VAGINAL ESTROGEN: IS IT SAFE? HOW SHOULD IT BE USED? B E T H S C H R O E D E R , R N , F N P, C U N P U N O F M O W O M E N ’ S H E A LT H C E N T E R C O N T I N E N C E & A DVA N C E D P E LV I C S U R G E R Y COLUMBIA, MO 57 3 - 817 - 316 5 OBJECTIVES The participants will be able to: • Describe the potential effects from use of vaginal estrogen • Discuss the pros & cons of vaginal estrogen • Identify patients most likely to benefit from vaginal estrogen CENTER FOR FEMALE CONTINENCE AND ADVANCED PELVIC SURGERY 500 N KEENE ST. ON THE NORTH SIDE OF WOMENS & CHILDRENS HOSPITAL BETH SCHROEDER FNP JULIE STARR FNP COMPREHENSIVE MANAGEMENT OF FEMALE PELVIC FLOOR DYSFUNCTION Pelvic organ prolapse Urinary incontinence Recurring UTIs Defecatory dysfunction Pelvic pain Urogenital atrophy Sexual pain / vaginismus Obstetrical lacerations DILATORS Pessary fitting Pelvic Floor Rehabilitation (Biofeedback and e-stim therapy) OUTCOMES COMPREHENSIVE PELVIC FLOOR REHABILITATION Urinary Symptoms Defecatory Symptoms Symptom Improvement (%) 80 60 40 100 80 60 40 20 20 1 2 3 4 6 Pelvic Pain 5 Session 1 2 3 4 5 6 Session 100 Symptom Improvement (%) Symptom Improvement (%) 100 80 60 40 20 1 2 3 4 Session 5 6 N=778 WE DON’T OFFER.... Well woman exams Birth control counseling Male exams We do offer surgery..... Dr. Foster is a board certified urogynecologist and Dr. Brennaman is OB/GYN offering vaginal reconstructive surgery, incontinence surgery, hysterectomy, mesh removal and Interstim placement Female Pelvic Medicine and Reconstructive Surgery Behavioral Health Vulvar Disease MultiSpecialty Center Comprehensive Pelvic Floor Rehabilitation Gastroenterology PM&R CLINICAL RESEARCH Effect of pelvic floor therapy on patient urinary and fecal incontinence, pelvic pain, and quality of life: a retrospective chart review. 778 enrolled Mean reported symptom improvement 83%, urinary defecatory and pain Recent publication Effect of pelvic floor therapy on patient pelvic floor dysfunction and quality of life. Currently 98 enrolled, 47 completed full course of therapy Questionnaires pre and post treatment, 6 months and annually Statistical significance in urinary, defecatory and prolapse symptoms (p<0.0001 all three areas) CLINICAL RESEARCH Healthy Bottoms: Prospective Outcomes after obstetrical injury. PI Currently 25 enrolled Questionnaires initial visit, 6 months and annually for lifetime Intravaginal diazepam for the treatment of pelvic pain among women with pelvic floor hypertonic disorder: a double blind, randomized, placebo controlled trial Currently 9 subjects enrolled Measure outcomes of women with pelvic pain prior to and after treatment VAGINAL ATROPHY Thinning of the top layer of the superficial epithelial cells Loss of elasticity of the vaginal epithelium Loss of sub-epithelial connective tissue Loss of rugae Shortening and narrowing of the vaginal canal Reduction in vaginal secretions Increase vaginal pH to >5 WHY IS VAGINAL ESTROGEN IMPORTANT? Maintain a collagen contact of the epithelium Maintain acidic pH Maintain optimal genital blood flow RISK FACTORS FOR VAGINAL ATROPHY Natural menopause Bilateral oophorectomy Ovarian failure Medications with anti-estrogenic effect Breast-feeding Elevated prolactin Amenorrhea OTHER FACTORS IN VAGINAL ATROPHY Cigarette smoking Lack of sexual activity Vaginal nulliparity Vaginal surgery SYMPTOMS OF UROGENITAL ATROPHY Vaginal dryness Vaginal burning or irritation Decreased vaginal lubrication during sexual intercourse Dyspareunia Vulvar or vaginal bleeding Vaginal discharge Pelvic pressure or vaginal bulge Urinary tract symptoms EVALUATION Pelvic examination Vaginal pH Cytologic or microscopic examination Cervical cytology Serial hormone levels Ultrasound of the uterine lining DIFFERENTIAL DIAGNOSIS Vaginal infections-BV, Yeast, bacterial Local reactions-contact dematitis Vulvovaginal lichen planus Vulvar lichen sclerosus Genital tract ulcers or fissures WHAT IS VAGINAL ESTROGEN THERAPY • Estrogen applied locally to the vaginal tissues • Types Cream-Premarin or Estrace cream Tablets-Vagifem Vaginal Ring-Estring PROS Appears to be more effective than