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/NCT06037226</url>
    </required_header>
    <id_info>
      <org_study_id>PekingUMCH-2021YFC20701303</org_study_id>
      <nct_id>NCT06037226</nct_id>
    </id_info>
    <brief_title>A National Observation Study on Pelvic Floor Dysfunction Diseases in China</brief_title>
    <official_title>A National Observation Study on Pelvic Floor Dysfunction Diseases Based on Electrophysiological Technology and a Newly Established Prevention and Treatment System in China</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>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this protocol, our team intend to conduct a nation-wide multicenter cohort research to&#xD;
        screening for PFD symptoms in early postnatal women in China. Beside clinically significant&#xD;
        symptoms, we will also measure the recovery trend of pelvic muscle function, aiming to&#xD;
        determine the clinically significant alterations that are sensitive to predict the PFD risks.&#xD;
        This is an observational prospective cohort study, following a natural regular clinical visit&#xD;
        process. Patients will voluntarily decide whether to receive PFD related treatments and the&#xD;
        types of treatments to adopt. Therefore, we will also be able to compare the effectiveness of&#xD;
        treatments.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">February 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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Urinary incontinence</measure>
      <time_frame>6 months</time_frame>
      <description>UI will be diagnosed via gynecological examination and self-reported symptoms</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pelvic organ prolapse</measure>
      <time_frame>6 months</time_frame>
      <description>Physical examinations will be performed to diagnose the incidence and degree of organ prolapse (i.e. anterior vaginal wall prolapse, posterior vaginal wall prolapse, uterine prolapse, and vaginal apex prolapse) according to the Pelvic Organ Prolapse Quantification (POP-Q).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Pelvic muscle function</measure>
      <time_frame>6 months</time_frame>
      <description>In palpation, pelvic floor muscle strength will be graded based on the Oxford Muscle Scale and Electronic-muscle strength Medical Record system</description>
    </other_outcome>
    <enrollment type="Anticipated">10000</enrollment>
    <condition>Pelvic Floor Dysfunction</condition>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Postpartum pelvic floor rehabilitation</intervention_name>
      <description>biofeedback with Pelvic floor muscle training (PFMT)</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All adult women in early postnatal period, 42 days+15 days after delivery, are eligible to&#xD;
          participate.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Postpartum women: 42 days+15 days after delivery&#xD;
  &#xD;
            2. Age:20-45&#xD;
  &#xD;
            3. Consent to participate in the research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Refuse gynecological and/or obstetrical examinations.&#xD;
  &#xD;
            2. Diagnosed with psychiatric disorders&#xD;
  &#xD;
            3. Diagnosed with other severe illnesses&#xD;
  &#xD;
            4. Received pelvic floor treatments&#xD;
  &#xD;
            5. Other factors that may confound with the research&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>October 2022</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pelvic floor dysfunction, postpartum women</keyword>
    <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/NCT06037226
  org study id: PekingUMCH-2021YFC20701303
  nct id: NCT06037226
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In this protocol, our team intend to conduct a nation-wide multicenter cohort research to
        screening for PFD symptoms in early postnatal women in China. Beside clinically significant
        symptoms, we will also measure the recovery trend of pelvic muscle function, aiming to
        determine the clinically significant alterations that are sensitive to predict the PFD risks.
        This is an observational prospective cohort study, following a natural regular clinical visit
        process. Patients will voluntarily decide whether to receive PFD related treatments and the
        types of treatments to adopt. Therefore, we will also be able to compare the effectiveness of
        treatments.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Urinary incontinence
  time frame: 6 months
  description: UI will be diagnosed via gynecological examination and self-reported symptoms
  measure: Pelvic organ prolapse
  time frame: 6 months
  description: Physical examinations will be performed to diagnose the incidence and degree of organ prolapse (i.e. anterior vaginal wall prolapse, posterior vaginal wall prolapse, uterine prolapse, and vaginal apex prolapse) according to the Pelvic Organ Prolapse Quantification (POP-Q).
  measure: Pelvic muscle function
  time frame: 6 months
  description: In palpation, pelvic floor muscle strength will be graded based on the Oxford Muscle Scale and Electronic-muscle strength Medical Record system
  intervention type: Behavioral
  intervention name: Postpartum pelvic floor rehabilitation
  description: biofeedback with Pelvic floor muscle training (PFMT)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor
  sharing ipd: No