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Botulinum Toxin Injection for Treatment of Vaginismus

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ClinicalTrials.gov Identifier: NCT00638066
Recruitment Status : Unknown
Verified March 2008 by Tehran University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : March 18, 2008
Last Update Posted : March 18, 2008
Sponsor:
Information provided by:
Tehran University of Medical Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
Vaginismus Drug: botulinum toxin Drug: botulinum toxin A Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : October 2007
Estimated Primary Completion Date : April 2008
Estimated Study Completion Date : April 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 50 percent of patient satisfaction [ Time Frame: first two month ]

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

Eligibility Criteria
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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
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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
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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
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Principal Investigator: Abbas noroozi, PhD Tehran University of Medical Sciences
More Information
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Responsible Party: Dr Shirin Ghazizadeh, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00638066    
Other Study ID Numbers: 130/6/6081
130/6/6081
First Posted: March 18, 2008    Key Record Dates
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:
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Vaginismus
Sexual Dysfunction, Physiological
Vaginal Diseases
Sexual Dysfunctions, Psychological
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
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