Vaginitis, PID, Unintended Pregnancy:

Sexually Related Diseases/Problems in Women: Vaginitis, PID, Unintended Pregnancy Sarah Guerry, MD Medical Director, LAC STDP UCLA April 22, 2009 Vaginitis: Scourge of the Secret Garden

Vaginitis What is it? Clinical syndrome caused by inflammation/ infection of the vagina Characterized by abnormal vaginal discharge Sometimes caused by an STD Vaginitis: Who Cares? Vaginal discharge is one of the most common symptoms among women of reproductive age around the world Most women experience vaginitis at least once

during their lives In the US, women spend $260 million annually in OTC anti-fungals, $100 million for douches and $60 million for other cosmetic vaginal preparations Vaginitis Etiologies Bacterial Vaginosis (BV) Trichomoniasis Vulvovaginal Candidiasis (VVC) Differential diagnosis: MCP from GC or CT Irritant Dermatitis Atrophic vaginitis

Foreign body UTI HSV Desquamative vaginitis Vaginitis Epidemiology Most common reason for doctors visit, ~10 million patient visits per year Of those: 40 -50% BV 20 -25% VVC 15 -20% Trichomonas

Co-infection common: 20 -30% Microbiology of the Vagina Vaginal epithelium sensitive to estrogen, which induces production of glycogen Lactobacillus spp. (normal flora) produce H2O2 and metabolize glycogen to lactic and acetic acid to keep pH at 3.8 - 4.2 Acidic pH and Lactobacillus spp. colonization inhibit overgrowth of vaginal pathogens If vaginal pH is increased, GNRs, anaerobes, yeast and Gardnerella colonize vagina

Normal Vaginal Physiology Characteristic discharge 1-4 ml fluid/24 hours White or transparent, thick, odorless Variation with cycle, OCPs, pregancy pH 4-4.5 Microscopy shows squamous cells with rare PMNs Factors Adversely Affecting Normal Vaginal Flora

Douching Antibiotic and antifungal therapy Hormonal changes: pregnancy, OCs Spermicides, lubricant Foreign bodies: tampons, IUD, diaphragm Intercourse, semen

Menses Effects of Estrogen Status on Vaginal Microflora Microbial loads are 100x lower in prepubertal and post-menopausal women compared to reproductive aged women Estrogen and resulting glycogen deposition supports growth of both beneficial bacteria (lactobacillus) and pathogens Infection as a Cause of Vulvovaginitis

Across the Lifespan 100 90 80 70 60 50 40 30 20 10 0

25 75 90 75 25 Prepubertal 10 Reproductive Post-menopausal Hillier, CID 1997; 25 (Supplement 2):S123-6

Non-infectious Infection Vaginitis: Clinical Presentation

Abnormal vaginal discharge Vulvar itch Odor Discomfort Burning with urination Painful intercourse Clinical Evaluation of Vaginitis Physical Exam Characteristics of vaginal discharge Appearance of the vulva Appearance of vaginal mucosa Appearance of cervix

Abdominal/bimanual exam Diagnostic Evaluation of Vaginitis Vaginal pH Whiff test (amine test) Microscopy Saline and KOH wet mounts Chlamydia and GC tests Vaginal pH Measurement Normal vaginal pH

STD Atlas, 1997 High vaginal pH (>4.5) Bacterial Vaginosis A sexually-associated disease Bacterial Vaginosis Vaginal lactobacilli are replaced by large numbers of Anaerobes: Mobiluncus Haemophilus

Bacteroides spp. peptostreptococci Prevotella spp. Aerobic GNRs: Gardnerella vaginalis Mollicutes: Mycoplasma hominis Underlying cause not fully understood Microbial Shifts in BV 11 Bacteria

10 G vaginalis Anaerobes Mycoplasmas Lactobacillus 4 10 100-1000 x increase in pathogenic bacteria Revised Model of Pathogenesis More partners/

Douching Frequent intercourse Absence of Lactobacilus Normal Bacterial Vaginosis RF Smoking Non-white race Hillier, The Secret Garden, Principles in STD/HIV Research, Seattle

2003 Clinical Presentation of BV Foul, fishy odor Increased or changes in vaginal discharge Vulvar itching and/or irritation

Symptoms worse after intercourse and during menses 50% may be asymptomatic Risk factors: multiple sexual partners, douching, lack of lactobacilli NOT an STD, but may be sexually associated BV: Diagnostic Criteria Amsel Criteria (3 of the following 4): Homogeneous white noninflammatory discharge that adheres to the vaginal walls Vaginal pH > 4.5 Positive whiff test

