Treatment For Genitourinary Syndrome Of Menopause Research Articles

A Novel Intrauterine Device for the Spatio-Temporal Release of Norethindrone Acetate as a Counter-Estrogenic Intervention in the Genitourinary Syndrome of Menopause.

The genitourinary syndrome of menopause (GSM) is a widely occurring condition affecting millions of women worldwide. The current treatment of GSM involves the use of orally or vaginally administered estrogens, often with the risk of endometrial hyperplasia. The utilization of progestogens offers a means to counteract the effects of estrogen on the endometrial tissue, decreasing unwanted side effects and improving therapeutic outcomes. In this study, a norethindrone acetate (NETA)-loaded, hollow, cylindrical, and sustained release platform has been designed, fabricated, and optimized for implantation in the uterine cavity as a counter-estrogenic intervention in the treatment of GSM. The developed system, which comprises ethyl cellulose (EC) and polycaprolactone (PCL), has been statistically optimized using a two-factor, two-level factorial design, with the mechanical properties, degradation, swelling, and in vitro drug release of NETA from the device evaluated. The morphological characteristics of the platform were further investigated through scanning electron microscopy in addition to cytocompatibility studies using NIH/3T3 cells. Results from the statistical design highlighted the platform with the highest NETA load and the EC-to-PCL ratio that exhibited favorable release and weight loss profiles. The drug release data for the optimal formulation were best fitted with the Peppas-Sahlin model, implicating both diffusion and polymer relaxation in the release mechanism, with cell viability results noting that the prepared platform demonstrated favorable cytocompatibility. The significant findings of this study firmly establish the developed platform as a promising candidate for the sustained release of NETA within the uterine cavity. This functionality serves as a counter-estrogenic intervention in the treatment of GSM, with the platform holding potential for further advanced biomedical applications.

Fractional CO2 laser for genitourinary syndrome of menopause: evaluating the evidence.

The fractionated CO2 laser has been marketed to women for a variety of gynecologic symptoms and conditions, including the genitourinary syndrome of menopause (GSM). The evidence has been limited, precluding conclusions regarding the efficacy and safety of the therapy. However, data from randomized, controlled trials evaluating this technology for GSM are now available. This Practice Pearl addresses the latest data concerning the use of the fractionated CO2 laser for the treatment of GSM.

Modern laser technologies in the treatment genitourinary syndrome of menopause: the role of an innovative neodymium laser

Modern laser technologies in the treatment genitourinary syndrome of menopause: the role of an innovative neodymium laser

CO2 Laser versus Sham Control for the Management of Genitourinary Syndrome of Menopause: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

In the context of the menopausal transition, genitourinary syndrome of menopause (GSM) refers to a range of genitourinary symptoms, from vaginal dryness to dysuria and urinary urgency. While hormonal treatments are standard, their associated side effects have driven the exploration of alternatives like vaginal CO2 laser. We aimed to evaluate the randomized controlled trials (RCTs) comparing vaginal CO2 laser treatment for GSM to sham controls. This systematic review sourced four electronic databases until June 2023. The analysis incorporated seven RCTs with 407 women. The CO2 laser and sham control were comparable for most parameters, including the female sexual function index (FSFI) and visual analogue scale (VAS) for dyspareunia, vaginal health index, pH, and patient satisfaction. However, the CO2 laser group showed significant improvement in the vaginal assessment scale for GSM symptoms. Sensitivity analyses revealed that parameters like FSFI showed significant differences in favor of CO2 laser group upon the exclusion of specific studies. In conclusion, vaginal CO2 laser therapy emerges as a promising alternative for GSM management, especially for most bothersome GSM symptoms; however, the need for further well-designed RCTs remains to validate its broad safety and efficacy.

OCT angiography in the monitoring of vaginal health.

