Day-to-Day Impact Of Vaginal Aging Research Articles

Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.

The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects. We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome. A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice. Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.

An effective non-hormonal option with high tolerability for mild to moderate symptoms of vaginal dryness associated with menopause

ObjectivesThe efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of vaginal dryness associated with menopause. Study designSeventy-nine postmenopausal women (mean age 60.8 ± 6.5 years) with mild to moderate symptoms of vaginal dryness (including dyspareunia) were enrolled in this open-label, prospective, post-market clinical follow-up trial, conducted in 2022 by one research center in Germany. The investigational pessary was applied for the first 7 days once daily and the subsequent 31 days twice a week, at bedtime. A treatment-free period of 6 days completed the trial. Main outcome measuresDuring the trial, participants filled out questionnaires that enabled the calculation of a total severity score for subjective symptoms of atrophy-related vaginal dryness and impairment of daily as well as sexual life. Furthermore, vaginal health index and safety were studied. ResultsA rapid and significant reduction in the severity scores for symptoms was observed over the 38-day course of treatment and beyond. Quality of life assessed by DIVA (day-to-day impact of vaginal aging) questionnaire, dyspareunia and vaginal health index also clearly improved. The tolerability was mainly rated as “good to very good” by the investigator and 94.9 % of participants. The vast majority were very satisfied with the simple and pleasant handling. No serious adverse events occurred. ConclusionOverall, the presented data suggest that the investigated non-hormonal pessary is an effective and well tolerated treatment option for vaginal symptoms associated with dryness, thus improving quality of life for women, even those who are sexually active.ClinicalTrials.gov identifier NCT05211505.

Vulvovaginal atrophy in women with and without a history of breast cancer: Baseline data from the PatiEnt satisfactiON studY (PEONY) in Italy

ObjectivesTo assess clinical characteristics of postmenopausal women with moderate/severe vulvovaginal atrophy, as well as its impact on sexual function, well-being, and quality of life, and to provide an overview of most used treatments. Study designOngoing longitudinal, observational study conducted in 17 Italian gynecology centers, involving women already treated or initiating a local vaginal estrogen therapy or ospemifene. We report baseline data for women with and without a history of breast cancer. Participants filled in self-reported questionnaires at study entry. Main outcome measuresSeverity of vulvovaginal atrophy; ongoing treatments; patient-reported outcomes, including severity of symptoms, Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and SF-12® Health Survey. ResultsOverall, 334 women (20.4 % with a history of breast cancer) started or continued local therapy (61.1 %) or ospemifene (38.8 %) at study entry. Vulvovaginal atrophy was severe in 28.6 %, and was responsible for severe symptoms, particularly vulvar dryness with burning or irritation and pain during sexual intercourse. Both sexual dysfunction (FSFI≤26) (81.5 %) and sexual distress (FSDS-R ≥ 11) (74.4 %) were common. A reduction in the SF-12 mental component score was documented. Women with breast cancer more often had severe vulvovaginal atrophy (41.2 %), had more severe symptoms, and the impact of vaginal symptoms on emotional well-being, sexual functioning and self-concept/body image was greater. The majority of them (83.8 %) received ospemifene as a treatment. ConclusionsModerate/severe vulvovaginal atrophy is a common, often neglected condition with an impact on QoL and sexuality, particularly in women with a history of breast cancer. It is important to alleviate the burden associated with the disease.

Study of Vulvovaginal Atrophy and Genitourinary Syndrome of Menopause and Its Impact on the Quality of Life of Postmenopausal Women in Central India.

