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

Vulvodynia Clinical Trial

Official title:

Immunological Factors and Risk of Vulvodynia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404961
• Other study ID #: 0907M69161
• Secondary ID: 5R01HD058608
• Status: Completed
• Start date: September 2009
• Est. completion date: December 2014

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30675
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vulvodynia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

References & Publications (4)

Harlow BL, Kunitz CG, Nguyen RH, Rydell SA, Turner RM, MacLehose RF. Prevalence of symptoms consistent with a diagnosis of vulvodynia: population-based estimates from 2 geographic regions. Am J Obstet Gynecol. 2014 Jan;210(1):40.e1-8. doi: 10.1016/j.ajog. — View Citation

Nguyen RH, Reese RL, Harlow BL. Differences in pain subtypes between Hispanic and non-Hispanic white women with chronic vulvar pain. J Womens Health (Larchmt). 2015 Feb;24(2):144-50. doi: 10.1089/jwh.2014.4892. Epub 2015 Jan 20. — View Citation

Nguyen RH, Turner RM, Rydell SA, Maclehose RF, Harlow BL. Perceived stereotyping and seeking care for chronic vulvar pain. Pain Med. 2013 Oct;14(10):1461-7. doi: 10.1111/pme.12151. Epub 2013 Jun 6. — View Citation

Nguyen RH, Turner RM, Sieling J, Williams DA, Hodges JS, Harlow BL. Feasibility of collecting vulvar pain variability and its correlates using prospective collection with smartphones. Pain Res Treat. 2014;2014:659863. doi: 10.1155/2014/659863. Epub 2014 Jun 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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	6 month post baseline visit
Primary	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.	Baseline