Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

Not Applicable

Completed

• Conditions: Provoked Vulvar Vestibulodynia; Vulvodynia
• Interventions: Behavioral: Physical therapy treatment

• Registration Number: NCT01628679
• Lead Sponsor: University of British Columbia

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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-12
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Study Start: 2012-08
• Primary Completion: 2020-03
• Status Verified: 2020-06
• Study Completion: 2020-06
• Last Update Submitted: 2020-06-20
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
physical therapy treatment	Physical therapy treatment	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dayan Physiotherapy and Pelvic Floor Clinic; 🇨🇦 Vancouver, British Columbia, Canada