> 20% Clue cells on saline wet mount >90% sensitive BV: Treatment Recommended regimens: Metronidazole 500 mg PO BID x 7 d Metronidazole gel 0.75% 5 g per vagina QD x 5 d Clindamycin cream* 2% 5 g per vagina QHS x 7 d Alternative regimens: Metronidazole 2 g PO x 1 Clindamycin 300 mg PO BID x 7 d Clindamycin ovules 100 mg per vagina QHS x 3 d *oil-based cream, may weaken condoms

and diaphragm BV: Complications Post-procedural endometritis

Endometrial biopsy Hysteroscopy IUD insertion Surgical abortion Post-hysterectomy vaginal cuff cellulitis Pathogens associated with PID ? Increased susceptibility to HIV ? Increased susceptibility to CT/GC BV: Complications in Pregnancy

Preterm delivery and low birth weight Premature rupture of membranes Chorioamnionitis Post-partum endometritis 1st trimester miscarriage in IVF patients BV: Screening in Pregnancy 2008 USPSTF Recommendations No screening in asymptomatic women at low risk for PTD Insufficient evidence for screening asymptomatic women at high risk for PTD

2006 CDC Guidelines No firm recommendation Some specialists recommend screening and treatment of women with a history of a premature birth. Screen at the first prenatal visit. BV: Treatment Criteria All symptomatic women Asymptomatic women if undergoing invasive intra-uterine procedure Asymptomatic high risk pregnant women with a history of preterm delivery

(+/-) BV: Recurrent Infection Up to 85% will have recurrence within one year 25% within 4-6 weeks after treatment Occurs equally often after vaginal or oral therapy, and after metronidazole or clindamycin No improvement in recurrence rates after treatment of male partners McCall's Magazine, July 1928

Whats Wrong with Douching? Alters vaginal ecosystem, kills protective lactobacillus Increases risk of acquiring BV, CT Increases risk of complications: PID, ectopic pregnancy NO safe product Probably no safe frequency Vaginal Cosmetics Product Douches Yeast-Guard

Yeast-X Vagisil cream Vagisil powder Vaginex Components Surfactants, Disinfectants Plant extracts, Dead yeast Plant extracts Benzocaine Cornstarch Antihistamine

Vulvovaginal Candidiasis (VVC) Vulvovaginal Candidiasis (VVC) Caused by various Candida spp. (albicans 7590%, glabrata 5-10%, tropicalis 5-10%) Candida may colonize 15-40% of women, so only considered pathogen if symptoms present In U.S., 13 million cases per year Affects 70-75% of women during their lifetime, with 40-50% having at least 1 recurrence

VVC: Risk Factors Hormonal changes Pregnancy Diabetes Antibiotic use HIV infection

Steroids VVC: Clinical Manifestations Abnormal discharge Vaginal soreness Vulvar burning or itching Dysuria may be only complaint NOT an STD, but may be sexually

associated Why does a woman get yeast vaginitis? Many women are colonized by yeast as part of normal flora Yeast colonization more frequent among those having vaginal lactobacilli, those who smoke, and women who are sexually active Unknown why some women develop symptoms and others remain asymptomatic Exposure to irritants may increase sensitization by yeasts

Yeast Colonization Study Baseline demographic data obtained Follow-up at 4-month intervals (0,4,8,12) for 1 year Vaginal swabs collected at 4-month intervals for 1 year Questions regarding vaginal symptoms and treatment obtained at all follow-up visits Correlated culture data with symptoms and RX after all data collected Beigi, et al, Abst. Ann Meeting IDSOG, 2002

Yeast Colonization Study % 100 90 80 70 60 50 40 30 20

10 0 35 24 23 Always Sometimes Always POS NEG N=213 POS N=470 N=26

Beigi, et al, Abst. Ann Meeting IDSOG, 2002 % patients reporting antifungal use Most Common Misdiagnoses among Women Reported to Have Recurrent VVC

Recurrent BV Genital herpes Contact dermatitis (mini pad syndrome) Lichen sclerosis Atrophic vaginitis Diagnosis of VVC Accurate diagnosis is crucial to treatment success --Signs and Symptoms PLUS --Positive saline and/or 10% KOH microscopy OR --Positive culture

Clinical signs and symptoms are not specific in VVC VVC: Diagnosis Mucosa often inflamed and erythematous Discharge is white, thick and curd-like, or may be thin and watery KOH wet mount with budding yeast or pseudohyphae (50-70% sensitive) pH usually normal Fungal culture for non-albicans spp. Uncomplicated VVC: OTC

Treatment Topical Therapies: Clotrimazole: 1% cream per vagina x 7-14 d 100 mg vaginal tab x 7 d or 2 tabs x 3 d 500 mg vaginal tab x 1 Miconazole: 2% cream per vagina x 7 d 200 mg vaginal suppository x 3 d 100 mg vaginal suppository x 7 d These medications are available without prescription *Topical therapies are oil-based and may

weaken condoms and diaphragm Uncomplicated VVC: Treatment Topical Therapies: Butoconazole 2% cream per vagina x 3 d (or sustained-release, single dose) Tioconazole 6.5% ointment per vagina x 1 Terconazole:

6.5% ointment per vagina, single dose 0.4% cream per vagina x 7 d 0.8% cream per vagina x 3 d 80 mg vaginal suppository x 3 d Oral Therapy: Fluconazole 150 mg PO x 1 *Topical therapies are oil-based and may weaken condoms and diaphragm These medications are available by prescription

Trichomonas Vaginalis A sexually transmitted infection Trichomoniasis Etiologic agent: Trichomonas vaginalis, flagellated anaerobic protozoa Estimated annual incidence in U.S: 7 million Long-term asymptomatic carriage documented in both men and women Increases susceptibility to HIV infection Associated with low birthweight and preterm babies

Trichomonas infections, who cares? High prevalence among minority populations in US and developing countries Infection leads to inflammatory infiltrate and punctate mucosal hemorrhages Degrades SLPI (Secretory Leukocyte Protease Inhibitor), an endogenous microbicide known to block HIV cell attachment Prevalence of T. Vaginalis by Race

% Positive for T. vaginalis Overall Black Nonblack OR NY, 1998 47% 51%

35% 1.6 SF, 1985 11% 28% 9% 3.7

5 Cities, 1991 13% 23% 6% 4.4 Phil, 1970 16%

30% 11% 3.6 Trichomonas: A Pathogen Over Lifetime Can be transmitted to prepubertal girls through sexual abuse Little evidence to support transmission through shared towels, toilet seats, etc.

Can be carried asymptomatically for years Can emerge as a new infection in postmenopausal women following antibiotic therapy or change in estrogen status Careful diagnosis and treatment of male partner essential Trichomoniasis Clinical Presentation May infect ectocervix, vagina, urethra or bladder In women, causes malodorous yellow-grey discharge with irritation and vulvar itching In men, can cause urethritis

Often asymptomatic ( 50%) Trichomoniasis: Diagnosis in Women Typical vaginal discharge: thin, frothy, grey/yellow May see punctate cervical hemorrhages (strawberry cervix) 5 -10% Motile trichomonads on saline wet mount (sensitivity may be as low as 60%) pH > 4.5 Whiff test may be positive Culture available (InPouch TV Test)

Point of care tests now available PCR tests exist but not FDA approved Trichomoniasis: Diagnosis in Men Laboratory diagnosis rarely performed Epi treatment of contacts to women with trichomoniasis or presumptive treatment for men with recurrent, persistent urethritis Microscopy of spun urine or discharge of symptomatic men Culture recommended for men with recurrent urethritis

Trichomonas vaginalis Seattle STD/HIV Prevention Training Center Trichomoniasis: Treatment Recommended regimen: Metronidazole 2 g PO x 1* Tinidazole 2g PO x 1 Alternative regimen: Metronidazole 500 mg PO BID x 7d Metronidazole highly effective: 95% if both

partners treated *Recommended regimen is the same in pregnancy Pelvic Inflammatory Disease Definition of PID Upper genital inflammation/infection - Endometritis - Salpingitis - Tubo-ovarian abscess

- Pelvic peritonitis CDC. MMWR. 1993; 42:75 PID Clinical Presentation STD Atlas, 1997 Reproductive Anatomy & Spread of Infections Pelvic Inflammatory Disease (PID):Magnitude of the Problem From All Causes in the United States

> 1 million cases per year resulting in: 2.5 million outpatient visits per year 275,000 hospitalizations per year Sequelae (25%) Infertility (12% to 50%) Ectopic Pregnancy ( 6 to 10 fold) Chronic Pelvic Pain (18%) 100,000 surgical procedures Psychological Problems: devastating Nationwide Costs of PID (1990) Cost 10 ($ billions)

