International Index Of Erectile Function-Erectile Function Score Research Articles

The potency and safety of platelet-rich plasma and its therapy protocol for erectile dysfunction: A systematic review and meta-analysis of randomized controlled trials

Abstract* Background Platelet-rich plasma (PRP) is a novel treatment for erectile dysfunction (ED) that is considered to be a cost-effective option. It has demonstrated positive outcomes and minimal adverse effects. By injecting PRP into the intracavernous tissue, it has the potential to promote angiogenesis and neuroregeneration, leading to a potential permanent improvement in erectile performance. The potency and safety as well as the variety of PRP administration protocols in the treatment of ED are the objectives of this paper. Method Using certain terms, a systematic search was done on three different databases: Science Directs, Scielo, and PubMed. Papers about PRP therapy for EDs within the last decade, be randomized controlled trials (RCTs), and be original studies with freely available full-text content were included in this study. This article omitted letters to the editor, reviews, and editorials regarding PRP and ED. Results Three RCT were included in this studies. The improvement is observed at one month, three months, and six months after the treatment, compared to the baseline. PRP group participants met the Minimal Clinically Important Difference (MCID) in the International Index of Erectile Function-Erectile Function (IIEF-EF) at a higher percentage than those in the placebo group at both one month and six months. Injection of PRP leads to a superior enhancement in the IIEF-EF score, compared to a placebo, in patients suffering from ED at one month, three months, six months. Conclusion PRP is a proven therapeutic technique that has been shown to greatly enhance ED. Yet, to establish uniform guidelines for PRP in treating erectile dysfunction, further investigation into PRP, particularly in protocol development, is imperative.

Renal Transplantation Enhances the Sildenafil Citrate Effectiveness in Patients with Erectile Dysfunction. A Single-Center Perspective

ObjectiveTo assess the efficacy and safety of Sildenafil citrate in the treatment of ED in (HD) compared to post-RT patients. Patients and methodsA concurrent cohort prospective study to evaluate the efficacy of Sildenafil in the treatment of ED in 24 HD patients (Group A) and 13 patients with persistent ED one-year post-RT (Group B). The initial dose of Sildenafil was 25 mg, increased to 50 mg if there is an adequate response. An Arabic-translated International Index of Erectile Function (IIEF) questionnaire was completed one week before and after Sildenafil treatment. An IIEF erectile function score of 26 or an improvement of at least 10 points for the total IIEF score was considered a favorable response to Sildenafil. ResultsGroup A included 22 patients with a mean age of 47.32 ± 7.013 years, whereas Group B included 13 patients with a mean age of 56.87 ± 9.612 years. The overall efficacy rate of Sildenafil was 40.9% and 76.9% in groups A and B, respectively. The post-treatment IIEF5-15 score increased from 11.1 ± 5.99 to 12.5 ± 6.41 (p = .458) and from 11.82 ± 7.534 to 21.91 ± 5.700 (p = .002) in groups A and B, respectively. In both groups, the duration of HD had no impact on ED improvement except in the post-RT non-responder subgroup. Hypertension, gastrointestinal symptoms, and flushing were both groups' most common side effects. ConclusionRT could enhance the response to sildenafil in treating patients with ED. The outcome is better in younger post-RT patients with moderate and severe erectile dysfunction and shorter dialysis duration.

Comparison of erectile and ejaculatory functional outcomes between unilateral and bilateral cavernosal rupture in penile fractures

This study aimed to compare the erectile and ejaculatory functional outcomes of unilateral and bilateral ruptures of the corpus cavernosum in penile fractures. Sixty patients’ data were analyzed retrospectively between June 2020 and January 2023. The patients were divided into two groups based on the affected corpus cavernosum (unilateral and bilateral). Preoperative and postoperative 3rd-, 6th-, and 12th-month self-estimated intravaginal-ejaculation-latency-time (IELT), and international index of erectile function-erectile function (IIEF-EF) scores as well as the presence of urethral injury were compared. Bilateral corpus cavernosum fractures were detected in 18.3% of the patients. The IIEF-EF scores of both groups at 3rd-, 6th-, and 12th-month were found to be significantly lower than the preoperative scores (unilateral group:24.1 ± 2.7 vs 23.2 ± 3.5 and 23.3 ± 3.4, respectively, p = 0.011 and 0.014, respectively; bilateral group: 24 ± 1.9 vs 23 ± 1.8 and 23.2 ± 1.5, respectively, p = 0.027 and 0.047, respectively). No significant difference was found between the preoperative and the postoperative 12th month IIEF-EF scores in either group (unilateral group: 24.1 ± 2.7 vs 23.4 ± 3.6, p = 0.207;bilateral group:24 ± 1.9 vs 23.2 ± 1.5, p = 0.057). The self-estimated IELTs of both groups at the postoperative 3rd, 6th, and 12th months demonstrated a significant increase from the preoperative values (unilateral group: 221.6 ± 81.8 vs 252 ± 94.6, 256.5 ± 97.6, and 250.5 ± 104.8, respectively, p < 0.001; bilateral group:241.8 ± 61.6 vs 278.1 ± 55.4, 281.8 ± 56.1, and 283.6 ± 54.2, respectively, p = 0.041, 0.030, and 0.047, respectively). The changes in self-estimated IELTs and IIEF-EF scores between the preoperative period and the postoperative 3rd, 6th, and 12th-months were compared, and no statistical difference was found between patients with unilateral and bilateral corpus cavernosum fractures (p > 0.05). In conclusion, no significant difference in erectile function was found in either group at the 12-month follow-up, and the self-estimated IELTs were found to be prolonged in both groups. Furthermore, no difference was noted between the groups at any follow-up. To explain the effects of unilateral and bilateral injuries on erectile and ejaculatory functions, further studies with a larger-number of patients are necessary.

(028) Intracavernosal Injection of Platelet-Rich Plasma for the Treatment of Erectile Dysfunction: A Meta-Analysis of Randomized Placebo-Controlled Trials

Abstract Introduction Erectile dysfunction (ED) affects 3 to 76.5% of men globally. Appropriate treatments for ED patients are vital to ensure their quality of life. However, the present conservative ED treatments cannot reverse the underlying pathology and often lead to discontinuation due to the lack of efficacy. Regenerative therapies, including platelet-rich plasma (PRP), have been gaining increasing interest for the last few years. Preclinical studies suggest that growth factors in PRP may be beneficial in ED. With the increasing evidence of PRP, a meta-analysis has yet to be conducted to determine its efficacy and safety compared to a placebo. Objective To systematically evaluate PRP's efficacy and safety for treating ED based on randomized placebo-controlled trials (RCTs) results. Methods A comprehensive search on PubMed, Scopus, and EMBASE databases was conducted on June 2023 to find relevant articles following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. RCTs in English evaluating PRP's efficacy and safety in treating ED were included. The primary outcomes were the International Index of Erectile Function-Erectile Function (IIEF-EF) score at 1-, 3-, and 6-months post-treatment. The secondary analysis includes the proportion of patients who met the minimal clinically important difference (MCID) of IIEF-EF score, IIEF score for sexual satisfaction and overall satisfaction, peak systolic velocity (PSV) in the cavernousal artery, and the complication rate after treatment. Quality of included studies was assessed using JADAD Score and Cochrane RoB2 tools. Meta-analysis with a random or fixed effects model based on the heterogeneity was performed using Revman 5.4. Results From 183 articles in initial research, three RCTs with low risk of bias were reviewed. We included 103 patients in the PRP group and 106 in the placebo group. The baseline of the evaluated score from both groups was comparable despite variable PRP protocol being used. The pooled analysis showed that PRP is associated with higher IIEF-EF scores at 1, 3, and 6 months follow up compared to placebo with a mean difference (MD) of 2.85 (95% CI, 1.68 – 4.03, p: &amp;lt;0.00001), 2.81 (95% CI, 1.57 – 4.05, p: &amp;lt;0.00001), 3.11 (95% CI, 1.96 – 4.27, p: &amp;lt;0.00001). Similarly, the proportion of patients who met MCID and PSV at follow-up also favoured the PRP group. On contrary, the IIEF score for sexual satisfaction and overall satisfaction domain, as well as VAS score post-injection were comparable between groups. No significant adverse event was reported in any study during follow-up. Conclusions The present meta-analysis suggests that PRP is effective and tolerable as a restorative therapy for managing ED patients compared to a placebo. Nevertheless, additional RCTs with more robust data from larger sample sizes and longer-term follow-ups are required to corroborate the findings. Disclosure No.

