Using advanced analytics to help identify women who are more likely to have a severe subjective experience of vulvovaginal atrophy: a modeling study.

OBJECTIVE: To develop a model to identify women likely to be severely impacted by vulvovaginal atrophy (VVA), based on their experience of symptoms and non-clinical factors. METHODS: Multivariate statistics and machine-learning algorithms were used to develop models using data from a cross-sectional, observational, multinational European survey. A set of independent variables were chosen to assess subjective VVA severity and its impact on daily activities. RESULTS: A final composite model was selected that included three categories of variables: clinical severity, patient demographics/clinical characteristics and Day-to-Day Impact of Vaginal Aging (DIVA) variables related to emotion/mood, impact on lifestyle and frequency of sex. The model accurately classified 71% of women. Three DIVA variables (feeling bad about yourself, desire/interest in sex, physical comfort related to sitting) explained much of the variation in the dependent variable of the model. Over 90% of the impact of VVA relates to certain psychosocial and behavioral aspects that can be identified without the need to consider physical signs/symptoms. CONCLUSION: Non-clinical factors can contribute significantly to the overall VVA burden.Questions used in developing the composite model could form the basis of an instrument to help screen women prior to clinical consultation and improve VVA management.

The European Vulvovaginal Epidemiological Survey (EVES). Impact of history of breast cancer on prevalence, symptoms, sexual function and quality of life related to vulvovaginal atrophy.

OBJECTIVE: Women with history of breast cancer (HBC) frequently suffer from vulvovaginal atrophy (VVA). European Vulvovaginal Epidemiology Survey (EVES) sub-analysis assesses the impact of HBC on VVA, sexual life and quality of life (QoL) in postmenopausal women. MATERIALS AND METHODS: Women with at least one VVA symptom aged 45-75 years were included. EuroQol (EQ-5D-3L) and Day-to-Day Impact of Vaginal Aging (DIVA) questionnaires were filled to investigate QoL. VVA diagnosis was confirmed with objective gynecological examination. Comparison of postmenopausal women with and without HBC, and evaluation of treatment impact on VVA were performed. RESULTS: 1985 postmenopausal women without HBC and 175 with HBC were included. VVA was confirmed in 90.4% of women without HBC and 91.4% of women with HBC. There were no differences in VVA symptoms severity or vulvovaginal discomfort between groups. However, women with HBC who had completed treatment and had surgery 11-20 years previously versus those without HBC presented significantly worse Vaginal Health Index scores, as well as a higher prevalence of VVA objective diagnosis, although their overall symptom severity score was lower. Health status and QoL comparisons were similar. CONCLUSIONS: Results support a similar burden in terms of VVA prevalence and symptoms, QoL and sexual function in postmenopausal women with and without HBC.

Macro-regional variation in attitudes toward and experiences of vulvar and vaginal atrophy among Italian post-menopausal women: a post hoc analysis of REVIVE survey data.

Italian participants in the European REVIVE survey reported that vaginal and vulvar atrophy (VVA) impaired various aspects of their lives, notably the ability to enjoy sex. The aim of the present study was to explore regional differences in knowledge, experiences, and treatment of VVA in the Italian REVIVE sample (n = 1000), which was analyzed according to region of residence. While many respondents were unfamiliar with the VVA condition, most could relate their VVA symptoms to the menopause. The rate of diagnosis of VVA was twice as high in Central Italy as in the North-East. For individual VVA symptoms, 25.4-41.6% of respondents judged that the symptom had worsened over time. There were no significant regional differences for symptoms in terms of reported rate, change in severity, impact on sexual activity, or health-care visits. Testosterone cream and OTC medication based on hyaluronic acid showed significant regional differences in lifetime rates of use. In Italy, there are modest regional differences in knowledge, diagnosis, and treatment of VVA, some of which may be explained by inter-regional differences in health care. Further efforts are needed to ensure that Italian women are properly informed about VVA and have access to appropriate health care and treatments.

