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Abstract Background This study aimed to explore the current situation and existing issues regarding the management of vulvovaginal atrophy (VVA) or the genitourinary syndrome of menopause (GSM). A nationwide web-based questionnaire survey was conducted among 1,031 Japanese women aged 40 years or older. Materials and methods Eligible women were asked to complete a questionnaire about how they dealt with their symptoms and how satisfied they were with their coping methods. Results Of those highly conscious of their GSM symptoms (n = 208; 20.2%), 158 had sought medical consultation (15.3%), with only 15 currently continuing to seek consultation (11.5%). Of the specialties consulted, gynecology was the most frequently consulted (55%). Furthermore, those unwilling to seek medical consultation despite their symptoms accounted for the greatest proportion (n = 359; 34.8%), with 42 (23.9%) having never sought consultation. Topical agents, e.g., steroid hormone ointments/creams, were the most frequent treatments provided by the clinics (n = 71; 40.3%), followed by oral and vaginal estrogens (n = 27; 15.5%), suggesting that estrogen therapy was not the first choice of treatment at the clinics. While 65% of patients treated at the clinics reported satisfaction with the treatments, this was inconsistent with the fact that many were reported to have remained untreated and very few continued with treatment. Conclusions Survey results suggest that GSM, including VVA, remains underdiagnosed and undertreated in Japan. Medical professionals should deepen their understanding of GSM and raise their level of care to select the appropriate treatment for the condition.

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.

Objectives The objective is to assess the perception of gynecologists regarding patients’ adherence to vulvovaginal atrophy (VVA) treatments, to evaluate the gynecologists’ opinions on what their patients think about treatment adherence, and to compare the gynecologists’ opinions with the patients’ own perceptions within the CRETA study.Methods Spanish gynecologists who participated in the CRETA study were asked to fill out an online 41-item questionnaire to evaluate their views on VVA management.Results From 29 centers across Spain, 44 gynecologists completed the survey. Their mean age was 47.2 years old, two-thirds of them were women, and the average professional experience was over 20 years. According to the gynecologists, the therapy most frequently used by VVA-diagnosed women was vaginal moisturizers (45.5%), followed by local estrogen therapy (36.4%) and ospemifene (18.2%). Nevertheless, ospemifene was viewed as the therapeutic option with the most efficacy, easiest route of administration, shorter time to symptom improvement, lower percentage of dropouts, and higher treatment adherence.Conclusions Spanish gynecologists are in general agreement with their patients regarding VVA treatment preferences and the main issues for adherence and effectiveness. However, there is an opportunity for doctor–patient communication improvement. Among the three therapeutic options evaluated, ospemifene is regarded as offering some competitive advantages.

This study aimed to measure safety, systemic pharmacokinetics and preliminary efficacy of a vaginal tamoxifen capsule (DARE-VVA1) among postmenopausal women with moderate-to-severe vulvovaginal atrophy. This was a randomized, placebo-controlled, double-blind, phase 1/2 study of DARE-VVA1, in four doses (1, 5, 10 and 20 mg). Seventeen women were enrolled and 14 completed the 8-week treatment. DARE-VVA1 was safe. All adverse events were of mild or moderate severity and distributed similarly among active and placebo groups. Plasma tamoxifen concentrations were highest among women using DARE-VVA1 20 mg, but the maximum mean (standard deviation) plasma tamoxifen concentrations on day 1 (2.66 ± 0.85 ng/ml) and day 56 (5.69 ± 1.87 ng/ml) were <14% of those measured after one oral tamoxifen dose. Active study product users had significant decreases from pre-treatment baseline in vaginal pH and proportion of vaginal parabasal cells (p = 0.04 for both endpoints), with women randomized to the 10 mg or 20 mg dose experiencing the largest treatment impact. The severity of vaginal dryness and dyspareunia decreased significantly from baseline with active study product use (p = 0.02 for both endpoints). DARE-VVA1 is safe and results in minimal systemic exposure to tamoxifen. Preliminary efficacy data support further development of this product. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the self-reported satisfaction of Spanish postmenopausal women currently treated for vulvovaginal atrophy (VVA) symptoms. The CRETA (CRoss sectional European sTudy on Adherence) is a multicenter cross-sectional study conducted in 29 public and private hospitals in Spain, which enrolled postmenopausal women receiving treatment with ospemifene, local hormone therapy (HT) or vaginal moisturizers for VVA. After the prior informed consent of the patients, sociodemographic and treatment perception data were collected using a structured questionnaire. Among 752 women who completed the survey, the satisfaction score was significantly higher for the group treated with ospemifene (mean 8.3 ± 1.4) compared with the local HT group (7.2 ± 1.7) and the vaginal moisturizer group (6.5 ± 2.1) according to a 10-point Likert scale (p < 0.0001). Compared to vaginal moisturizers and local HT, participants treated with ospemifene reported the highest adherence (96.7% vs. 70.2% and 78.6%, respectively) and the lowest number of missed doses in the last month (0.6 ± 1.3 standard deviation [SD] vs. 3.5 ± 4.3 SD and 2.0 ± 2.8 SD, respectively) (p < 0.0001). Ospemifene was significantly perceived as easy to use (83.9% vs. 44.9% and 58.6%, respectively; p < 0.0001), efficacious in reducing the time to relieve symptoms (17.1% vs. 7.0% and 6.7%, p = 0.0005 and p = 0.0006, respectively) and convenient for sexual life (53.1% vs. 25.6% and 42.3%, p < 0.0001 and p = 0.0234, respectively). Among postmenopausal women with VVA, treatment with ospemifene has the most positive perceptions and the highest overall satisfaction level and could be an optimal therapeutic approach, maximizing patient adherence. [ABSTRACT FROM AUTHOR]

