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Botulinum Toxin Injection for Treatment of Vaginismus

NCT ID: NCT00638066

Last Updated: 2008-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Vaginismus

Keywords

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vaginismus botulinum toxin A dyspareunia unconsummated marriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

Group Type EXPERIMENTAL

botulinum toxin A

Intervention Type DRUG

250 units of botulinum toxin A once

2

Group Type ACTIVE_COMPARATOR

botulinum toxin

Intervention Type DRUG

500 units of botulinum toxin for the second arm

Interventions

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botulinum toxin

500 units of botulinum toxin for the second arm

Intervention Type DRUG

botulinum toxin A

250 units of botulinum toxin A once

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tehran University of Medical Sciences

Principal Investigators

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Abbas noroozi, PhD

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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130/6/6081

Identifier Type: -

Identifier Source: secondary_id

130/6/6081

Identifier Type: -

Identifier Source: org_study_id