An observational study in Vulvodynia, sponsored by University of Minnesota. Completed. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by University of Minnesota · Observational
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.
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.
106 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's enrollment of 30,675 is above the median of 167 across 24 observational studies indexed under Vulvodynia.
Browse Vulvodynia studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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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
Exclusion Criteria:
Clinically-confirmed as a woman with no history of vulvodynia.
Other: Vulvodynia
Clinically-confirmed as a woman with vulvodynia.
Other: Vulvodynia
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.
Reproductive, gynecological and environmental exposures and their association with vulvodynia & immuno-inflammatory response
Determine whether reproductive, gynecological and environmental exposures influence the odds of vulvodynia, and whether the effect is associated with immuno-inflammatory response
Time frame: Baseline
Past psychological trauma and psychiatric morbidity and their association with vulvodynia & immuno-inflammatory response
Determine whether psychological trauma and psychiatric morbidity influence the odds of vulvodynia and whether the effect is associated with immuno-inflammatory response
Time frame: 6 month post baseline visit
immuno-inflammation and nerve fiber proliferation and vulvodynia.
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.
Time frame: Baseline
No study locations are listed for this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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