<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/NCT03808974</url>
  </required_header>
  <id_info>
    <org_study_id>2018-4707</org_study_id>
    <nct_id>NCT03808974</nct_id>
  </id_info>
  <brief_title>An Educational Video to Improve Patient Comprehension of Midurethral Sling</brief_title>
  <official_title>An Educational Video to Improve Patient Comprehension of Midurethral Sling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Irvine</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 purpose of this research project is to test the effectiveness of a previsit educational&#xD;
      video designed to help women understand the risks and benefits of a midurethral sling for&#xD;
      treatment of stress urinary incontinence. A total of 38 participants will be recruited from&#xD;
      both the Urogynecology pre-operative clinic of the university of California, Irvine Medical&#xD;
      Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange&#xD;
      County. Participants will be randomized either to watch a 10 minute educational video&#xD;
      (intervention group) or read a standard handout describing the midurethral sling (control&#xD;
      group). Participants will then complete their pre-operative visit in the usual fashion.&#xD;
      Participants will complete a pre- and post- intervention knowledge questionnaire to assess&#xD;
      the primary outcome (change in knowledge before and after intervention). Participants will&#xD;
      repeat the knowledge questionnaire and complete validated questionnaires for satisfaction&#xD;
      with decision scale and decision regret at 2 and 6 weeks post-operative.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient knowledge questionnaire (investigator-created)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The change in participant knowledge as measured with a patient knowledge questionnaire. This questionnaire was created by the study investigators and piloted by physicians within our institutions. It was submitted to and approved by our IRB for use in this study. This is a 15-point questionnaire (true/false/unknown answer choices) in which 1 point is given for each correct response and 0 points given for incorrect or unanswered questions (minimum score: 0/15, maximum score: 15/15). The questions pertain to the risks, benefits, and procedure of the mid-urethral sling surgery. Higher scores indicate better participant knowledge. A subscale of mesh-related questions will also be examined. This subscale reports the participant knowledge pertaining to complications and procedural knowledge specific to the use of mesh in the mid-urethral sling. The scale of this subset ranges from 0/5 to 5/5, with higher scores indicating greater participant knowledge.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <condition>Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will be shown an educational video</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will be given an educational leaflet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational video</intervention_name>
    <description>Short educational video describing the mid-urethral sling procedure</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational leaflet</intervention_name>
    <description>Standard educational leaflet describing the mid-urethral sling procedure</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women scheduled for a mid-urethral sling for stress urinary incontinence with a&#xD;
             urogynecology provider at a participating hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  Non-English speaking or requiring interpreter assistance&#xD;
&#xD;
          -  Presence of cognitive dysfunction&#xD;
&#xD;
          -  Women receiving a repeat midurethral sling (not primary)&#xD;
&#xD;
          -  Women with a history of pelvic mesh complication (erosion, pain, history of mesh&#xD;
             excision)&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bhumy D Heliker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Irvine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Huynh, Phuong Linh Huynh</last_name>
    <phone>(714) 456-6155</phone>
    <email>plhuynh@uci.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92628</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>P Huynh</last_name>
      <phone>714-456-6155</phone>
      <email>plhuynh@hs.uci.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  </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/NCT03808974
org study id: 2018-4707
nct id: NCT03808974
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this research project is to test the effectiveness of a previsit educational
      video designed to help women understand the risks and benefits of a midurethral sling for
      treatment of stress urinary incontinence. A total of 38 participants will be recruited from
      both the Urogynecology pre-operative clinic of the university of California, Irvine Medical
      Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange
      County. Participants will be randomized either to watch a 10 minute educational video
      (intervention group) or read a standard handout describing the midurethral sling (control
      group). Participants will then complete their pre-operative visit in the usual fashion.
      Participants will complete a pre- and post- intervention knowledge questionnaire to assess
      the primary outcome (change in knowledge before and after intervention). Participants will
      repeat the knowledge questionnaire and complete validated questionnaires for satisfaction
      with decision scale and decision regret at 2 and 6 weeks post-operative.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Patient knowledge questionnaire (investigator-created)
time frame: 6 weeks
description: The change in participant knowledge as measured with a patient knowledge questionnaire. This questionnaire was created by the study investigators and piloted by physicians within our institutions. It was submitted to and approved by our IRB for use in this study. This is a 15-point questionnaire (true/false/unknown answer choices) in which 1 point is given for each correct response and 0 points given for incorrect or unanswered questions (minimum score: 0/15, maximum score: 15/15). The questions pertain to the risks, benefits, and procedure of the mid-urethral sling surgery. Higher scores indicate better participant knowledge. A subscale of mesh-related questions will also be examined. This subscale reports the participant knowledge pertaining to complications and procedural knowledge specific to the use of mesh in the mid-urethral sling. The scale of this subset ranges from 0/5 to 5/5, with higher scores indicating greater participant knowledge.
arm group label: Intervention
arm group type: Experimental
description: The intervention group will be shown an educational video
arm group label: Control
arm group type: Active Comparator
description: The control group will be given an educational leaflet
intervention type: Other
intervention name: Educational video
description: Short educational video describing the mid-urethral sling procedure
arm group label: Intervention
intervention type: Other
intervention name: Educational leaflet
description: Standard educational leaflet describing the mid-urethral sling procedure
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bhumy D Heliker, MD
role: Principal Investigator
affiliation: University of California, Irvine
last name: Huynh, Phuong Linh Huynh
phone: (714) 456-6155
email: plhuynh@uci.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Urinary Incontinence, Stress
sharing ipd: No