Vulvovaginal Symptoms Research Articles

Pediatric Vulvovaginal Graft-Versus-Host Disease: A Retrospective Cohort Study and Literature Review

Study ObjectiveTo assess genital symptomatology, characterize the findings of genital examination, and describe the incidence and treatment of vulvovaginal graft-versus-host disease (vvGvHD) in girls and adolescents after allogeneic hematopoietic stem cell transplantation (HSCT). DesignRetrospective cohort. SettingMetropolitan-area children's hospital. ParticipantsFemale allogeneic HSCT recipients ages 0 to 22 years. Main Outcome MeasuresGenital symptoms, genital examination, diagnosis, and treatment of vvGvHD. ResultsA total of 57 participants were included in the analysis. The median age at the time of HSCT was 10 years (range 4 months−23 years). Most (n = 40, 71%) underwent transplant for a nonmalignant condition, most commonly sickle cell anemia (n = 19, 33%). The median time of onset of GvHD post HSCT was 62 days (IQR = 42 to 151 days). The most common initial site of GvHD was skin (n = 21, 64%), followed by GI tract (n = 10, 30%). Three patients (5%) were diagnosed with vvGvHD. The time of onset of vvGvHD post HSCT ranged from 62 to 1565 days. One patient (33%) was asymptomatic at the time of diagnosis. There was no difference in diagnosis of vvGvHD when race (P = 0.15), age at allogeneic HSCT (P = 0.64), nonmalignant vs malignant indication (P = 0.21), source of stem cells (P = 0.25), partial vs full human leukocyte antigens (HLA) donor match (P = 0.34), and GvHD prophylaxis regimen (P = 0.18) were compared. None had isolated vvGvHD. Vulvovaginal GvHD was preceded by skin GvHD in 1 patient, was preceded by lung GvHD in 1 patient, and occurred concurrently with skin GvHD in the third patient. ConclusionsPediatric vvGvHD can occur within the first 100 days after transplant and can be asymptomatic. Routine gynecologic evaluation post allogeneic HSCT in children and adolescents should include a thorough review of vulvovaginal symptoms and a gynecologic exam for the detection and treatment of vvGvHD.

The Impact of Local Estrogen on the Urogenital Microbiome in Genitourinary Syndrome of Menopause: A Randomized-Controlled Trial.

The postmenopausal urinary bladder microbiome is not well defined. The aims of this study were to characterize the effect of vaginal estrogen on the vaginal and urinary bladder microbiome in postmenopausal women and describe any clinical associations with the symptoms of genitourinary syndrome of menopause. This was a participant-masked, randomized controlled trial comparing the effect of a 12-week course of an estrogen-containing vaginal ring to a placebo vaginal ring. Standardized evaluations were performed at baseline and 12 weeks. Vaginal samples were obtained for pH, vaginal maturation index, and microbiome analysis. Concomitant catheterized urine samples were obtained for microbiome analysis. 16S ribosomal RNA gene sequencing was performed to characterize the resident microbial communities, with Lactobacillus relative abundance as the primary outcome variable. Genitourinary syndrome of menopause symptoms was measured using validated questionnaires (Pelvic Floor Distress Inventory-Short Form, Female Sexual Function Index, Vulvovaginal Symptoms Questionnaire). Of the 39 postmenopausal women randomized, baseline characteristics were similar between arms, with a mean age of 62 years and mean vaginal pH of 5.0. Using intention-to-treat analysis, there were no significant changes in vaginal or urinary Lactobacillus relative abundance. Two participants in each arm removed their ring prior to the end of the study. Eighty percent of participants experienced at least 1 bothersome genitourinary syndrome of menopause symptom. Vulvovaginal dryness and urinary frequency were most common at baseline, whereas painful intercourse and urinary urgency were most common at the final visit, none of which were statistically significant. Our study did not show a significant change in the bacterial composition of the vaginal or urinary bladder microbiome after either vaginal ring in this relatively asymptomatic postmenopausal population.

Lactobacilli reduce recurrences of vaginal candidiasis inpregnant women: a randomized, double-blind, placebo-controlled study.

The aim of this study was to investigate the effects of lactobacilli strains in preventing the recurrences of vaginal candidiasis (VC) in 78 pregnant women with VC (lactobacilli, n=39; placebo, n=39) and the potential benefits on quality of life. The lactobacilli putative probiotic (SynForU-HerCare; two capsules/day of 9·5 log CFU per capsule) or placebo was administered for 8-weeks in a randomized, double-blind, placebo-controlled study. Subjects were assessed for vaginal and gut health conditions at baseline, week-4 and week-8 via questionnaires. The vulvovaginal symptom questionnaire not only covered aspects pertaining to vulvovaginal symptoms but also the quality of life impacts such as emotional, social and sexual. The administration of lactobacilli reduced symptoms of irritation (P=0·023) and discharge (P=0·011) starting week-4 and continued after week-8 (P<0·05), accompanied by reduced symptoms for burning after week-8 (P=0·046) as compared to the placebo. Patients consuming lactobacilli also showed reduced concern about symptoms after week-4 (P=0·010) and continued after week-8 (P=0·001), accompanied by reduced impairment of daily activities attributed to vulvovaginal symptoms (P=0·012) and continued after week-8 (P=0·026). Insignificant differences were observed for sexual impacts between treatment groups. The administration of lactobacilli also reduced recurrences of both emotional and social stress as compared to the placebo at both week-4 and week-8 (P<0·05). Patients consuming lactobacilli showed higher defecation times per week at week-4 (P=0·010) and week-8 (P=0·001) as compared to the placebo group, indicating the potential to reduce risks of pregnancy-induced constipation. Lactobacilli probiotics are beneficial towards pregnant women, especially in reducing vulvovaginal symptoms and recurrences of VC, accompanied by improved emotional and social distress attributed to VC. The study demonstrated the preventive and modulatory roles of lactobacilli strains against VC in pregnant women. Taken altogether, our present data illustrated that lactobacilli probiotics are beneficial towards pregnant women, especially in reducing vulvovaginal symptoms and recurrences of VC, accompanied by improved emotional and social distress attributed to VC, thus could be a potential strategy for the maintenance of vaginal health during pregnancy.

The liquid Kangfuxin (KFX) has efficient antifungal activity and can be used in the treatment of vulvovaginal candidiasis in mice.

Vulvovaginal candidiasis (VVC) is an infectious disease caused mainly by Candida albicans. Kangfuxin (KFX) is a traditional Chinese medicine preparation made from Periplaneta americana extracts, which promotes wound healing and enhances body immunity and also acts as an antifungal agent. Here, we evaluated the effect of KFX in the treatment of VVC in vitro and in vivo. The minimum inhibitory concentration (MIC50 ) of KFX against C. albicans ranged from 7·65 to 20·57%. In addition, KFX was more efficient than fluconazole (FLC) in inhibiting the drug-resistant C. albicans, and the effect was more intense after 8 h. The KFX treatment also exhibited good activity in vivo. It restored the body weight and reduced the vulvovaginal symptoms in mice induced with VVC. It downregulated the expression of the hyphae-related gene, HWP1, thus inhibiting the growth and development of C. albicans hyphae. It also increased the number of neutrophils and promoted the secretion of interleukin-17A (IL-17A); however, the levels of interleukin-8 (IL-8) and interleukin-1β (IL-1β) decreased in mice with VVC. We deduce that KFX effectively treats vaginal candidiasis in two ways: by inhibiting the growth and development of mycelia to reduce colonization of C. albicans and by promoting the secretion and release of IL-17A and neutrophils in high numbers to fight C. albicans infection. This study provides a theoretical basis for the use of KFX for the clinical treatment of VVC.

Abnormal vaginal flora correlates with pregnancy outcomes: A retrospective study from 737 pregnant women

