Botulinum Toxin Injection for Treatment of Vaginismus

Phase 3

• Conditions: Vaginismus
• Interventions: Drug: botulinum toxin; Drug: botulinum toxin A

• Registration Number: NCT00638066
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-10
• Status Verified: 2008-03
• Study First Submitted QC: 2008-03-17
• Last Update Submitted: 2008-03-17
• Study First Posted: 2008-03-18
• Last Update Posted: 2008-03-18
• Primary Completion: 2008-04
• Study Completion: 2008-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	botulinum toxin	-
1	botulinum toxin A	-

Primary Outcome Measures

Name	Time	Method
50 percent of patient satisfaction	first two month

Secondary Outcome Measures

Name	Time	Method
total patient satisfaction	next four month

Trial Locations

Locations (1)

Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of