Women's Health Study: Immunological Factors and Risk of Vulvodynia

University of Minnesota (UMN)

Status: Completed

Conditions: Vulvodynia

Treatments: Other: Vulvodynia

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02404961

0907M69161

5R01HD058608 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30,675 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically confirmed vulvodynia
• Women with no history of vulvar discomfort and clinically confirmed as acceptably control.

Exclusion criteria

• Women with vulvar pain attributed to a known cause.
• Women with any active gynecological yeast, bacterial, or viral infection.

Trial design

30,675 participants in 2 patient groups

Control (no vulvodynia)

Description:

Clinically-confirmed as a woman with no history of vulvodynia.

Treatment:

Other: Vulvodynia

Vulvodynia Case

Description:

Clinically-confirmed as a woman with vulvodynia.

Treatment:

Other: Vulvodynia