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Vaginismus

Botox Injection for Treatment of Vaginismus

Sponsored by Plastic Surgery Professional Association

About this trial

Last updated 8 years ago

Study ID

BTX-PV-01

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
20 to 40 Years
Female
Female

Trial Timing

Ended 13 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

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Location

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