systemic estrogens for treatment of vaginal dryness No or little systemic effect Decreased risk of side effects of systemic estrogensblood clots, cancers CONS Local reaction/allergic reaction No help with vasomotor symptoms or preserving bone density DOSING • Creams • Premarin 0.625mg conjugated estrogens/1gm, usual dose 0.5-1.0 gm 3 times weekly initially • Estrace 100mcg estradiol/1gm cream, 1-2gms 3 times weekly initially • Tablet • Vagifem-10mcg tablet of estrodial, daily for 2 weeks then twice weekly • Generic estrodial DOSING • Ring • Estring-estradiol, 7.5mcg daily for 90 days • Femring-Estrdiol 5075 mcg daily, considered systemic WHAT CAN WE EXPECT VAGINAL ESTROGEN TO DO? Increase vaginal pH Improve blood flow to the vaginal tissues/pelvis Improve vaginal moisture & lubrication PATIENTS MOST LIKELY TO BENEFIT Urogenital Atrophy-vaginal dryness, itching, burning Urinary frequency, urgency, nocturia Urinary Incontinence Urinary Tract Infections COMMON COMPLAINTS Messy Burning or Irritation at vaginal opening Breast tenderness or leg heaviness “Just don’t feel right” SIDE EFFECTS Decreased appetite, nausea, or vomiting Swollen breasts Acne or skin color changes Decreased sex drive Migraine headaches or dizziness Vaginal pain, dryness, or discomfort Edema Depression SERIOUS SIDE EFFECTS Allergic reaction Shortness or breath or pain in the chest; Blood clot Abnormal vaginal bleeding Pain, swelling, or tenderness in the abdomen Severe headache, vomiting, dizziness, faintness, vision changes Yellowing of the skin or eyes Lump in a breast. BLACK BOX WARNINGS Endometrial Cancer Risk Cardiovascular and Other Risks ENDOMETRIAL EFFECT Cream- 0.5gm 3 times weekly for 6 months showed one patient had hyperplasia on biopsy, but not ultrasound. Estradiol vaginal tablet-nightly x2 weeks, then twice weekly, after 52 week one case of hyperplasia without atypia and one case of adenocarcinoma (pre-existing?) Estradiol ring-monthly dosing, no significant endometrial hyperplasia after 12 months. WHO SHOULD NOT TAKE ESTROGEN Women who: • Think they are pregnant • Have problems with vaginal bleeding • Have had certain kinds of cancers • Have had a stroke or heart attack • Have had blood clots • Have liver disease TYPES OF PATIENTS Vaginal atrophy Dyspareunia (peri & post menopausal) Urinary frequency & urgency Incontinence Recurrent UTI Pelvic muscle atrophy Pessary OTHER OPTIONS Vaginal lubricants and moisturizers Luvena Vagisil Replens K-Y Silk-E Sexual Intercourse Vaginal Dilators SHIRLEY HPI: Shirley is a 68 y/o G4P3 with complaints of over active bladder x 2 years. She describes symptoms of stress incontinence, urgency/frequency and urge incontinence which worsened at night. She wears a Depends pad and a large Poise pad and changes this ensemble 2-3 x day HPI CONT. On an average day she drinks 3 glasses of water, 2 glasses of juice, 1 cup of coffee and 1 soda. She reports 4 UTIs in the past year. She takes Miralax every morning and reports 1-2 bowel movements per day, but strains at stool. 24 hour pad weight 803 grams Bladder diary indicates 16 voids/24 hours She gets up 4 x night to void. MEDICAL/SURGICAL HISTORY Patient reports conditions of HPTN, anemia, hernia, sinusitis, GERD, hypothyroidism,Raynaud’s syndrome, constipation-predominant irritable bowel syndrome. Surgical history includes sacroplasty, cholecystectomy, appendectomy, hysterectomy and ovariectomy. DIAGNOSIS Stage II rectocele Perineal rectocele Defecatory dysfunction Urogenital atrophy Urinary urgency/frequency Urge incontinence Stress incontinence Urinary tract infection Recurrent urinary tract infections TREATMENT PLAN Bowel regimen Premarin vaginal cream for urogenital atrophy. Fosfomycin 1 x dose to treat UTI. Trimethoprim 100mg q hs for recurrent UTIs. Oxybutynin prn for OAB. Pelvic floor therapy x 5 sessions. Imipramine 25mg q hs for nocturia. OUTCOME Patient reported 100% improvement after 5 sessions of pelvic floor therapy. She voids 7-8 x day and 2 x night. Her daytime incontinence completely resolved and she leaks only drops during the night. She wears a panty liner for peace of mind. She remains on