Both the specialists at Maze Women’s Health, as well as Dr. Peter Pacik, truly believe that using the botulinum toxin injections as a treatment for vaginismus results in a cure rate of well over 90% when combined with the use of dilators and post procedure counseling. For the many patients who are willing to do the work, we are here to help.
“My body was locked. Nothing was going in and by nothing I mean that growing up I never used a tampon, so this problem dates back many years. Even when the time came for gynecological exams, the experience was excruciatingly painful and draining. This fear of penetration and automatic tightness followed me all the way to my honeymoon.”
If this sounds all too familiar, the vaginismus treatment plan using botulinum toxin may be right for you.
If you’re unsure how to proceed, please feel free to contact us for a free 10 minute phone consultation. We can review your specific concerns and determine the best next steps for you.
Peter Pacik, MD, FCS – Background
In 2005, a patient called the office to ask if Dr. Pacik would treat her vaginismus with botulinum toxin. He had never heard the term nor learned anything about this condition in medical school. He was stunned by the lack of medical information but had enough experience with botulinum toxin that he was confident he could help her. The outcome was successful and the patient was finally able to achieve pain free intercourse.
As Dr. Pacik treated more women, he realized that the treatment of vaginismus became a “calling”. He applied for and received a grant to study the treatment of vaginismus. This was followed by Institutional Review Board (IRB) approval and then FDA approval with an Investigational New Drug (IND) approval for his continued research using botulinum toxin to treat vaginismus.
In 2015, Dr. Pacik decided to retire and he began referring his vaginismus patients to Maze Women’s Health.
In 2010 Dr. Peter Pacik received FDA approval to continue his research using botulinum toxin to treat vaginismus. The entire program was submitted to the FDA and their approval not only included the use of botulinum toxin 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 botulinum toxin as an investigational new drug (IND 109343). Even though botulinum toxin has a high degree of safety, and is widely used for many conditions, the use of botulinum toxin 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. “Botulinum Toxin 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 Botulinum Toxin 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 botulinum toxin was no longer active after four months. One patient developed dryness of her natural vaginal lubrication, and this too cleared once the botulinum toxin 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 botulinum toxin 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 botulinum toxin.
Importance of understanding Botulinum Toxin for vaginismus
As with any drug, a knowledge of dosage and proper injection techniques is essential. Injecting botulinum toxin without proper training can create complications. Further, just injecting botulinum toxin 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 botulinum toxin injections elsewhere (some as many as two different courses of botulinum toxin). These failures are indicative of the importance of understanding the entire program used to treat vaginismus.