Immunological Factors and Risk of Vulvodynia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30,675
- 主要终点
- Reproductive, gynecological and environmental exposures and their association with vulvodynia & immuno-inflammatory response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinically confirmed vulvodynia
- •Women with no history of vulvar discomfort and clinically confirmed as acceptably control.
排除标准
- •Women with vulvar pain attributed to a known cause.
- •Women with any active gynecological yeast, bacterial, or viral infection.
结局指标
主要结局
Reproductive, gynecological and environmental exposures and their association with vulvodynia & immuno-inflammatory response
时间窗: 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
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点