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Journal of Women's Health (2002) Mar 2018Vulvovaginal atrophy (VVA) is characterized by vaginal/vulvar dryness, irritation, dyspareunia, or dysuria. The objective of this study was to examine the efficacy and... (Randomized Controlled Trial)
Randomized Controlled Trial
A Randomized, Multicenter, Double-Blind, Study to Evaluate the Safety and Efficacy of Estradiol Vaginal Cream 0.003% in Postmenopausal Women with Vaginal Dryness as the Most Bothersome Symptom.
BACKGROUND
Vulvovaginal atrophy (VVA) is characterized by vaginal/vulvar dryness, irritation, dyspareunia, or dysuria. The objective of this study was to examine the efficacy and safety of a very low-dose estradiol vaginal cream (0.003%) applied twice per week in postmenopausal women with VVA-related vaginal dryness.
MATERIALS AND METHODS
In this phase 3, randomized, double-blind, placebo-controlled, multicenter study, postmenopausal women with moderate-severe vaginal dryness as the most bothersome VVA symptom were randomized (1:1) to estradiol cream 0.003% (15 μg estradiol; 0.5 g cream) or placebo (0.5 g cream). Treatments were applied vaginally once daily for 2 weeks followed by two applications/week for 10 weeks. Coprimary outcomes were changes in severity of vaginal dryness, percentage of vaginal superficial and parabasal cells, and vaginal pH at final assessment. Additional outcomes comprised changes in severity of other VVA signs and symptoms. Adverse events (AEs) were assessed.
RESULTS
Of the 576 randomized participants, most were white and had an average age of 59 years. At final assessment, estradiol reduced vaginal dryness severity, decreased vaginal pH, increased superficial cell percentage, and decreased parabasal cell percentage versus placebo (p ≤ 0.05, all). Estradiol also reduced vaginal dryness severity at Weeks 4-12 and dyspareunia at Week 8 versus placebo (p ≤ 0.05, all). Improvements in vaginal/vulvar irritation/itching severity and dysuria were similar between estradiol and placebo. Estradiol had comparable rates of treatment-emergent AEs to placebo. No deaths occurred.
CONCLUSIONS
Very low-dose estradiol vaginal cream (0.003%) dosed twice weekly is an effective and well-tolerated treatment for VVA symptoms and dryness associated with menopause.
Topics: Administration, Intravaginal; Atrophy; Double-Blind Method; Dyspareunia; Estradiol; Estrogens; Female; Humans; Hydrogen-Ion Concentration; Middle Aged; Postmenopause; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases; Vulva
PubMed: 29193980
DOI: 10.1089/jwh.2017.6515 -
BMJ Open Jul 2021Menopause is a physiological and progressive phenomenon secondary to decreased ovarian follicular reserve. These changes have consequences: vaginal dryness, dyspareunia,...
INTRODUCTION
Menopause is a physiological and progressive phenomenon secondary to decreased ovarian follicular reserve. These changes have consequences: vaginal dryness, dyspareunia, discomfort, burning and irritation, vulvovaginal pruritus, dysuria and increased frequency of genitourinary infections. The therapy more suitable for vaginal symptoms in postmenopause yet is the use of a topical hormone. However, the prescription of topical oestrogens should also be avoided in women with a history of breast cancer, oestrogen-sensitive tumours and thromboembolism, emphasising the necessity of alternative treatments. Recently, physical methods, such as laser and radiofrequency (RF), in their non-ablative, ablative and microablative forms have been used in the vaginal mucosa to promote neocolagenesis and neoelastogenesis. This randomised study aims to compare the efficiency of microablative fractional RF (MAFRF) treatment with vaginal oestrogens and no treatment.
METHODS AND ANALYSES
This randomised, controlled clinical intervention trial with an open label design comparing the treatment of MAFRF with vaginal oestrogens and no treatment. Four important moments were considered to evaluate treatment results (T0, T1, T2 and T3). The primary outcome includes vulvovaginal atrophy (vaginal pain, burning, itching, dryness, dyspareunia and dysuria), and the secondary outcomes will be sexual function, vaginal health (epithelial integrity, vaginal elasticity, moisture, fluid volume and vaginal pH) and quality of life.
