Validation of Patient Reported Outcome Measures for Use in Vulvodynia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ipsen
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Validation of mVPAQ
Study Overview
Brief Summary
The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with Vulvodynia
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Fluent in understanding, speaking and reading US-English
- •Have vulvodynia with pain for at least 6 months
Exclusion Criteria
- •Clinically significant history of alcohol/drug abuse or dependence within the last 2 years
Outcomes
Primary Outcomes
Validation of mVPAQ
Time Frame: 1 week
Cognitive debrief and usability through interviews and completion of an electronic diary
Validation of mFSFI
Time Frame: 1 week
Cognitive debrief and usability through interviews and completion of an electronic diary
Validation of Pain on Intercourse Numeric Rating Scale (NRS)
Time Frame: 1 week
Cognitive debrief and usability through interviews and completion of an electronic diary. Pain on Intercourse NRS that describes pain experienced during this sexual intercourse episode by number. The higher is the number the worse is pain.
Secondary Outcomes
- Vulvar pain NRS(1 week)