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Vaginal Estrogen: Is it Safe? How Should it Be Used? Beth Schroeder, RN, FNP, CUNP Un of MO Women’s Health Center Continence & Advanced Pelvic Surgery Columbia, MO 573-817-3165
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
Julie Starr FNP Center for Female Continence and Advanced Pelvic Surgery500 N Keene St. on the north side of Womens & Childrens Hospital Beth Schroeder 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)
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/GYNoffering vaginal reconstructive surgery, incontinence surgery, hysterectomy, mesh removal and Interstim placement
Vulvar Disease Female Pelvic Medicine and Reconstructive Surgery Comprehensive Pelvic Floor Rehabilitation Multi-Specialty Center Behavioral Health 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 estrogens-blood 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