Vulvodynia: A state-of-the-art consensus on definitions, diagnosis and management

Department of Obstetrics, Gynecology and Reproductive Sciences, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
The Journal of reproductive medicine (Impact Factor: 0.7). 07/2006; 51(6):447-56.
Source: PubMed
ABSTRACT
Vulvodynia is a chronic pain syndrome affecting up to 18% of the female population. Despite its high prevalence and associated distress, the etiology, diagnosis and clinical management of the disorder have not been clearly delineated. This "white paper" describes the findings and recommendations of a consensus conference panel based on a comprehensive review of the published literature on vulvodynia in addition to expert presentations on research findings and clinical management approaches. The consensus panel also identified key topics and issues forfurther research, including the role of inflammatory mechanisms and genetic factors and psychosexual contributors.

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Available from: Alessandra Graziottin, Sep 09, 2015
1
Vulvodynia is a prevalent and highly distressing disor-
der, with major consequences for interpersonal and psy-
chologic well-being. Due to the high level of psychologic
distress commonly associat-
ed with the disorder, as well
as the absence of evidence-
based guidelines for clinical
practice, a multinational
consensus conference on the
topic of vulvodynia was con-
vened. The first National In-
stitutes of Health (NIH)–
sponsored conference on this
topic was held in 1997, shortly after which a program of
funded vulvodynia research was initiated. A second NIH
meeting was convened in 2003 to present an overview of
the science and epidemiology of vulvodynia with a focus
on the fundamental mechanisms of this pain disorder.
The meeting on which this article is based was held in
October 2004 in association with the Third Annual
Meeting of the International Society of Women’s Sexual
Health. The areas that were addressed included the defi-
nition of vulvodynia, comorbid conditions, disease pro-
gression, diagnosis and workup of the patient with vul-
vodynia, clinical
management and research
needs. The overall goals of
the conference were to criti-
cally assess available data on
vulvodynia and related syn-
dromes, to develop a consen-
sus paper on vulvodynia that
included recommendations
for research (basic and clini-
cal) and to consider future needs of this patient popula-
tion. (J Reprod Med 2006;51:0000–0000)
Keywords: vulvar diseases, consensus workshop,
vulvodynia.
Vulvodynia is a chronic disorder in women, charac-
terized by provoked or constant vulvar pain of
From ________________________.
Funding support for the majority of individual research projects, as well as development of the consensus conference report, was pro-
vided by grants from National Institutes of Health–National Institute of Child Health and Development and National Institutes of
Health–Office of Research on Women’s Health. Support of the conference also was provided by unrestricted educational grants from
Johnson & Johnson, Pfizer, Solvay, Yaminouchi and Noven.
Address correspondence to: __________________________.
Financial Disclosure: The authors have no connection to any companies or products mentioned in this article.
Vulvodynia
A State-of-the-Art Consensus on Definitions, Diagnosis and
Management
Gloria A. Bachmann, M.D., Raymond Rosen, Ph.D., Vivian W. Pinn, M.D.,
Wulf H. Utian, M.D., Ph.D., Charletta Ayers, M.D., M.P.H., Rosemary Basson,
F.R.C.P.(UK), Yitzchak M. Binik, Ph.D., Candace Brown, M.S.N., Pharm.D.,
David C. Foster, M.D., M.P.H., John M. Gibbons, Jr., M.D., Irwin Goldstein, M.D.,
Alessandra Graziottin, M.D., Hope K. Haefner, M.D., Bernard L. Harlow, Ph.D.,
Susan Kellogg Spadt, Ph.D., C.R.N.P., Sandra R. Leiblum, Ph.D., Robin M. Masheb,
Ph.D., Barbara D. Reed, M.D., M.S.P.H., Jack D. Sobel, M.D., Christin Veasley, M.A.,
Ursula Wesselmann, M.D., Ph.D., and Steven S. Witkin, Ph.D.
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Vulvodynia is a prevalent and highly
distressing disorder, with major
consequences for interpersonal and
psychologic well-being.
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varying intensity without obvious concomitant
clinical pathology. Two subsets of vulvodynia are
recognized: generalized and localized pain sub-
types, the latter currently referred to as vestibulody-
nia or vestibulitis. This condition has been shown to
affect 15–20% of women in the United States either
currently or previously.
1
As well as vulvar pain
there is typically burning and, less often, itching.
Pathologic findings include chronic inflammation
(thought to be due to up-regulation of local mast
cells), proliferation of local pain fibers (indicating
up-regulation of the local pain system) and contrac-
tion of the levator ani muscle in response to pain
(indicating up-regulation of pelvic muscle tone).
Despite the high prevalence and significant burden
of distress associated with this disorder, few large-
scale surveys of vulvodynia have been conducted,
and laboratory models of the disorder are lacking.
Several new methods, some validated and others
not, have been developed for assessment and mea-
surement of vulvar pain. Most self-report question-
naire methods in use today for assessing sexual
function and quality of life (including mood state)
and aspects of vulvar pain have been validated.
