Efficacy of Two Laser Treatment Strategies for Breast Cancer Survivors With Genitourinary Syndrome of Menopause.

Background A typical symptom of patients with genitourinary syndrome of menopause (GSM) is dyspareunia. Dyspareunia has been thought to be caused by vaginal dryness. In recent years, a survey of breast cancer survivors (BCS) with GSM has shown that para-hymen is the most painful. Dyspareunia and superficial vulvar pain (vulvodynia) may be closely linked. A recent study showed that vulvodynia is very common in BCS. Therefore, we believe treatment targeting the vagina and the vulva is necessary for pain in BCS with GSM. We hypothesized that treating both the vagina and the vulva would solve the problem of BCS with GSM. We compared the vaginal erbium SMOOTH mode laser (VEL) and neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser (VEL+Nd:YAG) combination treatment over time. This study explores therapeutic targets for pain in BCS with GSM. Methodology This retrospective, case-control study targeted sexually active BCS who reported GSM with vulvodynia and dyspareunia. After all women enrolled in the VEL treatment group had completed treatment, we treated women enrolled in the VEL+Nd:YAG treatment group. A total of 256 women who received either VEL+Nd:YAG or VEL were enrolled. Propensity score (PS)-matching analysis was used to compare two-year postoperative data retrospectively. The PS-matching results registered 102 patients in the VEL+Nd:YAG group and 102 patients in the VEL group. Symptoms were assessed using the visual analog scale (VAS) for vulvodynia before and after laser treatment for one, three, six, 12, and 24 months after completion. As a preliminary study, the vulvodynia swab test confirmed the causative location of dyspareunia. Moreover, the Female Sexual Function Index (FSFI) and Vaginal Health Index Score (VHIS) were assessed. FSFI and VHIS were treated as supplement research because the conditions were unmet. Results In the vulvodynia swab test, dyspareunia, and para-hymen (especially at 4 o'clock and 9 o'clock), all felt pain, and only a few felt pain in the vagina and labia. FSFI improved significantly in the VEL+Nd:YAG group and persisted for two years. VHIS improved equally in both groups and was not significantly different. After the first laser application, the VEL+Nd:YAG and the VEL groups showed sustained efficacy and safety in vulvodynia. Baseline VAS scores (8.74 ± 0.72 vs. 8.79 ± 0.74; p = 0.564) were similar in both groups. Both groups had a significant (p < 0.001) decrease in the VAS score. The VAS values in the VEL+Nd:YAG group and the VEL group decreased from the pretreatment to 3.79 ± 0.63 (p < 0.001 vs. baseline) and 5.56 ± 0.89 (p < 0.001 vs. baseline) after the third treatments, respectively. After 24 months, the VAS value in the VEL+Nd:YAG group and the VEL group was at 4.43 ± 1.38 (p < 0.001 vs. baseline) and 5.56 ± 0.89 (p < 0.001 vs. baseline), respectively. The side effects in both groups were short-term and minor. Conclusions Both VEL+NdYAG and VEL effectively and safely treat GSM dyspareunia and vulvodynia in BCS. Comparing the two groups, we confirmed that VEL+Nd:YAG treatment of the vaginal vestibule and vaginal opening reduced superficial vulvar pain more effectively, extensively, and over a longer period than VEL. The results of the vulvodynia swab test, FSFI, and VHIS suggest that the vulva and the vagina are important therapeutic targets for pain in BCS with GSM. The importance of treating the vulvar area for superficial pain and dyspareunia in GSM has been emphasized.

Breaking down barriers for prescribing and using hormone therapy for the treatment of menopausal symptoms: an experts' perspective.

