Company. Relationship. Content Area. Glaxo Smith Kline. Speaker. Over Active Bladder, Herpes

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1 Conflict of Interest Disclosure R. Mimi Secor, MS, NP, FAANP I disclose the following financial relationships with commercial entities that produce health care-related products or services relevant to the content I am planning, developing, or presenting: Company Glaxo Smith Kline Relationship Speaker Content Area Over Active Bladder, Herpes Current Clinical Issues in Primary Care

2 Vaginitis Update 2009: Best Practice Approaches to Vaginitis and Vulvar Complaints R. Mimi Secor, MS, M.Ed, FNP-BC, FAANP Newton Wellesley ObGyn, Newton, Massachusetts Newton, Massachusetts 1 Vaginitis Objectives Discuss optimal diagnostic testing for vulvovaginitis 10 minutes Describe strategies t to prevent and treat t acute and chronic Bacterial Vaginosis (BV), Yeast (VVC) and Trichomoniasis - 10 minutes Discuss common vulvar dermatologic conditions including causes, diagnosis & treatment of selected conditions 10 minutes 2 Normal Flora of Healthy Vagina Lactobacilli ph 4.0 Estrogen STI protection Gardnerella Mycoplasmas anaerobes Mobiluncus Others 3 4 Vulvitis: Need to Clarify Vaginal, Cutaneous Yeast, Contact, Allergic, Other Vulvar Symptoms Irritants, over cleansing Allergens Condom allergy is rare Infections Genital Herpes Type 2 Skin conditions Lichen Simplex Chronicus/LSC Lichen Sclerosis / LS Lichen Planus / LP Other Eczema, atrophy, etc. 6

3 Vulvar Irritants, Allergens Personal or Family History of Skin Sensitivities? Soaps Pads Shaving Oral sex Spermicides Lubricants Underwear Dyes, fragrances Soap in undies Bubble baths Shampoo Hot tubs OTCs, Scripts Preservatives in these Over cleansing You name it... Fair skin Light hair Sensitive skin Skin conditions Family history Sensitive vulva 7 8 Vulvar Care Guidelines, Less is More Wash with warm water only: NO soap Use mineral oil, Vaseline, Crisco: to prevent & treat itching Avoid shaving, thong underwear and douching! Wear all cotton, white underwear (wide design) Wash underwear in very hot water Use ½ laundry soap, double rinse, do NOT hand wash Sleep without underwear, wear loose clothing Avoid sex if symptoms, pain, infection: for 1 week+ Use non-irritating lubricants: Standard KY, Silk-E, Intrigue, Astroglide, vegetable oils 9 Diagnosis of Vulvovaginitis Vaginal discharge: inaccurate Vaginal ph: sensitive, not specific KOH amine whiff test: for BV & yeast Vaginal microscopy: 60-80% accurate Affirm test: BV/gardnerella, yeast, trich Must clinically correlate, especially with BV Vaginal cultures: NOT recommended STI testing: as indicated Lowe NK et al. Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard. Obstet Gynecol 2009 Jan; 113:89. Findings: 64.5% clinical correlation with DNA testing, Trich highest, BV lowest 10 Clinical Presentation of VVC: Vulvovaginal Candidiasis ical diagnosis of vaginitis compared with a DNA probe laboratory standard. Obstet Gynecol 2009 Jan; 113:89. Findings: 64.5% clinical correlatio 11 12

4 Identifying Yeast Forms Diagnostic Tests for Chronic VVC If wet mount negative Order vaginal fungal culture & speciate 1 week for results, or longer Unlikely yeast if premenstrual symptoms because low estrogen suppresses yeast Secor RMC. Clinical Excellence for Nurse Practitioners. 1997;1: Order Herpes Select serology IGG type 2 To rule out genital herpes 14 First Episode of Recurrent Herpes Atypical symptoms common 1/5 Americans, ¼ women Always rule out Especially if premenstrual Even if relieved with yeast meds Suppression is effective Valacyclovir 500-1gm po daily Acyclovir 400mg po BID CDC, Suppressive Therapy for Chronic C. albicans: per Vaginal Fungal Culture with Speciation VAGINAL Topicals Intermittently : 2 weeks x 6 months Terconacole, clotrimazole, or other azole cream Miconazole, butaconazole/ Gynazole (non-c. albicans) Or ORAL: Fluconazole 150 mg oral Day 1, 3, 7, total 10 days Fungal culture negative, then 150 mg weekly x 6 months (Less effective for non-c. albicans) 2 week Test of cure w/ fungal culture, then monthly Sobel, NEJM 2004:351: Suppressive Therapy for Chronic Non-C. albicans: per Vaginal Fungal Culture & Speciation BV Miconazole, butaconazole/ Gynazole Boric acid suppositories pv qd x 14 days (600 mg), x2 weekly Max 6 months, safety/toxicity issues, AVOID oral & in Pregnancy Nystatin suppositories pv qd x 14 days (100,000 u), x2 weekly Safe, effective, no drug/drug, toxicity or pregnancy concerns Test of cure vaginal fungal culture 1-2 wk post-induction therapy then suppression treatment Maintenance 1-2 x weekly x 6 months+, slow taper 17 Lactobacilli Gardnerella vaginalis Genital mycoplasmas Anaerobes Mobiluncus spp 35 bacterial species 18

5 BV Linked to Increased Risk of ObGyn Complications STIs Herpes HSV-2 HPV GC and Chlamydia HIV PID and Infertility Cervicitis Cystitis Post-Gyn surgery and Postpartum infections Increases risk of Preterm delivery T T T - often and early Treat - effectively - of cure, 1-2 months 20 Diagnose BV per CDC 3 of 4 Amsel s Criteria Coaty, white discharge: must correlate w/other criteria Elevated ph > 4.5: sensitive but not specific Clinical Presentation of BV KOH amine whiff test: predictive Clue cells: predictive Pap & vaginal cultures: unreliable Affirm test: correlate with other criteria, ph, amine

6 NEW 2006 CDC Guidelines, Non-pregnant Recommended: Similar efficacy Metronidazole 500 mg orally bid x 7 days Metronidazole gel, 1 applic x 5 days Clindamycin cream 1 applic x 7 days Alternatives: ti Similar il efficacy to recommended d regimens Clindamycin 300 mg orally bid x 7 days Clindamycin Vaginal Ovules, 1 hs x 3 days Clindamycin 100 mg vaginal single dose No Longer Recommended: Due to low efficacy Metronidazole 2 gm orally single dose 25 Tinidazole/ Tindamax Recently FDA Approved for BV Regimens: 2 gm PO stat for 2 days = 27.4% cure rate 4/4 Amsel s criteria resolved, +Nugents = nl bacteria 1gmpoqdx5days= days 36.8% cure rate 4/4 criteria, +Nugents More favorable side effect profile compared to oral MTZ Expensive compared to oral MTZ (metronidazole) Category C in pregnancy and lactation No head to head trials CDC Guidelines for BV in Pregnancy* Recommended Metronidazole 500 mg orally twice a day for 7 days Metronidazole 250 mg orally TID for 7 days Clindamycin 300 mg orally twice a day for 7 days Other Regimens Clindamycin vaginal; may use in 1 st half of pregnancy to 20 wks Metronidazole vaginal; effective in 1 small study (Yudin 2003) BUT CDC doesn t give guidance on use in pregnancy! Clindamycin versus Metronidazole? Clindamycin more effectively treats: Gardnerella Mobiluncus Mycoplasma hominis Atopobium vaginae, gram + anaerobe If High risk for Preterm labor, Screen first Prenatal Consider Test of Cure 1 month post-treatment treatment *MTZ 250mg tid po & vaginal do NOT reduce risk of PTL per CDC 27 Ferris, J Cl Micr, Mar 2007:45(3)1016. Nyirjesy et al. STDs; 2006:33(9). 28 Chronic BV: How Common and How to Prevent? 30% recur in 1-3 months, 80% at 9 Months Follow-up Test of Cure 1 month Amsel s criteria Condoms 29 30

7 Randomized trial of Duration of Therapy with Oral Metronidazole plus/minus Azithromycin for Treatment of Symptomatic BV N 568 with 420 completing study, 4 arms Metronidazole 750mg po daily for 7 days OR 14 days With & without Azithromycin 1 gm day 1, day 3 Azithromycin made no difference in any group Cure rates with 14 day higher initially: 80% vs 64% BUT at 21 days post-rx (1 mo), cure rates similar 31 Schwebke & Desmond. Clinical Infect Dis Jan 15;44(2): Chronic Bacterial Vaginosis Longer therapy: double initial therapy Clindamycin may be more effective Test of Cure, 1 month post-therapytherapy 4 months intermittent vaginal therapy; x2 week Sobel et al, AJOG 2006;194: Use condoms, avoid douching Schwebke & Desmond. Clinical Infect Dis Jan 15;44(2): Possibly effective: no thongs, reduce stress, shorten menses, vitamin D (new research) Bodnar, L.. J Nutr ;139: NOT Effective: LB supplements, yogurt, ph acidifying agents, H2O2 douches, treating male partner 33 Diagnosing Trichomoniasis in Women T T T - often and early Treat - effectively - of cure, follow-up 35 Variable symptoms, discharge, itching Profuse yellow, green, gray/watery Elevated vaginal ph > 4.5 Neg whiff, amine test Active A i flagella ll movements on smear 60-70% accurate, Higher if read immediately Avoid hypersonic saline, or drying! Pap not reliable, correlate with ph/wet mount Affirm: moderately sensitive 36

8 Diagnosing Trich in Women: Negative Wet Mount, Must Confirm Lab Culture: Diamond s, In-Pouch TV, Trichosel GOLD STANDARD Sensitivity 95%, Specificity 99.8% 3 day lab process Osom Rapid Antigen Test by Genzyme In-office option (CLIA waived) Sensitivity 83%, Specificity 97% CDC STI Guidelines for Trichomoniasis First Line 1. Metronidazole 2 gms orally, partner same (Cat B) May be given in pregnancy Or NEW 2. Tinidazole/Tindamax 2 gm orally, partner same (Cat C) Alternative 3. Metronidazole, 500 mg orally BID for 7 days May be more effective in men Consult specialist or CDC at Tel Vulvitis: Complex Vaginal, Cutaneous Yeast, Contact, Allergic Non-neoplastic Epithelial Disorders Selected Conditions Vulvitis: Vaginitis: mixed, atrophic effects Contact, irritant, allergic, infectious, cutaneous yeast Sensitive skin, various skin conditions Lichen Simplex Chronicus /LSC Squamous Cell Hyperplasia /SCH, Eczema Lichen Sclerosis/ LS Lichen Planus/ LP Desquamative Inflammatory Vaginitis/ DIV 41 42

9 Lichen Simplex Chronicus (LSC) Skin Thickening from Scratch, Itch High Grade VIN Vulvar Intraepithelial Neoplasia Unclear etiology Pruritis, burning, pain Irritants, allergens, infections Appearance variable Vulvar KOH Vaginal yeast culture Biopsy, when in doubt! LSC Management: Scratch, Itch Cycle from Skin Thickening Diagnosis of Exclusion Eliminate irritants, allergens, etc. Vulvar care guidelines Treat yeast: vaginal and cutaneous External anti-fungal 3+ wks And intravaginal anti-fungal if needed x 2 weeks Topical steroids (avoid Lotrisone, Mycolog combo) Clobetazole 0.05% BID x 2 weeks, then taper Hydrocortisone ointment 1% OTC, bid prn Oral options Diphenhydramine/ Benadryl mg po hs Hydroxyzine /Atarax10-50 mg po hs 45 Lichen Planus Lacey, reticulated lesions Focal erythema Associated gum disease Mimics LSC, LS early Vulvar biopsy Subset DIV, Desquamative Inflammatory Vaginitis Manage same as LS Intravaginal steroids Anusol 25 mg pv x wks 10% hydrocortisone pv REFER to specialist T T T - often and early Treat - effectively - of cure, follow-up 47 48

10 Thank You R. Mimi Secor, MS, M.Ed, FNP-BC, FAANP 49

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