Exosomas como tratamiento alternativo del síndrome genitourinario de la menopausia / Exosomes as an alternative treatment for genitourinary syndrome of menopause

Objetivo: Evaluar el efecto de los exosomas como tratamiento alternativo en la restauración del síndrome genitourinario de la menopausia en pacientes que acuden a una consulta ginecológica, en Valencia, Estado Carabobo, en el período junio - agosto de 2023. Métodos: Estudio prospectivo, descriptivo, exploratorio, incluyó tres casos de mujeres con diagnóstico de síndrome genitourinario de la menopausia. Se evaluó la respuesta en cuanto a los síntomas, examen clínico según el índice de salud vaginal, la satisfacción con el tratamiento y la tolerabilidad. Se aplicó el tratamiento con exosomas: 2 cc con técnica de punto a punto en todas las paredes vaginales y 1 cc en el vestíbulo, en 3 sesiones, con intervalo de 15 días. Resultados: La edad de las pacientes estuvo entre 53 y 56 años, con un promedio de tiempo de menopausia de 6,6 años. Previo al tratamiento, había un nivel alto de irritación vaginal (100 %), dolor en el introito (100 %), sequedad vaginal, dispareunia, hipersensibilidad y las no relaciones sexuales (66,67 %). Postratamiento predominó la ausencia de los síntomas: sequedad vaginal, dispareunia, hipersensibilidad y dolor en introito (100 %); irritación vaginal y no relaciones sexuales (66,67 %) (p = 0,0001). La mediana del índice de salud vaginal previa fue 13 (10 ­ 13) y posterior fue 18 (17 ­ 20) (p = 0,0476). La satisfacción y tolerabilidad fue de 66,67 %. Una paciente refirió dolor leve. Conclusión: La terapia con exosomas es eficaz para reducir los síntomas y signos del síndrome genitourinario de la menopausia, y bien tolerado(AU)

Objective: To evaluate the effect of exosomes as an alternative treatment in the restoration of genitourinary syndrome of menopause in patients attending a gynecological consultation in Valencia, Carabobo State, in the period June - August 2023. Methods: A prospective, descriptive, exploratory study included three cases of women diagnosed with genitourinary syndrome of menopause. Response was assessed in terms of symptoms, clinical examination according to vaginal health index, satisfaction with treatment and tolerability. Treatment with exosomes was applied: 2 cc with point-to-point technique on all vaginal walls and 1 cc in the vestibule, in 3 sessions, with an interval of 15 days. Results: The age of the patients was between 53 and 56 years, with a mean menopause time of 6.6 years. Prior to treatment, there was a high level of vaginal irritation (100%), pain in the introitus (100%), vaginal dryness, dyspareunia, hypersensitivity and non-sexual intercourse (66.67%). Post-treatment, the absence of symptoms predominated: vaginal dryness, dyspareunia, hypersensitivity and pain in the introitus (100%); vaginal irritation and no sexual intercourse (66.67%) (p = 0.0001). The median index of previous vaginal health was 13 (10 ­ 13) and subsequent was 18 (17 ­ 20) (p = 0.0476). Satisfaction and tolerability was 66.67%. One patient reported mild pain. Conclusion: Exosome therapy is effective in reducing the symptoms and signs of genitourinary syndrome of menopause, and well tolerated(AU)

Ospemifene for Genitourinary Syndrome of Menopause: Patient Selection.

Vulvar vaginal atrophy is a common condition affecting postmenopausal women, significantly impacting their quality of life. Fortunately, various treatment options are available, ranging from hormonal to non-hormonal therapies. Ospemifene has emerged as a promising non-hormonal alternative for managing vulvar vaginal atrophy. Its targeted approach, unique mechanism of action, favorable safety profile particularly for breast tissue, and efficacy make it a valuable option for women seeking relief from symptoms such as vaginal pain, dryness and dyspareunia and cannot receive estrogen supplementations. This is particularly the case for breast cancer survivors or women with a significant family history of estrogen-dependent cancers. Hence, tailored treatment plans, considering individual preferences and health circumstances, are essential in optimizing outcomes and improving the overall well-being of affected individuals.

