The Effectiveness of Vestibulectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00873301
First received: March 31, 2009
Last updated: March 29, 2012
Last verified: March 2012
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • pain [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sexual function [ Time Frame: 6 months afater surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • vulvodynia, scheduled for vestibulectomy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873301

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

No publications provided

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
Study First Received: March 31, 2009
Last Updated: March 29, 2012
Health Authority: Israel: Health Ministry

Keywords provided by Western Galilee Hospital-Nahariya:
vulvodynia
vestibulectomy
surgery
vestibulitis

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

ClinicalTrials.gov processed this record on August 26, 2014