Symptoms, attitudes and treatment perceptions of vulvo-vaginal atrophy in UK postmenopausal women: Results from the REVIVE-EU study.

OBJECTIVES: To describe the attitudes and perceptions of postmenopausal women from the United Kingdom regarding menopause, vulvo-vaginal atrophy and its therapeutic management. STUDY DESIGN: Post hoc analysis of the United Kingdom population from the REVIVE-EU Study. MAIN OUTCOME MEASURES: The survey contained questions about women's knowledge of menopause and vulvo-vaginal atrophy symptoms, impact on their life and sexual activities, communication with healthcare professionals and treatments. RESULTS: The most frequent symptom of menopause was hot flushes (75%). Vulvo-vaginal atrophy symptoms had a significant impact on participants' ability to enjoy sexual intercourse (66%), spontaneity (62%) and ability to be intimate (61%); however, only 68% of women had been to their healthcare professional for advice. Half of the sample expected that doctors would initiate a discussion of menopausal symptoms and sexual health, but was in fact rare (5%). Only 27% were under current treatment without a clear therapy pattern, of which 43% used vaginal over-the-counter treatments, 28% prescription (Rx), and 13% both. Efficacy was the main limitation for over-the-counter treatments, while for Rx products were side effects and safety. Women highlighted the restoring of the natural condition of the vagina as the main goal for a treatment (35%). Many United Kingdom women did not feel the need to see any healthcare professional for their gynaecological symptoms. Overall satisfaction with treatment was only 44%. CONCLUSIONS: Vulvo-vaginal atrophy remains underdiagnosed and undertreated in United Kingdom. There is a lack of coherent discussion about vulvo-vaginal atrophy symptoms with clinicians. Many United Kingdom healthcare professionals could improve proactive communication with patients about vulvo-vaginal atrophy.

The European Vulvovaginal Epidemiological Survey (EVES): impact on sexual function of vulvovaginal atrophy of menopause.

OBJECTIVE: To estimate the impact of vulvovaginal atrophy (VVA) on sexual function in a clinical population of postmenopausal women. METHODS: Women 45 to 75 years old and more than 12 months after the last menstruation, who attended menopausal/gynecological centers in Italy and Spain, were included. Women with at least one VVA symptom completed the following questionnaires: Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), and Female Sexual Distress Scale revised (FSDS-R). A physical gynecological examination was performed to confirm the VVA diagnosis. Data were analyzed by chi-square and Student's t tests. RESULTS: In all, 2,160 evaluable women were included in the study. VVA was confirmed in 90% of the included participants. The negative impact on sexual function was significantly higher in women with than in women without confirmed VVA, as evaluated with the sexual function component (DIVA-C) of the DIVA questionnaire (P = 0.013). Statistically significant differences (P < 0.0005) were also detected in the scores of overall FSDS-R, the overall FSFI, and of all the FSFI subdomains (desire, arousal, lubrication, orgasm, satisfaction, and pain). CONCLUSION: For postmenopausal women with at least one VVA symptom, the presence of physician-confirmed VVA is associated with significant impaired sexual function, as shown by unadjusted analyses. Given the impact on quality of life and the prevalence of VVA, further research to improve and reduce VVA is warranted.

No increase in incidence or risk of recurrence of breast cancer in ospemifene-treated patients with vulvovaginal atrophy (VVA).