Trimethoprim at bedtime. She remains on Imipramine q hs. She takes Oxybutynin only when going out. OUTCOME CONT Premarin vaginal cream 0.5 gm. weekly. Pelvic floor exercises 4 x day. Metamucil daily and reports 1-2 bowel movements per day without straining. She was able to take a vacation with her family in which they drove over 500 miles in the car. ANNE HPI: Anne is a 82 y/o with complaints of significant dysuria for 2 months. Hx of stress incontinence, urgency/frequency, urge incontinence and nocturia for the many years/Diabetes/Obesity. She wears 1-2 pads daily, especially when out. She reports a bowel movement every day. She takes fiber and stool softners. HPI CONT On an average day she drinks 4 glasses of water, 1.5 glass of milk, 1-2 cups of coffee She reports voiding hourly during the day, but only once a night. MEDICAL/SURGICAL HISTORY Patient reports multiple medical problems, but no surgeries. She reports two vaginal deliveries DIAGNOSIS Vaginal atrophy Vaginal yeast, vulvovaginitis Urinary urgency, frequency Stress & Urge Incontinence Pelvic Muscle Atrophy TREATMENT Wet prep, labial gram stain, labial fungal culture Treated Yeast infection Premarin vaginal cream 1 GM 3 times weekly Increase free water Consider another type of pad or leave pad off as much as possible Pelvic floor therapy for urge and stress incontinence. OUTCOME Wet Prep-yeast Gram stain-budding yeast Improvement in symptoms after treatment with Diflucan & Monistat suppositories Urge incontinence has resolved Mild stress incontinence 2-3 x month. Premarin vaginal cream 1 x week for urogenital atrophy. Pelvic floor exercises and urge suppression techniques daily. LINDA HPI-57 y/o with complaint of pain with intercourse, initial penetration, deep penetration with burning & cramping after for several hours. No sexual activity for few years after divorce. New husband and unable to tolerate intercourse. Menopausal since 52 y/0 No other significant history. Has not used any HRT PHYSICAL EXAM Healthy female, exam unremarkable except for vaginal atrophy. Moderate pelvic floor muscle spasm/pain Firm stool in rectum DIAGNOSIS Dyspareunia Vaginal Atrophy Pelvic muscle dysfunction Defecatory dysfunction THERAPY Vaginal estrogen-Premarin vaginal cream 1.0 gm nightly for 3-5 nights then 3 times weekly Pelvic floor therapy with vaginal e-stim 4-6 sessions Vaginal dilators, progressive sizes Literature-”Vaginismus”, “Tired Woman’s Guide to Passionate Sex” & “The Joy of Sex” FOLLOW-UP Vaginal atrophy resolved and now using Premarin 0.5gm once weekly Intercourse with little pain with insertion only after using vaginal estrogen and progressive dilators 5 sessions of PFT SALLY HPI- 56 y/o post menopausal. She has not been sexually active for about 5 years and now in a new relationship. She is having pain with initial penetration and deep penetration. So vaginal burning and postcoital cramping. She has been using Vagifem and KY for lubricant. No bleeding, except with intercourse. She also has some frequency, urgency, and nocturia. No incontinence. She reports having a soft BM daily without straining. History-rosacea, seasonal allergies, normal pap TREATMENT PLAN Stop Vagifem, switch to Premarin Try other lubricants Pelvic floor therapy for pelvic floor muscle spasm Dilator therapy Educational materials Wet prep-Negative Fungal culture-Negative Gram stain-positive with rare gm- rods, gm+ rods, gm+ cocci . Treated for 5 days with PCN OUTCOME One session of PFT, Premarin cream for 4-5 weeks, vaginal valium prior to intercourse, use of vaginal dilators daily. She is having less discomfort with intercourse. Not perfect yet, but she is pleased. RESOURCES Starr JA, Drobnis EZ, Lenger S, Parrot J, Barrier B, Foster R. Outcomes of a comprehensive nonsurgical approach to pelvic floor rehabilitation for urinary symptoms, defecatory dysfunction, and pelvic pain. Female Pelvic Med Reconstr Surg. 2013 Sep-Oct;19(5):260-5. www.uptodate.com Clinical Manifestations and Diagnosis of Vaginal Atrophy, Treatment of Vaginal Atrophy, Treatment and Prevention of Urinary Incontinence in Women, Sexual Dysfunction in Women: Management.