of Genitourinary Syndrome of Menopause(GSM)

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CAPA 2015 Annual Conference
Abracadabra The Magical World
of
Genitourinary Syndrome of
Menopause(GSM)
Michael L Krychman MD
Southern California Center for Sexual Health and
Survivorship Medicine
Associate Clinical Professor VCF- UCI
AASECT Certified Sexual Counselor
Unmet need
157 million women in the USA
41% are postmenopausal
Approximately 64 million postmenopausal
women
34 million atrophic women
40% of life in the postmenopause
Only 7% receive prescription treatment
– 2.3 million treated women
Krychman M, Wysocki S., Kingsberg S., REVIVE Survey October 2012: NAMS poster presentation
Genital Syndrome of Menopause
previously known as VVA
Symptoms of VVA, including dryness, irritation, itching, dysuria, and
dyspareunia, can affect QOL and sexual function.
VVA is also associated with lower urinary tract symptoms, such as dysuria,
urgency, frequency, nocturia, incontinence, and recurrent UTIs.
VVA is underDX and underTX.
Many postmenopausal women lack knowledge about vulvovaginal health
and treatment options for vulvovaginal discomfort.
Both patients and (HCPs) may be hesitant to discuss vulvovaginal health.
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CAPA 2015 Annual Conference
Manifestation of Estrogen and/or Androgen
Loss: Symptoms Over Time
Range of Estrogen
secretion levels (pg/mL)
Onset
insidious
with
significant
individual
variability
Long-term symptoms
Short-term symptoms
Mood, sleep, and/or
Hot
acute cognitive changes
flushes
Urogenital symptoms
Decreased sexual activity
Decreased arousal
Decreased libido
40
45
50
55
60
65
70
≥75
Age (y)
©2005 JL Alexander, http://www.afwh.org.
4
Physical Symptoms of AV
Atrophic epithelium (pale, smooth, shiny)
Loss of rugae
Increased friability
Sparse pubic hair
Fusion of labia
Introital stenosis
Bachman G, et al. Am Fam Physician. 2000; Parsons A, et al. Menop Med. 2003
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VVA
SYMPTOMS
Vaginal and vulvar dryness
Decreased lubrication with IC
Discomfort with Sexual Activity
Irritation, burning, Itching
Dysuria
Urinary frequency, urgency
Recurrent UTI
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CAPA 2015 Annual Conference
pH Confirms VVA
Premenopausal vaginal luminal pH is acidic
– –pH 4.5–6.0
– –~6.5 before ovulation
Estrogen loss → more alkaline pH
–pH 6.5–7.0
Ph test is medicare eligible
Routine measurement of vaginal pH may improve compliance
Department of Health & Human Services. Centers for Medicare and
Medicaid Services. New Waived Tests – December 17, 2002. Available at:
http//www.cms.gov/transmittals/ downloads/AB03013.pdf Accessed May
10, 2010.
Menopause is Not the Only
Condition Associated with VVA
Hormonal Contraception
Chemotherapy
Post-Partum
Diabetes
Artherosclerosis
IVF
Radiation
Medications
– Antihistamines, decongestants, anti-cholinergics
Cellular Shift Changes
Premenopausal
Superficial
Intermediate
Parabasal
Post menopausal
15%
80%
5%
Superficial
Intermediate
Parabasal
1%
60%
39%
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CAPA 2015 Annual Conference
Vaginal and
Sexual Pain
Painful
sex
Avoidant
Behavior
Partner may
feel guilt,
anxious
Change is
sexual
relationship
Marital ↑
Tension
No sex
Partner
may feel
rejected,
angry
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CAPA 2015 Annual Conference
Impact of Vaginal Atrophy on
Sexual Function
Vaginal Atrophy
Dyspareunia
Lack of Lubrication
Irritation
Loss of interest
in
Sexual Activity
Discomfort
During
Sexual Intercourse
Goals of Treatment
Relieve symptoms
Reverse anatomical changes
Improve sexual function and quality of life
Vulvovaginal Atrophy Can Impact
Overall Well-Being
Dsypareunia affects more than interest in sex—relationships, mood,
and self-esteem suffer
Strongly agree
Somewhat agree
Strongly disagree
Neither agree nor disagree
Percentage of Patients
35
Somewhat disagree
N=506
30
25
20
15
10
5
0
Sexual interest
Mood
Self-esteem
Relationships
Simon JA, Komi J. Vulvovaginal atrophy (VVA) negatively impacts sexual function, psychosocial well-being, and partner relationships.
Poster presented at North American Menopause Association Annual Meeting; October 3-6, 2007; Dallas, Texas.
Altman A. OBG Management. 2009.
