<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/NCT03256565</url>
  </required_header>
  <id_info>
    <org_study_id>106060-E</org_study_id>
    <nct_id>NCT03256565</nct_id>
  </id_info>
  <brief_title>Q-tip Test and Urodynamic Study</brief_title>
  <official_title>Correlation Between Q-tip Test and Urodynamic Study in Women With Stress Urinary Incontinence</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>
      Urethral hypermobility, which can be assessed with Q-tip test, has been considered to be&#xD;
      partly responsible for pathogenesis of women with stress urinary incontinence (SUI).&#xD;
      Nonetheless, Q-tip test has lost favor due to patient discomfort. Thus, the purpose of this&#xD;
      study was to search a surrogate for assessment of urethral hypermobility by correlating the&#xD;
      Q-tip angle and the urodynamic variables in women with SUI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All women with SUI and underwent Q-tip testing were reviewed. Patient characteristics, degree&#xD;
      of prolapse determined by Pelvic Organ Prolapse Quantification system, Q-tip angle, the&#xD;
      results of urodynamic studies, the Urinary Distress Inventory (UDI-6) Questionnaire and&#xD;
      Incontinence Impact (IIQ-7) Questionnaire were reviewed from their medical records. Spearman&#xD;
      correlation test, and univariate and multivariate backward stepwise linear regression&#xD;
      analysis were performed as appropriate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Actual">October 5, 2019</completion_date>
  <primary_completion_date type="Actual">October 2, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlations of Q-tip angle with pressure transmission ratio</measure>
    <time_frame>Between 2014 and 2020</time_frame>
    <description>Correlations of Q-tip angle with pressure transmission ratio at maximum urethral pressure during stress urethral pressure profile testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlations of Q-tip angle with the other parameters of urodynamic studies</measure>
    <time_frame>Between 2014 and 2020</time_frame>
    <description>clinical and urodynamic variables include maximum flow rate, voided volume, post-void residual, voiding time, strong desire, PdetQmax, MUCP, functional profile length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlations of Q-tip angle with pad weight</measure>
    <time_frame>Between 2014 and 2020</time_frame>
    <description>Correlations of Q-tip angle with 20 min pad testing result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlations of Q-tip angle with symptoms</measure>
    <time_frame>Between 2014 and 2020</time_frame>
    <description>Correlations of Q-tip angle with questionnaires of urinary symptoms</description>
  </secondary_outcome>
  <enrollment type="Actual">176</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Q-tip test</intervention_name>
    <description>A Q-Tip lubricated with anesthetic gel is inserted into the urethra, woman is then asked to cough and strain, and the angle of the Q-tip rotates is recorded.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women with stress urinary incontinence&#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 both Q-tip testing and&#xD;
             urodynamic study, and completed the Urinary Distress Inventory (UDI-6) Questionnaire&#xD;
             and Incontinence Impact (IIQ-7) Questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women who had incomplete exam or questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>October 2019</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>October 19, 2019</last_update_submitted>
  <last_update_submitted_qc>October 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 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>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</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/NCT03256565
org study id: 106060-E
nct id: NCT03256565
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Urethral hypermobility, which can be assessed with Q-tip test, has been considered to be
      partly responsible for pathogenesis of women with stress urinary incontinence (SUI).
      Nonetheless, Q-tip test has lost favor due to patient discomfort. Thus, the purpose of this
      study was to search a surrogate for assessment of urethral hypermobility by correlating the
      Q-tip angle and the urodynamic variables in women with SUI.
All women with SUI and underwent Q-tip testing were reviewed. Patient characteristics, degree
      of prolapse determined by Pelvic Organ Prolapse Quantification system, Q-tip angle, the
      results of urodynamic studies, the Urinary Distress Inventory (UDI-6) Questionnaire and
      Incontinence Impact (IIQ-7) Questionnaire were reviewed from their medical records. Spearman
      correlation test, and univariate and multivariate backward stepwise linear regression
      analysis were performed as appropriate.
observational model: Case-Control
time perspective: Retrospective
measure: Correlations of Q-tip angle with pressure transmission ratio
time frame: Between 2014 and 2020
description: Correlations of Q-tip angle with pressure transmission ratio at maximum urethral pressure during stress urethral pressure profile testing
measure: Correlations of Q-tip angle with the other parameters of urodynamic studies
time frame: Between 2014 and 2020
description: clinical and urodynamic variables include maximum flow rate, voided volume, post-void residual, voiding time, strong desire, PdetQmax, MUCP, functional profile length
measure: Correlations of Q-tip angle with pad weight
time frame: Between 2014 and 2020
description: Correlations of Q-tip angle with 20 min pad testing result
measure: Correlations of Q-tip angle with symptoms
time frame: Between 2014 and 2020
description: Correlations of Q-tip angle with questionnaires of urinary symptoms
intervention type: Diagnostic Test
intervention name: Q-tip test
description: A Q-Tip lubricated with anesthetic gel is inserted into the urethra, woman is then asked to cough and strain, and the angle of the Q-tip rotates is recorded.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: Undecided