Females spend a third to half of their life in menopause, and the number of US females in menopause is growing. A high percentage of postmenopausal females experience bothersome, sometimes debilitating genitourinary symptoms, which can affect quality of life. The genitourinary syndrome of menopause (GSM) describes the condition previously referred to as vulvovaginal atrophy, atrophic vaginitis, or urogenital atrophy. Of concern, many patients with symptoms of GSM have never been asked about nor have they initiated conversations about these concerns with a healthcare provider. This article addresses the need to improve screening, identification, and patient-centered management in primary care of females with GSM. [ABSTRACT FROM AUTHOR]

Vulvovaginal atrophy (VVA) is a chronic progressive condition that involves the genital and lower urinary tracts, related to the decrease of serum estrogenic levels when menopause occurs. The definition of genitourinary syndrome of menopause (GSM) is a medically more accurate, all-encompassing and publicly acceptable term than VVA. Due to the chronic progressive trend of GSM, symptoms tend to reappear after the cessation of therapy, and frequently long-term treatment is required. First-line therapies include vulvar and vaginal lubricant or moisturizers, and, in the case of failure, low-dose vaginal estrogens are the preferred pharmacological therapy. Populations of patients, such as breast cancer (BC) survivors, are affected by iatrogenic GSM symptoms with concerns about the use of hormonal therapies. The non-ablative erbium:YAG laser and the fractional microablative CO2 vaginal laser are the two main lasers evaluated for GSM treatment. The aim of this comprehensive review is to report the efficacy and safety of Er:YAG and CO2 vaginal lasers for GSM treatment. Vaginal laser therapy has been demonstrated to be effective in restoring vaginal health, improving VVA symptoms and sexual function. The data suggest that both Er:YAG and CO2 vaginal lasers are safe energy-based therapeutic options for management of VVA and/or GSM symptoms in postmenopausal women and BC survivors. [ABSTRACT FROM AUTHOR]

It is estimated that the 25–50% of women who are reaching menopause every year report symptoms related to the genitourinary syndrome of menopause (GSM). The symptoms are not due simply to lack of estrogen. One possible contributing cause of symptoms is the vaginal microbiota. The vaginal microbiota is a dynamic entity and plays a critical role in the pathogenic interplay of postmenopausal changes. Treatment of this syndrome depends on the severity and type of the symptoms and on the preferences and expectations of women. As there are many treatment options, therapy should be individualized. While new evidence on the role of Lactobacilli in premenopause is emerging, the role of Lactobacilli is still unclear in GSM and the impact of microbiota on vaginal health remains conflictual. However, some reports show promising data on the effect of probiotic therapy in menopause. In the literature there are few studies and small population samples on the role of an exclusive therapy with Lactobacilli and further data will be mandatory. Studies involving large numbers of patients and different intervention periods will be necessary to obtain evidence of the preventive and curative role of vaginal probiotics. [ABSTRACT FROM AUTHOR]

The vagina is traditionally thought of as a passive organ in the female reproductive system, serving primarily as a passageway for menstrual blood, sexual intercourse and childbirth. However, recent research has shed light on the vagina's role as an endocrine organ that plays a crucial role in female hormonal balance and overall health. Particularly, growing evidence shows that the human vagina can be considered both as source and target of androgens, in view of the novel concept of 'intracrinology'. Besides the well-known role of estrogens, androgens are also crucial for the development and maintenance of healthy genitourinary tissues in women. As androgen levels decline with age, and estrogen levels fall during the menopausal transition, the tissues in the vagina, together with those in the urinary tract, become thinner, drier and less elastic, leading to a variety of uncomfortable and sometimes painful symptoms, clustered in the genitourinary syndrome of menopause (GSM). Given the lack of testosterone-based or androstenedione-based products approved by regulatory agencies to treat GSM, the possibility of using intravaginal prasterone, which works by providing a local source of dehydroepiandrosterone (DHEA) to the vaginal tissues, appears to be a targeted treatment. Further studies are needed to better assess its safety and efficacy. [ABSTRACT FROM AUTHOR]

Local estrogen therapy (LET) is the mainstay of treatment for vaginal dryness, dyspareunia and other urogenital symptoms because it may reverse some pathophysiological mechanisms associated with decreasing endocrine function and increasing aging. Over the years, several vaginal products including different formulations (tablets, rings, capsules, pessaries, creams, gels and ovules) and molecules (estradiol [E2], estriol [E3], promestriene, conjugated equine estrogens and estrone) have been used with superimposable therapeutic results. Low-dose and ultra-low-dose LET is the gold standard due to its minimal systemic absorption, with circulating E2 levels persistently remaining in the postmenopausal range. In healthy postmenopausal women, preference among the various products is presently the main driver and dissatisfaction with LET seems high, namely because of the delayed use in those with severe symptoms of genitourinary syndrome of menopause (GSM). Specific concerns remain in high-risk populations such as breast cancer survivors (BCS), especially those under treatment with aromatase inhibitors. Based on the multitude of symptoms under the umbrella of GSM definition, which includes vulvovaginal atrophy (VVA), it is mandatory to investigate specific effects of LET on quality of life, sexual function and genitourinary conditions by conducting studies with a patient-tailored focus. [ABSTRACT FROM AUTHOR]

The demand for non-hormonal therapies for vulvovaginal atrophy (VVA) is increasing due to an increasing number of patients surviving long term post cancer diagnosis, as well as increased public knowledge of the symptoms of menopause and availability of non-hormonal therapies. Treatment options are wide-ranging and encompass different formulations and methods of application. This review summarizes the key characteristics of the main forms of these therapies, as well as considering the current evidence for each of them and where future clinical studies should be directed. Care for VVA may be in primary care, or under gynecology or oncology. Further research requirements include the need for long-term data as well larger randomized controlled trials into alternatives where vaginal estrogen cannot be used as first-line treatment. Widespread education of health-care providers and patients on VVA and the impact on quality of life is urgently needed, as well as increased use of non-hormonal methods in routine clinical practice. [ABSTRACT FROM AUTHOR]

Vulvovaginal atrophy (VVA) is a chronic and progressive disease that affects sexuality and quality of life. VVA is preventable and treatable, but requires long-term and often sequential treatment. Sequential treatment consists of designing a strategy that uses one or more medications for a long enough time to achieve the desired benefits with minimal risk and maximum adherence. Currently available therapeutic options consist of topical over-the-counter products (including non-hormonal lubricants and moisturizers applied to the vagina), systemic hormone therapy and estrogens, and prescribed vaginal dehydroepiandrosterone (DHEA). In addition, we have a selective estrogen receptor modulator, ospemifene, and new energy-based treatments (laser and radiofrequency). There are clear differences between the treatments both in the mechanism of action and in the efficacy. Compliance is very low, and patients complain about the use of the vaginal route, often due to its low efficacy, or express fear of the long-term use of estrogens or the price of the treatments. We believe that, as a first option, and for physiological, preventive and efficacy reasons, we should consider the prescription of treatments that work on estrogen receptors. As a second option, there are vaginal moisturizers, which are effective on symptoms but do not prevent or improve conditions. Finally, techniques using heat, which although each time represent a clearer alternative, but on the other hand are the cost and the long-term safety data, give us a third option. Of course, we consider that vulvar moisturizers and lubricants can be used at any time. [ABSTRACT FROM AUTHOR]

Numerous surveys have documented that sexuality and/or sexual activity is important to women at all stages of adulthood, including postmenopause. Genitourinary syndrome of menopause (GSM) and hypoactive sexual desire disorder (HSDD) are common disorders in postmenopausal women and may co-occur. Both are often undiagnosed due to a lack of knowledge of the disorder, health-care professional discomfort in discussing sexual problems or a lack of routine screening. It is incumbent upon health-care professionals to identify and differentiate these conditions in women through a biopsychosocial assessment, and may require a focused physical examination. Numerous treatments, both non-pharmacologic and pharmacologic, are available to address GSM and HSDD. [ABSTRACT FROM AUTHOR]

Vulvovaginal atrophy (VVA) is an underdiagnosed and undertreated chronic condition resulting in physiological and histological changes in the genitourinary tract of postmenopausal women. Treatment of moderate to severe VVA includes local estrogens, dehydroepiandrosterone (DHEA) and oral ospemifene, a third-generation selective estrogen receptor modulator (SERM). Due to venous thromboembolism (VTE) safety concerns classically associated with the SERM class, and as part of its original marketing authorization approval (MAA), the European Medicines Agency (EMA) requested the performance of a 5-year post-authorization safety study (PASS) to study the incidence rate of VTE among women receiving ospemifene. The results have led to important regulatory changes to ospemifene's labeling, extending its indication and eliminating concerted risk management measures. A panel of experts discussed and reached consensus on the impact of these regulatory changes on clinical practice, reflecting on the reassurance of ospemifene's benefit–risk balance and recommending its positioning as a first-line pharmacological treatment option for moderate to severe VVA together with local therapies. In a scenario where different treatments present similar efficacy and safety profiles, a shared decision between clinician and patient, according to her needs and preferences over time, is fundamental to improve adherence and persistence with sequential treatment, contributing to the achievement of health outcomes. [ABSTRACT FROM AUTHOR]

Many breast cancer survivors (BCS) suffer the consequences of antineoplastic treatments that induce a hypoestrogenic state, leading to chronic climacteric symptoms such as genitourinary syndrome of menopause (GSM), arousing significant alteration in their quality of life. Non-hormonal therapies (NHT) are first-line treatments, safe but with mild efficacy. When facing moderate–severe GSM, the options for BCS are limited: local estrogen therapy, considered the 'gold standard' but with concerns about safety; vaginal androgens and prasterone, which seem to trigger an activation of estrogen and androgen receptors of the vaginal epithelium layers, without activating estrogen receptors on other tissues, being potentially safe but still without strong evidence in favor of BCS; vaginal lasers, which appear to improve vascularization of vaginal mucosa by stimulating the remodeling of the underlying connective tissue, but with contradictory results of efficacy in recent randomized clinical trials; and ospemifene, an oral selective estrogen receptor modulator presenting mild vaginal estrogenic potency and anti-estrogenic effect at the endometrial and breast level, but still not recommended for use in BCS in recent North American Menopause Society guidelines. There is a need for further studies evaluating objectively the efficacy and safety of these promising therapeutic options. On the other hand, sexuality must be seen as a multifactorial issue, where GSM is only part of the problem; evidence shows that sexual counseling improves the quality of life of BCS. Finally, there is a need to limit the underdiagnosis and undertreatment of GSM in BCS; the primary goal of physicians treating BCS regarding this issue has to be the provision of information of what to expect regarding genital and sexual symptoms to BCS and to counsel on early first-line treatments that may help prevent more severe GSM. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: This report aims to prospectively describe the effectiveness and safety of injected cross-linked hyaluronic acid (HA) for the treatment of chronic vulvar fissures. Methods: A descriptive prospective case series design including 15 patients affected by chronic vulvar fissures who were treated with cross-linked HA filler between December 2020 and July 2021. The validated 21-item Vulvovaginal Symptoms Questionnaire (VSQ) was used to evaluate the results from baseline up to 9 months after the HA infiltration. Results: A total of 15 patients suffering from chronic vulvar fissures were treated with an injection of 19 mg/mL HA filler. We found a significant improvement in VSQ scores at the end of the treatment compared to baseline. Patients reported excellent tolerance of the procedure, and no complications were recorded. Conclusions: Cross-linked HA infiltration of the vulvar vestibule and posterior vaginal wall appeared to be a promising approach for chronic vulvar fissures. [ABSTRACT FROM AUTHOR]

