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Botox Injection for Treatment of Vaginismus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01352546
Recruitment Status : Completed
First Posted : May 12, 2011
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Information provided by (Responsible Party):
Peter T. Pacik, MD, FACS, Plastic Surgery Professional Association

Tracking Information
First Submitted Date  ICMJE May 10, 2011
First Posted Date  ICMJE May 12, 2011
Results First Submitted Date  ICMJE August 1, 2017
Results First Posted Date  ICMJE August 7, 2017
Last Update Posted Date August 7, 2017
Study Start Date  ICMJE August 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Botox Injection for Treatment of Vaginismus
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vaginismus
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: BOTOX
intravaginal Botox injections and progressive dilation under anesthesia to cure vaginismus.
Intervention: Biological: BOTOX
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2011)
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01352546
Other Study ID Numbers  ICMJE BTX-PV-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter T. Pacik, MD, FACS, Plastic Surgery Professional Association
Study Sponsor  ICMJE Plastic Surgery Professional Association
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Peter T Pacik, MD Plastic Surgery PA
PRS Account Plastic Surgery Professional Association
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP