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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 -
The Journal of Rheumatology May 2024Vaginal dryness is an important factor influencing sexual function in women with primary Sjögren syndrome (pSS). Previous studies showed a higher degree of inflammation...
OBJECTIVE
Vaginal dryness is an important factor influencing sexual function in women with primary Sjögren syndrome (pSS). Previous studies showed a higher degree of inflammation in vaginal biopsies from patients with pSS compared to non-pSS controls. However, the molecular pathways that drive this inflammation remain unclear. Therefore, the aim of this study was to investigate inflammatory pathway activity in the vaginal tissue of patients with pSS.
METHODS
Vaginal biopsies of 8 premenopausal patients with pSS experiencing vaginal dryness and 7 age-matched non-pSS controls were included. Expression of genes involved in inflammation and tissue homeostasis was measured using NanoString technology and validated using TaqMan Real-Time PCR. Vaginal tissue sections were stained by immunohistochemistry for myxovirus resistance protein 1 (MxA) and CD123 (plasmacytoid dendritic cells [pDCs]).
RESULTS
The most enriched pathway in vaginal biopsies from patients with pSS compared to non-pSS controls was the interferon (IFN) signaling pathway ( < 0.01). Pathway scores for Janus kinase and signal transducer and activator of transcription (JAK-STAT) and Notch signaling were also higher ( < 0.01 for both pathways). Conversely, transforming growth factor-β signaling and angiogenesis pathway scores were lower in pSS ( = 0.02 and = 0.04, respectively). Differences in IFN signaling between patients with pSS and non-pSS controls were confirmed by PCR and MxA tissue staining. No CD123+ pDCs were detected in vaginal biopsies. IFN-stimulated gene expression levels correlated positively with CD45+ cell numbers in vaginal biopsies and serum anti-SSA/Ro positivity.
CONCLUSION
Upregulation of IFN signaling in vaginal tissue of women with pSS, along with its association with tissue pathology, suggests that IFNs contribute to inflammation of the vaginal wall and potentially also to clinical symptomatology (ie, vaginal dryness).
PubMed: 38561184
DOI: 10.3899/jrheum.2023-1068 -
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 -
Lancet (London, England) Mar 2024Globally, 9 million women are diagnosed with cancer each year. Breast cancer is the most commonly diagnosed cancer worldwide, followed by colorectal cancer in... (Review)
Review
Globally, 9 million women are diagnosed with cancer each year. Breast cancer is the most commonly diagnosed cancer worldwide, followed by colorectal cancer in high-income countries and cervical cancer in low-income countries. Survival from cancer is improving and more women are experiencing long-term effects of cancer treatment, such as premature ovarian insufficiency or early menopause. Managing menopausal symptoms after cancer can be challenging, and more severe than at natural menopause. Menopausal symptoms can extend beyond hot flushes and night sweats (vasomotor symptoms). Treatment-induced symptoms might include sexual dysfunction and impairment of sleep, mood, and quality of life. In the long term, premature ovarian insufficiency might increase the risk of chronic conditions such as osteoporosis and cardiovascular disease. Diagnosing menopause after cancer can be challenging as menopausal symptoms can overlap with other common symptoms in patients with cancer, such as fatigue and sexual dysfunction. Menopausal hormone therapy is an effective treatment for vasomotor symptoms and seems to be safe for many patients with cancer. When hormone therapy is contraindicated or avoided, emerging evidence supports the efficacy of non-pharmacological and non-hormonal treatments, although most evidence is based on women older than 50 years with breast cancer. Vaginal oestrogen seems safe for most patients with genitourinary symptoms, but there are few non-hormonal options. Many patients have inadequate centralised care for managing menopausal symptoms after cancer treatment, and more information is needed about cost-effective and patient-focused models of care for this growing population.
Topics: Female; Humans; Quality of Life; Menopause; Hot Flashes; Hormone Replacement Therapy; Breast Neoplasms
PubMed: 38458217
DOI: 10.1016/S0140-6736(23)02802-7 -
Lancet (London, England) Mar 2024The potential risk for mental health conditions over the menopause transition shapes women's expectations and informs putative physiological mechanisms regulating... (Review)
Review
The potential risk for mental health conditions over the menopause transition shapes women's expectations and informs putative physiological mechanisms regulating women's mental health. We review evidence from prospective studies reporting on associations between mental health conditions and the menopause transition. Major depressive disorder and the more prevalent subthreshold depressive symptoms are the most common conditions studied. We reviewed 12 prospective studies reporting depressive symptoms, major depressive disorder, or both over the menopause transition and found no compelling evidence for a universal increased risk for either condition. However, specific subgroups of participants, primarily defined by menopause-related risk factors (ie, vasomotor symptoms that are severe or disturb sleep, a long duration of the transition, or reproductive hormone dynamics) and psychosocial risk factors (eg, stressful life events), were vulnerable to depressive symptoms. The increased risk of major depressive disorder over the menopause transition appears predominantly in individuals with previous major depressive disorder. Greater focus on recognising risk factors in primary care is warranted. On the basis of scarce data, we found no compelling evidence that risk of anxiety, bipolar disorder, or psychosis is universally elevated over the menopause transition. Potential misattribution of psychological distress and psychiatric disorders to menopause could harm women by delaying accurate diagnosis and the initiation of effective psychotropic treatments, and by creating negative expectations for people approaching menopause. A paradigm shift is needed. We conclude with recommendations for the detection and treatment of depressive symptoms or major depressive disorder and strategies to promote good mental health over the menopause transition, while responsibly preparing and supporting those at risk.
Topics: Female; Humans; Mental Health; Depressive Disorder, Major; Prospective Studies; Menopause; Women's Health; Depression
PubMed: 38458216
DOI: 10.1016/S0140-6736(23)02801-5