Visual Erotica, EMG, and Sexual Psychophysiological Arous... | NCT01700361

Studies
Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA)

NCT01700361

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Jun 1, 2017Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Sexual Arousal

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Aug 27, 2012

First Submission Date that Met QC Criteria

Oct 1, 2012

First Posted Date

Oct 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2017

Last Update Posted Date

Jun 1, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lori Brotto, Principal Investigator, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No treatment		This is an observational study. Women in this study are not receiving any treatments.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	This study involves 1 testing session approximately 20 minutes in duration

Secondary Outcomes

Measure	Description	Time Frame
Sexual Arousal	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Healthy females.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lori A. Brotto, PhD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gynaecology		Vancouver	British Columbia	V5Z 1M9	Canada