Validation of Patient Reported Outcome Measures for Use in Vulvodynia
- Conditions
- Vulvodynia
- Registration Number
- NCT03770169
- Lead Sponsor
- Ipsen
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- Fluent in understanding, speaking and reading US-English
- Have vulvodynia with pain for at least 6 months
- Clinically significant history of alcohol/drug abuse or dependence within the last 2 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validation of mVPAQ 1 week Cognitive debrief and usability through interviews and completion of an electronic diary
Validation of mFSFI 1 week Cognitive debrief and usability through interviews and completion of an electronic diary
Validation of Pain on Intercourse Numeric Rating Scale (NRS) 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 Outcome Measures
Name Time Method Vulvar pain NRS 1 week Assess understanding of the appropriateness of the vulvar pain NRS through interview and completion of an electronic diary
Trial Locations
- Locations (4)
San Diego Sexual Medicine
🇺🇸San Diego, California, United States
Center for Vulvovaginal Disorders
🇺🇸Washington, District of Columbia, United States
Omaha OB-GYN Associates, PC
🇺🇸Omaha, Nebraska, United States
The Center for Vulvovaginal Disorders
🇺🇸New York, New York, United States