"Vestibulitis Educational Seminar Trial" Study

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00278850
First received: January 16, 2006
Last updated: May 29, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention
Vulvar Vestibulitis
Behavioral: Educational

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: "Vestibulitis Educational Seminar Trial" Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Enrollment: 500
Study Start Date: January 2006
Study Completion Date: March 2009
Intervention Details:
    Behavioral: Educational
    three 1 hour long educational seminars
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

women diagnosed with vulvar vestibulitis

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278850

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

Publications:
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: Dr. Lori Brotto, University of British Columbia
ClinicalTrials.gov Identifier: NCT00278850     History of Changes
Other Study ID Numbers: C05-0592
Study First Received: January 16, 2006
Last Updated: May 29, 2009
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Vulvar vestibulitis
Treatment
Education

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

ClinicalTrials.gov processed this record on October 19, 2014