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Phase 2 randomized study of abobotulinumtoxinA in patients with provoked vestibulodynia: dose-finding results.

Hypertonicity of the pelvic floor muscles is commonly associated with provoked vestibulodynia (PVD); therefore, patients may benefit from treatments that relax the pelvic floor. To define optimal (safe and efficacious) doses of abobotulinumtoxinA (aboBoNT-A) for the treatment of PVD associated with hypertonic pelvic floor muscle dysfunction and to explore use of a novel endpoint for pain assessment for PVD. This phase 2, randomized, placebo-controlled study comprised two steps: dose escalation (Stage 1) and dose expansion (Stage 2). Stage 1 included up to four treatment cycles; Cycle 1 was double blind, Cycles 2-4 open label. Patients were assessed for retreatment every 6weeks. Stage 2 was not conducted because of early study termination by the sponsor, unrelated to observed safety signals. Enrolled patients-premenopausal women with PVD with associated pelvic-floor hypertonia-were randomized (n = 60) 4:1 to receive aboBoNT-A (doses: 100, 300, 400, or 500units [U]) or placebo. The primary endpoint was safety. Additionally, a novel composite endpoint, dilator maximum tested size was evaluated. This endpoint combined assessment of vaginal-dilator tolerability with patient-reported pain assessment on an 11-point numeric rating scale, used as a surrogate measure of sexual activity in this study. All treatment-emergent adverse events (AEs) were mild or moderate in intensity, with no serious AEs or AEs leading to withdrawal reported in the double-blind period. AEs of special interest (urinary incontinence, anal sphincter atonia) were observed at low incidence and predominantly with higher aboBoNT-A doses. The dilator test composite score might be a useful endpoint for pain assessment, with a greater reduction in pain score noted for the 300U dose group compared with other dose groups and placebo. aboBoNT-A was well tolerated in patients with PVD and a novel method for assessing dilator-induced pain was introduced. The study provided valuable data on use of aboBoNT-A in women with primary or secondary PVD and introduced a novel composite endpoint for assessing dilator-induced pain. Study limitations included the small sample size, limiting formal statistical analysis. aboBoNT-A was well tolerated in patients with PVD with no safety signals reported. Further studies are warranted to demonstrate clinically meaningful benefits with repeated treatment. NCT03598777.

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Endogenous testosterone levels moderate the negative impact of gender-related discrimination on well-being among LGBTQ+ individuals.

Previous studies have explored protective factors against gender minority stress among lesbian, gay, bisexual, transgender, queer, and other gender and sexually diverse (LGBTQ+) individuals. However, many of these studies have relied on self-report data, which may limit the validity of their findings due to potential common method bias. The present study seeks to understand the biological and psychological underpinnings of the stress-buffering mechanism among LGBTQ+ individuals, specifically examining the protective role of testosterone. A total of 107 LGBTQ+ individuals completed a survey on gender-related discrimination, loneliness, and well-being. Additionally, they provided a saliva sample, which was used to derive their endogenous testosterone levels. The main outcome was well-being, measured using the World Health Organization-Five Well-Being Index. The findings revealed that gender-related discrimination was associated with heightened levels of loneliness, which in turn were associated with reduced well-being. Testosterone levels significantly moderated the association between gender-related discrimination and well-being. Specifically, among individuals with higher levels of testosterone, the negative association between discrimination and well-being was not significant. These results suggest that higher levels of testosterone may protect against the psychological consequences of gender-related discrimination. This study represents a pioneering effort to gather empirical evidence on the protective role of testosterone among LGBTQ+ individuals, but it is unlikely that a single biomarker (testosterone) can fully capture the complexity of resilience. Understanding the biological and psychological foundations of minority stress necessitates the integration of multiple biological factors. Such an approach would provide a more comprehensive understanding of the stress-buffering mechanisms operating among LGBTQ+ individuals. The study suggests that testosterone may play a significant role in reflecting and regulating the response to gender minority stress.

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Photobiomodulation therapy for the treatment of vulvar pain among those with provoked vestibulodynia: a randomized controlled trial.

