Korean Journal of Urology
Ⓒ The Korean Urological Association, 2013
Korean J Urol 2013;54:48-52
A Retrospective Study of the Management of Vulvodynia
Yongseok Jeon, Youngjun Kim, Bosun Shim, Hana Yoon, Youngyo Park, Bongsuk Shim,
Woosik Jeong, Donghyun Lee
Department of Urology, Ewha Womans University School of Medicine, Seoul, Korea
Purpose: Vulvodynia is characterized by chronic vulvar pain caused by sexual inter-
course and often results in female sexual dysfunction. Because the causes of vulvodynia
are not clear, many patients do not receive optimal treatment. Recently, gabapentin
and botulinum toxin A have both been shown to be effective treatments for vulvodynia.
In this study, we retrospectively analyzed the clinical outcomes of botulinum toxin A
and gabapentin treatment for chronic pain in women with this condition.
Materials and Methods: Seventy-three women with vulvar pain were administered ei-
ther gabapentin (n=62) or botulinum toxin A (n=11) injections. Effectiveness was meas-
ured by use of a visual analogue scale (VAS). We analyzed the treatment method, treat-
ment duration, success of treatment, and side effects or adverse reactions.
Results: Pain levels in both groups significantly decreased after treatment. In the gaba-
pentin group, the VAS score decreased from 8.6 before treatment to 3.2 after treatment
(p＜0.001). The VAS score in the botulinum toxin A group was reduced from 8.1 to 2.5
(p＜0.001). Side effects for both therapies were few and subsided with treatment with
general antibiotics and nonsteroidal antiinflammatory drugs.
Conclusions: Gabapentin and botulinum toxin A are safe and effective treatments for
vulvodynia. This condition can cause sexual dysfunction and affect quality of life.
However, with proper management, satisfactory outcomes for women with vulvodynia
can be achieved.
Keywords: Dyspareunia; Gabapentin; Type A botulinum toxins; Vulvodynia
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial
License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use,
distribution, and reproduction in any medium, provided the original work is properly cited.
received 11 June, 2012
accepted 10 September, 2012
Department of Urology, Ewha Womans
University School of Medicine, 1071
Seoul 158-710, Korea
Vulvodynia is a condition in women that is characterized
by chronic vulvar pain. It may be present constantly, inter-
mittently, or only with intromission during sexual inter-
course. The term vulvodynia was originally coined by
McKay , and it has been adopted by the International
Society for the Study of Vulvar Disease Task Force to de-
scribe any vulvar pain . There are no standardized clas-
sifications for vulvodynia largely because it is a multi-
factorial condition in which certain subsets coexist within
others. Generalized vulvodynia, or essential vulvodynia,
usually occurs in postmenopausal or perimenopausal
women and is exhibited by diffuse, unremitting, and burn-
ing pain that is not cyclic [1-4]. This pain may occur in differ-
ent areas of the vulva at different times, and it may be con-
stant or occur only every once in a while. Vulvar vestibulitis
syndrome is specifically characterized by pain in the vesti-
bule and usually occurs in premenopausal women. In this
condition, pain occurs with vaginal entry by the penis or
a tampon [1,2].
Patients with vulvodynia usually describe their pain as
a chronic burning in the vulvovestibular area that typically
lasts more than 3 months. Before a diagnosis of vulvodynia
is made, other vulvovaginal problems should be ruled out
[3,4]. Vulvodynia not only causes pain, but often leads to
sexual dysfunction, including arousal and orgasmic diffi-
culty [3,4]. For many women, it reduces overall personal
health and quality of life.
The etiology of vulvodynia is not clear, and because of
Korean J Urol 2013;54:48-52
A Retrospective Study of the Management of Vulvodynia
FIG. 1. The process of pain mapping and intralesional botulinum toxin A injection. (A) Using the Q-tip test, all painful areas were
checked for intensity and localization. (B) Pain was scored by use of a visual analogue scale and mapped. (C) Botulinum toxin A was
injected on the basis of the pain map (20 IU in each site, up to a maximal total dose of 100 IU).
this, many patients do not receive optimal treatment. The
most common type of vulvodynia is vulvar vestibulitis syn-
drome, which usually has an acute onset . Vulvodynia
is generally associated with vaginitis, changes in sexual ac-
tivity, and a history of medical procedures on the vulva such
as cryotherapy or laser treatment (after which it often be-
comes a chronic problem). With vulvodynia in general, vul-
var pain is variable in intensity, from mild to disabling.
