1. 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

2. 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

3. Center for Female Continence and Advanced Pelvic Surgery 500 N Keene St. on the north side of Womens & Childrens Hospital
Julie Starr FNP
Beth Schroeder FNP

4. 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

5. Dilators Pessary fitting Pelvic Floor Rehabilitation
(Biofeedback and e-stim therapy)

6. Outcomes Comprehensive Pelvic Floor Rehabilitation

7. Dr. Foster is a board certified urogynecologist
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

8. Multi-Specialty Center
Vulvar Disease
Female Pelvic Medicine and Reconstructive Surgery
Comprehensive Pelvic Floor Rehabilitation
Multi-Specialty Center
Behavioral
Health
Gastroenterology
PM&R

9. 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< all three areas)

10. 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

11. 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
Vulvovaginal atrophy, urogenital atrophy, atrophic vaginitis. Caused by estrogen loss often results in urogenital symptoms
Up To 70% of women with symptoms of vaginal atrophy do not discussed her condition.
May consider it expected or necessary part of 18
Culture all, religious, or suicidal believes may be uncomfortable discussing concerns related to the GU system

13. Why Is vaginal estrogen important?
Maintain a collagen contact of the epithelium Maintain acidic pH Maintain optimal genital blood flow
Collagen fracture the thickness inelasticity of the tissue
The acid pH keeps the epithelial surfaces moist
Glycogen is changed into lactic acid creating the acidic environment that maintains normal vaginal flora and protection

14. Risk factors for vaginal atrophy
Natural menopause Bilateral oophorectomy Ovarian failure Medications with anti-estrogenic effect Breast-feeding Elevated prolactin Amenorrhea

15. Other factors in vaginal atrophy
Cigarette smoking Lack of sexual activity Vaginal nulliparity Vaginal surgery

16. 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
Dyspareunia may include full floor or vaginal pain, initial penetration or deep penetration
Vulvar or vaginal bleeding can be post coital bleeding or caused from fissures
Vaginal discharge can be yellow and malodorous or leukorrhea
Urinary tract symptoms can be frequency, urgency, dysuria, urethral discomfort, and hematuria

17. evaluation
Pelvic examination Vaginal pH Cytologic or microscopic examination Cervical cytology Serial hormone levels Ultrasound of the uterine lining
Pelvic exam may shows scarce pubic hair, diminished elasticity and turgor of the vulvar skin, introital narrowing or decreased moisture, fusion of the labia minora. Ureteral caruncle or urethral prolapse or polyps may occur

18. Differential diagnosis
Vaginal infections-BV, Yeast, bacterial Local reactions-contact dematitis Vulvovaginal lichen planus Vulvar lichen sclerosus Genital tract ulcers or fissures

19. What is vaginal estrogen therapy
Estrogen applied locally to the vaginal tissues
Types
Cream-Premarin or Estrace cream
Tablets-Vagifem
Vaginal Ring-Estring

20. 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

21. Cons Local reaction/allergic reaction
No help with vasomotor symptoms or preserving bone density

22. Dosing
Creams
Premarin 0.625mg conjugated estrogens/1gm, usual dose 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

24. Dosing Ring Estring-estradiol, 7.5mcg daily for 90 days
Femring-Estrdiol 5075 mcg daily, considered systemic

25. What can we expect vaginal estrogen to do?
Increase vaginal pH Improve blood flow to the vaginal tissues/pelvis Improve vaginal moisture & lubrication

26. Patients most likely to benefit
Urogenital Atrophy-vaginal dryness, itching, burning
Urinary frequency, urgency, nocturia
Urinary Incontinence
Urinary Tract Infections
Post menopausal woman with chronic health conditions-HTN, DM, COPD, Rec UTI

27. Common complaints
Messy Burning or Irritation at vaginal opening Breast tenderness or leg heaviness “Just don’t feel right”

28. 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
Are less serious, but more likely to occur. If the woman complains of burning, try to hang in there a week to 10 days…

29. 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.
Should stop medication immediately and go to ER

30. Black Box Warnings Endometrial Cancer Risk
Cardiovascular and Other Risks

31. 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.

32. 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

33. Types of patients Vaginal atrophy Dyspareunia (peri & post menopausal)
Urinary frequency & urgency
Incontinence
Recurrent UTI
Pelvic muscle atrophy
Pessary

34. Other options
Vaginal lubricants and moisturizers Luvena Vagisil Replens K-Y Silk-E Sexual Intercourse Vaginal Dilators

35. 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

36. 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.

37. 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.

38. DIAGNOSIS Stage II rectocele Perineal rectocele Defecatory dysfunction
Urogenital atrophy
Urinary urgency/frequency
Urge incontinence
Stress incontinence
Urinary tract infection
Recurrent urinary tract infections

39. 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.

40. 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.

41. 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.

42. 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.

43. 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.

44. MEDICAL/SURGICAL HISTORY
Patient reports multiple medical problems, but no surgeries. She reports two vaginal deliveries

45. DIAGNOSIS Vaginal atrophy Vaginal yeast, vulvovaginitis
Urinary urgency, frequency
Stress & Urge Incontinence
Pelvic Muscle Atrophy

46. 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.

47. 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.

48. 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

49. Physical exam
Healthy female, exam unremarkable except for vaginal atrophy. Moderate pelvic floor muscle spasm/pain Firm stool in rectum

50. Diagnosis
Dyspareunia Vaginal Atrophy Pelvic muscle dysfunction Defecatory dysfunction

51. 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”

53. 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

54. 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

55. 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

56. 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.

57. 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 Sep-Oct;19(5): Clinical Manifestations and Diagnosis of Vaginal Atrophy, Treatment of Vaginal Atrophy, Treatment and Prevention of Urinary Incontinence in Women, Sexual Dysfunction in Women: Management.