Indonesia's First: Botulinum Toxin Procedure as a Modality of

Successful Vaginismus Treatment

Robbi Asri Wicaksono

, Merlinda Nur Annissa

Obstetric and Gynecology, Limijati Woman and Children Hospital, Bandung, Indonesia

Dermatology and Venereology, Limijati Woman and Children Hospital, Bandung, Indonesia

Keywords: vaginismus, botulinum toxin

Abstract: Vaginismus is a common female sexual dysfunction, but mostly unknown among clinicians, that continues

to be ignored by many medical schools, residency programs and is rarely discussed at medical meetings.

Patients with vaginismus had involuntary spasm of the pelvic muscles surrounding of the vagina.

Penetration such as tampons, finger, vaginal dilators, gynecological exams, and intercourse is often painful

or impossible. This article aims to bring attention to the understanding and treatment of vaginismus.

Vaginismus patients came to Limijati Hospital between January and December 2017. Diagnosis was made

based on history taking and physical examination of vaginal spasm. The severity of vaginismus was ranked

1-5 according to Lamont-Pacik classification. Seventeen patients underwent the procedure consists of total

intravenous anesthesia, botulinum toxin (botox) injections, and progressive dilation, with 100% same day

successful self dilation using 4 inch silicone dilator, and 82.3% achieved sexual intercourse in average of

4,5 weeks after the procedure. Botox along with other modalities appear to be a promising result for

vaginismus treatment. Awareness among clinicians about diagnosis and treatment of vaginismus is

extremely needed.

1 INTRODUCTION

Vaginismus thought to be one of the most common

female sexual dysfunction (Pacik, 2014).

Approximately 1-7% of female worldwide suffer

with this condition, and in a clinical setting has been

estimated as 5% to 17% (Pacik, 2011). Vaginismus

patients usually remain silent, feels taboo, rarely

exposed in community nor clinicians (Pacik 2011;

Pacik and Gelatta, 2017), make patients become

neglected in many aspects.

Vaginismus is a physical disorder as noted by

vaginal spasm (Pacik, 2010; Pacik, 2014), persistent

or recurrent difficulty in allowing vaginal entry of

the penis, finger, or any object, despite the woman’s

expressed wish to do so. It is a condition in which

the muscles in the vagina spasm involuntarily

preventing any vaginal penetration. Or, if

penetration is possible, it can be very

painful(Bertolasi et al., 2009; Pacik, 2010).

The cause of vaginismus is unknown (Berek,

2007; Pacik, 2011; Pacik, 2014). Vaginismus is a

very serious problem for the patients. It is poorly

understood, and many physicians across a number of

specialties have limited experience with this entity.

It is hoped that with additional awareness,

physicians will have yet another modality for the

treatment of vaginismus (Pacik, 2015).

Severity of vaginismus was ranked 1-5 according

to Lamont-Pacik classification(Pacik, 2011; Pacik

and Gelatta, 2017). The treatment for vaginismus

depends on the severity, includes education, sexual

counseling, Kegel’s exercises, dilation with dilators,

hypnotherapy, lubricants (Pacik, 2010; Pacik, 2014),

use of local anesthesia, incision of spasmodic

perivaginal muscles, intravaginal botox injection

(Shafik and El-Sibaik, 2000; Ghazizadeh and

Nikzad, 2004; Bertolasi et al., 2009; Fageeh, 2011;

Pacik and Gelatta, 2017).

Botox type A is a neurotoxin produced by

Clostridium botulinum that paralyzes muscles by the

prevention of acetylcholine release and has been

shown to be useful in treating conditions associated

with neuromuscular dysfunction such as muscles

hyperactivity and spasms (Ghazizadeh and Nikzad,

2004). There was no reporting case in Indonesia

about vaginismus nor the therapy. This is the first

research about botox modalities as vaginismus

204

Wicaksono, R. and Annissa, M.

Indonesia’s First: Botulinum Toxin Procedure as a Modality of Successful Vaginismus Treatment.

