Botox Injection for Treatment of Vaginismus

August 1, 2017 updated by: Peter T. Pacik, MD, FACS, Plastic Surgery Professional Association

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Manchester, New Hampshire, United States, 03104
        • Plastic Surgery Professional Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BOTOX
intravaginal Botox injections and progressive dilation under anesthesia to cure vaginismus.
Biological: BOTOX
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to Achieve Pain Free Intercourse.
Time Frame: one year
Patients need to be able to transition from the use of vaginal dilators to pain free intercourse, or to be able to continue using the #5 or #6 of 6 dilators in the absence of a partner.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Plastic Surgery Professional Association

Collaborators

Allergan

Investigators

  • Principal Investigator: Peter T Pacik, MD, Plastic Surgery PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTX-PV-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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