Botulinum Toxin Injection for Treatment of Vaginismus
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|---|---|
|
Vaginismus |
Drug: botulinum toxin Drug: botulinum toxin A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus |
- 50 percent of patient satisfaction [ Time Frame: first two month ] [ Designated as safety issue: Yes ]
- total patient satisfaction [ Time Frame: next four month ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
| Experimental: 1 |
Drug: botulinum toxin A
250 units of botulinum toxin A once
|
| Active Comparator: 2 |
Drug: botulinum toxin
500 units of botulinum toxin for the second arm
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Unconsummated marriage
- Difficult mating
- No response to biofeedback
Exclusion Criteria:
- Patient unlikely to have toxin injection
- Not having mutual life with partner
- Non treated pelvic and vaginal infection
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Dr Shirin Ghazizadeh, Tehran University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00638066 History of Changes |
| Other Study ID Numbers: | 130/6/6081, 130/6/6081 |
| Study First Received: | January 10, 2008 |
| Last Updated: | March 17, 2008 |
| Health Authority: | Iran: Ministry of Health |
Keywords provided by Tehran University of Medical Sciences:
|
vaginismus botulinum toxin A dyspareunia unconsummated marriage |
Additional relevant MeSH terms:
|
Vaginismus Sexual Dysfunction, Physiological Genital Diseases, Female Vaginal Diseases Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Botulinum Toxins, Type A |
Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013