Moderate Erectile Dysfunction Research Articles

(125) Efficacy of Hilti Gold vs. Epimedyumlu Macun in Duration of Erection and Its Correlation with Partners ´Sexual Quality of Life

Abstract Introduction In healthy men, the average duration of sexual intercourse ranges from nine to ten minutes. However, duration of erection has been shown to be shorter in men with Erectile Dysfunction (ED) and even shorter for men with ED plus associated underlying conditions. Furthermore, duration of Penis erection is most important for sexual couple. Objective The aim of this study was to assess two herbal supplements: HILTI gold (Hg) vs Epimedyumlu Macun (EM) efficacy in terms of duration of erection and (i) Its correlation with other efficacy end points and male and female sexual quality of life (QoL) and (ii) Its impact on intercourse duration. Methods A double-blind, controlled trial randomized men (18–65 years of age) with ED for more than six months, to receive fixed-dose either Hg, 1 capsule or EM, 1 tea spoon (60 minutes prior intercourse) for 12 weeks in 52 patients with ED, after four-week without medication. Primary efficacy end points were stopwatch-assessed duration of erection (min) at any attempt and when leading to successful intercourse, and the erectile function domain of the International Index of Erectile Function (EF-IIEF) score was assessed at week 12/ last observation carried forward (LOCF). Secondary end points were Sexual Encounter Profile question three (SEP3) response rate and male sexual QoL. End points in participating women were stopwatch-assessed duration of intercourse and sexual QoL. Results 52 men included. 42% had moderate ED. 58% had severe ED at baseline. At week 12 / LOCF, patients taking Hg had longer duration of erections vs EM group (least square mean ± standard error 10.3±0.8 minutes vs. 7.7±0.7 minutes, and 10.3±0.8 vs. 7.8 ±1.0 minutes, respectively), and significant increases in EF-IIEF scores, the SEP3 response, and all sexual QoL items. An increased duration of intercourse was also observed. Female sexual QoL improved significantly. Both duration end points strongly correlated with EF-IIEF scores, and the three end points correlated well with SEP3 response. Correlation was good with sexual QoL scores in men and women and with duration of intercourse, with difference between groups only for duration end points. Safety was better in Hg than in EM group. Conclusions The results indicate that duration of erection represents a novel efficacy measures for evaluating those herbal supplements (HS), and could be used as a predictor or efficacy measure of sexual performance in couples affected by ED. With regard to the method of measuring duration, stopwatch method was shown to be reliable and capable of complementing traditional self-assessment efficacy methods for evaluating the efficacy of HS. Hg is the best to significantly improve: Duration of erection in men with ED and Sexual QoL, in both members of a couple affected by ED than EM Absolutely, Hg and EM: Increase duration of erection; Improve sexual pleasure. And, thereby improving the sexual QoL of the COUPLE. And, most important is that sexual couples don’t risk to be unfaithfulness. Disclosure No.

(268) Intracavernous Prostaglandin Injection as a Predictor and Effectiveness Measure for LISWT Sessions in ED Patients: A Single Urologist's Experience

Abstract Introduction In recent years, therapeutic approaches for treating vasculogenic Erectile Dysfunction (ED) have evolved, with Low Intensity Shock Wave Therapy (LISWT) emerging as a promising modality. Objective To objectively evaluate the efficacy of LISWT for ED patients and to predict the required number of sessions, we examined the effects of administering up to 10 mcg of intracavernous alprostadil injections both before and after treatment Methods 85 vasculogenic ED patients (Average age: 57); 33 with mild to moderate ED and 52 with moderate or severe ED. Intracavernous injection (ICI) of ≤10 mcg of alprostadil was given before LISWT and one month post-treatment. Depending on ICI response, patients underwent either six (Erection Hardness Score (EHS) ≤3) or four (EHS=4) weekly LISWT sessions using PiezoWave2 from Richard WOLF. LISWT Parameters: 0.16mj/mm2 energy flux density, 8 Hz frequency, 10mm wave focus penetration depth, and 6000 shocks per session distributed among the two crura of the penis (2000 shocks), dorsum penis (2000 shocks), and lateral penis (2000 shocks). Results 33 patients showed a robust response to the 10mcg ICI and were treated with four LISWT sessions. 52 patients exhibited a partial response to the 10mcg ICI, necessitating six LISWT sessions. 78.6% (26 out of 33) of the patients who initially responded well to 10 mcg ICI had a consistent response to 8 mcg ICI; 63.6% (33 out of 52) of those with a partial initial response to 10 mcg ICI demonstrated an improved reaction to the same dosage post-treatment (table 1) (fig. 1). No complications were reported from the ICI. Conclusions Intracavernous prostaglandin injection can serve as a predictor for the required number of LISWT sessions and can objectively gauge the treatment's effectiveness in ED patients. Further randomized studies, incorporating parameters such as EHS, IIEF, and the ICI dosage, are recommended to validate this method's feasibility Disclosure No.