DOI: 10.5220/0008154002040208

In Proceedings of the 23rd Regional Conference of Dermatology (RCD 2018), pages 204-208

ISBN: 978-989-758-494-7

 2021 by SCITEPRESS – Science and Technology Publications, Lda. All rights reser ved

treatment in Indonesia. This procedure is adapted

from a procedure developed by Peter T. Pacik, MD.,

FACS (Plastic Surgery Center, Manchester, NH,

USA) who has received approval from the United

States Food and Drug Administration (FDA) to

continue studies on the use of botox to treat

vaginismus.

2 METHODS

2.1 Assessment

Vaginismus patients initially contacted me without

hesitation through social media which dedicated for

vaginismus information, they know that they are

having vaginismus, since they have experienced

difficulties on penile penetration in sexual

intercourse during their marriage or acitive sexually.

A scheduled appointment for initial consultation and

physical examination was offered to each patient.

Until this paper is submitted, total 141 patients have

contacted me (from all over Indonesia, including 2

patients from Malaysia, and 1 patient from Nigeria),

admitting that they have penetration difficulties.

Fourty-nine patients came to my office for initial

examination and consultation, to get their

vaginismus and the severity confirmed, also for

determining therapy options. Fourty one of them

(83.6%) are candidates for the procedure (3rd to 5th

degree vaginismus). Nineteen patients underwent the

procedure.

Vaginismus diagnosis is based on history taking

and physical examination. When a patient complains

that attempted intercourse feels like it is ‘‘hitting a

wall’’, suggestive of spasm at the level of the

introitus, this is a symptom that helps differentiate

vaginismus from dyspareunia, vulvodynia and

provoked vestibulodynia (vestibulitis). A Q-tip test

is performed to ruled out vulvodynia by pressing the

wet Q-tip against the vestibule at the 2, 4, 6, 8, and

10 o’clock positions to determine if there is

provoked pain. If Q-tip test is negative, vulvodynia

is ruled out.

Next, simple finger penetration attempt

by examiner was perfomed to determine the vaginal

spasm (Goldstein, Pukall, and Goldstein, 2009).

Patients with 3rd-5th degree was adviced to

undergo the assisted dilation procedure enabling

them to start the successful self dilation using

silicone dilator.

Table 1: Severity of vaginismus

Grade Description

Lamont grade 1 Patient is able to relax for pelvic examination

Lamont

rade 2 Patient is unable to relax for

elvic examination

Lamont

rade 3 Buttocks lift off table. Earl

retreat

Lamont

rade 4 Generalized retreat: buttocks lift u

, thi

hs close,

atient retreats

Pacik grade 5 Generalized retreat as in level 4 plus visceral reaction, which may result in any one or

more of the following: palpitations, hyperventilation, sweating, severe trembling,

uncontrollable shaking, screaming, hysteria, wanting to jump off the table, a feeling of

ecomin

unconscious, nausea, vomitin

, and even a desire to attack the docto

(references : Lamont Pacik Classification)

Once the diagnosis and severity of vaginismus

had been determined, treatment options can be

discussed. Basically, if a patient can tolerate finger

penetration it means that they can start self dilation

immediately. But when a patient cannot tolerate any

kind of simple penetration, assisted dilation

procedure is the most suitable option for them. Other

characteristics such as age, duration of marriage or

active sexually, previous treatment, and minimal

progress of self dilation, are also used for procedure

consideration.

Some women choose the more traditional

treatment of dilation. Dilation consists of using

several dilators over time in increasing size. A

dilator is inserted into the vagina to gradually stretch

the vaginal muscles. Some patients become frustated

with the dilation process and prefer Botox procedure

so they can progress to the larger sized dilators.

Other women, seek the botox procedure directly.

Most women have tried dilation at home and were

either unsuccesful progressing to the larger sized

dilators or were too fearful to even begin

treatment.