Genitourinary syndrome in menopause: Impact of vaginal symptoms.

Objective: To describe the impact of genitourinary syndrome symptoms on daily activities and well-being in peri- and postmenopausal women living in an urban area. Materials and Methods: Observational, prospective, and cross-sectional research in a population of peri- and postmenopausal women living in the Lima region. A non-probabilistic sample was used. The instrument used is "The Day-to-Day Impact of Vaginal Aging" questionnaire. It consists of four domains and its internal reliability is between 0.82 and 0.93. The questions were answered using a Likert scale. High values indicate a more severe impact. Statistical procedures were performed using SPSS version 26. Results: One thousand seventy women participated; the mean age was 54±7.5 years. The results about the activities of daily living showed that 35% of women reported regular vaginal symptoms and 14.7% major symptoms. In the emotional well-being domain, 90% had minor symptoms. In the sexual function domain, 57.6% reported minor vaginal symptoms, and in the self-concept and body image domain, 60.9% reported minor symptoms and 20.7% major symptoms. According to the global score, 60.9% reported minor discomfort, 36.3% regular discomfort, and 2.8% major discomfort. The sexually active women declared an impact of severity in terms of their daily activities and sexual function (p<0.05). Conclusion: There is a relationship between activities of daily living, sexual function, and women with sexual activity, causing a negative impact on social life and quality of life.

Effects of oxytocin versus promestriene on genitourinary syndrome: a pilot, prospective, randomized, double-blind study.

OBJECTIVES: In this pilot, prospective, randomized, double-blind study, the authors compared the efficacy of oxytocin with promestriene in improving vaginal atrophy of Genitourinary Syndrome of Menopause (GSM). METHODS: A total of 51 postmenopausal women with symptoms of GSM were evaluated. They were randomized into two groups: oxytocin (25 patients) and promestriene (26 patients) and were evaluated before and after 90 days of treatment; the evaluation was based on the domains of the Female Sexual Function Index (FSFI) (lubrication, satisfaction, and pain during sexual intercourse), clinical visual examination, and vaginal wall thickness. RESULTS: After the use of the medications, both groups showed significant improvement in the three evaluated FSFI domains (p < 0.05) and there was no significant difference between the groups (p > 0.05). On clinical examination, the medications improved all the evaluated parameters but without statistical significance (p > 0.05). The evaluation of the thickness of the vaginal epithelium showed that both treatments led to increase in the vaginal epithelium (p < 0.05); however, the efficacy of promestriene was higher than that of oxytocin (p < 0.05). CONCLUSIONS: Both medications were effective, however, studies with larger samples and longer follow-ups are needed to confirm the clinical applicability.

Microablative radiofrequency versus pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The efficacy of radiofrequency (RF) in stress urinary incontinence (SUI) is as yet unknown. The aim was to compare the effect of fractional microablative RF and pelvic floor muscle training (PFMT) against the combination of both therapies (RF + PFMT) in the SUI and on genitourinary syndrome (GSM). METHODS: This was a three-arm randomized clinical trial including 117 climacteric women with SUI. In group 1 the treatment consisted of three monthly sessions of RF; in group 2 it was 12 weekly PFMT sessions; in group 3 it was RF + PFMT simultaneously. Assessments at baseline and 30 days after the end of therapy were conducted using validated questionnaires and scales for urinary, vaginal, and sexual functions and cytology for vaginal trophy. RESULTS: Urinary scores improved significantly in all three groups post-treatment (p < 0.001) with a higher improvement in the RF + PFMT group (p = 0.002). One-hour pad test results were equal in the three groups. Vaginal symptoms showed an incremental improvement in RF (p < 0.007), and vaginal laxity showed a similar improvement in the three groups (p = 0.323). Vaginal Health Index score was more significant in RF and RF + PFMT groups. Sexual function improved in RF and PFMT. CONCLUSIONS: The association between RF and PFMT showed significant improvement in the SUI symptoms assessed by questionnaire. The vaginal symptoms and dryness showed greater improvement in the RF treatment and vaginal laxity showed similar improvement in the three groups. The combination of RF and PFMT in sexual function did not show benefits superior to those achieved by the therapies alone.

Vaginal collagen I and III changes after carbon dioxide laser application in postmenopausal women with the genitourinary syndrome: a pilot study.

OBJECTIVE: The aim of the study was to evaluate the clinical response and collagen remodeling in the vaginal wall after three sessions of carbon dioxide (CO2) laser application. METHODS: Fourteen postmenopausal women with vulvovaginal atrophy, aged 45-65 years and sexually active, were evaluated with clinical questionnaires, gynecological examinations and histological techniques before and after 20 weeks of treatment (ClinicalTrials.gov NCT03939078). Treatment consisted of 3-monthly sessions of the CO2 laser. Clinical questionnaires included the Vaginal Health Index, the Female Sexual Function Index and the International Consultation on Incontinence Questionnaires Short Form. Biopsies were taken from the lateral vaginal wall at week 0 (left wall) and week 20 (right wall). Tissue samples were stained with hematoxylin and eosin, Periodic Acid-Schiff, Picrosirius Red Stain and Orcein dyes. Immunohistochemical study was used to quantify collagens I and III in the samples. RESULTS: The mean age was 54.4 ± 4.5 years, and the average time of amenorrhea was 7.6 ± 5.1 years. The Female Sexual Function Index and the Vaginal Health Index Score values increased while the International Consultation on Incontinence Questionnaire Short Form score decreased after the programmed treatment. There was no significant change in vaginal pH. Histological studies showed increases in the total and superficial epithelial cell layers, and type III collagen fibers (from 10.86 ± 7.66 to 16.87 ± 3.96, p < 0.05), and immunohistochemical studies confirmed the significant increase in collagen III. CONCLUSION: Histological findings revealed epithelial atrophy reversal and collagen remodeling of the vaginal wall. Immunohistochemical analysis showed an increase in collagen type III fibers.

Effects of oxytocin versus promestriene on genitourinary syndrome: a pilot, prospective, randomized, double-blind study

Abstract Objectives: In this pilot, prospective, randomized, double-blind study, the authors compared the efficacy of oxytocin with promestriene in improving vaginal atrophy of Genitourinary Syndrome of Menopause (GSM). Methods: A total of 51 postmenopausal women with symptoms of GSM were evaluated. They were randomized into two groups: oxytocin (25 patients) and promestriene (26 patients) and were evaluated before and after 90 days of treatment; the evaluation was based on the domains of the Female Sexual Function Index (FSFI) (lubrication, satisfaction, and pain during sexual intercourse), clinical visual examination, and vaginal wall thickness. Results: After the use of the medications, both groups showed significant improvement in the three evaluated FSFI domains (p < 0.05) and there was no significant difference between the groups (p > 0.05). On clinical examination, the medications improved all the evaluated parameters but without statistical significance (p > 0.05). The evaluation of the thickness of the vaginal epithelium showed that both treatments led to increase in the vaginal epithelium (p < 0.05); however, the efficacy of promestriene was higher than that of oxytocin (p < 0.05). Conclusions: Both medications were effective, however, studies with larger samples and longer follow-ups are needed to confirm the clinical applicability.

Hormonal Approach for Postmenopausal Vulvovaginal Atrophy.

Menopause is a physiological and progressive phenomenon secondary to decreased ovarian follicular reserve that significantly affects the genital tract. Although postmenopausal vulvovaginal atrophy primarily affects postmenopausal women, it is also seen in premenopausal women. The hypoestrogenic condition results in hormonal and anatomical changes, with the main symptoms, are dryness, burning and genital irritation, decreased lubrication, urinary urgency, dysuria, and recurrent urinary tract infections. This review aims to update hormone therapy for urogenital atrophy, both local and systemic, and discusses the importance of understanding and the need for active treatment of this condition. The main therapeutic objective is the relief of symptoms, and hormonal therapy (HT) is still the most effective choice for treating clinical manifestations, despite the side effects of its use. HT should be used in an individualized way to the needs of the women and appropriate to the stage in which she is menopausal, perimenopausal, or after menopause.

Use of Moisturizers and Lubricants for Vulvovaginal Atrophy.

The estrogen decrease in postmenopausal women results in functional and anatomical changes in the genitourinary tract. The most prevalent and bothersome symptoms are vaginal dryness, dyspareunia, and reduced lubrication, which can significantly affect the quality of life of these women, principally those who are sexually active. Hormonal therapy with local estrogens is generally considered the "gold standard." However, there are cases in which there are clinical concerns about its use or women opt for non-hormonal options. Thus, safe and effective non-hormonal options are needed to improve symptoms in these women. Moisturizers and lubricants are first-line therapy for breast cancer survivors.

Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic.

Genitourinary syndrome of menopause (GSM) is a term used to define a compilation of signs and symptoms arising from decreased estrogenic stimulation of the vulvovaginal and lower urinary tract. Among 27-84% of women in postmenopausal are affected for symptoms of GSM, and these can unquestionably impair health, sexual function, consequently the quality of life of these women. The main signs and symptoms of GSM include, among others, burning, irritation, vulvovaginal dryness, dyspareunia, urinary symptoms of urgency, dysuria, or recurrent urinary tract infection. The diagnosis can be made through anamnesis, questionnaires, physical exams, and, sometimes, complementary exams. Objective vaginal assessment is essential and can be complemented by using the Vaginal Health Index (VHI), Vaginal Maturation Index (VMI), or vaginal pH measurement. The acknowledgment of this condition by health professionals is crucial for its identification and proper management and exclusion of other conditions that make a differential diagnosis with it.

Postmenopausal Vaginal Microbiome and Microbiota.

The ovulatory cycle has a significant influence on the microbial composition, according to the action of estrogen and progesterone on the stratified squamous epithelium, due to an increase in epithelial thickness, glycogen deposition, and influence on local immunology. The 16S rRNA gene amplification and pyrosequencing study demonstrated that healthy women have community state types (CST), classified as; type "L," with a predominance of Lactobacillus crispatus, type II, with a predominance of Lactobacillus gasseri, type III, where Lactobacillus iners predominates, and type V with a predominance of Lactobacillus jensenii. Type IV does not identify lactobacilli but a heterogeneous population of bacteria. There seems to be a relationship between increased vaginal bacterial diversity and poverty of lactobacilli with the complaining of vaginal dryness. With menopause, there appears to be a reduction in lactobacilli associated with higher serum levels of follicle-stimulating hormone (FSH) and lower estrogen levels. The evaluation of Gram-stained vaginal smears in postmenopause women must take into account the clinical-laboratory correlation. We should observe two meanly possibilities, atrophy with few bacterial morphotypes, without inflammatory, infiltrate (atrophy without inflammation), and atrophy with evident inflammatory infiltrate (atrophy with inflammation or atrophic vaginitis). The relationship between the microbiome and postmenopausal vulvovaginal symptoms seems to be related to the bacterial vaginal population. However, more robust studies are needed to confirm this impression.

Efficacy of Fractional CO2 Laser, Promestriene, and Vaginal Lubricant in the Treatment of Urinary Symptoms in Postmenopausal Women: A Randomized Clinical Trial.

BACKGROUND AND OBJECTIVES: Evaluating the efficacy of the fractional CO2 laser, promestriene, and vaginal lubricant to treat urinary symptoms in women with genitourinary syndrome of menopause. STUDY DESIGN/MATERIALS AND METHODS: We conducted a randomized clinical trial with 72 postmenopausal women aged 50 years or older. The participants were randomized to one intervention each in three treatment groups fractional CO2 laser, promestriene, and vaginal lubricant. Urinary symptoms were assessed prior to treatment and 2 weeks after treatment completion using validated questionnaires, the International Consultation on Incontinence Questionnaire (ICIQ-UI SF), and the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB). RESULTS: There was a significant reduction in the total ICIQ-UI SF score in the intragroup comparison (baseline vs. week 14) of the CO2 laser group (P = 0.004). This group also showed a statistically significant reduction in nocturia (1.33 ± 0.87 vs. 1.00 ± 0.76, respectively; P = 0.031). In the intergroup comparison after treatment, nocturia in the lubricant group had worsened compared with that of the other two groups (P = 0.002). Regarding the total ICIQ-OAB score, the results of the CO2 laser group were superior to those of the lubricant group in the intergroup comparison (7.76 ± 3.36, P = 0.020; analysis of variance P = 0.038). CONCLUSION: The results were significantly different between the intravaginal fractional CO2 laser and topical estrogen groups for treating urinary symptoms related to the genitourinary syndrome of menopause. Further controlled and randomized studies are needed. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.