(030) Hand Held, Self-Applicable Radio Frequency Device for the Treatment of Erectile Dysfunction. A Pilot Study with 6 Months Follow-Up

Abstract Introduction Collagen is an essential component of the structures involved in the erectile mechanism. Radiofrequency (RF) energy has been shown to renew and restore the spatial structural arrangement of collagen fibers and may improve erectile function of men suffering from erectile dysfunction (ED). Objective To assess the feasibility, safety, and efficacy of low-intensity radiofrequency (RF) therapy in men with ED. Methods Men with moderate & mild to moderate ED, with or without the use of PDE5-inhibitors were included. After instructions, each patient treated himself with the radiofrequency device (Vertica®), applying his selected individual RF intensity. Patients underwent, according to the protocol, 12 sessions of 30-minute treatments over 2 months. Patients were evaluated at baseline, 1, 3 and 6 months after treatment using validated questionnaires; International Index of Erectile Function (Full IIEF), IIEF-EF, and erection Hardness score (EHS), satisfaction (EDITS, BSW), and disease-specific quality and quality of life (QEQ, SQOL). In each session, patients filled safety and side-effect questions (pain, fever, burning, discomfort, urinary disorders). The Wilcoxon signed ranks test and the Marginal Homogeneity test were used for statistical processing. Results Twenty-seven out of 28 men treated, were available for 6 months follow-up, mean age 59.2±9.7. The mean ED duration was 41.2±29 months. Mean baseline IIEF-EF was 16.8±1 and improved significantly to 24.8±1.6, 24.3±1.8, and 24.2±2.08 at 1, 3 and 6 months respectively (p<0.001). The Minimal Clinical Important Difference (MCID) criteria were met by 25/28 (89%) at 1-month follow-up and 20/27(74%) at 6-month follow-up (p<0.001). A statistically and clinically significant improvement was demonstrated in the Full IIEF and EHS scores at baseline and during follow-up. No correlation was found between IIEF improvement and the age of the patients. Borderline significance (p=0.05) was found between the duration of ED and IIEF-EF improvement. No side effects were reported and participants rated the device as very comfortable and easy to operate. Conclusions The novel radiofrequency, home-use device for the treatment of ED shows promising results and the potential to improve erectile function. In this study, it was feasible and safe. Further high-quality randomized controlled trials are needed to determine the long-term efficacy of the treatment. Disclosure Yes, this is sponsored by industry/sponsor: Ohhmed, Israel. Clarification: No industry support in study design or execution. Any of the authors act as a consultant, employee or shareholder of an industry for: Ohhmed, Freya, Besins, Verility.

(228) Cell-Based Therapy Can Restore Erectile Function in Men with Type 2 Diabetes and Metabolic Syndrome by Promoting Angiogenesis and Endothelial Repair

Abstract Introduction Although there has been a growing interest in restorative therapies for erectile dysfunction (ED) in recent years, there is still limited mechanistic evidence to support their effectiveness in the clinical setting. Objective The goal of this research was to investigate the mechanistic impact of cell-based therapy in men with ED secondary to Type 2 Diabetes Mellitus (DM2) and Metabolic Syndrome (MetS) through analysis of plasma biomarkers. Methods International Index of Erectile Function (IIEF) was completed by all men in the ACESO (NCT02886884) and CERES (NCT03059355) clinical trials. ACESO and CERES were both randomized, blinded, pilot phase clinical trials in which all participants received cellular therapy at varying doses and sources to treat endothelial dysfunction secondary to either DM2 or MetS, respectively. The intervention in both trials was peripheral intravenous infusion of allogeneic Mesenchymal Stem Cells (MSCs) of either 20 or 100 million cells derived from either bone marrow (BM) or umbilical cord tissue (UC). Follow-up was for 1 year. Endothelial function was measured via Brachial Artery Flow Mediated Vasodilation (FMD) and Endothelial Progenitor Cell-Colony Forming Units (EPC-CFU) assay. Plasma aliquots were isolated from blood samples and subjected to multiplex ELISA assay for analysis of angiogenic biomarkers. Results Data was pooled from all 20 men in the ACESO and CERES clinical trials. Overall, 7 received 20 million BM-MSCs, 9 received 100 million BM-MSCs, 2 received 20 million UC-MSCs, and 2 received 100 million UC-MSCs. There were no treatment emergent serious adverse effects (TE-SAEs) within 30 days following infusion in any of the participants. Among men with ED (IIEF-EF<25), 31.25% achieved MCID in erectile function. Participants with mild or moderate ED at baseline showed greater improvements in erectile function and endothelial function compared to those with severe ED. Participants who achieved MCID following cell therapy also experienced statistically significant improvements in FMD (P=0.05), whereas those who did not achieve MCID or had normal erectile function at baseline did not experience an improvement in FMD. Furthermore, men with Metabolic Syndrome who met MCID criteria were found to have increased Angiopoietin 1 and decreased Angiopoietin 2 following cell therapy. Conclusions The findings of this study demonstrate the potential of cell-based therapies in improving erectile function, angiogenic, and endothelial function. Future studies should aim to identify the causative mechanisms underlying these restorative effects in humans, paving the way for enhanced understanding and optimization of such therapies. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Longeveron LLC.

