{"title":"Efficacy and safety of simenafil in men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group, phase 3 trial.","authors":"Yuzhuo Yang, Xiansheng Zhang, Tao Jiang, Lianming Zhao, Fubiao Li, Wenliang Yao, Junhong Deng, Xiangsheng Zhang, Jin Yang, Zhigang Ji, Zhigang Tong, Yun Chen, Zhen Wang, Jiaxiang Juan, Huaqing Duan, Hui Jiang","doi":"10.1093/jsxmed/qdaf109","DOIUrl":"https://doi.org/10.1093/jsxmed/qdaf109","url":null,"abstract":"<p><strong>Background: </strong>Simenafil, a potent and highly selective oral phosphodiesterase type 5 (PDE5) inhibitor, is currently under investigation for erectile dysfunction (ED) treatment.</p><p><strong>Aims: </strong>To evaluate the efficacy and safety of simenafil for ED treatment.</p><p><strong>Methods: </strong>This was a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 3 study in men aged 18-75 years with a history of ED of 6 months or more. The subjects were randomized in a ratio of 1:1:1:1 to on-demand receive fixed-dose either placebo or simenafil (2.5 mg, 5 mg or 10 mg) for 12 weeks.</p><p><strong>Outcomes: </strong>Primary efficacy endpoints were the least square mean (LSM) changes from baseline to week 12 in the erectile function (EF) domain of the International Index of Erectile Function (IIEF), percentages of \"yes\" responses to sexual encounter profile (SEP) diary question 2 (SEP Q2: Were you able to insert your penis into your partner's vagina?) and question 3 (SEP Q3: Did your erection last long enough for you to have successful intercourse?).</p><p><strong>Results: </strong>A total of 765 patients were randomized and 92.3% completed the study. The mean age of subjects was 41.3 years and 81.6% had moderate to severe ED (mean overall International Index of Erectile Function-Erectile Function (IIEF-EF) domain score 13.4). After 12 weeks of treatment, doses of 2.5, 5, and 10 mg of simenafil exhibited substantial increases than placebo in IIEF-EF score (12.3, 12.3, 12.7 vs. 9.6), the percentages of \"yes\" responses to SEP Q2 (40.58%, 42.43%, 43.98% vs. 32.05%), and SEP Q3 (61.91%, 63.70%, 65.19% vs. 46.70%) (all P < .001). Adverse drug reactions (ADRs) occurred in 36.2% of patients who received simenafil (32.6% in simenafil 5 mg group, the clinically recommended dose) and in 30.9% of those who received placebo. The most common (≥2%) ADRs were dizziness, headache, flushing, nasal congestion, and dry mouth, and most were mild or moderate. Furthermore, abnormal vision (PDE6 related) and myalgia (PDE11 related) did not occur in patients who received simenafil.</p><p><strong>Clinical implications: </strong>Simenafil is highly effective in all 3 dose groups and has a low effective dose and good safety profile, providing a novel, favorable treatment option for patients with ED.</p><p><strong>Strengths and limitations: </strong>The efficacy and safety evaluation of simenafil in difficult-to-treat patients with ED, ED patients with other concomitant diseases, and other ethnic populations was not performed.</p><p><strong>Conclusion: </strong>Simenafil is an effective and well-tolerated therapy for patients with ED.</p>","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aya Mohamed Nasr, Mohab Alsaid Saad, Amer Salah Mohamed, Yousif Ahmad Hanafi, Bilal Walid Bazbaz, Sarra Salah Amer Mohamed, Sayed Mahmoud Selim, Zaid Fatehi Altawallbeh
{"title":"Efficacy of CO2 laser vs vaginal estrogen in perimenopausal women with genitourinary syndrome of menopause: systematic review and meta-analysis.","authors":"Aya Mohamed Nasr, Mohab Alsaid Saad, Amer Salah Mohamed, Yousif Ahmad Hanafi, Bilal Walid Bazbaz, Sarra Salah Amer Mohamed, Sayed Mahmoud Selim, Zaid Fatehi Altawallbeh","doi":"10.1093/jsxmed/qdaf153","DOIUrl":"https://doi.org/10.1093/jsxmed/qdaf153","url":null,"abstract":"<p><strong>Background: </strong>Genitourinary syndrome of menopause (GSM) is characterized by vaginal dryness, itching, burning, pain during intercourse, and urinary symptoms. Traditionally, hormone replacement therapy (HRT), specifically estrogen therapy, has been the first-line treatment for GSM, due to its side effects, fractional CO2 laser therapy has emerged as an alternative for managing GSM symptoms.</p><p><strong>Aim: </strong>The primary focus is to compare CO2 fractional laser therapy and estrogen therapy on postmenopausal women with GSM through systemically reviewing all the randomized controlled trials.Methods: A comprehensive search of electronic databases, including PubMed, Scopus, Web of Science, Medline, Cochrane, Scielo, UC Berkeley library, and Google Scholar, was performed in October 2024. The inclusion criteria targeted randomized controlled trials comparing CO2 fractional laser therapy and estrogen therapy on postmenopausal women with GSM, which used at least 1 of these outcomes: Female Sexual Function Index (FSFI), Vaginal Health Index, Visual Analog Score, and Urinary Distress Inventory 6.</p><p><strong>Results: </strong>Out of 688 studies, 7 studies were included for final analysis with a total of 302 participants: 154 had CO2 fractional laser therapy with a mean age of 55.9 years, and 148 had estrogen therapy with a mean age of 57.2 years. The analysis revealed no statistically significant difference between CO2 laser and estrogen in Vaginal Health Index (mean difference [MD], 1.60; 95% CI, -0.36 to 3.56; P = .09), FSFI-total (MD, 0.10; 95% CI, -2.03 to 2.23; P = .93), and Urinary Distress Inventory 6 (MD, -3.18; 95% CI, -6.77 to 0.42; P = .08). We used a sensitivity analysis on the FSFI-arousal subscale due to high heterogeneity, excluding 1 study. It showed that the CO2 laser group had a statistically significant difference when compared with the estrogen group (MD, 0.47; 95% CI, 0.15-0.79; P = .01).</p><p><strong>Conclusion: </strong>CO2 laser therapy is an effective line of treatment for GSM. However, its comparison with estrogen therapy did not reach a statistically significant difference favoring one line over the other.</p>","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144576890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tuncay Toprak, Deniz Kulaksiz, Muhsin Balaban, Basar Ayribas, Asgar Garayev, Sule Yildirim Kopuk, Recep B Degirmentepe, Mehmet O Ozgur, Eda Ozcan, Ahmet Guzel, Ismail Baglar, Mehmet Yilmaz
{"title":"The impact of female and male İnfertility on men's depression, anxiety, sexual function, self-esteem, and quality of life: a prospective cross-sectional study from Turkiye.","authors":"Tuncay Toprak, Deniz Kulaksiz, Muhsin Balaban, Basar Ayribas, Asgar Garayev, Sule Yildirim Kopuk, Recep B Degirmentepe, Mehmet O Ozgur, Eda Ozcan, Ahmet Guzel, Ismail Baglar, Mehmet Yilmaz","doi":"10.1093/jsxmed/qdaf156","DOIUrl":"https://doi.org/10.1093/jsxmed/qdaf156","url":null,"abstract":"","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144530985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrew Shin, William Boysen, Alexandra J Berger Eberhardt, Martin Kathrins
{"title":"Exclusion of sexual and gender minorities from erectile dysfunction clinical trials.","authors":"Andrew Shin, William Boysen, Alexandra J Berger Eberhardt, Martin Kathrins","doi":"10.1093/jsxmed/qdaf117","DOIUrl":"10.1093/jsxmed/qdaf117","url":null,"abstract":"","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":"1287-1288"},"PeriodicalIF":3.3,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144136403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrew Rosenzweig, Joseph Visingardi, Paul Feustel, Michael Pignanelli, Elise De, Brian Inouye, Charles Welliver
{"title":"Antihypertensive medications and erectile dysfunction: is this association accurate?","authors":"Andrew Rosenzweig, Joseph Visingardi, Paul Feustel, Michael Pignanelli, Elise De, Brian Inouye, Charles Welliver","doi":"10.1093/jsxmed/qdaf108","DOIUrl":"10.1093/jsxmed/qdaf108","url":null,"abstract":"","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":"1285-1286"},"PeriodicalIF":3.3,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144144296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Association between lower urinary tract symptoms and female sexual function: results from the GENitourinary syndrome of menopause in JApanese women (GENJA) study.","authors":"Yumi Ozaki, Hikaru Tomoe, Mayuka Shimomura, Noriko Ninomiya, Yuki Sekiguchi, Yoshikazu Sato, Yoshimitsu Takahashi, Satoru Takahashi","doi":"10.1093/jsxmed/qdaf080","DOIUrl":"10.1093/jsxmed/qdaf080","url":null,"abstract":"<p><strong>Background: </strong>Female sexual dysfunction (FSD) is highly prevalent in women with lower urinary tract symptoms (LUTS); however, few studies have assessed the association between specific LUTS and FSD.</p><p><strong>Aim: </strong>To identify which specific LUTS are associated with which domains of female sexual function in Japanese women.</p><p><strong>Methods: </strong>Data from 1337 sexually active women aged 40-79 years who participated in the GENitourinary syndrome of menopause in JApanese women (GENJA) study were analyzed. All participants answered web-based questionnaires including the Core Lower Urinary Tract Symptom Score, Female Sexual Function Index (FSFI), and Vulvovaginal Symptoms Questionnaire. We used multivariable regression to assess the association between LUTS and FSFI domain scores, adjusted for age, menstrual status, hormone therapy, hypertension, dyslipidemia, diabetes mellitus, and depression.