Background Urogenital health is a necessary part of health for all women, especially in the postmenopausal age group. We suspected that the increased incidence of vulvovaginal atrophy (VVA) had some or other effects on the quality of life of older women. So, we aimed to study VVA/genitourinary syndrome of menopause (GSM) and its impact on the quality of life of postmenopausal women in Central India.Despite its significant prevalence and detrimental impact on women's health, VVA/GSM is underdiagnosed and undertreated. In view of the feminization of aging, VVA management is becoming increasingly crucial. This study contributes to postmenopausal women's understanding that keeping their urogenital and sexual longevity is a critical step towardhealthy living and gender equality. Given its relationship with urogynecological conditions, this study will help to evaluate both subjectively and objectively the incidence of symptoms related to VVA and its effects on the quality of life of postmenopausal women. This will eventually help to understand the need to address this issue while making postmenopausal women health-related policies. Potential remedies to overcome the obstacles currently preventing patient-HCP interactions addressing sexual health include providing communication tools to facilitate the "uncomfortable" conversation, educating women, and providing enough training for healthcare professionals. Methods The current study was conducted at a rural tertiary healthcare center in Central India and is a cross-sectional study. The study population taken into consideration were all the postmenopausal women between the age group 45and 75 years with at least one vulvovaginal symptom attending the Outpatient Department (OPD). The total study sample size was 100 women. Further study was conducted by interview method using a questionnaire by the principal investigator. Data was gathered with the help of a pretested questionnaire in the patient's language. Symptoms related to GSM were studied by the vaginal symptom Bothersomeness Scale. Further, a gynecological clinical examination for the confirmation of VVA was carried out, which included a gynecological physical examination. The Vaginal Health Index (VHI) was calculated for each female using the score scale. Assessment of the quality of life of postmenopausal females using the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire was performed. Results The majority of females (34%) who presented with the symptoms were in the category of 55-60 years followed by 22% in the age group of 61-65 years. The most common symptoms experienced by females were vaginal dryness (77%) followed by vaginal discharge (74%). Our study confirmed that 79% of the total females included in the study have a VHI score of less than 15, i.e., they suffer from VVA, thuspresenting our incidence at 79%. Conclusion According to the surveys discussed in this research, a significant portion of postmenopausal women have symptoms linked to VVA that have a negative impact on their quality of life, including their sexual relationships and self-esteem.

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.

A potent non-hormonal option for the treatment of postmenopausal vaginal dryness with high tolerability

Genitourinary syndrome of menopause (GSM) is considered a chronic condition with urogenital implications caused by estrogen deficiency typically after onset of menopause. Vaginal dryness accompanied by burning and itching is one of the most prevalent and bothersome symptoms of GSM. Affected women suffer from reduced lubrication and, those who are sexually active, also from dyspareunia. Non-hormonal therapies, such as vaginal moisturizers or lubricants, are recommended as first-line treatments to achieve the relief of symptoms, while improving the quality of life. Due to emerging demand for pessary formulations, we evaluated the efficacy and tolerability of a non-hormonal pessary containing nourishing lipids and lactic acid. Therefore, a prospective, open-label clinical trial was performed, including 79 postmenopausal women with symptoms of vaginal dryness. The patients applied one pessary daily within the first week followed by two pessaries per week for the next 31 days. After 38 days of treatment, a treatment free period of 6 days completed the trial. Subjective symptoms of vaginal dryness, such as feeling of dryness, itching, burning and pain (unrelated and related to sexual intercourse), were assessed at every visit, while the objective vaginal health index (VHI) was only examined at beginning and end of treatment. Data regarding the impact on patients’ quality of life, efficacy and tolerability were evaluated using various questionnaires. Our data show that symptoms of vulvovaginal dryness, itching, burning and pain as well as dyspareunia significantly decreased from baseline to end of treatment (day 38) and beyond. Quality of life assessed by DIVA (day-to day impact of vaginal aging) questionnaire, and VHI also clearly improved over the study period. The tolerability was rated as 'good' or 'very good' by most of the patients and by the investigator. No serious adverse events and only a low number of mild adverse events rated as related to the vaginal pessary were reported. Overall, this study identifies the investigated non-hormonal pessary as a potent option for the treatment of postmenopausal symptoms of vaginal dryness with a high tolerability. It can therefore be recommended as a first-line treatment that contributes to maintaining a healthy vaginal environment in postmenopausal women.

Sexual function and quality of life in women with idiopathic premature ovarian insufficiency.

Premature ovarian insufficiency (POI) is a disruptive diagnosis for women, with major consequences on fertility but also on quality of life and sexual functioning. The aim of this study was to evaluate the impact of vaginal symptoms from the genitourinary syndrome of menopause on the quality of life and sexual functioning of women with POI. This cross-sectional observational study involved 88 women who were investigated in a specialized setting at the University Hospital of Toulouse (France) between 2014 and 2019. All women completed the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire on well-being and quality of life and the Female Sexual Function Index (FSFI) on sexual functioning. Analysis of total scores and subdomains of the questionnaire was performed and compared according to use of hormone replacement therapy or local low-dose estrogen treatment, age at POI, and use of antidepressant therapy or current psychological support. Outcomes included the DIVA questionnaire and the FSFI. Among the 88 women who fulfilled the inclusion criteria, 66 (75%) answered the questionnaires. Mean ± SD age at POI diagnosis was 32.6 ± 6.9 years and mean age at questionnaire time was 41.6 ± 6.9 years. The highest mean scores on the DIVA questionnaire were found in the self-perception and body image domain (2.05 ± 1.36), followed by the sexual functioning domain (1.52 ± 1.28). The mean FSFI score was 23.08 (95% CI, 21.43-24.73), with 32 women (78% of sexually active women) having a score <26.55, which defines sexual dysfunction. There was no difference in the FSFI score and for all DIVA domains whether or not women were taking hormone replacement therapy or local hormone therapy. This should encourage practitioners to systematically discuss the impact of POI on sexuality and vulvovaginal symptoms to provide women with specific care and advice to improve their quality of life. This is the first French study that aimed to assess the impact of the genitourinary syndrome of menopause on the quality of life and sexual well-being in women with POI by using standardized validated questionnaires with a very good participation rate (75%). The sample size was limited, and we could not eliminate selection bias due to university hospital recruitment. POI can have a negative impact on sexual quality of life, which raises the needs for specific advice and care.

Psychometric evaluation of the German Day-to-Day Impact of Vaginal Aging questionnaire using data from two intervention studies.

We aimed to further validate the German version of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. Data were collected in the context of two intervention studies. Forty-two women participated in clinical trial VMP-03/2018 (NCT04222647) and 79 women in clinical trial VFCrC-01/2021 (NCT05211505). Internal consistency was calculated using Cronbach α . Correlations with other outcome measures such as a subjective assessment of symptoms and dyspareunia, the Vaginal Health Index, and the Vaginal Maturation Index were calculated regarding construct validity. A priori hypotheses were formulated for construct validity. Responsiveness was assessed after 43 (±3) and after 38 (±1) days in the two clinical trials. Strong internal consistency in all of the DIVA domains was found ( α ≥ 0.80). Regarding construct validity (at baseline and over time), many hypotheses were confirmed. Furthermore, all of the DIVA domains were able to detect changes over time ( P ≤ 0.006). Moderate to strong effect sizes were found (≥0.460). The data supported the responsiveness of the DIVA. Our findings from two independent intervention studies support internal consistency, construct validity, and responsiveness of the German version of the DIVA (domains).

Turkish day-to-day impact of vaginal aging questionnaire: reliability, validity and relationship with pelvic floor distress.