This study evaluates the efficacy and safety of fractional CO2 lasers for treating genitourinary syndrome of menopause (GSM) in Korean women. The patients received three laser applications at an interval of 4 weeks each. The severity of GSM symptoms was assessed using a visual analog scale (VAS) at baseline and at every visit. The objective scale was measured using the vaginal health index score (VHIS) and Vaginal Maturation Index (VMI) after completion of the laser procedure. During each procedure, the patients' pain in the VAS score was recorded. In the last visit, patients evaluated their satisfaction with the laser therapy using a 5-point Likert scale. Thirty women completed all the study protocols. After two sessions of laser therapy, some GSM symptoms (vaginal dryness and urgency) and VHIS improved significantly. After completion of the treatment, all GSM symptoms improved (p < 0.05), and the VHIS further increased significantly (VHIS at baseline, 8.86 ± 3.2 vs. V3, 16.83 ± 3.15, p < 0.001). The average satisfaction was 4.3. This study shows that fractional CO2 laser treatment is effective and safe for Korean women with GSM. Further studies are needed to confirm these results and assess the long-term effects of laser therapy. [ABSTRACT FROM AUTHOR]

Overactive bladder (OAB) is a complex and multifactorial syndrome associated with urinary frequency, urgency and incontinence. The menopause-associated hormonal changes play a role in the development of this condition. Vaginal estrogens are effective in improving OAB in postmenopausal women (PMW) with vulvovaginal atrophy (VVA). Ospemifene is a selective estrogen receptor modulator licensed for the treatment of VVA. This study aimed to evaluate the effects of ospemifene on OAB symptoms in PMW with VVA. Forty PMW suffering from OAB and VVA received oral ospemifene (60 mg/day) for 12 weeks. All patients were assessed with a urodynamic study, a 3-day bladder diary and validated questionnaires (International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form [ICIQ-UI SF] and International Consultation on Incontinence Questionnaire – Overactive Bladder [ICIQ-OAB]) at enrollment and at the end of the study. Cytometric capacity, bladder compliance and verbal sensory threshold responses during bladder filling were improved after treatment. The voiding diary showed a significant reduction of daily voids, urge urinary incontinence episodes and nocturnal events. The median overall scores of the ICIQ-UI and ICIQ-OAB were also significantly improved. Our study suggest that treatment with ospemifene in PMW suffering from OAB is associated with a reduction of OAB symptoms due to a decreased bladder sensitivity and with an improvement in quality of life. [ABSTRACT FROM AUTHOR]

• The Cervantes scale allows the quality of life of postmenopausal women to be measured. • Vulvovaginal atrophy impairs the quality of life of postmenopausal women. • Women treated with ospemifene have a better quality of life than those treated with local therapies. • These benefits of ospemifene are more evident in the domains of sexual and couple relations. To assess the correlation of different vulvovaginal atrophy therapeutic options with the quality of life of postmenopausal women. The CRETA study is a descriptive, observational, cross-sectional, multicenter study designed to measure, besides treatment satisfaction and adherence, the quality of life of postmenopausal women diagnosed with vulvovaginal atrophy in 29 hospitals and centers across Spain. The study enrolled postmenopausal women currently receiving treatment with vaginal moisturizers, local estrogen therapy or ospemifene. Clinical features and treatment perceptions were collected by self-report questionnaire and quality of life was evaluated using the Cervantes scale. Among the 752 women included, the ospemifene cohort showed a statistically significant lower global score (44.9 ± 21.7) on the Cervantes scale (and therefore, a better quality of life) than the cohorts treated with moisturizers (52.5 ± 21.6, p = 0.003) or local estrogen therapy (49.2 ± 23.8, p = 0.0473). In the analysis by domains, ospemifene-treated women showed statistically significant better scores in menopause & health and psychological status than moisturizers-treated women (p < 0.05). In the domains of sexuality and couple relations, the score for the quality of life of the ospemifene cohort was statistically significantly better than the scores in either of the cohorts treated with moisturizers (p < 0.001) or local estrogen therapy (p < 0.05). Postmenopausal women diagnosed with vulvovaginal atrophy and treated with ospemifene have better quality of life than women treated with vaginal moisturizers or local estrogen therapy. The improvement observed with ospemifene is more remarkable in those aspects related to sex life and couple relations. NCT04607707. [ABSTRACT FROM AUTHOR]