</p><p><strong>Outcomes: </strong>FSFI domain and total scores associated with LUTS.</p><p><strong>Results: </strong>The mean age of participants was 54.0 ± 10.7 years. Women with LUTS were more likely to have lower total FSFI scores than those without, except for increased daytime urinary frequency. The multivariate analysis revealed that nocturia was associated with lower orgasm scores (coefficient: -0.23; 95% confidence interval [CI]: -0.45 to -0.01; P = .044), urgency with lower pain scores (coefficient: -0.62; CI: -1.09 to -0.14; P = .011), stress urinary incontinence (coefficient: -0.51; CI: -0.90 to -0.12; P = .011), and vaginal bulge/lump sensations (coefficient: -0.42; CI: -0.81 to -0.04; P = .031) with lower satisfaction scores.</p><p><strong>Clinical implications: </strong>This study highlights the need to include routine assessments of sexual function in women with LUTS.</p><p><strong>Strengths and limitations: </strong>This is the first study to comprehensively examine the association between specific LUTS and FSFI domain scores using validated questionnaires in a nationwide epidemiological survey among sexually active Japanese women. Limitations include non-random participant selection and reliance on self-reported data, which represent subjective symptoms.</p><p><strong>Conclusion: </strong>LUTS, including nocturia, urgency, stress urinary incontinence, as well as vaginal bulge/lump sensations, were associated with FSD regardless of age, menstrual status, lifestyle-related diseases, or depression.</p>","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":"1139-1146"},"PeriodicalIF":3.3,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144008337","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to: Association between surgeon procedure volume and reoperation rates for penile prosthesis implantation.","authors":"","doi":"10.1093/jsxmed/qdaf128","DOIUrl":"10.1093/jsxmed/qdaf128","url":null,"abstract":"","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":"1307"},"PeriodicalIF":3.3,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144095569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Baptiste Sauterey, Virginie Berger, Clémence Herrenschmidt, Julia De Freitas, Anne Patsouris, Nathalie Beaumont, Manon Marmouset De La Taille
{"title":"Sexual dysfunction in women with breast cancer: the role of patient education.","authors":"Baptiste Sauterey, Virginie Berger, Clémence Herrenschmidt, Julia De Freitas, Anne Patsouris, Nathalie Beaumont, Manon Marmouset De La Taille","doi":"10.1093/jsxmed/qdaf116","DOIUrl":"10.1093/jsxmed/qdaf116","url":null,"abstract":"","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":"1289-1290"},"PeriodicalIF":3.3,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144129608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
George Van Doorn, Garry Power, Peter Gill, Robert Teese, Shaun Watson, Jacob Dye
{"title":"Sexual problems among a representative sample of Australian men who have experienced physical and emotional intimate partner abuse.","authors":"George Van Doorn, Garry Power, Peter Gill, Robert Teese, Shaun Watson, Jacob Dye","doi":"10.1093/jsxmed/qdaf093","DOIUrl":"10.1093/jsxmed/qdaf093","url":null,"abstract":"<p><strong>Background: </strong>The experiences of being emotionally and physically abused by a romantic partner are associated with several deleterious outcomes including poor mental health, being sexually assaulted, and partner homicide.</p><p><strong>Aim: </strong>To explore the roles of emotional and physical abuse in relation to men's sexual functioning.</p><p><strong>Methods: </strong>The sample comprised 5642 Australian men (Mage = 45.87 years, SD = 12.36) who completed Wave 4 (2022) of the Australian Longitudinal Study on Male Health: Ten to Men (T2M). As part of the T2M survey, participants completed questions relating to physical and emotional intimate partner abuse, and the National Survey of Sexual Attitudes and Lifestyles - Sexual Function subscale (Natsal-SF). Hierarchical binary logistic regression analyses were conducted to explore whether experiences of abuse in romantic relationships predicted the likelihood of sexual dysfunction in Australian men.</p><p><strong>Outcomes: </strong>The variance in sexual dysfunction explained by men's experiences of physical and emotional abuse over and above the variance explained by relevant covariates.</p><p><strong>Results: </strong>The analyses showed that, after controlling for several covariates, physical abuse was not associated with any physio-psychological aspects of sexual dysfunction. However, emotional abuse was significantly associated with all aspects of physio-psychological functioning except for reaching climax more quickly than the man would have liked and experiencing pain as a result of sex.