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

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

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

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

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

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

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

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

Vulvodynia Clinical Study: Phase 3 Three-arm treatment intervention study: Tricyclic antidepressant (TCA) Combination TCA and topical steroid Self Management Intervention

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

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.

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

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

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

Vulvodynia: For Further Information Contact: UMDNJ-Robert Wood Johnson Medical School Women’s Health Institute or National Vulvodynia Association Vulvar pain foundation