INTRODUCTION: Around 80% of women suffer menopause-related symptoms that affect their daily activities and quality of life. Menopausal hormone therapy (MHT) has proven to be beneficial in relieving these symptoms. Nevertheless, only 20/30% of symptomatic women seek treatment. This has resulted in neglect of a generation of healthcare professionals' (HCPs) education in menopausal medicine and a reduction in the prescription of MHT in menopausal women for over two decades. AREAS COVERED: The aim of this article was to identify the main barriers that HCPs face for prescribing MHT and menopausal women for using it. Six European experts in menopause agreed on the profiles of women that benefit from MHT and proposed strategies to break down these barriers. EXPERT OPINION: The most important barrier for HCPs was deficient knowledge of the true evidence-based information, with inadequate training regarding the efficacy and safety of personalized MHT and the real benefit/risk ratio in the treatment of symptomatic women. For patients, fear of developing breast cancer was identified as the single most important barrier. Breaking down barriers is possible, by providing appropriate training and education to HCPs and women. This should result in fully informed, evidence based, shared treatment decisions by women and their physicians.

Superficial dyspareunia treatment with hyperstacking of erbium:yttrium-aluminum-garnet SMOOTH laser: a short-term, pilot study in breast cancer survivors.

OBJECTIVE: This prospective pilot study aimed to evaluate the effects of a modified vaginal erbium laser (VEL) protocol, using the hyperstack mode on the vaginal vestibulum and introitus to treat superficial dyspareunia in postmenopausal breast cancer survivors suffering from the genitourinary syndrome of menopause. METHODS: In this pilot, prospective, randomized study, two groups of postmenopausal women suffering from superficial dyspareunia were included: 34 women (VEL group) were treated with erbium laser crystal yttrium-aluminum-garnet (XS Fotona SMOOTH; Fotona, Ljubljana, Slovenia) with a wavelength of 2,940 nm; for the other 34 (hyperstack group), a modified second step of the VEL protocol for the treatment of vestibulum and introitus was used, with hyperstacked (repeating a number of) subablative, long pulses with very low fluences. For each group, three laser applications at 30-day intervals were performed. Symptoms were assessed before, after each application, and after 1 and 3 months from the last laser application, using the visual analog scale score for superficial dyspareunia. RESULTS: Superficial dyspareunia improved in both groups over time (P < 0.001), regardless of age and years since menopause status. The reduction in visual analog scale score after the third laser application was 58% in VEL versus 73.5% in hyperstack. The hyperstack group, since the first laser application, showed a greater (P < 0.001) and persistent improvement of superficial dyspareunia. CONCLUSIONS: The hyperstack treatment of the introitus and vestibulum in breast cancer survivors leads to a more significant improvement in superficial dyspareunia than the VEL alone.

EMAS position statement: Vitamin D and menopausal health.

INTRODUCTION: There is increasing evidence that vitamin D has widespread tissue effects. In addition to osteoporosis, vitamin D deficiency has been associated with cardiovascular disease, diabetes, cancer, infections and neurodegenerative disease. However, the effect of vitamin D supplementation on non-skeletal outcomes requires clarification, especially in postmenopausal women. AIM: This position statement provides an evidence-based overview of the role of vitamin D in the health of postmenopausal women based on observational and interventional studies. MATERIALS AND METHODS: Literature review and consensus of expert opinion. RESULTS AND CONCLUSIONS: Vitamin D status is determined by measuring serum 25-hydroxyvitamin D levels. Concentrations <20 ng/ml (<50 nmol/l) and <10 ng/ml (<25 nmol/l) are considered to constitute vitamin D deficiency and severe deficiency, respectively. Observational data suggest an association between vitamin D deficiency and adverse health outcomes in postmenopausal women, although they cannot establish causality. The evidence from randomized controlled trials concerning vitamin D supplementation is not robust, since many studies did not consider whether people were deficient at baseline. Moreover, high heterogeneity exists in terms of the population studied, vitamin D dosage, calcium co-administration and duration of intervention. Concerning skeletal health, vitamin D deficiency is associated with low bone mass and an increased risk of fractures. Vitamin D supplementation at maintenance doses of 800-2000 IU/day (20-50 µg/day), after repletion of vitamin D status with higher weekly or daily doses, may be of benefit only when co-administered with calcium (1000-1200 mg/day), especially in the elderly populations and those with severe vitamin D deficiency. Concerning cardiovascular disease, vitamin D deficiency is associated with an increased prevalence of cardiovascular risk factors, mainly metabolic syndrome, type 2 diabetes mellitus and dyslipidemia. Vitamin D deficiency, especially its severe form, is associated with an increased risk of cardiovascular events (coronary heart disease, stroke, mortality), independently of traditional risk factors. Vitamin D supplementation may have a modestly beneficial effect on lipid profile and glucose homeostasis, especially in obese individuals or those ≥60 years old and at doses of ≥2000 IU/day (≥50 µg/day). However, it has no effect on the incidence of cardiovascular events. Concerning cancer, vitamin D deficiency is associated with increased incidence of and mortality from several types of cancer, such as colorectal, lung and breast cancer. However, the data on other types of gynecological cancer are inconsistent. Vitamin D supplementation has no effect on cancer incidence, although a modest reduction in cancer-related mortality has been observed. Concerning infections, vitamin D deficiency has been associated with acute respiratory tract infections, including coronavirus disease 2019 (COVID-19). Vitamin D supplementation may decrease the risk of acute respiratory tract infections and the severity of COVID-19 (not the risk of infection). Concerning menopausal symptomatology, vitamin D deficiency may have a negative impact on some aspects, such as sleep disturbances, depression, sexual function and joint pains. However, vitamin D supplementation has no effect on these, except for vulvovaginal atrophy, at relatively high doses, i.e., 40,000-60,000 IU/week (1000-1500 IU/week) orally or 1000 IU/day (25 µg/day) as a vaginal suppository.