</p><p><strong>Clinical implications: </strong>The results have important implications for relationship therapy and intimacy counselling, with greater awareness of how emotional abuse impacts sexual functioning providing valuable insight for men and their partners.</p><p><strong>Strengths and limitations: </strong>The study used data from the Australian Longitudinal Study on Male Health, which sourced data from a nationally representative sample of Australian men. A potential limitation is that individual Natsal-SF items were used in lieu of the total score, and thus the same variance may be explained in multiple analyses.</p><p><strong>Conclusion: </strong>The results suggest that emotional abuse is more damaging to male sexual functioning than physical abuse.</p>","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":"1196-1205"},"PeriodicalIF":3.3,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144188510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Paula Norinho, Rosa Zulmira Vaz de Macedo, Mariana M Martins, Hélder Ferreira
{"title":"Comparison of Enzian and rASRM classifications in predicting symptoms of sexual dysfunction in endometriosis.","authors":"Paula Norinho, Rosa Zulmira Vaz de Macedo, Mariana M Martins, Hélder Ferreira","doi":"10.1093/jsxmed/qdaf086","DOIUrl":"10.1093/jsxmed/qdaf086","url":null,"abstract":"<p><strong>Background: </strong>Endometriosis is known to negatively impact sexual function; however, limited research has explored whether classification systems can help pinpoint specific anatomical locations associated with sexual dysfunction. This study was necessitated by the paucity of literature on classification systems that allow clinicians to associate specific symptoms of sexual dysfunction with particular locations of deep infiltrating endometriosis (DIE).</p><p><strong>Aim: </strong>This study aimed to investigate whether the Enzian and revised American Society for Reproductive Medicine (rASRM) classification systems can predict sexual dysfunction based on the localization and extent of DIE.</p><p><strong>Methods: </strong>A clinical study was conducted with 77 women with histologically confirmed DIE. Data were collected from gynecological consultations and surgical reports classified using the rASRM and Enzian systems. Sexual function was assessed using the Female Sexual Function Index. Statistical analyses included Fisher's exact test, Mann-Whitney test, and Student's t-test.</p><p><strong>Outcomes: </strong>The primary outcome was to examine the relationship between endometriosis localization, disease extent, and sexual dysfunction as indicated by the two classification systems under investigation.</p><p><strong>Results: </strong>A possible association was identified between sexual dysfunction and Enzian B classification (p = 0.013*), implicating involvement of the sacrouterine ligaments, cardinal ligaments, or pelvic sidewall. No significant association was found between sexual dysfunction and rASRM scores. A correlation between the number of endometriosis locations and the presence of sexual dysfunction was also observed (p = 0.015*). However, it is important to note that patients classified as Enzian B may have had additional, undocumented lesions in other locations not identified through available medical records, imaging, or surgical reports. These unidentified lesions could have influenced their sexual dysfunction, representing a potential confounding factor in our analysis.</p><p><strong>Clinical implications: </strong>These findings suggest that the localization of DIE may contribute to sexual dysfunction, but further validation is required before drawing clinical conclusions regarding surgical interventions.</p><p><strong>Strengths & limitations: </strong>This is the first study to explore the ability of a classification system to pinpoint sexual dysfunction in endometriosis to a particular anatomical location, providing novel insights into DIE's impact on sexual health. However, variability in referral sources, the potential for undocumented lesions, and a small sample size for cases of sexual dysfunction may limit the generalizability of these findings.</p><p><strong>Conclusion: </strong>Disease localization, particularly in the uterosacral ligaments and pelvic sidewall, may contribute to sexual dysfunction, offering po","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":" ","pages":"1147-1157"},"PeriodicalIF":3.3,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144043622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}