ObjectiveAbnormal vaginal flora (AVF) is a common cause of vulvovaginal symptoms in women. This study aims to investigate the prevalence of AVF in pregnant women and assess associations between diverse AVF subtypes and pregnancy outcomes. MethodsThis study retrospectively collected clinical data of pregnant women who had vaginal flora tests (VFT) between January 2015 and December 2018 in the First Affiliated Hospital of Xi'an Jiaotong University. AVF were defined into different subtypes according to the results of VFT, including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), aerobic bacteria (AV), cytolytic vaginosis (CV), and trichomoniasis. Pregnancy outcomes included gestational age at delivery, preterm birth (PTB), premature rupture of membranes (PROM), and infant birth weight. Student’s t-test and Fisher’s exact test was used for analyses using SPSS 22.0. P < 0.05 was considered as statistical significance. ResultsA total of 737 pregnant women were included in this study. Pregnant women in AVF group suffered more PROM than women in normal vaginal flora (NVF) group (18.8% [33/176] vs 10.6% [32/302], P = 0.012); pregnant women with BV (31.3% [5/16] vs 10.6% [32/302], P = 0.018) and mixed vaginitis (55.6% [5/9] vs 10.6% [32/302], P = 0.001) had higher PROM rates than women in the NVF group. In addition, pregnant women in NVF and AVF groups had similar PTB rates (5.0% [15/302] vs 3.5% [32/302], P = 0.38). ConclusionsAVF, including BV and Mixed vaginitis, augments PROM risk in pregnant women, demonstrating the need for vaginal flora examination during pregnancy.

Intravaginal cleansing practices among women attending a female pelvic medicine and reconstructive surgery clinic

To determine the prevalence of intravaginal cleansing practices, the associated factors, and the relationship with vulvovaginal and urinary symptoms amongst women attending a Female Pelvic Medicine and Reconstructive Surgery (FPMRS) clinic. This cross-sectional study was conducted between October 20, 2019 and February 20, 2020. We included women aged eighteen and above who presented for a new patient visit to our FPMRS clinic. We excluded women who were unable to speak and read either English or Spanish and women with a history of dementia. The primary outcome was the overall prevalence of intravaginal cleansing practices among women who practice at least monthly intravaginal cleansing. We obtained baseline demographic and clinical characteristics, information regarding intravaginal/vulvar cleansing practices, vulvovaginal/urinary symptoms, as well as the history of treatment for urinary/vaginal infections during the preceding 12 months. Validated questionnaires including the Vulvovaginal Symptom Questionnaire (VSQ) and the Urinary Distress Inventory Short Form (UDI-6) were collected. Data was analyzed utilizing Student’s t-test and chi-squared test or Fisher’s exact test, as appropriate. Seventy-nine women were recruited in this study. The mean age was 61.1±14.5 years. Most women were white (75%), married (62%), born in the United States (81%), with a bachelor’s degree or higher (49%), with incomes above $100,000 (45%), non-smokers (93%), currently sexually active (53%) and not currently using vaginal estrogen (85%). Fifteen women (19%) reported current intravaginal cleansing practice. The most common reasons for intravaginal cleansing were cleanliness (100%), reducing unpleasant odors (58%), protection against infections (33%), and cleaning after and before sexual intercourse (42% and 25%, respectively). Vulvovaginal symptoms were significantly higher in women who currently perform intravaginal cleansing (19%) compared to those who do not (81%) (p=0.02). However, there were no significant correlations between intravaginal cleansing and sensation of vaginal bulge or UDI-6 score (p=0.78 and p=0.07, respectively). Moreover, urinary tract and vaginal infections treatment over the prior twelve months were not associated with current intravaginal cleansing (p=0.3 and p=0.98, respectively). Despite its potential adverse effects, intravaginal cleansing is still a common practice among women across various age groups. Vulvovaginal symptoms were higher in women who cleansed intravaginally, whereas urinary tract and vaginal infections were not associated. Larger and more diverse populations are necessary to more accurately determine possible associations with intravaginal cleansing.

Abstract P4-11-15: Breast cancer survivors vulvo-vaginal atrophy symptoms: Morphological aspects unveiled

