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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01628679
Other study ID # H11-01805
Secondary ID H11-01805
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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