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Gynecological Endocrinology : the... Dec 2023The objective is to assess the perception of gynecologists regarding patients' adherence to vulvovaginal atrophy (VVA) treatments, to evaluate the gynecologists'...
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.
Topics: Female; Humans; Male; Middle Aged; Atrophy; Delivery of Health Care; Perception; Postmenopause; Tamoxifen; Vagina; Vaginal Diseases; Vulva; Treatment Adherence and Compliance; Gynecologists
PubMed: 37811796
DOI: 10.1080/09513590.2023.2264405 -
Infectious Diseases in Obstetrics and... 2022Vulvovaginal candidosis (VVC) is a symptomatic vaginal yeast infection, especially caused by spp. Although VVC is common among reproductive-age women, prevalence... (Review)
Review
Vulvovaginal candidosis (VVC) is a symptomatic vaginal yeast infection, especially caused by spp. Although VVC is common among reproductive-age women, prevalence studies notice the uprise of vaginal Candida colonization to 30% during pregnancy by culture, especially in the last trimester. Recent studies have considered it a severe problem due to the emerging evidence showing the association of VVC with a higher chance of pregnancy-related complexities (e.g., preterm labor, premature rupture of membranes, congenital cutaneous candidosis, and chorioamnionitis). In this review, we have reassessed and summarized the prevalence rate of VVC in expecting mothers and analyzed the association of several factors to the increased risk of VVC during pregnancy in different regions of the world. Altogether, these data collected from various studies showed the highest prevalence of VVC during pregnancy, mostly in Asian and African countries (90.38%, 62.2%, and 61.5% in Kenya, Nigeria, and Yemen, respectively). The prevalence rate of VVC during pregnancy was also found to differ with age, gestation period, parity, educational status, and socioeconomic level. Some pregnancy-related factors (e.g., weakened immunity; elevated level of sex hormones, glycogen deposition; low vaginal pH; decreased cell-mediated immunity) and several clinical and behavioral factors can be suggested as potential risk factors of candidosis during pregnancy.
Topics: Candida; Candidiasis, Vulvovaginal; Female; Humans; Infant, Newborn; Nigeria; Pregnancy; Prevalence; Risk Factors
PubMed: 35910510
DOI: 10.1155/2022/6195712 -
Drug Design, Development and Therapy 2023Vulvovaginal candidiasis (VVC) is experienced by an estimated 75% of women at least once in their lifetime and is recurrent, defined as three or more infections per year... (Review)
Review
Vulvovaginal candidiasis (VVC) is experienced by an estimated 75% of women at least once in their lifetime and is recurrent, defined as three or more infections per year (RVVC) in 5-9%. Candida albicans is the most common causative agent, but up to 19% of infections may be related to non-albicans species. Available treatment options for VVC have consisted of oral and topical azoles (except for topical nystatin, a polyene). Oral polyenes are not absorbed and therefore not effective for VVC. Fluconazole is the only oral medication FDA approved for VVC. None of these treatments are FDA approved for RVVC. Ibrexafungerp, a triterpenoid fungicidal agent, was FDA approved in 2021, becoming the first oral non-azole agent for VVC. Ibrexafungerp reaches concentrations up to 9-fold higher in vaginal tissues versus plasma. In Phase 2 clinical trials, ibrexafungerp had a clinical cure rate comparable to fluconazole at day 10, but significantly better at day 25. In Phase 3 clinical trials, ibrexafungerp had both a higher clinical and mycologic cure rate versus placebo at both days 10 and 25. In December 2022, Ibrexafungerp received FDA approval for once monthly dosing to decrease the incidence of RVVC. This approval was based on data from the CANDLE STUDY, which showed 65.4% resolution of symptoms and culture negative success through week 24, compared to 53.1% of placebo. Ibrexafungerp provides an alternative oral option for treatment of acute, severe VVC. It is the only FDA approved antifungal for RVVC. Currently, the population likely to benefit from this drug are those with azole allergy, non-albicans or azole resistant albicans species, or other azole contraindications such as drug interactions (like statins or tricyclics). Side effects are mostly gastrointestinal and mild in nature. Ibrexafungerp, like fluconazole, should be used with caution in women who are or may become pregnant.