8 >9 6 4.2 4 2.7 2 0

1.5 Direct Cost Indirect Cost Washington, Katz. JAMA. 1991;266:2565. Total Cost

Estimated Total in Year 2000 Microorganisms that Cause PID Chlamydia trachomatis No pathogen identified Vaginal

Bacteria Chlamydia trachomatis and Neisseria gonorrhoeae Freund, KM, Hosp Prac. 1992;27:187. Neisseria gonorrhoeae Recovery of Microorganisms from Upper Genital Tract

80 N=387/6 studies 61% 60 Percent of Women 40 31% 27%

20 0 Chlamydia trachomatis Neisseria gonorrhoeae Anaerobes and Facultative Microorganisms

Brunham, et al. J Infect Dis. 1988; 158:510. Heinonen, et al. Obstet Gynecol. 1985;66:384. Kiviat, et al. Am J Surg Pathol. 1990;14:167. Paavonen, et al. Br J Obstet Gynaecol. 1987;94:454. Sweet. Infect Dis Clin North Am. 1987;1:199. Sweet, et al. JAMA. 1983;250:2641. Wasserheit, et al. Ann Intern Med. 1986;104:187 CT Screening Prevents PID: Clinical trial, Seattle HMO, 1990-1992 Randomized controlled trial 1009 high risk women 18-34 assigned to intervention (invitation to get tested) & 1598 to usual care Among intervention group, 64% were tested and 7% were positive and treated Outcome of PID w/i 1-year:

9 cases in screening group, 33 cases in usual care group (RR=0.44 (0.20-0.90)) 25 PIDRate(per 1000) 20 15 10 5 0

Usual Care Screened Scholes et al., NEJM, 1996; 334:1362-6 PID Diagnostic Considerations Diagnosis based on clinical findings Wide variation of symptoms and signs Many women with PID have subtle or mild symptoms Delay in diagnosis and treatment probably

contributes to inflammatory sequelae Clinical Diagnosis Imprecise Positive predictive value (PPV) for salpingitis of 65%-90% compared with laparoscopy. PPV of clinical diagnosis depends on epidemiology of population: higher among sexually active young women, STD clinic patients, or other settings where high rates of chlamydia and gonorrhea CDC.MMWR. 2006

Clinical Diagnosis (2) No single historical, physical, or lab finding is both sensitive and specific for the diagnosis of acute PID Combinations of diagnostic findings that improve sensitivity or specificity do so at the expense of the other. CDC Diagnostic Criteria for PID Minimal Criteria* - Uterine tenderness or

- Cervical motion tenderness or - Adenexal tenderness CDC.MMWR. 2006 * Start empiric treatment for PID if sexually active women with pelvic or lower abdominal pain and any criteria are present and if no competing diagnosis is suspected. CDC Diagnostic Criteria for PID (contd) Additional Criteria* Oral temperature > 101oF (>38.3oC)

Abnormal cervical/vaginal mucopurulent discharge WBCs on saline microscopy of vaginal secretions Erythrocyte sed rate C-reactive protein + Lab Neisseria gonorrhoeae or Chlamydia trachomatis Used to enhance the specificity of the minimum criteria and support the diagnosis of PID CDC.MMWR. 2002;51 (RR-6):48-52. CDC Diagnostic Criteria for PID (contd) Elaborate Criteria

Endometrial biopsy Endometritis; Transvaginal sonogram or MRI showing thickened fluid-filled tubes w/ or w/o free pelvic fluid or tubo-ovarian abscess; and Laparoscopic evidence CDC.MMWR. 2002;51 (RR-6):48-52. PID Treatment Treatment requires broad empiric coverage of likely pathogens. All regimens are effective against chlamydia

and gonorrhea All regimens have anaerobic coverage +/activity against BV Hospital-based and outpatient regimens Improving Prevention of Unintended Pregnancy with Emergency Contraception Unintended Pregnancy Approximately 4 million unintended pregnancies occur each year in the US. Most result from the non-use of contraception or from a noticable

contraceptive failure. Estimated that that of the 900,000 pregnancies in California each year are unintended and >1/4 end in abortion. (Alan Guttmacher Institute, 2002) Unintended Pregnancy in LAC In LAC, ~46% of pregnancies resulting in live births are unintended. Unintended pregnancy rate in LAC likely much higher when pregnancies resulting in abortion and miscarriage are considered.

