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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 -
Menopause International Mar 2012Postmenopausal estrogen deficiency can lead to symptoms of urogenital atrophy. Individuals with urogenital atrophy have symptoms that include vaginal dryness, vaginal... (Review)
Review
Postmenopausal estrogen deficiency can lead to symptoms of urogenital atrophy. Individuals with urogenital atrophy have symptoms that include vaginal dryness, vaginal and vulval irritation, vaginal soreness, pain and burning during urination (dysuria), increased vaginal discharge, vaginal odour, vaginal infections, recurrent urinary tract infections, pain associated with sexual activity (dyspareunia) and vaginal bleeding associated with sexual activity. Despite the frequency and effects of vaginal atrophy symptoms, they are often under-reported and, consequently, under-treated. Therefore, care of a menopausal woman should include a physical assessment of vaginal atrophy and a dialogue between the physician and the patient that explores existing symptoms and their effect on vulvovaginal health, sexuality and quality-of-life issues. The development of the ultra-low-dose 10-µg estradiol vaginal tablets is in line with the requirements of regulatory agencies and women's health societies regarding the use of the lowest effective hormonal dose. Because of its effectiveness and safety profiles, in addition to its minimal systemic absorption, the 10-µg estradiol vaginal tablet can offer greater reassurance to health-care providers and postmenopausal women with an annual estradiol administration of only 1.14 mg.
Topics: Atrophy; Estradiol; Estrogen Replacement Therapy; Estrogens; Female; Humans; Postmenopause; Tablets; Vagina
PubMed: 22393176
DOI: 10.1258/mi.2012.011120 -
Menopause (New York, N.Y.) Apr 2023
Topics: Female; Humans; Pilot Projects; Postmenopause; Vaginal Diseases; Vagina; Ultrasonic Therapy; Atrophy; Treatment Outcome; Dyspareunia; Vulva; Administration, Intravaginal
PubMed: 36749915
DOI: 10.1097/GME.0000000000002157 -
Maturitas Jul 2024The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of... (Clinical Trial)
Clinical Trial
OBJECTIVES
The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of vaginal dryness associated with menopause.
STUDY DESIGN
Seventy-nine postmenopausal women (mean age 60.8 ± 6.5 years) with mild to moderate symptoms of vaginal dryness (including dyspareunia) were enrolled in this open-label, prospective, post-market clinical follow-up trial, conducted in 2022 by one research center in Germany. The investigational pessary was applied for the first 7 days once daily and the subsequent 31 days twice a week, at bedtime. A treatment-free period of 6 days completed the trial.
MAIN OUTCOME MEASURES
During the trial, participants filled out questionnaires that enabled the calculation of a total severity score for subjective symptoms of atrophy-related vaginal dryness and impairment of daily as well as sexual life. Furthermore, vaginal health index and safety were studied.
RESULTS
A rapid and significant reduction in the severity scores for symptoms was observed over the 38-day course of treatment and beyond. Quality of life assessed by DIVA (day-to-day impact of vaginal aging) questionnaire, dyspareunia and vaginal health index also clearly improved. The tolerability was mainly rated as "good to very good" by the investigator and 94.9 % of participants. The vast majority were very satisfied with the simple and pleasant handling. No serious adverse events occurred.
CONCLUSION
Overall, the presented data suggest that the investigated non-hormonal pessary is an effective and well tolerated treatment option for vaginal symptoms associated with dryness, thus improving quality of life for women, even those who are sexually active.
CLINICALTRIALS
gov identifier NCT05211505.
Topics: Humans; Female; Middle Aged; Vaginal Diseases; Quality of Life; Aged; Prospective Studies; Dyspareunia; Vagina; Menopause; Pessaries; Surveys and Questionnaires; Severity of Illness Index; Postmenopause; Treatment Outcome
PubMed: 38583316
DOI: 10.1016/j.maturitas.2024.107978 -
Reproductive Sciences (Thousand Oaks,... Oct 2013Vulvar and vaginal atrophy (VVA) is a chronic, progressive medical condition prevalent among postmenopausal women, which produces symptoms such as dyspareunia, vaginal... (Review)
Review
Vulvar and vaginal atrophy (VVA) is a chronic, progressive medical condition prevalent among postmenopausal women, which produces symptoms such as dyspareunia, vaginal dryness, and vaginal irritation. Currently, the only prescription options are systemic and vaginal estrogen therapies that may be limited by concerns about long-term safety and breast cancer risk. Ospemifene is a tissue-selective estrogen agonist/antagonist (a selective estrogen receptor modulator) recently approved by the US Food and Drug Administration for treatment of dyspareunia, a symptom of VVA, due to menopause. Ospemifene, the first nonestrogen oral treatment for this indication, may provide an alternative to treatment with estrogen. Animal models with ospemifene suggest an inhibitory effect on growth of malignant breast tissue, but animal data cannot necessarily be extrapolated to humans. Clinical trials, including 3 long-term studies assessing the overall safety of ospemifene, support that ospemifene is generally well tolerated, with beneficial effects on the vagina, neutral effects on the breast, and minimal effects on the endometrium.
Topics: Animals; Breast; Dyspareunia; Female; Humans; Postmenopause; Selective Estrogen Receptor Modulators; Tamoxifen; Vagina; Vulva
PubMed: 23945733
DOI: 10.1177/1933719113497290 -
Maturitas Sep 2011Vaginal atrophy is a common symptom of postmenopausal estrogen deficiency and can present as dryness, irritation, infection and dyspareunia and can affect sexual... (Review)
Review
Vaginal atrophy is a common symptom of postmenopausal estrogen deficiency and can present as dryness, irritation, infection and dyspareunia and can affect sexual function and quality of life. Currently vaginal atrophy is treated with the intravaginal application of preparations containing estradiol or estriol, which are both effective and safe. It has been proposed that intravaginally administered dehydroepiandrosterone (DHEA) can be used to treat vaginal atrophy. DHEA and its sulphate DHEAS are the most abundant circulating sex steroid hormones in women, and provide a large precursor reservoir for the intracellular production of androgens and estrogens in non-reproductive tissues. Levels of DHEA and DHEAS decline with age. Although there is some evidence to support the use of intravaginal DHEA for postmenopausal women with symptoms of vaginal atrophy, independent studies are required to confirm this. In addition studies regarding the effects of vaginal DHEA on sexual function in women without vaginal atrophy are needed. Given that the efficacy and long term safety of low dose vaginal estradiol and estriol therapy is well established and that vaginal estrogen requires application of 2-3 times a week, rather than daily dosing; the benefit of daily vaginal DHEA over estrogen also needs to be considered as women may find it unpalatable to adhere to daily dosing with a cream preparation.
Topics: Administration, Intravaginal; Atrophy; Dehydroepiandrosterone; Endometrium; Female; Humans; Randomized Controlled Trials as Topic; Vagina; Vaginal Diseases
PubMed: 21733647
DOI: 10.1016/j.maturitas.2011.06.005 -
Nursing Standard (Royal College of...
Topics: Adolescent; Adult; Aging; Child; Female; Humans; Infant, Newborn; Menopause; Middle Aged; Puberty; Vagina; Vaginal Diseases; Vulva
PubMed: 1903642
DOI: 10.7748/ns.5.31.24.s38 -
Wiener Medizinische Wochenschrift (1946) May 2017Vaginal dryness and associated symptoms may occur in women of any age and are a frequent burden after menopause. The North American Menopause Society recommends... (Clinical Trial)
Clinical Trial
Vaginal dryness and associated symptoms may occur in women of any age and are a frequent burden after menopause. The North American Menopause Society recommends long-acting non-hormonal vaginal creams as first-line therapy. A new type of such creams was developed (Remifemin® FeuchtCreme in Austria and Germany). This hormone-free cream contains hamamelis virginiana distillate and well-established vaginal cream ingredients. We explored its physical function and tolerability in an open interventional clinical trial. 20 postmenopausal women (54 to 76 years, median 60) treated their vaginal dryness using this cream once daily for 7 days and reported about their symptoms before, 4 to 8 h after first and 14 to 22 h after last application. A physician assessed tolerability and local physical function. All patients completed the study. Local physical function significantly improved from dryness at baseline (mean 4.0 ± SD 1.8) to a normal moisture level, on average (6.3 ± 2.1 after first, 6.7 ± 2.1 after last application, p = 0.0001). Subjective assessment of a feeling vaginal dryness showed a significant improvement at both times (p = 0.0001). Onset and duration of feeling moisturized were reported to be 0 to 2 min and 11.3 ± 6.9 h after application. All women reported vaginal dryness at baseline. 55 and 80% of patients reported no dryness after first application and at the end of the investigation. The cream was seen at the application site for up to 21 h. Tolerability assessments did not reveal any relevant change over time. There were four adverse events in 4 patients, all not serious and of mild intensity: urinary urgency (2), diarrhoea (1) and mild spotting after first application (1). The latter was caused by the dry surface of the applicator and was avoided by moisturizing the surface of the applicator at subsequent applications. In conclusion, these study results indicate a well-tolerated and long-acting function of this new vaginal moisturizing cream. Further clinical research in more patients will follow.
Topics: Cimicifuga; Climacteric; Female; Humans; Middle Aged; Phytotherapy; Plant Extracts; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases
PubMed: 28091974
DOI: 10.1007/s10354-016-0536-0 -
International Journal of Environmental... Apr 2021Radiotherapy, as a method of treatment of cervical and uterine cancers, may induce severe late-onset vaginal side effects. Unfortunately, little evidence on the... (Review)
Review
BACKGROUND
Radiotherapy, as a method of treatment of cervical and uterine cancers, may induce severe late-onset vaginal side effects. Unfortunately, little evidence on the management of adverse effects has been presented. This study aimed to evaluate the available interventions which reduce symptoms of vaginitis and vaginal atrophy by improving dyspareunia, mucosal inflammation, vaginal pH and vaginal dryness in women who have undergone brachytherapy or radiotherapy due to uterine or cervical malignancies.
MATERIALS AND METHODS
A comprehensive literature search was performed following PRISMA guidelines. The systematic search was conducted using electronic databases, namely Scopus, Web of Science and PubMed, between October and November 2020 to identify randomized controlled trials (RCT) and, prospective randomized studies (PRS).
RESULTS
The analyzed population consists of 376 patients with uterine or cervical cancer, treated with hyaluronic acid, vitamin A, vitamin E, alpha-tocopherol acetate and dienestrol. Intervention with HA along with vitamin A and vitamin E revealed advantage in endpoints such as reduced dyspareunia, vaginal mucosal inflammation, vaginal dryness, bleeding, fibrosis and cellular atypia. Administration of alpha-tocopherol acetate reduced vaginal mucosal inflammation and improved vaginal acanthosis, whereas dienestrol resulted in reduced dyspareunia, vaginal caliber and bleeding.
CONCLUSIONS
Vaginal suppositories were found to be clinically effective at the management of late-onset vulvovaginal side effects after radiotherapy.
Topics: Atrophy; Brachytherapy; Dyspareunia; Female; Humans; Vaginal Diseases; Vaginitis
PubMed: 33918070
DOI: 10.3390/ijerph18083932 -
PloS One 2019This open, prospective, multicenter, observational study was performed to investigate the efficacy and safety of a non-hormonal cream in women undergoing breast cancer... (Observational Study)
Observational Study
This open, prospective, multicenter, observational study was performed to investigate the efficacy and safety of a non-hormonal cream in women undergoing breast cancer treatment and experiencing vulvovaginal dryness symptoms. Overall, 128 patients from 22 study centers participated. The cream was applied to the vagina and vulva for 28 days. For the efficacy analysis, changes in subjective symptoms (feeling of dryness, itching, burning, pain independent of sexual intercourse, dyspareunia, urinary incontinence) were evaluated. Additionally, the following objective diagnostic findings were assessed by a physician: thinning of vaginal epithelium, redness, petechiae, and discharge. Safety and tolerability were assessed by evaluating type and frequency of adverse events, including adverse medical device-related effects. The frequency and intensity of all subjective symptoms significantly improved from baseline at 28 days (p<0.0001). Additionally, 21.4% of patients were completely free of symptoms (p<0.0001) and urinary incontinence was improved or eliminated in 30.8% of women. The overall sum score for all four objective findings was significantly improved from baseline at 28 days (p<0.0001). The frequency of petechial bleedings was significantly reduced (p<0.0001). Further, significant decreases in the severity of vaginal epithelium thinning, redness and petechiae were observed (p<0.0001). More than 88% of patients and investigators assessed the efficacy and tolerability as being good or very good. No serious adverse events were documented. This study demonstrates that the investigated cream is an effective and safe non-hormonal, topical option in the treatment of vulvovaginal dryness symptoms in patients undergoing breast cancer treatment for. However, the study duration and follow-up time of 4 weeks as well as the non-randomized trial design are limitations of the study.
Topics: Administration, Intravaginal; Administration, Topical; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Atrophy; Emulsions; Female; Humans; Lubricants; Menopause, Premature; Middle Aged; Prospective Studies; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases; Vulva
PubMed: 30677065
DOI: 10.1371/journal.pone.0210967