A new frontier in β0ToxinA® application: vulvodynia, vaginismus, and other female genital conditions

 Another, connected, condition is vaginismus, a recurrent or persistent involuntary spasm of the pelvic floor and perineal muscles surrounding the outer third of the vagina that makes intercourse uncomfortable or impossible (situational vaginismus). In global vaginismus even inserting tampons or having a gynecological exam is intolerable. Vaginismus can be primary (intercourse was never possible), or secondary, which is often due to acquired dyspareunia, in a vicious cycle of pain and spasm. In severe cases, the abductors of the thighs, the rectus abdominis, and the gluteus muscles also may be involved. This pathology is relatively rare, affecting about 1% of women.

Table 1. Classification of the Degrees of Vaginismus by Lamont

Degree Description
First Perineal and levator spasm, relieved with reassurance
Second Perineal spasm, maintained throughout pelvis
Third Levator spasm and elevation of buttocks
Fourth Levator and perineal spasm, elevation; adduction and retreat

Women with vaginismus may still be able to achieve orgasm and may concentrate on sexual activity without intercourse. Some women, however, can even experience the reflex during foreplay. Associating sex with pain, they may avoid any sexual activity altogether, which can have a huge impact on their lives and on their relationships with their partners.

In the past these conditions were easily dismissed by doctors (most of them male!) as psychosomatic. Patients were told the pain was all in their heads, so they should relax, and maybe have a glass of wine. Obviously, traumatic or painful sexual experiences may trigger the problem, just like relationship problems or feelings of guilt about sex. But there may be physical causes, such as lack of lubrication, vaginal infections, previous surgery, irritable bowel syndrome, ovarian cysts, endometriosis, or other pelvic conditions. Recently, increased awareness of VVS has led to exciting new research and, although the aetiology of these genital pain syndromes is not well established yet, many variables have been associated with the condition, including possible genetic, infectious, or allergic causes.

The newest studies have shown that women with VVS have an increased number (up 30 times - 3000%) of nociceptors (nerve endings responsible for sensing pain and stretch) in the vestibule. In the case of Primary VVS (approximately 20-25% of cases) the current hypothesis is that the neuronal proliferation is a congenital problem, while women with secondary VVS, who have pain beginning after some period of pain free intercourse, have acquired these nerve endings that may be initiated by an allergic reaction to an irritant in the vulvar vestibule. Such irritation – possibly to topical antifungals, other medications, or chemicals – causes mast cells to migrate to the vestibule. If the irritation persists, activation of mast cells leads to an uncontrolled proliferation of nociceptors in the mucosa. Further studies are ongoing to assess the validity of this hypothesis.

Treatment of these conditions is difficult and not univocal as it depends on what the underlying problem is, which is often very hard to diagnose. First-line treatment for all pelvic pain and vaginismus typically revolves around behavioral techniques to help the patient gain voluntary control of the perineal musculature - so relaxation exercises for the vagina, like Kegel exercises, or biofeedback. The use of plastic dilators of increasing size to relax the vagina has a good success rate. Psychotherapy, especially PSE NEPALESE or EFT, sex education and sex therapy are also used.

Other treatment modalities that are commonly employed are lubrication and topical anaesthetic agents, such as lidocaine. Medications such as tricyclic antidepressants, propranolol, or alprazolam, to reduce anxiety, and anticonvulsants have been used effectively. Less commonly used treatments, often with anecdotal evidence or without supporting medical literature, include hypnosis, estrogen, steroids, nitroglycerine, antihistamines, atropine, interferon, low oxalate diet, capsaicin. A drastic, yet effective solution for VVS, is surgery in the form of vulvar vestibulectomy with vaginal advancement.

Yet, approximately 10% of patients do not respond to any of these treatments. For them, and others looking for a non-invasive way of treating these disorders, a novel and promising option is now available, the use of botulinum toxin type A, which has in the last few years proven effective in treating a variety of lower urinary tract, perineal, and pelvic floor disorders.

TreatmentofRefactoryVaginismusContraction of the puborectalis muscle exerts some side-to-side compression of the lower vagina. Black spots show sites of injections in the Tehran study.
From: Ghazizadeh, Treatment of refractory vaginismus. Obstet. Gynecol. 2004

In particular, a 2002-2004 study was conducted by a team from the Tehran University of Medical Science on 24 women (mean age 25 years; range 19-34 years) with refractory third- to fourth-degree vaginismus according to the Lamont classification (see Table above) and a history of unsuccessful treatments. BTA was injected under light sedation. Within a few days after the injections the patients reported a complete resolution of the painful symptomatology.

