xml: <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/NCT05987085</url>
    </required_header>
    <id_info>
      <org_study_id>WLPFD-PUMCH</org_study_id>
      <nct_id>NCT05987085</nct_id>
    </id_info>
    <brief_title>Medical Weight Loss on Pelvic Floor Dysfunction</brief_title>
    <acronym>WLPFD</acronym>
    <official_title>Effect of Medical Weight Loss on Pelvic Floor Dysfunction: a Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn about the effect of medical weight loss on&#xD;
        the symptom of pelvic floor dysfunction in obese and overweight women. The main question it&#xD;
        aims to answer is: whether medical weight loss improves symptoms of pelvic floor dysfunctions&#xD;
        in obese or overweight women.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Pelvic floor symptoms before and after medical weight loss</measure>
      <time_frame>At least half a year</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>To explore the related factors of symptom improvement in pelvic floor dysfunction</measure>
      <time_frame>At least half a year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To explore the improvement of quality of life before and after medical weight loss</measure>
      <time_frame>At least half a year</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Weight Loss</condition>
    <condition>Pelvic Floor Disorders</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Diet and exercise</intervention_name>
      <description>Routine intervention included diet control and exercise</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult women seeking medical weight loss&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 or higher&#xD;
  &#xD;
            -  BMI 24 kg/m2 or higher&#xD;
  &#xD;
            -  Willing to follow the weight loss plan set by the physician follow-up and complete&#xD;
               this study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Urinary tract infection or gynecologic reproductive system infection in the past month&#xD;
  &#xD;
            -  Treatment history of pelvic floor disorders&#xD;
  &#xD;
            -  Pregnancy or delivery in the past half year&#xD;
  &#xD;
            -  Women with severe systemic disease&#xD;
  &#xD;
            -  No follow-up conditions&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhijing Sun</last_name>
        <phone>19800312327</phone>
        <email>sunzhj2001@sina.com</email>
      </contact>
      <investigator>
        <last_name>Zhao Tian</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
      <investigator_full_name>Zhijing Sun</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pelvic Floor Disorders</mesh_term>
      <mesh_term>Body Weight</mesh_term>
      <mesh_term>Weight Loss</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05987085
  org study id: WLPFD-PUMCH
  nct id: NCT05987085
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the effect of medical weight loss on
        the symptom of pelvic floor dysfunction in obese and overweight women. The main question it
        aims to answer is: whether medical weight loss improves symptoms of pelvic floor dysfunctions
        in obese or overweight women.
  observational model: Cohort
  time perspective: Prospective
  measure: Pelvic floor symptoms before and after medical weight loss
  time frame: At least half a year
  measure: To explore the related factors of symptom improvement in pelvic floor dysfunction
  time frame: At least half a year
  measure: To explore the improvement of quality of life before and after medical weight loss
  time frame: At least half a year
  intervention type: Other
  intervention name: Diet and exercise
  description: Routine intervention included diet control and exercise
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking Union Medical College Hospital
  investigator full name: Zhijing Sun
  investigator title: Professor
  mesh term: Pelvic Floor Disorders
  mesh term: Body Weight
  mesh term: Weight Loss
  sharing ipd: No