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Clinical Trial Summary

According to high rate of vaginismus (about 10 percent) which leads to unconsummated marriage (about 1 percent) and low efficacy for conventional treatments such as biofeedback therapy, analgesic drugs and pain killers and surgical treatment, there`s necessity to find more effective method.

In our previous study, injecting botulinum toxin in 23 patients cured 75% of them.Now we are to make comparison between different doses of toxin injection and record the patient sexual satisfaction.


Clinical Trial Description

Vaginismus is the recurrent or persistent involuntary contraction of the perineal muscles surrounding the outer third of the vagina when penile, finger, tampon, or speculum penetration is attempted . Vaginismus can be primary, in which the women has never been able to have intercourse, or secondary, which is often due to acquired dyspareunia. It is relatively rare, affecting about 1% of women . Treatment of vaginismus is directed toward extinguishing the conditioned involuntary vaginal spasm. This can be accomplished by teaching Kegel exercises to acquaint the patient with voluntary control of her levator muscles. Medications such as lubricants, anesthetic creams, propranolol, or alprazolam to reduce anxiety have been used effectively, but approximately 10% of patients do not respond. Botulinum toxin type A has been successfully used to treat a wide range of muscular disorders such as strabismus, blepharospasm, and cervical dystonia. It is also been used to reduce facial lines and wrinkles.The extent of paralysis depends on the amount of toxin to which there is exposure relative to muscle bulk.In our previous study, one week after injecting botulinum toxin in 23 patients (95.8%) had a vaginal exam, which showed no or little resistance; 18 (75%) achieved satisfactory intercourse after the first injection. Now we are to make comparison between different doses of toxin injection and record the patient sexual satisfaction. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00638066
Study type Interventional
Source Tehran University of Medical Sciences
Contact
Status Active, not recruiting
Phase Phase 3
Start date October 2007
Completion date April 2008

See also
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Recruiting NCT05529407 - Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus N/A
Completed NCT01859507 - Injection of Botox in the Perineal Muscles in Resistant Cases of Vaginal Spasm N/A
Completed NCT04436172 - Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus N/A
Completed NCT00281372 - Sexual Dysfunction and Dental Care N/A
Completed NCT03176069 - Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus) N/A
Completed NCT01352546 - Botox Injection for Treatment of Vaginismus Phase 1
Recruiting NCT04635345 - Feasibility of Use of Vibrators With Vaginal Dilators for Vaginismus. (Vibrator Therapy and Dilators in Vaginismus) N/A
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