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Botulinum Toxin Injection for Treatment of Vaginismus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Tehran University of Medical Sciences.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00638066
First Posted: March 18, 2008
Last Update Posted: March 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tehran University of Medical Sciences
  Purpose

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.


Condition Intervention Phase
Vaginismus Drug: botulinum toxin Drug: botulinum toxin A Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 50 percent of patient satisfaction [ Time Frame: first two month ]

Secondary Outcome Measures:
  • total patient satisfaction [ Time Frame: next four month ]

Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Study Completion Date: April 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: botulinum toxin A
250 units of botulinum toxin A once
Active Comparator: 2 Drug: botulinum toxin
500 units of botulinum toxin for the second arm

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

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638066


Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Abbas noroozi, PhD Tehran University of Medical Sciences
  More Information

Responsible Party: Dr Shirin Ghazizadeh, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00638066     History of Changes
Other Study ID Numbers: 130/6/6081
First Submitted: January 10, 2008
First Posted: March 18, 2008
Last Update Posted: March 18, 2008
Last Verified: March 2008

Keywords provided by Tehran University of Medical Sciences:
vaginismus
botulinum toxin A
dyspareunia
unconsummated marriage

Additional relevant MeSH terms:
Vaginismus
Sexual Dysfunction, Physiological
Genital Diseases, Female
Vaginal Diseases
Sexual Dysfunctions, Psychological
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents