Sexual ArousalVESPANCT01700361
Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA)
An observational study of Sexual Arousal, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Arousal
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy females.
Who may be able to join
- Must be female, between the ages of 19-45
- Must be premenopausal
- Must be previously sexually active
- Must be fluent in English
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sexual Arousal
- Keywords
- sexual arousal, pelvic floor sEMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | This is an observational study. Women in this study are not receiving any treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle sEMG activity
Changes in pelvic floor muscle activity in responsive to exposure to explicit sexual stimuli will be assessed using pelvic floor surface electromyography (sEMG).
Measured: This study involves 1 testing session approximately 20 minutes in duration
Secondary outcomes (2)
Sexual Arousal
Self-report sexual arousal will be measured with the Sexual Arousability Inventory (SAI ; Hoon, Hoon, \& Wincze, 1976)
Measured: This study involves 1 testing session approximately 20 minutes in duration
Sexual Function
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).
Measured: This study involves 1 testing session approximately 20 minutes in duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ArousalStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
- Investigators
- Lori A. Brotto, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700361
- Sponsor's protocol ID
- H12-01852
- Acronym
- VESPA
- Status last verified
- May 2017
- First submitted
- 27 Aug 2012
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA)
- ClinicalTrials.gov ID
- NCT01700361
- Acronym / sponsor ID
- VESPA / H12-01852
- Conditions
- Sexual Arousal
- Keywords
- sexual arousal, pelvic floor sEMG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –This is an observational study. Women in this study are not receiving any treatments. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy females.
Key inclusion criteria (4 listed)
- Must be female, between the ages of 19-45
- Must be premenopausal
- Must be previously sexually active
- Must be fluent in English
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Sexual Arousal
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- UBC Sexual Health Lab WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A. Brotto, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Arousal, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle sEMG activity (time frame: This study involves 1 testing session approximately 20 minutes in duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.