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"Vestibulitis Educational Seminar Trial" Study

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ClinicalTrials.gov Identifier: NCT00278850
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : June 15, 2015
Information provided by (Responsible Party):
Lori Brotto, University of British Columbia

Brief Summary:
The purpose of this study is to investigate the efficacy of an educational seminar series for women with vulvar vestibulitis syndrome (VVS).

Condition or disease Intervention/treatment
Vulvar Vestibulitis Behavioral: Educational

Detailed Description:

HYPOTHESIS: It is hypothesized that this educational seminar series might be effective in reducing the pain experienced and improving sexual response and quality of life of women with Vulvar Vestibulitis Syndrome (VVS) by providing an open forum for discussion of the pathology, etiological theories, treatment plans as well as the impact of sexual pain on sexual relationships and ways to cope with VVS.

At Vancouver Hospital, the current waitlist for women with distressing, unremitting genital pain is approximately 10 months. Once accepted for management, the diagnosis of VVS is given, where applicable, by Dr. Sadownik. Only women with pure VVS and without a compounding skin condition are then referred on to the 3-session educational seminars given by Dr. Thomson. By the end of the educational series, women have an understanding of current scientific literature on etiology and treatment of VVS, and it's interaction with sexual health factors. At this point they are referred for individualized treatment of the VVS either by Dr. Thomson, Dr. Sadownik or back to their referring physician. This study aims to explore the existing VVS Educational Seminars by measuring sexual function, sexual distress, pain levels (general pain, genital pain and pain upon sexual activity), psychological well-being (depression and anxiety), relationship satisfaction, sexual knowledge and overall quality of life at pre- and post seminar. An age-matched control group of women diagnosed with VVS, but unable to attend the Seminar series, will complete the measures at the same intervals as the treatment group. The use of the control group allows us to accurately evaluate the efficacy of the Educational seminars, above and beyond non-specific factors.

Vulvar Vestibulitis Syndrome Educational Seminars have been run through the Vulvar Disease Clinic at Vancouver Hospital since 2001, however no data has been collected to determine the effects of this program. By collecting pre- & post seminar and follow up data, this study will allow us to assess the efficacy of the VVS Educational Seminars when compared to a group of women suffering from VVS but unable to attend the information seminars. Given that a large proportion of the women cannot be treated at Vancouver Hospital and are instead referred back to their family physician, the VVS Educational Seminar is a necessary first step in the treatment process for ensuring that women receive accurate and timely treatment. It will also help treatment providers improve and expand their current treatment practices

Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: "Vestibulitis Educational Seminar Trial" Study
Study Start Date : January 2006
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Behavioral: Educational
    three 1 hour long educational seminars

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women diagnosed with vulvar vestibulitis

Inclusion Criteria:

  • Women who meet the diagnostic criteria for VVS by the Vancouver Hospital Vulvar Disease Clinic
  • Women who have been referred to VVS Educational Seminars at Vancouver Hospital
  • Proficient in English

Exclusion Criteria:

  • Any women referred to the VVS Educational Seminars will be eligible for participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278850

Canada, British Columbia
Vancouver Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Lori A Brotto, PhD University of British Columbia

Bergeron, S., Binik, YM., Khalifé, S., Meana, M., Berkely, KJ. & Pagidas, K. (1997). The treatment of vulvar vestibulitis syndrome: Towards a multimodal approach. Sexual & Marital Therapy, 12(4), 305-311.
Pukall, C.F., Payne, K.A., Kao, A., Khalife, S. & Binik, Y.M. (2005). Dyspareunia. In R. Balon & R.T. Segraves, (Ed.s), Handbook of Sexual Dysfunction (pp. 249-272). New York: Taylor and Francis.
ter Kuile, MM. & Weijenborg, ThM, (2003). A cognitive behavioural group treatment programme for women with vulvar vestibulitis syndrome: factors associated with treatment success. Sexual Pain Disorders Symposium, Amsterdam, Holland, Oct. 20-24, 2003.

Responsible Party: Lori Brotto, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT00278850     History of Changes
Other Study ID Numbers: C05-0592
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015

Keywords provided by Lori Brotto, University of British Columbia:
Vulvar vestibulitis

Additional relevant MeSH terms:
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female