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The Effectiveness of Vestibulectomy

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ClinicalTrials.gov Identifier: NCT00873301
Recruitment Status : Completed
First Posted : April 1, 2009
Last Update Posted : April 2, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya

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.

Condition or disease Intervention/treatment Phase
Vulvodynia Procedure: vestibulectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: vulvodynia Procedure: vestibulectomy
Evaluation of the outcome of vestibulectomy which is the treatment of vulvar vestibulitis



Primary Outcome Measures :
  1. pain [ Time Frame: 6 months following surgery ]

Secondary Outcome Measures :
  1. sexual function [ Time Frame: 6 months afater surgery ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • vulvodynia, scheduled for vestibulectomy

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): NCT00873301


Locations
Israel
Western Galilee Hospital- Nahariya
Nahariya, Israel, 22100
Sponsors and Collaborators
Western Galilee Hospital-Nahariya

Responsible Party: Prof. Jacob Bornstein, Chairman, Obstetrics and Gynecology, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT00873301     History of Changes
Other Study ID Numbers: JB 13-08-2008
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012

Keywords provided by Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya:
vulvodynia
vestibulectomy
surgery
vestibulitis

Additional relevant MeSH terms:
Vulvodynia
Vulvar Diseases
Genital Diseases, Female