15
15
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CAPA 2015 Annual Conference
Management of Vaginal Atrophy
Lubricants
Moisturizers
Systemic Estrogen
Local Vaginal Estrogen
Selective Estrogen Receptor Modulator
Off label/compounded options
Laser “rejuvenation”
Adjuncts
– Physical Floor Therapy
– Dilators
– Intravaginal Valium
Lubricants and Moisturizers
Lubricants are considered temporary
measures to relieve vaginal dryness during
intercourse
– Short duration of action
– Must be applied frequently
– Sexual aid
Moisturizers are promoted as providing
long-term relief of vaginal dryness
– Continuous use- several times a week
– Everyday aid
Both OTC and FDA approved as
cosmetics
Moisturizer =
Maintenance
Lubricant = Love making
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CAPA 2015 Annual Conference
Lubricants
Minimize friction and irritation
– Around the clitoris, labia and vaginal entrance
– Both partners’ genitals
Gel or liquid
Water-based, oil-based, silicone-based
Avoid lubricants that contain perfumes,
flavors or warming ingredients
Water based
Oil Based
Silicone Based
Thickening agents in a watersoluble base
differ by:
Oil: mineral, almond, olive..
Petrolatum
Silicone
Dimethicone
Dry quickly
Needs reapplication
Stay slippery
Messy/Greasy
Stay slippery
“Coating” effect
Compatible with latex
condoms
Breaks condoms,
diaphragms
Not compatible with silicone
rubber sex toys
Sticky
Bad smell
Bad taste
consistency (watery – thick), feel , how
long they last
Contains preservatives,
antiseptics, glycerin
Non-irritating
Non-irritating
wash away easily
water-resistant: difficult to
wash off body, staining
clothes or sheets
water-resistant: difficult to wash
off body, clothes or sheets
Needs soap to remove
KY, Astroglide, Slippery
stuff, Yes
Oil: mineral, almond,
olive..
Petrolatum, Yes
Eros, Pink, ID Millenium,
Wet Platinum
Oil Based
• Not condom
compatible
• Increased
vaginal yeast
infections
Vaseline
• Not condom
compatible
• 2X increase
in Bacterial vaginosis
Brown, et al. Intravaginal Practices and risk of Bacterial Vaginosis among a Cohort of Women in the United States
ObGyn Vol 121, No 4, April 2013
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CAPA 2015 Annual Conference
Advantages
inexpensive
available
toy compatible
condom compatible
easily washes off
Advantages
more slippery
lasts longer
less irritating
no glycerine
condom compatible
Disadvantages
sticky
short acting
many have preservatives
(irritation and infection)
Disadvantages
expensive
not as readily available
not toy compatible
can stain sheets
“Specialty” Lubes
Flavored Lubes
– Water based-edible
– Silicone based-not
edible, but not toxic.
Warming Lubes
– capsaicin
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CAPA 2015 Annual Conference
Watch for Irritating Ingredients
Benzyl Alcohol
Maybe drying agent
Glycerin
Can be considered a
drying agent
Maybe irritant for some
women with severe
atrophy
May be associated with
yeast infections
Consider avoidance in
vulvodynia patients
May upset balance of
vaginal flora
Lubricant Analysis
Vulvar Contact Dermatitis
Suspect via history:
–
–
–
–
Sudden onset
Intense pruritus
Vesiculation
Weeping lesions
Common vulvar irritants
– Spermicide, Bactericides
Common vulvar allergens
– Benzocaine
– Chlorhexidine (KY jelly)
– Parabens and propylene
glycol
– Latex
– Lanolin
Treatment
Stop all irritants
Stop overzealous hygiene
Topical steroids
- Low potency
- daily for 5-7 days
Bland emollients
– A&D, mineral oil
Sleep aid for sedation
avoid scratching
Antibiotics prn infections
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CAPA 2015 Annual Conference
Vaginal Moisturizers- Mode of Action
Bio adhesive-based polymers
Attach to mucin and epithelial cells on the vaginal wall
Carries up to 60 times its weight in water
Holds water in place on vaginal epithelial surface until it
is sloughed off
Require only two to three applications a week and does
not require reapplication before sexual intercourse.
Bachmann GA, Clin Pract Sex 1991;7: 1-8
Moisturizers
Product
Ingredients
Use
Price
Replens
Polycarbophil
Every 3 days
$17.5/14
app
Yes
Me again
Hyaluronic acid
7 days > 2/wk
$18/8 app
HA-yes
KY Liquibeads
(ovules)
Dimethicone, Gelatin,
KY long lasting
Various polymers
Glycerin, mineral oil
Studies
Propylene glycol, paraben
?
No
Glycerin, Dimethiconol
?
