Vaginismus Clinical Trial
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
Verified date | August 2017 |
Source | Plastic Surgery Professional Association |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Plastic Surgery Professional Association | Manchester | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Plastic Surgery Professional Association | Allergan |
United States,
Pacik PT, Cole JB. When Sex Seems Impossible. Stories of Vaginismus & How You Can Achieve Intimacy. Odyne Publishing 2010
Pacik PT, Geletta S. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients. Sex Med. 2017 Jun;5(2):e114-e123. doi: 10.1016/j.esxm.2017.02.002. Epub 2017 Mar 28. — View Citation
Pacik PT. Botox treatment for vaginismus. Plast Reconstr Surg. 2009 Dec;124(6):455e-6e. doi: 10.1097/PRS.0b013e3181bf7f11. — View Citation
Pacik PT. Understanding and treating vaginismus: a multimodal approach. Int Urogynecol J. 2014 Dec;25(12):1613-20. doi: 10.1007/s00192-014-2421-y. Epub 2014 Jun 4. — View Citation
Pacik PT. Vaginismus: review of current concepts and treatment using botox injections, bupivacaine injections, and progressive dilation with the patient under anesthesia. Aesthetic Plast Surg. 2011 Dec;35(6):1160-4. doi: 10.1007/s00266-011-9737-5. Epub 2011 May 10. Review. — View Citation
Pacik, P. T. (2015), OnabotulinumtoxinA as Part of a Multimodal Program to Treat Vaginismus. Journal of Applied Biobehavioral Research, 20: 25-36. doi:10.1111/jabr.12037
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability to Achieve Pain Free Intercourse. | 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. | one year |
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