(117) Is Platelet-Rich Plasma Effective and Safe for Managing Erectile Dysfunction? A Meta-Analysis of Before-After Data from Clinical Studies

Abstract Introduction Erectile dysfunction (ED) is common health issues among men with increasing prevalence along with age. With the advancement of technology, the aim of therapy for ED is start to shift in reversing the pathology and not only relieving the symptoms. Platelet-rich plasma (PRP) are one of the regenerative modalities that has gained popularity in many medical disciplines. Many studies have been conducted that favour PRP in improving erectile function. However, no relevant meta-analysis of PRP have been performed to date. Objective A single-arm meta-analysis were conducted to evaluate the outcome of PRP for the treatment of ED based on the data before and after the procedures. Methods We systematically searched PubMed, Embase, Scopus in June 2023 to find the relevant articles based on the Preferred Reporting Items for Systematic Review and Meta-analysis statement. All randomized controlled trials (RCTs), observational, and case control studies in English with 10 or more subjects and a minimum of 1 month follow-up after PRP treatment reporting International Index of Erectile Function-Erectile Function (IIEF-EF) score were included. Pooled analysis on outcomes that were reported in at least 2 studies were performed using RevMan 5.4 and STATA18 with 95% confidence intervals (CIs). We also conduct heterogeneity test and a leave-one-out sensitivity analysis. Results A total of three RCTs, three observational studies and one case-control study, comprising 236 patients, were included from 183 studies identified. The pooled analysis showed that PRP injection significantly increased the IIEF-EF score by 3.87 (95% CI: 2.92, 4.83, p&amp;lt;0.00001), 3.01 (95% CI: 2.27, 3.74, p&amp;lt;0.0001), 3.29 (95% CI: 2.26, 4.32, p&amp;lt;0.00001), at 1, 3, and 6, months follow-up. Subgroup analysis of IIEF-EF based on the use of PDE5i in the protocol or during follow-up period also found the same finding result. The proportion of patient who met MCID after 6 months of follow of was 70% (95% CI: 59%, 80%). In term of penile hemodynamic, a significant improvement was found in peak systolic velocity and end diastolic velocity at the end-point of follow-up. On contrary, there was no significant improvement were found for IIEF score of intercourse satisfaction and overall satisfaction domain. The most common complication reported were transient subcutaneous bruising. Two cases reported a formation of painless plaque but no other major adverse events were reported. Consistent result was found after a leave-one-out sensitivity analysis. Conclusions PRP is a promising restorative modality for ED with improvement in IIEF-EF score and penile hemodynamic. However, further studies and human trials are required to confirm the efficacy and durability of this novel treatment as well as to find out the best protocol of administration. Disclosure No.