Patients may feel burning, stinging, rawness, aching, sore-
ness, or throbbing that occurs in the vulva, labia, or vagina.
A large proportion of patients attend multiple medical con-
sultations before receiving a diagnosis, and no single treat-
ment or combination of treatments have been shown to con-
sistently improve the symptoms. Recently, gabapentin a
γ-aminobutyric acid (GABA) analogue anticonvulsant and
botulinum toxin A have been shown to be effective in treat-
ing vulvodynia [3,6]. In this study, we performed a retro-
spective analysis of the clinical characteristics and the out-
comes of these 2 drugs in the treatment of patients with
MATERIALS AND METHODS
This study was conducted by use of data from 73 patients
presenting with sexual dysfunction and vulvodynia out of
164 total women with vulvar pain who visited our clinic
from 2002 to 2010. We reviewed the patients’ medical his-
tories and noted the type of drugs administered for pain
treatment and the duration of treatment. We also per-
formed physical examinations, including a vaginal exami-
nation and vulvovaginal pain mapping with a cotton tip,
to determine the location and degree of pain and to rule out
other treatable causes of vulvar pain, such as infections of
the vagina or uterus and genitourinary benign or malig-
nant tumors. Vulvodynia was diagnosed if the patient had
no other causes of vulvar pain that occurred either only dur-
ing sexual activity or constantly. To rule out other painful,
treatable, vulvar diseases, the patients’ previous and cur-
rent medical histories and medications were reviewed and
urinalysis, urine culture with sensitivity test, papanico-
laou test smears, and basic hematological tests were per-
formed on all 164 vulvar pain patients. Patients with ab-
normal test results suggesting definitive infection, benign
tumor, or painful bladder syndrome were excluded, result-
ing in 73 patients with a diagnosis of vulvodynia of un-
Using the Q-tip test, a cotton-tip was used to confirm pain
in the vulvovestibular area and to measure its intensity
and localization (Fig. 1A, B). The patient’s objective pain
intensity was evaluated by use of a visual analogue scale
(VAS) and was scored from 0 to 10. All pain characteristics
were self-recorded by the patient on a questionnaire.
Patient data were analyzed according to treatment (either
botulinum toxin A injection or gabapentin oral medi-
cation), treatment response, treatment duration, side ef-
fects, and pre- and posttreatment changes in VAS score.
The method of vulvodynia treatment was selected accord-
ing to patient preference or response to previous treat-
ment. Gabapentin was prescribed to the patients who pre-
ferred to take oral medication, with an initial dose of 300
mg per day that was flexibly increased depending on
response. Gabapentin administration was intended for at
least 2 months, although the actual duration depended on
patient willingness and response.
Intralesional injection of botulinum toxin A (Botox,
Allegran Inc., Irvine, CA, USA) was used for patients who
preferred an injectable treatment and for those experienc-
ing no pain relief from gabapentin oral treatment after
more than 3 months. For treatment with botulinum toxin
A, the entire vulvovestibular pain area was mapped with
a Q-tip. The drug was injected into the submucosal layer
at each painful area, after the pain in that area was re-
confirmed (Fig. 1B, C). The dose of botulinum toxin A at
each injection site was 20 IU, and the total number of in-
jection sites was limited to 5. The minimum total dose was
40 IU and the maximum dose was 100 IU. Two weeks after
the injection, a telephone interview was conducted to check
for any adverse reactions. If significant pain persisted at
any area of the vulvar vestibule at the 4-week follow-up,
additional injections were administered by use of the same
method. After the second round of injections, no further
treatments were administered. Side effects, adverse re-
Korean J Urol 2013;54:48-52
Jeon et al
TABLE 1. Patient ages and treatment characteristics
CharacteristicGabapentin Botulinum toxin A
No. of patients
Age (y), mean±SD (range)
Treatment duration (mo)
Dose, mean (range)
329.03 mg/d (300–900 mg/d)
Nausea (6.5%, 4/62)
Drowsy (9.7%, 6/62)
Follow-up, 12.7 (6–24)
59.1 IU (40–100 IU; median, 50 IU)
Temporary pain on injection site (18.2%, 2/11)
SD, standard deviation.
FIG. 2. Pre- and posttreatment changes in visual analogue scale
scores for the gabapentin and botulinum toxin A treatment
actions, and treatment outcomes were assessed at 4 and 8
weeks after the initial injections. Every 2 months after the
final round of injections, change in pain level and total dose
received were recorded.
All procedures were performed in an outpatient clinic
with informed consent. To prevent infection, prophylactic
antibiotics were prescribed. To compare changes in pre-
and posttreatment VAS scores, data were analyzed by use
of a paired t-test with statistical significance set at p＜0.05.
Seventy-three patients with vulvodynia were analyzed for
this study, 6 of whom reported being unable to have sexual
intercourse as the result of severe vulvar pain. Sixty-two
patients (mean age, 45.7±9.0 years; range, 31 to 65 years)
were treated with gabapentin and 11 (mean age, 39.9±9.5
years; range, 25 to 55 years) were treated with botulinum
toxin A (Table 1). Four (6.5%) of the 62 women treated with
gabapentin later converted to botulinum toxin A treatment
owing to unsatisfactory improvement after more than 2
months of gabapentin treatment (600 mg in 2 patients, 300
mg in 2 patients). The mean duration of gabapentin treat-
ment was 2.3±1.8 (range, 0.5 to 6 months) months, and the
mean dose was 329.0 mg/d (range, 300 to 900 mg/d). The
effective dose was 600 mg for 4 patients (6.5%), 900 mg for
1 patient (1.6%), and 300 mg for the remaining 57 patients
(91.9%). The mean duration of botulinum toxin A treat-
ment was 12.7 months (range, 6 to 24 months), and the
mean effective dose was 59.1 IU (range, 40 to 100 IU). The
effective dose of botulinum toxin A was 40 IU for 2 patients
(18.1%), 70 IU for 1 patient (9.1%), and 100 IU for 8 patients
(72.7%). Five patients received 2 rounds of injections: 2 of
these received 20 IU initially and 20 IU at week 4 (total 40
IU), 1 received 40 IU initially and 30 IU at week 4 (total 70
IU), and 2 received 40 IU initially and 60 IU at week 4 (total
100 IU). The other 6 patients had only initial injections, all
at a total dose of 100 IU.
Pretreatment VAS scores were 8.6 (range, 6 to 10) for the
gabapentin treatment group and 8.1 (range, 5 to 10) for the
botulinum toxin A treatment group. Posttreatment VAS
scores were significantly reduced for each group: 3.2
(range, 1 to 8) for the gabapentin group and 2.5 (range, 0
to 5) for the botulinum toxin A group (p＜0.001) (Fig. 2).