2.2 Assessment

In the operating room, patients are given total

intravenous anesthesia. A pelvic exam performed to

assess vaginal tightness and anatomical

abnormalities, speculum is placed inside the vagina,

initially for inspection of vagina and cervix. Then

total of 100 units botox injected throughout the

vaginal vault, 50 units of Botox injected into the

Indonesia’s First: Botulinum Toxin Procedure as a Modality of Successful Vaginismus Treatment

205

puborectalis and pubococcygeus muscles; divided

into four clumns of thhree injections bilaterally.

After that, 18 ml of local anesthetic (0,25%

marcaine with epinephrine 1:400.000) then injected

throughout the vault in a similar distribution to the

previous botox injections.

The bulbocavernosus then injected in three

columns; one proximal, one inferior and one distal

bilaterally. A largest dilator (number 6) which had

covered with xylocaine gel and natural lubricant

inserted and remain in placed as the patient brought

to the recovery room. This allows patients to wake

up in recovery with pain-free experience for the first

time while a static penetration using largest dilator

happened.

Figures 1. Area of botox injection

Patients transported to her room for dilation

excercise. For the next 3-4 hours, patient has some

rest and recover for maximum alertness. The dilator

was totally removed for the first time as preparation

for urinating after the procedure. After that, patient

is able to successfully reinsert the dilator without

any significant pain and fear. During that process,

doctor supervised dilation process all the time, and

also give them positive direction and encouragement

as form of psychological support. Patients must do

the dilation using method and movement as

instructed in a certain time, such as rotating, move

back forward, and changing size. At night, number 4

dilator was worn through the night while she was

sleeping.

On the next day, doctor evaluate the progress of

the dilation and gave patient and her spouse

counseling about transition from dilation to sexual

intercourse. They were discharged with a dilation

program at home with typical method and

movement. First follow up is one month after the

procedure. Patient will undergo a simulation of

several vaginal examination, such as pelvic

examination, speculum examination, and

transvaginal ultrasound. Patients are allowed to have

direct communication to make doctor keep informed

about their problem and progress.

3 RESULTS

Fourty one patients (83.6%) with 3-5 level of

vaginismus are candidates for the procedure, 17

patients underwent the procedure. Seventeen

patients (100%) achieved nonsexual penetration and

self dilation at same day as procedure. Seventeen

patients (100%) have successful vaginal ultrasound

and pelvic examination in 1 month post procedure

follow up. For penile penetration in sexual

intercourse, 14 patients (82.3%) achieved it within

average of 4,5 weeks after the procedure.

4 DISCUSSIONS

Vaginismus is a more common sexual problem than

previously reported (Lamont, 1978). There is no data

about vaginismus di indonesia. This is the first study

about vaginismus in Indonesia.

Vaginismus is a subset of the genito-pelvic pain

and penetration disorders and is currently defined by

the Diagnostic and Statistical Manual of Mental

Disorders, Fifth Edition (DSM-V) as a penetration

disorder (Pacik, 2014), in accordance in ICD-10

definition as involuntary spasm of the pelvic

muscles surrounding the outer third of the vagina,

spesifically the perineal muscles and the levator ani

muscles (Lamont, 1978; Pacik, 2014). In severe

cases of vaginismus the adductors of the thighs, the

rectus abdominis, and the gluteus muscles may be

involved (Lamont, 1978). The diagnosis of

vaginismus is made by history and physical

examination (Pacik, 2014).

Patient came mostly for their unconsummated

marriage and infertility. Two patients referred by

dermatologists. Nineteen vaginismus patient treated

with botox procedure in this study has the range of

marriage duration between 6 months and 9 years. All

of them never had penile penetration, they

complains that attempted intercourse feels like it is

‘‘hitting a wall’’, suggestive of muscles spasm at

surrounding vagina.

