“Vestibulitis Educational Seminar Trial” Study

Brief Title

"Vestibulitis Educational Seminar Trial" Study

Official Title

"Vestibulitis Educational Seminar Trial" Study

Brief Summary

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

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




Condition

Vulvar Vestibulitis

Intervention

Educational


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

500

Start Date

January 2006

Completion Date

March 2009

Primary Completion Date

March 2009

Eligibility 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.
      

Gender

Female

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Lori A Brotto, PhD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00278850

Organization ID

C05-0592


Responsible Party

Principal Investigator

Study Sponsor

University of British Columbia


Study Sponsor

Lori A Brotto, PhD, Principal Investigator, University of British Columbia


Verification Date

June 2015