$16/6 app
No
Glycerin, mineral oil
Emerita personal
moisturizer
Aloe Vera Gel, Calendula,
Vitamin E, Ginseng,
Chamomile, Allantoin
As needed
$16/4 oz
No
Moist Again
Carbomer, aloe vera
As needed
$7/4 oz
No
glycerin, chlorhexidine
Hyalofemme
Hyaluronic acid
7 days > 2/wk
$17/30gram
HA-yes
Pre-seed
Hydroxyethylcellulose,
As needed
$20/9 app
Yes
Pluronic, Arabinogalactan
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CAPA 2015 Annual Conference
Hybrid: Moisturizer/Lubricant
Luvena Antibiotic® Vaginal moisturizer and lubricant
No paraben, no glycerin, no estrogens
Contains Pre-biotic lacto-peroxidase
(helps to maintain pH and decrease BV)
Lactoferrin – antagonists against yeast
Dual effect moisturizer and lubricant
Laser Treatment
Persistent Dyspareunia Post
Treatment
Evaluate tissue
Dilator Assessment
Hypertonic Pelvic floor
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CAPA 2015 Annual Conference
When Lubricants & Moisturizers
are Not Enough..
Vulvovaginal atrophy:
*BURNING
*DRYNESS
*ITCHING
*RAWNESS
*PAIN
*THIN, PALE, FRAGILE EPITHELIUM
*DECREASED SUBCUTNAEOUS FAT
*PATCHY ERYTHEMA
*INCREASES FRIABILITY
*DYSPAREUNIA
*SYMPTOMS DO NOT ABATE AND OFTEN PROGRESS OVER TIME
Local Vaginal Estrogens Boxed Warnings
Dementia
Increased risk of stroke, DVT, PE
Increased risk of endometrial cancer
Increased risk of invasive breast Cancer
Effects of Local Estrogen
Improve sensory perception
Increase central and peripheral nerve transmission
Increase lubrication
Reduce pH
Increase peripheral blood flow
Augment capacity to develop muscle tension
Increase vibratory sensation
Increase vaginal vault relaxation
Increase vaginal vault size
Increase tissue elasticity
Increase vaginal collagen content
–
Sarrel PM. Sexuality in the middle years. Obstet Gynecol Clin North Am. 1987; 14: 49-52. Gescheider GA, Verillo RT, McCann JT, et al.
Effects of the menstrual cycle on vibrotactile sensitivity. Percept Psychophys 1984; 36: 586-592. Kow L, Pfaff D. Effects of oestrogen
treatment o the size of receptive field and response threshold of the pudendal nerve in the female rat. Neuroendocrinology 1973; 13:
299-313. Lara LA, et al. J Sex Med. 2009;6:30-39. NIH State-of-the-Science Conference Statement on management of menopause-
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CAPA 2015 Annual Conference
Minimally Absorbed Local Vaginal
Topical Estrogens
Composition
Dosing
Vaginal Cream 17 B Estradiol cream
Initial 2-4 g 1-2 wk
Maintenance: 1g/d(0.1mg active ingredient /g)
Conjugated estrogens
0.5-2.0 g/d ( 0.625 mg active ingredient/g)
(Formally conjugated equine estrogens)
Vaginal Ring
17 Beta Estradiol
Device contains 2mg
Releases 7.5 microgram per day for 90 d
Vaginal tablet
Estradiol hemihydrate
Initial dose: 1 tab q/day for 14day
Maintenance 1 tab BIW
(Tablet 10.3 mcg of estradiol
hemihydrate, equivalent to 10mcg of
estradiol)
North American Menopause Society. Menopause. 2007;14:357-369. Cirigliano M. J Women's Health (Larchmt). 2007;16:600–
631.
Simon JA, et al. Obstet Gynecol. 2008;112:1053-1060. Simon JA, et al. Obstet Gynecol. 2010; 116 (4): 1-8
Is Local Really Local?
Kendall et. al. cautions that vaginal estradiol is
contraindicated in postmenopausal women on adjuvant
aromatase inhibitors1.
Labrie et. al. demonstrate that even small doses of vaginal
preparations
– Vagifem 25 μg; Premarin Vaginal Cream result in significant
systemic absorption through estrogen naive vaginas(2).
Naessen et al showed that 7.5 μg/24h could improve the
lipid profile and bone density without affecting the
endometrium3-5.
1Kendall A, et. al. Ann Oncol 2006;17:584-587. 2Labrie F, et. al. Menopause 2009;16:30-36. 3-5Naessen T, et. al. J Clin Endocrinol
Metab 2001;86:2757-2762.; Am J Obstet Gynecol 1997;177:115-119.; Am J Obstet Gynecol 2002;186:944-947.
