Examining the Relationship Between Behçet's Disease and Depression, Anxiety, and Sexual Dysfunctions. / Behçet Hastaligi ile Depresyon, Anksiyete ve Cinsel Islev Bozukluklari Arasindaki Iliskinin Incelenmesi.

OBJECTIVE: People with Behçet's Disease, as many individuals with chronic diseases, often face depression, anxiety, poor quality of life and sexual problems. In this study, it was aimed to evaluate depression, anxiety, and sexual dysfuntions in people with Behcet's Disease. METHOD: A total of 100 participants, 50 patients (29 female) and 50 healthy volunteers (28 female), participated in the study. Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Female Sexual Function Index (FSFI), and International Index of Erectile Function (IIEF) were administered to the participants. RESULTS: Depression and sexual dysfunctions were significantly related with Behçet's Disease. In our study, all female participants with Behçet's Disease had problems in sexual functions. Erectile dysfunction was more frequent in participants with Behcet's. The results also showed that there is a significant relationship between depression and orgasmic function (p=0.004), sexual desire (p=0.028), sexual satisfaction (p=0.023), and general satisfaction (p=0.028). There was a significant difference between people with Behçet's Disease (10.54±6.45) and healthy group (7.36 ±6.13) in depression scores (p=0.009). Patients with systemic involvement and those with mucocutaneous involvement were found to be similar in terms of BDI and BAI scores (p>0.05). CONCLUSION: Behçet's Disease was found to be a risk factor for depression and sexual dysfunctions.

Systemic immune-inflammatory index and its association with female sexual dysfunction, specifically low sexual frequency, in depressive patients: Results from NHANES 2005 to 2016.

Sexual dysfunction, particularly in females, is a complex issue influenced by various factors, including depression and inflammation. The Systemic immune-inflammation index (SII), an inflammatory biomarker, has shown associations with different health conditions, but its relationship with female sexual dysfunction (FSD) remains unclear. This study aimed to investigate the association between SII and FSD in the context of depression, utilizing low sexual frequency as an assessment indicator. Data from the National Health and Nutrition Examination Survey (NHANES) 2005 to 2016, involving 1042 depressed female participants, were analyzed. FSD, indicated by low sexual frequency, and SII, derived from complete blood count results, were assessed. Logistic regression and subgroup analyses were conducted, considering demographic and health-related factors. A total of 1042 individuals were included in our analysis; 11.5163% of participants were categorized as having FSD, which decreased with the higher SII tertiles (tertile 1, 13.8329%; tertile 2, 13.5447%; tertile 3, 7.1839%; p for trend < 0.0001). Multivariate linear regression analysis showed a significant negative association between SII and FSD [0.9993 (0.9987, 0.9999)]. This negative association in a subgroup analysis is distinctly and significantly present in the Mexican American subgroup [0.9959 (0.9923, 0.9996)], while it does not reach statistical significance in other racial categories. Furthermore, the association between SII and FSD was nonlinear; using a 2-segment linear regression model, we found a U-shaped relationship between SII and FSD with an inflection point of 2100 (1000 cells/µL). In summary, in depressed individuals, a higher SII is independently associated with a decreased likelihood of FSD, emphasizing the potential role of inflammation in female sexual health.

Dysorgasmia in women: Case report and preliminary assessment guide.

Dysorgasmia in women is an infrequent reason for consulting a clinician. In this article, the authors describe the case of a woman with right-sided pelvic pain immediately after orgasm. Dysorgasmia is likely to negatively impact sexual health but is rarely discussed in medical literature. Furthermore, assessment and treatment guidelines for clinicians are currently lacking. Therefore, the authors conducted a literature review and created a preliminary assessment guide, considering both medical and gray literature. A brief flowchart was developed which can facilitate the assessment of dysorgasmia in women for clinicians and improve the quality of care for patients. Further research on the etiology and pathophysiology of dysorgasmia in women is warranted, as is a more proactive attitude of clinicians to discuss sexual health. More guidance on diagnosis and treatment is needed.

Female sexual dysfunction and distress in premenopausal women with migraine followed in a tertiary headache center: A pilot study.