Is Erbium/Neodymium Laser Combination Therapy an Effective Treatment Option for Interstitial Cystitis/Bladder Pain Syndrome With Vulvodynia?

Interstitial cystitis/bladder pain syndrome (IC/BPS) is often associated with vulvodynia and poor vaginal health. IC/BPS causes pelvic and bladder pain and urinary symptoms, which considerably reduce the quality of life. To date, this condition has no definitive cure. Local estrogen therapy (LET) has been proposed as a treatment for vulvodynia and poor vaginal health to improve the symptoms of IC/BPS. However, chronic LET could be contraindicated or not desired in some patients. The present study reports the case of a 55-year-old postmenopausal woman with IC/BPS who was successfully treated with combined vaginal erbium (VEL)/neodymium (Nd:YAG) laser (VEL+Nd:YAG) therapy. The patient presented with a five-year history of pelvic pain and urinary frequency. Direct approaches for the bladder (such as hydrodistension, anticholinergic drugs, and transurethral Hunner lesion ablation/cauterization) were conducted with inconsistent results. Immediately prior to the patient's presentation, LET was administered for 12 weeks; however, this therapy resulted in mild improvement and poor patient satisfaction. After presentation, VEL+Nd:YAG therapy was conducted once a month for three months. The patient reported considerable decrease in pain during urination. The improved symptoms were maintained for six months after the last therapy session. These results suggest that VEL+Nd:YAG therapy is an effective method for improving symptoms in patients with IC/BPS.

Examining vaginal and vulvar health and sexual dysfunction in patients with interstitial cystitis (UNICORN-1 study).

INTRODUCTION AND HYPOTHESIS: The Vaginal Health Index Score (VHIS) and vulvodynia swab tests are used to assess vaginal health and vulvodynia. However, few studies have used these tests in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). IC/BPS is a chronic, debilitating disorder, characterised by urinary frequency, urinary urgency and pelvic pain. It adversely affects organs adjacent to the urinary system, leading to complications of sexual dysfunction. This study was aimed at understanding sexual dysfunction in patients with IC/BPS, as well as deterioration of vaginal health and vulvodynia. METHODS: This study compared the vaginal health of IC/BPS patients with that of asymptomatic control individuals. The Pain Urgency Frequency (PUF) score, Female Sexual Function Index (FSFI), VHIS, and vulvodynia swab tests, were used as tools. The PUF and FSFI are questionnaire-based surveys of bladder symptoms and sexual function respectively. VHIS evaluation and vulvodynia swab tests are performed by physicians. The PUF was used to assess baseline IC/BPS symptoms to validate the patient population, and FSFI, vulvodynia swab tests and VHIS were used to determine between-group differences. RESULTS: Thirty-seven patients were recruited in each group. The IC/BPS group had a higher PUF score (18.19±3.51 vs 3.56±2.35; p<0.05), worse total FSFI (15.72±4.46 vs 26.3±4.93; p<0.05), and worse vulvodynia swab test and total VHIS (11.59±2.87 vs 22.05±3.05; p<0.05) scores than those of the control group. CONCLUSIONS: Asian women with IC/BPS experienced greater sexual dysfunction, worsened vaginal health and increased vulvodynia compared with control individuals. Information on vaginal and vulva health is very useful in evaluating IC/BPS patients.