A total of 50 (80.6%) of 62 patients in the gabapentin
treatment group were satisfied with the treatment, and 8
(72.7%) of 11 patients in the botulinum toxin treatment
group were satisfied with the treatment. All four patients
who converted from gabapentin to botulinum toxin in-
jection were satisfied with the result after the injection. In
the gabapentin group, 4 patients (6.5%) experienced nau-
sea and 6 (9.7%) experienced drowsiness, but there were
no cases of drug withdrawal. Two patients in the botulinum
toxin A group (18.2%) felt a burning sensation with tran-
sient pain at the injection sites, but these symptoms were
resolved with conservative treatment without any sig-
Vulvodynia is a chronic vulvar pain syndrome, the cause
and visible pathology of which remain unclear. Patients
with vulvodynia usually describe their pain as a chronic
burning occurring in the vulvovestibular area that typi-
cally lasts longer than 3 months . The vulvovestibular
areas of these patients appear normal, and therefore the
syndrome is often misdiagnosed as psychosomatization or
female urethral syndrome. In 1988, the International
Society for the Study of Vulvovaginal Disease adopted the
term vulvodynia with the following classifications: vulvar
Korean J Urol 2013;54:48-52
A Retrospective Study of the Management of Vulvodynia
dermatoses, cyclical vulvitis (or cyclical candidiasis), vul-
var vestibulitis, vulvar papillomatosis, and essential (or
dysaesthetic) vulvodynia . Although this classification
is currently not often used, it may be generally applied to
patients who have chronic pain or burning lasting for 3
months and with no obvious visible lesions . For women
with sexual dysfunction, the clinical diagnosis of vulvody-
nia is generally limited to essential vulvodynia without any
Pain is a complex sensation involving sensory-discrim-
inative, affective-motivational, and cognitive-evaluative
aspects. A recent theory on the cause of vulvodynia sug-
gests that neurogenic inflammation and the accompanying
pain are chronic sequelae of central and peripheral sensiti-
zation resulting from the bidirectional influence of periph-
eral inflammation and the nervous system [8-10]. Gaba-
pentin a GABA analogue anticonvulsant possesses both
antiepileptic and antinociceptive effects. It is used to treat
sympathetic dystrophy, trigeminal neuralgia, postherpet-
ic neuralgia, diabetic neuropathy, migraine, acute pain in
herpes zoster infection, and other types of neuropathic pain
. Although its mechanism of action is unclear, several
possibilities have been suggested, including 1) selective ac-
tivation of the heterodimeric GABA (B) receptor subunits
GABA (B1a) and GABA (B2), 2) selective enhancement of
the N-methyl-D-aspartate current at GABAergic inter-
neurons, 3) blockage of the α-amino-3-hydroxy-5-meth-
yl-4-isoxazolepropionic acid-receptor-mediated transmi-
ssion in the spinal cord, 4) binding to the L-alpha-amino
acid transporter, 5) activation of adenosine triphospha-
te-sensitive K(+) channels, 6) activation of hyperpolariza-
tion-activated cation channels, and 7) modulation of
Ca(2+) current by selective binding to the specific binding
site of [3H]gabapentin (the alpha 2/delta subunit of volt-
age-dependent Ca(2+) channels) . Gabapentin is be-
lieved to have different mechanisms of action for different
Several studies have shown that gabapentin admin-
istration yields significant results in the treatment of vul-
vodynia, with more than 80% of patients reported to experi-
ence symptom improvement [11-14]. Boardman et al. 
found this treatment to reduce vulvar pain from a VAS
score of 7.26 to a score of 2.49. In our study, gabapentin pro-
duced similar antinociceptive outcomes, reducing VAS
scores from 8.6 to 3.2 (p＜0.001). However, the mechanism
of action by which gabapentin relieves chronic vulvodynia
is not entirely clear. The neuromatrix theory suggests that
pain is a multidimensional experience induced by charac-
teristic nerve impulse neurosignature patterns generated
by the body-self neuromatrix in the brain . The concept
of central sensitization of peripheral neurogenic inflam-
mation suggests that gabapentin inhibits afferent pain
pathways to the central nervous system, thereby reducing
pain perception in the vulvovestibular area [8,15,16]. The
benefits of gabapentin include few side effects and minimal
interactions with other medications. Ness et al.  re-
ported on its use in 260 patients experiencing chronic pain
of multiple etiologies and found that only 14% quit the trial
as a result of negative side effects, which primarily in-
cluded drowsiness, confusion, dizziness, imbalance, and
nausea. Seventy-three percent of the patients in that study
experienced less pain as a result of treatment and, of those,
54% achieved long-term benefit. Of those patients suffer-
ing from peripheral neuropathic pain, 87% improved with
Similar to that report, in our study, there were only mild
side effects and satisfactory pain relief was achieved for the
majority of patients. In 91.9% of patients, the effective dose
of gabapentin was 300 mg. Some of the patients in the 300
mg and 600 mg treatment groups converted to botulinum
toxin A treatment owing to unsatisfactory results, but not
because of drug side effects. Therefore, our results suggest
that gabapentin can be safely and effectively used in vulvo-
dynia patients. One of the benefits of gabapentin is that the
dosage can be adjusted depending on patient response.
