Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

Vulvodynia Clinical Trial

Official title:

Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628679
• Other study ID #: H11-01805
• Secondary ID: H11-01805
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: June 2020

Study information

• Verified date: June 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Provoked Vulvar Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Intervention

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.

Locations

Country	Name	City	State
Canada	Dayan Physiotherapy and Pelvic Floor Clinic	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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