The first reported use of Botox to treat

vaginismus was in 1997 (Ghazizadeh and Nikzad,

2004). Mechanism action of botox is the toxin enters

the nerves by binding to surface protein receptors

and undergoing into internalized vesicles. The light

chain is released into the nerve cytosol, and the

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SNARE (soluble N-ethylmaleimide-sensitive factor

attachment protein receptor) protein complex is

cleaved to inhibit exocytosis of the neurotransmitters

such as acethylcholine (Goldsmith, Katz, and

Gilchrest, 2012) at the neuromuscular junction

(Shafik and El-Sibaik, 2000). The end result is a

chemodenervation of the cholinergic neurons, either

motor nerves or autonomic nerves, leading to

localized absence of muscle activity (Goldsmith,

Katz, and Gilchrest, 2012).

Botox produces its effect

by causing muscle paralysis, thus will inhibit

muscles spams in vaginimus. Improvement in

vaginismus is presumably due to paralysis of the

bulbospongiosus muscle. The latter appears to be

responsible for closure of the vaginal introitus on

trial of vaginal penetration. The other pelvic floor

muscles, levator ani and puborectalis muscles are

apparently not involved during vaginalpenetration as

the levator ani is inserted into the vaginal fornices

while the puborectalis is related to the lower part of

the vagina (Shafik and El-Sibaik, 2000).

Ghazizadeh and Nikzad reported the used of

Botox in the treatment of refractory vaginismus in

24 patients. In this study, Dysport (150 to 400 mIU)

was used. Twenty three patients were able to have

vaginal examinations 1 week after the procedure,

showing little or no vaginismus. One patient refused

vaginal examination and did not attempt coitus. Of

the 23 patients, 18 (78%) achieved satisfactory

intercourse, four (17%) had mild pain, and one was

unable to have intercourse because of her husband’s

impotence.

Botox procedure in this study consist of botox

injection in bulbospongiosus muscle, dilation with

the biggest dilator under anesthesia. The results were

100% patients have successful painfree penetration

without muscle spasm through self dilation using 4

inch silicone dilator at the same day of the

procedure, and 82,3% achieved sexual intercourse in

average of 4,5 weeks after the procedure.

Dilation, in the treatment of vaginismus is a

simple method buy may require long-term therapy

and fail in persistent cases (Shafik and El-Sibaik,

2000). Most women have tried dilation at home and

were either unsuccesful progressing to the larger

sized dilators or were too fearful to even begin

treatment (Pacik and Gelatta, 2017). Likewise,

behavioural therapy and psychotherapy, besides

being lengthy and expensive, may not succeed in

cureing the condition, especially in persistent and

severe degree of vaginismus. Meanwhile, botox

procedure is a simple, easy, rapid, and effective

treatment for vaginismus.

Side effects of botox including minor discomfort,

bruising (Goldsmith, Katz, and Gilchrest, 2012), dry

mouth, dysphagia, paresis extremities, or urine

incontinence (Shafik and El-Sibaik, 2000). Two

patients in this study report temporary mild urine

incontinence, this expected gone by the time botox

loses its effectiveness.

Botox is a safe drug when used according to the

manufacturer’s recommendations. During the past

20 years, Pacik has treated thousands of patients

using botos for dynamic facial wrinkles, excessive

sweating, migraine headhaches, and vaginismus,

with only rare minor untowards effects mostly the

result of migration of botox to nearby tissues.

Around 391 vaginismus patient were treated with

this botox procedure, there only few minor untoward

events such as temporary mild stress incontinence

(Pacik and Gelatta, 2017), same as this study. No

permanent sequele were noted.

Botox has a long duration of action up to 6

months,

loses its effectiveness within 4 to 6 months

(Goldsmith, Katz, and Gilchrest, 2012), but another

repeated botox procedure is usually not needed. At

this time period, patient has made the transition from

post-operative dilation to intercourse. In this study,

no patient was in need of re-procedure and there was

no reccurence during the follow-up period. Botox

procedure effected cure in all of the vaginismus

patients with no complications or recurrence.

5 CONCLUSIONS

Botox procedure appears to be safe and effective as

vaginismus treatment. This procedure has helped

many women to immediately start effective dilation

and also end their unconsummated marriage. It is

important for health care providers to know more

about vaginismus. Medical school, residency

program, and medical meetings are needed to spread

the knowledge about vaginismus and its treatment.

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