measure>
    <time_frame>Baseline and within 6 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>within 6 months aftr surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Benign Uterine Disease</condition>
  <arm_group>
    <arm_group_label>Simple hysterectomy group</arm_group_label>
    <description>Patients will undergo simple hysterectomy due to benign uterine disease.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patinets who undergo simple hysterectomy due to benign uterine disease at university&#xD;
        hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who is planed to undergo simple hysterectomy due to benign uterine disease&#xD;
&#xD;
               1. Uterine leiomyoma&#xD;
&#xD;
               2. Uterine adenomyosis&#xD;
&#xD;
               3. Endometrial hyperplasia&#xD;
&#xD;
               4. Cervical intraepithelial neoplasia (including carcinoma in situ, FIGO stage IA1&#xD;
                  cancer)&#xD;
&#xD;
               5. Dysfunctional uterine bleeding&#xD;
&#xD;
               6. Other benign uterine disease requiring hysterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are taking medication for overactive bladder&#xD;
&#xD;
          -  Patients who underwent incontinence surgery due to urinary incontinence&#xD;
&#xD;
          -  Acute or chronic infectious disease of urinary tract&#xD;
&#xD;
          -  Neurologic disease causing urinary abnormality&#xD;
&#xD;
          -  Previous pelvic radiation therapy&#xD;
&#xD;
          -  Patients who are undergoing incontinence surgery with hysterectomy&#xD;
&#xD;
          -  Pregnant woman&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee-Dong Chae, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>May 27, 2017</last_update_submitted>
  <last_update_submitted_qc>May 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Hee-Dong Chae</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Bladder symptoms</keyword>
  <keyword>Sexual function</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Simple hysterectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Diseases</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/NCT01683890
org study id: SBSFSH
nct id: NCT01683890
lead sponsor: 
collaborator: 
has dmc: No
To evaluate the incidence and pattern of bladder symptoms and sexual function change occuring
      after simple hysterectomy and to analyze the influence of bladder symptoms and sexual
      function change on quality of life of patients.
observational model: Cohort
time perspective: Prospective
measure: Incidence of bladder symptoms
time frame: within 6 months after surgery
measure: Pattern change of bladder symptoms after surgery
time frame: Baseline and within 6 months after surgery
measure: Sexual function change
time frame: Baseline and within 6 months after surgery
measure: Quality of life
time frame: within 6 months aftr surgery
arm group label: Simple hysterectomy group
description: Patients will undergo simple hysterectomy due to benign uterine disease.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hee-Dong Chae, M.D., Ph.D.
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Hee-Dong Chae
investigator title: Professor
mesh term: Uterine Diseases