(201) Impact of a Natural Mixture with the Black Chocolate, Chili, Spices in Order to Improve Male Sexual Function

Abstract Introduction The Aztec emperor Montezuma was reported to have drunk up to fifty cups a day of chocolate with chili and spices in it. He had to keep up his stamina to satisfy his many wives. It is thought that the ingredients of this mixture dilates the blood vessels and creates energy and focus. Objective Referring to Montezuma, the purpose of this study was to verify whether is enough to drink every night one cup as Montezuma, by ED men making a nice intercourse with their partners’ women, at least once a week. Methods 101 patients with erectile dysfunction (ED) were enrolled between January 2014 and December 2017. Patients were classified as having mild (47), moderate (38) or severe (16) ED. Mean age was 50.3 years. A cup with black chocolate, chili and spices in it was administered by each patient, every night for 12 weeks. International Index of Erectile Function-Erectile Function (IIEF-EF) questionnaire was administered pre and post-treatment with all pts. Patients with concomitant medical diseases were excluded. Results IIEF-EF scores were significantly improved, with an increase of 79% in the mild ED group, an 83% improvement in the moderate ED group, and an improvement of 67% in the severe ED group compared with the baseline. The mean IIEF-EF scores for all patients showed significant improvement after 12 weeks of treatment (baseline 14.3±1.5 to 26.2 ±3.3; P= 0.01). Among other parameters penile rigidity and tumescence, showed significant improvement for all patients. No, significant side effects. Conclusions The black chocolate, chili and spices when mixed together, seem to work in synergy improving erectile function and in patients with ED, too. We reached the goal that nearly all patients performed a nice intercourse, once a week with their partners’ women. This study tell that what they quote about Emperor Montezuma are in fact true. Disclosure No.

Effectiveness of Low-Intensity Extracorporeal Shock Wave Therapy in Erectile Dysfunction: An Analysis of Sexual Function and Penile Hardness at Erection: An Umbrella Review.

The present umbrella review of five systematic reviews and meta-analyses was conducted to investigate the effectiveness of Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) in the treatment of vascular origin Erectile Dysfunction (ED). A search was carried out in the databases of Pubmed, Scopus, Medline, Scielo and Embase. Participants were divided into two groups: an experimental group receiving Li-ESWT and a control group receiving simulated shock waves. The main variable of this study is ED, measured using the International Index of Erectile Function-Erectile Function (IIEF-EF) and the Erection Hardness Score (EHS) scale. The results showed a statistically significant increase in the mean IIEF-EF score in the experimental group. Overall, four out of five articles reported an increase in the EHS score in the Li-ESWT group compared to the placebo. Concerning the treatment parameters, better outcomes were observed with an energy density of 0.09 mJ/mm2 and the application of 1500-2000 pulses. Additionally, a follow-up of 6-12 months resulted in greater improvement in ED compared to 3 months, although more studies investigating follow-ups beyond 12 months are needed. Obtaining conclusive and clear results is challenging; however, everything indicates that Li-ESWT is an innovative therapeutic alternative for vascular-origin ED due to its low risk and improvement in erectile function.

Long-term tadalafil once daily in Chinese men with erectile dysfunction: a 2-year final analysis of a post-marketing, multicenter, randomized, open-label trial.

The long-term safety and effectiveness of once-daily tadalafil is crucial, but limited data are available in Chinese patients with erectile dysfunction (ED). In this post-marketing, multicenter, randomized, open-label trial with 2-year follow-up, 635 ED cases were randomized to receive daily oral tadalafil 2.5 mg or 5 mg for 3 months, of whom 580 continued once-daily tadalafil 5 mg for 21 months. Treatment-emergent adverse events in the 12-month and 24-month period were similar, with the most common being viral upper respiratory tract infection, upper respiratory tract infection, and headache. Significant improvement from baseline in the International Index of Erectile Function-Erectile Function (IIEF-EF) score was detected at month 12 (least squares mean [LSM] change: 7.9, 95% confidence interval [CI]: 7.5-8.4, P < 0.001) and was maintained to month 24 (LSM change: 8.6, 95% CI: 8.1-9.0, P < 0.001). The proportions of patients regaining normal erectile function (IIEF-EF score ≥26) were 43.7% and 48.0% at months 12 and 24, respectively. Global Assessment Questionnaire results showed improved erection function in 97.5% of patients and improved ability to engage in sexual activity in 95.9% of patients at month 12; these values were 96.1% and 95.0% at month 24, respectively. The quality of sexual life score based on the Sexual Life Quality Questionnaire (SLQQ) was increased by 52.2% at month 12 and by 55.3% at month 24 (both P < 0.001). The treatment satisfaction score determined by SLQQ (mean ± standard deviation) was 62.4 ± 21.0 at month 12 versus 65.9 ± 20.2 at month 24. Two-year daily application of tadalafil 5 mg in Chinese men with ED showed a favorable safety profile and durable improvement in sexual performance and satisfaction.