Clinical evaluation currently includes detailed his-
tory and careful examination of the vulva and in-
troitus, physiologic testing, general medical exami-
nation, laboratory evaluation, and psychologic and
sexual assessment. Imaging methods, as well as ge-
netic, immunologic, hormonal, neurogenic, muscu-
lar and inflammatory markers also have been em-
ployed in vulvar pain assessment, but none have
been standardized or widely adopted. Recent mul-
tidimensional treatment approaches have been de-
scribed but await prospective evaluation in well-
controlled clinical trials. Although treatment for all
medical disorders should be directed, if possible, at
the underlying etiology or pathophysiologic
processes involved, this is difficult to achieve with
vulvodynia in view of the uncertainty of the etiolo-
gy and the heterogeneity of pathophysiologic
mechanisms thought to be involved. Indeed, vulvo-
dynia may be a final result or common pathway for
several pathologic processes such that any 1 man-
agement strategy may not be adequate for all
women with complaints of vulvar pain. Treatment
interventions, given sequentially or in combination,
have ranged from psychotherapy and behavioral
counseling, pharmacologic interventions and
pelvic floor physiotherapy to surgical removal of
portions of the affected vestibule. Management
guidelines have been proposed by specific profes-
sional organizations, although these have yet to be
broadly adopted.
The meeting was cochaired by Dr. Vivian Pinn
(NIH Office of Research on Women’s Health
[ORWH]) and Dr. Wulf Utian (founding president,
North American Menopause Society). Program
cochairs were Drs. Gloria Bachmann and Raymond
Rosen of the Robert Wood Johnson Medical School
(University of Medicine and Dentistry of New Jer-
sey). A multidisciplinary, international faculty rep-
resenting endocrinology, epidemiology, family
medicine, infectious diseases, neurology, obstetrics
and gynecology, pathology, pharmacology, psychi-
atry, psychology, sexual medicine, and urology was
convened. Seven funded NIH–National Institute of
Child Health and Development (NICHD) investi-
gators presented clinical and basic science data as
well as new assessment and treatment models
based on their research programs. The conference
also brought together representatives from the
leading funding agencies (NICHD, ORWH), the
National Vulvodynia Association, representatives
of the pharmaceutical industry, and investigators
from academic and clinical settings working in this
area.
For this consensus paper, the panel reviewed the
guidelines and publications from professional or-
ganizations as well as specific research findings re-
ported at the meeting and in the recent peer-re-
viewed literature. Our major focus was on topics or
concerns considered to be priority areas for future
investigation or understanding. The paper does not
specifically address clinical guidelines and scientif-
ic data that have been previously reported in the lit-
erature. Emphasis also was placed on the pressing
need for professional and public education in this
underrecognized area of women’s health.
Section 1: Definition, Comorbid Conditions and
Disease Progression
Definitions of generalized and localized vulvody-
nia have varied widely. Vulvodynia (derived from
the Latin vulva and Greek odynia, or pain) is a de-
scriptive term referring to chronic pain in the vul-
var area of at least 3–6 months’ duration. The con-
dition was not officially recognized until 1880, was
overlooked for more than 80 years and then resur-
faced in gynecologic texts in the 1980s. The working
definition for the consensus panel was chronic pain
lasting from 3 to 6 months in the vulvar region
without a definable cause.
Vulvodynia may be chronic or unremitting, inter-
2
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mittent or episodic (often exacerbated premenstru-
ally) or may occur only in response to a touch stim-
ulus, including tight clothing or physical stimula-
tion in the vulvar area (such as with coitus or pelvic
examination). The sensation of pain from a touch
stimulus is termed allodynia. Physical signs of vul-
vodynia are limited to variable erythema of the
vestibule, although this finding has been found to
lack reliability and interrater consistency.
2
The con-
dition of vestibulodynia (vulvar vestibulitis [VVS]),
considered a subtype of vulvodynia, is defined as
chronic pain in the vestibule associated with allo-
dynia of the introital margin (outer edge of hymen
and inner edge of inner surface of labia minora),
often extending to the openings of the Skene ducts
on each side of the urethra. There was a lack of
agreement as to whether vestibular allodynia with-
out ongoing chronic vulvar pain represents a med-
ical entity different from vulvodynia.
3
Other recog-
nized medical disorders with a possible chronic
vulvar pain component include vulvovaginal Can-
dida infections, endometriosis, nonneoplastic ep-
ithelial conditions and neoplasms, contact dermati-
tis, hypoestrogenic and hypoandrogenic atrophy,
neurologic etiologies (pudendal nerve entrapment
syndrome), referred pain from myalgic muscles (le-
vator ani), iatrogenic conditions (painful outcome
after perineal surgery, such as episiorraphy and
hemorroidectomy) and pelvic/perineal radiothera-
py. However, these conditions do not fit the classi-
fication of vulvodynia since they have a concomi-
tant clinical pathology
The panel had several recommendations regard-
ing definition, comorbid conditions and disease
progression.
1. Standardize the Definition
Currently, multiple terms are used to describe this
condition. The terminology is ambiguous and po-
tentially confusing for clinicians as well as patients.
A diagnostic terminology needs to be developed
and adopted by specialty societies, such as the
American College of Obstetricians and Gynecolo-
gists, the Sexual Medicine Society of North Ameri-
ca, the International Society for the Study of Vulvo-
vaginal Disease (ISSVD), the North American
Menopause Society and the International Associa-
tion for the Study of Pain, so that clinicians who
treat women with this condition can communicate
reliably and accurately regarding their findings and
diagnoses. Terminology developed recently by the
ISSVD recommends classification into subtypes of
generalized vs. localized and provoked vs. unpro-
voked vulvodynia.
