Treatment of vaginismus with onabotulinumtoxin A: results from a pilot study
Peter T. Pacik, MD, FACS gave a podium presentation to the 34th Annual Scientific Meeting of the American Urogynecologic Society at Caesars Palace in Las Vegas on October 18,2013 discussing the use of Botox to treat vaginismus. About 1200 participants attended the lecture which was titled: “Treatment of vaginismus with onabotulinumtoxin A: results from a pilot study”
The data and long term follow up from the FDA approved 2010 pilot study using Botox showed a 97% success rate with no adverse events (complications) nor any need to repeat the Botox injections in patients at least one year follow up. The presentation reviewed an understanding of vaginismus as well as the vaginismus treatment.
Specific areas of presentation included:
- the struggles that women experience who have vaginismus
- the need to stratify the severity of vaginismus using the Lamont and Pacik systems of classification
- to choose the appropriate treatment for vaginismus
- an analysis of prior treatments that were unsuccessful in this group of vaginismus patients
- vaginismus treatment using Botox under anesthesia, how to inject the drug and correct dosage
- importance of combining progressive dilation during vaginismus treatment
- post procedure counseling
- the need to fully support these patients during their follow up.
The long term benefits showed that 97% of the patients were able to achieve pain free intercourse, or in the two patients without partners, the use of the large dilators without pain. After vaginismus treatment with Botox there were no adverse events and no recurrences.
Female Sexual Function Index (FSFI), a validated 19-item questionnaire, at baseline and 1 year post-treatment were noted to be improved long-term in this pilot study.
Continued annual reporting to the FDA clinical trials.gov explains the Botox treatment program, results and follow up.
Conclusions of this study using Botox for the treatment of vaginismus:
- Onabotulinumtoxin A injection with bupivacaine injection, progressive dilation under anesthesia, and post-treatment support was effective in the treatment of vaginismus
- This treatment is currently being further investigated in a larger clinical trial at this center
The larger group of 247 patients treated for vaginismus was presented at the conclusion of the presentation to bring the audience up to date. The audience was very appreciative for this added knowledge and many questions were answered at the end of this scientific session.
Abstract: Treatment of vaginismus with onabotulinumtoxin A: results from a pilot study
Peter Pacik, MD
Plastic Surgery Professional Association, Manchester, NH, USA
2013 annual meeting of the American Urogynecologic Society, Las Vegas, NV
October 16-19, 2013
Objectives: Vaginismus is a poorly understood condition that involves involuntary spasms of the vaginal muscles, resulting in an inability to have sexual intercourse. Prior evidence suggested that botulinum toxin may be an effective treatment for vaginismus. Thus, this open-label, single-center, pilot study (NCT01352546) was performed to evaluate the efficacy and safety of intravaginal injection of onabotulinumtoxinA (BOTOX®, Allergan, Inc.) combined with bupivacaine injection and progressive dilation under anesthesia along with post-procedure support in the treatment of vaginismus.
Methods: Eligible patients were non-pregnant females aged 20-40 with primary vaginismus who were naïve to any kind of botulinum toxin treatment. Patients under heavy sedation or general anesthesia received a one-time intravaginal injection of onabotulinumtoxinA 150U into the bulbocavernosus, pubococcygeus, and puborectalis muscles along each left and right lateral wall, along with 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine, followed by insertion of progressively larger dilators coated with 2% xylocaine jelly mixed with surgical lubricant. Supervised dilation continued for 2-3 days post-procedure, and dilation was recommended for 15-30 minutes prior to attempted intercourse. The primary endpoint was the ability to achieve pain-free intercourse, or in the absence of a partner, to use a #5 or #6 dilator, within one year post-treatment. The Female Sexual Function Index (FSFI), a validated 19-item questionnaire, was also administered before and after treatment (FSFI scores range from 2-36; higher scores indicate better sexual function). Adverse events (AEs) were monitored throughout the study.
Results: A total of 31 patients were included in the study. The mean age was 27.3 y (range 20-37) with an average duration of vaginismus of 7.2 y (range 0.5-22 y) from time of discovery. Vaginismus was classified as Lamont level 4 (most severe) at baseline in 20 (64.5%) patients; 48.4% of patients had previously been unable to undergo a gynecological exam. Most patients had failed prior treatments, with the most common being dilator use and Kegel exercises, attempted by 80.6% and 64.5% of patients, respectively, with respective average durations of treatment of 33.7 (range 5-150) and 40.2 (range 1-312) weeks. After onabotulinumtoxinA treatment, 28 (90.3%) patients achieved pain-free intercourse by an average of 8.0 weeks (range 0.3-51). Two (6.5%) patients were without partners but were able to comfortably use the #5 or #6 dilators at 0.4 and 3 weeks post-procedure, respectively. One patient (3.2%) was unable to achieve intercourse despite the ability to use the #5 or #6 dilators 4 weeks post-procedure. Of the 19 patients with complete data for the FSFI, the median score was 17.1 (range 7.1-30.2) at baseline and 23.6 (range 2-34.3) 12 months post-onabotulinumtoxinA treatment. No recurrences of vaginismus and no AEs were noted within the follow-up period.
Conclusions: Intravaginal injection of onabotulinumtoxinA with progressive dilation and post-procedure support enabled patients with vaginismus to achieve pain-free intercourse and exhibit greater levels of sexual function within one year post-treatment in this pilot study. As such, this treatment warrants additional investigation in larger clinical trials.
For a short video clip of Dr. Pacik’s lecture on understanding and treating vaginismus, click the following link: Dr. Pacik’s Podium presentation to the 34th Annual Scientific Meeting of the American Urogynecologic Society at Caesars Palace