Background and Objectives: Vulvovaginal atrophy (VVA) is a condition that affects a large number of women and can significantly impact their quality of life. While several treatments are currently available for VVA, there are potential risks associated with their use. Non-hormonal medical devices have been developed to treat VVA, offering a potential alternative to traditional hormone-based therapies. This study aimed to evaluate the safety and efficacy of the combined treatment with two medical devices, Plurigin Ovules and Plurigin Solution, used as an adjuvant in the treatment of VVA. Materials and Methods: This is a retrospective, observational study. Data were collected from medical records of all patients who received the combination treatment of both medical devices as part of normal clinical practice for the treatment of VVA. The performance of the medical devices was analyzed using the THIN Prep. A comprehensive physical examination and gynecological evaluation were conducted before the initiation of treatment (day 0), as well as at follow-up 1 (day 90), follow-up 2 (day 180), and follow-up 3 (day 270). Data analysis included descriptive analysis and statistical tests. Results: The study included 76 women (mean age: 59 years). At follow-up 3, 61% of the respondents demonstrated improved THIN Prep results and symptom resolution (p < 0.001; CI [0.5003, 0.7197]). Moreover, the percentage of patients reporting dyspareunia, burning, and irritation decreased over the course of the study, with the majority of patients reporting no symptoms at follow-up 3. Conclusions: The use of Plurigin Ovules plus Plurigin Solution may be an effective treatment option for VVA, improving vaginal health, alleviating symptoms, and improving sexual function, leading to improved quality of life for women suffering from this condition. However, the study has limitations, such as its retrospective nature, and further studies are needed to confirm the efficacy and safety of these devices. [ABSTRACT FROM AUTHOR]

Background: This study aimed to explore the current situation and existing issues regarding the management of vulvovaginal atrophy (VVA) or the genitourinary syndrome of menopause (GSM). A nationwide web-based questionnaire survey was conducted among 1,031 Japanese women aged 40 years or older. Materials and methods: Eligible women were asked to complete a questionnaire about how they dealt with their symptoms and how satisfied they were with their coping methods. Results: Of those highly conscious of their GSM symptoms (n = 208; 20.2%), 158 had sought medical consultation (15.3%), with only 15 currently continuing to seek consultation (11.5%). Of the specialties consulted, gynecology was the most frequently consulted (55%). Furthermore, those unwilling to seek medical consultation despite their symptoms accounted for the greatest proportion (n = 359; 34.8%), with 42 (23.9%) having never sought consultation. Topical agents, e.g., steroid hormone ointments/creams, were the most frequent treatments provided by the clinics (n = 71; 40.3%), followed by oral and vaginal estrogens (n = 27; 15.5%), suggesting that estrogen therapy was not the first choice of treatment at the clinics. While 65% of patients treated at the clinics reported satisfaction with the treatments, this was inconsistent with the fact that many were reported to have remained untreated and very few continued with treatment. Conclusions: Survey results suggest that GSM, including VVA, remains underdiagnosed and undertreated in Japan. Medical professionals should deepen their understanding of GSM and raise their level of care to select the appropriate treatment for the condition. [ABSTRACT FROM AUTHOR]

• A non-invasive measure is an unmet need in the evaluation of genitourinary syndrome of menopause. • Measurement of vaginal wall thickness by abdominal and transperineal ultrasound was not accurate. • The transvaginal approach might offer more precise measurement due to the use of high-frequency probes. • Transvaginal ultrasound was able to clearly differentiate the two groups studied. • The transvaginal approach could be a tool for quantifying response to different therapies. There is need for a straightforward objective measure to evaluate vaginal wall changes related to hypoestrogenism. The aim of this pilot study was to evaluate a transvaginal ultrasound procedure for the quantification of vaginal wall thickness in order to differentiate between healthy premenopausal women and postmenopausal women with genitourinary syndrome of menopause using ultra-low-level estrogen status as a model. We performed a prospective, two-arm, cross-sectional pilot study comparing vaginal wall thickness measured by transvaginal ultrasound in postmenopausal breast cancer survivors using aromatase inhibitors with genitourinary syndrome of menopause (GSM group) and healthy premenopausal women (control or C group) from October 2020 to March 2022. After intravaginal introduction of 20 cm3 of sonographic gel, vaginal wall thickness was measured by transvaginal ultrasound in the anterior, posterior, and right and left lateral walls (four quadrants). The study methods followed the STROBE checklist. According to the results of a two-sided t -test, the mean vaginal wall thickness of the four quadrants in the GSM group was significantly less than that of the C group (2.25 mm vs 4.17 mm, respectively; p < 0.001). Likewise, the thickness of each of the vaginal walls (anterior, posterior, right and left lateral) statistically differed between the two groups (p < 0.001). Transvaginal ultrasound with intravaginal gel may be a feasible objective technique to assess genitourinary syndrome of menopause, showing clear differences in vaginal wall thickness between breast cancer survivors using aromatase inhibitors and premenopausal women. Possible correlations with symptoms or treatment response should be assessed in future studies. [ABSTRACT FROM AUTHOR]

The real-world treatment of genitourinary syndrome of menopause has several limitations: contraindications to topical estrogen therapy, which is currently recognized as the "gold standard" treatment for vulvovaginal atrophy (VVA), fear of the systemic effects of topical estrogens or/and carcinophobia, and poor compliance of patients to intravaginal agents. Therefore, there is an unmet need for alternative noninvasive or minimally invasive therapies, mostly non-hormonal. A PubMed, Cochrane Library, Science Direct, and ELibrary databases were searched for the keywords CO2-laser, Er:YAG-laser, vulvovaginal atrophy, genitourinary syndrome of menopause, treatment, postmenopausal age for 20122022. Remodeling microablative laser therapy using carbon dioxide (CO2) is a promising method for treating VVA, acting pathogenetically and symptomatically. CO2 laser relieves VVA symptoms and improves the condition of the vaginal mucosa by enhancing regeneration and restoring vaginal pH. However, evidence of the efficacy and long-term safety of the method, obtained in high-quality studies, is needed before the method can be introduced into widespread clinical practice. Aim. To analyze and summarize the evidence-based and experimental data on the efficacy and safety of laser therapy for VVA and genitourinary syndrome of menopause.