Fractional-pixel CO2 laser therapy shows promise for treating the genitourinary syndrome of menopause (GSM). Nevertheless, it remains controversial in the field of female pelvic medicine. This is due to the inherent difficulties in obtaining noninvasive biopsies to evaluate the treatment's efficacy and safety objectively. To address this challenge, we developed a noninvasive intravaginal optical coherence tomography (OCT)/OCT angiography (OCTA) endoscopic system, whose probe features a shape identical to the laser treatment probe. This system can provide high-resolution OCT images to identify the microstructure of vaginal tissue and visualize the vasculature network in vivo. We conducted clinical research on 25 post-menopausal patients with GSM. OCT/OCTA scans were acquired at four different locations of the vagina (distal anterior, distal posterior, proximal anterior, and proximal posterior) during the whole laser treatment session. A U-Net deep learning model was applied to segment the vaginal epithelium for assessing vaginal epithelial thickness (VET). Blood vessel density and VET were quantified to monitor the efficacy of fractional-pixel CO2 laser therapy. Statistical correlation analyses between these metrics and other clinical scores were conducted, validating the utility of our system. This OCT/OCTA endoscopic system has great potential to serve as a noninvasive biopsy tool in gynecological studies to screen, evaluate, and guide laser treatment for GSM.

Efficacy of a Diode Vaginal Laser in the Treatment of the Genitourinary Syndrome of Menopause.

Genitourinary syndrome of menopause (GSM) and vulvovaginal atrophy (VVA) are the most frequent menopause-related clinical entities and are consistently included in the definition of pelvic floor disorders (PFDs). Nonhormonal therapies, such as lubricants and moisturizers, are indicated as first-line treatments, while the "gold standard'' is represented by topical estrogen products; however, in cancer survivors hormonal treatment is not indicated. For this reason, energy-based therapeutic approaches-for instance, through laser technologies-may be employed as alternative options in this kind of patient; however, there are no studies evaluating the efficacy of a pure diode vaginal laser in the treatment of GSM. As a consequence, with our study, we aimed to evaluate outpatient nonablative diode laser treatment in sexually active women, with contraindications, no response, or refusal of local estrogenic therapy. This prospective study included patients with GSM, aged ≥ 18 years old, with contraindications, or refusal of local estrogen therapies. Women were evaluated via the use of their Vaginal Health Index (VHI) scores, which consists of five measures: elasticity, fluid volume, pH, epithelial integrity, and moisture. Moreover, the intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) was measured using a 10 cm visual analog scale (VAS), where the left extreme of the scale (score = 0) indicated "absence of symptom" and the right indicated "symptom as bad as it could be" (score = 100). Sexual function was evaluated with the Female Sexual Function Index (FSFI-19) questionnaire. The treatment was performed using a Leonardo Dual diode laser (Biolitec Italia Srl, Milano, Italy). The laser treatment consisted of three sessions, one per month. One month after the third session, the VHI, symptom VAS, and FSFI-19 were re-evaluated. In addition, the Patient Global Impression of Improvement (PGI-I) questionnaire was collected. Our study enrolled a total of 26 consecutive patients. All patients were either in menopause or under treatment with gonadotropin-releasing hormone (GnRH). None of the patients reported adverse effects after laser treatment. In total, 19 (73.1%) patients referred improvements of their symptoms according to PGI-I scores. All domains of the FSFI-19 questionnaire, significantly improved after the diode laser treatment. The mean VHI score increased by 3.2 points, from 12.2 to 15.4 (p < 0.001). Additionally, we documented a significant improvement in symptoms affecting the VAS score, from 69.2 to 43.5 points (p < 0.001). A diode vaginal laser is an effective and easily tolerated ambulatory procedure for vaginal functional restoration in the treatment of GSM and VVA.

Efficacy and safety of carbon dioxide laser therapy compared with sham for genitourinary syndrome of menopause management: a meta-analysis of randomized clinical trials.

Data on whether the carbon dioxide (CO 2 ) laser is useful for treatment of genitourinary syndrome of menopause (GSM) are inconsistent. This meta-analysis evaluated the benefits and safety of CO 2 laser compared with sham treatment of GSM. A relevant literature search of Europe PMC, MEDLINE, Scopus, and ClinicalTrials.gov databases using specific keywords was conducted. The results of continuous variables were pooled into the standardized mean difference (SMD), whereas dichotomous variables were pooled into odds ratio with 95% confidence intervals (95% CI) using random-effects models. A funnel plot was used to assess for the presence of publication bias. A total of six randomized clinical trials were included. Pooled analysis revealed that CO 2 laser therapy was associated with a higher reduction in the Vaginal Assessment Scale (SMD, -0.81 [95% CI, -1.59 to -0.04]; P = 0.04; I2 = 88%) and Urinary Distress Inventory short form (SMD, -0.45 [95% CI, -0.84 to -0.06]; P = 0.02; I2 = 0%), and greater patient satisfaction rate (odds ratio, 5.46 [95% CI, 2.23 to 13.37]; P = 0.0002; I2 = 0%) when compared with sham-only treatment. Meanwhile, the Female Sexual Function Index, Vaginal Health Index, and Patient Global Impression Improvement did not differ significantly between groups. Adverse events were only mild with no serious adverse events reported. CO 2 laser therapy may improve the overall treatment of GSM with a relatively good safety profile. However, further randomized clinical trials with larger sample sizes are still needed to confirm the results of this study.

Long term CO2 laser: evaluation of satisfaction in women with iatrogenic menopause for BRCA mutations or gynecological and breast cancer treatments

Background: Genitourinary syndrome of menopause (GSM) is one of the most frequent complaints in menopausal women. This syndrome is very common and prominent. One of the most active treatments for GSM is fractional CO2 Laser that acts on the vaginal mucosa through a special device stimulating a process production of new collagen.

(070) Treatment of Genitourinary Syndrome of Menopause is Beneficial for Lichen Sclerosus Patients

Abstract Introduction Postmenopausal women with Lichen Sclerosus frequently report vulvar symptoms consistent with genitourinary syndrome of menopause (GSM) including pruritus, dyspareunia, or non-provoked pain. Our data revealed not surprising vulvar itching as the most frequently reported symptom of LS, second most frequent was general irritation, followed by vaginal dryness, and vulvar burning. Distinguishing these symptoms from GSM which occurs in 27-84% of postmenopausal women can be problematic. Objective The purpose of this study was to understand the symptoms of postmenopausal women with LS. We specifically surveyed them regarding their symptoms and treatments they had tried including both prescription and over the counter. Methods We interviewed 25 women with biopsy proven LS. This was part of a larger study on the microbiome and genetics of postmenopausal women with LS. Results Our data revealed that while the majority of the women in our study were using standard treatments such as high or medium potency steroid ointments or calcineurin inhibitor, less than 25% reported using hormonal medicines in their vulva (4 of 17), a common treatment for postmenopausal symptoms of vulvar burning, general irritation and dryness; Our data revealed that 50% of the women reported they had used at least more than one prescription or over the counter product to manage symptoms, none of which were hormone related. Conclusions Our data suggests that while these women were treated for their LS, their menopausal symptoms were not addressed. These findings lead us to believe perhaps their menopausal symptoms had been undertreated and that LS symptoms may be difficult to manage exclusively with standard treatments such as steroids and/or calcineurin inhibitors in postmenopausal women. Treatment of GSM with standard recommended treatments is beneficial for LS patients. Disclosure No

(011) Beneficial Effects of Vaginal Prasterone (DHEA) on the Vaginal Histology of Women with GSM Beyond the Epithelium

Abstract Introduction There is mounting evidence that androgens play an important role, together with estrogens, in the maintenance of genitourinary health. Objective Vaginal prasterone was used to characterize the histological changes associated with the dual androgen - estrogen stimulation of the vaginal wall in the treatment of the genitourinary syndrome of menopause (GSM). Since prasterone is converted to androgens which are subsequently aromatised in estrogens, a group of patients on aromatase inhibitors (AI) was included to isolate changes attributable to androgens. Methods Vaginal biopsies and vulvar pictures were collected before and after 12 weeks of treatment with 6.5 mg intravaginal prasterone daily (Intrarosa®). Eight women with GSM were recruited, including two breast cancer survivors on AI. Results Following treatment, the epithelium showed striking histological improvements, regaining thickness, ridges, active proliferation and glycogen synthesis. In the lamina propria, treatment led to increases in elastin content and nerve endings density. Visual evaluation of the vulva showed reduction of the redness and inflammation in the vestibule and the urethral meatus as well as a relaxation of the vaginal entrance. All observations were consistent between the groups with and without AI. Conclusions Data presented here are believed to be the first demonstration of the beneficial effects of androgens deep into the lamina propria of GSM patients both together with or independently from estrogens. Tissue changes observed could help understand some of the GSM symptomatology improvements observed before on dyspareunia and other sexual function parameters. While further studies are warranted to better understand how androgens and estrogens work synergistically in the treatment of GSM, the data presented here strongly suggest that prasterone has deep beneficial impacts on the urogenital tissue. Disclosure Yes, this is sponsored by industry/sponsor: Endoceutics Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Endoceutics

