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Sleep Medicine: X Dec 2023To examine factors associated with poor sleep quality in community-dwelling midlife women.
OBJECTIVE
To examine factors associated with poor sleep quality in community-dwelling midlife women.
METHODS
Healthy women (aged 45-69 years) of Chinese, Malay and Indian ethnicities attending well-women clinics at the National University Hospital, Singapore, completed the Pittsburgh Sleep Quality Index (PSQI). A PQSI score >5 denoted poor sleep quality. The women filled out validated questionnaires covering menopausal and genito-urinary symptoms, and mental health. Physical performance was measured. Bone mineral density and visceral adiposity were assessed by dual energy X-ray absorptiometry. Binary logistic regression analyses assessed independent factors for poor sleep.
RESULTS
Poor sleep quality was reported in 38.2% of women (n = 1094, mean age: 56.4 ± 6.2 years). Indian women had higher sleep disturbance scores than Chinese women (mean ± SD: 1.33 ± 0.58 vs 1.17 ± 0.49). Malays experienced more daytime dysfunction (0.54 ± 0.60 vs 0.33 ± 0.55) and had a higher overall PSQI score (6.00 ± 3.31 vs 5.02 ± 2.97) than the Chinese. A low education level (aOR: 1.76, 95% CI: 1.01-3.05), feelings of irritability (2.67, 1.56-4.60) and vaginal dryness (1.62, 1.03-2.54) were associated with poor sleep quality in the adjusted multivariable model. Women with moderate to severe disability were ∼3 times (2.99, 1.20-7.44) more likely to experience less than ideal sleep quality, while urinary incontinence (1.53, 1.08-2.17) and breast cancer history (2.77, 1.36-5.64) were also associates of poor sleep quality.
CONCLUSION
Self-reports of education level, irritability, vaginal dryness, disability, urinary incontinence, and breast cancer history were independently related to poor sleep. Ethnic differences suggest the need for targeted interventions among the ethnic groups.
PubMed: 36568060
DOI: 10.1016/j.sleepx.2022.100060 -
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 -
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 -
Cureus Feb 2024Background Urogenital health is a necessary part of health for all women, especially in the postmenopausal age group. We suspected that the increased incidence of...
Background Urogenital health is a necessary part of health for all women, especially in the postmenopausal age group. We suspected that the increased incidence of vulvovaginal atrophy (VVA) had some or other effects on the quality of life of older women. So, we aimed to study VVA/genitourinary syndrome of menopause (GSM) and its impact on the quality of life of postmenopausal women in Central India. Despite its significant prevalence and detrimental impact on women's health, VVA/GSM is underdiagnosed and undertreated. In view of the feminization of aging, VVA management is becoming increasingly crucial. This study contributes to postmenopausal women's understanding that keeping their urogenital and sexual longevity is a critical step toward healthy living and gender equality. Given its relationship with urogynecological conditions, this study will help to evaluate both subjectively and objectively the incidence of symptoms related to VVA and its effects on the quality of life of postmenopausal women. This will eventually help to understand the need to address this issue while making postmenopausal women health-related policies. Potential remedies to overcome the obstacles currently preventing patient-HCP interactions addressing sexual health include providing communication tools to facilitate the "uncomfortable" conversation, educating women, and providing enough training for healthcare professionals. Methods The current study was conducted at a rural tertiary healthcare center in Central India and is a cross-sectional study. The study population taken into consideration were all the postmenopausal women between the age group 45 and 75 years with at least one vulvovaginal symptom attending the Outpatient Department (OPD). The total study sample size was 100 women. Further study was conducted by interview method using a questionnaire by the principal investigator. Data was gathered with the help of a pretested questionnaire in the patient's language. Symptoms related to GSM were studied by the vaginal symptom Bothersomeness Scale. Further, a gynecological clinical examination for the confirmation of VVA was carried out, which included a gynecological physical examination. The Vaginal Health Index (VHI) was calculated for each female using the score scale. Assessment of the quality of life of postmenopausal females using the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire was performed. Results The majority of females (34%) who presented with the symptoms were in the category of 55-60 years followed by 22% in the age group of 61-65 years. The most common symptoms experienced by females were vaginal dryness (77%) followed by vaginal discharge (74%). Our study confirmed that 79% of the total females included in the study have a VHI score of less than 15, i.e., they suffer from VVA, thus presenting our incidence at 79%. Conclusion According to the surveys discussed in this research, a significant portion of postmenopausal women have symptoms linked to VVA that have a negative impact on their quality of life, including their sexual relationships and self-esteem.
PubMed: 38529421
DOI: 10.7759/cureus.54802 -
Gynecological Endocrinology : the... Dec 2024To assess menopausal symptoms and determine awareness of menopausal related information in mid-aged women.
OBJECTIVE
To assess menopausal symptoms and determine awareness of menopausal related information in mid-aged women.
METHODS
This was a cross-sectional study in which 140 women aged 40 to 60 years from Guayaquil, Ecuador were surveyed with the short 10-item Cervantes Scale (CS-10) and a questionnaire containing personal data and questions assessing awareness of menopause related information.
RESULTS
The mean age of the sample was 48.0 ± 5.6 years. More than half of surveyed women had low education and non-urban residency, none were on menopausal hormone therapy, 33.6% had hypertension, 35% were postmenopausal, 78.6% had an increased body mass index (overweight/obese) and 92.9% had abdominal obesity (waist > 88 cm). The average CS-10 score was 15.3 ± 9.0 with a median of 14.0. The three most frequent menopausal symptoms were muscle-joint pain (75.0%), changes in skin texture (74.3%) and vaginal dryness (71.4%). Regarding awareness of information related to the menopause, it was found that 98.6% of women had no idea about what the menopause is and the average age of its onset. Interestingly, although 61.4% knew that during the menopause there is weight gain, 57.9% were sedentary. Married, postmenopausal, older and less educated women presented higher mean total CS-10 scores. Contrarily, those with less awareness of menopause related information present lower scores.
CONCLUSION
In this low-income mid-aged female sample there was a high rate of non-awareness regarding information related to the menopause, including an unhealthy cardiometabolic profile. There is a need for educational programs aimed to increase awareness in this high-risk population in relation to the surveyed aspects in order to improve their health status and prevent chronic conditions.
Topics: Female; Humans; Middle Aged; Adult; Ecuador; Cross-Sectional Studies; Menopause; Hormone Replacement Therapy; Hypertension; Surveys and Questionnaires; Obesity
PubMed: 38563054
DOI: 10.1080/09513590.2024.2333418 -
Cureus Apr 2024Background Menopause is a physiological state that occurs in all women and refers to the halt of the reproductive phase. The cessation of the reproductive phase occurs...
Background Menopause is a physiological state that occurs in all women and refers to the halt of the reproductive phase. The cessation of the reproductive phase occurs through various stages and presents different symptoms such as hot flashes, night sweats, insomnia, anxiety, depression, and irritability. Such pre- and post-menopausal symptoms may affect the daily activities and production capacities of women, impacting the quality of life (QoL) of women. Hormone replacement therapy (HRT) is primarily used to manage menopausal symptoms. However, various side effects have been reported related to HRT. Therefore, women are choosing alternative medicine such as Ayurveda that can benefit them with less or no adverse effects. Shatavari () is known in Ayurveda as an effective medicinal plant source for various women's health remedies since ancient times. This study aimed to evaluate the safety and efficacy of the Ayurvedic Shatavari formulation on menopausal symptoms compared to the placebo. Methodology This is a randomized, double-blinded, multicenter, placebo-controlled, clinical study. Altogether, 70 patients were randomized to two groups, i.e., the test group (active group) and the placebo group (microcrystalline cellulose), with 35 participants in each group. Results The study outcomes showed a positive and significant effect of the active test ingredient over the placebo in terms of reduction in hot flashes, night sweats, insomnia, anxiety, nervousness, vaginal dryness, and loss of libido. The Utian QoL improved significantly in the test group compared to the placebo group. No significant adverse events were recorded in the test group, suggesting the safety of this formulation. Conclusions The test compound could be a safe alternative to modern drugs. The findings of this study support the traditional use of Shatavari. Further clinical and pharmacological studies with longer duration and larger and more diverse sample sizes are required to understand the generalized effect of Shatavari root extract in menopausal women.
PubMed: 38725785
DOI: 10.7759/cureus.57879 -
Scientific Reports Jan 2024The genitourinary symptom of menopause (GSM) affects up to 65% of women, resulting in symptoms such as vulvovaginal dryness, discomfort, and dysuria, which significantly...
The genitourinary symptom of menopause (GSM) affects up to 65% of women, resulting in symptoms such as vulvovaginal dryness, discomfort, and dysuria, which significantly impacts quality of life. The current assessment methods rely on subjective questionnaires that can be influenced by individual differences, as well as invasive measurements that are time-consuming and not easily accessible. In this study, we explore the potential of a non-invasive and objective assessment tool called diffuse reflectance spectroscopy and imaging (DRSI) to evaluate tissue chromophores, including water, lipid, oxyhemoglobin, and deoxyhemoglobin. These measurements provide information about moisture content, lipid levels, oxygen saturation, and blood fraction, which can serve as surrogate markers for genital estrogen levels. Our findings reveal distinct differences in these chromophores among pre, peri, and postmenopausal subjects. By using lipid and blood fraction tissue chromophores in a K-Nearest Neighbour classifier model, we achieved a prediction accuracy of 65% compared to vaginal maturation index (VMI) that is clinically used to assess estrogen-related hormonal changes. When age was included as the third feature, the accuracy increased to 78%. We believe that by refining the study protocol and configuring the fiber probe to examine tissue chromophores both in the superficial vulva skin for epidermal water content and the deeper layers, DRSI has the potential to provide objective diagnosis and aid in monitoring the treatment outcome of GSM.
Topics: Female; Humans; Pilot Projects; Quality of Life; Menopause; Vagina; Spectrum Analysis; Estrogens; Water; Lipids; Atrophy
PubMed: 38212347
DOI: 10.1038/s41598-023-49655-4 -
Maturitas May 2024To assess clinical characteristics of postmenopausal women with moderate/severe vulvovaginal atrophy, as well as its impact on sexual function, well-being, and quality... (Observational Study)
Observational Study
OBJECTIVES
To assess clinical characteristics of postmenopausal women with moderate/severe vulvovaginal atrophy, as well as its impact on sexual function, well-being, and quality of life, and to provide an overview of most used treatments.
STUDY DESIGN
Ongoing longitudinal, observational study conducted in 17 Italian gynecology centers, involving women already treated or initiating a local vaginal estrogen therapy or ospemifene. We report baseline data for women with and without a history of breast cancer. Participants filled in self-reported questionnaires at study entry.
MAIN OUTCOME MEASURES
Severity of vulvovaginal atrophy; ongoing treatments; patient-reported outcomes, including severity of symptoms, Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and SF-12® Health Survey.
RESULTS
Overall, 334 women (20.4 % with a history of breast cancer) started or continued local therapy (61.1 %) or ospemifene (38.8 %) at study entry. Vulvovaginal atrophy was severe in 28.6 %, and was responsible for severe symptoms, particularly vulvar dryness with burning or irritation and pain during sexual intercourse. Both sexual dysfunction (FSFI≤26) (81.5 %) and sexual distress (FSDS-R ≥ 11) (74.4 %) were common. A reduction in the SF-12 mental component score was documented. Women with breast cancer more often had severe vulvovaginal atrophy (41.2 %), had more severe symptoms, and the impact of vaginal symptoms on emotional well-being, sexual functioning and self-concept/body image was greater. The majority of them (83.8 %) received ospemifene as a treatment.
CONCLUSIONS
Moderate/severe vulvovaginal atrophy is a common, often neglected condition with an impact on QoL and sexuality, particularly in women with a history of breast cancer. It is important to alleviate the burden associated with the disease.
Topics: Female; Humans; Atrophy; Breast Neoplasms; Patient Satisfaction; Quality of Life; Tamoxifen; Vagina; Vaginal Diseases; Vulva
PubMed: 38462385
DOI: 10.1016/j.maturitas.2024.107950 -
Internet Interventions Jun 2024No web-based interventions addressing sexual problems are available for young adult survivors of childhood cancer.
BACKGROUND
No web-based interventions addressing sexual problems are available for young adult survivors of childhood cancer.
AIM
This study aimed to test the efficacy of a web-based psychoeducational intervention, Fex-Can Sex, to alleviate sexual problems in young adults treated for cancer during childhood.
METHOD
This randomized controlled trial tested the effects of a 12-week, self-help, web-based intervention. Young adults (aged 19-40) reporting sexual dysfunction were drawn from a population-based national cohort of childhood cancer survivors and randomized to either an intervention group (IG, = 142) or a wait-list control group (CG, = 136). The primary outcome was 'Satisfaction with sex life' assessed by the PROMIS® SexFS v 2.0. Secondary outcomes included other SexFS domains, body image (BIS), emotional distress (HADS), health-related quality of life (EORTC QLQ-C30), and sex-related self-efficacy. Surveys were completed at baseline (T0), directly after the intervention (T1), and three months later (T2). The effects of the intervention were tested using -test and linear mixed models, including intention-to-treat (ITT) and subgroups analysis. Adherence was based on log data extracted from the website system. The intervention included an open-ended question about perceived sexual problems.
RESULTS
No effect of the intervention was found in the primary outcome. Regarding secondary outcomes, the IG reported less vaginal dryness (Lubrication subscale) than the CG at T1 ( = 0.048) and T2 ( = 0.023). Furthermore, at T1, the IG reported less emotional distress than the CG ( = 0.047). Subgroup analyses showed that those with greater sexual problems at T0 improved over time (T1 and T2), regardless of group allocation. Overall, adherence to the intervention was low and participants' activity levels did not change the results. Additionally, some members of the IG reported increased understanding and acceptance of their sexual problems.
CONCLUSION
The Fex-Can Sex intervention shows potential to improve sexual function, especially among those with greater dysfunction. To increase adherence and effect, we recommend the intervention to be further developed including more tailored content.
CLINICAL TRIAL REGISTRATION
ISRCTN Registry, trial number: 33081791 (registered on November 27, 2019).
PubMed: 38623084
DOI: 10.1016/j.invent.2024.100739