Abstract Introduction: One of most frequent symptoms of breast cancer survivors using antiestrogen therapy (BCSA) is vulvovaginal atrophy (VVA). This condition decreases women's quality of life in many aspects such as social, sexual and psychological. Although this clinical condition is very frequent, few is kwon about morphological consequences that could affect function.Objective: Evaluate clinical signs and symptoms of VVA and to access histological and morphological features.Methods: Were selected BCSA with moderate or severe symptoms of VVA (score &amp;gt;4 of visual analogic scale of symptoms - burning, discomfort, dryness, lack of vaginal lubrification, dyspareunia) and control group composed by non-oncological post menopause women with the same symptoms. They underwent to clinical evaluation of Vaginal Health Index (VHI), vaginal pH, validated quality of life questionnaires (Incontinence quality of Life- I-Qol, Female Sexual Function - index (FSF-I), and biopsy of vagina. Morphological variables evaluated were epithelial differentiation, presence of atrophy, stromal cellular and vascular distribution. Results: Were included 62 women, 50 BCSA (18 - tamoxifen and 32 - anastrozole) and 12 control group. The groups have similar age, time of menopause, BMI and parity, the mean time of anti-estrogen agent use was 2 to 5 years. Clinical evaluation and quality of life questionnaires scores are presented on table 1. Vaginal biopsy findings revealed were presented on table 2 Conclusion: Symptoms of VVA do not correlate with tissue modifications as expected, however a trend of enhance of papillomatosis and subepithelial vascularization was observed, and they were predominant in BCSA compared to controls. TamoxifenAnastrozolePost-menopause controlN183212VHI (Mean±SD)16.6 (±3.2)13.7 (±3.9)15.7 (±4.7)Vaginal pH (Mean±SD)5.3 (±0,7)6.2 (±0.4)4.9 (±1.5)IU n/%9 (50%)12 (37.5%)4 (33.4%)nocturia n/%3 (16.7%)2 (6.25%)3 (25%)I-Qol (Mean±SD)57.3 (±18.2)57.9 (±19.6)84.4 (±25.4)Active sexual life n/%14 (77.8%)18 (56.2%)7 (58.33%)FSF-I (Mean±SD)14.7 (±5,1)15.7(±6.2)21.1(±8.4) TamoxifenAnastrozolePost-menopause control groupN183212Reduction in epithelial layers1 (5.5%)4 (12.5%)1 (8.3%)Reduction of epithelial maturation1(5,5%)5 (15.6%)1(8.3%)Enhance of epithelial papillae12 (66.7%)15 (46.8%)2 (16.7%)Enhance of subepithelial vascularization5 (27.8%)14 (43.7%)2 (16.7%)Reduction of Stromal cellular density1(5.5%)3 (9.4)0 (0%) Citation Format: Ana Maria Homem de Mello Bianchi-Ferraro, Angela Flavia Lugollo, Zsuzsanna IlonaKatalin Jarmy-di Bella, Marair GracioFerreira Sartori, Neila Mariade Gois Speck, Marisa Teresinha Patriarca, Rita de Cassiade Maio Dardes, Gabriela Cruz Cantarelli, Marcela Furtado Roberto, Chayane Dedonato, Maria Cristina Caceres Nogueira, Madalena LeonorPereira Campos, Carla Dias Oliveira, Gil Facina, Afonso CelsoPinto Nazaro, Manoel JoãoBatistaCastelo Girão. Breast cancer survivors vulvo-vaginal atrophy symptoms: Morphological aspects unveiled [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-11-15.

Genitourinary Syndrome of Menopause among Postmenopausal Women in a Tertiary Care Centre: A Descriptive Cross-sectional Study.

Genitourinary syndrome of menopause incorporates vulvovaginal and lower urinary tract symptoms related to estrogen deficiency which affects more than half of postmenopausal women. This study aimed to find out the prevalence of genitourinary syndrome of menopause among postmenopausal women attending a tertiary care center. A descriptive cross-sectional study was conducted at the Department of Obstetrics and Gynaecology of tertiary care hospital from October 2019 to April 2021 after obtaining ethical approval from the Institutional Review Committee (Reference number: 452 6-11). A convenience sampling method was used among postmenopausal women aged 40-75 years attending gynaecology outpatient departments. The information was obtained by interview and examination. Analysis was done using the Statistical Package for the Social Sciences version 20. Point estimate at 95% Confidence Interval was calculated along with frequency and proportion for binary data. Among the 385 postmenopausal women, 285 (74.02%) (69.63-78.40 at 95% Confidence Interval) had a diagnosis of genitourinary syndrome of menopause. The mean age of menopause was 48.2±3.6years. The most common symptom and sign were vaginal dryness in 223 (78.2%) and decreased moisture 200 (70.2%). Regarding the impact of genitourinary syndrome of menopause on quality of life, it least affected the activities of daily living and mostly on sexual functioning. The study showed three-fourth of postmenopausal women suffered from genitourinary syndrome of menopause which is similar to the previous studies done in other countries, in postmenopausal women. Therefore, understanding genitourinary syndrome of menopause is vital, and assuring women those treatments are available to relieve symptoms may improve their quality of life.

Hematometrocolpos in chronic vulvovaginal GVHD

Chronic Graft-Versus-Host Disease (GvHD) is one of the most common cause of poor quality of life after Hematopoietic Stem Cell Transplantation (HSCT). Chronic GVHD can present with vulvovaginal symptoms which is usually under reported. Only small series have been reported so far and its incidence, pathophysiology, clinical manifestations and management are not well understood. So also, there are currently no vvGVHD screening guidelines for children who undergo HSCT. In this report, we describe our experience of managing an adolescent girl who developed hematometrocolpos as a complication of chronic GVHD after bone marrow transplant.

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.

The Utilization of Dehydroepiandrosterone as a Sexual Hormone Precursor in Premenopausal and Postmenopausal Women: An Overview.

Dehydroepiandrosterone (DHEA), and its metabolite, dehydroepiandrosterone sulfate ester (DHEAS), are the most abundant circulating steroid hormones, and are synthesized in the zona reticularis of the adrenal cortex, in the gonads, and in the brain. The precise physiological role of DHEA and DHEAS is not yet fully understood, but these steroid hormones can act as androgens, estrogens, and neurosteroids, and perform many roles in the human body. Since both levels decline with age, use of DHEA supplements have gained more attention due to being advertised as an antidote to aging in postmenopausal women, who may have concerns on age-related diseases and overall well-being. However, current research has not reached an overall consensus on the effects of DHEA on postmenopausal women. This overview is a summary of the current literature, addressing the metabolic pathway for DHEA synthesis and utilization, as well as the effects of DHEA on premenopausal and postmenopausal women with disease states and other factors. As for the therapeutic effects on menopausal syndrome and other age-related diseases, several studies have found that DHEA supplementations can alleviate vasomotor symptoms, preserve the integrity of the immune system, reduce bone loss, and increase muscle mass. Intravaginal DHEA has shown significant beneficial effects in menopausal women with severe vulvovaginal symptoms. On the other hand, DHEA supplements have not shown definitive effects in cardiovascular disease, adrenal insufficiency, insulin sensitivity, and cognition. Due to inadequate sample sizes and treatment durations of current studies, it is difficult to assess the safety and efficacy of DHEA and draw reliable conclusions for the physiological role, the optimal dosage, and the effects on premenopausal and postmenopausal women; therefore, the study of DHEA warrants future investigation. Further research into the roles of these steroid hormones may bring us closer to a therapeutic option in the future.

The Vaginal Microbiome: III. The Vaginal Microbiome in Various Urogenital Disorders.

ObjectiveThis series of articles, titled The Vaginal Microbiome (VMB), written on behalf of the International Society for the Study of Vulvovaginal Disease, aims to summarize the recent findings and understanding of the vaginal bacterial microbiota, mainly regarding areas relevant to clinicians specializing in vulvovaginal disorders.Materials and MethodsA search of PubMed database was performed, using the search terms “vaginal microbiome” with “Candida,” “vaginitis,” “urinary microbiome,” “recurrent urinary tract infections,” “sexually transmitted infections,” “human immunodeficiency virus,” “human papillomavirus,” “nonspecific vaginitis,” “vulvodynia,” and “vulvovaginal symptoms.” Full article texts were reviewed. Reference lists were screened for additional articles. The third article in this series describes VMB in various urogenital disorders.ResultsVariable patterns of the VMB are found in patients with vulvovaginal candidiasis, challenging the idea of a protective role of lactobacilli. Highly similar strains of health-associated commensal bacteria are shared in both the bladder and vagina of the same individual and may provide protection against urinary tract infections. Dysbiotic VMB increases the risk of urinary tract infection. Loss of vaginal lactic acid–producing bacteria combined with elevated pH, increase the risk for sexually transmitted infections, although the exact protective mechanisms of the VMB against sexually transmitted infections are still unknown.ConclusionsThe VMB may constitute a biological barrier to pathogenic microorganisms. When the predominance of lactobacilli community is disrupted, there is an increased risk for the acquisition of various vaginal pathogents. Longitudinal studies are needed to describe the association between the host, bacterial, and fungal components of the VMB.

107. A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules versus Fluconazole and Placebo in the Treatment of Acute Vulvovaginal Candidiasis Episodes in Subjects with Recurrent Vulvovaginal Candidiasis (ultraViolet)

BackgroundRecurrent vulvovaginal candidiasis (RVVC) affects nearly 138 million women globally each year. Currently there are no FDA approved treatments. The study was conducted to evaluate the efficacy of oral oteseconazole (VT-1161) in the prevention of culture-verified acute VVC episodes through Week 50 and compare the efficacy of oteseconazole and fluconazole in treatment of an acute VVC episode in RVVC subjects.Methods219 subjects with history of RVVC (≥ 3 acute episodes within prior 12 months) were enrolled at 51 US sites. The study consisted of two phases.Induction Phase: Subjects who presented with a vulvovaginal signs and symptoms score of ≥ 3 and positive KOH test identifying Candida were randomized to either:• 600 mg oteseconazole on Day 1, 450 mg oteseconazole on Day 2 and matching placebo capsules; OR• 3 sequential 150 mg doses (every 72 hours) of over-encapsulated fluconazole together with matching placebo capsulesMaintenance Phase: 185 subjects with resolved acute VVC infections (clinical signs and symptoms score of < 3) on Day 14 received:• 150 mg oteseconazole or placebo weekly for 11 weeks • then 37-week Follow-up periodResultsStudy achieved primary and secondary efficacy endpoints. Oteseconazole was superior to fluconazole/placebo in the proportion of subjects with ≥ 1 culture-verified acute VVC episode through Week 50 in the intent-to-treat (P < 0.001).The average percentage of subjects with ≥ 1 culture-verified acute VVC episode through Week 50 was lower in the oteseconazole group (5.1%) compared to the fluconazole/placebo group (42.2%). Oteseconazole was noninferior to fluconazole in the proportion of subjects with resolved acute VVC infections at Day 14; 93.2% oteseconazole group, 95.8% fluconazole/placebo group.The percentage of subjects who had ≥ 1 treatment-emergent adverse event (TEAE) was similar; oteseconazole (54%), fluconazole/placebo (64%). Most TEAEs experienced were mild or moderate severity in both groups and no drug-related SAEs or adverse effects on liver function or QT intervals.ConclusionOteseconazole was shown to be safe and effective in treatment of acute VVC, treatment of RVVC and prevention of recurrence of acute VVC episodes in RVVC subjects. Oteseconazole was non-inferior to fluconazole for treatment of acute VVC in subjects with RVVC.Disclosures Bassem Maximos, MD, Evofem Biosciences (Scientific Research Study Investigator, Speaker's Bureau)Mycovia Pharmaceutical (Scientific Research Study Investigator)Sage Therapeutics (Scientific Research Study Investigator, Speaker's Bureau) Thorsten Degenhardt, Ph.D, Mycovia Pharmaceuticals (Employee, Shareholder) Karen Person, M.S., Mycovia Pharmaceuticals, Inc. (Employee)Mycovia Pharmaceuticals, Inc. (Employee) Mahmoud Ghannoum, PhD, Mycovia Pharmaceuticals (Grant/Research Support, Research Grant or Support) Stephen Brand, Ph.D, Mycovia Pharmaceuticals (Employee)

LINGUISTIC VALIDATION OF JAPANESE VERSION OF THE VULVOVAGINAL SYMPTOMS QUESTIONNAIRE (VSQ)

(Purpose) To translate the Vulvovaginal Symptoms Questionnaire (VSQ) into Japanese and evaluate the linguistic validation of the translated VSQ. (Methods) The translation and evaluation of the VSQ were performed through 3 steps: forward translation based on 2 urologists and discussed by another 3 urologists; the community review process, which consisted of one-on-one cognitive interviews with 20 patients by professional interviewers; backward translation by a native English speaker, which was discussed with the original author of the VSQ. (Results) The original author of the VSQ generally approved our translation. (Conclusion) The Japanese version of the VSQ was translated in a linguistically valid manner. It is equivalent to the original English questionnaire. It may provide a tool to assess sexual function for Japanese women with genitourinary syndrome of menopause.

Vaginal symptoms in women who are affected by gynecologic cancer.

Pelvic floor disorders are common among gynecologic cancer survivors. With improvements in survivorship, quality of life conditions in these women need greater attention and care. This review focuses specifically on vulvovaginal symptoms, which are common and have a negative impact on sexual health and quality of life in women affected by gynecologic cancer. We review publications on treatment-specific sexual health outcomes, screening and treatment of vulvovaginal symptoms and sexual pain, and surgical management options. Recent evidence regarding the safety of concomitant prolapse repair at the time of surgery for gynecologic malignancies and CO2 laser therapy is discussed and areas needing further research and innovation are highlighted. Pelvic floor disorders, including vaginal and sexual health concerns, are common in women affected by gynecologic cancer due to both common risk factors and as a side effects of cancer treatment. Gynecologists play a critical role in screening, treatment, and collaboration with other specialists to provide comprehensive care for these women throughout their lifetime.

Histopathological spectrum of vulvar lesions on a remote Indian Island

A wide spectrum of normal, benign, premalignant, and malignant lesions may occur on the vulva. Symptoms of vulvar disorders may be non-specific. Empiric treatment of vulvovaginal symptoms is common but usually not helpful. Though the varied clinical presentation and diverse histopathological spectrum of vulvar lesions have amazed Pathologists, only a few studies have been reported in the literature. The present study consists of a histopathological spectrum of vulvar lesions. 1.To evaluate the histopathological spectrum of vulvar lesions. 2. To compare the incidences of non-neoplastic and neoplastic lesions of the vulva. Present study includes all types of vulvar lesion specimens received in the Department of pathology over a period of four years. All thirty-nine vulvar biopsies received in the Department of Pathology were studied for histomorphologic features. The lesions were categorized as non-neoplastic, neoplastic. The neoplastic ones were further divided into benign, malignant, and premalignant. The age of the women ranged from 15 to 69 years (mean 36.18±12.71) with the maximum number of patients between 30 to 40 years of age. Non neoplastic lesions were more common (22; 56.4%) than the (17; 43.6%) neoplastic lesions. There were 15(38.5%) benign lesions while 2 cases (5.13%) were malignant. Among the non-neoplastic lesions, Bartholin's duct cyst was the most common histopathologic diagnosis (35.9%). The fibroepithelial polyp was the most common benign neoplastic lesion constituting 15.3%. In the present study nonneoplastic lesions were more common than neoplastic lesions. Among the neoplastic lesions, benign neoplasms were more frequent than malignant lesions.

The CO2 ablative laser treatment in perimenopausal patients with vulvovaginal atrophy.

The aim of the study was to evaluate the effectiveness of CO₂ fractional laser therapy on perimenopausal urogenital symptoms. This prospective, open-label study included 205 patients who received three CO₂ laser treatments. Clinical assessment was checked at baseline as well as at six weeks and 12 months post-treatment. The following scores were measured Vaginal Health Index Score (VHIS), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and assessment of the severity of selected urogenital symptoms. Significant improvements in dryness, dyspareunia, burning, vaginal laxity, urinary incontinence, as were the results on the VHIS and ICIQ-UI SF at six weeks post-treatment (p < 0.05 for all scores), which were maintained through the follow-up visit at 12 months. No complications were observed either during or after laser therapy. CO₂ ablative laser treatment can be effective in reducing vulvovaginal atrophy symptoms such as vaginal laxity, dryness, painful sexual intercourse, burning, and decreases the severity of stress urinary incontinence and urge incontinence symptoms. Positive results were maintained at 12 months after the laser treatment.

Ibrexafungerp Versus Placebo for Vulvovaginal Candidiasis Treatment: A Phase 3, Randomized, Controlled Superiority Trial (VANISH 303)

BackgroundCurrent treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC.MethodsPatients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS] = 0) at test-of-cure (day 11 ± 3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS ≤ 1) at test-of-cure, and symptom resolution at follow-up (day 25 ± 4).ResultsPatients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P = .001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P < .001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P < .001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P = .009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for Black patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity.ConclusionsIbrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.

Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study

BackgroundVulvo-vaginal atrophy (VVA) is one of the common consequences of estrogen deficiency especially after the menopause. Several studies have assessed the effects of Hyaluronic acid (HA) on physical and sexual symptoms associated with VVA with promising results. However, most of these studies have focused on subjective assessment of symptom response to topically administered preparations. Nonetheless, HA is an endogenous molecule and it is logical that its effects are best realized if injected in the superficial epithelial layers. Desirial® is the first crosslinked HA that is administered by injection in the vaginal mucosa. The aim of this study was to explore the effect of multipoint vaginal intra-mucosal injections of specific cross-linked hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) on several clinical and patient reported core outcomes.MethodsA cohort bi-centric pilot study. The chosen outcomes included change in vaginal mucosa thickness, biological markers for collagen formation, vaginal flora, vaginal pH, vaginal health index, vulvo-vaginal atrophy symptoms and sexual function 8 weeks post Desirial® injection. Patients’ satisfaction was also assessed using the patient global impression of improvement (PGI-I) scale.ResultsA total of 20 participants were recruited between 19/06/2017 and 05/07/2018. At the end of the study, there was no difference in the median total thickness of the vaginal mucosa or in procollagen I, III or Ki67 fluorescence. However, there was a statistically significant increase in COL1A1 and COL3A1 gene expression (p = 0.0002 and p = 0.0010 respectively). There was also a significant reduction in reported dyspareunia, vaginal dryness, vulvar pruritus, vaginal chafing and significant improvement in all female sexual function index dimensions. Based on PGI-I, 19 patients (95%) reported varying degrees of improvement where, 4 (20%) felt slightly better; 7 (35%) better and 8 (40%) much better.ConclusionsMulti-point vaginal intra-mucosal injections, of Desirial® (a crosslinked HA) was significantly associated with the expression of CoL1A1 and CoL3A1 suggesting stimulation of collagen formation. Furthermore, there was a significant reduction in VVA symptomatology and a significant improvement in patient satisfaction and sexual function scores. However, there was no demonstrable change in the total vaginal mucosal thickness.Study registration ID-RCB: 2016-A00124-47, Protocol code number: LOCAL/2016/PM-001.

Correspondence Between Clinician Ratings of Vulvovaginal Health and Patient-Reported Sexual Function After Cancer

BackgroundTools for diagnosing sexual dysfunction and for tracking outcomes of interest include clinician interviews, physical exam, and patient self-report. Limited work has described relationships among these three sources of information regarding female sexual dysfunction and vulvovaginal health. AimWe describe correlations among data collected from clinician interviews, clinical gynecological examination, and patient self-report. MethodsData are from a single-site, single-arm, prospective trial in 100 postmenopausal patients with a history of breast or endometrial cancer who sought treatment for vulvovaginal symptoms. The trial collected a standardized clinical gynecologic exam, clinician-reported outcome (ClinRO) measures of vulvovaginal dryness and pain, and patient-reported outcome (PRO) measures of sexual function, including PROMIS Sexual Function and Satisfaction (SexFS) lubrication, vaginal discomfort, labial discomfort, and clitoral discomfort and Female Sexual Function Index (FSFI) lubrication and pain. We examined polyserial correlations between measures with bootstrapped 95% confidence intervals from the baseline and 12–14-week timepoints. ResultsAll of the relationships between the ClinRO variables and the PRO variables were in the expected direction (ie, positive), but the strength of the relationships varied substantially. At 12–14 weeks, there were medium-to-large correlations between ClinRO vaginal dryness and SexFS Lubrication (0.64), ClinRO vulvar dryness and SexFS Lubrication (0.46), ClinRO vulvar discomfort and SexFS Labial Discomfort (0.70), and ClinRO vulvar discomfort and SexFS Clitoral Discomfort (0.43). With one exception, the correlations between the exam variables and the corresponding PRO scores were small (range 0.01–0.27). Strengths & LimitationsOur study included a comprehensive, standardized gynecologic exam designed specifically to evaluate sexual dysfunction as well as established PRO measures with significant evidence for validity. A limitation of our findings is that the sample size was relatively small, and our sample was restricted to women who received cancer treatments known to have dramatic effects on vulvovaginal tissue quality. ConclusionPatient- and clinician-reported vulvovaginal dryness and discomfort were moderately correlated with each other but not with clinical gynecologic exam findings. Understanding the relationships among these different types of data highlights the distinct contributions of each to understand vulvovaginal tissue quality and patient sexual function after cancer. Flynn KE, Lin L, Carter J, et al. Correspondence Between Clinician Ratings of Vulvovaginal Health and Patient-Reported Sexual Function After Cancer. J Sex Med 2021;18:1768–1774.