Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT01628679

Collaborator

(none)

125

Enrollment

Location

Arm

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvodynia Provoked Vulvar Vestibulodynia	Behavioral: Physical therapy treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

Actual Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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 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.

Outcome Measures

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 [2 years]
Time frame: Following completion of data collection

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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