BACKGROUND: Female sexual dysfunction (FSD) is an underdiagnosed and undertreated problem. Few studies have addressed sexual distress in migraine. We aimed to perform a pilot study to determine if there is an association between migraine and sexual dysfunction/distress in premenopausal women and to identify their respective risk factors. METHODS: Retrospective, cross-sectional pilot study, including 71 premenopausal female patients with migraine, from the headache outpatient clinic of a tertiary hospital, and 34 age-matched-controls. Female Sexual Function Index-6 (FSFI-6), Female Sexual Distress Scale-Revised (FSDS-R), Migraine Disability Assessment (MIDAS) Scale, Brief Pain Inventory (BPI), Hospital Anxiety and Depression Scale (HADS) and Sleep Health Scale (RU-SATED) were applied. RESULTS: Of the 71 patients [40.0 (IQR = 11.00) years], only 12.7 % (n = 9) were not under migraine prophylactic treatment, and most (n = 33, 62.3 %) reported severe disability (MIDAS-IV). FSD and sexual distress were present in 50.7 % (36) patients with migraine [vs 20.6 % (7) controls]. Migraine patients showed lower FSFI-6 scores [19.0 (9.0) vs 24.0 (6.0), p = 0.005], with significantly lower levels of desire (p = 0.011), lubrication (p = 0.002), and satisfaction (p = 0.013), higher sexual distress [11.2 (25.6) vs 3.2 (9.6), p = 0.001], anxiety (p < 0.001), and depression (p < 0.001) levels, and lower sleep health scores (p = 0.005). Old age of onset, being under preventive medication, anxiety/depression, and dysfunctional sleep, were significantly associated with sexual distress. Certain domains of sexual function were associated with sociodemographic and migraine characteristics, anxiety, depression, and sleep health. CONCLUSIONS: This pilot study highlights the possible association between migraine and elevated sexual dysfunction/distress levels among premenopausal women. It underscores the importance of sexual health assessments in these individuals, particularly those with higher levels of anxiety, depression, or poor sleep quality. It is important to exercise caution when interpreting results, as they may not be applicable to a wider context. This research paves the way for a larger study that will include a broader population of women from the community and encompass patients followed in different levels of health care.

[HORROR, SHAME AND GUILT IN THE BEDROOM: THE EFFECTS OF EXPOSURE TO TRAUMA ON SEXUAL FUNCTION].

INTRODUCTION: Since the brutal October 7, 2023 attacks on Israel, the encroachment of the battlefield into the daily lives of all Israelis has impacted both civilians and combatants in various ways. The development of post-traumatic stress reactions has far-reaching effects across numerous aspects of life. One of the lesser-discussed consequences is the onset of sexual dysfunction. Reactions to such distressing events can adversely affect sexual desire, arousal, orgasm, the frequency of sexual activities, and satisfaction derived from them. These issues may present directly in clinical settings, or indirectly through other symptoms. The impact of trauma on sexual function can be attributed to disruptions in biological mechanisms, cognitive impairments, mood changes, and diminished motivation. This review explores how responses to post-traumatic stress relate to sexual function. We present case studies of patients recovering from such events, describe the underlying mechanisms that trigger these adverse reactions, and discuss interventions that can enhance sexual health, which can be implemented in primary care settings. It is advisable for assessments of sexual function to be included in routine evaluations by primary care physicians. Early identification of sexual dysfunction can help prevent the progression of more persistent issues and enhance overall quality of life for patients.

Sexual Interventions in the Metaverse: Attitudes Towards Novel Therapeutic Approaches, a Qualitative Study.

BACKGROUND AND OBJECTIVE: Mental health treatment for psychosexual problems is effective, but treatment rates are low. Metaverse-based therapy offers one solution to increase overall treatment rates. Understanding attitudes towards this novel approach could lead to wider adoption of metaverse-based therapy, resulting in higher treatment rates for psychosexual problems. METHODS: Twenty-one participants across three focus groups of different ages shared their perceptions and attitudes about metaverse-based therapy broadly and for treating sexual disorders. A content analysis of the transcribed text from the focus groups using qualitative data analysis software was conducted. RESULTS: Participants identified several perceived benefits of metaverse-based intervention, including avoiding the perceived embarrassment of going to a clinic and accessing patients (a) with diverse physical or mental functionality, (b) living in remote areas and/or (c) balancing different family/work obligations or duties. The two main concerns with metaverse-based therapy were the fear of online therapy being less personal than traditional therapy and the technological fluency needed. Clarifying their acceptance of the therapy, participants reported that they would be more likely to engage in metaverse-based therapy if they trusted their therapist. Also, although it might be effective for mild and moderate disorders, participants were more reluctant about its use for severe mental illness. CONCLUSIONS: Results suggest that attitudes towards metaverse-based intervention are mainly positive, since it removes some barriers that hinder access to psychological treatment in general and, specifically, for problems of a sexual nature. PATIENT AND PUBLIC CONTRIBUTION: During the design stage, a person with sexual difficulties was consulted to understand the patient's perspective. Members of the public advised the implementation of the focus groups. Three potential service users were involved in the coding of the text during the content analysis.

Association of Body Image and Genital Self-Image with Female Sexual Function: A Systematic Review.

The aim of this study was to identify, through a systematic review, how perceptions of genital and body self-image can influence the sexual function of young adult women. A systematic review was performed in which 704 studies were selected. After analyzing the articles, only 10 articles were included, from which the data for this research were extracted. The studies showed that there is an association between body and genital image and sexual function. However, those perceptions carry independent and distinct values depending on the associated condition and the audience being evaluated.

Exploring the Associations of Personality and Sexual Health Using the DSM-5 Alternative Model for Personality Disorders.

This study explored the relationships between sexual health indicators (i.e., sexual satisfaction, distress, and function) and the DSM-5 Alternative Model for Personality Disorders, a promising dimensional framework for assessing personality pathology. A sample of 489 participants seeking help in private practice clinics completed self-report measures of sexual satisfaction, distress, and function, as well as dyadic adjustment, psychological distress, romantic attachment, personality impairment, and pathological personality facets. Results first showed that participants reaching the cutoffs for a personality disorder had significantly higher sexual distress and lower sexual function compared to participants without a personality disorder. Second, path analyses controlling for psychological distress, dyadic adjustment, and romantic attachment revealed that, for women, the Criterion B Intimacy Avoidance facet was consistently linked with higher sexual distress and lower sexual satisfaction and function. For men, result patterns were more complex, linking Criterion B Separation Insecurity with high sexual distress, and Separation Insecurity and Intimacy Avoidance facets with low sexual function. In addition, Criterion B Irresponsibility, Rigid Perfectionism, as well as Criterion A Intimacy impairment were linked with higher sexual satisfaction. These findings improve our understanding of the links between personality and sexual health and provide support for considering personality difficulties in sexual health interventions.

Current investigation of the high prevalence of sexual dysfunction in female patients with systemic lupus erythematosus: a cross-sectional study.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that affects women of childbearing age and has been reported to cause sexual dysfunction in women. Although there are articles on sexual function in women with SLE, the number of articles is small, and the factors affecting sexual function in women with SLE are controversial. Based on this, this study aimed to investigate the prevalence of sexual dysfunction in Chinese female SLE patients and to explore the factors that influence it. The study design was a cross-sectional study conducted from December 2023 to April 2024 in the Department of Rheumatology and Immunology of a tertiary hospital in Hefei, Anhui Province. A total of 293 female patients diagnosed with SLE were enrolled using face-to-face questionnaires and online questionnaires. The questionnaire consisted of four parts: general information questionnaire, fatigue severity scale (FSS), depression-anxiety-stress scale (DASS-21), and female sexual functioning index (FSFI) scale. A total of 173 (59.04%) patients had sexual dysfunction, including 251 (85.67%) with decreased libido and 186 (63.46%) with difficulty in sexual arousal. There was a correlation between the patients' total FSFI scores and age (p = 0.028), marital satisfaction (p < 0.001), own education level (p = 0.008), partner's education level (p = 0.003), place of residence (p = 0.039), monthly household income (p < 0.001), family financial satisfaction(p < 0.001), menstrual status (p = 0.003), hormone use (p = 0.021),immunosuppressant use (p = 0.042), disease activity (p = 0.016), FSS score (p < 0.001), stress score (p < 0.001), anxiety score (p < 0.001) and depression score (p < 0.001)were correlated. The results of stepwise regression analysis showed that marital satisfaction (b = 2.011, t = 3.797, p < 0.001), monthly household income (b = 0.854, t = 2.316, p = 0.021), menstrual status (b = 1.218, t = 2.350, p = 0.019), fatigue scale score (b = - 0.069, t = - 2.302, p = 0.022), and depression score (b = - 0.117, t = - 2.910, p = 0.004) were the influencing factors of FSFI total score, and the difference was statistically significant. The incidence of sexual dysfunction in Chinese female SLE patients is high, and medical personnel should pay more attention to patients' sexual problems, to provide theoretical and practical bases for further prevention, treatment, and care of sexual dysfunction in female SLE patients.

