We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effectiveness of Vestibulectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873301
First Posted: April 1, 2009
Last Update Posted: April 2, 2012
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 (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
  Purpose
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 Intervention
Vulvodynia Procedure: vestibulectomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya:

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

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

Enrollment: 40
Study Start Date: January 2009
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vulvodynia Procedure: vestibulectomy
Evaluation of the outcome of vestibulectomy which is the treatment of vulvar vestibulitis

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  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): NCT00873301


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

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 Submitted: March 31, 2009
First Posted: April 1, 2009
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