Back to resultsThe Effectiveness of Vestibulectomy
Primary Purpose
Vulvodynia
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
vestibulectomy
Sponsored by
About this trial
This is an interventional treatment trial for Vulvodynia focused on measuring vulvodynia, vestibulectomy, surgery, vestibulitis
Eligibility Criteria
Inclusion Criteria:
- vulvodynia, scheduled for vestibulectomy
Sites / Locations
- Western Galilee Hospital- Nahariya
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vulvodynia
Arm Description
Outcomes
Primary Outcome Measures
pain
Secondary Outcome Measures
sexual function
Full Information
NCT ID
NCT00873301
First Posted
March 31, 2009
Last Updated
March 29, 2012
Sponsor
Western Galilee Hospital-Nahariya
1. Study Identification
Unique Protocol Identification Number
NCT00873301
Brief Title
The Effectiveness of Vestibulectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Galilee Hospital-Nahariya
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Women with vulvodynia will fill out a questionnaire and undergo a gynecological examination before and 6 months after vestibulectomy. The investigators hypothesize that pain will decrease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia
Keywords
vulvodynia, vestibulectomy, surgery, vestibulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vulvodynia
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
vestibulectomy
Intervention Description
Evaluation of the outcome of vestibulectomy which is the treatment of vulvar vestibulitis
Primary Outcome Measure Information:
Title
pain
Time Frame
6 months following surgery
Secondary Outcome Measure Information:
Title
sexual function
Time Frame
6 months afater surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
vulvodynia, scheduled for vestibulectomy
Facility Information:
Facility Name
Western Galilee Hospital- Nahariya
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Vestibulectomy
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