Sexual dysfunction among female patients with rheumatic diseases.

To demonstrate the burden of sexual dysfunction (SD) among females with rheumatic diseases, we conducted a cross-sectional comparative study in patients with systemic sclerosis (SSc), systemic lupus erythematosus (SLE), and Behçet's syndrome (BS) along with suitable healthy controls (HCs). Age-matched female patients with SSc (n = 50), SLE (n = 49), and BS (n = 54), along with 52 female HCs were included in this study between April and October, 2021. Sociodemographic features were recorded, and psychometric tests, i.e., female sexual function index (FSFI), Beck depression inventory (BDI), body cathexis scale, and marital adjustment test (MAT) were performed. Scale scores were compared, and binary logistic regression was used to identify predictors for SD in the whole group. The total FSFI and body cathexis scores among the patient groups were significantly lower than those of the HCs (p < 0.001). Depression was significantly more frequent in the patient groups. MAT scores did not differ significantly between the study groups. Patients with SSc had the worst scores in each psychometric index, including MAT. Decreased body cathexis score [OR 0.974, 95% CI (0.957-0.991), p = 0.003] and low MAT score [OR 0.937, 95% CI (0.896-0.980), p = 0.005], and being diagnosed with SSc [OR 6.6, 95% CI (1.975-22.498), p = 0.002], SLE [OR 2.7, 95% CI (0.998-7.753), p = 0.050], and BS [OR 2.8, 95% CI (1.100-7.359), p = 0.031], were identified as independent predictors for SD. Body cathexis seems to be the most important independent predictor for SD, and the burden of SD appears heavier in patients with SSc, probably due to poor body image satisfaction.

The Interplay of Worry and Relationship Satisfaction to Understand Sexual Distress: An APIM Study with Heterosexual Couples Using Cross-Sectional Data.

The current study takes an integrative approach, considering individual transdiagnostic processes and relationship outcomes. It assumes an interdependence approach and aims to test a dyadic model to analyze the impact of worry and relationship satisfaction on heterosexual couples' sexual -distress, an essential factor for diagnosing sexual dysfunction. The current study recruited 103 couples from the community to complete an online survey containing the Female Sexual Distress Scale-Revised, the Penn State Worry Questionnaire - Abbreviated, and the Global Measure of Relationship Satisfaction. The results show that women's and men's worries are associated with their own sexual distress, and men's relationship satisfaction has an effect on their own and their partner's sexual distress. These results highlight the critical role of cognitive processes in shaping the experience of sexual distress and reinforce the importance of taking an integrative perspective that considers relationship (satisfaction), individual (worry) and social factors (gender) in interventions to treat sexual distress.

New management approaches for female sexual dysfunction.

PURPOSE OF REVIEW: The goal of this paper is to review the most recent studies evaluating treatments for female sexual dysfunction (FSD), including distressing symptoms of desire, arousal, and orgasm disorder. We divide the sections into psychological and pharmacological. RECENT FINDINGS: There is excellent evidence in favour of mindfulness, cognitive behavioural therapy, and psychoeducation for improving low sexual desire in women, and less evidence in support of these approaches to address other sexual dysfunctions in women. There are two US Food and Drug Administration (FDA) approved pharmacological treatments for low desire in premenopausal women that have modest benefits above placebo, and a significant proportion of users will experience side effects. Evidence also supports the use of transdermal testosterone for low desire in postmenopausal women. SUMMARY: Sexual dysfunction in women is common and distressing, and there are a variety of psychological and pharmacological treatments. More research is needed to better understand the predictors of a positive treatment response in order to deliver more personalized care.