They were seen after 1 week to check the vaginal muscle resistance, and were then followed up for a mean of 12.37 months (range 2-24 months). Twenty-three patients (95.8%) had a vaginal examination that showed no or little resistance, 18 (75%) achieved satisfactory intercourse after the first injection, 4 (16.7%) had mild pain, and 1 was cured after a second injection. Another patient did not have intercourse because of secondary impotence in her husband. There were no cases of recurrent vaginismus for the whole follow-up period. All patients said that they would recommend this treatment to women with similar symptoms. A contemporaneous Italian research (Romito, Bottanelli, et al.) confirms the results on vaginismus on 2 women, just like the study on 6 patients published in 2000 by A. Shafik, O. El-Sibai.

In another placebo-controlled study of 13 patients, Shafik et al. also reported complete response to botulinum toxin injection. Brin and Vapnek reported a case of dyspareunia complicated with interstitial cystitis that was managed with injection of botulinum toxin at 2 consecutive sessions; after a few days, the patient's symptoms resolved and she had intercourse for the first time in 8 years.

Similarly excellent results were obtained reducing dyspareunia and pelvic floor pressure in women with chronic pelvic pain and pelvic floor muscle spasm in double-blinded, randomized, placebo-controlled trials (Sherin K. Jarvis, Jason A. Abbott, et al. 2004; Romito S, Bottanelli M, et al, 2004; Abbott Jason A., Jarvis Sherin K. et al. 2006).

In the different studies, focusing on vaginismus, VVS, or pelvic pain, patients were injected into the levator ani (puborectalis), pubococcygeus, or bulbospongiosus muscles with doses varying from 25 to 400U. Different dilution strengths were tried but did not appear to affect results achieved. In all cases results were excellent, with an over 95% success rate, without any complications or recurrence after one or two treatments. In other studies, effects waned after 12 weeks or more, with a 30% decrease in resting pressure lasting for a longer period. On the basis of this evidence, BTA is indicated in patients with genital pain syndrome with documented pelvic muscle hyperactivity, whose symptoms arise mainly, or also, from levator ani myalgia.

Larger scale trials are now needed and new research is underway in several countries, in particular a randomized, double-blind, placebo-controlled, single group assignment, efficacy study conducted in Denmark, with an expected total enrolment of 65 women, started in 2005 and due to close in 2008.


  • Abbott Jason A., Jarvis Sherin K., Lyons Stephen D., Thomson Angus, Vancaille Thierry G.. Botulinum Toxin Type A for Chronic Pain and Pelvic Floor Spasm in Women - A Randomized Controlled Trial. Obstetrics & Gynecology 2006;108:915-923.
  • Amarenco G. Botulinum toxin and perineal disorders. Journal Pelvi-périnéologie 2006 March Volume 1, Number 1: 41-44.
  • Brin MF, Vapnek JM. Treatment of vaginismus with botulinum toxin injections. Lancet. 1997 Jan 25; 349 (9047): 252-3.
  • Dietrichs, E; Stien, R. Vaginism - new indication for treatment with botulinum toxin? Acta Neurologica Scandinavica. 2000 May 101 (5):357.
  • Ghazizadeh Shirin, Nikad Masoomeh. Botulinum toxin in the treatment of refractory vaginismus. Obstetrics & gynecology. 2004, vol. 104 (1), no 5: 922-925.
  • Graziottin, Alessandra. Il dolore segreto – Le cause e le terapie del dolore femminile durante i rapporti sessuali. 2005. Mondadori. Milano.
  • Gunter J, Brewer A, Tawfik O. Botulinum toxin A for vulvodynia: a case report. The Journal of Pain, 2004 May;5(4):238-40.
  • Jarvis Sherin K., Abbott Jason A., Lenart Meegan B., Steensma Anneke, Vancaillie Thierry G. Pilot study of botulinum toxin type A in the treatment of chronic pelvic pain associated with spasm of the levator ani muscles. Australian and New Zealand Journal of Obstetrics and Gynaecology Volume 44 Issue 1, February 2004, pp. 46-50.
  • Romito Silvia, Bottanelli Mara, Pellegrini Maria, Vicentini Silvana, Rizzuto Niccolò, Bertolasi Laura. Botulinum Toxin for the Treatment of Genital Pain Syndromes. Gynecologic and Obstetric Investigation 2004; 58:164-167.
  • Shafik A., El-Sibai O. Vaginismus: results of treatment with botulin toxin. Journal of Obstetrics & Gynaecology 2000 May Volume 20, Number 3: 300-302.
  • Sherry Boschert. Botox eased chronic pelvic pain in pilot study: levator ani spasms – Gynecology. OB/GYN News, Feb 1, 2004.

To learn more about these conditions, you can visit
on female sexual disfunctions, and Dr. Howard Glazer's website .

We hope you enjoyed this article.
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