Therapeutic Choices for Genitourinary Syndrome of Menopause (GSM) in Breast Cancer Survivors: A Systematic Review and Update.

(1) Background: Genitourinary syndrome of menopause (GSM) is a medical condition that can affect breast cancer survivors (BCS). This is a complication that often can occur as a result of breast cancer treatment, causing symptoms such as vaginal dryness, itching, burning, dyspareunia, dysuria, pain, discomfort, and impairment of sexual function. BCS who experience these symptoms negatively impact multiple aspects of their quality of life to the point that some of them fail to complete adjuvant hormonal treatment; (2) Methods: In this systematic review of the literature, we have analyzed possible pharmacological and non-pharmacological treatments for GSM in BCS. We reviewed systemic hormone therapy, local hormone treatment with estrogens and androgens, the use of vaginal moisturizers and lubricants, ospemifene, and physical therapies such as radiofrequency, electroporation, and vaginal laser; (3) Results: The data available to date demonstrate that the aforementioned treatments are effective for the therapy of GSM and, in particular, vulvovaginal atrophy in BCS. Where possible, combination therapy often appears more useful than using a single line of treatment; (4) Conclusions: We analyzed the efficacy and safety data of each of these options for the treatment of GSM in BCS, emphasizing how often larger clinical trials with longer follow-ups are needed.

Endometrial safety of low-dose vaginal estrogens.

It is estimated that up to 50% to 90% of postmenopausal women may experience genitourinary syndrome of menopause (GSM), which may have a detrimental impact on quality of life. One of the most effective modes of treatment of GSM is low-dose vaginal estrogens. Numerous studies have addressed the safety of these estrogens using endometrial biopsy and/or endometrial thickness on ultrasound. Based on these studies, the consensus is that low-dose vaginal estrogens do not substantially increase the risk of endometrial hyperplasia or cancer; however, the data are severely limited by short duration of follow-up. Although long-term trials are warranted, they are difficult to carry out, costly, and will not yield data for years. More immediate information regarding endometrial safety may be obtained from studies measuring endometrial tissue and serum concentrations of estradiol, estrone, and relevant equine estrogens after administration of different estrogen formulations and doses. This would allow us to understand better the metabolism of estrogens by the vagina and endometrium, and how much estrogen is reaching the endometrium. Here, we discuss metabolism, receptor binding, and signaling of estrogens in vaginal and endometrial tissue, and summarize the existing studies on the endometrial impact of low-dose vaginal estrogen treatment in postmenopausal women.

Abstract P4-07-34: CO2 laser, radiofrequency, and promestriene in treatment of genitourinary syndrome of menopause in breast cancer survivors. Clinical and histological aspects of a randomized control trial

