- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01700361
Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA) (VESPA)
May 30, 2017 updated by: Lori Brotto, University of British Columbia
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.
Study Overview
Status
Completed
Conditions
Detailed Description
HYPOTHESES:
- 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.
- 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.
- Investigators hypothesize that continuously measured subjective sexual arousal (via the arousometer) will correlate significantly with PFM EMG activity during the erotic film.
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Department of Gynaecology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 41 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Healthy females.
Description
Inclusion Criteria:
- Must be female, between the ages of 19-45
- Must be premenopausal
- Must be previously sexually active
- Must be fluent in English
Exclusion Criteria:
- Lack of fluency in English
- Not female between the ages of 19-45
- Not previously sexually active
- Any previous deliveries, either vaginal or by c-section
- Any sexual arousal disorder
- Any genital pain or pelvic pain disorders
- Any bowel or bladder syndromes (e.g. interstitial cystitis, irritable bowel disease, Chron's disease)
- Any urinary incontinence or pelvic organ prolapse
- Undergone medically induced menopause
- Undergone total or partial hysterectomy
- Undergone surgery for incontinence or prolapse
- Using estrogen suppression medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
|
No treatment
This is an observational study.
Women in this study are not receiving any treatments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic floor muscle sEMG activity
Time Frame: This study involves 1 testing session approximately 20 minutes in duration
|
Changes in pelvic floor muscle activity in responsive to exposure to explicit sexual stimuli will be assessed using pelvic floor surface electromyography (sEMG).
|
This study involves 1 testing session approximately 20 minutes in duration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual Arousal
Time Frame: This study involves 1 testing session approximately 20 minutes in duration
|
Self-report sexual arousal will be measured with the Sexual Arousability Inventory (SAI ; Hoon, Hoon, & Wincze, 1976)
|
This study involves 1 testing session approximately 20 minutes in duration
|
|
Sexual Function
Time Frame: This study involves 1 testing session approximately 20 minutes in duration
|
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).
|
This study involves 1 testing session approximately 20 minutes in duration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lori A. Brotto, PhD, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
August 27, 2012
First Submitted That Met QC Criteria
October 1, 2012
First Posted (Estimate)
October 4, 2012
Study Record Updates
Last Update Posted (Actual)
June 1, 2017
Last Update Submitted That Met QC Criteria
May 30, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H12-01852
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sexual Arousal
-
Kern Pharma, S.L.Analysis and Research Network, S.LUnknownFemale Sexual Arousal DisorderSpain
-
University of Texas at AustinCompletedFemale Sexual Arousal DisorderUnited States
-
Biozeus Biopharmaceutical S.A.Not yet recruitingFemale Sexual Arousal Disorder | Female Sexual Dysfunction (FSD)Brazil
-
Dalhousie UniversityUniversity of British Columbia; Université de MontréalRecruitingSexual Interest/Arousal DisorderCanada
-
Biozeus Biopharmaceutical S.A.RecruitingFemale Sexual Dysfunction | Female Sexual Arousal DisorderBrazil
-
Procare Health Iberia S.L.WithdrawnFemale Sexual Interest/Arousal DisorderSpain
-
Radboud University Medical CenterCompletedArousal Disorders, SexualNetherlands
-
University of British ColumbiaCompletedLow Female Sexual Arousal | Low Female Sexual DesireCanada
-
University of Texas at AustinCompletedFemale Sexual Arousal DisorderUnited States
-
Cedars-Sinai Medical CenterTerminatedFemale Sexual Arousal DisorderUnited States