Transcript Vaginal Estrogen: Is it Safe? How Should it Be Used?

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)
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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
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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
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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
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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
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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.