NCT00873301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

3 years

First QC Date

March 31, 2009

Last Update Submit

March 29, 2012

Conditions

Vulvodynia

Keywords

vulvodyniavestibulectomysurgeryvestibulitis

Outcome Measures

Primary Outcomes (1)

  • pain

    6 months following surgery

Secondary Outcomes (1)

  • sexual function

    6 months afater surgery

Study Arms (1)

vulvodynia

EXPERIMENTAL
Procedure: vestibulectomy

Interventions

vestibulectomyPROCEDURE

Evaluation of the outcome of vestibulectomy which is the treatment of vulvar vestibulitis

vulvodynia

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • vulvodynia, scheduled for vestibulectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galilee Hospital- Nahariya

Nahariya, 22100, Israel

Location

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Obstetrics and Gynecology

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 1, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

April 2, 2012

Record last verified: 2012-03

Locations

IL(1)