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Vulvodynia Research Studies: National Institutes of Health

Vulvodynia Research Studies: National Institutes of Health. Vulvodynia: Clinical Study. UMDNJ- Robert Wood Johnson Medical School Women’s Health Institute. Vulvodynia clinical study: Research Questions.

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Vulvodynia Research Studies: National Institutes of Health

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  1. Vulvodynia Research Studies: National Institutes of Health

  2. Vulvodynia:Clinical Study UMDNJ- Robert Wood Johnson Medical School Women’s Health Institute

  3. 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

  4. Vulvodynia clinical study:Current 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

  5. 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

  6. Vulvodynia Clinical Study:Phase 1: Preliminary Data Vulvodynia responders: • 49.6 years (average age) • 86.4% of responders-white • OCP use not associated with increased risk

  7. Vulvodynia Clinical Study:Subject 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

  8. 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

  9. 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

  10. 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

  11. Vulvodynia Clinical Study: Phase 3 Three-arm treatment interventionstudy: • Tricyclic antidepressant (TCA) • Combination TCA and topical steroid • Self Management Intervention

  12. Vulvodynia Clinical Study:Phase 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

  13. 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.

  14. 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

  15. 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

  16. 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

  17. Vulvodynia:For Further Information Contact: • UMDNJ-Robert Wood Johnson Medical School Women’s Health Institute email: whiinfo@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

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