NCT00278850

Brief Summary

The purpose of this study is to investigate the efficacy of an educational seminar series for women with vulvar vestibulitis syndrome (VVS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

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, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

3.2 years

First QC Date

January 16, 2006

Last Update Submit

June 11, 2015

Conditions

Vulvar Vestibulitis

Keywords

Vulvar vestibulitisTreatmentEducation

Interventions

EducationalBEHAVIORAL

three 1 hour long educational seminars

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women diagnosed with vulvar vestibulitis

You may qualify if:

  • Women who meet the diagnostic criteria for VVS by the Vancouver Hospital Vulvar Disease Clinic
  • Women who have been referred to VVS Educational Seminars at Vancouver Hospital
  • Proficient in English

You may not qualify if:

  • Any women referred to the VVS Educational Seminars will be eligible for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (12)

  • Abramov L, Wolman I, David MP. Vaginismus: an important factor in the evaluation and management of vulvar vestibulitis syndrome. Gynecol Obstet Invest. 1994;38(3):194-7. doi: 10.1159/000292478.

    PMID: 8001875BACKGROUND

  • Bergeron S, Binik YM, Khalife S, Pagidas K, Glazer HI. Vulvar vestibulitis syndrome: reliability of diagnosis and evaluation of current diagnostic criteria. Obstet Gynecol. 2001 Jul;98(1):45-51. doi: 10.1016/s0029-7844(01)01389-8.

    PMID: 11430955BACKGROUND

  • Bergeron S, Binik YM, Khalife S, Pagidas K. Vulvar vestibulitis syndrome: a critical review. Clin J Pain. 1997 Mar;13(1):27-42. doi: 10.1097/00002508-199703000-00006.

    PMID: 9084950BACKGROUND

  • Bornstein J, Livnat G, Stolar Z, Abramovici H. Pure versus complicated vulvar vestibulitis: a randomized trial of fluconazole treatment. Gynecol Obstet Invest. 2000;50(3):194-7. doi: 10.1159/000010309.

    PMID: 11014954BACKGROUND

  • Pukall CF, Payne KA, Binik YM, Khalife S. Pain measurement in vulvodynia. J Sex Marital Ther. 2003;29 Suppl 1:111-20. doi: 10.1080/713847136.

    PMID: 12735095BACKGROUND

  • Bergeron, S., Binik, YM., Khalifé, S., Meana, M., Berkely, KJ. & Pagidas, K. (1997). The treatment of vulvar vestibulitis syndrome: Towards a multimodal approach. Sexual & Marital Therapy, 12(4), 305-311.

    BACKGROUND

  • Glazer HI, Rodke G, Swencionis C, Hertz R, Young AW. Treatment of vulvar vestibulitis syndrome with electromyographic biofeedback of pelvic floor musculature. J Reprod Med. 1995 Apr;40(4):283-90.

    PMID: 7623358BACKGROUND

  • Pukall, C.F., Payne, K.A., Kao, A., Khalife, S. & Binik, Y.M. (2005). Dyspareunia. In R. Balon & R.T. Segraves, (Ed.s), Handbook of Sexual Dysfunction (pp. 249-272). New York: Taylor and Francis.

    BACKGROUND

  • ter Kuile, MM. & Weijenborg, ThM, (2003). A cognitive behavioural group treatment programme for women with vulvar vestibulitis syndrome: factors associated with treatment success. Sexual Pain Disorders Symposium, Amsterdam, Holland, Oct. 20-24, 2003.

    BACKGROUND

  • Friedrich EG Jr. Vulvar vestibulitis syndrome. J Reprod Med. 1987 Feb;32(2):110-4.

    PMID: 3560069BACKGROUND

  • Schover LR, Youngs DD, Cannata R. Psychosexual aspects of the evaluation and management of vulvar vestibulitis. Am J Obstet Gynecol. 1992 Sep;167(3):630-6. doi: 10.1016/s0002-9378(11)91562-2.

    PMID: 1530015BACKGROUND

  • Weijmar Schultz WC, Gianotten WL, van der Meijden WI, van de Wiel HB, Blindeman L, Chadha S, Drogendijk AC. Behavioral approach with or without surgical intervention to the vulvar vestibulitis syndrome: a prospective randomized and non-randomized study. J Psychosom Obstet Gynaecol. 1996 Sep;17(3):143-8. doi: 10.3109/01674829609025675.

    PMID: 8892160BACKGROUND

MeSH Terms

Conditions

Vulvar Vestibulitis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lori A Brotto, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 18, 2006

Study Start

January 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations

CA(1)