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Sponsored by: |
University of British Columbia |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00278850 |
The purpose of this study is to investigate the efficacy of an educational seminar series for women with vulvar vestibulitis syndrome (VVS).
Condition | Intervention |
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Vulvar Vestibulitis |
Behavioral: Educational |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | "Vestibulitis Educational Seminar Trial" Study |
Enrollment: | 500 |
Study Start Date: | January 2006 |
Study Completion Date: | March 2009 |
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
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
women diagnosed with vulvar vestibulitis
Inclusion Criteria:
Exclusion Criteria:
Canada, British Columbia | |
Vancouver Hospital | |
Vancouver, British Columbia, Canada, V5Z 1M9 |
Principal Investigator: | Lori A Brotto, PhD | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Lori Brotto ) |
Study ID Numbers: | C05-0592 |
Study First Received: | January 16, 2006 |
Last Updated: | May 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00278850 History of Changes |
Health Authority: | Canada: Health Canada |
Vulvar vestibulitis Treatment Education |
Genital Diseases, Female Vulvar Vestibulitis Vulvar Vestibulitis Syndrome Vulvar Diseases |
Genital Diseases, Female Vulvar Vestibulitis Vulvitis Vulvar Diseases |