We aimed to translate the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire into Turkish, adapt it culturally, and investigate its reliability and validity. Another aim of the study was to examine the relationship between the impacts of vaginal symptoms and pelvic floor symptoms on quality of life (QoL). We hypothesized primarily that the the Turkish DIVA had good internal consistency, test-retest reliability and construct and criterion validity. Our secondary hypothesis was that the effects of vaginal symptoms and pelvic floor symptoms on QoL would be positively related. A total of 218 postmenopausal women were included. In the reliability analyses, Cronbach α coefficients, item-total correlation coefficients and intraclass correlation coefficients (ICCs) were used. Construct validity was investigated with explanatory and confirmatory factor analyses. Criterion validity and the relationship between the effects of vaginal symptoms and pelvic floor symptoms were examined by Pearson correlation analysis. While the Cronbach's alpha coefficients ranged between 0.87 and 0.96, the item-total score correlation coefficients were 0.60-0.91. ICCs ranged from 0.90 to 0.99. It was found with confirmatory factor analysis that the model fit the data. Moderate-strong correlations (r = 0.47-0.73) were observed between DIVA scores and the scores of other scales (p < 0.001). The Turkish DIVA is a reliable and valid tool that comprehensively evaluates the impact of vaginal symptoms on women's QoL. The positive relationship between the impacts of vaginal and pelvic floor symptoms on functionality and well-being of women suggests a holistic view in pelvic health care.

Validation of the German Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire in peri- and postmenopausal women

Purpose: The Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire is a validated patient-reported outcome measure (PROM) capturing the impacts of vaginal symptoms in postmenopausal women. We aimed to psychometrically validate the German version of the DIVA questionnaire.

Validation of the German Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire in Peri- and Postmenopausal Women.

BackgroundThe Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire is a validated patient-reported outcome measure (PROM) capturing the impacts of vaginal symptoms in postmenopausal women.AimWe aimed to psychometrically validate the German version of the DIVA questionnaire.MethodsData was collected online and by paper-pencil. We ran confirmatory factor analyses to confirm the a priori four-factor structure of the DIVA. Internal consistency was calculated using Cronbach's alpha. Correlations with other outcome measures such as the Patient Health Questionnaire-4 (PHQ-4), the SF-12 SOEP (socio-economic panel) version and self-created anchor questions were calculated regarding convergent validity. Known groups regarding age, home country and disease severity were analyzed. Test-retest reliability after 1 week and responsiveness after 4 weeks were only descriptively assessed due to low sample sizes.Main Outcome MeasuresThe DIVA questionnaire, the Menopause Rating Scale (MRS II), the PHQ-4 and the SF-12 SOEP version were the main outcome measures.Results185 postmenopausal women reporting vaginal complaints participated in the survey. The mode of administration did not influence the severity of vaginal symptoms. The four-factor structure of the DIVA could be confirmed and the model fit indicated sufficient structural validity. Furthermore, strong internal consistency in all of the DIVA domains was found. Regarding convergent validity, no hypothesis has failed completely. The results regarding known-groups validity were mostly in line with our a priori hypotheses. Descriptive evidence for sufficient test-retest reliability and responsiveness was given, however, the sample size for the assessment of those two measurement properties was low.ConclusionThis study supports the excellent structural validity, internal consistency and construct validity of the German version of the DIVA questionnaire. It can be recommended for the assessment of the impacts of vaginal symptoms in postmenopausal women in future clinical GSM trials.Gabes M, Stute P, Apfelbacher C. Validation of the German Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire in Peri- and Postmenopausal Women. Sex Med 2021;9:100382

A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy and Safety of a Transdermal Gel that Delivers CO2 in the Treatment of Vulvovaginal Atrophy

This prospective study aimed to assess the efficacy of a transdermal CO2 gel in promoting regeneration in the vulvovaginal area in postmenopausal women experiencing symptoms as part of genitourinary syndrome of menopause (GSM). Transdermal carboxytherapy refers to the application of CO2 through the skin's superficial layer, which is intended to increase oxygenation (through the Bohr effect) and angiogenesis, thus helping to reduce symptoms of GSM. In this study, 20 women with moderate or severe signs or symptoms of vulvovaginal atrophy were randomized to receive either transdermal CO2 therapy (n=10) or a placebo gel (ultrasound gel, n=10). The gels (transdermal CO2 gel or the placebo) were applied by the patients at home. The gels were applied in two treatment cycles (10 days of total treatment). Each cycle involved daily applications of the gel to the vulvovaginal area, from Monday to Friday, with no application on weekends. The Female Sexual Function Index (FSFI) and Day-to-Day Impact of Vaginal Aging (DIVA) questionnaires were used to gather standardized information, and biopsy samples were obtained from the vagina and vulva for histological analysis, both on the first day of treatment and 10 days after the final application of gel. Patients who received the transdermal CO2 gel showed significant improvements on the FSFI and DIVA questionnaires and the biopsies revealed that the CO2 gel had a regenerative effect on vulvovaginal tissues.

Vulvovaginal atrophy of menopause and its impact on sexual function in an Italian clinical cohort of post-menopausal women

The aim of current study was to estimate the impact of vulvovaginal atrophy (VVA) on sexual function in a clinical population of Italian postmenopausal women. Women aged 45–75 years with at least one VVA symptom completed three questionnaires: Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI) and Female Sexual Distress Scale revised (FSDS-R). A gynaecological examination was performed for VVA confirmation. Among the 1,066 evaluable patients, VVA was confirmed in around 90% of the sample. Sexual function impairment was significantly higher in patients with confirmed VVA as observed by significant differences in the sexual function component of the DIVA questionnaire (p = .014), the FSDS-R (p < .0005), and the FSFI (p < .0005), as well as for all the FSFI subdomains: desire (p < .0005), arousal (p < .0005), lubrication (p < .0005), orgasm (p < .0005), satisfaction (p < .0005) and pain (p < .0005). Significant impairment of sexual function was demonstrated in Italian postmenopausal women who were clinically confirmed with signs of VVA through gynaecological examination. IMPACT STATEMENT What is already known on this subject: At least half of postmenopausal women report VVA associated symptoms with significant impact on sexual function and ultimately on sexual activity. What the results of this study add: As compared with patients without confirmed VVA, the negative impact on sexual function was significantly higher in patients with confirmed VVA. This difference was observed for the sexual function component (DIVA-C) of the DIVA questionnaire, for the overall FSDS-R result, and for the overall FSFI score, as well as for all the FSFI subdomains (desire, arousal, lubrication, orgasm, satisfaction and pain). What the implications are of these findings for clinical practice and/or further research: An impairment of sexual function is significantly associated with VVA diagnosis in Italian post-menopausal women, especially when diagnosis was objectively confirmed by clinical signs of VVA visible in the gynaecological examination. In addition, this study demonstrates that inquiring about VVA using a structured questionnaire may increase the diagnosis of VVA related changes in sexual function.

The European Vulvovaginal Epidemiological Survey (EVES) in Italy. Impact of vulvovaginal atrophy on the quality of life and sexual function in breast cancer survivors

The European Vulvovaginal Epidemiology Survey (EVES) sub-analysis assesses the impact of history of breast cancer (HBC) on vulvovaginal atrophy (VVA), sexual function and quality of life in a sample of postmenopausal women. Women aged 45-75 years with at least one symptom of VVA attending Italian menopause centers were included; subgroup data were described according to the absence (N = 967) or presence (N = 78) of HBC. VVA confirmed by gynecological examination and Vaginal Health Index &lt; 15 was more prevalent in women with HBC (93.6% vs. 86.0% and 78.2% vs. 65.9%, respectively). Self-reported vaginal discharge, itching and urinary frequency were more prevalent in women without HBC compared to different HBC subgroups. Day-to-Day Impact of Vaginal Aging (DIVA) and sexual function scores were similar between women with or without HBC, but women who have completed breast cancer (BC) therapy showed lower sexual distress. Women with HBC had a higher vaginal prevalence and severity of signs of VVA, while self-reported VVA symptoms were generally less disruptive in women with HBC. These exploratory findings warrant confirmation in larger studies.

Refinement of the German Day-to-Day Impact of Vaginal Aging questionnaire in perimenopausal and postmenopausal women using item response theory and classical test theory.

We aimed to assess the structural validity of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire using item response theory/Rasch analysis and classical test theory and refine the current version of the DIVA if necessary. Postmenopausal women reporting vaginal symptoms related to menopause participated in the study. Item characteristic curves were analyzed to see whether the response categories were functioning optimally. The assumptions of the Rasch model were tested for the whole DIVA as well as for each domain separately. Exploratory factor analyses were carried out and correlations of the single items with the DIVA domains were analyzed to identify the most-fitting items. Finally, validation analyses were carried out on the refined version. We registered 185 eligible postmenopausal women. Revising the response categories of each of the four domains led to adequate looking item characteristic curves. The whole DIVA represented a multidimensional construct, however, each of the four domains fulfilled the Rasch requirements of unidimensionality, local independence, monotonicity, and an adequate model fit. Integrating item response theory/Rasch and classical test theory, two items (item 5 and item 17) showing relevant issues were identified and removed from the refined version. In the subsequent validation, the refined DIVA showed similar validation results like its original equivalent. We created a validated refined version of the DIVA, having now three response categories instead of five. With 17 items (short-version) or rather 21 items (long-version for women with recent sexual activity), the refined DIVA is more feasible and showed several excellent measurement properties.

Improving the identification of genitourinary syndrome of menopause through the utilization of the Day-to-Day Impact of Vaginal Aging questionnaire.

Genitourinary syndrome of menopause (GSM) affects nearly 50% of postmenopausal women. Yet women fail to recognize GSM as a chronic condition and are reluctant to discuss their vaginal or sexual complaints with a health care provider. This quality improvement project implemented the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire to improve the identification and diagnosis of GSM in women ≥ 45 years of age presenting for an annual wellness examination or a vulvovaginal/genitourinary complaint. From October 2019 to February 2020, the DIVA questionnaire was distributed in a large women's health practice setting to women ≥ 45 years of age, for completion before their annual wellness visit or for evaluation of a GSM-related complaint. GSM diagnosis rates during the implementation period were compared with diagnosis rates during a 4-month period immediately preceding the implementation. Data collected during the implementation period were examined to evaluate if GSM diagnosis was more likely in patients who completed the DIVA questionnaire when compared to those women who did not complete the questionnaire. Of the 175 women who met the inclusion criteria, 113 completed the DIVA questionnaire. Completion of the DIVA questionnaire demonstrated a relative percentage increase in GSM diagnosis by 30.7% when compared to the 4-month preimplementation period (10.1% to 13.2%, P = 0.231). This change was not statistically significant. During the implementation period, a statistically significant difference in GSM diagnosis was observed for patients who completed the DIVA questionnaire when compared to those patients who did not complete the questionnaire (37.2% vs 9.7%, P < 0.001). When results were stratified by visit type, women presenting for an annual wellness visit who completed the DIVA questionnaire had a higher GSM diagnosis rate than those who did not complete the questionnaire (37.2% vs 10%, P < 0.001). When results were stratified by menopausal status, GSM diagnosis rates were also more likely for postmenopausal women who completed the DIVA questionnaire when compared to those who did not complete the questionnaire (44.2% vs 8.5%, P < 0.001). The DIVA questionnaire is a brief, but comprehensive screening tool that can increase GSM identification and treatment, particularly for postmenopausal, and midlife women presenting for an annual wellness visit in a busy women's health practice setting. : Video Summary:http://links.lww.com/MENO/A655.

Impact of Vulvovaginal Symptoms in Women Diagnosed with Cancer: A Psychometric Evaluation of the Day-to-Day Impact of Vaginal Aging Questionnaire.