Abstract Background: 74% of women have urogenital symptoms classified as Genito-urinary Syndrome of menopause (GSM) during breast cancer treatment. Promestriene is effective and safe in the treatment of GSM. However, some women and oncologists are not comfortable with long-term use. Therefore, new options for and alleviating GSM have been considered, such as microablative fractional CO2 laser (CO2L) and microablative fractional radiofrequency (RF). Objective: To compare the effect of promestriene, CO2L, and RF treatments of GSM in women with breast cancer in the use of antiestrogens therapy, concerning clinical and histological findings of vulvar vestibule. Methods: This is a secondary analysis of a Multi-arm randomized controlled trial (NCT04081805). Were eligible for the study 100 women with breast cancer using adjuvant endocrine therapy referring moderate to severe symptoms of GSM (itching, dyspareunia, fissures, thinning of vaginal rugae, and tropism reduction). After providing written informed consent, they were evaluated according to pre and post-treatmentpost-treatment protocol by filling the VAS of GSM and by clinical evaluation including a standardized gynecological exam with vestibular biopsy. Women were then randomized to either CO2L, RF or promestriene groups. The CO2L and RF groups received 3 consecutive monthly outpatient vulvovaginal energy applications. The CT was oriented for domiciliary use of promestriene, 1g/d for 21 days and, subsequently, twi4 month seek for 4 months. The follow-up visit was performed 120 days after interventions and also included an evaluation of global patient impression of improvement (5 points Likert scale). Results: 94 women were randomized as follows: 32 in the CO2L group, 32 in the RF and 30 in the promestriene. 70 patients concluded the treatment and had adequate pre and post-treatment material to analyze, 23 CO2L, 21 RF and 26 promestriene. Pre-treatment demographic and clinical data are presented on table 1. The evolution of GSM according to each treatment is demonstrated on table 2. Was also reported a high satisfaction after the treatment protocol in all groups evaluated by Likert Scale:CO2L 4,783 (0,518), RF 4,150 (0,813), CT 4,280 (1.13), p=0,055. The histological parameters were presented on table 3. Histological atrophy was surprisingly identified in only 4 women (5.7%), pre-treatment. No injuries to the histological structure of the vulvar vestibule or relevant clinical adverse events were identified post-treatments. Conclusion: CO2L, RF, and promestriene provided significant and similar improvement of GSM in women with breast cancer using anti-estrogens. The use of energies did not cause structural tissue damage or relevant clinical complications. Table 1. Clinical and demographic parameters before treatment Mean (standard deviation); BMI body mass index, Tukey test: Similar letters (a, b) mean similar results. Chi-Square Table 2. Evolution of GSM (VAS) after treatment with CO2L, RF, and promestriene Mixed ANOVA. VAS - Visual Analog Scale of GSM Symptoms, values expressed in mean (SD) Table 3. Histological parameters according groups and pre and post-treatment Citation Format: Angela Flavia L. Waitzberg, Andreia Fabiana V. Franco, Ana Maria Bianchi-Ferraro, Roberto Marcela, Gabriela Cantarelli, Chayane Dedonatto, Marisa Patriarca, Rita Dardes, Neila Speck, Zsuzsanna Jarmy-di Bella, Marair Sartotti, Joaquim Almeida. CO2 laser, radiofrequency, and promestriene in treatment of genitourinary syndrome of menopause in breast cancer survivors. Clinical and histological aspects of a randomized control trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-34.

Optical coherence tomography evaluation of vaginal epithelial thickness during CO2 laser treatment: A pilot study.

Genitourinary syndrome of menopause (GSM) negatively affects more than half of postmenopausal women. Energy-based therapy has been explored as a minimally invasive treatment for GSM; however, its mechanism of action and efficacy is controversial. Here, we report on a pilot imaging study conducted on a small group of menopause patients undergoing laser treatment. Intravaginal optical coherence tomography (OCT) endoscope was used to quantitatively monitor the changes in the vaginal epithelial thickness (VET) during fractional-pixel CO2 laser treatment. Eleven patients with natural menopause and one surgically induced menopause patient were recruited in this clinical study. Following the laser treatment, 6 out of 11 natural menopause patient showed increase in both proximal and distal VET, while two natural menopause patient showed increase in VET in only one side of vaginal tract. Furthermore, the patient group that showed increased VET had thinner baseline VET compared to the patients that showed decrease in VET after laser treatment. These results demonstrate the potential utility of intravaginal OCT endoscope in evaluating the vaginal tissue integrity and tailoring vaginal laser treatment on a per-person basis, with the potential to monitor other treatment procedures.

Laser treatment for genitourinary syndrome of menopause: Scientific Impact Paper No. 72 (July 2022): Scientific Impact Paper No. 72 (July 2022).

