Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

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.

Completed

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Key information

Conditions

Vulvodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Provoked Vulvar Vestibulodynia Urogenital Diseases Vulvar Diseases

Age range

16 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dayan Physiotherapy and Pelvic Floor Clinic

Vancouver, British Columbia, V5Z 1H8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical therapy treatment

Behavioral

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 outcomes

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: 2 years

Time frame: Following completion of data collection

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2020
Study completion: 2020
First posted: Jun 27, 2012
Registry last updated: Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed