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Botulinum Toxin Injection for Treatment of Vaginismus
This study is ongoing, but not recruiting participants.
Study NCT00638066   Information provided by Tehran University of Medical Sciences
First Received: January 10, 2008   Last Updated: March 17, 2008   History of Changes

January 10, 2008
March 17, 2008
October 2007
April 2008   (final data collection date for primary outcome measure)
50 percent of patient satisfaction [ Time Frame: first two month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00638066 on ClinicalTrials.gov Archive Site
total patient satisfaction [ Time Frame: next four month ] [ Designated as safety issue: Yes ]
Same as current
 
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

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.

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Efficacy Study
Vaginismus
  • Drug: botulinum toxin
  • Drug: botulinum toxin A
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
40
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Female
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00638066
Dr Shirin Ghazizadeh, Tehran University of Medical Sciences
130/6/6081, 130/6/6081
Tehran University of Medical Sciences
 
Principal Investigator: Abbas noroozi, PhD Tehran University of Medical Sciences
Tehran University of Medical Sciences
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP