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| Tracking Information | |||||
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| First Received Date ICMJE | January 10, 2008 | ||||
| Last Updated Date | March 17, 2008 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
50 percent of patient satisfaction [ Time Frame: first two month ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00638066 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
total patient satisfaction [ Time Frame: next four month ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Botulinum Toxin Injection for Treatment of Vaginismus | ||||
| Official Title ICMJE | Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus | ||||
| Brief 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. |
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| Detailed 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Vaginismus | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | April 2008 | ||||
| Estimated Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 20 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00638066 | ||||
| Responsible Party | Dr Shirin Ghazizadeh, Tehran University of Medical Sciences | ||||
| Study ID Numbers ICMJE | 130/6/6081, 130/6/6081 | ||||
| Study Sponsor ICMJE | Tehran University of Medical Sciences | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Tehran University of Medical Sciences | ||||
| Verification Date | March 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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