Sexual abuse and dysfunction in people with addiction problems and the general population. A descriptive study.

The fact of having suffered Childhood Sexual Abuse (ASI) is considered a risk factor for the subsequent development of sexual dysfunctions, these being more frequent among women than among men. The objective of this work is to analyze the different sexual dysfunctions in people who have suffered ASI, with addiction problems and in the general population. The sample is made up of 426 participants (241 men and 185 women). A retrospective ex post facto study has been carried out using a sociodemographic data questionnaire (ad hoc) and the Golombok Rust Inventory of Sexual Satisfaction (GRISS). For data analysis, the Kolomogorov-Smirnov and Mann Whitney U tests were performed. The Mann-Whitney U test has been carried out to verify if there are significant differences between the people who present sexual dysfunction, between the groups that have suffered sexual abuse and have addiction problems, and the group that has not suffered sexual abuse and have addiction problems. The results indicate that the variables in which significant differences are found are the following: Dissatisfaction (p = 0.013), Avoidance (p < 0.001), No sensuality (p = 0.008), Vaginismus (p < 0.001), Anorgasmia (p < 0.001), erectile dysfunction (p = 0.045), and premature ejaculation (p = 0.007). The average scores that have been obtained among people who have addiction problems, without having suffered ASI in comparison with those who have suffered it, are the following: Dissatisfaction (5.09 vs. 6.41), Avoidance (2.03 vs. 2.22), No Sensuality (2.96 vs. 4.50), Vaginismus (0.88 vs. 2.94), Anorgasmia (0.97 vs. 3.78), Erectile Dysfunction (2.41 vs. 1.69), Premature Ejaculation (3.60 vs. 2.22). People who have suffered ASI present, with a greater probability, sexual dysfunctions than those who have not suffered it.

An analytic cross-sectional study of Somali women on the sexual and psychosocial status during pregnancy.

BACKGROUND: Pregnancy is associated with physical, psychological, hormonal, and social alterations that may lead to detrimental effects on sexual function and psychological well-being. This study sought to examine sexual function and psychosocial well-being of pregnant women in Somalia in comparison with their non-pregnant counterparts. METHODS: We enrolled 487 consecutive women in monogamous marriages. Data included maternal age, gravida, parity, gestational week, education status of wives and husbands, and residence area. The participants completed the Female Sexual Function Index (FSFI) and the Brief Symptom Inventory-18 (BSI-18). RESULTS: Of 487 women, 241 were pregnant, and 246 were non-pregnant. The overall incidence of sexual dysfunction was 57.7%, being 64.0% for pregnant and 51.6% for non-pregnant women (p = 0.010). Pregnant women exhibited significantly lower FSFI scores on desire, arousal, lubrication, and orgasm, and significantly higher total BSI, anxiety, depression and somatization scores. The frequencies of sexual dysfunction were 57.9%, 45.9%, and 78.9% during the first, second, and third trimesters, respectively (p = 0.0001). As compared with the first and second trimesters, and non-pregnancy, the third trimester of pregnancy was associated with a significantly lower total FSFI score and significantly decreased levels of desire, arousal, lubrication, and orgasm, as well as a significantly higher total BSI score and a significantly increased level of anxiety. In regression analysis, pregnancy was inversely associated with sexual function parameters of desire, arousal, lubrication, and orgasm, and with BSI parameters of depression, anxiety and somatization. CONCLUSION: Our findings suggest that pregnant women experience considerable sexual and psychosocial deterioration as compared with their non-pregnant counterparts.

Can cognitive behavioral therapy improve vasomotor symptoms and recurrent depression in postmenopausal women?

OBJECTIVE: The aim of this study was to evaluate the effectiveness of cognitive behavioral therapy in the treatment of vasomotor, sexual dysfunction, and recurrent depression in postmenopausal women. METHODS: This prospective, open study evaluated 112 postmenopausal women with vasomotor symptoms. Sexual dysfunction has cultural, social, biological, and emotional issues and divided into two groups: G1, without depression (n=65) and G2, with recurrent depression (n=47). The subjects underwent 12 sessions of in-person cognitive behavioral therapy and 12 sessions of home-based activity over a period of 6 months. They were evaluated at 3 months following the completion of therapy. Depression, memory, and attention-related functions, as well as climactic symptoms, were assessed using a questionnaire. RESULTS: In the depression questionnaire, the G1 group had a lower initial score than the G2 group (p<0.01). Following 6 months of therapy, both groups had similar improved scores. In the depression questionnaire, the women in group G1 had higher baseline values. In the assessment of vasomotor symptoms, the values in both groups were similar and showed an improvement in vasomotor symptoms after 24 weeks of treatment, but these effects disappeared after the follow-up of 48 weeks in the G2 group. Both groups improved the sexual dysfunction after 24 weeks. CONCLUSION: Cognitive behavioral therapy may be effective in reducing vasomotor symptoms and ameliorate the sexual dysfunction and recurrent depression in postmenopausal women after 24 weeks of treatment.

Prostate Cancer Related Sexual Dysfunction and Barriers to Help Seeking: A Scoping Review.

OBJECTIVE: Despite available support, sexuality needs are the most frequently reported unmet need among men with prostate cancer, which may be due to low help-seeking rates. Using the Ecological Systems Framework as a theoretical foundation, we conducted a scoping review of the available literature to understand what factors impact help-seeking behaviour for sexual issues after prostate cancer treatment among men who had received treatment. METHODS: Following PRISMA guidelines, a systematic search on Medline, PsychInfo, Embase, Emcare, and Scopus was conducted to identify studies of adult prostate cancer patients post-treatment, which reported barriers and/or facilitators to help-seeking for sexual health issues. Quality appraisals were conducted using Joanna Briggs Institute appraisal tools, and results were qualitatively synthesised. RESULTS: Of the 3870 unique results, only 30 studies met inclusion criteria. In general, studies were considered moderate to good quality, though only six used standardised measures to assess help-seeking behaviour. Barriers and facilitators for sexual help-seeking were identified across all five levels of the Ecological Systems Framework, including age, treatment type, and previous help seeking experience (individual level), healthcare professional communication and partner support (microsystem), financial cost and accessibility of support (meso/exosystem), and finally embarrassment, masculinity, cultural norms, and sexuality minority (macrosystem). CONCLUSIONS: Addressing commonly reported barriers (and inversely, enhancing facilitators) to help-seeking for sexual issues is essential to ensure patients are appropriately supported. Based on our results, we recommend healthcare professionals include sexual wellbeing discussions as standard care for all prostate cancer patients, regardless of treatment received, age, sexual orientation, and partnership status/involvement.

Nonalcoholic fatty liver disease and female sexual dysfunction in Egyptian premenopausal women: is there a link between metabolic syndrome and sexual function?