(049) Prevalence of Erectile Dysfunction in Men with Stress Urinary Incontinence After Radical Prostatectomy

Abstract Introduction Stress urinary incontinence (SUI) and erectile dysfunction (ED) are significant complications that have a negative impact on patients' quality of life following radical prostatectomy (RP). Objective This study aimed to assess the prevalence of ED in men with SUI who underwent RP the first year after RP. Methods This study included men who underwent RP and followed up for 1 year post-surgery. Men who received androgen deprivation therapy (ADT) or radiation therapy before or after RP were excluded. We performed a descriptive assessment of demographics, comorbidities, erectile function (EF), laboratory, surgical pathology, and nerve-sparing status (NSS). Post-op SUI was described based on the number of pads used per day, categorized as 0 to 1 pad per day (continent or mild/social SUI), 2 pads per day (moderate SUI), and ≥ 3 pads per day (severe SUI) at 3, 6, and 12 months post-RP. ED was described based on IIEF score as normal EF normal (≥24), mild ED (18-23), moderate ED (11-17), and severe ED (≤10) at 3, 6, and 12 months post-RP. We reported the prevalence of ED among men with SUI during the first year after RP. We assessed if the severity of the SUI was a predictor of severe ED in a multivariable logistic regression model at 3, 6, and 12 months post-RP. Factors entered into the model included: patient age, number of comorbidities (≥ 3), NVB status (both resected), pre-RP EF, PDE5i exposure post-RP (yes), and severe SUI (≥ 3 pads per day). Results 9953 men were included in this study, with a median age of 62 (56, 67). The median number of comorbidities was 1 (0, 2). 10% had diabetes, 27% obstructive sleep apnea, and 19% reported 3 or more comorbidities. Preoperative median PSA was 5.7 ng/ml, with a median Gleason grade of 2 (2, 3).73% had Bilateral NSS, 20% unilateral, and 7% had both sides resected. The prevalence of severe ED was higher among men with severe SUI compared to men with 0 to 1 pad per day at 3, 6, and 12 months post-RP. At 3 months, men with 0 to 1 pad per day reported 31% no/mild ED and 59% severe ED, vs. men with severe SUI described 18% no/mild ED and 75% severe ED (p-value <0.001). At 6 months, for men with continence/mild SUI, 35% described no/mild Ed and 51% severe ED vs. men with severe SUI who had 20% no/mild ED and 70% severe ED (p-value <0.001). And at 12 months, men with 0 to 1 pad per day reported 42% no/mild ED and 46% severe ED, vs. men with severe SUI described 22% no/mild ED and 70% severe ED (p-value <0.001). In the multivariable regression model, severe SUI significantly predicted severe ED at 3, 6, and 12 months (Table1). Conclusions Men experiencing severe SUI have a high prevalence of severe erectile dysfunction. Severe SUI significantly predicted severe ED during the first year following RP. Disclosure No.

(122) Preservation of Sexual Function: 12-month Outcomes from a Randomized, Double-Blind, Sham Controlled Study Evaluating the Optilume BPH System, a Novel Drug Coated Balloon

Abstract Introduction Many front-line treatments for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), such as medications and transurethral resection of the prostate, have well established negative effects on sexual function. New minimally invasive surgical therapy (MIST) for LUTS/BPH need to preserve sexual function to meet the needs of men. Data from the randomized controlled blinded study of the Optilume BPH System was analyzed to evaluate the sexual side effects of this novel treatment. Objective The PINNACLE study is a prospective, randomized, double-blind, sham controlled study evaluating the Optilume BPH System. Optilume BPH is a novel MIST that combines mechanical dilation with delivery of paclitaxel for treatment of LUTS/BPH. The mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing, while preserving sexual function. Methods 148 subjects with symptomatic LUTS/BPH and a prostate size between 20-80 grams were randomized in a 2:1 fashion (Optilume to Sham) at 18 centers in the US and Canada. Follow-up is complete through 12-months. To evaluate the effect of the treatment on sexual function, the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire to assess Ejaculatory Dysfunction (MSHQ-EjD) questionnaires were used. Questionnaires were administered at baseline and 3, 6, and 12-months post procedure, regardless of sexual activity at baseline. A sub-set of 15 non-randomized subjects treated with Optilume BPH underwent further testing for semen quality and measurement of the amount of paclitaxel found in semen post-treatment. Results The average IIEF-EF score at baseline was 15-16 for both arms, mild to moderate erectile dysfunction (Figure 1). Scores across all domains improved slightly from baseline through 12 months, indicating that treatment with the Optilume BPH device had no significant impact on perceived sexual function. This finding is consistent when looking at men who were sexually active at baseline (Figure 2). Ejaculatory function also showed slight improvement from baseline to 12 months in both the overall population and the subset of men who were sexually active at baseline (Figure 1, Figure 2). There is no appreciable change in ejaculation bother from baseline to 12-months in the overall population and the sexually active subset (Figure 1, Figure 2). Overall semen quality parameters did not change post-procedure (Table 1). A slight decrease in sperm concentration was noted post-treatment, although this decrease was not significant at the 3- and 6-month timepoints. Paclitaxel was detected in semen in the majority of subjects tested at 30 days and 3 months post-procedure. The paclitaxel concentration in semen steadily decreased over time, nearing the limit of quantitation of the method by 6 months post-procedure. Conclusions Treatment with Optilume BPH preserved erectile and ejaculatory function. IIEF and MSHQ-EjD scores were not different from control at any time point. New MISTs for LUTS/BPH need to preserve sexual function to meet the needs of men and Optilume appears to meet this objective. Disclosure Yes, this is sponsored by industry/sponsor: Urotronic. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Urotronic.

(151) Safety and Feasibility of the COCKTAIL (Combining Shockwave Therapy and Platelet-Rich Plasma for Erectile Dysfunction) Trial: A Single Center, Randomized, Double-Blind, Sham-Controlled Study Update

Abstract Introduction Therapeutic approaches focusing on tissue neovascularization play a crucial role in the development of treatments for erectile dysfunction (ED). Autologous Platelet-Rich Plasma (PRP) and Low-Intensity Shockwave Therapy (SWT) are two restorative therapies that potentially target underlying causes of ED. Pre-clinical evidence suggests their angiogenic and regenerative properties, indicating a potential synergistic pathway to improve vasculogenic ED. Objective The primary objective aims to investigate and compare the treatment efficacy of PRP injection and SWT vs placebo injection/SHAM treatment in men with mild-moderate ED, as measured by IIEF. The secondary objective aims to study incidence of adverse events and safety of PRP injection and SWT treatment in men with mild-moderate ED, as measured by IIEF. Methods The COCKTAIL (Combining Shockwave Therapy and Platelet Rich Plasma) trial is a Phase II, single-center study assessing the safety and efficacy of PRP and SWT in combination for ED (NCT05048667). Thirty-five men with mild to moderate ED were enrolled based on International Index of Erectile Function-EF subdomain (IIEF-EF) questionnaire (12-25). Data from a cohort of men treated with PRP and SWT were analyzed, comparing it to men who received placebo saline injections and sham SWT. Patients received two PRP or placebo injections directly into the corpus cavernosum and penile SWT every week for 5 weeks. Assessment included pain scale evaluations, immediate post-procedure examination, and follow-up for complications. IIEF scores were recorded at baseline, 3-month, and 6-month follow-up visits. All statistics and analyses were conducted with IBM SPSS Statistics 27.0.1. Non-parametric tests were used for analysis. Mann-Whitney U test was used to compare independent groups (Group A vs. Group B) at different time points. Related Samples Wilcoxon -Signed Rank test was used for dependent repeated groups, the serial measurements of IIEF-EF scores at different time points for each patient within a specific group. Findings at p< 0.05 were considered statistically significant. Results The primary endpoint of this study was to investigate the incidence of Serious Adverse Events (SAEs). Encouragingly, no adverse events were reported, suggesting that the procedure appears to be safe for the participants. The median baseline IIEF scores for patients in Group A were 17 (±4), and at the three-month follow-up, the scores increased to 19 (±4), slightly dropping to 18 (±8) at six months. In Group B, the median baseline IIEF scores were 19.50 (±4), which improved to 20 (±7) at the three-month follow-up and further increased to 21 (±10) at six months. No statistical differences were found likely because this is an ongoing study, and we only have complete data for 12 men. We aim to accrue a total of 30 men in each arm and plan to complete the recruitment by January 2024 and complete the study by July 2024. Currently, both the investigators and the patients remain blinded. Conclusions The combination of PRP and SWT appears to be safe, as no adverse events were reported. Although preliminary data do not show differences between the treatment and sham groups currently, we intend to complete the trial to perform a comprehensive statistical calculation for efficacy. Disclosure No.

Differences in Psychological Inflexibility Among Men With Erectile Dysfunction Younger and Older Than 40 Years: Web-Based Cross-Sectional Study.

Psychological inflexibility is a core concept of acceptance and commitment therapy (ACT), which is a comprehensive, transdiagnostic interpretation of mental health symptoms. Erectile dysfunction (ED) is a condition that affects male sexual performance, involving the inability to achieve and maintain a penile erection sufficient for satisfactory sexual activity. Psychosocial factors primarily influence ED in men younger than 40 years, whereas biological factors are more likely to be the underlying cause in older men. This web-based cross-sectional study examined differences in depression, anxiety, and psychological inflexibility among men with ED younger and older than 40 years in a Japanese population. We used a web-based survey to gather data from various community samples. ED was assessed by the International Index of Erectile Function-5 (IIEF-5) questionnaire, while depression, anxiety, and psychological inflexibility were evaluated by the Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7), Acceptance and Action Questionnaire-II (AAQ-II), Cognitive Fusion Questionnaire (CFQ), and Valuing Questionnaire-Obstacle Subscale (VQ-OB) questionnaires. The chi-square test estimated the scores of PHQ-9 and GAD-7 among men with ED, comparing those younger than 40 years and those older than 40 years. Additionally, a two-way ANOVA was conducted with ED severity and age group as independent variables, assessing psychological inflexibility. Valid responses from 643 individuals (mean age 36.19, SD 7.54 years) were obtained. Of these, 422 were younger than 40 years (mean age 31.76, SD 5.00 years), and 221 were older than 40 years (mean age 44.67, SD 2.88 years). There was a statistical difference in the prevalence of depression as judged by PHQ≥10 between men with ED younger and older than 40 years (P<.001). On the other hand, there was no difference in the prevalence of anxiety as judged by GAD≥10 (P=.12). The two-way ANOVA revealed that the interactions for CFQ (P=.04) and VQ-OB (P=.01) were significant. The simple main effect was that men with ED younger than 40 years had significantly higher CFQ (P=.01; d=0.62) and VQ-OB (P<.001; d=0.87) scores compared to those older than 40 years in moderate ED and severe ED. Additionally, it was found that men younger than 40 years with moderate to severe ED had significantly higher CFQ (P=.01; d=0.42) and VQ-OB (P=.02; d=0.38) scores compared to men younger than 40 years without ED. On the other hand, no interaction was found for AAQ-II (P=.16) scores. To the best of our knowledge, this web-based cross-sectional study is the first to examine the relationship between psychological inflexibility and ED. We conclude that men with moderate and severe ED younger than 40 years have higher psychological inflexibility and might be eligible for ACT.

Predicting Anxiety and Depression Among Erectile Dysfunction Patients: A Cross-Sectional Study.

In Vietnam, erectile dysfunction (ED) is prevalent and recognized to be associated with mental disorders; however, societal taboos impede a comprehensive understanding of this connection. Our study aims to investigate the factors related to higher levels of anxiety and/or depression (HAD) in individuals with ED. Between November 2022 and March 2023, a face-to-face survey was conducted at the Center for Andrology of Viet Duc University Hospital, involving 390 patients diagnosed with ED. The survey included 51 questions covering general patient information, the International Index of Erectile Function-15 (IIEF-15), the Patient Health Questionnaire-9 (PHQ-9), and the Generalized Anxiety Disorder-7 (GAD-7). The stepwise Akaike Information Criterion (AIC) method was used to identify factors associated with HAD. The study revealed an average age of 37.63 (11.84) years among participants, with a HAD prevalence of 17.69%. Several factors were associated with a higher likelihood of belonging to the HAD group in ED patients. These factors included non-office workers (OR: 1.11; 95% CI: [1.01, 1.21], p = .025), medium and high levels of work-related stress (OR: 1.23; [1.06, 1.44], p = .008; OR: 1.22; [1.04, 1.45], p = .018), multiple shameful experiences related to ED (OR: 1.16; [1.08, 1.25], p < .001), moderate and severe ED (OR: 1.17; [1.03, 1.32], p = .013; OR: 1.31; [1.14, 1.51], p < .001), and dissatisfaction with intercourse skills (OR: 1.09; [1.01, 1.17], p = .028). Our findings suggest a 16% higher likelihood of HAD status in individuals with multiple shameful experiences related to ED, while moderate and severe ED are associated with respective increases of 17% and 31% in the likelihood. These findings emphasize the importance of considering mental health in the care of individuals with ED.

Men with erectile dysfunction (ED) should be screened for cardiovascular risk factors - Cost-benefit considerations in Swiss men.

Background: Current evidence indicates that erectile dysfunction (ED) is an independent risk factor for future cardiovascular events. This study aimed to estimate the cost-effectiveness of screening and subsequent preventive treatment for cardiovascular risk factors among men newly diagnosed with ED from the Swiss healthcare system perspective. Methods: Based on known data on ED and cardiovascular disease (CVD) prevalence and incidence costs and effects of a screening intervention for cardiovascular risk including corresponding cardiovascular prevention in men with ED were calculated for the Swiss population over a period of 10 years. Results: Screening and cardiovascular prevention over a period of 10 years in Swiss men with ED of all seriousness degrees, moderate and severe ED only, or severe ED only can probably avoid 41,564, 35,627, or 21,206 acute CVD events, respectively. Number needed to screen (NNS) to prevent one acute CVD event is 30, 23, and 10, respectively. Costs for the screening intervention are expected to be covered at the seventh, the fifth, and the first year, respectively. Conclusion: Screening and intervention for cardiovascular risk factors in men suffering from ED is a cost-effective tool not only to strengthen prevention and early detection of cardiovascular diseases but also to avoid future cardiovascular events.

Efficacy of Chinese Herbal Medicine Formula in the Treatment of Mild to Moderate Erectile Dysfunction: Study Protocol for a Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

Erectile dysfunction (ED) is a prevalent condition in urology, primarily managed with PDE5 inhibitors (PDE5Is). However, approximately 20% of patients do not experience improvement in overall sexual satisfaction (OS) after taking PDE5Is. Among these, traditional Chinese medicine (TCM) has emerged as a complementary approach, with formulas like Hongjing I granules (HJIG) showing promise in preliminary studies. This study aims to rigorously evaluate the effectiveness and safety of HJIG in mild to moderate ED cases, assessing improvement in both sexual function and TCM pattern alignment. This study is a randomized, double-blind, placebo-controlled multicentre trial. Recruitment will be conducted from patients who have a strong willingness to try using only traditional Chinese medicine treatment (This is very common in traditional Chinese medicine hospitals.). A total of 100 patients diagnosed with mild to moderate ED caused by qi deficiency and blood stasis will be recruited and randomly assigned to receive one of two treatments: HJIG (N = 50) or placebo (N = 50). Patients will receive 8 weeks of treatment and a 16-week follow-up starting from the fourth week of treatment. Outcome measures, including the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score, Sexual Encounter Profile (SEP), and Traditional Chinese Medicine symptom score, will be evaluated. The expected outcome of this trial is that the use of the herbal formula HIJG alone can improve overall sexual satisfaction (OS) in patients with mild to moderate ED, while also improving their traditional Chinese medicine symptom scores. This will provide evidence-based support for the use of Chinese medicine in the treatment of ED in China. Chinese Clinical Trial Registry, ChiCTR2000041127, Registered on 19 December 2020, https://www.chictr.org.cn/showproj.html?proj=46469. Recruitment began in March 2021, therefore 80 patients have been recruited. It is expected to finish recruiting in December 2023.

Erectile Dysfunction among Male Infertile Men Attending the Surgical Outpatient Clinic in a Tertiary Hospital in Nigeria over a 7-Year Period—A Single Surgeon’s Experience

Background: There is misconception about male Infertility and erectile dysfunction (ED) with poor health seeking behaviour in our clime. This study aims at finding the association between erectile dysfunction and male infertility in Ibadan. Methods: This was a retrospective comparative study that analysed records of all men with male infertility between May 2016 and April 2023 at the surgical outpatient in a tertiary hospital in Ibadan. Data included demography, social habit, the severity and prevalence of ED, and type of infertility. The data were analysed with a Statistical Package for the Social Sciences (SPSS) version 25. Logistic regression analysed the association between male infertility and erectile dysfunction. A p-value of &lt; 0.05 was regarded as statistically significant. Results: A total of 109 cases of male infertility of which 65 (59.6%) had ED. The overall mean age for primary and secondary infertility were 37.62 ± 6.95years and 40.62 ± 8.322 years respectively (t=2.892; p&lt; 0.004). The mean age for absence and presence of ED were 39.08 ± 6.61years and 39.56 ± 7.94years respectively (t=0.340; p= 0.734). There is association between alcohol consumption and ED (χ2=6.969; p&lt; 0.008). Similarly, statistically significant association between the ED and the type of infertility as mild, mild-moderate, and moderate ED were commoner among men with primary infertility and all men with severe ED had secondary infertility (χ2=12.283; p&lt;0.015). Conclusions: The prevalence of erectile dysfunction among male infertility was 59.6% with statistically significant association between the severity of ED and male infertility. Public awareness is advocated.

Erectile dysfunction in copper and cobalt miners: a cross-sectional study in the former Katanga province, Democratic Republic of the Congo.

The African Copperbelt is a site of intense artisanal and industrial mining and refining of copper and cobalt. We aimed to investigate factors that are possibly associated with erectile dysfunction (ED) in metal miners in the former Katanga province of the Democratic Republic of the Congo. In a cross-sectional study of 138 miners and 139 controls (bakers), we administered questionnaires to obtain sociodemographic and occupational data and to assess male sexual function (International Index of Erectile Function [IIEF]) and marital relation quality (Revised Dyadic Adjustment Scale). Furthermore, we measured trace metals in blood and urine, as well as testosterone and thyroid hormones in serum. Outcomes included the prevalence of questionnaire-derived ED and the relation of ED with individual characteristics, serum testosterone, and environmental factors. Miners were on average 4years older than bakers (mean ± SD, 37.5 ± 6.9 vs 33.3 ± 5.7 years). Miners had significantly lower scores than bakers on the IIEF (median [IQR], 66 [49-73] vs 73 [66-74]) and the 3 domains of the Revised Dyadic Adjustment Scale (consensus, satisfaction, cohesion). Free testosterone was significantly lower in miners than bakers (ng/dL; 8.11 [6.90-10.10] vs 10.52 [8.83-12.58]; P ˂ .001). In miners, sex hormone-binding globulin correlated positively with blood Pb and urinary Cd. In a multivariable analysis, mild to moderate ED or moderate ED (IIEF-erectile function score ≤18) was significantly associated with having a mining-related job (adjusted odds ratio [aOR], 2.6; 95% CI, 1.3-5.3), work seniority ˃5years (aOR, 2.3; 95% CI, 1.1-4.6), alcohol consumption (aOR, 2.8; 95% CI, 1.2-6.7), and aphrodisiacs use (aOR, 4.2; 95% CI, 2.2-8.0). Mediation analysis showed that marital relationship partially mediated the relation between work seniority >5years in mining and ED. The high prevalence of ED found in artisanal mine workers indicates that work-related factors should be considered as possibly contributing, directly or indirectly, to sexual dysfunction in men. Strengths include being the first epidemiologic study documenting ED with validated questionnaires and its possible determinants, including exposure to toxic metals, among young artisanal miners vs a suitable control group. Limitations are the cross-sectional design with convenience sampling and absence of objective confirmation of ED. As compared with controls, miners reported poorer sexual function and lower quality of their marital relationship, and they had lower free testosterone levels, which may be due to their high exposure to trace metals.

Association between MTHFR c.677C>T variant and erectile dysfunction among males attending fertility clinic.

Genetic risk factors have been shown to contribute to the development of sexual dysfunction. However, the role of methylenetetrahydrofolate reductase ( MTHFR ) gene variants in the risk of erectile dysfunction (ED) remains unclear. In this study, we recruited 1254 participants who underwent ED assessed by the International Index of Erectile Function-5. The MTHFR c.677C>T variant was also measured by fluorescence polymerase chain reaction (PCR). No significant difference in the genotypic frequency of the MTHFR C677T polymorphism (CC, CT, and TT) was observed between men from the ED and non-ED groups. In addition, on binary logistic regression analysis, both crude and adjusted models showed that the risk of ED was not significantly associated with the C677T polymorphism. Interestingly, a significantly higher frequency of the 677TT polymorphism was found in severe and moderate ED (P = 0.02). The positive correlation between the MTHFR 677TT polymorphism and severe ED was confirmed by logistic regression analysis, even after adjusting for potential confounders (odds ratio [OR] = 2.46, 95% confidence interval [CI] 1.15-5.50, P = 0.02). These findings suggest a positive correlation between the MTHFR 677TT polymorphism and the risk of severe ED. Identification of MTHFR gene polymorphisms may provide complementary information for ED patients during routine clinical diagnosis.

Predictive value of Prognostic Nutritional Index (PNI) for the severity of vasculogenic erectile dysfunction.

Our aim was to investigate the association of prognostic nutritional index (PNI) score with erectile dysfunction (ED), therefore, we prospectively evaluated the relationship between penile doppler ultrasonography (PDU) findings, PNI and Sexual Health Inventory for Men (SHIM) scores in patients with ED. A total of 414 patients' characteristics, laboratory findings, SHIM and PNI scores were recorded. The PNI is calculated using the formula: 10 × serum albumin + 0.005 × total lymphocyte count. PDU was performed in patients with a SHIM score of 17 and below, while patients with a SHIM score ≥ 18 were recruited for the control group. Correlation analysis was performed to evaluate the relationship between PNI, SHIM scores and PDU parameters. The predictive value of variables for severe ED was assessed with regression analysis. A significant difference was demonstrated between the ED subgroups and control group for total cholesterol (p = 0.04), serum albumin (p = 0.03), total lymphocyte count (p = 0.02), BDI score (p < 0.001), and PNI score (p = 0.03). A strong positive correlation between PNI score and PSV (rho = 0.73; p = 0.001), a moderate negative correlation between PNI score and EDV (rho = - 0.54; p = 0.02), and a moderate positive correlation between PNI and SHIM scores (rho = 0.61; p = 0.02) were demonstrated. PNI score ≤ 40 (OR: 3.49; p = 0.01), age (OR: 2.15; p = 0.03) and total cholesterol (OR: 2.03; p = 0.04) were determined as significant predictors of severe ED in multivariate analysis. Our results demonstrated that PNI score is significantly lower in patients with severe and moderate ED. It has been also revealed that the PNI score is an independent predictive factor for severe ED.

Prevalence of Erectile Dysfunction among Type-2 Diabetes Mellitus &amp; Availability of Treatment Options in Pakistan

Introduction Erectile dysfunction has been defined as failure to obtain and maintain an erection sufficient for sexual intercourse or decreased erectile turgidity on 75% of sexual occasions, lasting for at least six months. Estimates of the prevalence of erectile dysfunction (ED) in men with diabetes range from 20% to 85% [1]. Type 2 Diabetes patients have a high risk of sexual dysfunction in men; three times increased risk of ED was seen in diabetic compared with nondiabetic men. There are multiple risk factors which include, obesity, age-related hormonal changes metabolic syndrome in young patients, it is associated with a greater increase in the risk of future cardiac events as compared to its first detection in older males. Aim The aim of the study is to determine the relative prevalence of Erectile Dysfunction in the Pakistani population attending diabetes with help of the SHIMS score/IELTS. To establish further management of this commonly under-recognized, under-discussed, and commonly untreated complication of diabetes. But it is also one of the most treatable diabetic complications. It is a “couple’s disorder,” affecting both the patient and his partner. In Pakistan, there is not much evidence &amp; options for treatment are not ideally available inclusive of the availability of PD5 drugs. Methodology Male patients with diabetes mellitus having poor glycemic control, hypertension, and hyperlipidemia with or without active complaint of Erectile Dysfunction attending The Diabetes Centre (TDC) during the study period were enrolled in the study. 319 males with diabetes were examined by the Diabetologist, endocrinologist, and clinical psychologist. Patients were surveyed using the five items version of the International Index of Erectile Dysfunction questionnaire, also known as the Sexual Health Inventory of Men (SHIM) to determine the presence and severity of ED and the efficacy of ED treatment conditions. Discussion and Results In the study, a total of 319 diabetic patients were enrolled and assessed/examined. Those with severe ED were found to have poor glycemic control, abnormal lipid profile, with BMI. 19%, 15%, and 31% of patients scored as severe, moderate, and mild to moderate ED respectively; 65% were scored as suffering in ED, whereas 20% of diabetic male patients have a higher proclivity of developing server ED. Male patients with poor glycemic control &amp; hyperlipidemia were suffering from severe erectile dysfunction. Conclusion The accumulated percentage of diabetic male patients who have signs of ED is higher therefore the prevalence of ED is too high in diabetic male patients. In addition, there are no appropriate management options like the availability of safe drugs and treatment in Pakistan.

Efficacy of Low-Intensity Extra Corporal Shockwave Therapy (LI-ESWT) in Patients With Erectile Dysfunction.

Erectile dysfunction (ED) is a common cause of sexual disorders in men with limited treatment options. This study aimed to determine the efficacy of low-intensity extra corporal shockwave therapy (LI-ESWT) in patients suffering from ED. A single-group, pre-test, and post-test pre-experimental study were conducted. Thirty-one ED patients were prospectively selected according to the eligibility criteria. In each session, 3000 shocks were applied at 5 points over the penis. Eight sessions were delivered in total with a 2-3-day interval. The patient's condition was assessed using the International Index of Electric Function (IIEF-5) questionnaire at baseline and one month after the last treatment session. Paired t-test was used to determine the difference between the pre-test and post-test. Mean age of the patients was 44.6 (± 14.70) ranging from 25 to 78 years. The majority of them were married (83.9%) and service providers (51.6%). We have also found 51.6% overweight, 9.7% obese, 48.4% diabetic, 45.2% hypertensive, 12.9% with enlarged prostate, 45.2% smoker, 25.8% alcoholic, and 71% with sleep disturbances. During the pre-test, 9.7% had severe ED and 51.6% had moderate ED. After the treatment, no patients were found with severe ED, and few of them had moderate ED (9.7%). The mean difference in IIEF-5 score during the pre-test and post-test was statistically significant (p= < 0.001). The study showed efficacy of LI-ESWT in a subset of patients with ED. Future studies with larger sample size, placebo group, and longer follow-up periods are recommended.

Systematic Review of The Efficacy of Korean Ginseng in Men with Erectile Dysfunction

Erectile dysfunction (ED) is a common condition that has a substantial impact on quality of life. It is described as the continuous inability to develop or maintain sufficient stiffness of the penis to allow satisfactory sexual performance. Early detection and treatment of ED and comorbidities associated with ED, such as hypertension, diabetes mellitus, and hyperlipidemia, can significantly improve the quality of life for men and their partners. About 35.6% of Indonesian adults have ED. The bulk of ED treatments now on the market are pharmacological and surgical procedures. Even though there has been substantial progress, it seems that the aforementioned treatment has a high dropout rate due to cultural restrictions and taboos. These patients would then look for herbal nutritional supplements like ginseng as an alternative. This systematic review evaluates the current evidence for the effectiveness of red ginseng in managing erectile dysfunction. We performed systematic review conducted from MEDLINE, ScienceDirect, ProQuest. The authors screened the articles based on inclusion criteria : (1) Mild-to-moderate erectile dysfunction; (2) Ginseng as interventional therapy; (3) Human studies that have IIEF score as an outcome; (4) Written in English. Four randomized control trials (RCT) using keywords “((Erectile Dysfunction) AND (Korean Ginseng) AND (Ginseng))” were included. Three randomized control trials (RCT) study involving 454 male patients with mild to moderate erectile dysfunction, aged from 20 to 70 years old. Our findings support that the mean in International Index of Erectile Function scores were significantly higher in patients treated with Korean ginseng than in those who received placebo. Korean ginseng could be an effective alternative treatment for male erectile dysfunction if more research with larger-scale clinical trials and higher standards is done in the future on the safety and effectiveness of ginseng.

Safety and Effectiveness of Repeated Botulinum Toxin A Intracavernosal Injections in Men with Erectile Dysfunction Unresponsive to Approved Pharmacological Treatments: Real-World Observational Data.

Intracavernosal injections of botulinum toxin A (BTX/A ic) may be effective for difficult-to-treat erectile dysfunction (ED). This is a retrospective case series study of the effectiveness of repeated off-label BTX/A ic (onabotulinumtoxinA 100U, incobotulinumtoxinA 100U or abobotulinumtoxinA 500U) in men with ED and insufficient response to phosphodiesterase type 5 inhibitors (PDE5-Is) or prostaglandinE1 intracavernosal injections (PGE1 ICIs), defined as an International Index of Erectile Function-Erectile Function domain score (IIEF-EF) < 26 on treatment. Further injections were performed on patients' requests, and the files of men who underwent at least two injections were reviewed. The response to BTX/A ic was defined as the achievement of the minimally clinically important difference in IIEF-EF adjusted to the severity of ED on treatment at baseline. Out of 216 men treated with BTX/A ic and PDE5-Is or PGE1-ICIs, 92 (42.6%) requested at least a second injection. The median time since the preceding injection was 8.7 months. In total, 85, 44 and 23 men received, respectively, two, three and four BTX/A ic. The overall response rate was 77.5%: 85.7% in men with mild ED, 79% for moderate ED and 64.3% for severe ED on treatment. The response increased with repeated injections: 67.5%, 87.5% and 94.7%, respectively, after the second, third and fourth injections. Post-injection changes in IIEF-EF were similar across injections. The time from injection to request for a further injection varied little. Four men reported penile pain at the time of injection (1.5% of all injections), and one experienced a burn at the penile crus. Repeated BTX/A injections combined with PDE5-Is or PGE1-ICIs produced an effective and durable response, with acceptable safety.

Carotid artery intima media thickness can predict the response to phosphodiesterase 5 inhibitors in patients with moderate erectile dysfunction.

Increased carotid artery intima-media thickness (CIMT) has been shown to be associated with erectile dysfunction (ED), but studies evaluating the efficacy of CIMT in predicting drug response are lacking in the literature. We aimed to evaluate the efficacy of CIMT in predicting the response to phosphodiesterase-5 inhibitors (PDE5-I). A total of 274 subjects were divided into two groups: ED patients (n = 150) and controls (n = 124). The patients in the ED group were further divided into the subgroups of severe, moderate, mild-moderate, and mild ED. Blood tests, carotid ultrasonography, and the International Index of Erectile Function-5 (IIEF-5) diagnostic tool were applied to all subjects. Tadalafil was administered to each patient. The patients were re-evaluated using the IIEF-5 questionnaire after 2 months of treatment. According to their response to medication, the patients were evaluated as responders or nonresponders. Increased CIMT was significantly associated with the failure of PDE5-I therapy, especially in patients with moderate/mild-moderate ED. Fasting blood glucose, body mass index, and CIMT were significantly higher in the ED group compared to the control group (P =.021, P = .006, and P < .001, respectively). The IIEF-5 score was significantly lower in the ED group (P < .001). CIMT was significantly correlated with the IIEF-5 score. When the total patient group was evaluated, the CIMT value of the responders was significantly lower than that of the nonresponders (P = .001). CIMT was significantly higher among the nonresponders with moderate/mild-moderate ED compared to the responders (P = .004 and .008, respectively), while there was no significant difference in CIMT between the responders and nonresponders with severe or mild ED. A receiver operating characteristic (ROC) analysis of CIMT was performed for discrimination between nonresponders and responders with moderate/mild-moderate ED. The area under the ROC curve was 0.801 (0.682-0.921) (P = .001), and the cutoff value was determined to be 0.825mm, at which CIMT predicted the response to treatment with 65% sensitivity and 89% specificity. Using a validated CIMT cutoff value can help the physician inform the patient about the possibility of drug failure and avoid attempting second-line therapy too soon. There are three main limitations to our study. First, the number of participants was low. Second, ultrasound is a relatively subjective method, and third, all measurements were made by the same radiologist. CIMT can be used as a predictor of response to PDE5-I therapies in patients with moderate/mild-moderate ED.