Long-term efficacy and safety of extracorporeal shock wave therapy (Li-ESWT) protocols in the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) patients

Aim This study aims to evaluate the long-term effectiveness of Li-ESWT in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) patients and to compare the effect of treatment protocol differences on success. Method Between December 2019 and January 2021, the data of male patients over the age of 18 who applied to the urology outpatient clinic with CP/CPPS symptoms were retrospectively analyzed. International Prostate Symptom Index (IPSS) and International Index of Erectile Function—Erectile Function (IIEF-EF) questionnaires were filled in for the evaluation of erectile function. All patients received treatment with the Medispect Bold Li-ESWT. The treatment responses of the patients who received a total of 6 sessions from one session per week and 12 sessions from two sessions per week were compared. Results A total of 129 patients were included in the study. Significant improvements were observed in the NIH-CPSI, IPSS, and IIEF-EF scores at the third month follow-ups of the patients after EWST (p < 0.001 for each). Improvements in scores were also found to be significant in NIH-CPSI, IPSS, and IIEF-EF at the 12th month evaluation. When the patients were evaluated according to the number of Li-ESWT sessions they received, the IPSS score average of the patient group who received 12 sessions of Li-ESWT was found to be lower than the patients who received 6 sessions of Li-ESWT (5.67 ± 2, 30 vs 4.51 ± 2.21; p = 0.005). There was no significant difference in the IIEF-EF and IPSS scores in the 12th month evaluations of the patients, but the mean NIH-CPSI score was found to be higher in the group that received 12 sessions of Li-ESWT (p = 0.003). Conclusion Li-ESWT in the treatment of CP/CPPS patients shows positive improvements in urinary symptoms, erectile function, and quality of life in patients unresponsive to other medical treatments. The increase in the number of sessions does not seem to influence the symptoms of the patients.

The Efficacy and Safety of Avanafil During a Treatment of Male Erectile Dysfunction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Erectile dysfunction (ED) contributes to a large burden and impairs the quality of life among males. Avanafil appears to be a promising treatment for ED; however, its efficacy and safety profile remain unclear. This study aimed to evaluate the efficacy and safety of avanafil for the treatment of ED. An extensive search of PubMed, ScienceDirect, Web of Science, and Embase databases with 11 publications was performed, with outcomes evaluated are International Index of Erectile Function - Erectile Function (IIEF-EF), Sexual Encounter Profile (SEP), and Treatment-Emergent Adverse Events (TEAE). Statistical parameter Mean Difference (MD) and Risk Ratio (RR) with 95% Confidence Interval (CI) were used to measure effect size. The pooled estimates demonstrated that changes in IIEF-EF function (MD=4.39, 95% CI [3.41, 5.37], p<0.001), SEP-2 (RR=3.43, 95% CI [2.79, 4.22], p<0.001), SEP-3 (RR=2.30, 95% CI [2.01, 2.62], p<0.001), and TEAE (RR=1.49, 95% CI [1.12, 1.96], p=0.005) were significantly higher in the avanafil group than in the placebo group. Moreover, 200 mg avanafil was superior to that mg 100 mg-avanafil, indicated by the IIEF-EF score (MD=-1.15, 95% CI [-1.40, -0.89], p<0.001). In contrary, there were no significant differences in SEP-2 (RR=0.90, 95% CI [0.75, 1.08], p=0.26), SEP-3 (RR=0.92, 95% CI [0.81, 1.05], p=0.21) and TEAE (RR=1.00, 95% CI [0.87, 1.15], p=0.99) for both 100 mg and 200 mg doses. This review highlights the potential use of this drug in ED treatment. Further large-scale Randomized Controlled Trials investigations involving various racial groups are required to confirm these findings.