Topics: Pregnancy; Female; Humans; Candidiasis, Vulvovaginal; Fluconazole; Antifungal Agents; Triterpenes; Candida albicans; Azoles; Polyenes
PubMed: 36785761
DOI: 10.2147/DDDT.S339349 -
Frontiers in Immunology 2019Recurrent vulvovaginal infections (RVVI), a devastating group of mucosal infection, are severely affecting women's quality of life. Our understanding of the vaginal... (Review)
Review
Recurrent vulvovaginal infections (RVVI), a devastating group of mucosal infection, are severely affecting women's quality of life. Our understanding of the vaginal defense mechanisms have broadened recently with studies uncovering the inflammatory nature of bacterial vaginosis, inflammatory responses against novel virulence factors, innate Type 17 cells/IL-17 axis, neutrophils mediated killing of pathogens by a novel mechanism, and oxidative stress during vaginal infections. However, the pathogens have fine mechanisms to subvert or manipulate the host immune responses, hijack them and use them for their own advantage. The odds of hijacking increases, due to impaired immune responses, the net magnitude of which is the result of numerous genetic variations, present in multiple host genes, detailed in this review. Thus, by underlining the role of the host immune responses in disease etiology, modern research has clarified a major hypothesis shift in the pathophilosophy of RVVI. This knowledge can further be used to develop efficient immune-based diagnosis and treatment strategies for this enigmatic disease conditions. As for instance, plasma-derived MBL replacement, adoptive T-cell, and antibody-based therapies have been reported to be safe and efficacious in infectious diseases. Therefore, these emerging immune-therapies could possibly be the future therapeutic options for RVVI.
Topics: Adaptive Immunity; Disease Susceptibility; Female; Genetic Predisposition to Disease; Host-Pathogen Interactions; Humans; Immunity, Innate; Oxidative Stress; Polymorphism, Single Nucleotide; Receptors, Pattern Recognition; Recurrence; Vagina; Vulvovaginitis
PubMed: 31555269
DOI: 10.3389/fimmu.2019.02034 -
Journal of Fungi (Basel, Switzerland) Aug 2021Recurrent vulvovaginal candidiasis (RVVC) is a relapsing vaginal fungal infection caused by species. The prevalence varies among age populations and can be as high as... (Review)
Review
Recurrent vulvovaginal candidiasis (RVVC) is a relapsing vaginal fungal infection caused by species. The prevalence varies among age populations and can be as high as 9%. Treatment options are limited, and in 57% of the cases, relapses occur within six months after fluconazole maintenance therapy, which is the current standard of care. The pathogenesis of RVVC is multifactorial, and recent studies have demonstrated that the vaginal microenvironment and activity of the immune system have a strong influence on the disease. Medical-grade honey (MGH) has protective, antimicrobial, and immunomodulatory activity and forms a putative alternative treatment. Clinical trials have demonstrated that honey can benefit the treatment of bacterial and -mediated vaginal infections. We postulate that MGH will actively fight ongoing infections; eradicate biofilms; and modulate the vaginal microenvironment by its anti-inflammatory, antioxidative, and immunomodulatory properties, and subsequently may decrease the number of relapses when compared to fluconazole. The MGH formulation L-Mesitran Soft has stronger antimicrobial activity against various species than its raw honey. In advance of a planned randomized controlled clinical trial, we present the setup of a study comparing L-Mesitran Soft with fluconazole and its practical considerations.
PubMed: 34436203
DOI: 10.3390/jof7080664 -
Frontiers in Endocrinology 2019Vaginal health is an essential component of active and healthy aging in women at midlife and beyond. As a consequence of hormonal deprivation and senescence, the anatomy... (Review)
Review
Vaginal health is an essential component of active and healthy aging in women at midlife and beyond. As a consequence of hormonal deprivation and senescence, the anatomy and function of urogenital tissues are significantly affected and vulvovaginal atrophy (VVA) may occur. In a high proportion of postmenopausal women, progressive and chronic VVA symptoms have a strong impact on sexual function and quality of life. The new definition of genitourinary syndrome of menopause (GSM) comprises genital symptoms (dryness, burning, itching, irritation, bleeding), sexual symptoms (dyspareunia and other sexual dysfunctions) and urinary symptoms (dysuria, frequency, urgency, recurrent urinary infections). Many variables (age, sexual activity and partnership status) influence the clinical impact VVA/GSM symptoms and attitudes of elderly women to consult for receiving effective treatments. Psychosocial factors play a critical role in sexual functioning, but the integrity of the urogenital system is as well important affecting many domains of postmenopausal women's health, including sexual function. Several international surveys have extensively documented the need to improve VVA/GSM management because of the strong impact on women's daily life and on couple's intimacy. Health care providers (HCPs) need to be proactive in the early recognition of VVA/GSM in order to preserve urogenital and sexual longevity, by using hormonal and non-hormonal strategies. The clinical diagnosis is based on genital examination to identify objective signs and on the use of subjective scales to rate most bothersome symptoms (MBS), especially vaginal dryness. Recent studies point to the importance of addressing VVA/GSM as a potential early marker of poor general health in analogy with vasomotor symptoms. Therefore, a standard of VVA/GSM care in elderly women is desirable to enhance physical, emotional and mental well-being.