4
This recommendation raises
further questions regarding whether vulvar pain
that is localized to 1 trigger point should be diag-
nosed as distinct from generalized vulvar pain. An-
other concern raised by the panel was whether
women with referred pain that involves other areas
of the body in addition to the vulvar-vaginal area
should receive the same diagnosis as women with
pain confined only to the vulva.
The panel noted that subtyping and diagnostic
classification of vulvodynia have not been stan-
dardized, nor are they evidence based. Not all pan-
elists endorsed the need for such subtyping. The
panel proposed that the definition of vulvodynia, as
one of the chronic urogenital pain syndromes, be
limited to pain located in the vulvar area of at least
3–6 months’ duration without another definable
cause. Descriptors such as “generalized or local-
ized” should be used, together with an accurate
pain map, which describes the site and the intensi-
ty of pain by the woman’s history and elicitation of
symptoms by the woman’s report during pelvic ex-
amination. The use of other terms to define and sub-
type underlying conditions may not be warranted.
Other urogenital pain syndromes that should be
considered before the diagnosis of vulvodynia is
made include urethral syndrome, interstitial cysti-
tis and coccygodynia.
5
The terminology used to de-
scribe these other urogenital pain syndromes is cur-
rently under review by several specialty societies.
In the future, it may be necessary to coordinate the
diagnostic terminology used for chronic pain con-
ditions since the etiology and pathophysiology of
these syndromes may be similar. Regardless of the
etiology and characterization, the panel viewed
vulvodynia, similar to headache, as a legitimate
medical entity, with a spectrum of etiologies and
clinical presentations.
2. Characterize the Pain Precisely
Nomenclature describing the type and intensity of
pain and the chronicity and impact of symptoms
should be standardized. Pain modifiers, such as the
degree and characterization of the pain (burning,
pressure, throbbing, etc.), also should be included
in the description. The panel questioned whether
variations in pain severity or by location be consid-
ered different symptoms or (in the future) distinct
subtypes of vulvodynia.
The issue of whether vulvodynia reflects pelvic
floor dysfunction with trigger points of pain or
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whether it is a form of referred pain or a result of
dysfunctional nerve fibers in the pelvis also was
raised. Any pain “locally” perceived in any region
of the body can be: (1) elicited by any agonist factor,
causing local damage and inflammation (chemical,
physical, infectious, degenerative, endocrine, etc.);
(2) referred (like the nondermatomic referred pain
from myalgic muscles); (3) mediated via antidromic
neurotransmission along sensory nerves leading to
neurogenic degranulation of mast cells with further
antegrade stimulation from mast cell chemicals, in-
cluding histamine, tryptase and bradykinin; (4) re-
ferred from damaged afferent nerves (in the vulva,
pudendal neuralgia); and (5) resulting from central
sensitization of dorsal horn cells from altered de-
scending inhibitory and/or excitatory input from
the brain.
3. Encourage Universal Recognition of the Term
Vulvodynia
A major effort should focus on better recognition of
the term vulvodynia, especially by the lay public;
that would ultimately translate into improved iden-
tification of the condition by health care providers.
A distressing aspect of vulvodynia is that women
with this condition frequently report that they have
experienced the pain for many months, usually
years, before a diagnosis is made. Others are told
that their symptoms are “all in their head.” This im-
plies to the woman that somehow her pain is not
real. Failing to make the diagnosis of vulvodynia
and to explain the current understanding of this
condition may contribute in some instances to in-
terpersonal distress and lack of family support for
the woman. Missing the diagnosis also may pre-
clude access to the more specialized medical care
often needed for this condition. Because the termi-
nology is not widely recognized, many women
with this condition are unaware of such terms as
vulvodynia and vestibulodynia and may erroneously
self-label themselves with an inaccurate diagnosis.
Working with professional societies and public or-
ganizations that care for women is necessary and
could serve as a means of promoting and encourag-
ing clinical trial work and educational programs
and projects.
4. Identify Comorbid Conditions and Risk Factors
for Vulvodynia
Multiple pathologies may initiate or exacerbate
symptoms, or may share common pathogenic fac-
tors with vulvodynia. Irritable bowel syndrome
and interstitial cystitis, for example, have been sug-
gested as comorbidities or risk factors.
6
However, it
is not certain which comorbidities or contributing
factors are directly related to vulvodynia, and re-
search on the nature and importance of comorbid
conditions/risk factors is needed. For example, re-
cent data suggest that age at first use of hormonal
contraception and early difficulty with tampon use
(suggestive of a primary hyperactive pelvic floor)
may be independent predictors of vulnerability to
vulvodynia and dyspareunia.
1
Additionally, other
reports suggest that the lower levels of ethinyl
estradiol in some hormonal contraceptives might
contribute to vaginal dryness and dyspareunia,
which increase the probability of pain.
7
The condi-
tion may also be iatrogenic in some instances, such
as associated with overzealous and chronic use of
topical vulvar preparations.
5. Investigate the Biologic Mechanisms Involved
Many biologic mechanisms are being actively in-
vestigated, including inflammatory and infectious
disease processes,
8,9
as well as the role of neurolog-
ic
10
and genetic factors.
11
Stress factors, either inter-
nal or external, may increase vulnerability, either
directly, by altering the immune, neurologic and
hormonal systems, or indirectly, through increased
use of caffeine, nicotine or other lifestyle behav-
iors.
12
6. Clarify Antecedent and Subsequent Sexual
Dysfunction
The role of sexual dysfunction as a symptom or cor-
relate of vulvodynia has been insufficiently stud-
ied.
13
It is not clear whether serious sexual or psy-
chologic factors increase a woman’s risk for
vulvodynia or whether these problems more com-
monly are a consequence of chronic vulvar pain and
the resulting disruption of sexual activity.
7. Establish the Natural Progression of Vulvodynia
Scant information is available regarding the natural
history and progression of vulvodynia, with or with-
out medical intervention. Predisposing, precipitat-
ing and maintaining factors, biologic, psychosexual
and context dependent, should be carefully identi-
fied/diagnosed and addressed.
14
Furthermore, the
proportion of women with vulvodynia who are di-
agnosed in a timely manner is unknown. How
many clinicians women typically consult before ac-
curate diagnosis and assistance and factors associ-
ated with an increased likelihood of obtaining a cor-
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rect diagnosis are also unclear. An average delay of
over 4 years has been reported between the onset of
symptoms and the appropriate diagnosis of VVS.
15
Two studies of women nonselected for symptoms
indicated that as many as half of those with proba-
ble vulvodynia by history no longer have the symp-
toms, suggesting transience, previously unrecog-
nized
1,16
Section 2. Diagnosis and Workup
Although references to genital pain appear as far
back as antiquity, it was not until 1977 that
Friedrich and Dodson proposed guidelines for di-
agnosing vulvodynia.
17
These authors stated that
women with this condition typically refrain from
intercourse, have emotional lability, and are reluc-
tant to acknowledge a psychologic component to
their condition. Ten years later, specific diagnostic
criteria for VVS, variable vulvar erythema (as the
sole physical finding), pain on vestibular touch or
vaginal entry, and tenderness upon localized
vestibular pressure, were proposed by Friedrich.
18
The evaluation and diagnosis of vulvodynia have
minimally advanced over the ensuing 2 decades, as
diagnosis of the condition remains largely one of
exclusion. In addition to clarity regarding definition
and comorbid risk factors, criteria for a standard-
ized workup are needed.
Clinicians commonly suspect the diagnosis of
vulvodynia after treatment for vulvovaginal in-
flammatory and infectious etiologies have failed. At
the point of failure with treatment for other etiolo-
gies, aside from eliciting a history of pain, perform-
ing a pelvic examination, and, in some instances, a
vaginal wet prep and culture, it appears that few
clinicians perform a careful vulvar examination, in-
cluding pain mapping of the vestibule. Moreover, a
thorough “pain map” recording should include the
perineal area and inner thighs in addition to the
vulva. Bilateral tenderness and trigger points at the
insertion of the levator ani on the spine, suggestive
of a referred myalgic component of the vulvar pain
and of a key contributor to the associated dyspare-
unia, should be elicited. This finding suggests the
possibility of a referred component of vulvar pain
and the importance of a routine examination of
pelvic floor tone. Spontaneous or elicited pain in the
lower third of the anterior vaginal wall also should
be part of the pelvic examination, as it may be asso-
ciated with bladder-related comorbidities (cystal-
gia, urethralgia, postcoital cystitis, interstitial cysti-
tis) reported in up to one third of vulvodynia
patients.
5
The standard method of vulvar pain mapping is
by the use of a cotton-tipped applicator. Systemati-
cally, pressure is applied to the various parts of the
vulva to assess the extent and character of the pain
and to quantify at what exertion of pressure applied
by the examiner the pain is provoked.
19
The woman
typically rates the sensation on a nominal pain
scale, such as 1 (minimal pain) to 3 (mild pain) to 5
(maximum pain). However, this test has limited
utility since the outcome depends upon both the
clinician’s skill and consistency and the patient’s
subjective rating of the pain. To help standardize
the pressure evoking pain, use of an algesiometer or
vulvagesiometer, which allows more precise mea-
surement of pressure exerted on the vulva, has been
proposed by several investigators.
20,21
Aside from pain measurement on the vulva, a
simple set of questions, such as, “Where do you feel
pain?” (helping to record the most accurate pain
map), “When do you feel pain?” (to differentiate
spontaneous from provoked vulvodynia), “What
are your thoughts when you feel the pain?” and
“What are the associated problems or symptoms
you experience?” may aid the clinician in assessing
the pain and the woman’s reaction to it. These ques-
tions also may help the clinician to substantiate the
nature of the woman’s pain complaint, as well as af-
firming the woman’s subjective assessment of her
condition. The latter objective may be especially im-
portant for both the woman herself and for the cou-
ple, particularly in cases in which there has been an
inaccurate assessment of the vulvodynia complaint
for months or years.
The panel had several recommendations regard-
ing assessment.
1. Specific Education on the Diagnosis and
Treatment of Vulvodynia Should Be Offered During
Medical School and Residency Training Programs
That Focus on Women’s Health
The panel thought that clinicians who care for
women should have directed training in assess-
ment of vulvodynia so that diagnosis is not de-
layed. Many women erroneously are told that they
have infectious vaginitis, which may or may not be
present, and are treated for extended periods of
time with unnecessary and ineffective medications.
