FDA approval for Dr. Pacik’s research using Botox to treat vaginismus
In 2010, the FDA approved Dr. Pacik’s research to study the use of Botox as a treatment protocol for vaginismus. The protocol included the use of Botox, bupivacaine injections (a long acting local anesthesia), and progressive dilation under anesthesia as well as post procedure counseling. As part of the FDA approval to study the benefits of using the Botox program to treat vaginismus, the FDA required registering the study with clinicaltrials.gov.
What is clinicaltrials.gov?
ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives information about a trial’s purpose, who may participate, locations, and phone numbers for more details. Currently over 100,000 trials from around the world are being monitored.
Excerpts from Dr Pacik’s study of Botox for vaginismus
Excerpts from the study are listed below, or the entire study can be read by linking to clinicaltrials.gov.
Title: Botox Injection for Treatment of Vaginismus
Current Primary Outcome Measures: 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.
Descriptive Information: Brief Title: Botox Injection for Treatment of Vaginismus
Official Title: 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%.
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 psychotherapy, sex counseling and physical therapy.
The use of Botox injections as a treatment for vaginismus dates back to 1997. Since then several reports, including publications from our practice, have shown the efficacy of Botox injections for vaginismus. Botox is a very safe drug when used correctly. Currently 68 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% and there have been no known complications. 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 light anesthesia to determine where the Botox should be injected. The injections are followed by additional injections of a long acting local anesthetic. 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 three mornings. During this time sex counseling is done with the couple to help with relationship issues and to instruct how to transition from dilators to intercourse. Written instructions are given and close follow up by phone and email ensures success of the program.
Study Type: Interventional
Study Phase: Phase I
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Condition: Vaginismus
Intervention: 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 onetime injection under anesthesia.
Study Arms: Experimental: BOTOX
intravaginal Botox injections and progressive dilation under anesthesia to cure vaginismus.
Intervention: Biological: BOTOX
Publications: Pacik PT. Botox treatment for vaginismus. Plast Reconstr Surg. 2009 Dec;124(6):455e-6e. No abstract available.
Eligibility Criteria:
Inclusion Criteria:
- Non-pregnant healthy females aged 20-40 with Lamont level 1-4 primary vaginismus.
- Willing to practice a reliable method of contraception for the first 4 months after treatment.
- Able to understand and comply with the requirements of the study and sign Informed Consent.
Exclusion Criteria:
- 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.
- Allergy or sensitivity to any component of the test medication
- History of poor cooperation, non-compliance with medical treatment, or unreliability.
- 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.
- Treatment with botulinum toxin of any serotype prior to enrollment in study.
- 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.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition.
- Infection or skin disorder at an anticipated injection site.
- 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.
- Participation in an investigational drug study within 30 days of the Baseline Visit.
Administrative Information: NCT01352546
- Other Study ID Numbers BTX-PV-01
- Has Data Monitoring Committee Yes
- Responsible Party Peter T. Pacik, MD, FACS, Plastic Surgery Professional Association
- Study Sponsor Plastic Surgery Professional Association
- Collaborators Allergan
- Principal Investigator: Peter T Pacik, MD Plastic Surgery PA
- Information Provided By Plastic Surgery Professional Association
- Verification Date October 2011