Efficacy and safety of a non-hormonal intravaginal moisturizer for the treatment of vaginal dryness in postmenopausal women with sexual dysfunction.

OBJECTIVE: Evaluate the efficacy and safety of a non-hormonal intravaginal moisturizer on reducing the symptoms arising from vaginal dryness and sexual dysfunction. STUDY DESIGN: A total of 37 postmenopausal women used a non-hormonal intravaginal Moisturizer (polycarbophil, butyl ester of a copolymer of methyl vinyl ether/ copolymer PVM/MA, 50% sodium lactate solution, and Carbopol) twice a week for 12 weeks. The vaginal moisture levels, volume of fluid, elasticity, and epithelium integrity were assessed using the Vaginal Health Index. Sexual function was measured using the Female Sexual Function Index questionnaire. All women were evaluated before starting treatment and at the 4th, 8th and 12th weeks of the study. At the end of the study, the patients analysed the treatment regarding to their satisfaction with the product, and its application system, their sense of well-being after using it as well as their perception bout the discharge of the moisturizer (if it run or was held by the vaginal mucosa). RESULTS: There was a significant improvement in the vaginal moisture, fluid volume, elasticity and epithelial integrity (p < 0.001). Sexual function improved in the total score and in all six domains (p < 0.001). More than 50% of all patients reported being very satisfied with the treatment and product application. The sense of well-being was considered very good by 51.4% of the participants and most (91.9%) indicated that the product did not leak and did not stick to the vaginal mucosa. No severe adverse events were reported. CONCLUSION: Our study suggests that treatment with the non-hormonal intravaginal moisturizer is a safe and efficient therapeutic option for the improvement of vaginal dryness with encouraging benefits for the sexual function of postmenopausal women.

The efficacy and safety of estriol to treat vulvovaginal atrophy in postmenopausal women: a systematic literature review.

OBJECTIVES: To evaluate the efficacy and safety of estriol for the treatment of vulvovaginal atrophy in postmenopausal women. METHODS: A systematic literature review was performed. We searched the following electronic databases: Medline, Cochrane, Embase, Lilacs, CINHAL and Google Scholar. The studies selected included controlled clinical trials and quasi-experimental studies. Selections were made in pairs and independently, first by title and abstract and then complete texts. RESULTS: We identified 188 studies, 22 of which met the inclusion criteria; 13 were controlled clinical trials and nine were quasi-experimental, and 1217 women were included. These studies confirmed the efficacy of local estrogens to treat symptoms of vulvovaginal atrophy with few adverse effects reported. Following treatment, serum estriol levels rose, peaking at 1 h. At the 6-month follow-up, there was no increase in serum estriol in treated women. CONCLUSIONS: The available evidence (of low and moderate quality) shows that, when administered vaginally, estriol preparations appear to be safe for women who have risk factors related to systemic estrogen therapy.

Tratamento da atrofia vaginal da mulher na pós­menopausa / Treatment of vaginal atrophy of women in postmenopausal

Sintomas relacionados com a atrofia vulvovaginal apresentam um impacto negativo sobre a qualidade de vida de até 50% das mulheres na pós­menopausa. No entanto, algumas recusam o uso de estrogênios, que é a terapia eficaz padrão, devido à publicidade negativa nos últimos anos e à disponibilidade de outras terapias opcionais. Esta revisão avaliou a eficácia de tratamentos hormonais, fitoterápicos de uso oral ou tópico para aliviar os sintomas da atrofia vaginal em mulheres na pós­menopausa. Foram avaliados estudos do Medline, Scopus e Cochrane Central Register de Ensaios Controlados com as palavras­chaves vagina, postmenopause, isoflavones, estrogen, syndrome genitourinária, vulvovaginal atrophy, clinical applications. Estudos de revisão e ensaios clínicos randomizados foram incluídos neste estudo. Os dados mostraram que os estrogênios de uso sistêmico ou local são os mais indicados, as isoflavonas só mostraram efeitos positivos quando de uso local. Alguns tratamentos não hormonais, como hidratantes, lubrificantes e o uso de laser vaginal, também são indicados. Outra possibilidade de tratamento é o ospemifeno, um modulador de receptor hormonal seletivo (SERM) na dispareunia e na atrofia vulvovaginal. Assim, o uso de opções é benéfico para mulheres com risco de neoplasia relacionada aos estrogênios.(AU)

Symptoms related to atrophy vulvovaginal have a negative impact on quality of life up to 50% of women after menopause. However, some refuse the use of estrogens that is the standard effective therapy due to negative publicity in recent years and other available alternatives therapies. This review assessed the effectiveness of hormonal treatments, herbal oral or topical use to relieve the symptoms of vaginal atrophy in women after menopause. We evaluated studies of Medline, Scopus, Cochrane Central Register of Controlled Trials using vagina, postmenopause, isoflavones, estrogen, syndrome genitourinária, vulvovaginal atrophy, clinical applications, as keywords. Review studies and randomized controlled trials were included in this study. The data showed that the systemic or local use of estrogens are the most appropriate, and the isoflavones only showed positive effects when used locally. Some non­hormonal treatments such as moisturizing, lubricating and the use of vaginal laser are also suitable. Another possible treatment is ospemifene, a selective estrogen receptor modulator (SERM) on dyspareunia and vulvovaginal atrophy. Thus, the use of alternatives is beneficial for women with cancer risk related to estrogens.(AU)

Láser erbium vaginal como tratamiento del síndrome genitourinario de la menopausia: resultados preliminares / Erbium vaginal laser as a treatment for genitourinary syndrome of menopause: preliminary results

ANTECEDENTES: El síndrome genitourinario de la menopausia (SGM) afecta hasta el 50% de las mujeres posmenopáusicas. Sus síntomas presentan un curso crónico y progresivo, pudiendo alterar significativamente la sexualidad y la calidad de vida. OBJETIVO: Evaluar efectividad a corto plazo y aceptabilidad del láser vaginal de Erbium en cristal de itrio-aluminio-granate (Er:YAG) como una terapia fototérmica no invasiva, no ablativa para el manejo del SGM. MÉTODO: Estudio longitudinal prospectivo, realizado en 28 mujeres posmenopáusicas con SGM. Se aplica láser vaginal Er:YAG en 3 sesiones cada 30 días. En todos los controles, se evalúa sequedad vaginal, dispareunia mediante escala visual analógica, y se registra el "vaginal health index score" (VHIS). Al final del tratamiento se evalúa la aceptabilidad del método. RESULTADOS: Se observa mejoría significativa de los síntomas (sequedad vaginal y dispareunia; p<0,01) durante todo el periodo de estudio y del VHIS (8,2 ± 1,3 previo al tratamiento vs. 19,2 ± 0,4 posterior al tratamiento; p<0,01). El 93,4% de las pacientes calificó el procedimiento como excelente o bueno. CONCLUSIÓN: Nuestro estudio piloto muestra que el tratamiento con láser Er:YAG en mujeres posmenopáusicas con síntomas de SGM es eficaz, factible y seguro en el corto plazo. Se requieren datos a más largo plazo y de mayor tamaño muestral para confirmar nuestros resultados.

BACKGROUND: The genitourinary syndrome of menopause (GSM) affects up to 50% of postmenopausal women. Symptoms are chronic and likely worsen over time. This complains may interfere with sexual function and quality of life. OBJECTIVE: To evaluate the short-term effectiveness and acceptability of Erbium in yttrium aluminum-garnet crystal Laser (Er:YAG) as a non-invasive, non-ablative photothermal therapy for the treatment of GSM. METHODS: Prospective longitudinal study performed in 28 postmenopausal women suffering from GSM. All participants were treated intravaginally with Er:YAG laser in 3 applications performed every 30 days. Symptoms (vaginal dryness and dyspareunia) were evaluated by a visual-analogic scale (VAS) and the vaginal health index score (VHIS). After therapy, the women were asked to evaluate the acceptability of the intervention. RESULTS: Er:YAG laser treatment was effective to improve symptoms (vaginal dryness and dyspareunia; p<0.01) at all the study period, as well the VHIS (8.2 ± 1.3 at baseline vs. 19.2 ± 0.4 after treatment; p<0.01). Satisfaction with the procedure was reported as excellent or good by 93.4% of women. CONCLUSION: Our pilot study shows that the Er:YAG treatment in postmenopausal women with GSM is effective, feasible, and safe. Further larger, long-term and controlled studies are required to confirm this data.

Effects of Glycine max (L.) Merr. soy isoflavone vaginal gel on epithelium morphology and estrogen receptor expression in postmenopausal women: a 12-week, randomized, double-blind, placebo-controlled trial.

OBJECTIVE: Evaluate the effects of vaginal administration of isoflavones derived from Glycine max (L.) Merr. as a treatment option for vaginal atrophy, on the morphology and expression of estrogen receptors in vaginal epithelium of postmenopausal women. METHODS: The double-blind, randomized, placebo-controlled, clinical trial. Sixty women were treated for 12 weeks with isoflavone vaginal gel 4% (1g/day) and a placebo gel. After 4 and 12 weeks, the vaginal atrophy symptoms were classified at none, mild, moderate and severe and the vaginal cytology were taken to determine the maturation value. Vaginal pH was measured at the beginning and end of therapy. Microbiopsies in vaginal fornix were performed before the treatment and after 12 weeks of treatment. RESULTS: Isoflavone vaginal gel was effective for relief of vaginal dryness and dyspareunia symptons and an increase in the intermediate and superficial cells was noted. The vaginal pH in the isoflavone group was 7.1 at baseline and 5.4 after 12 weeks, whereas in the placebo group there was no significant change. A significant increase in thickness after treatment was detected in the Isoflavone Group. The percentage of estrogen receptor positive cells in vaginal epithelium for the Isoflavone Group ranged from 58.5% at the beginning of treatment to 82.6% after 12 weeks. These results were superior to placebo gel. CONCLUSION: Glycine max (L.) Merr. at 4% vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms, maturation values, vaginal pH, morphology and expression of estrogen receptors in vaginal epithelium. Isoflavones proved good treatment options for relief of vulvovaginal atrophy.

Efeito do uso de gel não hormonal na região genital em mulheres na pós-menopausa / Effect of the use of no hormonal gel in genital region in postmenopausal women

Introdução: A queixa genital é comum em mulheres menopausadas. A diminuição dos níveis de estrogênio neste período causa atrofia vulvovaginal que pode ser acompanhada de vaginite, prurido, dispareunia, dentre outros sintomas. Objetivo: O objetivo deste estudo foi avaliar o efeito da utilização de um gel não hormonal a base de extratos vegetais em mulheres menopausadas com queixas vulvovaginais. Método: Trinta e cinco voluntárias, com idade entre 45 e 65 anos, com vida sexual ativa e em menopausa há pelo menos 6 meses, realizaram aplicações diárias vulvares do gel por quatro semanas. Todas as pacientes responderam a um questionário não estruturado com questões referentes ao conforto durante a relação sexual, hidratação e maciez genital no final do tratamento. Resultados: Todas as pacientes referiram mais conforto na atividade sexual. Houve melhora da hidratação da região genital em 97% e sensação de maciez local em 100% das pacientes. Conclusão: A utilização do gel não hormonal promoveu maior hidratação e maciez tecidual genital melhorando a sexualidade.