Botulinum Toxin Injection for Treatment of Vaginismus
Primary Purpose
Vaginismus
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
botulinum toxin
botulinum toxin A
Sponsored by
About this trial
This is an interventional treatment trial for Vaginismus focused on measuring vaginismus, botulinum toxin A, dyspareunia, unconsummated marriage
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
Sites / Locations
- Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
50 percent of patient satisfaction
Secondary Outcome Measures
total patient satisfaction
Full Information
NCT ID
NCT00638066
First Posted
January 10, 2008
Last Updated
March 17, 2008
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00638066
Brief Title
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
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2008 (Anticipated)
Study Completion Date
April 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginismus
Keywords
vaginismus, botulinum toxin A, dyspareunia, unconsummated marriage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
botulinum toxin
Intervention Description
500 units of botulinum toxin for the second arm
Intervention Type
Drug
Intervention Name(s)
botulinum toxin A
Intervention Description
250 units of botulinum toxin A once
Primary Outcome Measure Information:
Title
50 percent of patient satisfaction
Time Frame
first two month
Secondary Outcome Measure Information:
Title
total patient satisfaction
Time Frame
next four month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbas noroozi, PhD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin Injection for Treatment of Vaginismus
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