Women's Health Study: Immunological Factors and Risk of Vulvodynia
Condition: Vulvodynia
MeSH terms: Vulvodynia
Study type: Observational

Summary: 
      The investigators plan to study the etiology of vulvodynia, a condition characterized by
      chronic vulvar discomfort, most often described as burning pain, occurring in the absence of
      relevant visible findings or a specific, clinically identifiable, neurologic disorder. Our
      hypothesis is that vulvodynia is the result of an altered immuno-inflammatory response
      mechanism that occurs as a consequence of reproductive, gynecologic, environmental, or
      psychological exposures, with abnormal vaginal microflora and genetic polymorphisms as
      potential modifiers of the effects of interest. Therefore, the investigators propose to
      collect information about reproductive, gynecological and environmental exposures,
      psychological trauma and psychiatric morbidity, and biological markers of immuno-inflammation
      and nerve fiber proliferation.
    

Detailed description: 
      Women aged 18-40 years who were seen for any reason within a 2-year period at one of the Twin
      Cities metro-area's Fairview Health Services outpatient clinics will be send a confidential
      self-administered questionnaire, and given the option to return it by mail, or complete it
      via phone or via a secure online server. This questionnaire will serve to determine any
      history of unexplained vulvar pain. Those with a history of past or current vulvar pain
      likely to represent vulvodynia, will be asked to come to one of four study clinic locations
      to confirm the diagnosis of vulvodynia. If confirmed, they will be asked to provide venous
      blood and vulvovaginal specimens. In addition, they will be asked to complete a medical
      history and psychosocial survey, along with an interviewer-administered Structured Clinical
      Interview for the Diagnostic and Statistical Manual-IV (SCID-IV). A random sample of women
      with no history of vulvar pain will be asked to serve as controls. Those confirmed as
      controls will also be asked to provide the same biological specimens and complete the same
      questionnaires/interview.

      The long-term objective of this research is to provide etiological information that may prove
      critical to the treatment and prevention of vulvodynia, an under-recognized and extremely
      debilitating condition that we and others have shown may affect up to 10% of the adult female
      population.
    

Intervention name(s): Vulvodynia
Intervention type(s): Other
Intervention description(s): Comparison of reproductive, gynecological and environmental exposures, psychological trauma and psychiatric morbidity, and biological markers of immuno-inflammation and nerve fiber proliferation between cases and controls to determine potential etiology of vulvodynia.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women aged 18-40 years who were seen for any reason within a 2-year period at one of the
        metro-area's Fairview Health Services outpatient clinics
      
Biospecimen description: 
      Venous Blood and Vulvar punch biopsy