<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/NCT03800615</url>
  </required_header>
  <id_info>
    <org_study_id>107183-C</org_study_id>
    <nct_id>NCT03800615</nct_id>
  </id_info>
  <brief_title>Iatrogenic Impairment of Urethral Coitus Owing to Midurethral Sling Procedure in a Woman With Vaginal Agenesis.</brief_title>
  <official_title>Iatrogenic Impairment of Urethral Coitus Owing to Midurethral Sling Procedure in a Woman With Vaginal Agenesis.</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>
      To report a case of impairment urethral coitus after the midurethral sling procedure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To report a case of impairment urethral coitus after the midurethral sling procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sexual function</measure>
    <time_frame>1 year</time_frame>
    <description>Asking the patient whether she can resume sexual intercourse or not after surgery</description>
  </primary_outcome>
  <enrollment type="Actual">1</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <condition>Vaginal Agenesis</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cut the sling</intervention_name>
    <description>Cut the mid-urethral sling for stress urinary incontinence</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A 59-year-old woman had previous history of hysterectomy due to nonfunctional uterine&#xD;
        obstruction at 19 years old and urinary incontinence status post transvaginal tape&#xD;
        procedure at 45 years old with clinical symptoms of difficulty in urethral coitus after&#xD;
        midurethral sling procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  midurethral sling procedure for stress urinary incontinence&#xD;
&#xD;
          -  woman with vaginal agenesis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nil&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <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>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>March 6, 2019</last_update_submitted>
  <last_update_submitted_qc>March 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2019</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</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 Incontinence, Stress</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03800615
org study id: 107183-C
nct id: NCT03800615
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To report a case of impairment urethral coitus after the midurethral sling procedure
To report a case of impairment urethral coitus after the midurethral sling procedure.
observational model: Case-Only
time perspective: Retrospective
measure: Sexual function
time frame: 1 year
description: Asking the patient whether she can resume sexual intercourse or not after surgery
intervention type: Procedure
intervention name: Cut the sling
description: Cut the mid-urethral sling for stress urinary incontinence
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
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, Department of Obstetrics & Gynecology
mesh term: Urinary Incontinence
mesh term: Urinary Incontinence, Stress
mesh term: Congenital Abnormalities
sharing ipd: Undecided