## Protocol Section
### Identification Module
**NCT ID:** NCT01628679

**Brief Title:** Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

**Official Title:** Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

#### Organization Study ID Info
**ID:** H11-01805
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
#### Secondary ID Infos
**ID:** H11-01805
### Status Module
#### Completion Date
**Date:** 2020-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-23

**Type:** ACTUAL

**Last Update Submit Date:** 2020-06-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-03

**Type:** ACTUAL

#### Start Date
**Date:** 2012-08

**Type:** ACTUAL

**Status Verified Date:** 2020-06

#### Study First Post Date
**Date:** 2012-06-27
**Type:** ESTIMATED
**Study First Submit Date:** 2012-02-12
**Study First Submit QC Date:** 2012-06-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of British Columbia

#### Responsible Party

**Investigator Affiliation:** University of British Columbia

**Investigator Full Name:** Marcy Dayan

**Investigator Title:** Registered Physiotherapist, Clinical Instructor Department of PhysicalTherapy

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Vulvodynia

- Provoked Vulvar Vestibulodynia

**Keywords:**

- provoked

- vulvar

- vestibulodynia

- vestibulitis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 125

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Physical therapy treatment

**Label:** physical therapy treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- physical therapy treatment

**Description:** 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.

**Name:** Physical therapy treatment

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Time frame: Following completion of data collection

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 40 Years

**Minimum Age:** 16 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Vancouver

**Country:** Canada

**Facility:** Dayan Physiotherapy and Pelvic Floor Clinic

**State:** British Columbia

**Zip:** V5Z 1H8

#### Overall Officials

**Official 1:**

**Affiliation:** Clinical Instructor, Dep't of Physical Therapy, Faculty of Medicine, University of British Columbia

**Name:** Marcy L Dayan, BSc Rehab

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014845

- Term: Vulvar Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000014847

- Term: Vulvitis

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M28529

- Name: Vulvodynia

- Relevance: HIGH

- As Found: Vestibulodynia

- ID: M27753

- Name: Vulvar Vestibulitis

- Relevance: HIGH

- As Found: Vestibulodynia

- ID: M17588

- Name: Vulvar Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T5878

- Name: Vulvar Vestibulitis Syndrome

- Relevance: HIGH

- As Found: Vestibulodynia

### Condition Browse Module - Meshes

- ID: D000056650

- Term: Vulvodynia

- ID: D000054515

- Term: Vulvar Vestibulitis

### Misc Info Module

- Version Holder: 2024-05-24