ETHICS AND DISSEMINATION
Due to the nature of the study, we obtained approval from the ethics committee. All participants must sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journals. The data collected will also be available in a public repository of data.
TRIAL REGISTRATION NUMBER
RBR-94DX93.
Topics: Atrophy; Dyspareunia; Female; Humans; Lasers, Gas; Menopause; Quality of Life; Randomized Controlled Trials as Topic; Vagina; Vaginal Diseases
PubMed: 34226218
DOI: 10.1136/bmjopen-2020-046372 -
Journal of Cancer Survivorship :... Sep 2010As the number of breast cancer survivors increases, the long term consequences of breast cancer treatment are gaining attention. Sexual dysfunction is a common complaint... (Review)
Review
BACKGROUND
As the number of breast cancer survivors increases, the long term consequences of breast cancer treatment are gaining attention. Sexual dysfunction is a common complaint amongst breast cancer survivors, and there are few evidence based recommendations and even fewer well designed clinical trials to establish what treatments are safe or effective in this patient population.
DESIGN
We conducted a PubMed search for articles published between 1995-2009 containing the terms breast cancer, sexual dysfunction, libido, vaginal dryness, testosterone, and vaginal estrogen. We initially reviewed articles focusing exclusively on sexual issues in breast cancer patients. Given the paucity of clinical trials addressing sexual issues in breast cancer patients, we also included studies evaluating both hormone and non-hormone based interventions for sexual dysfunction in post-menopausal women in general.
CONCLUSIONS
Among breast cancer survivors, vaginal dryness and loss of libido represent some of the most challenging long term side effects of breast cancer treatment. In the general post-menopausal population, topical preparations of estrogens and testosterone both appear to improve sexual function; however there are conflicting reports about the efficacy and safety of these interventions in women with a history of breast cancer, and further research is warranted.
Topics: Breast Neoplasms; Female; Humans; Quality of Life; Sexual Behavior; Sexual Dysfunction, Physiological; Survivors
PubMed: 20602189
DOI: 10.1007/s11764-010-0130-1 -
Frontiers in Cellular and Infection... 2021Postmenopausal women often suffer from vaginal symptoms associated with atrophic vaginitis. Additionally, gynecologic cancer survivors may live for decades with...
Postmenopausal women often suffer from vaginal symptoms associated with atrophic vaginitis. Additionally, gynecologic cancer survivors may live for decades with additional, clinically significant, persistent vaginal toxicities caused by cancer therapies, including pain, dyspareunia, and sexual dysfunction. The vaginal microbiome (VM) has been previously linked with vaginal symptoms related to menopause ( dryness). Our previous work showed that gynecologic cancer patients exhibit distinct VM profiles from healthy women, with low abundance of lactobacilli and prevalence of multiple opportunistic pathogenic bacteria. Here we explore the association between the dynamics and structure of the vaginal microbiome with the manifestation and persistence of vaginal symptoms, during one year after completion of cancer therapies, while controlling for clinical and sociodemographic factors. We compared cross-sectionally the vaginal microbiome in 134 women, 64 gynecologic patients treated with radiotherapy and 68 healthy controls, and we longitudinally followed a subset of 52 women quarterly (4 times in a year: pre-radiation therapy, 2, 6 and 12 months post-therapy). Differences among the VM profiles of cancer and healthy women were more pronounced with the progression of time. Cancer patients had higher diversity VMs and a variety of vaginal community types (CTs) that are not dominated by , with extensive VM variation between individuals. Additionally, cancer patients exhibit highly unstable VMs (based on Bray-Curtis distances) compared to healthy controls. Vaginal symptoms prevalent in cancer patients included vaginal pain (40%), hemorrhage (35%), vaginismus (28%) and inflammation (20%), while symptoms such as dryness (45%), lack of lubrication (33%) and dyspareunia (32%) were equally or more prominent in healthy women at baseline. However, 24% of cancer patients experienced persistent symptoms at all time points, as opposed to 12% of healthy women. Symptom persistence was strongly inversely correlated with VM stability; for example, patients with persistent dryness or abnormally high pH have the most unstable microbiomes. Associations were identified between vaginal symptoms and individual bacterial taxa, including: with vaginal dryness, with pain following vaginal intercourse, and with low levels of lubrication during intercourse. Taken together our results indicate that gynecologic cancer therapy is associated with reduced vaginal microbiome stability and vaginal symptom persistence.
Topics: Dyspareunia; Female; Humans; Lactobacillus; Menopause; Microbiota; Neoplasms; Vagina
PubMed: 34778097
DOI: 10.3389/fcimb.2021.680038 -
Indian Journal of Psychological Medicine Oct 2014There are limited numbers of studies which have evaluated the sexual dysfunction (SD) in patients with alcohol and opioids dependence. This article reviews the existing... (Review)
Review
There are limited numbers of studies which have evaluated the sexual dysfunction (SD) in patients with alcohol and opioids dependence. This article reviews the existing literature. Electronic searches were carried out using the PubMed, Google Scholar, and ScienceDirect to locate the relevant literature. Subjects addicted to heroin or on methadone maintenance treatment (MMT) or buprenorphine maintenance treatment (BMT) show higher rates of SD in comparison to the general population. SD rates have ranged 34-85% for heroin addicts, 14-81% for MMT, 36-83% for BMT, and 90% for naltrexone maintenance. The rates of SD in alcohol-dependent population have ranged 40-95.2%, with rates being consistently much higher in alcohol-dependent population than in the healthy controls or social drinkers. The common SDs reported have been erectile dysfunction followed by premature ejaculation, retarded ejaculation and decreased sexual desire among men, and dyspareunia and vaginal dryness among women. This review suggests that long-term use of alcohol and opioids are associated with SD in almost all domains of sexual functioning. There is a need to increase the awareness of clinicians about this association as many times SD in patients with substance abuse lead to poor treatment compliance and relapse. Further, there is a need to carry out more number of studies to understand the relationship in a better way.
PubMed: 25336765
DOI: 10.4103/0253-7176.140699 -
Revista Brasileira de Ginecologia E... Oct 2022To explore the main sexuality complaints of gynecologic cancer survivors after treatment and to identify the care strategies provided.
OBJECTIVE
To explore the main sexuality complaints of gynecologic cancer survivors after treatment and to identify the care strategies provided.
DATA SOURCE
Searches were conducted in six electronic databases: Scopus, Web of Science, LILACS, MEDLINE, PsychINFO, and EMBASE.
STUDY SELECTION
Articles published between 2010 and 2020 were selected and the following descriptors were used in the English language: and . The methodological quality of the studies used the Mixed Methods Appraisal Tool (MMAT).
DATA COLLECTION
The primary data extracted were: names of the authors, year of publication, country of origin, objective and type of study, data collection instrument, sample size and age range, types of cancer, and symptoms affected with the strategies adopted.
DATA SUMMARY
A total of 34 out of 2,536 screened articles were included. The main strategies found for patient care were patient-clinician communication, practices for sexuality care, individualized care plan, multiprofessional team support, and development of rehabilitation programs. For sexuality care, the most common practices are pelvic physiotherapy sessions and the use of vaginal gels and moisturizers.
CONCLUSION
The main complaints identified in the scientific literature were low libido and lack of interest in sexual activity, vaginal dryness, pain during sexual intercourse, and stenosis. Different care strategies may be adopted, such as follow-up with a multidisciplinary health team and sexual health rehabilitation programs, which could minimize these symptoms and ensure the quality of life of patients.
Topics: Female; Humans; Quality of Life; Sexuality; Sexual Behavior; Genital Neoplasms, Female; Survivors
PubMed: 36174653
DOI: 10.1055/s-0042-1756312 -
BJUI Compass Jan 2023Bladder cancer (BC) treatments are known to be invasive; nevertheless, research into the long-term effects is limited and in the context of sexual function often male... (Review)
Review
BACKGROUND
Bladder cancer (BC) treatments are known to be invasive; nevertheless, research into the long-term effects is limited and in the context of sexual function often male focussed. Female sexual dysfunction (FSD) has been reported in up to 75% of female patients. This systematic scoping review examines the literature on sexual consequences of BC in female patients.
OBJECTIVE
This study aimed to systematically evaluate the evidence on female sexual function in BC to identify areas of unmet need and research priorities.
EVIDENCE ACQUISITION
We performed a critical review of PubMed, PsychMed, CINAHL, MEDLINE and the Cochrane Library in March 2020 according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement following Levac et al. methodology. Identified reports were reviewed according to the Critical Appraisal Skills Programme (CASP) criteria. 45 publications were included.
EVIDENCE SYNTHESIS
There was an inconsistent use of patient-reported outcome measures (PROMs), with commonly used PROMs having a narrow symptom focus. However, common symptoms emerged: loss of desire, orgasmic disorders, vaginal dryness, dyspareunia, difficult intromission, reduced clitoral sensation, psychological concerns related to diagnosis, fear of contamination and body image. Sexual activity was reduced in most groups, despite women expressing a motivation to retain sexual function. The degree of symptom distress associated with FSD is underreported. Evidence emerged regarding a gap for women in clinician counselling and follow-up.
CONCLUSIONS
The patient's perspective of FSD in BC patients is poorly understood and under-addressed in clinical practice. There have been very few qualitative studies of FSD in BC. Any intervention designed to address the problem must start with greater understanding of both the patients' and clinicians' perspective.
LAY SUMMARY
We examined the evidence on sexual consequences of BC in women. It is apparent that despite common themes of sexual dysfunction emerging, the problem is poorly understood and addressed in clinical practice.
PubMed: 36569507
DOI: 10.1002/bco2.186 -
Nursing ResearchMidlife perimenopausal and postmenopausal women with metabolic syndrome experience multiple symptoms concurrently.
BACKGROUND
Midlife perimenopausal and postmenopausal women with metabolic syndrome experience multiple symptoms concurrently.
OBJECTIVE
The study objectives were to examine the relationship among symptoms through network visualization and identify and compare symptom clusters and key symptoms across symptom occurrence and symptom severity dimensions in midlife perimenopausal and postmenopausal women with and without metabolic syndrome.
METHODS
Cross-sectional data from the Study of Women's Health Across the Nation (Visit 5) were used for analysis. A machine-learning-based network analysis and the Walktrap algorithm were used to fulfill the study objectives.
RESULTS
The number and types of symptom clusters differed between the groups. Midlife perimenopausal and postmenopausal women with metabolic syndrome experienced the psychological/somatic/genital cluster (key symptom: frequent mood change), the sleep/urinary cluster (sleep disturbance), and the vasomotor cluster (cold sweat) in the symptom occurrence dimension and the psychological/somatic/sexual cluster (anxiety), the sleep/urinary cluster (sleep disturbance), and the vasomotor/genital cluster (night sweat) in the symptom severity dimension. In contrast, midlife perimenopausal and postmenopausal women without metabolic syndrome experienced the psychological cluster (anxiety), the sleep/somatic/genitourinary cluster (sleep disturbance), and the vasomotor cluster (night sweat) in the symptom occurrence dimension and the psychological/somatic cluster (anxiety), the sleep/urinary cluster (sleep disturbance), the vasomotor cluster (night sweat), and the sexual/genital cluster (vaginal dryness) in the symptom severity dimension.
DISCUSSION
The study findings may serve as a knowledge basis for effective assessment and management of symptom clusters and key symptoms in clinical settings and provide directions for future development of targeted symptom management interventions.
Topics: Cross-Sectional Studies; Female; Hot Flashes; Humans; Metabolic Syndrome; Perimenopause; Postmenopause; Sleep Wake Disorders
PubMed: 35759720
DOI: 10.1097/NNR.0000000000000591 -
Frontiers in Microbiology 2019For decades hormone therapy (HT) has been prescribed to treat the symptoms of menopause, such as vaginal dryness, itching and burning. Here we sought to compare the...
For decades hormone therapy (HT) has been prescribed to treat the symptoms of menopause, such as vaginal dryness, itching and burning. Here we sought to compare the vaginal microbiomes of postmenopausal women who received low dose estrogen therapy to those of premenopausal and postmenopausal women, and to do so in conjunction with assessing the alleviation of symptoms associated with vaginal atrophy. In this study vaginal swab samples were obtained from 45 women who were classified as either premenopausal, postmenopausal, or postmenopausal and undergoing HT. The vaginal microbiomes of these women were characterized by gene sequencing and bacterial abundances were quantified by qPCR. We found that the vaginal communities from our cohort could be divided into six clusters (A-F) based on differences in the composition and relative abundances of bacterial taxa. Communities in cluster A were dominated by , and those of cluster B were dominated by . Communities in cluster C had high proportions of , while those in cluster D were more even and included several co-dominant taxa. Communities in clusters E and F were dominated by and , respectively. The vaginal communities of most postmenopausal women receiving HT (10/15) were dominated by species of lactobacilli and belonged to clusters A, C, and F ( < 0.001). This sharply contrasts with vaginal communities of postmenopausal women without HT, most of which (10/15) were in cluster D, depleted of lactobacilli, and had about 10-fold fewer total bacteria ( < 0.05). The vaginal communities of women in each study group differed in terms of the dominant bacterial species composition and relative abundance. Those of postmenopausal women receiving HT significantly differed from those of postmenopausal women without HT and were most often dominated by species of . Noteworthy, HT greatly improved vaginal atrophy scores, decreased vaginal pH, and significantly increased bacterial numbers in comparison to postmenopausal women not receiving HT.
PubMed: 30837959
DOI: 10.3389/fmicb.2019.00193 -
Nutrients May 2023Menopause is a hormone-deficiency state that causes facial flushing, vaginal dryness, depression, anxiety, insomnia, obesity, osteoporosis, and cardiovascular disease as...
Menopause is a hormone-deficiency state that causes facial flushing, vaginal dryness, depression, anxiety, insomnia, obesity, osteoporosis, and cardiovascular disease as ovarian function decreases. Hormone-replacement therapy is mainly used to treat menopause; however, its long-term use is accompanied by side effects such as breast cancer and endometriosis. To identify the effect of a complex extract of () and () on improving menopause without side effects, an ovariectomized rat model was established to analyze several menopause symptoms. Compared to single extracts, the complex extract restored vaginal epithelial cell thickness and decreased serotonin concentration by increasing the estrogen receptors ERα (ESR1) and ERβ (ESR2), depending on the ratio. Although the complex extract exerted a lower weight-loss effect than the single extracts, improved blood-lipid metabolism was observed after increasing high-density lipoprotein cholesterol levels and decreasing low-density lipoprotein cholesterol and triglyceride levels, and ovariectomy-induced osteoporosis was alleviated by suppressing osteoclast production. Thus, by increasing only ERβ expression without regulating ERα expression in the uterus, the complex extract of PS and NS may be a natural treatment for improving menopause symptoms without side effects, such as endometriosis.
Topics: Female; Humans; Rats; Animals; Estrogen Receptor beta; Estrogen Receptor alpha; Plant Extracts; Polygonatum; Endometriosis; Receptors, Estrogen; Menopause; Cholesterol; Osteoporosis; Hormones; Ovariectomy
PubMed: 37299404
DOI: 10.3390/nu15112443