Botox Injection for Treatment of Vaginismus
Condition: Vaginismus
MeSH terms: Vaginismus
Intervention: BOTOX
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
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

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Non-pregnant healthy females aged 20-40 with Lamont level 1-4 primary vaginismus.

          2. Willing to practice a reliable method of contraception for the first 4 months after
             treatment.

          3. Able to understand and comply with the requirements of the study and sign Informed
             Consent.

        Exclusion Criteria:

          1. Female subjects who are pregnant (positive urine pregnancy test), trying to become
             pregnant, breast-feeding, or who are of childbearing potential and not practicing a
             reliable method of birth control.

          2. Allergy or sensitivity to any component of the test medication

          3. History of poor cooperation, non-compliance with medical treatment, or unreliability.

          4. Intact hymen, dyspareunia, secondary vaginismus, vulvodynia, dermatopathology of the
             vulva or perineum, anal fissure, associated urinary or rectal problems, complex pain
             disorders of the urogenital diaphragm or pelvic floor including pudendal nerve
             entrapment, psychiatric illness.

          5. Treatment with botulinum toxin of any serotype prior to enrollment in study.

          6. Any medical condition that may put the subject at increased risk with exposure to
             BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic
             lateral sclerosis, or any other disorder that might interfere with neuromuscular
             function.

          7. Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition.

          8. Infection or skin disorder at an anticipated injection site.

          9. Any condition or situation that, in the investigator's opinion, may put the subject at
             significant risk, confound the study results, or interfere significantly with the
             subject's participation in the study.

         10. Participation in an investigational drug study within 30 days of the Baseline Visit.