Although most of our patients noted improvements at 300
mg, some patients who were not satisfied after more than
2 months of treatment at this dose received increased doses
and experienced improvement at doses of 600 mg or 900 mg
gabapentin. This suggests that clinicians should deter-
mine the optimal treatment dose on the basis of the pa-
tient’s specific pain tolerance.
Botulinum toxin is a natural neurotoxin derived from the
Gram-positive anaerobic bacterium Clostridium botu-
linum . It binds to the synaptic cholinergic terminals
of a neuromuscular junction and inhibits acetylcholine
release. The affected nerve terminals do not degenerate;
thus, neural function recovers through axonal sprouting
and the formation of new synaptic contacts . The auto-
nomic effects of botulinum toxin are based on the blocking
of acetylcholine release in all parasympathetic and
post-ganglionic sympathetic neurons. The time necessary
to recover function from paralysis depends on the types of
toxin and the nerve terminal; it usually takes 2 to 4 months
at the mammalian neuromuscular junction and occasion-
ally up to 1 year or more in autonomic neurons . The
peripheral antinociceptive effects of botulinum toxin A
have been indicated in the treatment of various diseases,
and its potential indications are growing. Chronic pain dis-
eases such as bladder pain syndrome, interstitial cystitis,
and chronic pelvic pain syndrome have all shown effective
relief through botulinum toxin A injections [21-23]. In
those studies, botulinum toxin A treatment resulted in
marked improvements in patients with intractable pain
that could not be controlled with other conventional pain
management approaches [21-23].
There have been few studies on botulinum toxin A treat-
ment for vulvodynia. Our results suggest that for vulvody-
nia without pelvic floor muscle spasms, the effects of botu-
linum toxin A may be the result of neuronal uptake of the
toxin or its metabolites, with subsequent influence on pe-
ripheral or central nociceptors. The induced alterations in
the neurosecretion of neurotransmitters and neuropep-
tides may also contribute to pain relief. In our study, botu-
Korean J Urol 2013;54:48-52
Jeon et al
linum toxin A produced significant reductions in pain with-
out short-term recurrence. The antinociceptive action of
botulinum toxin A is known to last for approximately 1 year
and usually appears within 1 to 2 months after injection.
Therefore, our protocol was to follow up at the fourth week
to check for unimproved lesions and to administer addi-
tional injections. After the second round of injections, pain
was assessed. The majority of patients received more than
40 IU, and the patients receiving 100 IU at the initial treat-
ment did not receive additional doses during the follow-up.
This suggests that an initial maximal dose would be a more
effective approach to pain relief with botulinum toxin A.
However, this should be investigated in future studies. In
our previous study on a small number of patients, botu-
linum toxin A was effective at relatively large doses, where-
as doses less than 20 IU showed no significant effect com-
pared with placebo [4,24,25]. An optimal dose therefore re-
mains to be determined. It should also be noted that, to ach-
ieve successful botulinum toxin A treatment of vulvodynia,
it is important to correctly identify the localization of pain
in the vulvovestibular area.
This study had several limitations. Although the treat-
ment protocol was universal for all patients, the study was
not controlled because it was performed retrospectively
through chart review. In addition, the treatment dose was
not fixed. Therefore, we need to perform further studies
comparing treatment efficacy between each drug as well as
with placebo. Nonetheless, in this study, we have ascer-
tained effective clinical management strategies for vulvo-
Gabapentin and botulinum toxin A are both safe and effec-
tive treatments for vulvodynia that lead to significant re-
ductions in pain. The improvements in patient outcomes
that we found suggest that vulvodynia has physiological,
and possibly neuropathic, bases. This condition can neg-
atively impact quality of life, but with proper management,
satisfactory pain relief is achievable. Urologists should
therefore be attentive to this condition and consider these
promising treatment options.
CONFLICTS OF INTEREST
The authors have nothing to disclose.
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