<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/NCT01700361</url>
  </required_header>
  <id_info>
    <org_study_id>H12-01852</org_study_id>
    <nct_id>NCT01700361</nct_id>
  </id_info>
  <brief_title>Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA)</brief_title>
  <acronym>VESPA</acronym>
  <official_title>Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine whether measurement of pelvic floor muscle sEMG activity is&#xD;
      responsive to explicit sexual stimuli, and whether it correlates with self-reports of sexual&#xD;
      arousal in healthy women. Participants' vaginal, labial and anal sEMG readings will be&#xD;
      monitored during exposure to neutral, erotic and anxiety-provoking films. Participants will&#xD;
      also be required to provide subjective ratings of sexual arousal before and after each film.&#xD;
      If pelvic floor sEMG is validated as a psychophysiological measure, these findings may have&#xD;
      important clinical and research implications by providing a greater understanding of the&#xD;
      mechanisms involved in sexual arousal and for providing a relatively easy method of assessing&#xD;
      sexual arousal in a clinical or research setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HYPOTHESES:&#xD;
&#xD;
        1. Investigators hypothesize that, relative to the neutral films, PFM EMG activity will&#xD;
           significantly increase in response to the erotic film as measured by the labial, anal,&#xD;
           and vaginal EMG probes.&#xD;
&#xD;
        2. Investigators hypothesize that, relative to the anxiety-provoking film, PFM EMG activity&#xD;
           will significantly increase in response to the erotic film as measured by the labial,&#xD;
           anal, and vaginal EMG probes.&#xD;
&#xD;
        3. Investigators hypothesize that continuously measured subjective sexual arousal (via the&#xD;
           arousometer) will correlate significantly with PFM EMG activity during the erotic film.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic floor muscle sEMG activity</measure>
    <time_frame>This study involves 1 testing session approximately 20 minutes in duration</time_frame>
    <description>Changes in pelvic floor muscle activity in responsive to exposure to explicit sexual stimuli will be assessed using pelvic floor surface electromyography (sEMG).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sexual Arousal</measure>
    <time_frame>This study involves 1 testing session approximately 20 minutes in duration</time_frame>
    <description>Self-report sexual arousal will be measured with the Sexual Arousability Inventory (SAI ; Hoon, Hoon, &amp; Wincze, 1976)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Function</measure>
    <time_frame>This study involves 1 testing session approximately 20 minutes in duration</time_frame>
    <description>Self-reported sexual function will be measured using the Female Sexual Function Inventory (FSFI; Rosen et al., 2000) and the Derogatis Sexual Functioning Inventory (DSFI; Derogatis &amp; Melisaratos, 1979).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Sexual Arousal</condition>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <description>This is an observational study. Women in this study are not receiving any treatments.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy females.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be female, between the ages of 19-45&#xD;
&#xD;
          -  Must be premenopausal&#xD;
&#xD;
          -  Must be previously sexually active&#xD;
&#xD;
          -  Must be fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of fluency in English&#xD;
&#xD;
          -  Not female between the ages of 19-45&#xD;
&#xD;
          -  Not previously sexually active&#xD;
&#xD;
          -  Any previous deliveries, either vaginal or by c-section&#xD;
&#xD;
          -  Any sexual arousal disorder&#xD;
&#xD;
          -  Any genital pain or pelvic pain disorders&#xD;
&#xD;
          -  Any bowel or bladder syndromes (e.g. interstitial cystitis, irritable bowel disease,&#xD;
             Chron's disease)&#xD;
&#xD;
          -  Any urinary incontinence or pelvic organ prolapse&#xD;
&#xD;
          -  Undergone medically induced menopause&#xD;
&#xD;
          -  Undergone total or partial hysterectomy&#xD;
&#xD;
          -  Undergone surgery for incontinence or prolapse&#xD;
&#xD;
          -  Using estrogen suppression medication&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori A. Brotto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gynaecology</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.obgyn.ubc.ca/SexualHealth/</url>
    <description>UBC Sexual Health Lab Website</description>
  </link>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>May 30, 2017</last_update_submitted>
  <last_update_submitted_qc>May 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Lori Brotto</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sexual arousal</keyword>
  <keyword>pelvic floor sEMG</keyword>
  <!-- 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/NCT01700361
org study id: H12-01852
nct id: NCT01700361
lead sponsor: 
has dmc: No
This study will examine whether measurement of pelvic floor muscle sEMG activity is
      responsive to explicit sexual stimuli, and whether it correlates with self-reports of sexual
      arousal in healthy women. Participants' vaginal, labial and anal sEMG readings will be
      monitored during exposure to neutral, erotic and anxiety-provoking films. Participants will
      also be required to provide subjective ratings of sexual arousal before and after each film.
      If pelvic floor sEMG is validated as a psychophysiological measure, these findings may have
      important clinical and research implications by providing a greater understanding of the
      mechanisms involved in sexual arousal and for providing a relatively easy method of assessing
      sexual arousal in a clinical or research setting.
HYPOTHESES:

        1. Investigators hypothesize that, relative to the neutral films, PFM EMG activity will
           significantly increase in response to the erotic film as measured by the labial, anal,
           and vaginal EMG probes.

        2. Investigators hypothesize that, relative to the anxiety-provoking film, PFM EMG activity
           will significantly increase in response to the erotic film as measured by the labial,
           anal, and vaginal EMG probes.

        3. Investigators hypothesize that continuously measured subjective sexual arousal (via the
           arousometer) will correlate significantly with PFM EMG activity during the erotic film.
observational model: Other
time perspective: Cross-Sectional
measure: Pelvic floor muscle sEMG activity
time frame: This study involves 1 testing session approximately 20 minutes in duration
description: Changes in pelvic floor muscle activity in responsive to exposure to explicit sexual stimuli will be assessed using pelvic floor surface electromyography (sEMG).
measure: Sexual Arousal
time frame: This study involves 1 testing session approximately 20 minutes in duration
description: Self-report sexual arousal will be measured with the Sexual Arousability Inventory (SAI ; Hoon, Hoon, & Wincze, 1976)
measure: Sexual Function
time frame: This study involves 1 testing session approximately 20 minutes in duration
description: Self-reported sexual function will be measured using the Female Sexual Function Inventory (FSFI; Rosen et al., 2000) and the Derogatis Sexual Functioning Inventory (DSFI; Derogatis & Melisaratos, 1979).
arm group label: No treatment
description: This is an observational study. Women in this study are not receiving any treatments.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lori A. Brotto, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
url: http://www.obgyn.ubc.ca/SexualHealth/
description: UBC Sexual Health Lab Website
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Lori Brotto
investigator title: Principal Investigator