The Burden of Vulvovaginal Atrophy on Women's Daily Living

Implications on Quality of Life From a Face-to-face Real-life Survey

Rossella E. Nappi, MD, PhD; Santiago Palacios, MD, PhD; Nico Bruyniks, MD, MRCOG, MFSRH; Martire Particco, MD; Nick Panay, BSc, FRCOG, MFSRH; on behalf of the EVES Study investigators

Disclosures

Menopause. 2019;26(5):485-491. 

In This Article

Methods

Design and Participants

The EVES study was a cross-sectional multinational survey performed in menopause and gynecology centers in Italy and Spain. The study was conducted in accordance with the Declaration of Helsinki and received approval from an independent institutional review board. All participants provided written informed consent before study entry. The study included postmenopausal women aged 45 to 75 years old. Postmenopause status was defined as more than 12 months after the last menstrual period.

Study Procedures

Women were invited to participate in the survey when attending menopause and/or gynecology clinics. Initially, investigators assessed the menopause status and screened for VVA-related symptoms and ongoing treatments. Women with at least one VVA symptom provided data on demographics and lifestyle, and scored 19 potentially VVA-related complaints on a 4-point severity scale (absent, mild, moderate, and severe).[19] In addition, participants filled in both the EuroQol questionnaire (EQ-5D-3L)[20] and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire[14] to measure the impact of VVA on quality of life. EQ-5D-3L comprises an index score (0–1) for each of five dimensions (mobility, self-care, daily activities, pain-discomfort, and anxiety-depression) as well as a visual analog scale (VAS) for current health status (0–100). DIVA scores quality of life for four dimensions: daily activities, emotional well-being, sexual functioning, and self-concept/body image. The DIVA dimensions and the overall scale are scored from 0 to 4, with higher scores indicating a greater impact of symptoms. A gynecologic clinical assessment of signs of VVA, consisting of a gynecologic physical examination and tests according to routine clinical practice (complete pelvic examination and measurement of vaginal pH), was performed by the investigator.[21] This examination was to confirm the presence of VVA as observed by the gynecologist.

As detailed in a previous publication based on the EVES study, the EQ-5D-3L and DIVA results were analyzed versus severity of VVA symptoms recorded in three categories (vaginal, vulvar, and urinary symptoms).[19] For each of the symptoms in the three groups, as well as for the additional nonclassified symptom of abdominal pain, women were asked to grade intensity as none, mild, moderate, or severe. Intensity was, in turn, transformed into a 0- to 3-point score. This procedure assigned a severity score for each group of symptoms. For the purpose of classification of participants, the following scores were considered as threshold values for severe symptomatology: >11 for the group of vaginal symptoms, >5 for vulvar symptoms, and >8 for urinary symptoms.

Statistical Analyses

For continuous variables, descriptive statistics were calculated as the mean, SD, and range for normally distributed variables, and the median and interquartile range for nonparametric variables. Categorical variables were summarized as counts and percentages. Chi-square test was used to compare categorical variables. Student's t test (or Mann–Whitney U test for nonparametric continuous data) was used to compare quantitative variables. Positive and negative correlations between quantitative variables were assessed with the Pearson correlation coefficient for normally distributed data and the Spearman correlation coefficient if the data were not normally distributed.

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