Vulvodynia Research Studies: National Institutes of Health

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Vulvodynia Research Studies National Institutes
of Health
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VulvodyniaClinical Study

• UMDNJ-
• Robert Wood
• Johnson Medical
• School
• Womens Health
• Institute

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Vulvodynia clinical study Research
Questions

• Characterize demographics and epidemiologic
  aspects of vulvodynia
• Examine efficacy of popularly prescribed
  interventions for vulvodynia in a rigorously
  controlled environment

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Vulvodynia clinical studyCurrent Research Design

• Phase 1 Survey study to evaluate chronic
  gynecologic pain in a central New Jersey
  population of women
• Phase 2 Diet intervention of low oxalate vs. low
  fat/high fiber diet
• Phase 3 Three-arm treatment intervention study
• Self management Intervention
• Tricyclic antidepressant (TCA)
• Combination TCA and topical steroid
• Phase 4 National survey to evaluate chronic
  gynecologic pain
• Phase 5 International Meeting for Data
  Dissemination

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Vulvodynia Clinical Study Phase 1 Data
(Central New Jersey Survey)

• 1794 questionnaires mailed
• 37 response rate
• 21 positive for chronic gynecologic pain
• 13.5 positive for vulvodynia-type pain

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Vulvodynia Clinical StudyPhase 1 Preliminary
Data

• Vulvodynia responders
• 49.6 years (average age)
• 86.4 of responders-white
• OCP use not associated with increased risk

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Vulvodynia Clinical StudySubject Inclusion
Criteria for Phases
2 and 3

• Ages 18 to 80 years
• Vulvar pain present for at least 6 months
• Vulvar symptoms of pain, itching, burning and/or
  tenderness of the vulva
• No active vulvovaginal infection
• May not be on TCA for Phase 3 of the study

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Vulvodynia Clinical Study Phase
2 Dietary Intervention

• Visit 1A- Subject completes informed consent and
  questionnaires
• Visit 1B- Pelvic exam, blood and urine tests.
  Subject gets pain and symptom intensity
  questionnaires and diet diaries

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Vulvodynia Clinical Study
Phase 2 Dietary Intervention

• Visit 2- Pain, symptom, diet data collected.
  Subjects randomly assigned to one of the two
  study diets
• Visit 3-Depending on the response, subject may
  continue the diet for another 6 weeks or return
  in 2 weeks for entry into the Phase 3 of the
  study

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Vulvodynia Clinical Study Phase 3

• Goal
• To compare the response of subjects with vulvar
  pain to one of three interventions in a 12 week
  randomized study

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Vulvodynia Clinical Study Phase 3

• Three-arm treatment intervention study
• Tricyclic antidepressant (TCA)
• Combination TCA and topical steroid
• Self Management Intervention

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Vulvodynia Clinical StudyPhase 3

• Visit 1 After informed consent signed, subject
  randomized to one of three intervention groups
• Visit 2 (Week 6) Review of diaries, medication,
  and side effects. Pelvic exam done, medication
  adjusted and diaries dispensed
• Visit 3 (Week 12) A pelvic exam done and subject
  fills out several questionnaires

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Vulvodynia Clinical Study
Phase 3 Two Pharmacologic Interventions

• Two pharmacologic interventions
• Oral tricyclic antidepressant (amitriptyline)-
  10mg at bedtime may be increased to 20 mg daily
• Topical corticosteroid (triamcinolone acetonide)
  applied in evening for first 4 weeks and Oral
  tricyclic antidepressant (amitriptyline)
  prescribed as above.

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Vulvodynia Clinical Study Phase
3 Self Management Intervention

• Subjects attend weekly meetings for twelve weeks
• Meetings conducted by psychologist and physical
  therapist/nurse practitioner
• Up to six subjects per group

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Vulvodynia Clinical Study
Phase 3 Self Management Intervention

• Weekly meetings provide information about
• Causes of vulvar pain
• Role of stress
• Helpful interventions taught
• Other contributing factors
• Relaxation, methods of stress reduction, self
  massage and sexual therapy techniques reviewed

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Vulvodynia Conclusion

• Vulvodynia is a chronic pain condition-
  prevalence underestimated in the female
  population
• Diagnosis difficult due to poorly defined
  diagnostic criteria.
• Other etiologies must be excluded before
  vulvodynia diagnosis

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VulvodyniaFor Further Information

• Contact
• UMDNJ-Robert Wood Johnson Medical School
• Womens Health Institute
• email whiinfo_at_umdnj.edu
• 732-235-7799 or 732-235-7965
• National Vulvodynia Association
• www.nva.org
• 301-299-0775
• Vulvar pain foundation
• www.vulvarpainfoundation.org
• 336-226-0704