OBJECTIVE: To estimate the incidence and recurrence of breast cancer (BC) in patients with vulvovaginal atrophy (VVA) treated with ospemifene and matched untreated VVA patients using real-world data. STUDY DESIGN: Retrospective matched cohort study. MAIN OUTCOME MEASURES: VVA patients were identified from the 2011-2018 US MarketScan® insurance claims database. For incidence, ospemifene-treated VVA patients without evidence of BC prior to index treatment were matched to two untreated VVA controls similarly without history of BC on age, index VVA year, geographic region, Charlson Comorbidity categories, and follow-up time. BC after the index treatment was identified by BC diagnosis codes, mastectomy, chemotherapy, or radiation procedure. Incidence rate, rate ratio (RR) and their 95 % confidence intervals (CI) were calculated. The process was repeated to estimate BC recurrence in patients with a history of BC in 1:1, 1:2 and 1:3 matches. RESULTS: 1728 ospemifene users and 3456 untreated patients met the inclusion and matching criteria for assessing incidence. The average number of days for which ospemifene was supplied was 314 (standard deviation [SD] = 340). Average follow-up time from index treatment was 937 days (SD = 392) for treated patients and 915 days (SD = 396) for controls. BC incidence rates per 1000 person-years was 2.03 (95 % CI: 1.06-3.91) for treated patients and 3.53 (95 % CI: 2.49-4.99) for controls (RR = 0.58, 95 % CI: 0.28-1.21). No difference in recurrence was observed between ospemifene-treated and matched untreated patients. Ten (32.3 %) treated vs. 25 (40.3 %) controls in the 1:2 matched analysis had a recurrence. CONCLUSION: No differences were observed in the BC incidence and recurrence rates in ospemifene users compared with matched controls.

Symptom severity and quality of life in the management of vulvovaginal atrophy in postmenopausal women.

OBJECTIVES: To evaluate the association between treatments for vulvovaginal atrophy (VVA) and symptom frequency and severity, quality of life (QoL) and sexual functioning in postmenopausal women. STUDY DESIGN: Cross-sectional survey conducted in postmenopausal women aged 45-75 years. Data on demographic and clinical variables, as well as vaginal, vulvar and urinary symptoms were collected. The EuroQoL questionnaire (EQ5D3L), the Day-to-Day Impact of Vaginal Aging (DIVA), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale - revised (FSDS-R) were filled out. MAIN OUTCOME MEASURES: Association between treatments for VVA and symptom frequency. RESULTS: Women on VVA treatment presented with more severe symptoms. The sexual function score was higher in the treated women (FSFI: 15.6 vs 16.7; p = 0.010), as was the score for sexual distress (FSDS-R: 9.2 vs 12.3, p < 0.0005). The systemic hormone group presented with fewer VVA symptoms, lower vaginal impact (DIVA), and better sexual function (FSFI and FSDS-R) and vaginal health. The rates of sexual distress and vulvar atrophy were higher in the non-hormonal treatment group. No significant differences were found according to treatment duration. CONCLUSIONS: Postmenopausal women with VVA receiving treatment complained of more severe symptoms than those untreated. Women on systemic treatment had fewer and milder VVA symptoms and presented with better vaginal and vulvar health than women on other treatments. Many women request effective local treatment too late, when VVA symptoms are already severe. Our data suggest that VVA treatments should ideally be initiated when symptoms commence and cause distress, rather than later, when symptoms may have become more severe and even a cause of intolerable distress for the woman.

The burden of vulvovaginal atrophy on women's daily living: implications on quality of life from a face-to-face real-life survey.

OBJECTIVE: This subanalysis of the European Vulvovaginal Epidemiology Survey study aimed to assess the correlation of vulvovaginal atrophy (VVA) symptoms and severity, when confirmed by objective gynecologic examination, with the quality of life of postmenopausal women. METHODS: Women aged 45 to 75 years with confirmation of last menstrual period more than 12 months before, who attended menopause or gynecology centers, were included. Those women had at least one VVA symptom filled in a group of questionnaires, including EuroQol-EQ-5D-3L and Day-to-Day Impact of Vaginal Aging (DIVA). To confirm the VVA diagnosis, an objective gynecologic examination was also performed. RESULTS: Of a total of 2,160 evaluable women, 66.3%, 30.5%, and 11.2% suffered from severe vaginal, vulvar, and urinary symptoms, respectively. VVA was confirmed in more than 90% of the participants. Mean (±SD) EQ-5D-3L score was 0.892 ±â€Š0.144 and mean (±SD) score on the associated visual analog scale was 71.7 ±â€Š16.0. Mean (±SD) DIVA score was 0.922 ±â€Š0.653. For both EQ-5D-3L and DIVA, the overall scores and most of the dimensions/components were statistically significantly worse for women with severe VVA symptoms (vulvar and urinary) compared with women not affected by severe symptoms. Quality of life questionnaires showed worse scores in women where the diagnosis of VVA was confirmed by gynecologic examination. CONCLUSIONS: Severe VVA symptoms showed a direct association with worse quality of life in postmenopausal women. This important effect on the quality of life of many women should be recognized as equivalent to those from other conditions and pathologies of which there is greater awareness.

The REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey in Europe: Country-specific comparisons of postmenopausal women's perceptions, experiences and needs.

OBJECTIVES: To achieve a better comprehension of the variability of perceptions, experiences and needs in terms of sexual and vaginal health in postmenopausal women (PMW) from four different European countries. METHODS: An internet-based survey was conducted in Italy, Germany, Spain and the United Kingdom with a total surveyed population of 3768 PMW aged between 45 and 75 years. RESULTS: The UK sample was significantly older, with almost a quarter of participants over 65 years of age, and had the highest proportion of women experiencing recent vulvar and vaginal atrophy (52.8%). The majority of Italian and Spanish participants were receiving VVA treatment, whereas in the UK only 28% of PMW were on medication. The most common menopausal symptom was vaginal/vulvar dryness, with almost 80% of participants reporting it in all the countries except the UK (48%). On the other hand, vaginal/vulvar irritation was more frequently reported in the UK (41%). The percentage of participants with a partner was lower in the UK (71%), as was the monthly rate of sexual activity (49%). In the UK, the proportion of participants who had seen a healthcare professional for gynaecological reasons in the last year was lower than in other countries (27% vs. ≥50%), as was the proportion who has discussed their VVA symptoms with them (45% vs. ∼67%). In this sense, UK PMW waited for a longer before asking for help (especially for pain with intercourse and dryness). The main issues relating to VVA treatment difficulties expressed by participants were administration route in the UK, efficacy in Germany, and side-effects in Italy. CONCLUSIONS: Although all European women shared the same expectation of improving the quality of their sex lives, the opportunity for that varied among different countries in relation to the healthcare system and to the effective communication achieved with healthcare professionals when managing VVA.

Attitudes and perceptions towards vulvar and vaginal atrophy in Italian post-menopausal women: Evidence from the European REVIVE survey.

OBJECTIVES: To achieve a deeper understanding of the attitudes and perceptions of Italian post-menopausal women (PMW) regarding vulvo-vaginal atrophy (VVA). STUDY DESIGN: As part of the EU REVIVE study, an online survey was conducted in four European countries; the Italian arm comprised 1000 participants from representative regions of Italy. MAIN OUTCOME MEASURES: The perceptions, experiences and needs of Italian PMW in relation to sexual and vaginal health. RESULTS: The most frequent VVA symptom was vaginal dryness (78%). Usually, the severity of symptoms was similar to or worse than when they first appeared. This was particularly true for dyspareunia, the most bothersome symptom (76%). VVA symptoms had a significant impact on Italian participants' ability to achieve pleasurable relations (74%) and spontaneity (70%). Although 75% of participants were still sexually active, their sex drive had been reduced by a third because of VVA. Women expected that doctors would start a discussion of menopausal symptoms and sexual health, but this was rarely the case (11%). Most women had been treated with a vaginal over-the-counter (OTC) product. Women who had discussed their condition with a physician were more likely (68%) to be under treatment for VVA than those who had not (36%). Low compliance was associated with symptom improvement (23%), not having annoying symptoms (22%), and the impossibility if restoring the vagina to normal (14%). Common reasons for treatment dissatisfaction were related to route of administration or discomfort. Lack of efficacy and fear of a hormone effect were perceived as the main limitations for OTC and local estrogen products, respectively. CONCLUSIONS: Despite the commonness of VVA and its significant impact on quality of life, the condition remains underdiagnosed in Italy. Discussion of symptoms with doctors influences the diagnosis, and patients' satisfaction with available treatments is not high.