Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-31 @ 3:49 AM
Study NCT ID:
NCT01700361
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2012-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-30', 'studyFirstSubmitDate': '2012-08-27', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic floor muscle sEMG activity', 'timeFrame': '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).'}], 'secondaryOutcomes': [{'measure': 'Sexual Arousal', 'timeFrame': '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', 'timeFrame': '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).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sexual arousal', 'pelvic floor sEMG'], 'conditions': ['Sexual Arousal']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.obgyn.ubc.ca/SexualHealth/', 'label': 'UBC Sexual Health Lab Website'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'HYPOTHESES:\n\n1. 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.\n2. 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.\n3. Investigators hypothesize that continuously measured subjective sexual arousal (via the arousometer) will correlate significantly with PFM EMG activity during the erotic film.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy females.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be female, between the ages of 19-45\n* Must be premenopausal\n* Must be previously sexually active\n* Must be fluent in English\n\nExclusion Criteria:\n\n* Lack of fluency in English\n* Not female between the ages of 19-45\n* Not previously sexually active\n* Any previous deliveries, either vaginal or by c-section\n* Any sexual arousal disorder\n* Any genital pain or pelvic pain disorders\n* Any bowel or bladder syndromes (e.g. interstitial cystitis, irritable bowel disease, Chron's disease)\n* Any urinary incontinence or pelvic organ prolapse\n* Undergone medically induced menopause\n* Undergone total or partial hysterectomy\n* Undergone surgery for incontinence or prolapse\n* Using estrogen suppression medication"}, 'identificationModule': {'nctId': 'NCT01700361', 'acronym': 'VESPA', 'briefTitle': 'Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA)', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA)', 'orgStudyIdInfo': {'id': 'H12-01852'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment', 'description': 'This is an observational study. Women in this study are not receiving any treatments.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Department of Gynaecology', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Lori A. Brotto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lori Brotto', 'investigatorAffiliation': 'University of British Columbia'}}}}