Physiotherapy Intervention for Provoked Vulvar Vestibulodynia
1 other identifier
interventional
125
1 country
1
Brief Summary
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.
- 2.A combination of physiotherapy, group educational sessions and group cognitive behavioural therapy will have better outcomes than physiotherapy alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 23, 2020
June 1, 2020
7.6 years
February 12, 2012
June 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Study Arms (1)
physical therapy treatment
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- years and under
- diagnosis of provoked vulvar vestibulodynia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dayan Physiotherapy and Pelvic Floor Clinic
Vancouver, British Columbia, V5Z 1H8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcy L Dayan, BSc Rehab
Clinical Instructor, Dep't of Physical Therapy, Faculty of Medicine, University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Registered Physiotherapist, Clinical Instructor Department of PhysicalTherapy
Study Record Dates
First Submitted
February 12, 2012
First Posted
June 27, 2012
Study Start
August 1, 2012
Primary Completion
March 1, 2020
Study Completion
June 1, 2020
Last Updated
June 23, 2020
Record last verified: 2020-06