Provoked vestibulodynia (PVD) is characterized by recurring pain confined to the vulvar vestibule; histological studies show inflammatory mediators and neural proliferation in the vulvar tissues. To determine whether a 15-session photobiomodulation (PBM) intervention is more effective than sham-PBM for reducing vulvar pain. Secondary objectives were to evaluate the effect of the PBM intervention on broader domains of vulvar pain, psychological outcomes, sexual function, perceived improvement and satisfaction, as well as to describe adverse events and adherence. Randomized controlled trial. Participants with PVD were recruited from the local community. Randomized allocation to real- or sham-PBM (1:1) was concealed from participants and all members of the research team until after data analysis was complete. Primary outcomes: pressure pain threshold (PPT), pain reported on the tampon test, and vulvar pain sensitivity reported on the Vulvar Pain Assessment Questionnaire (VPAQ). Secondary outcomes: pain-related domains reported on the VPAQ, sexual function, depression, anxiety and stress, pain catastrophizing, central sensitization to pain, Patient Global Perception of Improvement (PGPI), Perceived overall percent improvement (P%I), perceived satisfaction with treatment (%), adherence and adverse events. The primary end point was one week following the last PBM intervention session. Fifteen sessions of a real- or sham-PBM intervention were delivered over an 8-week period, progressing through five stages of incremental exposure to light in the red and near-infrared spectra applied to the vulvar vestibule, the perineum, and the sacral region. Thirty participants (16 real-PBM, 14 sham-PBM) enrolled and received their intended intervention; one (sham-PBM) was lost to follow-up. Vulvar pain was reduced more in the real- compared to the sham-PBM group; between group differences were 28.2-112.0g/cm2 (d = 0.61) for PPT, 0.1-2.5 1(d = 0.60) for pain reported on the tampon test, and 0.1-0.9 (d = 0.87) for pain sensations reported on the VPAQ. Changes in other pain-related domains reported on the VPAQ, psychological outcomes and sexual function were not different between the real- and sham-PBM groups. Adherence to the intervention was nearly 100% among those who completed the study. Most participants in both groups were satisfied or very satisfied with the intervention (real-PBM = 80%; sham-PBM = 64%), with no group differences in satisfaction or perception of improvement. The PBM intervention resulted in greater reductions in vulvar pain than the sham intervention. However, patients did not perceive that the real-PBM was significantly better than the sham-PBM intervention, and the intervention did not impact psychological outcomes or sexual function. ClinicalTrials.gov Identifier: NCT04234542.

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Device-assisted versus manual circumcision: a prospective, comparative, multicenter study.

Circumcision is a common urological procedure performed for various medical, cultural, religious, and aesthetic reasons. This study aimed to compare the effectiveness and safety of device-assisted (DeCi) and manual circumcision (MaCi) in adult European patients. We conducted a prospective, comparative, non-randomized multicenter study including 200 consecutive adult males undergoing circumcision under local anesthesia. Patients were divided into two groups (MaCi or DeCi) based on patient preferences following proper counseling. Follow-up was scheduled at 1week and 1month post-surgery. Surgical and postoperative outcomes were recorded, with patient satisfaction with aesthetic results as the primary outcome, and procedure-related complications as secondary outcomes. Satisfaction was assessed using a 5-point Likert scale, while postoperative complications were classified using the Clavien-Dindo (CD) system. A total of 200 patients (100 per group) were included. The DeCi group had a significantly shorter mean operative time than the MaCi group (11.20 ± 5.92 vs. 23.20 ± 7.93minutes, P < .001). Patient satisfaction with aesthetic results was significantly higher in the DeCi group, with 67.4% of patients being "very satisfied" or "satisfied" compared to 36.7% in the MaCi group (P < .001). The DeCi group also reported significantly lower perceived pain during surgery (mean ± SD visual analogue scale [VAS] score: 1.54 ± 1.77 vs. 4.20 ± 2.10 points, P = .025) and at 1month postoperatively (mean ± SD VAS score: 0.54 ± 1.03 vs. 2.35 ± 2.77, P < .001). Intraoperative and postoperative complication rates were similar between groups, with no significant differences (P > .05). Only 5% of patients in the MaCi group and 4% in the DeCi group experienced a CD Grade ≥ 3 postoperative complication. DeCi appears to offer superior aesthetic outcomes and reduced pain compared to MaCi, making it a promising option for circumcision in adult European men. This is the first study directly comparing DeCi and MaCi in a European adult population. The study's strengths include its prospective multicenter design, large sample size, and use of validated tools for outcome evaluation, which enhance the reliability and generalizability of the results. However, the non-randomized design, the age difference between groups, the testing of only one circumcision device model, and the lack of a cost-effectiveness analysis limit the generalizability of the findings. In adult European men, DeCi offers superior aesthetic results and a similar safety profile compared to MaCi, though further research is needed to address the study's limitations.

