Obesity and menopause.

Obesity is not a choice or a result of lack of willpower, but a multifactorial, chronic, progressive, and relapsing disease. During menopause, hormonal and body composition changes lead to greater visceral adiposity, that aggravates women's health at a cardiometabolic, mechanic and mental level. Adiposity has been identified as an important modifier of reproductive hormones. During female midlife, obesity has been associated with menstrual cycle alterations (anovulatory cycles ending with abnormal bleedings), menopausal symptoms including hot flashes, poor quality of sleep, aches and joint pain, genitourinary symptoms, and reduced quality of life. However, the relationships between weight, the menopausal process, aging, and hormone levels remain poorly understood. Women with obesity have an increased risk of thromboembolic disease when using menopause hormone therapy (MHT), and it is probably the main medical condition to prescribe or not MHT. However, this risk depends on the route and type of MHT. The use of estrogen-only or combined transdermal MHT does not increase the risk of a thrombotic event in women with obesity.

Rural residence and health-related quality of life in a sample of Spain perimenopausal women.

BACKGROUND: The prevalence and severity of perimenopausal symptoms are typically associated with multiple factors, including demographic characteristics. The sociodemographic characteristics of women living in rural areas differ from those residing in urban areas, and it has been suggested that these differences could potentially influence the prevalence of symptoms experienced during perimenopause. OBJECTIVES: To evaluate if perimenopausal women living in Spanish rural areas have a higher prevalence of perimenopausal symptoms and assess their influence on health-related quality of life. METHODS: A cross-sectional study was conducted in a sample of 270 perimenopausal women residing in rural and urban areas. The participants completed the Cervantes Scale Short Version and Beck Depression Inventory 2. RESULTS: Perimenopausal women in rural areas reported a higher incidence of perimenopausal symptoms and a lower perception of health-related quality of life compared to those in urban areas, as evidenced by higher scores on the total Cervantes Scale Short Version scale (33.2 (±16.2) vs. 26.4 (±18.1), p = .001). No differences in the Beck Depression Inventory 2 score were detected. CONCLUSIONS: Perimenopausal women residing in rural areas of Spain reported a higher prevalence of perimenopausal symptoms and experienced a poorer Health-Related Quality of Life compared to those living in urban areas of Spain.

Prospective, multicenter, uncontrolled study on the effectiveness and safety of a hyaluronic acid water-based vaginal lubricant in alleviating vaginal dryness and dyspareunia.

BACKGROUND: Vaginal dryness (VD) represents a significant concern affecting women across diverse life stages, encompassing both pre- and postmenopausal women at any age. Dyspareunia, defined by genital pain that can be experienced before, during, or after intercourse, is often associated with vaginal dryness. AIM: This study aimed to evaluate the effectiveness and safety of a water-based vaginal lubricant with hyaluronic acid to reduce sexual discomfort associated with vaginal dryness. METHODS: A prospective, multicenter, uncontrolled clinical investigation was conducted over a three-month period in women aged 18 years or older experiencing pain or difficulty during sexual intercourse for whom the use of a vaginal lubricant was recommended. RESULTS: Significant improvements were observed in the FSFI scores, indicating enhanced sexual function (p < .001). Vaginal dryness symptoms, including irritation, dryness, itching, and dyspareunia, significantly decreased after product use (p < .001). CLINICAL IMPLICATIONS: This study contributes to the limited scientific knowledge on the application of lubricants in the context of symptoms associated with VD. STRENGTHS & LIMITATIONS: In addition to the short study period, inherent limitations of the study design, and lack of placebo control, it is pertinent to acknowledge that some of the pros used in this study were not based on validated questionnaires. However, as far as we know, this study is the only one that analyzes well-being and sexual pleasure as results using a lubricant formulated with hyaluronic acid. CONCLUSION: This tested vaginal lubricant with hyaluronic acid has demonstrated efficacy in improving vaginal dryness and female sexual function, particularly in reducing pain and improving lubrication during sexual intercourse, and showed a favorable safety profile, with minimal and transient adverse events.

Chronic vulvar fissure: approach with cross-linked hyaluronic acid.

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.

Vulvovaginal atrophy in the CRETA study: the healthcare professionals' perception.

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.

