Botulinum Toxin Injection for Treatment of Vaginismus

Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus

Sponsors

Lead Sponsor: Tehran University of Medical Sciences

Source Tehran University of Medical Sciences
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.

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.

Overall Status Unknown status
Start Date 2007-10-01
Completion Date 2008-04-01
Primary Completion Date 2008-04-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
50 percent of patient satisfaction first two month
Secondary Outcome
Measure Time Frame
total patient satisfaction next four month
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: botulinum toxin

Description: 500 units of botulinum toxin for the second arm

Arm Group Label: 2

Intervention Type: Drug

Intervention Name: botulinum toxin A

Description: 250 units of botulinum toxin A once

Arm Group Label: 1

Eligibility

Criteria:

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

Gender:

Female

Minimum Age:

20 Years

Maximum Age:

45 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Abbas noroozi, PhD Principal Investigator Tehran University of Medical Sciences
Location
Facility: Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center
Location Countries

Iran, Islamic Republic of

Verification Date

2008-03-01

Responsible Party

Name Title: Dr Shirin Ghazizadeh

Organization: Tehran University of Medical Sciences

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Label: 2

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Care Provider)

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