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Cross-sectional and prospective associations between self-compassion and sexual distress in couples coping with sexual interest/arousal disorder.

When an individual in a relationship is coping with low desire/arousal, both partners experience difficulties, including higher levels of sexual distress. Effective emotional regulation strategies, such as self-compassion, could have individual and interpersonal benefits for couples with sexual interest/arousal disorder (SIAD). Using a dyadic design, we examined the role of self-compassion in the sexual distress of couples coping with SIAD, accounting for overall relationship satisfaction. The associations were analyzed cross-sectionally and prospectively. We also explored the moderating roles of having at least one member identify as sexually or gender diverse within the couple in the potential associations between self-compassion and sexual distress. Individuals with SIAD and their partners (N = 263 couples) completed online measures at baseline and 6months later. Individuals with SIAD and their partners completed the Sexual Distress Scale-Short Form and the Couples Satisfaction Index. Controlling for relationship satisfaction, when individuals coping with SIAD and their partners reported greater self-compassion at baseline, they also reported lower sexual distress. For partners only, greater self-compassion was associated with the person with SIAD's lower levels of sexual distress at baseline. No statistically significant prospective associations were found between levels of self-compassion and sexual distress 6months later. Belonging to a sexually diverse couple was a significant moderator of the cross-sectional associations between partners' level of self-compassion and their own level of sexual distress at baseline, such that the link between greater self-compassion and lower sexual distress was observed only in partners belonging to a sexually diverse couple. Belonging to a gender diverse couple did not moderate any of the associations. Findings indicate that self-compassion could be a promising tool to reduce sexual distress in couples coping with SIAD. Strengths of this study include the large, diverse sample of couples coping with SIAD, the use of a cross-sectional and prospective design, and the examination of the moderating role of belonging to a gender or sexually diverse couple. However, the possible lack of statistical power to measure moderation based on belonging to a gender diverse couple and the recall bias due to the use of self-report questionnaires should be considered when interpreting the results. Greater self-compassion is associated with lower sexual distress in both partners of couples coping with SIAD. Self-compassion may be particularly beneficial for partners of individuals with SIAD belonging to a sexually diverse couple.

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Toys in the bedroom: use of sexual devices in partnered sexual activity is associated with higher female orgasmic intensity, arousal, and sexual satisfaction and is not related to psychopathologies.

Sex devices are tools that can improve the sexual health of users, but their effects on sexual outcomes in partnered intercourse have rarely been evaluated. The aim of this study was to assess the relationship between partnered and solitary use of sex devices and different sexual health outcomes among sexually active women aged 18-35 in a heterosexual relationship. The cross-sectional descriptive study was conducted with 361 participants between May and June 2023 recruited through a social media campaign. Female sexual function was measured with the Female Sexual Function Index and the Orgasmometer-F. The Generalized Anxiety Disorder scale, the Patient Health Questionnaire and the Dark Future Scale were used to investigate psychological health. Statistical analysis was performed with the statistical software R; the significance level for statistical analyses was set as P<0.05. The outcomes of the study include female sexual function and orgasmic intensity, as well as measures of symptoms of anxiety, depression, and uncertainty for the future. Compared to those who only used sex devices for solitary masturbation, women using sex devices in the context of partnered intercourse had higher arousal and satisfaction scores (P= 0.042 and P= 0.004, respectively), as well as higher subjective perception of orgasmic intensity over the last 6months (P= 0.005) and in partnered sexual intercourse in the last 4weeks (P= 0.002). Conversely, orgasmic intensity during masturbation in the last 4weeks was higher among solitary users (P< 0.001). No significant difference was found between the two study groups for all other outcome measures. The use of sex devices in the context of partnered intercourse is associated with increased sexual function and more intense orgasmic experience. The study investigates a novel topic, on a large sample size, by using several validated instruments to measure sexual functioning of participants. However, a definite cause-effect relationship cannot be established due to the study design. Self-report bias and lack of clinical data on study participants are further limitations. Additionally, being a study limited to heterosexual, sexually active women involved in a relationship, results cannot be generalized to all women. The study found an association between better sexual functioning and use of sex devices in partnered intercourse.

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Evaluation of the efficacy of novel treatment strategy to treat Dhat syndrome: a pilot study.

Dhat Syndrome is difficult to treat due to the unwavering belief of the patients about the harmful effects of semen loss. We hypothesized that this belief can be overcome by objective demonstration of zero health benefit of zero semen loss using reversible anejaculation property of silodosin. To prospectively evaluate the efficacy of objective demonstration of zero health benefits of zero semen loss as treatment strategy to alter the mental construct of the Dhat syndrome patients using a randomized double blind placebo controlled two arm switchover study design. The patients with complaints of Dhat syndrome were recruited post-confirmation of the diagnosis by Dhat Syndrome Evaluation Questionnaire (DSEQ). After excluding participants based on exclusion criteria, participants' anxiety and perceived physical fitness was assessed using Hamilton Anxiety Rating Scale (HARS) and Perceived Physical Fitness Scale (PPFS) respectively. They were randomized into two groups with Group 1 receiving placebo and Group 2 receiving silodosin 8mg respectively with counseling being common for both. After 2months, and a drug wash out period of 7 days, the participants were switched and interventions continued for another two months. In the end, Dhat symptomatology with DSEQ, anxiety with HARS and perceived physical fitness with PPFS were assessed and compared with initial assessment and discussed with the participants in a one to one session. Main outcome measure: The post-intervention change in Dhat Syndrome symptomatology in our study participants. A total of 32 adult males grouped as 1 (N = 18, mean age 28.9 ± 4.8years) and 2 (N = 14, mean age 27.4 ± 4.3years) participated in the study with none and 59% reporting semen loss while on silodosin and placebo respectively. The PPFS showed no statistically significant difference irrespective of the type of treatment in our participants and approximately 2/3rds of the participants reported relief from Dhat symptomatology and significant reduction in anxiety related to semen loss. Objective demonstration of zero health benefits of total prevention of semen loss to the patients of Dhat syndrome directly contradicts the unwavering belief about the harmful effects of semen loss in these patients thus altering their mental constructs. Prospective randomization design and objective demonstration of zero health benefits of zero semen loss are the strengths and the small sample size is the limitation of the study. The alteration of the mental construct of the Dhat syndrome patients using novel treatment strategy was successful in majority of our study participants.

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Sexual dysfunction in female patients with multiple sclerosis: relationship with functional status, fatigue, depression, sleep quality, and quality of life.

Although sexual dysfunction is one of the most common symptoms in patients with multiple sclerosis (MS), there are relatively few studies on this topic. The aim of this study was to assess sexual function in female MS patients and investigate its association with functional state, fatigue, depression, sleep, and quality of life. This descriptive cross-sectional study was conducted between May and November 2019 with MS patients attending an MS outpatient clinic at a university hospital. Patients' sexual function was assessed using the Female Sexual Function Index (FSFI). Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Multiple Sclerosis Quality of Life Scale (MSQoL-54) were used to determine their relationship to sexual function. Sexual function, functional status, depression, sleep quality, and quality of life. The mean age of the 83 patients included in the study was 41.8 (±8.5) years, and all were married. The mean FSFI score of the patients was 21.1 (±8.9) and 26.55, 72.3% of patients were found to have sexual dysfunction. FSFI scores were found to have a negative correlation with age (r = -0.398, P = .001), duration of diagnosis (r = -0.338, P = .001), and EDSS scores (r = -0.326, P = 0.040). Patients taking symptomatic medication (P = .032) and antidepressants (P = .012) had lower mean FSFI scores. Additionally, the FSFI score showed a significant negative correlation with the FSS (r = -0.368, P = .001), the BDI (r = -0.423, P < .001), the PSQI (r = -0.314, P = .004), and the MSQoL-54 (physical health: r = 0.509, P < .001 and mental health: r = 0.431, P < .001). A comprehensive evaluation of sexual dysfunction and the development of tailored treatment plans, taking into account associated factors, will be beneficial for female patients with MS. Small sample size and assessment of sexual function by a generic scale are the limitations of this study. Considering the multifactorial nature of sexual dysfunction in female MS patients, it is recommended that patients be assessed multidimensionally during outpatient follow-up visits.

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