<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/NCT04412928</url>
  </required_header>
  <id_info>
    <org_study_id>109048-E</org_study_id>
    <nct_id>NCT04412928</nct_id>
  </id_info>
  <brief_title>Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure</brief_title>
  <official_title>Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure</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>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We will estimate the incidence of patients with overactive bladder syndrome after surgery and&#xD;
      explore related predictors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At present, around 30% of women with stress urinary incontinence have overactive bladder&#xD;
      syndrome after mid-urethral sling procedure. But its predictive factor is still unclear. We&#xD;
      will estimate the incidence of patients with overactive bladder syndrome after surgery and&#xD;
      explore related predictors. In addition, we will explore the cure rate and predictors of cure&#xD;
      of overactive bladder syndrome after the mid-urethral sling procedure for women with stress&#xD;
      urinary incontinence. The above results will be used as a reference for preoperative and&#xD;
      postoperative consultation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 13, 2020</start_date>
  <completion_date type="Actual">April 20, 2021</completion_date>
  <primary_completion_date type="Actual">March 12, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Factors affecting the presence of overactive bladder syndrome after mid-urethral sling procedure</measure>
    <time_frame>10 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors affecting cure of overactive bladder syndrome after mid-urethral sling procedure</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">591</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>mid-urethral sling procedure</intervention_name>
    <description>mid-urethral sling procedure</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All women with stress urinary incontinence who underwent mid-urethral sling procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women with stress urinary incontinence who underwent mid-urethral sling procedure&#xD;
             from January 01, 2008 to July 31, 2019 will be reviewed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing other gynecological operations at the same time, except for&#xD;
             cystoscopy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women with stress urinary incontinence</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei</state>
        <zip>22050</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 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 of Department of Obstetrics &amp; Gynecology, Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04412928
org study id: 109048-E
nct id: NCT04412928
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
We will estimate the incidence of patients with overactive bladder syndrome after surgery and
      explore related predictors.
At present, around 30% of women with stress urinary incontinence have overactive bladder
      syndrome after mid-urethral sling procedure. But its predictive factor is still unclear. We
      will estimate the incidence of patients with overactive bladder syndrome after surgery and
      explore related predictors. In addition, we will explore the cure rate and predictors of cure
      of overactive bladder syndrome after the mid-urethral sling procedure for women with stress
      urinary incontinence. The above results will be used as a reference for preoperative and
      postoperative consultation.
observational model: Cohort
time perspective: Retrospective
measure: Factors affecting the presence of overactive bladder syndrome after mid-urethral sling procedure
time frame: 10 year
measure: Factors affecting cure of overactive bladder syndrome after mid-urethral sling procedure
time frame: 10 years
intervention type: Procedure
intervention name: mid-urethral sling procedure
description: mid-urethral sling procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: women with stress urinary incontinence
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Sheng-Mou Hsiao
investigator title: Chief of Department of Obstetrics & Gynecology, Associate Professor
mesh term: Urinary Incontinence
mesh term: Urinary Bladder, Overactive
mesh term: Urinary Incontinence, Stress
sharing ipd: No