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a major health problem with a paucity of available information about its impact on female sexual dysfunction (FSD). AIM: We aimed to study the association between NAFLD and FSD in Egyptian premenopausal women. METHODS: Sexually active married premenopausal women who visited our NAFLD outpatient screening clinic (2019 to 2022) were divided into NAFLD and non-NAFLD (control) groups based on liver ultrasound and fatty liver index data. All participants completed the Arabic Female Sexual Function Index (ArFSFI) questionnaire. The resulting data were used to calculate the domains and total scores. FSD is then graded as follows: no FSD (≥28.2), minimal (21.7-28.1), mild (14.5-21.6), moderate (7.3-14.4), and severe (≤7.2). OUTCOMES: We determined the proportions of patients and controls for whom ArFSFI scores indicated dissatisfaction with their sexual lives. RESULTS: Of 995 women participants whose FSFI scores were available, NAFLD was detected in 487 (48.9%) and absent in 508 (51.1%). The two groups were comparable in age, socioeconomic level, residence, and history of female genital cutting. The NAFLD patients had significantly much lower mean scores for the sexual arousal, lubrication, orgasm, satisfaction, and pain domains of the FSFI (P < .001 for all), while no statistical difference was noticed in the desire domain for NAFLD patients compared with the controls. NAFLD women had significantly lower mean total FSFI scores than the controls (mean [SD] 16.7 [6.8] vs 21.7 [5.1], respectively; P < .001) with higher rates of FSD (98.5% vs 82.1%; P < .001, respectively). Most NAFLD women had higher FSD grades than controls (%): no FSD (1.5, 17.9), minimal (20.6, 51.8), mild (42.5, 38.8), moderate (26.2, 9.4), and severe (10.7, none), respectively. CLINICAL IMPLICATIONS: Given the high prevalence of FSD in patients with NAFLD, greater attention to FSF could improve the quality of life in patients with NAFLD. STRENGTHS AND LIMITATIONS: This study was limited by the lack of testing of sex hormones and some other important factors that were not tested (eg, age, socioeconomic level, residence, and female genital cutting), as these characteristics were previously matched. Strengths of the study include the large study size, to our knowledge the largest to date to investigate the possible link between FSD and NAFLD in premenopausal women, together with the inclusion of the detailed version of the validated ArFSFI. CONCLUSIONS: In Egyptian premenopausal women, NAFLD could harm their sexual function.

Comparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder.

BACKGROUND: Efficacy assessments in clinical trials of treatments for female sexual arousal disorder (FSAD) and other female sexual dysfunction (FSD) diagnoses rely on various patient-reported outcomes (PROs). AIMS: We sought to compare 1-month recall PRO measures among participants enrolled in a clinical trial who provided these data without (test population) vs with (control population) use of an at-home, 24-hour recall electronic diary (eDiary), capturing similar data. METHODS: Preplanned subset analysis as performed during a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream, 3.6% (sildenafil cream) among healthy premenopausal women with FSAD. Preliminary product efficacy was assessed via 1-month recall and 24-hour recall questionnaires. A subset of the participants, the Evaluation of Recall Subset [ERS] provided PROs via the 1-month recall instruments but did not provide data via the 24-hour recall eDiary. OUTCOMES: Responses to the 1-month recall instruments were compared among ERS (test) vs non-ERS (control) participants. Among the non-ERS population, correlations between 1-month and 24-hour recall endpoints were calculated. RESULTS: There were no significant differences in the study co-primary 1-month recall efficacy endpoints, the Arousal Sensation (AS) domain of the 28-item Sexual Function Questionnaire (SFQ28) and the Female Sexual Distress Scale - Desire, Arousal, Orgasm question 14, among ERS vs non-ERS participants during the initial 1-month no-drug run-in period or the 1-month single-blind placebo run-in period (P values > .47). Scores on these 1-month recall PROs continued to be similar after randomization for sildenafil cream (P values > .30) and placebo cream (P values > .20) assigned ERS and non-ERS participants during the 3-month double-blind dosing period. There were strong correlations between the SFQ28 AS and eDiary AS scores during the no-drug run-in (R = 0.79, P < .01) and the single-blind run-in (R = 0.73 P < .001). During the double-blind dosing period, the SFQ28 AS score continued to be highly correlated with the eDiary AS score among sildenafil cream users (R = 0.83; P < .001) and placebo cream users (R = 0.8; 2 P < .001). CLINICAL IMPLICATIONS: There was no evidence that 1-month recall PRO instruments introduce recall bias; assessing arousal sensations with 24-hour vs 1-month PRO instruments is similar and either method could be used to assess efficacy depending on study objectives. STRENGTHS AND LIMITATIONS: This preplanned subset analysis compared efficacy of PROs based on recall duration. While the subset was preplanned, the study was powered to detect significant differences in the primary efficacy objectives, not among this subset analyses. CONCLUSION: These data will be used in planning future efficacy assessments of sildenafil cream for FSAD. CLINICAL TRIAL REGISTRATION: This clinical trial was registered with ClinicalTrials.gov, NCT04948151.