Genitourinary syndrome of menopause (GSM) is the term used to describe the group of symptoms including vaginal pain, vaginal dryness, itching, pain during sexual intercourse and fragile vaginal tissues as well as urinary symptoms including urinary frequency, urgency, incontinence, blood in the urine (haematuria) and recurrent urinary tract infections that occur due to a lack of the hormone estrogen. These symptoms can have a significant negative impact on psychosexual issues, sexual function and quality of life in postmenopausal women. Traditionally women have been treated with vaginal lubricants, vaginal moisturisers or low-dose vaginal estrogens. Lasers have been used in the cosmetic industry for collagen remodelling and repair of the skin. Therefore, it has been suggested that laser therapy may be used on the vagina as an alternative treatment for GSM. A review of all the published studies assessing the safety and efficacy of laser therapy for GSM have shown promising beneficial results. The majority of studies to date have been small, short-term, observational studies. However, there are randomised controlled trials underway. Laser treatment may be beneficial for the symptoms of GSM but until more robust evidence is available it should not be adopted into widespread practice, and should be used as part of a research study only.

Beneficial Effects of Intrarosa® (Vaginal Prasterone) on the Vaginal Histology of Women With VVA Treated or not With Aromatase Inhibitors: A Breakthrough in the Understanding of the Role of Androgens in Vaginal Health

ABSTRACT Introduction The vaginal mucosa relies on a constant turnover of its epithelium to remain healthy. Epithelial parabasal cells divide and fill up with glycogen as they get pushed towards the vaginal lumen. They end up desquamating and releasing glycogen for the resident lactobacilli to feed on and acidify the medium. The stimulation required for this quintessential mechanism to go on has historically been attributed to estrogens, however, growing clinical evidence supports that androgens may play a role. Aromatase inhibitors (AI) are used in breast cancer survivors to completely inhibit the synthesis of estrogens. Administering a steroid precursor such as prasterone (DHEA) to patients suffering from vulvovaginal atrophy (VVA) and taking AI will therefore only result in local synthesis of androgens, but no estrogens. Objective We set out to compare the histological changes an atrophic vaginal mucosa goes through with prasterone treatment, with and without exclusion of the estrogenic benefits by AI. Methods A Wittner punch was used to collect biopsies both before and after 12 weeks of treatment with 6.5 mg intravaginal prasterone daily (Intrarosa®). Upon collection, samples were formalin fixed and paraffin embedded for further processing. Morphological assessment of the biopsies was conducted using Masson's trichrome staining. Six menopausal women suffering from VVA and meeting the inclusion criteria were recruited, as well as two breast cancer survivors on AI. Results The degree of epithelial atrophy visible at baseline histology for VVA patients was variable, but all six patients had the histological characteristics of a thick, healthy epithelium by the end of the study. At baseline, both patients on aromatase inhibitors had a very thin, flattened epithelium. Following treatment with prasterone and despite the aromatase inhibitors, the epithelium showed striking histological improvements, regaining thickness, ridges and glycogen synthesis. Conclusions Although there is some level of clinical evidence in the literature suggesting that androgens can help treat symptoms of the genitourinary syndrome of menopause (GSM), data presented here are believed to be the first demonstration of profound beneficial effects of androgens on VVA, independently from estrogens. While further studies are warranted to better understand the respective contributions of androgens and estrogens to the benefits observed with prasterone in the treatment of GSM, the data presented here strongly suggests that androgens play a significant role in the physiopathology of VVA. Disclosure Yes, this is sponsored by industry/sponsor: Endoceutics

PD44-12 VAGINAL ESTROGEN THERAPY FOR GENITOURINARY SYNDROME OF MENOPAUSE (GSM) IN WOMEN WITH A PERSONAL HISTORY OF BREAST CANCER - A CLAIMS DATABASE ANALYSIS

You have accessJournal of UrologyCME1 May 2022PD44-12 VAGINAL ESTROGEN THERAPY FOR GENITOURINARY SYNDROME OF MENOPAUSE (GSM) IN WOMEN WITH A PERSONAL HISTORY OF BREAST CANCER - A CLAIMS DATABASE ANALYSIS Kathryn Dumas, Sajya Singh, Jaden R. Kohn, Taylor P. Kohn, and Marisa Clifton Kathryn DumasKathryn Dumas More articles by this author , Sajya SinghSajya Singh More articles by this author , Jaden R. KohnJaden R. Kohn More articles by this author , Taylor P. KohnTaylor P. Kohn More articles by this author , and Marisa CliftonMarisa Clifton More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002605.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Systemic therapies for breast cancer - selective estrogen receptor modulators (SERM), aromatase inhibitors (AI), and chemotherapies - can result in genitourinary syndrome of menopause (previously recognized as vulvovaginal atrophy) for up to 70% of postmenopausal breast cancer survivors. While systemic estrogen therapy is often avoided in these women, vaginal estrogen can be safely used to treat GSM symptoms. Our objective is to assess the use of vaginal estrogen for women with a diagnosis of GSM and a personal history of breast cancer using a large US claims database. METHODS: The TriNetX Diamond network database was queried: a US health research network of 190 million patients, encompassing healthcare encounters and prescriptions between 2009-2021. Females with a diagnosis of postmenopausal atrophic vaginitis or atrophy of the vulva (ICD-10 N95.2, N90.5) were included. Of these, women with breast cancer (C50 or Z86.000) were included if the diagnosis was at least 1 month prior to VVA diagnosis. Estrogen receptor status was collected when available (ICD-10 Z17.0, Z17.1). Prescriptions for treatment of GSM were included if prescribed the day of VVA diagnosis up to 1 year after index diagnosis. Incidence of vaginal estrogen use in patients with a history of breast cancer was determined for 2013-2015, 2016-2018, and 2019 to present. RESULTS: A total of 2,159,766 women with GSM were identified; of whom, 4.8% (n=104,327) had a personal history of breast cancer. Vaginal estrogen prescriptions were less frequent in women with history of breast cancer compared to women without (11% vs 22%, p<0.01, Table 1). Incidence rate of vaginal estrogen prescriptions for women with GSM and history of breast cancer remained stable around 10-11% from 2013 to present. 25,410 women with GSM and history of breast cancer had positive estrogen receptor status (ER+) and 4,893 had negative estrogen receptor status (ER-). There was no difference in vaginal estrogen prescribing between ER+ and ER- patients (7.4% vs 8.4%). CONCLUSIONS: While vaginal estrogen can be safely used in women with GSM and personal history of breast cancer, it is prescribed for few eligible patients. Barriers to use of vaginal estrogen in this population should be explored to optimize patient’s quality of life. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e712 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kathryn Dumas More articles by this author Sajya Singh More articles by this author Jaden R. Kohn More articles by this author Taylor P. Kohn More articles by this author Marisa Clifton More articles by this author Expand All Advertisement PDF DownloadLoading ...

Management of genitourinary syndrome of menopause in breast cancer survivors: An update.

There is increasing attention about managing the adverse effects of adjuvant therapy (Chemotherapy and anti-estrogen treatment) for breast cancer survivors (BCSs). Vulvovaginal atrophy (VVA), caused by decreased levels of circulating estrogen to urogenital receptors, is commonly experienced by this patients. Women receiving antiestrogen therapy, specifically aromatase inhibitors, often suffer from vaginal dryness, itching, irritation, dyspareunia, and dysuria, collectively known as genitourinary syndrome of menopause (GSM), that it can in turn lead to pain, discomfort, impairment of sexual function and negatively impact on multiple domains of quality of life (QoL). The worsening of QoL in these patients due to GSM symptoms can lead to discontinuation of hormone adjuvant therapies and therefore must be addressed properly. The diagnosis of VVA is confirmed through patient-reported symptoms and gynecological examination of external structures, introitus, and vaginal mucosa. Systemic estrogen treatment is contraindicated in BCSs. In these patients, GSM may be prevented, reduced and managed in most cases but this requires early recognition and appropriate treatment, but it is normally undertreated by oncologists because of fear of cancer recurrence, specifically when considering treatment with vaginal estrogen therapy (VET) because of unknown levels of systemic absorption of estradiol. Lifestyle modifications and nonhormonal treatments (vaginal moisturizers, lubricants, and gels) are the first-line treatment for GSM both in healthy women as BCSs, but when these are not effective for symptom relief, other options can be considered, such as VET, ospemifene, local androgens, intravaginal dehydroepiandrosterone (prasterone), or laser therapy (erbium or CO2 Laser). The present data suggest that these therapies are effective for VVA in BCSs; however, safety remains controversial and a there is a major concern with all of these treatments. We review current evidence for various nonpharmacologic and pharmacologic therapeutic modalities for GSM in BCSs and highlight the substantial gaps in the evidence for safe and effective therapies and the need for future research. We include recommendations for an approach to the management of GSM in women at high risk for breast cancer, women with estrogen-receptor positive breast cancers, women with triple-negative breast cancers, and women with metastatic disease.

The Er:YAG vaginal laser for management of women with genitourinary syndrome of menopause (GSM).

The purpose of our study was to investigate the effects of vulvovaginal erbium laser on the genitourinary syndrome of menopause (GSM) and sexual function of postmenopausal women.We conducted a retrospective studyof sixty-fourpostmenopausal women with GSM, and these patients were scheduled for three times of vulvovaginal erbium laser treatment. A baseline and post-treatment vaginal status was assessed by measuring vaginal pH, patients' subjective vulvovaginal atrophy (VVA) symptoms, which included dryness, dyspareunia, itching, and burning. The urinary response to treatment was assessed using ICIQ-SF, UDI-6, IIQ-7, OABSS, and POPDI-6. Sexual function was evaluated using the Female Sexual Function Index (FSFI) before and after vulvovaginal laser therapy. Patient follow-ups were scheduled for 12months after treatment. A total of sixty-four patients were enrolled in the study. We observed the significant improvement in the percentage of negative symptoms (dryness/dyspareunia/itching/burning) and in lower urinary tracts symptoms evaluated with ICIQ-SF, UDI-6, IIQ-7, OABSS, and POPDI-6 (P < 0.05). Patients' overall satisfaction regarding their sexual life, assessed via Female Sexual Function Index (FSFI), showed significant improvement in its six domains of sexual function (P < 0.05). The pH level of vaginal secretions significantly decreased. No long-term complications were found post-treatment. The Er:YAG vaginal laser procedure is associated with a significant improvement in GSM and sexual function of postmenopausal women. Our result demonstrates that it can be a safe and efficacious treatment for patients with GSM without any serious adverse effects up to 1-year post-treatment. The long-term effects of using vulvovaginal laser in the treatment of GSM should be investigated.

The role of non-hormonal methods in treatment of urogenital menopausal syndrome: modern views

The article is devoted to a review of the literature on the problem of overcoming the negative outcomes of the genitourinary syndrome of menopause (GSM). It is known that a woman is in menopause almost 30–40% of her life, and according to WHO, by 2030, 1.2 billion women will be in postmenopause. At the same time, there is an increase in life expectancy in developed countries, which also leads to an increase in the number of women with GSM. The article presents the pathogenetic mechanisms of the development of GSM, in particular, it is indicated that the occurrence and degree of manifestations of this pathology are proportional to the decrease in estrogens level and their metabolism in the organism. The prevalence of GSM symptoms among menopausal women has been shown in the article. The negative impact of the GSM outcomes on the quality of life of patients is described. Women who are sexually active during menopause are more likely to have the manifestations of this pathology and consult with the doctor, but sexually inactive women can also benefit from awareness of the manifestations and the treatment of GSM. Unlike vasomotor symptoms, which may become less pronounced over time, the manifestations of GSM progress if not to treat them, tend to more severe course, and almost never disappear spontaneously.Modern approaches to the treatment of this pathology are also given. In particular, the possibility of prescribing plant therapy as an alternative to menopausal hormone therapy is considered. Herbal medicines can be used for a long time and without health risks. A range of vaginal oils, vaginal moisturizers with hyaluronic acid, isoflavones (a medicine with fennel, chamomile and saffron) are commonly used to treat women with GSM.The article discusses the issues of recommendations for the prescription of herbal therapy, its advantages and features of use. The possibility of treating the symptoms of GSM for sexually active and inactive women with vaginal suppositories, which include hyaluronic acid (in the form of sodium salt), tocopherol acetate, Asian centella extract, chamomile flower extract, calendula officinalis flower extract, which have a moisturizing, regenerative effect, antiseptic, anti-inflammatory action for the rapid restoration of the vaginal mucosa. The effectiveness and safety of such therapy was established.