Physiotherapy Intervention for Provoked Vulvar Vestibulodynia
Primary Purpose
Vulvodynia, Provoked Vulvar Vestibulodynia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical therapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Vulvodynia focused on measuring provoked, vulvar, vestibulodynia, vestibulitis
Eligibility 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
Sites / Locations
- Dayan Physiotherapy and Pelvic Floor Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
physical therapy treatment
Arm Description
Outcomes
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: Following completion of data collection
Secondary Outcome Measures
Full Information
NCT ID
NCT01628679
First Posted
February 12, 2012
Last Updated
June 20, 2020
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01628679
Brief Title
Physiotherapy Intervention for Provoked Vulvar Vestibulodynia
Official Title
Physiotherapy Intervention for Provoked Vulvar Vestibulodynia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia, Provoked Vulvar Vestibulodynia
Keywords
provoked, vulvar, vestibulodynia, vestibulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
physical therapy treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Physical therapy treatment
Intervention Description
Subjects will be given pelvic floor motor control,proprioception and relaxation exercises. This will be with and without the use of external surface Electromyography (EMG) biofeedback. Education will also be given on pain management, female sexual response and vestibulodynia. Subjects will also practice inserting vaginal inserts of graduating diameter into their vaginas, practicing the skills learned in physical therapy sessions.
Primary Outcome Measure Information:
Title
Upon completion of data analysis, establishment of the efficacy of pelvic floor physiotherapy for the treatment of Provoked Vulvar Vestibulodynia will be determined
Description
Time frame: Following completion of data collection
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcy L Dayan, BSc Rehab
Organizational Affiliation
Clinical Instructor, Dep't of Physical Therapy, Faculty of Medicine, University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dayan Physiotherapy and Pelvic Floor Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Physiotherapy Intervention for Provoked Vulvar Vestibulodynia
We'll reach out to this number within 24 hrs