Abstract Background Genitourinary syndrome of menopause (GSM) comprises genital symptoms (dryness, burning, itching, irritation, bleeding), sexual symptoms (dyspareunia and other sexual dysfunctions) and urinary symptoms (dysuria, frequency, urgency, recurrent urinary infections) associated with menopause. To avoid invasive testing and painful physical examinations, validated questionaries, which can assess the prevalence and risk factors associated with symptoms of GSM. We aimed to investigate the prevalence and risk factors associated with GSM in middle-aged and older women in the communities of Beijing, China. Methods A cross-sectional, questionnaire study was performed among 35–70 years old Chinese woman. Vaginal health index score and urinary distress inventory (UDI-6) was used to evaluate vulvovaginal atrophy (VVA) and urinary incontinence (UI). Stages of pelvic organ prolapse (POP) was measured during gynecological examination with POP-Q system. Mean ± standard deviation (SD) and proportion/percentages were used to summarize continuous and categorial variables respectively. The Bonferroni method was used to adjust for multiple comparisons. Results A total of 2702/3000 participants completed the questionnaire survey. The mean ± SD age of participants was 53.7 ± 7.0 years and prevalence of VVA among participants was 34.8% (941/2702). In UDI-6 questionnaires total 47.5% (1284/2702) participants reported experiencing urinary incontinence (UI). Further, POP was highly prevalent in anterior vaginal wall 38.9% (1050/2702) followed by posterior vaginal wall 25.3% (683/2702) and uterine 22.2% (599/2702). Besides, multiple logistic regression analysis inferred older age (45–54 years [OR (95% CI): 3.38 (2.03, 5.64)]; 55–64 years [OR (95% CI): 8.63 (5.09, 14.64)]), menopause [OR (95% CI): 2.20 (1.71, 2.85)] and Faecal Inconsistence (FI) [OR (95% CI): 1.31(1.00, 1.72)] as independent risk factors for VVA. Conclusions Our study evidenced that GSM is prevalent in old age Chinese women. GSM is related with UI, POP and VVA. Further older age, menopause and FI were risk factors associated with VVA. Our findings could help health care personnel to get a comprehensive overview of factors associated with VVA and urinal distress, which may facilitate early detection and prevention of GSM.

Background: Physiological changes in a woman's life, such as labor, weight fluctuations, hormonal changes, aging, and menopause, cause changes in both appearance and function of the vagina. As estrogen deficiency continues, changes occur in the form of atrophy and dystrophy in the vaginal mucosa, vulva, and other structures in the urogenital tract which are called symptoms of vulvovaginal atrophy. It affects women's quality of life, self-confidence, and sexuality. As alternative modality for noninvasive therapy, topical therapy in vaginal rejuvenation is becoming available in the care of outpatients. This makes it increasingly important for dermatologists to be well-informed about these treatment options. Purpose: This review aims to assess the role of topical therapy in vaginal rejuvenation, especially in vulvovaginal atrophy cases. Literature Review: Vulvovaginal atrophy has a negative effect on interpersonal relationships, quality of life, daily activities, and sexual function. Topical hormone replacement therapy includes all preparations such as estradiol, estradiol valerate, or conjugated estrogen. considered in cases with vulvovaginal atrophy accompanied by atrophy of the urogenital system as well as the accompanying complaints because this therapy is intended to prevent systemic complications. The topical use of hyaluronic acid, lubricants, moisturizers, and herbs is a therapeutic choice in vulvovaginal atrophy patients contraindicated with estrogen therapy or in patients who do indeed choose nonhormonal therapy. Conclusion: Topical therapy of hormonal and non-hormonal rejuvenation in various studies has shown improvement in symptoms of vaginal dryness, vaginal itching, dyspareunia, cell maturity, and changes in vaginal pH toward acidity.

Vulvovaginal atrophy (VVA) is detected in more than 50% of postmenopausal women, and at 4049 years of age, 15-19% of women have relevant signs. Atrophic changes in the female urogenital system are associated with hypoestrogenism, which results in the defective synthesis of collagen and elastin due to reduced functional activity of fibroblasts. Although the symptoms of genitourinary syndrome of menopause significantly impair the quality of life, women rarely seek medical help for urogenital symptoms, considering them a normal condition for the period of aging. We searched Cochrane Library, PubMed, Science Direct, and ELibrary databases for the keywords vulvovaginal atrophy, genitourinary syndrome of menopause, quality of life, epidemiology, and postmenopausal age for 20122022. The literature review suggests that the prevalence of VVA is extremely high but underestimated due to the infrequent seeking of medical care by female patients with relevant symptoms. The genitourinary syndrome of menopause dramatically impacts patients' quality of life, but not all women eligible for treatment receive it. One of the reasons for refusing hormonal treatment is patients' fear of the systemic effects of hormonal drugs. There is an unmet need for alternative non-hormonal therapies. The objective is to analyze and systematize the scientific data accumulated over the past ten years on the epidemiology of VVA, its impact on patients' quality of life, and the challenges in diagnosing and treating the disease.

