Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01628679
First received: February 12, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

Hypothesis:

  1. Specific physiotherapy interventions will decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastrophizing behaviour in women with provoked vulvar vestibulodynia.

    This study will look at specific physiotherapy treatment interventions to see if they decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastophizing behaviour. Participants will fill out a questionnaire on their pain symptoms and complete standardized scales prior to starting treatment and after 4 sessions to determine change due to interventions.

  2. A combination of physiotherapy, group educational sessions and group cognitive behavioural therapy will have better outcomes than physiotherapy alone.

Results of physiotherapy intervention alone will be compared to results of those treated with physiotherapy, group educational sessions and group cognitive behavioural therapy at a separate treatment centre. Physiotherapy interventions and outcome measures are the same between both groups.

Justification:

Standard treatment is hard to identify as many approaches are taken, none with any evidence to support them. This study aims to look at specific techniques (pelvic floor coordination and relaxation exercises, education on female sexual response and pain pathophysiology education) to see if there is a benefit.


Condition Intervention
Vulvodynia
Provoked Vulvar Vestibulodynia
Behavioral: Physical therapy treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Upon completion of data analysis, establishment of the efficacy of pelvic floor physiotherapy for the treatment of Provoked Vulvar Vestibulodynia will be determined [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time frame: Following completion of data collection


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: physical therapy treatment Behavioral: Physical therapy treatment
Subjects will be given pelvic floor motor control,proprioception and relaxation exercises. This will be with and without the use of external surface EMG biofeedback. Education will also be given on pain management, female sexual response and vestibulodynia. Subjects will also practice inserting vaginal inerts of graduating diameter into their vaginas, practicing the skills learned in physical therapy sessions.

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 years and under
  • diagnosis of provoked vulvar vestibulodynia

Exclusion Criteria:

  • early menopause
  • have had a total or partial hysterectomy
  • are on estrogen suppression medication
  • have a primary arousal disorder
  • declined admission to the Multidisciplinary Vulvodynia Program at Vancovuer General Hospital
  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: NCT01628679

Contacts
Contact: Marcy L Dayan, BSc Rehab 604-739-3133 dayanphysio@telus.net

Locations
Canada, British Columbia
Dayan Physiotherapy and Pelvic Floor Clinic Recruiting
Vancouver, British Columbia, Canada, V5Z 1H8
Contact: Marcy L Dayan, BSc Rehab    604-739-3133    dayanphysio@telus.net   
Principal Investigator: Marcy L Dayan, BSc Rehab         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Marcy L Dayan, BSc Rehab Clinical Instructor, Dep't of Physical Therapy, Faculty of Medicine, University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01628679     History of Changes
Other Study ID Numbers: H11-01805, H11-01805
Study First Received: February 12, 2012
Last Updated: January 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
provoked
vulvar
vestibulodynia
vestibulitis

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

ClinicalTrials.gov processed this record on August 28, 2014