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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
History of Changes
  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
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 May 23, 2013