Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM

Description

The goal of this study is to perform a quantitative assessment of the psychometric properties of the Vulvovaginal Atrophy Questionnaire (VVAQ), a novel patient reported outcome measure (PROM), through a REDCap survey of menopausal women with and without symptomatic vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM).

Conditions

Vulvovaginal Atrophy, Menopause, Genitourinary Syndrome of Menopause

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Study Overview

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Study Details

Study overview

The goal of this study is to perform a quantitative assessment of the psychometric properties of the Vulvovaginal Atrophy Questionnaire (VVAQ), a novel patient reported outcome measure (PROM), through a REDCap survey of menopausal women with and without symptomatic vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM).

Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel Patient Reported Outcome Measure (PROM)

Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM

Condition
Vulvovaginal Atrophy
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female
  • * Age \> 45 years
  • * Menopausal, defined as: \> 1 year since last menses (with a uterus, without progestin- releasing IUD, without prior endometrial ablation), or \> 6 months since bilateral oophorectomy
  • * Pelvic exam completed as part of visit
  • * Able to communicate in English
  • * Chronic, bothersome vaginal symptoms before menopause (e.g. vulvar or vaginal pain, dryness, itching, discharge, discomfort with sexual activity)
  • * History of chronic urogenital condition (vulvar, vaginal, urinary), involving pain, pruritis, discharge, or inflammation, unrelated to menopausal estrogen deficiency
  • * History of lichen sclerosis or lichen planus
  • * History of vulvar, vaginal or cervical cancer
  • * Prior vulvar or vaginal surgery (office biopsy allowed)
  • * Active major medical illness (e.g., unstable heart disease, untreated psychiatric disorder) that might interfere with the ability to participate in the study
  • * Undiagnosed vaginal bleeding
  • * Exam findings consistent with a urogenital condition unrelated to menopausal estrogen deficiency (e.g. yeast or BV vaginitis, vulvodynia, vulvo-vestibulitis, lichen sclerosis, lichen planus)

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Jan Shifren, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2024-05-01