2. Evidence-Based Guidelines for Assessment
Should Be Developed
A standardized medical assessment, including past
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and current medical, sexual, psychologic, psychi-
atric and surgical issues, as well as a detailed, struc-
tured physical examination, should be developed.
Certain questions appear to be helpful in making
the diagnosis, such as the ability to use tampons or
wearing tight undergarments or trousers without
discomfort. Vulvar burning after intercourse at-
tempts, the presence of postcoital dysuria and vul-
var burning from a male partner’s ejaculate are typ-
ical symptoms that may be elicited from women
with vulvodynia.
Standard pelvic examination guidelines for eval-
uation of women with chronic vulvar pain are not
available. Protocols outlining how the genitalia and
pelvic floor are optimally assessed should be devel-
oped. The need for colposcopy, vulvoscopy,
22
wet
prep of vaginal secretions, vaginal culture, yeast
subtyping, bacterial markers, pH evaluation and
cytologic markers should be determined in diag-
nosing vulvodynia and following the response to
treatment.
23
Clinical advantages of vulvalgesiome-
ter assessment vs. cotton swab testing, use of graph-
ic representation or a picture chart to map areas of
allodynia and pain threshold testing should be in-
vestigated. Any role of comprehensive neurologic
evaluation or immune function assessment also
needs evaluating.
Some panelists thought that for study purposes a
vestibular biopsy was useful in understanding the
subtype of vulvodynia since an inflammatory com-
ponent with up-regulation of mast cells has been
histologically documented with immunotryptase
staining.
8
Biopsy also has been reported to demon-
strate the proliferation (up to 10 times) and more su-
perficial location of pain fibers in vestibular speci-
mens of VVS patients.
8,10
This proliferation,
probably induced by the nerve growth factor nerve
growth factor (NGF), produced by the up-regulated
mast cells and superficial location of pain fibers,
may be responsible for the hyperalgesia and allody-
nia, respectively.
11
These histologic findings sup-
port the hypothesis that VVS is an expression of hy-
perregulation of local immune and pain systems
that may be induced in susceptible individuals by a
variety of etiologies. Performing biopsies may help
to differentiate women with an inflammatory (not
necessarily infectious) etiology of pain from others
with a different pathophysiology (such as neuro-
genic), although current criteria for this are lacking.
Section 3: Clinical Management of Vulvodynia
As with any medical intervention, a clear under-
standing of the woman’s goals of management,
along with those of her partner, is necessary. Treat-
ment goals may include the wish to regain or re-
store a rewarding sexual life; to increase the under-
standing of chronic or intermittent pain, including
the mind-body connection and role of various med-
ications; to reduce self-generated stress; to deal
more effectively with external stress; and to experi-
ence a reduction and eventually elimination of pain.
The panel reviewed several treatment studies
and recent management guidelines. No standard-
ized, evidence-based treatment guidelines or algo-
rithms are available since clinical trials have not
been performed to allow evidence-based guide-
lines. Current interventions include systemically
administered drugs, such as tricyclic antidepres-
sants
24,25
; selective seritonin reuptake inhibitors
26
and anticonvulsants
27
; venlafaxine; and duloxetine.
Topical applications used by others include corti-
costeroids,
28
estrogen,
29
antiinflammatories (e.g.,
cromolyn), and anesthetics (such as lidocaine).
30
Dietary approaches include reduced oxalate,
31
and
vitamin and mineral supplements. Physical therapy
suggestions include pelvic floor manipulation,
32
electromyographic biofeedback,
33
local applica-
tions of ice packs and sitz baths, and electroanalge-
sia or antalgic block of the ganglion impar.
34
Exci-
sional vestibular surgery is an additional modality
advocated in some centers for localized vulvodynia
after other treatments have failed.
35,36
All currently
used interventions have limited data objectively
measuring safety and efficacy. A comprehensive
vulvodynia guideline with an algorithm included
was published by Haefner et al in January 2005.
37
As “best clinical practices” guidelines are devel-
oped from clinical trial data, a treatment protocol
should be prepared to include state-of-the-art rec-
ommendations for clinicians as well as practice
guidelines. The panel concurred on the need for
evidence-based, “stepped care” guidelines for clin-
ical management of vulvodynia. As the etiology
and pathophysiology of the disorder is further elu-
cidated (including the roles of potential genetic, en-
docrine, psychologic and immune aspects), future
guidelines may be tailored more to the individual
woman’s needs.
The panel had several recommendations regard-
ing management:
1. Commence Well-Designed, Prospective,
Multicenter Trials
These trials should include comprehensive med-
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ical—including genetic, immune and infectious—
evaluation of all subjects along with comprehensive
assessment of psychosexual and mental health. It
might then be possible to investigate which subsets
of women are most likely to benefit from specific
and combined interventions (e.g., diet, pharmaco-
logic therapy, self-management). Self-management
interventions include diet and lifestyle changes, in
addition to stress management, self pelvic floor
massage and sex therapy interventions. Either sin-
gle agents or a combination of 2 pharmacologic in-
terventions or 1 pharmacologic intervention paired
with self-management intervention should be sys-
tematically studied. Additionally, trials may clarify
which women are likely to benefit from the various
treatment options. Evidence-based guidelines to
measure treatment outcomes for medical and surgi-
cal intervention need to be established. Procure-
ment of long-term efficacy and outcome data also
should be encouraged for treatment effects, espe-
cially from surgical interventions. Recommended
treatments should ideally be based on results of
well-controlled, randomized, clinical trials and sub-
ject subgroup analysis. In the interim, further study
of the individual treatments used, reported side ef-
fects, and effects on pain and other outcomes
should be conducted and published.