Menopause, wellbeing and health: A care pathway from the European Menopause and Andropause Society.

This care pathway from the European Menopause and Andropause Society (EMAS) provides an updated pathway for monitoring and guidance of women at midlife, focusing on those approaching the end of the reproductive life-cycle, going through the menopausal transition and beyond. The care pathway is written by professionals involved in women's health and provides a stepwise individualized approach, stratified according to needs, symptoms and reproductive stage. Furthermore, the pathway provides details on screening for chronic diseases related to menopause and ageing. Treatment options for climacteric symptoms range from menopausal hormone therapy to non-hormonal alternatives and lifestyle modifications. Therapy should be tailored to personal needs and wishes. The pathway aims to offer a holistic, balanced approach for monitoring middle-aged women, aiming to control health problems effectively and ensure healthy ageing.

The essential menopause curriculum for healthcare professionals: A European Menopause and Andropause Society (EMAS) position statement.

INTRODUCTION: The menopause, or the cessation of menstruation, is a stage of the life cycle which will occur in all women. Managing perimenopausal and postmenopausal health is a key issue for all areas of healthcare, not just gynecology. AIM: To provide recommendations for the curriculum of education programs for healthcare professionals worldwide, so that all can receive high quality training on menopause. MATERIALS AND METHODS: Literature review and consensus of expert opinion. SUMMARY RECOMMENDATIONS: Training programs for healthcare professionals worldwide should include menopause and postmenopausal health in their curriculum. It should include assessment, diagnosis and evidence-based management strategies.

What women think about menopause: An Italian survey.

INTRODUCTION: Menopause is a critical period for most women who experience associated symptoms while they are still socially and individually active. OBJECTIVES: The objective of this study is to report how Italian women perceive and approach menopause. MATERIALS AND METHODS: A survey of 1028 Italian women aged 45-65 years was conducted by the Italian Center for Studies of Social Investments (CENSIS) through anonymous interviews using two methods: CATI (Computer Assisted Telephone Interviewing) and CAWI (Computer Assisted Web Interviewing). PRINCIPAL OUTCOME MEASURES: Principal outcome measures were women's perceptions and experiences of menopause and its treatments. RESULTS: The global consciousness and understanding of menopause was common (82.8 %) among Italian women and it was usually considered a physiological condition (77 %). Overall, 74.6 % of the sample were postmenopausal. Hot flushes were reported to be the most frequent (37.9 %) and bothersome symptoms (43.1 %) while 12.9 % of the women were asymptomatic. As for menopausal therapies, 24.5 % were on treatment; herbal medications were the most common remedy (63.3 %) whereas 7.6 % of the women took hormone replacement therapy (HRT). About half of the sample (50.4 %) had not sought help from the Italian National Health System (INHS). Medical expertise in the field of menopause was thought to be moderately satisfactory by 54.5 % of the sample. CONCLUSIONS: Italian women consider menopause a physiological condition. Most postmenopausal women had experienced symptoms but relied on non-hormonal treatments. The median women's satisfaction with the role of the INHS and medical competence suggests the need to improve current knowledge and awareness concerning menopause.

Viewing symptoms associated with Vulvovaginal Atrophy (VVA)/Genitourinary syndrome of menopause (GSM) through the estro-androgenic lens - Cluster analysis of a web-based Italian survey among women over 40.

OBJECTIVE: we aimed to explore the use of an estro-androgenic symptom questionnaire in women (EASQ-W), including items typically associated with menopausal hypoestrogenism and some others possibly related to androgen insufficiency that may be relevant to further characterize women reporting VVA/GSM at midlife. METHODS: web-based survey involving a representative sample of 1505 Italian women (age range: 40-65 years). The responders completed a structured, online questionnaire, reporting symptoms (yes/no option) and rating them (from 1 to 10), if present during the past 4 weeks. A factor analysis methodology (principal component analysis and K-MEANS clustering algorithm) was used to segment women. Statistically significant differences between groups were determined at the 95 % level of confidence. RESULTS: more than half of our study sample were aged 50-65 years (n = 901; 59.9 %) and 55 % were postmenopausal women (PMW). We obtained 8 principal domains of the EASQ-W with PMW reporting significantly more severe symptoms in the majority of domains related to well-being at mid-life. The K-MEANS clustering algorithm identified 4 clusters of women characterized by different symptoms: vasomotor (VMS; n = 341), sexual (SEX; n = 301), poorly symptomatic (LOWSYMPT; n = 766), sexual and anatomic, mainly at genital level (SEX + ANAT; n = 97), independently from the menopausal status. The cluster SEX + ANAT was the one reporting overall more symptoms in each of the other principal domains. Some symptoms (impression of being diminished in height, deterioration in work performance, more memory lapses/confusion than before, more wrinkles/signs of aging in the mirror, put on more tummy than usual) and the entire urological (UROL) cluster were significantly more reported by women in the cluster SEX + ANAT. Even when only severe symptoms were analysed, women in the SEX + ANAT cluster were the ones more symptomatic. The SEX only cluster identified younger women, with significantly less day and night hot flushes and sweats and less vaginal dryness and low lubrication associated with sexual pain as compared to SEX + ANAT. CONCLUSION: our results provide insight into the constellation of symptoms associated with VVA/GSM by identifying women with distinct clusters of complaints that may require a tailored diagnostic and therapeutic approach across age and menopause.

Long-term treatment with α-lipoic acid and myo-inositol positively affects clinical and metabolic features of polycystic ovary syndrome.

The aim of this retrospective study was to evaluate the effects of a long-term treatment with α-lipoic acid (ALA) combined with myo-inositol (MI) on clinical and metabolic features of women with polycystic ovary syndrome (PCOS). Fifty-seven women with PCOS and a history of oligoamenorrhea were treated with MI and ALA (800 mg + 2000 mg per day). Forty-four of them had complete clinical charts and were considered eligible for the study. Information about cycle length and body mass index (BMI) was checked after 6, 12, and 24 months. After 12 months ovarian volume, total testosterone plasma levels and changes in hirsutism were also evaluated. The metabolic parameters were evaluated in 16 women after 6 and 18 months of the treatment. Cycle length was significantly reduced at 6 (p < .001), 12, and 24 months of treatment (p < .01). BMI showed a reduction only at 6 months (p < .05), thereafter returning similar to the basal values. No changes of testosterone and ovarian volume were observed. HOMA-IR and fasting insulin were unchanged, but the insulin response to a 3 h OGTT was improved after 6 (p < .01) and 18 months (p < .05) of treatment. No individual suffered from any adverse event. In conclusion, the combination of ALA and MI showed to be useful as long-term therapy in PCOS women, providing a normalization of the menstrual cycle and an amelioration of insulin levels with a high tolerability.

The effect of vulvovaginal atrophy on women's quality of life from an Italian cohort of the EVES study.

Vulvovaginal atrophy (VVA) has an impact on the quality of life (QoL) of women. This post hoc analysis of the EVES study provides an overview of the QoL in postmenopausal Italian women in relation with VVA severity. We included 1066 women attending menopause/gynaecologic centres. A face-to-face survey (including QoL and sexual life questionnaires), joining an objective gynaecological examination to confirm VVA, were performed. The 65.5% of the participants presented severe vaginal, vulvar and/or urinary symptoms; an 86.9% had an objective confirmed VVA. Women with severe symptoms presented with significantly worse QoL scores than the women without. We found there were moderately significant correlations between vaginal and vulvar symptoms' severity and lower overall DIVA QoL scores (p<.0005, in both cases). Women with a confirmed VVA presented worse QoL scores than women without confirmation. Our data suggest a clear relationship between VVA severity and a decrease in QoL in postmenopausal Italian women.IMPACT STATEMENTWhat is already known on this subject? Vulvovaginal atrophy (VVA) appears as a common chronic disorder in postmenopausal women that, as soon as the oestrogen levels decrease, becomes a severe condition affecting their quality of life (QoL).What do the results of this study add? We provide new insight about QoL related to VVA severity in Italian postmenopausal women. Our local data demonstrates that QoL in Italian women suffering from menopause is directly related to the severity of vaginal and vulvar symptoms. The same correlation exists for urinary symptoms. QoL is also reduced in patients with an objectively confirmed VVA diagnosis.What are the implications of these findings for clinical practice and/or further research? The implications of our findings involve the need for a better management, not only of the physical aspects of VVA, but also of the non-physical dimensions. Clinicians should ask for the impact of VVA on QoL aspects, making postmenopausal women aware about the possible affected spheres. Medical personnel should conduct future campaigns in the Italian general population, not only in those asking for medical help, to make all women conscious about this silent disorder affecting physical and non-physical dimensions and in order to treat it at early stages.

Genitourinary syndrome of menopause (GSM) and laser VEL: a review.

The purpose of this publication is to summarize the results of the vaginal erbium:yttrium-aluminum-garnet (Er:YAG) Smooth® laser (VEL) on the vaginal atrophy component of the genitourinary syndrome of menopause (GSM). GSM has two categories of clinical signs related to estrogen deficiency: symptoms of vulvovaginal atrophy (VVA) and urinary symptoms. This symptomatology is chronic, progressive over the years and affects a majority of women concerned by natural menopause but not exclusively: we must also consider the growing number of survivors of gynecological or non-gynecological cancers (breast, cervix, uterus, vagina, anus, etc.). At a time when hormonal treatment of menopause is contested as is the installation of under urethra prosthesis, the innovation provided by the VEL technology has the merit of offering the women concerned an effective therapeutic alternative with the security of a patent. The VEL technology has an original and unique process: acting only by thermal effect and not by ablation on tissue, VEL is a safe solution in terms of side effects and potential complications. Studies have been increasing since 2012 and all demonstrate a significant improvement in the GSM signs and symptoms, as well as an improved sexual life after VEL treatment. Double-blind, placebo-controlled, randomized studies are expected in order to ultimately confirm the safety and effectiveness of VEL.

Joint recommendations for the diagnosis and treatment of vulvo-vaginal atrophy in women in the peri- and post-menopausal phases from the Società Italiana per la Menopausa (SIM) and the Società Italiana della Terza Età (SIGiTE).

Herein, joint recommendations for diagnosis and treatment of vulvo-vaginal atrophy (VVA) in women in the peri- and post-menopausal phases from the Società Italiana per la Menopausa (SIM) and the Società Italiana della Terza Età (SIGiTE) are presented. The recommendations are aimed at all healthcare personnel caring for women in the menopausal transition or postmenopausal phase, and are also intended to raise awareness of VVA. Recent data clearly indicate VVA is a highly prevalent condition among postmenopausal women, and that the vast majority of women with VVA are not adequately treated. In reality, diagnosis of VVA is simple and largely clinical. Many types of treatments are available for VVA, ranging from preventive education measures to local non-hormonal therapies, local agents that modulate hormonal receptors and systemic as well as laser therapy and radiofrequency. Regardless of the therapeutic approach adopted, greater communication between the physician and the woman with VVA should be actively encouraged. This is also in light of the difficulty of talking about the VVA and related disorders. Greater communication also encourages adequate therapy and thus minimizes the impact of VVA on the quality of life of the woman and her partner.