California Maternal and Infant Health Assessment, 2005 Costs of Unintended Pregnancy Associated with negative health consequences for women and newborns Delayed prenatal care Increased risk preterm delivery Disproportionately impacts minority women, low income women, and women on Medicaid.

CDC 2006, MIHA 2005 Fiscal Costs of Unintended Pregnancy Cost LAC taxpayers $440,000,000/year due to negative health outcomes, lost income and tax revenue, and increased need for public assistance. Estimated that every dollar spent on publicly subsidized family planning services saves $4.40 of costs on medical care and social services provided to women who become pregnant.

Bixby, 2004. Constantine, 2006. Emergency Contraception Overview Only effective form of birth control that works AFTER sex. Also known as morning after pill. Safe and effective oral contraceptive that prevents pregnancy if taken soon after intercourse. Does not harm an already established pregnancy. Plan B, a progestin only OCP, is the only FDA approved dedicated product.

Trussell AJPH 1997, Alan Guttmacher Institute, 2002 Potential Impact of Universal Access to Emergency Contraception (EC) Reduce unintended 1.5 million fewer pregnancies by half Reduce abortions needed by half 0.7 million fewer Reduce

pregnancies after rape by 88% 22 thousand fewer Trussell AJPH 1997 Mechanism of Action EC primarily works to delay or inhibit ovulation. EC MAY keep the sperm from meeting the egg. EC MAY keep the fertilized egg from

implanting. Other methods that MAY keep the fertilized egg from implanting. OCPs, Norplant, Vaginal ring, Patch & DepoProvera IUDs (Mirena and Paraguard) Breastfeeding Source: ACOG 1998 What is Plan B? A commercial product that is equivalent to Ovrette (progestin only birth control pills). Levonorgestrel 1.50mg (two .75 mg

tablets) First dose within 120 hours after intercourse, and second dose 12 hours later Both doses can be taken at the same time Plan B PLAN B

Less nausea Less emesis More effective Consists of two .75 mg Leveongestrel tablets OLDER VERSIONS (combined ECP) 50% experienced nausea

20% experience emesis Less effective than progestin only pills Variable amount of tablets of estrogen and progestin Effectiveness of Plan B If Plan B taken within x it will prevent 24 hours 95% of expected pregnancies

72 hours 86% of pregnancies 120 hours 61% of pregnancies Risks of Providing EC No evidence-based contraindications. Not indicated for a woman with a suspected or confirmed pregnancyno harm if mistakenly taken.

Has not been shown to increase sexual risk behavior, STD acquisition, or decrease regular contraception use. Common Side Effects Plan B Nausea 20% Emesis 5% Headaches 17% Fatigue 17%

Dizziness 10% Breast Tenderness 10% Less Common Side Effects abdominal pain

cramps diarrhea Irregular bleeding or spotting Next period may be either early or late Access to EC 1997 FDA declared oral contraceptive pills safe for use as EC and made EC available by prescription only 10 states allowed pharmacists to prescribe (California, October 2001) FDA approved over-the-counter access Nov 2006

Access to EC in California Part of comprehensive care package covered by FPACT and MediCal. Direct pharmacy access of Plan B available since Jan 2002. (SB 1169) Only 1 in 4 LA pharmacists provide this service. Only 9% of women surveyed knew about this option (KFF, 2004) Over-the-counter access since Nov 2006 Available for individuals 18 years and older with proof of age; cost ~ $40

Behind-the-counter status available in drug stores only when pharmacist on site Barriers to Access in OTC Plan B Era After hours access: FDA requires Plan B be kept

behind the counter and dispensed by authorized practitioners. Consumer awareness: in LAC, >55% of women of reproductive age are unaware that EC may be taken after intercourse to prevent pregnancy. (UCSF CRHP, 2005) Cost: $40 OTC or with Pharmacy Access Lack of identification: FDA requires proof of age to receive OTC EC. Undocumented women and those without ID impacted. Adolescents: highest risk group for unintended pregnancy unable to obtain Plan B without prescription (pharmacy or provider)

EC Dispensing/Prescribing Strategies Acute need: provision of EC within 5 days of episode of unprotected sex Advance prescription (in-advance of need): provision of medication or prescription in advance AMA, ACOG, AAP, SAM AAFP all support advance prescription. Not associated with increased risk taking or STDs Solutions to increasing access

Educate Providers (dispense/prescribe in-advance of need) Consumers Extend OTC status to minor The End Contact info: Sarah Guerry, MD Medical Director STDP 2615 S. Grand Ave. Room 500 LA, CA 90007

[email protected] 213.744.3133

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