FDA Approved Clinical Trial Completed Using Botox Injections for Vaginismus

Open Label, Single Center, Pilot Study of the Use of BOTOX Injections, Sensorcaine Injections and Progressive Dilation Under Anesthesia for the Treatment of Primary Vaginismus BTX-PV-01 IND/IDE Number: 109343

Brief Summary of Clinical Trial Using Botox Injections for Vaginismus

The use of Botox injections for vaginismus intravaginally and progressive dilation under anesthesia has been shown to cure vaginismus. This study expands the use of Botox injections to include progressive dilation, post procedure supervised dilation and sex counseling to help women transition from dilators to intercourse. Since 2005, patients continue to experience a cure rate in excess of 90%. As of July 2014, more than 300 vaginismus patients have been treated this way.


In this completed study of 30 patients with a minimum of one year follow-up, 29 vaginismus patients were able to advance to pain free intercourse (97%) and one patient failed to achieve her goals presumably due to uncontrolled anxiety relating to vaginal penetration.

Detailed Description of Clinical Trial Using Botox Injections for Vaginismus

Vaginismus is the most common reason for unconsummated marriages. The more severe forms of vaginismus are often refractory to a variety of treatments such as kegel exercises, dilator therapy, psychotherapy, sex counseling, physical therapy, hypnotherapy, biofeedback, anti-depressants, anti-anxiety drugs, hymenectomy and vestibulectomy. In a larger cohort of 150 patients, the average length of time of failed treatments was more than 7 years. 25% of vaginismus women suffered with this condition for more than a decade.

Spasm of the vaginal muscles is well defined in the scientific literature, first described by Sims in his 1861 report, as well as Lamont in 1978 and included in the DSM-IV definition of vaginismus. Pacik has reported on the prevalence of spasm of the bulbocavernosum, especially in the more severe forms of vaginismus, consistent with the history that intercourse feels like it is “hitting a wall”. The use of Botox injections for vaginismus dates back to 1997. Since then several reports, including papers and presentations from our practice, have shown the efficacy of Botox injections for vaginismus. Botox is a very safe drug when used correctly. As of July, 2014 more than 300 patients have been treated in our practice, mostly the more severe forms of vaginismus, who have been refractory to other forms of therapy. In this population dating back to 2005, the cure rate is in excess of 90%. There have been three minor complications of mild stress incontinence all of which resolved after about four months when the Botox was no longer active. One patient in this large cohort developed excessive vaginal dryness, likely due to block of the parasympathetic nerves, which govern “letdown”. Several patients have become pregnant and delivered normal children by vaginal childbirth.

The program to cure vaginismus is more than just injecting Botox under anesthesia and incorporates the following additional essential steps:

  • The areas of maximum spasm of the vaginal muscles are identified under sedation to determine where the Botox should be injected.
  • The injections done under anesthesia are followed by additional injections of a long acting local anesthetic bupivacaine.
  • After this, the vagina is progressively dilated while the patient is still under anesthesia, and the dilators are further coated with a topical anesthetic.

All these measures allow the patient to wake up in the recovery room with the large dilator in place and no discomfort.

  • Following this, supervised dilation continues so that the patient becomes comfortable moving the dilator in and out of the vagina. This supervised dilation continues for a total of two to three mornings.
  • During this time counseling is done with the couple to help instruct the correct use of the dilators, transition from dilators to intercourse, positions of pelvic floor relaxation and couple’s counseling.
  • Written instructions are given as well as a DVD addressing these aspects with close follow up and support by phone and email to ensure success of the program.

This multimodal program has had continued success since 2005. In the future a randomized study would help delineate the individual components of this program.


  1. American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders. Washington D.C.(2000)
  2. Sims, JS (1861) On Vaginismus. Transactions Obstetrical Society of London 3:356-367
  3. Lamont JA (1978) Vaginismus. Am J Obstet Gynecol.131(6):633-6.
  4. Pacik PT. Botox treatment for vaginismus. Plast Reconstr Surg. 2009 Dec;124(6):455e-6e.
  5. Pacik, PT (2011) Vaginismus: Review of Current Concepts and Treatment Using Botox Injections, Bupivacaine Injections, and Progressive Dilation with the Patient Under Anesthesia Aesth Plast Surg. DOI 10.1007/s00266-011-9737-5
  6. Pacik PT, Cole JB. When Sex Seems Impossible. Stories of Vaginismus & How You Can Achieve Intimacy. Odyne Publishing 2010
  7. Pacik, PT. (2010) Open Label, Single Center, Pilot Study of the Use of BOTOX Injections, Sensorcaine Injections and Progressive Dilation Under Anesthesia for the Treatment of Primary Vaginismus. ClinicalTrials.gov NCT 01352546
  8. Pacik PT. Understanding and Treating Vaginismus-a Multimodal Approach. International Urogynecology Journal  DOI: 10.1007/s00192-014-2421-y

ClinicalTrials.gov was updated and completed December 8, 2012

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