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Sponsored by: |
Tehran University of Medical Sciences |
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Information provided by: | Tehran University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00638066 |
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.
Condition | Intervention | Phase |
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Vaginismus |
Drug: botulinum toxin Drug: botulinum toxin A |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: botulinum toxin A
250 units of botulinum toxin A once
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2: Active Comparator |
Drug: botulinum toxin
500 units of botulinum toxin for the second arm
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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.
Ages Eligible for Study: | 20 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of | |
Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center | |
Tehran, Iran, Islamic Republic of |
Principal Investigator: | Abbas noroozi, PhD | Tehran University of Medical Sciences |
Responsible Party: | Tehran University of Medical Sciences ( Dr Shirin Ghazizadeh ) |
Study ID Numbers: | 130/6/6081, 130/6/6081 |
Study First Received: | January 10, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00638066 History of Changes |
Health Authority: | Iran: Ministry of Health |
vaginismus botulinum toxin A dyspareunia unconsummated marriage |
Sexual Dysfunctions, Psychological Genital Diseases, Female Botulinum Toxins Sexual Dysfunction, Physiological |
Mental Disorders Vaginismus Vaginal Diseases Dyspareunia |
Sexual Dysfunctions, Psychological Genital Diseases, Female Botulinum Toxins Sexual Dysfunction, Physiological Anti-Dyskinesia Agents Mental Disorders |
Therapeutic Uses Vaginismus Vaginal Diseases Central Nervous System Agents Sexual and Gender Disorders Pharmacologic Actions |