The study and development of new therapies for genitourinary syndrome of menopause (GSM) remain an area of focus in modern gynecology. The relevance and need for scientific research in this area are undeniable due to the significant negative impact of GSM on patients' quality of life. At this point, however, a great deal of controversy is arising as the knowledge of the treatment of GSM-associated disorders deepens. Local hormonal therapy remains the "gold standard" for vulvovaginal atrophy treatment, but alternative therapies for GSM are launching in the pharmaceutical market. Have we got more answers? Yes. Have we got more questions? Sure. So why does the very fact of studying GMS require us to be so pedantic and focus the attention of the entire global medical community? Let's get to the bottom of this.

The review presents data on the management tactics of women with vulvovaginal atrophy in patients of reproductive age and menopause. The influence of vulvovaginal atrophy on the psycho-emotional and sexual spheres, modern methods of diagnosis and therapy of this pathology are considered. Special attention is paid to the role of rehabilitation and an integrated interdisciplinary approach to patients with symptoms of atrophic changes in the urogenital tract: the experience of rehabilitation measures is highlighted on the example of foreign and local studies, the effectiveness of "prerehabilitation" at the stage of the period from diagnosis to treatment is indicated. There is still a need for further studies of complex rehabilitation and its implementation in clinical recommendations.

OBJECTIVE: Vulvovaginal atrophy is a condition closely related to low circulating estrogen levels, with post-menopause being the main cause. However, patients of childbearing age may also present with these symptoms due to treatments that reduce estrogen production. Local estrogen therapy is the causal treatment of local symptoms, but it is not always accepted and is often abandoned by patients. In recent years, alternative therapies have been proposed: fractional CO2 laser or the conjugate treatment with normobaric oxygen and hyaluronic acid, the latter being the subject of this study. The study aimed to evaluate the effectiveness of conjugate topical treatment with normobaric oxygen and hyaluronic acid. PATIENTS AND METHODS: 50 patients were evaluated and treated with 5 applications of 15 minutes each, every 15 days, with Caressflow ®. All patients presented at least one of the symptoms related to vulvovaginal atrophy: dryness, burning, and dyspareunia. In all cases, vulvoscopy, colposcopy, and cervicovaginal cytology were performed. The patients were interviewed with an analogic scale (VAS) concerning the severity of symptoms before and after the treatment. Colposcopy and PAP-smear were assessed by mean of Vaginal Health Index Score (VHI) at baseline and at the end of the treatment. RESULTS: All patients completed the treatment scheme and presented with a significant improvement in subjective symptoms. The colposcopy and PAP-smear performed 10 days after the end of the last treatment showed a significant improvement in the appearance and elasticity of the vaginal epithelium and the cytological picture, which showed, in the sample taken after treatment, hyaluronic acid vesicles within the cell cytoplasm. CONCLUSIONS: This study corroborates the data presented in the latest published papers on the effectiveness of treatment with normobaric O2 and hyaluronic acid on vaginal atrophy. Efficacy has been confirmed both in terms of subjective symptoms reported by the patients and objective improvement at colposcopy and PAPsmear cytology. [ABSTRACT FROM AUTHOR]

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This study aimed to examine the impact of fractional CO2 laser treatment of pelvic symptoms in women who have undergone perineal trauma from vaginal delivery. It was a retrospective, monocentric analysis that encompassed all women assessed for pelvic discomfort or signs of vulvovaginal atrophy following vaginal delivery between 2013 and 2018. The severity of symptoms was assessed using the Visual Analogue Scale (VAS). Twenty-seven patients met the inclusion criteria and were sorted into two groups: (1) women who had undergone episiotomies during labor (n = 11); and (2) women who had experienced spontaneous tears during vaginal delivery (n = 16). For women with episiotomies, each treatment and subsequent evaluation consistently showed a significant reduction in dyspareunia intensity. A similar positive trend was observed regarding pain at the introitus (7.5 vs. 6.5 after the first treatment, p = 0.03; 6.5 vs. 3 after the second treatment, p = 0.01; 3 vs. 1 after the third treatment, p = 0.01). Among women experiencing spontaneous perineal tears during delivery, there was a notable decrease in dyspareunia following all treatments (8 vs. 7 after the first treatment, p = 0.01; 8 vs. 4 after the second treatment, p = 0.02; 3 vs. 1 after the third treatment, p = 0.03). The impact of laser treatment did not exhibit significant differences between women who underwent episiotomies and those who experienced spontaneous perineal tears. In conclusion, fractional CO2 laser can be regarded as a non-pharmacological option for managing pelvic floor symptoms in women who encountered perineal trauma during delivery, independently from the nature, spontaneity, or iatrogenesis of the perineal laceration.

