Botox Injection for Treatment of Vaginismus (NCT01352546) | Clinical Trial Compass
CompletedPhase 1
Botox Injection for Treatment of Vaginismus
United States31 participantsStarted 2010-08
Plain-language summary
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.
Who can participate
Age range
20 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.