Background: Vulvovaginal symptoms (VVS), such as dyspareunia, dryness, and itching, are common following cancer treatment and can negatively impact sexual well-being, daily activities, mood, self-concept, and overall quality of life. Information about the impact of VVS after cancer treatment is scarce, mainly because of a dearth of validated measures. This study aimed to validate the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire, which assesses impact of VVS on women's lives, in a sample of women with cancer. Methods: Women diagnosed with cancer (n = 202) completed a questionnaire package, including the DIVA and measures of VVS, sexual function, and sexual distress. Data were collected as part of study evaluating an educational workshop. Confirmatory factor analysis (CFA) was used to examine whether the factor structure of the DIVA in this population reflected that of the original validation study. Results: CFA showed that the DIVA assesses VVS impact on four domains: activities of daily living, sexual functioning, emotional well-being, and self-concept and body image. All subscales showed excellent internal consistency reliability; however, item analyses indicated that items in the activities of daily living subscale showed very low means. Correlations with sexual function and distress provided evidence that the DIVA assesses impact of VVS. Conclusions: This is the first study aimed at validating the DIVA in women treated for cancer. Results provide evidence of the DIVA's utility in assessing the impact of VVS on four relevant domains. Although issues with certain scale items need to be resolved in future research, the DIVA provides opportunity to understand the impact of VVS after cancer treatment, to address unmet needs of cancer survivors.

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.

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

To estimate the impact of vulvovaginal atrophy (VVA) on sexual function in a clinical population of postmenopausal women. 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. 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). 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.

Convergent-Divergent Validity and Correlates of the Day-to-Day Impact of Vaginal Aging Domain Scales in the MsFLASH Vaginal Health Trial

IntroductionClinical research and management of postmenopausal vaginal symptoms have been limited by the lack of validated measures for assessing symptom impact. AimTo evaluate convergent-divergent validity of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire among postmenopausal women with moderate-to-severe vulvovaginal symptoms and identify demographic and clinical factors associated with greater symptom impact. MethodsWe examined baseline data from postmenopausal women with moderate-to-severe vulvovaginal itching, pain, irritation, dryness, or pain with intercourse in a randomized trial of vaginal estradiol, moisturizer, or placebo. In addition to completing the DIVA questionnaire, participants rated the severity of their most bothersome vulvovaginal symptom, underwent assessment of vaginal pH and epithelial cytology, and completed other self-report measures including the Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), and Patient Health Questionnaire-8 for depression (PHQ-8). Main Outcome MeasureThe main outcome measures were the unadjusted correlations and multivariable-adjusted associations with 4 DIVA domain scales designed to assess symptom impact on day-to-day activities, sexual functioning, emotional well-being, and body image/self-concept on a scale of 0 to 4. ResultsAmong 301 women, we detected moderately strong correlations between the DIVA emotional well-being scale and PHQ-8 scores (Pearson correlation coefficient [r] = 0.39) and strong correlations between the DIVA sexual functioning scale and FSFI and FSDS scores (r > 0.50). No significant correlations were detected between any DIVA scales and vaginal pH or epithelial cytology. In adjusted linear-regression analyses, greater vulvovaginal symptom severity was associated with worse DIVA scores for emotional well-being, sexual functioning, and self-concept/body image (average 0.3- to 0.5-point higher DIVA score for each 1-point difference in vulvovaginal symptom severity). Depression symptoms were associated with worse DIVA scores for activities of daily living and emotional well-being (0.2- to 0.4-point higher DIVA score for each 5- point worsening of PHQ-8 score). Women reporting recent sexual activity had lower symptom impact on sexual functioning and self-concept/body image domains (−0.3- to −0.4-point lower DIVA score with weekly sexual activity). Clinical ImplicationsFindings suggest that the impact of postmenopausal vaginal symptoms on functioning and well-being is greater in women with co-morbid depression symptoms and less frequent sexual activity, independent of symptom severity. Strengths & LimitationsStrengths include the multicenter sample and wide array of measures. Results may not generalize to women with mild symptoms. ConclusionOur results support the construct validity of the DIVA questionnaire for clinical practice and research and indicate that depression and lower frequency of sexual activity are markers of greater impact of postmenopausal vaginal symptoms on multiple dimensions of functioning and quality of life.Hunter MM, Guthrie KA, Larson JC, et al. Convergent-Divergent Validity and Correlates of the Day-to-Day Impact of Vaginal Aging Domain Scales in the MsFLASH Vaginal Health Trial. J Sex Med 2020;17:117–125.