Stem cell transplant proved its efficacy in increasing the survival rate among young patients diagnosed with hematological malignancies. A transplant conditioning regimen is particularly destructive on the genital system, often determining premature ovarian failure, accompanied by vulvovaginal atrophy and sexual dysfunctions. The aims of the present study were, first, to evaluate sexual dysfunctions among transplanted women, using clinical examination and the female sexual function index (FSFI), and second, to determine their impact on a couple’s relationship. A prospective observational comparative study was performed and included 38 patients who underwent allogenic stem cell transplant (SCT) procedures for different hematological malignancies and 38 healthy patients (control group). This study included baseline evaluation, one-year, and three-year follow-up visits. In addition to anamnesis and medically obtained information, FSFI was evaluated to determine the impact of gynecological damage in a subjective manner. In the study group, vulvovaginal atrophy was diagnosed in 76.32%, with subsequent sexual dysfunctions in 92.10% of patients, based on FSFI scoring. Even though the results improved throughout the study, at the last visit, mild vulvovaginal atrophy was diagnosed in 81.58% of patients, and the FSFI score was abnormal for 21.05%. When compared to the control group, both sexual dysfunctions and FSFI results were considerably impaired, with statistical significance. There is a confirmed negative impact of sexual dysfunctions and self-declared FSFI on couple/marital status and couple relationships, with statistical significance, at the last visit. In conclusion, anatomical, functional, and psychological difficulties are a reality of long-term survivors after a stem cell transplant. They should be addressed and assessed equally to other medical conditions, as they may determine serious consequences and impact the sexual quality of life and the couple’s relationship.

IntroductionVulvovaginal atrophy (VVA) is a common condition in post-menopausal women. Symptoms of VVA include dyspareunia, vaginal dryness, vaginal and/or vulvar itching, burning and soreness, dysuria and vaginal bleeding accompanying sexual activity. These symptoms are physiological responses to hypoestrogenicity, inducing atrophy of the vagina epithelia and sudden reduction in mucous production. Prevailing therapy for VVA is hormone replacement therapy (HRT), notably estrogen, progesterone or a combination of the two. However, using HRT is associated with an increased incidence of breast and endometrial cancer, venous thromboembolism in the lungs and legs, stroke and cardiovascular complications.MethodsThis study evaluated Malaysian Gelam honey as a nutraceutical alternative to estrogen HRT (ERT) in alleviating VVA. A total of 24 female 8-weekold Sprague Dawley rats underwent bilateral oophorectomy. A minimum of 14 days elapsed from the time of surgery and administration of the first dose of Gelam honey to allow the female hormones to subside to a stable baseline and complete recovery from surgery. Vaginal tissues were harvested following a 2-week administration of Gelam honey, the harvested vagina tissue underwent immunohistochemistry (IHC) analysis for protein localization and qPCR for mRNA expression analysis.ResultsResults indicated that Gelam honey administration had increased the localization of Aqp1, Aqp5, CFTR and Muc1 proteins in vaginal tissue compared to the menopause group. The effect of Gelam honey on the protein expressions is summarized as Aqp1>CFTR>Aqp5>Muc1.DiscussionGene expression analysis reveals Gelam honey had no effect on Aqp1 and CFTR genes. Gelam honey had up-regulated Aqp5 gene expression. However, its expression was lower than in the ERT+Ovx group. Additionally, Gelam honey up-regulated Muc1 in the vagina, with an expression level higher than those observed either in the ERT+Ovx or SC groups. Gelam honey exhibits a weak estrogenic effect on the genes and proteins responsible for regulating water in the vaginal tissue (Aqp1, Aqp5 and CFTR). In contrast, Gelam honey exhibits a strong estrogenic ability in influencing gene and protein expression for the sialic acid Muc1. Muc1 is associated with mucous production at the vaginal epithelial layer. In conclusion, the protein and gene expression changes in the vagina by Gelam honey had reduced the occurrence of vaginal atrophy in surgically-induced menopause models.

This review article reviews the published results of the clinical use of intravaginal non-invasive HIFU therapy for the treatment of urogenital atrophy, stress urinary incontinence, and wide vagina syndrome. Vaginal distension and genitourinary syndromes of menopause create physical, psychological, and functional problems for women and their partners. Existing invasive treatments can lead to certain complications, so safer and more effective minimally invasive medicine is desirable. Our goal was to evaluate the efficacy and safety of microfocus ultrasound therapy as a form of non-invasive HIFU therapy administered in the vaginal canal in female patients. This review uses the results of a number of recent studies from Argentina, Poland, Japan and other countries using medical devices: Feminine HIFU, manufactured by Sveltia, Argentina, and Ultra Vera, manufactured by Hironic, Republic of Korea. The purpose of the study is to study the results of the clinical application of high-intensity focused ultrasound as a new treatment method in the field of gynecology. High Intensity Focused Ultrasound (HIFU) is a new technology in gynecology that involves regenerative thermal effects on deeper layers of vaginal tissues that cannot be achieved with laser and radio frequency equipment. The results of studies with a total number of participants in more than 100 patients from several groups who underwent clinical examination support suggestions for a potential therapeutic effect as a preferred method of therapy or an addition to laser and other methods of treatment, supported by an evidence base. The value of the study is to provide effective treatment of pathologies due to the formation of new collagen fibers that create a structural framework in the fascial plate of the vagina and adjacent fascia, and the muscles of the small pelvis due to a certain mode of HIFU exposure. The results are promising and motivate further research. [ABSTRACT FROM AUTHOR]

Breast cancer treatment, such as chemotherapy and endocrine therapy, can cause earlier and more sudden menopausal symptoms. Genitourinary syndrome of menopause (GSM) is one of the most bothersome side effects of breast cancer treatment, resulting in sexual dysfunction and impaired quality of life. GSM includes genital, urinary, and sexual symptoms. However, alleviating symptoms of GSM for breast cancer survivors may be challenging due to ineffectiveness, contraindications, and low adherence to treatment. The most recent data show the feasibility and safety of vaginal laser to treat GSM for breast cancer survivors. This narrative review provides the aspects of GSM in breast cancer patients, putting the focus on the efficacy and safety of vaginal laser therapy. [ABSTRACT FROM AUTHOR]