Botox Injection for Treatment of Vaginismus

Completed · Phase 1

Conditions studied: Vaginismus

In brief

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.

Key facts

Study ID

NCT01352546

Run by

Plastic Surgery Professional Association

People needed

31

Starts

2010-08-01

Expected to finish

2012-12-01

Last updated by the study team

2017-08-07

Who can join

Age: 20 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Plastic Surgery Professional Association — Manchester, New Hampshire, United States

Full record on ClinicalTrials.gov

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