PubMed: 31496993
DOI: 10.3389/fendo.2019.00561 -
International Journal of Molecular... May 2022Vulvovaginal candidiasis (VVC) is one of the most common types of vaginal infections in women around the world and is often underestimated by both patients and doctors.... (Review)
Review
Vulvovaginal candidiasis (VVC) is one of the most common types of vaginal infections in women around the world and is often underestimated by both patients and doctors. Research on the pathogenesis of fungal vaginal infections over the last 20 years has resulted in a closer understanding of the virulence factors involved in epithelial invasion and their mechanisms of action. Recently, attention was drawn to the enormous complexity of the interaction between yeast-like fungi and host cells, as well as the level of complexity of the host's response to infection and their impact on the course and treatment of VVC. Our work provides a broad description of already known and some new reports on virulence factors (such as phenotypic switching or biofilm formation capacity) and their importance for tissue invasion in VVC. At the same time, we also focus on interactions with host cells and local innate immune mechanisms involved in the response to vaginal fungal invasion that are now considered equally important in this case. The presented review describes the most important aspects of the still unknown pathogenicity of associated with vaginal infections.
Topics: Antifungal Agents; Candida; Candida albicans; Candidiasis, Vulvovaginal; Female; Humans; Immunity; Vagina; Virulence Factors
PubMed: 35682581
DOI: 10.3390/ijms23115895 -
Journal of Clinical Microbiology Mar 2023In this prospective, observational, method comparison clinical study, the Xpert Xpress MVP test (MVP) was evaluated using both clinician-collected (CVS) and... (Observational Study)
Observational Study
In this prospective, observational, method comparison clinical study, the Xpert Xpress MVP test (MVP) was evaluated using both clinician-collected (CVS) and self-collected vaginal swabs (SVS) collected in a clinical setting. The study was conducted at 12 sites, including point-of-care (POC) settings, from geographically diverse locations in the United States. Participants were biologically female patients ≥ 14 years old with signs and/or symptoms of vaginitis/vaginosis. MVP test results for BV were compared to the BD MAX Vaginal Panel (BDVP). Results for Candida group and Candida glabrata and Candida krusei targets (species not differentiated) were assessed relative to yeast culture followed by mass spectrometry for species identification. Trichomonas vaginalis (TV) results were compared relative to a composite method that included results from the BDVP and InPouch TV culture. The investigational test demonstrated high positive percent agreement ranging from 93.6 to 99.0%, and negative percent agreement ranging from 92.1% to 99.8% for both CVS and SVS specimens, indicating it may be a valuable tool for the diagnosis of vaginitis/vaginosis in laboratory and POC settings.
Topics: Humans; Female; Adolescent; Trichomonas Vaginitis; Candidiasis, Vulvovaginal; Vaginosis, Bacterial; Prospective Studies; Vagina; Trichomonas vaginalis
PubMed: 36853028
DOI: 10.1128/jcm.01748-22 -
Medicina (Kaunas, Lithuania) Nov 2023: Signs and symptoms of vulvovaginitis, especially when recurrent, have a significant impact on a woman's quality of life. The aim of this study was to survey... (Observational Study)
Observational Study
Efficacy of a Novel Rigenase and Polyhexanide (Fitostimoline Septagel) Hydrogel Device for the Treatment of Vulvovaginitis Symptoms: Cross-Sectional Analysis of a National Survey and Prospective Observational Study.
: Signs and symptoms of vulvovaginitis, especially when recurrent, have a significant impact on a woman's quality of life. The aim of this study was to survey gynecologists about their habits regarding the treatments of the pathology and to evaluate the efficacy of a novel vaginal hydrogel composed of wheat extracts and polyhexanide aimed at reducing vulvovaginitis symptomatology. : A cross-sectional analysis of a national survey using 155 Italian gynecologists and a prospective, open-label, observational study were carried out in 75 outpatient clinics across Italy. Pre- and postmenopausal women with suspicion of vulvovaginitis due to at least four of the following symptoms (leucoxanthorrhea, bad odor from genitalia, vulvovaginal dryness, petechiae, burning, and pruritus) while waiting for microbiological swab analysis were included and treated with one hydrogel application every 3 days for 1 week. Primary endpoint was the complete resolution of symptomatology. : The pre-study survey reported that, for most clinicians, local or oral treatment (65.7% and 82.8%, respectively) with antibiotics or antifungals is used very often. Therefore, we proceeded to carry out an observational study. Overall, 615 (362 of fertile age and 253 in postmenopause) women were included in this study. At the 28th follow-up examination, complete resolution of symptomatology was achieved in 578/615 (94.1%; < 0.001) within 12.72 ± 6.55 and 13.22 ± 6.33 days for those of fertile age and in postmenopause, respectively ( = 0.342). All of the evaluated symptoms were significantly reduced after treatment ( = 0.001) without differences according to the patient's menopausal status. A slightly significant reduction in ( = 0.040) and ( = 0.049) was found after treatment. No patient reported side effects, adverse reactions, or discontinued therapy. : This pilot study showed that a hydrogel based on Rigenase (wheat extract) and polyhexanide could be a promising treatment for the relief of vulvovaginitis symptoms. However, these results are limited by the absence of a control group. Additional comparative and randomized controlled trials between the hydrogel and other non-antibiotic devices as well as local antibiotic therapy should be performed to increase the validity of the findings.
Topics: Female; Humans; Cross-Sectional Studies; Hydrogels; Prospective Studies; Pilot Projects; Quality of Life; Vulvovaginitis; Anti-Bacterial Agents
PubMed: 38004053
DOI: 10.3390/medicina59112004 -
PloS One 2022This prospective, open-label, multicentre, multinational, randomised trial investigated the non-inferiority of treatment with a vaginal hormone-free moisturising cream... (Randomized Controlled Trial)
Randomized Controlled Trial
This prospective, open-label, multicentre, multinational, randomised trial investigated the non-inferiority of treatment with a vaginal hormone-free moisturising cream compared to a vaginal estriol (0.1%) cream in a panel of post-menopausal women suffering from symptoms of vulvovaginal dryness in a parallel group design. In total, 172 post-menopausal women were randomly allocated to either one of the two treatments, each administered for 43 days. The primary endpoint was the total severity score of subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) of the respective treatment period. Secondary endpoints were severity of single subjective symptoms (including dyspareunia if sexually active), impairment of daily life, Vaginal Health Index, as well as assessment of safety. In both groups, women treated with hormone-free moisturising cream and those treated with estriol cream, total severity score improved significantly compared to baseline by 5.0 (from 6.1 to 1.1) and by 5.4 (from 6.0 to 0.6), respectively, after 43 days of treatment (p < 0.0001). One-sided test of baseline differences (for a clinically relevant difference Δ = 1.5) confirmed the hormone-free moisturising cream to be non-inferior to the estriol cream. Severity of dyspareunia as well as impairment of daily life due to subjective symptoms, significantly improved for both treatment groups (p<0.0001). Subgroup analysis of women with mild or moderate impairment of daily life at baseline caused by "vaginal dryness" symptoms benefited from both creams, while women with severe impairment showed a significantly greater benefit from the estriol cream (p = 0.0032). Both treatments were well tolerated with no serious adverse events occurring. This study provides clinical evidence that a hormone-free vaginal moisturising cream cannot only improve vaginal dryness compared to an 0.1% estriol cream but also can relieve dyspareunia as well as improve woman's impairment of daily life, justifying its use as a first choice for mild or moderate vulvovaginal dryness symptoms.
Topics: Administration, Intravaginal; Atrophy; Dyspareunia; Estriol; Female; Humans; Postmenopause; Prospective Studies; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases
PubMed: 35551533
DOI: 10.1371/journal.pone.0266633