Current Overview of the Management of Urological
Atrophy in Women with Breast Cancer
Pruthi S, Simon JA, Early AP. Breast J. 2011 Jul-Aug;17(4):403-8. doi: 10.1111/j.1524-4741.2011.01089.x. Epub 2011 Jun 6
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CAPA 2015 Annual Conference
Perivaginal Blood Flow During
Estrogen Replacement Therapy
Milliwatts (mW)
250
244.7
240
236.6
230
225.8
220
210
208.4
200
190
Baseline
1 Month
3 Months
6 Months
Increase in blood flow values in women estrogen-deprived
at baseline, and then administered conjugated estrogens.
Semmens J et al. JAMA. 1982;248:445-448.
Normalized Change in
Clitoral Volume Subjects 5–12
Subject 5
Subject 6
Subject 7
Subject 8
Subject 10
Subject 12
25
20
Normalized to pre-erotic time point
Volume (cc)
15
10
5
0
-5
Erotic Video
Neutral Video
Neutral Video
Dynamic MRI Time Points
MRI = magnetic resonance imaging.
Courtesy of Ken Maravilla, MD - Seattle, WA, 2003
Alternative
Intravaginal DHEA
Intravaginal testosterone
Intravaginal Oxytocin
Intravaginal Bovine Colostrum
Intravaginal Estriol
ORAL: Osphena®
ORAL: DuaVee ®
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CAPA 2015 Annual Conference
Intravaginal DHEA
(Vaginorm/Prasterone ®)
Labrie et al
– Journal of Steroid Biochemistry and Molecular
Biology 111 (2008) 178-194
Treatment
– One ovule of DHEA 0.0%, 0.5%, 1.0% or 1.8%
– 7 days vaginal PH was significantly decreased
– Serum Estradiol and Testosterone remained within normal
postmenopausal values at all DHEA values
– DHEA permits rapid effects for local beneficial effects against
vaginal atrophy, without changes in estradiol thus avoiding the
increased risk of breast cancer associated with the current
intravaginal or systemic estrogenic formulations
Labrie et al. Menopause vol 16 no 5 907-922
Ospemifene (Osphena(r)
Vaginal Estrogen Receptor Agonist
2010 RCT Stage III: SERM ospemifene
– Quatrix Inc/ Shionogi Inc
827 women randomized either 30, 60 mg or placebo for 12 weeks
60 mg was shown to be effective, well tolerated for vaginal dryness and
dyspareunia
No proliferative effect on endometrium
Side effect: 8 % hot flashes
– 0.7% severe in 60mg group
– one participant (0.4%) in the 60 mg group discontinued because of
hot flashes.
–
Bachman et al. Menopause: 17:3:: 480-486
Interesting: Ospemifene and 4-hydroxyospemifene effectively prevent
and treat breast cancer in Mtag.TG Transgenic Mouse.
–
Burich et al Menopause 19:1: 96-103
Ospemifene and The Breast
Breast Antagonist
Pre-clinical Trials: Ospemifene shrunk
breast tumors in rats
Clinical Trials: Breast neutral
Patient with breast cancer or at risk for
breast cancer is the ideal candidate.
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CAPA 2015 Annual Conference
Neogyn Feminine Cream
Cellular Lysate Cream that has been shown to be
soothing for vulvar tissues
MORE THAN 100 CYTOKINES; GROWTH FACTORS; INTERFERONS
AND ANTI-INFLAMMATORY INTERLEUKINS IL-1RA, IL-4, AND IL-10.
*In clinical Studies
improvement in symptoms of atrophy
vulvar pain disorders
vulvodynia,
lichen sclerosus
No evidence that local vaginal estrogen
use increases recurrence
NAMS position Statement give
“permission”
Many physicians still reluctant to prescribe
local estrogen to women with breast
cancer
Even with physician reassurance, most
women are reluctant to use a local vaginal
estrogen
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CAPA 2015 Annual Conference
Dilators
GOAL: Reconnection with the vagina;
Vaginal biofeedback
Center Program
– Use 2-3 times a week
– Use lubricant with exercises
– Slowly and progressive ( 2-3 weeks per size)
– Gradually increase size and time
– Premedication is allowed
– Lidocaine and lubricant should be used
– Relaxation and distraction techniques during medical
exercise
– Frequent follow up visits
Self stimulation is a medical treatment
Write it on a prescription pad
The Impact of Atrophy
Emotional
Isolation
Physical changes
Atrophy
Relationship
Discord
Decreased Sexual
Self Esteem
50
Summary
Aging is a natural, progressive
process
Sexual dysfunction affects the
couple, not just the individual
Chronic diseases play a major role
in sexual health status
The neurohormonal connection
facilitates desire and the arousal
response
Multiple therapy options exist for
both partners
17
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