In addition to traditional interventions, the role
of alternative therapies warrants further investiga-
tion. These include, but are not limited to, the role
of wicking underwear, mineral oil products, olive
oil, organic sanitary pads, physical therapy, dietary
restrictions, special seats for such activities as bicy-
cle riding, acupuncture, tai chi, aromatherapy, hyp-
nosis, herbal medications and self-management in-
terventions. Additionally, studies are needed to
assess the role of complementary interventions
when used prior to, or in conjunction with, phar-
macologic or surgical interventions.
2. Standardize Dosing Requirements for
Pharmacologic Interventions
Ideally, a management manual for clinicians should
be developed in cooperation with 1 or several pro-
fessional societies, with recommendations based on
clinical trial data. When pharmacologic therapies
are employed, not only should the actual chemical
class of the intervention be evaluated, but also the
dosage of medication, duration of treatment, use of
other interventions simultaneously and adverse
events/worsening of symptoms experienced by the
woman should be recorded.
3. Address Sexual Issues
A frequent and often debilitating correlate of the
disorder is sexual dysfunction. The impact of vul-
vodynia and related sexual dysfunction on the
woman’s relationship is an important area that
needs to be addressed. In addition to management
interventions, recommendations as to when the
couple needs to be referred to a specialist are need-
ed, as are criteria that characterize a specialist as ap-
propriate for such a referral.
Section 4: Expand Vulvodynia Research
With 8–15% of women in the United States experi-
encing chronic vulvar pain at some point in their
adult lives and only 70% of whom typically consult
a clinician, there is a need to add more well-
controlled, epidemiologic studies or clinical trials
directed toward this medical condition.
1
Because of
the scant data available, basic questions, such as in-
cidence and etiology, are not accurately known.
Limited investigation of the disorder may be at-
tributed to 3 factors: first, the condition was unrec-
ognized for years; second, there has been a lack of
consensus on terminology and diagnosis of the con-
dition in the medical literature; and third, many cli-
nicians do not recognize vulvodynia as a legitimate
medical disorder in women. Therefore, funding for
vulvodynia research has been virtually nonexistent
until recently.
In 1998 the NIH recognized the need for research
in this field and issued an invitation for grant appli-
cations to study the prevalence, pathology, diagno-
sis and treatment of vulvodynia Since that time, in-
vestigators at 7 academic institutions have been
awarded funding to examine the epidemiologic,
pathologic, and treatment aspects of vulvodynia:
University of Medicine and Dentistry of New
Jersey–Robert Wood Johnson Medical School (epi-
demiology, therapeutic interventions), Harvard
University (epidemiologic studies), Yale University
(cognitive behavior therapy), University of
Rochester (lidocaine and desipramine clinical tri-
als), University of Michigan (neuroimmunology
and sensory processing), Johns Hopkins University
(pathophysiologic mechanisms) and University of
Iowa (bowel and bladder comorbidity).
Current ongoing basic research is suggesting that
certain genetic variations are associated with spe-
cific subsets of women with VVS, with clusters of
these genetic variations expressed differently
among races and ethnicities. For example, data sug-
gest that American and Swedish VVS patients have
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a higher rate of carrying a variant of the mannose
binding lectin (MBL) gene than do controls.
38
An
increased susceptibility to candidal infection of the
genital tract and a reduced capacity to inhibit pro-
liferation of Candida as well as bacteria and viruses
are associated with carriage of this MBL variant.
Witkin’s data show that women with VVS had an
increased prevalence of specific polymorphisms in
genes coding for the interleukin-1 receptor antago-
nist (IL-1ra) and interleukin-1β (IL-1β) as compared
to control, and that these variations are associated
with susceptibility to inflammation and prolong the
proinflammatory response.
9
Both these findings
imply that specific subsets of women with VVS are
genetically more susceptible to vulvovaginal infec-
tion and/or inflammation and may respond with
an exaggerated inflammatory reaction. Foster’s
data complement these findings by reporting that
genetic polymorphisms of the melanocortin-1 re-
ceptor (MC1r) and IL-1ra may interact to enhance
the inflammatory and pain response in VVS.
11
In 36
VVS patients and 69 pain-free controls studied, the
combined presence of the allele 2 IL-1ra gene poly-
morphism and at least 1 of 6 MC1r polymorphisms
resulted in an 8-fold additive risk of having VVS.
Based on the MCIr polymorphisms, women with
light skin and red hair have an increased risk of
VVS. Melanocortin analogues may have potential
preventive and treatment indications in the future.
Reed also presented data supporting immunologic
alterations in women with VVS at the proceedings.
Fifty-two VVS subjects had increased levels of stim-
ulated NGF when compared to 54 matched con-
trols. This finding might explain the increased
branching of distal nerve fibers noted in women
with VVS.
Findings from these studies support the need for
basic research in helping to identify genetic, im-
munologic and infectious variations that influence
susceptibility to vulvodynia in as yet undefined
subsets of women.
Several specific issues were explored by the
panel. Vulvodynia’s role in predisposing to sexual
dysfunction was highlighted. An important ques-
tion is whether dyspareunia is a core symptom that
can precede, be concomitant with or be consequent
to vulvodynia. Also, does the identification of pri-
mary, life-long sexual dysfunction associated with
vulvodynia identify a subset of women/couples re-
quiring specific psychosexual support?
The role of cofactors, such as a primary hyperac-
tive pelvic floor (alerting symptom, difficulty with
tampon use), and/or fear of penetration and a more
general “risk adverse” attitude towards “risks” of
sexual behavior (such as early use of hormonal con-
traception) also should be explored. Regarding hor-
monal contraception, do women reporting vaginal
dryness during low-dose oral contraception use
have increased vulnerability to vulvodynia? In this
regard, do early interventions (such as teaching a
woman how to relax the pelvic floor)
14
and/or use
of hormonal contraception with higher ethinyl
estradiol content (30 μg)
7
reduce the vulnerability
to dyspareunia and vulvodynia?
Since many women may go through several treat-
ment cycles with an antiinfectious agent, data have
to be generated on the effects of repeated antibiotic
and antifungal courses of treatment (especially in
the subset of women reporting comorbidity with re-
current cystitis/irritative bladder symptoms). Re-
current Candida infection appears to be an indicator
of vulvodynia (past positive swabs for Candida in
58.1% of vulvodynia patients versus 5–8% preva-
lence in the general population).
39
Last, what are the common pathophysiologic
pathways behind medical comorbidities that ap-
pear to be more prevalent in women with vulvody-
nia?
The panel had several recommendations regard-
ing future research:
1. Investigate the Biologic and Genetic Basis of
Vulvodynia
Investigation is needed into the biologic and genet-
ic basis of vulvodynia. There may be genetic link-
ages with other well-known pain disorders in
women (e.g., fibromyalgia), and further research in
this area may help to elucidate the pathophysiology
of the disorder.
2. Increase the Number of Clinical Trials
Multicenter, randomized clinical trials with defined
outcomes, using assessment instruments with re-
producible outcome measures of outcome, should
be conducted. Randomized clinical trials and obser-
vational studies should address the role of non-
pharmacologic or self-management approaches as
well as medical and surgical interventions for vul-
vodynia. Multicenter trials are feasible to perform
on this topic, given the presence of approximately
20 clinical sites in North America that have partici-
pated in clinical studies and have clinical and/or re-
search expertise in this area. In addition, the im-
munologic, genetic or other biochemical markers in
8
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women with vulvodynia should be further studied
and correlated to treatment response. Also advocat-
ed are qualitative studies (e.g., focus groups, sur-
veys) to obtain clinical impressions and subjective
data, with an emphasis on how subjective data can
be combined with objective, or laboratory-based,
results.
3. Establish a Vulvodynia Registry
Outcome data from multicenter, randomized, clini-
cal trials or long-term registry studies are needed. A
registry study should be developed that includes
baseline and follow-up data from multiple practice
settings. Such a registry study might evaluate out-
comes associated with first- and second-line inter-
ventions, long-term care and education and pre-
vention initiatives along with the progression and
natural history of the condition.
4. Establish a National Vulvodynia Referral Network
Establishment of a national vulvodynia referral net-
work that makes referrals to individuals who are
using set protocols, pooling their outcome data and
working with health insurance agencies, is advocat-
ed. Many women are challenged trying to find
health care providers familiar with the diagnosis
and treatment of vulvodynia. A national (ideally, at
some point, international) registry of health care
providers interested in treating this patient popula-
tion is needed who are willing to monitor response
to interventions, collect outcomes and pool data, es-
pecially to follow vulvodynia longitudinally and
prospectively.
Section 5: Conclusion
Vulvodynia is a poorly defined and understudied
problem in women. In particular, evidence-based
guidelines are needed to define, diagnose and treat
this common disorder. Specific issues to be ad-
dressed include standardization of definition, re-
quirements for diagnosis and selection of outcome
measures for clinical and research use.
The number of RFAs for collaborative research
projects with strict criteria for inclusion criteria
should be increased. These should ideally focus on
the etiology, pathophysiologic mechanisms, risk
factors and comorbidities associated with vulvody-
nia. Treatment interventions should also be system-
atically evaluated in randomized, prospective clini-
cal trials, particularly multicenter trials, when
possible. Vulvodynia studies should be designed to
determine the predictors of clinical course or re-
sponse to treatment and answer questions of
whether genetic, epidemiologic, infectious, hyper-
activity of the pelvic floor and psychosocial factors
are predictive of outcome.
It is anticipated that significant advances will
occur in the next several years as the results of on-
going studies become available and greater clinical
experience with the disorder is developed. Hope-
fully these studies will not only provide some im-
mediate answers to management questions but out-
line the direction of future basic and clinical
research in this area.
