SUI in postmenopausal women: advantages of an intraurethral + intravaginal Er:YAG laser.

OBJECTIVE: This study aimed to compare the efficacy of concomitant application of an intraurethral (IU) + intravaginal (IV) non-ablative Erbium (Er):YAG laser with IV application in improving the symptoms of stress urinary incontinence (SUI) in women. METHODS: This observational retrospective cohort study included 122 patients with SUI, 60 women in the IU + IV laser arm and 62 in the IV laser arm. The primary outcome was the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form score at entry and at 3, 6 and 12 months from baseline. RESULTS: Demographic characteristics were comparable in both arms. Significant improvement in SUI symptoms was seen 3 months after the intervention and was sustained until the end of month 12 in both arms. The women who had severe SUI symptoms initially showed greater improvement. A higher number of women who initially had mild to moderate SUI symptoms were dry after treatment. Patients treated with IU + IV Er:YAG laser showed significant improvement in SUI symptoms compared to IV laser only, especially at postmenopausal state (p = 0.003). CONCLUSIONS: The Er:YAG laser appears to be an efficient treatment method for SUI. Concomitant application of an IU + IV Er:YAG laser is more effective in relieving SUI symptoms at postmenopausal state.

Short-term effects of an erbium/neodymium laser combination in superficial dyspareunia: a pilot study.

OBJECTIVE: This prospective pilot study aimed to evaluate the effects of associating a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser with a vaginal erbium laser (VEL), as a non-ablative photothermal therapy for superficial dyspareunia in postmenopausal women (PMW) suffering from genitourinary syndrome of menopause (GSM). METHODS: Two groups of sexually active PMW reporting superficial dyspareunia were selected: one (15 patients, VEL) was treated using an erbium:yttrium-aluminum-garnet laser crystal (XS Fotona SMOOTH; Fotona, Ljubljana, Slovenia) with a wavelength of 2940 nm; in the other group (15 patients, VEL + Nd:YAG) this treatment was followed by Nd:YAG laser (Fotona SP Dynamis, PIANO mode) treatment. Treatment consisted of three laser applications at 30-day intervals. Symptoms were assessed before, after each laser application and after 1 and 3 months from the end of the treatment, using the subjective visual analog scale (VAS) for superficial dyspareunia. RESULTS: Both groups showed a rapid and significant improvement of superficial dyspareunia over time (p < 0.001) independently from age and years since menopause. The VEL + Nd:YAG group showed a greater improvement of superficial dyspareunia (p < 0.001); this difference was evident since the first treatment and remained stable over time. CONCLUSIONS: The addition of Nd:YAG to VEL may induce greater improvement in superficial dyspareunia in PMW with GSM.

Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms - an update on the evidence.

A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of -0.694 in favor of iCR (p < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John's wort (Hypericum perforatum [HP]) were given (-1.020 and -0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCR+HP combination was superior to iCR monotherapy. Efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCR+HP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCR+HP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.

Sexual function after vaginal erbium laser: the results of a large, multicentric, prospective study.

The aim of this multicentric, prospective study was to evaluate the effects of vaginal erbium laser (VEL-SMOOTH®) on sexual function in postmenopausal women suffering from the genitourinary syndrome of menopause (GSM). This study was performed on an outpatient basis without anesthesia or drug use before or after the intervention, using an erbium laser (XS Fotona Smooth®, Fotona, Ljubljana, Slovenia) in 1081 postmenopausal women (age 54.3 ± 3.9 years) treated with up to three laser applications every 30 days. Patients were assessed using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R). No adverse events were recorded during the study. The FSDS-R scores (n = 554), from basal values of 25.5 ± 3.5, were 11.5 ± 3.0, 10.5 ± 3.5 and 11.5 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Individual FSFI domain scores (n = 569) significantly (p < 0.001) increased after VEL-SMOOTH® treatment and remained significantly higher up to the 24th week after the end of treatment. The total scores, from basal values of 15.5 ± 1.5, were 27.5 ± 2.5, 27.6 ± 2.7and 27.0 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Albeit not randomized, this large, prospective study shows that VEL-SMOOTH® treatment may improve sexual function in postmenopausal women suffering from GSM.

Er:YAG laser in hysterectomized women with stress urinary incontinence: a VELA retrospective cohort, non-inferiority study.

Objective: To test whether the erbium-doped yttrium aluminum garnet (Er:YAG) SMOOTH® laser treatment efficacy on stress urinary incontinence (SUI) in hysterectomized patients is non-inferior to its efficacy in non-hysterectomized patients.Methods: In this real-world, retrospective cohort study performed in Turkey, Croatia and Italy, we enrolled a consecutive sample of 35 hysterectomized and 34 non-hysterectomized patients with SUI. We used the Er:YAG SMOOTH® laser (Fotona, Slovenia) with a wave length of 2940 nm. The primary outcome was median reduction of SUI symptoms measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-SF) with the non-inferiority margin defined as the minimum clinically important difference of ICIQ-SF (δ < 2.52 points).Results: In hysterectomized patients, the ICIQ-SF was reduced by 5 points (95% confidence interval 3-8; p < 0.001), a reduction of 45% (95% confidence interval 36-67%). After adjustment for baseline ICIQ-SF and five covariates, the reduction of symptoms in the hysterectomized group was not inferior to the reduction in the non-hysterectomized group.Conclusion: The Er:YAG SMOOTH® laser treatment seems to improve the symptoms of SUI in hysterectomized women not clinically relevantly less than in non-hysterectomized women. It seems that the beneficial effect of Er:YAG SMOOTH® laser treatment for SUI in hysterectomized women is time-limited.

Safety of vaginal erbium laser: A review of 113,000 patients treated in the past 8 years.

Background: Energy-based devices are becoming a popular option for minimally invasive vaginal procedures. The aim of this study was to obtain information on the frequency of occurrence of adverse effects (AEs) related to vaginal erbium laser (VEL™) treatment.Materials and methods: The global survey was conducted among practitioners using the non-ablative VEL™ (Fotona, Ljubljana, Slovenia). Users were invited to provide the number of patients treated with VEL™ and the number of observed laser-related AEs.Results: The survey was conducted from August 2018 to April 2019. Responses from 535 practitioners were collected, with a total of 113,174 patients treated in the period from 2012 to 2019. Out of 535 respondents, 160 (30%) shared detailed information about the indications they treated in a population of 62,727 patients, whereas 188 (35%) respondents provided information on the frequency of AEs observed in their treated population of 43,095 patients. All observed AEs were mild to moderate, transient and appeared with low frequencies.Conclusions: Minimally invasive thermal-only laser treatment using the non-ablative VEL™ procedures appears to be safe and the incidence of AEs is low.

Tailored hormonal approach in women with premature ovarian insufficiency.

Premature ovarian insufficiency (POI) is probably one of the most devastating diagnoses for women of reproductive age. The major implications for fertility, climacteric symptoms, and quality of life, the great impact of long-term consequences such as bone loss and cardiovascular health, and the lack of a coherent and shared clinical approach make the choice for the right hormonal therapy challenging. In this review we propose an integrated and patient-based hormonal approach for women with POI, from puberty to late reproductive age.

Effects of ospemifene on bone in postmenopausal women.

Ospemifene is a selective estrogen-receptor modulator approved for treating menopause-related moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy (VVA), in the United States, and for treating menopause-related, symptomatic VVA in women not appropriate for local estrogen therapy in Europe. This review summarizes the effects of ospemifene on bone, including bone biomarker data from a phase 3 vaginal dryness study. Early-phase studies of postmenopausal women showed that ospemifene dose-dependently decreased bone turnover markers versus placebo, similar to raloxifene. A 12-week, phase 3 study of ospemifene 60 mg/day in postmenopausal women showed improvements in all VVA parameters and significantly greater decreases in seven of nine bone biomarkers versus placebo. Lower bone resorption markers with ospemifene were observed regardless of time since menopause (≤5 years or >5 years) or baseline bone mineral density (BMD) (normal [n = 18], osteopenia [n = 164], or osteoporosis [n = 21]). Biomarker studies (n = 565 who took ospemifene) therefore support a potential role for ospemifene in maintaining bone health (and possibly reducing fracture risk) in postmenopausal women taking it for VVA; however, caution is warranted because data are limited to biochemical markers, rather than fracture and BMD. Although studies show that bone turnover predicts BMD and fractures, any hypothesis about a bone-sparing effect of ospemifene needs testing in rigorous, long-term, phase 3 studies monitoring fractures and BMD.

Vaginal atrophy across the menopausal age: results from the ANGEL study.

OBJECTIVES: This study aimed to investigate the prevalence of vaginal atrophy (VA) in women across the menopausal age. METHODS: A multicenter cross-sectional investigation was performed on 747 females, 40-55 years of age, in 30 outpatient public services across the nation. The VA diagnosis was based on the combination of patient sensation of vaginal dryness, an objective sign of VA, and pH >5. RESULTS: VA was diagnosed in 36.8% of women. Prevalence ranged from 19.2% (40-45 year olds) to 53.8% (52-55 year olds). pH >5 (37.5%) was less prevalent than isolated VA symptoms or signs. Vaginal dryness (64.0%) was the most prevalent symptom followed by dyspareunia (54.5%), itching (38.5%) burning (38.3%), and dysuria (28.9%). Prevalence of vaginal signs declined from vaginal dryness (60.3%) to vaginal thinning (54.5%), vaginal pallor (47.4%), presence of petecchiae (15.7%), and mucosa fragility (15.1%). Most signs and symptoms showed an age-related increase in frequency and intensity. VA was independently associated (R2 = 0.139; p < 0.0001) with age (odds ratio [OR] 1.08; 95% confidence interval [CI] 1.03-1.13), being in postmenopause (OR 3.45; 95% CI 2.29-5.19), and presence of vasomotor symptoms (OR 3.10; 95% CI 2.09-4.60). CONCLUSION: VA and its symptoms are common in women across the menopausal age. VA identification may favor early management and treatment.

Hormone replacement therapy and prevention of chronic conditions.

Nowadays, postmenopausal women are largely undertreated. Analysis of conflicting results among different studies suggests that hormone replacement therapy (HRT) can prevent osteoporosis and cardiovascular disease in symptomatic, early postmenopausal women. In fact, climacteric symptoms are related to an increased risk of chronic conditions, including hypertension and cardiovascular disease. Different scientific societies have pointed out that patient selection, timing of initiation, and the choice of the type and dose of HRT used are the major determinants of the ultimate effect of HRT on women's health and quality of life in selected women. HRT may prevent chronic conditions when started in symptomatic women before the age of 60 years or within 10 years of the onset of the menopause, taking into consideration the characteristics and risk profiles of each given woman. The bulk of scientific evidence from preclinical, clinical, epidemiological, and also randomized studies indicates that wisely selected HRT is generally useful and rarely dangerous. Following simple and well-established rules, HRT benefits outweigh all of the possible risks. Progestogen choice can make the difference in terms of cardiovascular disease benefits.

Menopausia y terapia hormonal de la menopausia. Las recomendaciones 2018 de la Unidad de Endocrinología Ginecológica de Clínica Alemana de Santiago -Sociedad Italiana de la Menopausia y la Sociedad Chilena de Endocrinología Ginecológica / Menopause and menopausal hormone therapy. The 2018 recommendations of the Gynecological Endocrinology Unit of Clínica Alemana de Santiago -Italian Society of Menopause and the Chilean Society of Gynecological Endocrinology

ABSTRACT In the last decade, the risk benefits ratio of MHT has been evaluated mainly in terms of cardiovascular risk. Present Consensus Statement is largely inspired by the Global Consensus on Menopausal Hormone Therapy in 2013 and 2016 by leading global menopause societies (The American Society for Reproductive Medicine, The Asia Pacific Menopause Federation, The Endocrine Society, The European Menopause and Andropause Society, The International Menopause Society, The International Osteoporosis Foundation and The North American Menopause Society). The aim of these Recommendations is to provide a simple and updated reference on postmenopausal MHT. The term MHT typically includes estrogen replacement therapy (ERT) and estrogen-progestogen therapy (EPT). EPT can be sequential (Seq) when progestogen is added to ERT for 10-14 days a month, or continuous combined (CC) when progestogen is administered continuously every day along with a fixed amount of estrogen. MHT also includes Tibolone and the Tissue Selective Estrogen Complex (TSEC).

Long-term effects of vaginal erbium laser in the treatment of genitourinary syndrome of menopause.

OBJECTIVES: To evaluate the long-term efficacy of a second generation of vaginal laser treatment, the vaginal erbium laser, as a non-ablative photothermal therapy for the management of genitourinary syndrome of menopause. METHODS: The study was performed using an erbium laser crystal yttrium-aluminum-garnet (XS Fotona Smooth™, Fotona, Ljubljana, Slovenia) with a wavelength of 2940 nm. Postmenopausal women (n = 205) were treated with three laser applications at 30-day intervals. Symptoms were assessed before and after treatment throughout 24 months, using the subjective visual analog scale (VAS) and the objective vaginal health index score (VHIS). In addition, postmenopausal women suffering from stress urinary incontinence were evaluated with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). RESULTS: Vaginal erbium laser treatment induced a significant (p < 0.01) decrease in VAS for both vaginal dryness and dyspareunia, as well an increase in VHIS (p < 0.01) up to the 12th month after the last laser treatment. The values returned to levels similar to the baseline after 18 and 24 months. In addition, vaginal erbium laser treatment improved mild-moderate stress urinary incontinence in 114 postmenopausal women. Less than 3% of patients discontinued treatment due to adverse events. CONCLUSIONS: These results suggest that vaginal erbium laser may be effective and safe for the treatment of genitourinary syndrome of menopause.

Vasomotor symptoms in menopause: a biomarker of cardiovascular disease risk and other chronic diseases?

Menopausal disorders may include shorter-term symptoms, such as hot flushes and night sweats (vasomotor symptoms, VMS) and longer-term chronic conditions such as cardiovascular disease (CVD), osteoporosis, and cognitive impairment. Initially, no clear link between the shorter-term symptoms and longer-term chronic conditions was evident and these disorders seemed to occur independently from each other. However, there is a growing body of evidence demonstrating that VMS may be a biomarker for chronic disease. In this review, the association between VMS and a range of chronic postmenopausal conditions including CVD, osteoporosis, and cognitive decline is discussed. Prevention of CVD in women, as for men, should be started early, and effective management of chronic disease in postmenopausal women has to start with the awareness that VMS during menopause are harbingers of things to come and should be treated accordingly.

Female urinary stress incontinence.

Urinary incontinence (UI) is more common than any other chronic disease, such as hypertension, depression or diabetes, with the prevalence estimated between 9 and 74%. Among the various forms of urinary incontinence, stress incontinence (SUI) is the most prevalent (50%), with urgency incontinence (UUI) representing 11% and mixed type (MUI) 36% (3% not classified). Nowadays, the restoration of urinary continence is one of the greatest challenges for the well-being and quality of life of women. The introduction of minimally invasive surgical procedures changed the anti-incontinence surgery, leading to similar, or even better results as traditional, invasive techniques. The development of the mid-urethral slings offers a viable alternative to surgical correction of SUI. These further developments of mini-sling procedures are appropriate for local anesthesia, less traumatic, 'tension-free' (to ensure continence without obstruction), simple, rapid and repeatable. The latest minimally invasive approaches can be performed in day surgery, with clear advantages compared to traditional procedures. A novel approach through the use of vaginal laser techniques could represent an additional opportunity, as a non-invasive, outpatient method to treat SUI.