The views of women and pharmacists on the desirability of a progestogen-only pill over the counter. Results of a survey in Germany, Italy and Spain.

PURPOSE: To explore the perceived need and enthusiasm for over the counter (OTC) progestogen-only pills (POP). MATERIALS AND METHODS: A web-based survey of 1000 sexually active women (16-45) and 100 pharmacists in Germany, Italy and Spain. RESULTS: Despite not wanting to conceive, 5-6% of women in each country were not using contraception and 8-20% were using methods less effective than condoms. At least 74% of respondents felt knowledgeable about the different contraceptives available but at least 1/3 had experienced difficulty accessing oral contraceptive (OCs) in the past two years. The cost of contraceptives, the need to see a doctor and long waits for appointments were cited as barriers for not using OCs. The majority agreed they would discuss with their doctor the decision to buy the POP, consult about side effects and other reproductive health issues. Over 2/3 of pharmacists in each country would be very, or fairly, likely to recommend the POP, agreeing that the benefits included improved access for women, and offered them more independence. CONCLUSIONS: Asked directly, women in Germany, Spain and Italy currently using contraception are positive about a POP OTC. Pharmacists are also positive, with the overwhelming majority in favour of providing POPs.

Pulsed Magnetic Stimulation for Stress Urinary Incontinence and Its Impact on Sexuality and Health.

It is becoming increasingly common that patients' preferences move towards non-surgical approaches, such as pulsed magnetic stimulation, for female stress urinary incontinence. OBJECTIVE: We evaluated the efficacy and safety of a device that uses electromagnetic technology to treat urinary incontinence, with an emphasis on health-related quality of life. METHODS: A total of 47 female subjects from 18 to 80 years old were enrolled. After block randomization, treatment consisted of 2 pulsed planar magnetic stimulation sessions per week for 4 weeks (8 sessions). Validated questionnaires: Female Sexual Function Index, International Consultation on Incontinence Questionnaire for Urinary Incontinence: Short Form, and Pelvic Floor Bothersome. Follow-ups were performed at weeks 1, 9, and 14. RESULTS: The present study is one of the first clinical trials published evaluating the efficacy and safety of the electromagnetism-based device with flat configuration in patients with stress urinary incontinence, showing a reduction in PFBQ, ICQSF, and Oxford test scores during follow-up, and significantly at week 14 of follow-up, which implied a favorable impact on clinical outcomes, quality of life, and sexuality. CONCLUSIONS: The improved results in the treatment group compared with the simulated group show that pulsed magnetic stimulation is a safe and attractive non-invasive alternative for patients who prefer non-surgical treatments.

What are the mechanisms of action of the different contraceptive methods to reduce the risk of ovarian cancer?

OBJECTIVE: Ovarian cancer (OvCa) is the deadliest gynaecologic malignancy. Knowing that OvCa, as a disease, has different origins has allowed us to relate them to the mechanisms of action of different contraceptive methods with the aim of evaluating the possibility of their use in reducing risk. STUDY DESIGN: This commentary review article will instead focus on the recent findings on the role of contraceptive methods in preventing of OvCa. RESULTS: Combined hormonal contraceptive (CHC) use is an effective method of chemoprevention for OvCa in the general population and in women with genetic disorders. Salpingectomy, better than tubal ligation, should be offered for ovarian/tubal/peritoneal cancer prevention. Progestogen-only methods can decrease the risk of OvCa via reduced menstrual bleeding and by changes in the hormonal environment that surrounds the ovary. IUDs of any type, through different mechanisms, decrease the risk of OvCa. Barrier methods prevent the passage of germs into the tubes and ovaries and the inflammatory state they produce. CONCLUSIONS: Most contraceptive methods have a mechanism of action that may favour a reduction in the risk of OvCa. The theories of incessant ovulation, retrograde menstruation, and that the fallopian tubes are the site of origin of a proportion of high-grade serous OvCa, have led to the recommendation that anovulatory methods, those that decrease menstrual bleeding, and those that blocked tubes, or even better, 'opportunistic salpingectomy' are a current approach to prevent OvCa in the population general and, above all, in the population at risk.

Ospemifene efficacy and safety data in women with vulvovaginal atrophy.