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  • Source
    • "Chronic vulvar pain affects approximately 8% of the female population under 40 years old in the USA [1], with prevalence increasing to 18% across the lifespan [2]. Pharmaceutical therapy for vulvar pain has been found to be only moderately effective, with combined therapies including physical, psychological, and alternative therapies eliciting the greatest relief [3]. "
    [Show abstract] [Hide abstract] ABSTRACT: Context. Vulvar pain level may fluctuate in women with vulvodynia even in the absence of therapy; however, there is little evidence suggesting which factors may be associated with variability. Objective. Determine the feasibility of using smartphones to collect prospective data on vulvar pain and factors that may influence vulvar pain level. Methods. 24 clinically confirmed women were enrolled from a population-based study and asked to answer five questions using their smartphones each week for one month. Questions assessed vulvar pain level (0-10), presence of pain upon wakening, pain elsewhere in their body, treatment use, and intercourse. Results. Women completed 100% of their scheduled surveys, with acceptability measures highly endorsed. Vulvar pain ratings had a standard deviation within women of 1.6, with greater variation on average among those with higher average pain levels (P < 0.001). On the weeks when a woman reported waking with pain, her vulvar pain level was higher by 1.82 on average (P < 0.001). Overall, average vulvar pain level was not significantly associated with the frequency of reporting other body pains (P = 0.64). Conclusion. Our smartphone tracking system promoted excellent compliance with weekly tracking of factors that are otherwise difficult to recall, some of which were highly associated with vulvar pain level.
    Full-text · Article · Jun 2014 · Pain Research and Treatment
  • Source
    • "Our findings confirm that FMS and PVD syndromes can develop independently and that patients affected by FMS + PVD display sexual disfunctions similar to those reported by patients affected only by PVD [12, 49, 50]. The reduction in the intercourse frequency in FMS + PVD compared to FMS may be due not only to coital pain but also to the greater symptom severity which influences these patients quality of life [6, 51]. "
    [Show abstract] [Hide abstract] ABSTRACT: Objective. The aim of the study was to compare the pain symptoms of fibromyalgia patients exhibiting (FMS+PVD) and not exhibiting (FMS) comorbidity with provoked vulvodynia. Study Design. The case control study was performed in 39 patients who had been diagnosed with FMS and accepted to undergo gynaecological examination and in 36 healthy women (C). All patients completed standardized questionnaires for pain intensity, pain area, and psychological functioning. The gynaecological examination included vulvar pain pressure reactivity (Q-tip), pelvic tone assessment (Kegel manoeuver), and a semistructured interview collecting detailed information about pelvic symptoms and sexual function. Results. FMS+PVD patients displayed a higher number of associated symptoms than FMS patients. The vulvar excitability was significantly higher in FMS+PVD than in FMS and in both groups than in Controls. Half of FMS+PVD patients were positive to Kegel manoeuver and displayed higher scores in widespread pain intensity, STAI-Y2, and CESD levels than Kegel negative patients. Conclusions. The study reveals that increased vulvar pain excitability may occur in FMS patients independently of the presence of coital pain. Results suggest that coital pain develops in patients with higher FMS symptoms severity due to the cooperative effects of peripheral and central sensitization mechanisms.
    Full-text · Article · Jan 2014 · Pain Research and Treatment
  • Source
    • "Approximately 8%–18% of American women at some point in their lives have had chronic vulvar pain symptoms consistent with a diagnosis of vulvodynia.1–4 As defined by the International Society for the Study of Vulvovaginal Disorders, vulvodynia is characterized by vulvar discomfort in the absence of gross anatomical and neurological findings.3 This condition can be further subdivided into multiple classifications, highlighting its heterogeneous nature. "
    [Show abstract] [Hide abstract] ABSTRACT: The pattern and extent of clustering of comorbid pain conditions with vulvodynia is largely unknown. However, elucidating such patterns may improve our understanding of the underlying mechanisms involved in these common causes of chronic pain. We sought to describe the pattern of comorbid pain clustering in a population-based sample of women with diagnosed vulvodynia. A total of 1457 women with diagnosed vulvodynia self-reported their type of vulvar pain as localized, generalized, or both. Respondents were also surveyed about the presence of comorbid pain conditions, including temporomandibular joint and muscle disorders, interstitial cystitis, fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, endometriosis, and chronic headache. Age-adjusted latent class analysis modeled extant patterns of comorbidity by vulvar pain type, and a multigroup model was used to test for the equality of comorbidity patterns using a comparison of prevalence. A two-class model (no/single comorbidity versus multiple comorbidities) had the best fit in individual and multigroup models. For the no/single comorbidity class, the posterior probability prevalence of item endorsement ranged from 0.9% to 24.4%, indicating a low probability of presence. Conversely, the multiple comorbidity class showed that at least two comorbid conditions were likely to be endorsed by at least 50% of women in that class, and irritable bowel syndrome and fibromyalgia were the most common comorbidities regardless of type of vulvar pain. Prevalence of the multiple comorbidity class differed by type of vulvar pain: both (37.6% prevalence, referent), generalized (21.6% prevalence, adjusted odds ratio 0.41, 95% confidence interval 0.27-0.61), or localized (12.5% prevalence, adjusted odds ratio 0.31, 95% confidence interval 0.21-0.47). This novel work provides insight into potential shared mechanisms of vulvodynia by describing that a prominent comorbidity pattern involves having both irritable bowel syndrome and fibromyalgia. In addition, the prevalence of a multiple comorbidity class pattern increases with increasing severity of vulvar pain.
    Preview · Article · Apr 2013 · Journal of Pain Research
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