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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01700361
Other study ID # H12-01852
Secondary ID
Status Completed
Phase N/A
First received August 27, 2012
Last updated May 30, 2017
Start date October 2012
Est. completion date February 2013

Study information

Verified date May 2017
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Department of Gynaecology Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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). This study involves 1 testing session approximately 20 minutes in duration