Botox Injection for Treatment of Vaginismus
Condition: Vaginismus
MeSH terms: Vaginismus
Study type: Interventional
Phase: Phase 1

Summary: 
      The use of Botox injections 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 December 2012 more than 200 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: 
      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 the larger cohort of
      200 patients, a detailed data analysis of 150 patients (paper submitted) 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 currently 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", also noted by Lamont. The use of
      Botox injections as a treatment 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
      December 2012 more than 200 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 and close follow up and support by phone and email to ensure success
      of the program.
    

Intervention name(s): BOTOX
Intervention type(s): Biological
Intervention description(s): 150 units of Botox injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vaginismus; painful sex; painful intercourse; dyspareunia; inability to have intercourse; inability to consummate marriage; vaginal spasm; "hitting a wall"; pain during sex; pain during intercourse; burning with intercourse