Clinical trial NCT00638066: Botulinum Toxin Injection for Treatment of Vaginismus
Official title: Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vaginismus
Keywords: vaginismus
botulinum toxin A
dyspareunia
unconsummated marriage
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-03-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 50 percent of patient satisfaction
timeFrame: first two month
Secondary outcomes:
measure: total patient satisfaction
timeFrame: next four month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center
Study officials:
affiliation: Tehran University of Medical Sciences
name: Abbas noroozi, PhD
role: PRINCIPAL_INVESTIGATOR
References: