Dr. Pacik Received FDA Approval

Research for Botox treatment for vaginismus receives IRB and FDA approval

In 2010 Dr. Peter Pacik received FDA approval to continue his research using Botox to treat vaginismus. The entire program was submitted to the FDA and their approval not only included the use of Botox injections and a long acting local anesthesia (bupivacaine) to treat vaginismus, but also the concept of progressive dilation under anesthesia as well as post procedure counseling. This is the first time the FDA approved research for the treatment of vaginismus and represents a major milestone for vaginismus sufferers. This gives credibility to the diagnosis of vaginismus as a sexual pain disorder and provides authenticity to insurance companies that vaginal spasm does indeed exist separate from the more common diagnosis of vulvodynia.

Investigational New Drug status for vaginismus

As part of the FDA approval Dr. Pacik also received permission to use Botox as an investigational new drug (IND 109343). Even though Botox has a high degree of safety, and is widely used for many conditions, the use of Botox for a new indication and a new route of administration, called for this additional approval. Dr. Pacik’s treatment program for vaginismus in the only such program approved by the FDA in the United States. This clinical trial was registered with clinicaltrrials.gov. “Botox Injection for Treatment of Vaginismus”. Excerpts from this study can be found by linking to Dr. Pacik Clinicaltrials.gov. All patients signed a comprehensive permit. No compensation was given to Dr. Pacik. Findings have been published in a number of journals.

Two years to achieve FDA approval for vaginismus treatment

The entire process from Institutional Review Board (IRB) approval to FDA approval took close to two years and required the submission of countless forms supporting the safety of the study. Though the first phase of the study is complete, ongoing analysis of data continues. This includes documenting any complications, and following the course of pregnancies and births.

Risks and complications of Botox for vaginismus

To date, there continues to be a high level of safety. Two patients to date (160 patients as of February 2012) developed minor stress incontinence losing a few drops of urine when straining such as skiing or working out in the gym. This corrected itself once the Botox was no longer active after four months. One patient developed dryness of her natural vaginal lubrication, and this too cleared once the Botox was no longer active. No other complications have been noted. Patients have had normal pregnancies and normal deliveries. Success as defined by achieving pain free intercourse or the ability to use large dilators without discomfort in single women, continues to be noted in well over 90% of the patients. From 2006 to February 2012 no patient has had to return for additional Botox injections. About 10-12 failures have occurred and are more related to a lack of compliance in that these patients failed to stay in communication with Dr. Pacik after treatment and/or failed to continue with their dilation programs. Recurrence of sexual pain is unusual. Two patients with secondary vaginismus had recurrence of their symptoms. Both were successfully treated using dilators and neither had to return for additional Botox.

Botox is used for many medical conditions

Botox is used for approximately 150-200 diverse medical conditions, and has a long record of safety involving millions of injections throughout the world. New indications for the use of Botox appear with considerable frequency. Dr. Pacik has many years of experience with thousands of injections of Botox for hundreds of patients in conditions that not only include vaginismus, but also the treatment of excessive sweating, migraine headaches and facial rejuvenation.

Importance of understanding Botox for vaginismus

As with any drug, a knowledge of dosage and proper injection techniques is essential. Injecting Botox without proper training can create complications. Further, just injecting Botox for vaginismus without addressing the other important aspects of the entire program, such as progressive dilation under anesthesia and comprehensive post procedure counseling, is a setup for failure. To date a number of patients have been treated successfully by Dr. Pacik who failed to progress with previous Botox injections elsewhere (some as many as two different courses of Botox). These failures are indicative of the importance of understanding the entire program used to treat vaginismus.

Use of FDA approved Botox

Allergan, Inc. is the only company authorized by the FDA to manufacture Botox. “Knockoffs” of Botox are unsafe and potentially dangerous. They should not be used. Other forms of botulinum toxin A are made by reputable companies and have a variety of trade names.

Summary

FDA approval for continued research using Botox, bupivacaine injections and progressive dilation, in conjunction with post procedure counseling, represents a major milestone for women suffering from vaginismus. High cure rates, a minimal minor complication rate and a minimal recurrence rate of vaginismus make the Botox program for vaginismus a viable addition to treatment alternatives. The Botox program for vaginismus is especially suitable for the more severe cases of vaginismus, refractory to other types of therapy.