Vulvovaginal atrophy (VVA) is a frequent, underreported and underdiagnosed condition. Ospemifene is a third-generation Selective Estrogen Receptor Modulator (SERM) that has been shown to be effective in women with VVA and dyspareunia, vaginal dryness and vulvar vestibular symptoms. Some of the possible side effects included by FDA and EMA are hot flushes, headache, muscle spasms, vaginal bleeding and vaginal discharge. Ospemifene does not increase the incidence of endometrial cancer or hyperplasia. While the efficacy is comparable with that of estrogenic treatments, ospemifene is not only well tolerated and safe but also reduces bone turnover in postmenopausal women, and available data indicate no safety concerns for breast tissue.

Prevention of unintended pregnancies by using emergency contraception: the differences between levonorgestrel and ulipristal acetate. A theoretical model using data from a survey on the use of emergency contraception in Spain, 2017.

Objective: To estimate the differences in unintended pregnancies avoided using either levonorgestrel (LNG) or ulipristal acetate (UPA) emergency contraception (EC). Design: Cross-sectional study. Setting: Survey carried out in Spain. Participants: 1000 Spanish women reporting unprotected sex in 2017. Main measurements: EC use, reasons for not using EC, calculation of the number of unintended pregnancies avoided. Results: 39% of Spanish women having had unprotected sex used EC. 61% of those women did not use EC and 11% did not know the existence of this resource. In 2017 the use of EC prevented 101,271 unintended pregnancies. If instead of using LNG every woman had used UPA another 15,979 additional pregnancies could have been prevented. Conclusions: If all Spanish women having unprotected sex used EC we could expect a significant decrease in the number of unintended pregnancies and abortions. Using UPA instead of LNG would have a greater impact on that reduction with the corresponding benefit for women and society as a whole.

In response to the FDA warning about the use of photomedicine in gynecology.

To alert patients and health care providers about the use of energy-based devices to perform a vaginal "rejuvenation," cosmetic vaginal procedures, or nonsurgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function, the US Food and Drug Administration (FDA) has issued a warning about the effectiveness and safety of such devices. We agree with the FDA that certain devices (laser, radiofrequency, etc.) have been marketed inappropriately for uses that are outside of their cleared or approved intended uses. We want to position ourselves in the strict training of professionals so that the indications and techniques are used in the best possible way, knowing that, similar to any medical or surgical technique, the side effects can appear in the short and long term, and should be recognized and remedied.

What do TSECs provide in the menopausal hormone therapy?

Tissue-selective estrogen complex (TSEC) is projected as a progestogen-free option for the treatment of estrogen deficiency symptoms in postmenopausal, non-hysterectomized women. TSEC combines the benefits of estrogen with a selective estrogen receptor modulator (SERM), in this case bazedoxifene acetate (BZA), which has an antagonistic effect on the endometrium, thus avoiding the use of progestins. The authorized TSEC combination (conjugated estrogens [CE] 0.45 mg/BZA 20 mg) for the alleviation of vasomotor symptoms has been demonstrated in randomized clinical trials compared with placebo or menopausal hormone therapy (MHT). In addition, TSEC has shown improvements in quality of life and vaginal atrophy. In respect to MHT using progestins, the benefits of TSEC are found mainly in the bleeding pattern, amenorrhea rate, and reduction in mammary repercussion (i.e., breast tenderness and radiological density). The objective of this guide will be to analyze the efficacy and safety of TSEC consisting of CE/BZA in postmenopausal women.

Cross-sectional evaluation of the impact of information on flexible extended regimens of oral contraceptives in the choices made by women seeking contraceptive counselling: the FLEXO study.

OBJECTIVE: Oral combined hormonal contraceptives (CHCs) are available that limit the number of menses when used in a flexible extended regimen. Our aim was to investigate the decision-making processes of women presented with a flexible extended CHC option. METHODS: The FLEXO study is an epidemiological, cross-sectional, multicentre study conducted under typical clinical practice conditions to determine women's acceptance of a flexible continuous CHC regimen versus a cyclical 21/7 day regimen, after receiving standardised information during contraceptive counselling. RESULTS: A total of 1350 women were invited to participate, of whom 1156 were enrolled. Of these, 47.2% chose the flexible extended CHC regimen. Their main reason for choosing this regimen was to reduce the number of menses (25.7%), followed by the desire to avoid symptoms related to menstruation (21.6%). The reasons given for rejecting this regimen were the desire to have monthly menstrual cycles (24.9%) and the fear of becoming pregnant and not being aware of it due to the absence of menstruation (18.1%). CONCLUSION: Many women chose the extended flexible regimen when they received information about this option. Women primarily chose this pattern to relieve or eliminate discomfort related to menstruation.

Effect on quality of life of switching to combined oral contraception based on natural estrogen: an observational, multicentre, prospective phase IV study (ZOCAL Study).

OBJECTIVES: This observational, multicentre, prospective phase IV study examined change in health-related quality of life (QOL) from baseline to 6 months in women initiating combined oral contraception (COC) based on natural estrogen. METHODS: Eligible women attending a baseline and 6-month gynaecology appointment belonged to one of three groups: group 1 used barrier contraception (condoms) and elected to continue this method; group 2 used condoms and elected to switch to COC based on natural estrogen; group 3 used COC based on ethinylestradiol and elected to switch to COC based on natural estrogen. The Spanish Society of Contraception (SEC)-QOL scale assessed health-related QOL. Secondary outcomes included symptoms of premenstrual syndrome, intermenstrual bleeding, duration and intensity of menstrual bleeding, contraception continuation rate, and tolerability. RESULTS: A total of 857 women were enrolled and 785 completed the study. Group 2 (n = 224 completed) had significantly lower SEC-QOL global and dimension scores at baseline and significantly greater increases in SEC-QOL from baseline to 6 months compared with groups 1 (n = 72) and 3 (n = 489). Group 3 reported a similar SEC-QOL score to that of group 1 at baseline but showed significantly greater improvement in SEC-QOL global and psychological scores from baseline to 6 months. Among women receiving COC based on natural estrogen, the contraception continuation rate was 713/780 (91.4%); treatment-related adverse events were reported by 13/780 (1.7%). CONCLUSIONS: Improved SEC-QOL after 6 months was found in women who were dissatisfied with their current contraception at baseline and chose to switch to COC based on natural estrogen.

Extended regimens of combined hormonal contraception to reduce symptoms related to withdrawal bleeding and the hormone-free interval: a systematic review of randomised and observational studies.

OBJECTIVE: To assess whether continuous and extended regimens (CRs/ERs) of combined hormonal contraceptives (CHCs) improve symptoms related to withdrawal bleeding or the hormone-free interval and to compare the efficacy, safety, and cost of CRs/ERs to those of conventional 28-day regimens. STUDY DESIGN: A literature search of the PubMed database was conducted for randomised clinical trials (RCTs) and observational studies published in any language between 2006 and 2013. RESULTS: Sixteen RCTs and 14 observational studies evaluated issues related to our objectives. CRs/ERs, whose efficacy and safety were comparable to those described for conventional regimens, were preferred due to their improvement of symptoms related to withdrawal bleeding or the hormone-free interval and the lower costs resulting from the reduced incidence of these symptoms. CONCLUSION: The contraceptive efficacy and safety of CR/ER use of CHCs is at least equal to that of 28-days conventional regimens, and this use may have some cost savings. CRs/ERs are recommended for women willing to take a CHC for treatment of symptoms related to withdrawal bleeding or the hormone-free interval.

Assessment of female prevalence of overactive bladder (OAB) in Barcelona using a self-administered screening questionnaire: the Cuestionario de Autoevaluación del Control de la Vejiga (CACV).

INTRODUCTION AND HYPOTHESIS: Overactive bladder (OAB) syndrome is common urological condition, usually underdiagnosed and difficult to identify. The screening of lower urinary tract symptoms (LUTS) through patient self-administered questionnaires can be useful not only for timely identification of these patients but to implement early interventions for symptoms and their implication in a patients' quality of life (QOL). Our objective was to assess the prevalence of OAB symptoms in patients attending general gynecology units in Barcelona, Spain, through a self-administered screening questionnaire. MATERIALS AND METHODS: A cross-sectional, multicenter, observational, epidemiological study was carried out at general gynecology units of ten primary health centers in Barcelona, Spain. The study was conducted during a patient's single visit through self-administered forms. Patients recorded sociodemographic data, medical history and comorbidities, and scored the presence and bother related to specific urological symptoms using the Cuestionario de Autoevaluación del Control de la Vejiga (CACV), the validated Spanish version of the Bladder Control Self-Assessment Questionnaire (B-SAQ). A score ≥6 on the symptoms scale of the CACV was taken as an indicator of suspected OAB. RESULTS: One thousand and four women aged between 18 and 82 participated in the study. The overall prevalence of OAB was 11.8 %. A patient being >50 years was significantly associated with suspected OAB in comparison with the younger group [odds ratio (OR) 3.1 (2.1-4.7); p < 0,001]. Overactive bladder showed significant association with factors other than age, menopause, and previous urogynecological history, such as high body mass index (BMI) and parity. CONCLUSIONS: The estimated prevalence of suspected OAB in patients attending general gynecological services in Barcelona is 11.8 %. Overweight or obese patients and those with three or more children were found to be at elevated risk for developing OAB.

A multigenic combination of estrogen related genes are associated with the duration of fertility period in the Spanish population.

OBJECTIVE: The duration of the fertile period (FP) can be considered a complex parameter that depends on the interaction of multiple factors. In the present study, the role of interaction between genetic variants within estrogen synthesis and signaling pathways in the FP in Spanish women is studied. MATERIAL AND METHODS: Nine single nucleotide polymorphisms (SNPs) located at different candidate genes related to the estrogen signaling pathway were analyzed in 1980 Spanish postmenopausal women. RESULTS: Independently, none of the nine markers were significantly associated with age at menopause. In contrast, survival analysis techniques suggest several epistatic interactions including these markers in relation to age at menopause, especially between ESR2, NRIP1 and BMP15: women who showed the three markers ESR2 (AA), BMP15 (rs3897937) (TC) and NRIP1 (AA), the FP was shorter than the control group of women without any of these markers (32.36 ± 1.49 versus 34.94 ± 0.32 years; p = 0.026). The digenic BMP15 (rs3897937) (TC) and NRIP1 (AA) combination were also associated with a decreased duration of the FP (33.32 ± 0.96 years, p = 0.031). CONCLUSIONS: The results suggest that interactions of estrogen-related alleles may contribute to variance in FP in Spanish women.

Impact of vulvovaginal atrophy therapies on postmenopausal women's quality of life in the CRETA study measured by the Cervantes scale.

OBJECTIVE: To assess the correlation of different vulvovaginal atrophy therapeutic options with the quality of life of postmenopausal women. STUDY DESIGN: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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). CONCLUSIONS: 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. CLINCIALTRIALS. GOV NUMBER: NCT04607707.

Recommendations on the management of fragility fracture risk in women younger than 70 years.

The risk for fragility fracture represents a problem of enormous magnitude. It is estimated that only a small fraction of women with this risk take the benefit of preventive measures. The relationship between estrogen and bone mass is well known as they are the other factors related to the risk for fracture. There are precise diagnostic methods, including a tool to diagnose the risk for fracture. Yet there continues to be an under-diagnosis, with the unrecoverable delay in instituting preventive measures. Women under the age of 70 years, being much more numerous than those older, and having risk factors, are a group in which it is essential to avoid that first fragility fracture. Today it is usual not to differentiate between the treatment and the prevention of osteoporosis since the common aim is to prevent fragility fractures. Included in this are women with osteoporosis or with low bone mass and increased risk for fracture, for whom risk factors play a primary role. There is clearly controversy over the type of treatment and its duration, especially given the possible adverse effects of long-term use. This justifies the concept of sequential treatment, even more so in women under the age of 70, since they presumably will need treatment for many years. Bone metabolism is age-dependent. In postmenopausal women under 70 years of age, the increase in bone resorption is clearly predominant, related to a sharp drop in estrogens. Thus a logical treatment is the prevention of fragility fractures by hormone replacement therapy (HRT) and, in asymptomatic women, selective estradiol receptor modulators (SERMs). Afterwards, there is a period of greater resorption, albeit less intense but continuous, when one could utilise anti-resorptive treatments such as bisphosphonates or denosumab or a dual agent like strontium ranelate. Bone formation treatment, such as parathyroid hormone (PTH), in women under 70 years will be uncommon. That is because it should be used in cases where the formation is greatly diminished and there is a high risk for fracture, something found in much older women.