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

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.

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Key information

Conditions

Vulvodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vulvodynia

Other

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.

Primary outcomes

Reproductive, gynecological and environmental exposures and their association with vulvodynia & immuno-inflammatory response

Time frame: Baseline

Determine whether reproductive, gynecological and environmental exposures influence the odds of vulvodynia, and whether the effect is associated with immuno-inflammatory response
Past psychological trauma and psychiatric morbidity and their association with vulvodynia & immuno-inflammatory response

Time frame: 6 month post baseline visit

Determine whether psychological trauma and psychiatric morbidity influence the odds of vulvodynia and whether the effect is associated with immuno-inflammatory response
immuno-inflammation and nerve fiber proliferation and vulvodynia.

Time frame: Baseline

Determine whether markers of immuno-inflammation and nerve fiber proliferation are directly associated with the odds of vulvodynia, and, whether genetic and microbiological markers modify associations, as well as associations evaluated in aims 1 and 2 above.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Immunological Factors and Risk of Vulvodynia

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Apr 1, 2015
Registry last updated: Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed