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International Journal of Women's Health 2024Vulvar vaginal atrophy is a common condition affecting postmenopausal women, significantly impacting their quality of life. Fortunately, various treatment options are... (Review)
Review
Vulvar vaginal atrophy is a common condition affecting postmenopausal women, significantly impacting their quality of life. Fortunately, various treatment options are available, ranging from hormonal to non-hormonal therapies. Ospemifene has emerged as a promising non-hormonal alternative for managing vulvar vaginal atrophy. Its targeted approach, unique mechanism of action, favorable safety profile particularly for breast tissue, and efficacy make it a valuable option for women seeking relief from symptoms such as vaginal pain, dryness and dyspareunia and cannot receive estrogen supplementations. This is particularly the case for breast cancer survivors or women with a significant family history of estrogen-dependent cancers. Hence, tailored treatment plans, considering individual preferences and health circumstances, are essential in optimizing outcomes and improving the overall well-being of affected individuals.
PubMed: 38855356
DOI: 10.2147/IJWH.S431520 -
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 -
Annals of Translational Medicine Apr 2024The bladder neck area of the vagina is known as the "zone of critical elasticity" (ZCE). Adequate vaginal elasticity at ZCE is required for the oppositely-acting muscles... (Review)
Review
The bladder neck area of the vagina is known as the "zone of critical elasticity" (ZCE). Adequate vaginal elasticity at ZCE is required for the oppositely-acting muscles to independently close the distal urethra and bladder neck. Scarring at ZCE "tethers" the more powerful posterior muscles to the anterior muscles and the bladder neck is forcibly pulled open, resulting in massive urine loss. This condition is known as "tethered vagina syndrome" (TVS). In developed countries, the main cause of TVS is iatrogenic. Vaginal repairs, vaginal mesh, may cause scarring at ZCE and this directly links the oppositely-acting muscle forces. Over-elevated Burch colposuspensions may stretch the ZCE to the point where its elasticity is lost so the muscles can no longer function independently. The treatment is to dissect the vagina clear of the scarring and to insert a skin graft to the bladder neck to restore ZCE elasticity. In developing countries, extensive trauma to the vagina and bladder from obstructed childbirth can cause obstetric fistulas. In up to 40-50% of these women, there is ongoing massive urine loss after the fistula has been successfully closed. Performing a prophylactical skin graft during fistula closure if there is vaginal tissue deficit is proving to be revolutionary. In women with Goh type 4 fistula (n=45), 46% were cured (full dryness) against an expected 19%. The same operation can produce equally dramatic cures in women who continue to leak urine after successful fistula repair.
PubMed: 38721454
DOI: 10.21037/atm-23-1866 -
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 -
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 -
Gynecological Endocrinology : the... Dec 2024Dienogest (DNG) improves endometriosis-associated pain (EAP) and patients' quality of life; however, the modern cornerstone of the management of endometriosis is the...
BACKGROUND
Dienogest (DNG) improves endometriosis-associated pain (EAP) and patients' quality of life; however, the modern cornerstone of the management of endometriosis is the long-term adherence of the patient to medical treatment.
OBJECTIVE
To evaluate DNG as a long-term treatment of endometriosis, focusing on patients' compliance and side effects, also correlating with different phenotypes of endometriosis.
METHODS
This was a cohort study on a group of patients with endometriosis ( = 114) undergoing long-term treatment with DNG. During the follow up visits (12, 24, and 36 months) patients were interviewed: an assessment of EAP was performed by using a visual analogue scale (VAS) and side effects were evaluated by using a specific questionnaire of 15 items.
RESULTS
At 12 months, 81% were continuing the DNG treatment, with a significant reduction of dysmenorrhea, dyspareunia, dyschezia, dysuria and chronic pelvic pain. Of the 19% that discontinued the treatment: 62% was due to spotting, reduced sexual drive, vaginal dryness, and mood disorders. The improvement of EAP was significant for all endometriosis phenotypes, especially in patients with the deep infiltrating type. At 36 months, 73% of patients were continuing the treatment, showing a significant reduction of EAP through the follow up, along with an increase of amenorrhea (from 77% at 12 months to 93% at 36 months). In a subgroup of 18 patients with gastrointestinal disorders, DNG was administered vaginally at the same dosage, showing similar results in terms of efficacy and tolerability.
CONCLUSIONS
DNG was an effective long-term treatment for all endometriosis phenotypes, with few side effects that caused the discontinuation of the treatment mainly during the first year. Thus, the course of 1-year treatment is a predictive indicator for long-term treatment adherence.
Topics: Female; Humans; Endometriosis; Treatment Outcome; Cohort Studies; Quality of Life; Pelvic Pain; Nandrolone
PubMed: 38579790
DOI: 10.1080/09513590.2024.2336121 -
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 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... Mar 2024Vaginal dryness (VD) represents a significant concern affecting women across diverse life stages, encompassing both pre- and postmenopausal women at any age....
Prospective, multicenter, uncontrolled study on the effectiveness and safety of a hyaluronic acid water-based vaginal lubricant in alleviating vaginal dryness and dyspareunia.
BACKGROUND
Vaginal dryness (VD) represents a significant concern affecting women across diverse life stages, encompassing both pre- and postmenopausal women at any age. Dyspareunia, defined by genital pain that can be experienced before, during, or after intercourse, is often associated with vaginal dryness.
AIM
This study aimed to evaluate the effectiveness and safety of a water-based vaginal lubricant with hyaluronic acid to reduce sexual discomfort associated with vaginal dryness.
METHODS
A prospective, multicenter, uncontrolled clinical investigation was conducted over a three-month period in women aged 18 years or older experiencing pain or difficulty during sexual intercourse for whom the use of a vaginal lubricant was recommended.
RESULTS
Significant improvements were observed in the FSFI scores, indicating enhanced sexual function ( < .001). Vaginal dryness symptoms, including irritation, dryness, itching, and dyspareunia, significantly decreased after product use ( < .001).
CLINICAL IMPLICATIONS
This study contributes to the limited scientific knowledge on the application of lubricants in the context of symptoms associated with VD.
STRENGTHS & LIMITATIONS
In addition to the short study period, inherent limitations of the study design, and lack of placebo control, it is pertinent to acknowledge that some of the pros used in this study were not based on validated questionnaires. However, as far as we know, this study is the only one that analyzes well-being and sexual pleasure as results using a lubricant formulated with hyaluronic acid.
CONCLUSION
This tested vaginal lubricant with hyaluronic acid has demonstrated efficacy in improving vaginal dryness and female sexual function, particularly in reducing pain and improving lubrication during sexual intercourse, and showed a favorable safety profile, with minimal and transient adverse events.
Topics: Female; Humans; Atrophy; Dyspareunia; Hyaluronic Acid; Lubricants; Pain; Prospective Studies; Vagina; Vaginal Diseases; Water
PubMed: 38468593
DOI: 10.1080/09513590.2024.2317268 -
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