(276) Sexual Health of Transfeminine Individuals: A Chance to Educate Medical Providers

Abstract Introduction Providers may be unfamiliar with the sexual health needs of transgender patients. This hinders chances to provide comprehensive care, as many patients require prompting to discuss sensitive sexual issues. To increase awareness of these issues, we developed a questionnaire which assessed the sexual health of transfeminine individuals. Objective We sought to describe the sexual experiences and preferences of transfeminine individuals, and to categorize sexual health needs in this population. Methods IRB approval was obtained to develop (with transgender community feedback) a questionnaire assessing urinary and sexual health. Sexual preferences, symptoms, and quality of life (QOL) responses were compared among vaginoplasty (VP) and non-vaginoplasty (NVP) groups. NVP respondents were evaluated based on the International Index of Erectile Function (IIEF) categories: erectile function (EF), orgasmic function (OF), and sexual desire (SD). Results 53 transfeminine individuals (11 vaginoplasty, 10 orchiectomy, 32 no procedure) with mean age of 40 years (range 21-80) participated. Sexual QOL was similar for both groups (Table 1). There was an association between self-reported sexual activity and VP/NVP status, where a higher proportion of NVP respondents reported sexual activity with others and penetrative anal sex (p&amp;lt;0.05). Among NVP respondents, 38 (90.4%) of whom were undergoing hormone therapy, 23 (55%) indicated penile function was important to them. NVP IIEF EF, OF, and SD categories mean scores were 13.3, 5.8, and 5.6, respectively, compared to 25.8, 9.8, and 7.0 from the cis-gender controls in the initial IIEF study. 5 (11.9%) individuals used oral medications for erectile assistance, while 1 (2.3%) had a prosthesis. Conclusions When comparing VP and NVP respondents, we found similarities in sexual QOL while noticing differences in sexual preference, highlighting the diversity of this population. While many NVP respondents reported importance of penile function and presence of erectile dysfunction, only a minority were on treatment. This highlights an opportunity for providers to discuss sexual health with transfeminine patients and offer appropriate treatments. Disclosure No

Retrospective evaluation of the efficacy of daily paroxetine/tadalafil combination in patients with premature ejaculation and erectile dysfunction.

Premature ejaculation (PE) and erectile dysfunction (ED) are sexual dysfunction diseases affecting males. The phosphodiesterase type 5 (PDE5) inhibitors such as tadalafil are used to treat ED whereas selective serotonin reuptake inhibitors (SSRIs) are preferred for PE. Most of the patients with ED also suffer from PE simultaneously. The combined drug therapies are commonly preferred as they favor elevated intra-vaginal ejaculation latency time (IELT) scores and improved sexual function. The study aimed to evaluate the efficacy and safety of daily paroxetine and tadalafil combination therapy in patients with PE and ED. A total of 81 PE patients with ED were enrolled in the study. Patients were treated with daily paroxetine 20 mg and tadalafil 5 mg for 4 weeks. Pre- and post-treatment IELT, premature ejaculation profile (PEP), and International Index of Erectile Function-Erectile Function (IIEF-EF) scores of the patients were analyzed. The mean IELT and PEP index scores, and mean IIEF-EF values improved after combination therapy (p<0.001 for each). When lifelong and acquired PE+ED patients were compared, significant improvements were observed in IELT, PEP, and IIEF-EF scores in both groups (p<0.001). Even though the treatment methods are different, combined therapies to treat simultaneous PE and ED presence are effective compared to monotherapies. However, there is still no definitive treatment that can cure all subtypes of PE or ED.

The Impact of Metabolic Syndrome Components on Erectile Function in Patients with Type 2 Diabetes

Erectile dysfunction is commonly encountered in diabetic patients and in patients with metabolic syndrome; however, only a few studies have assessed patients with metabolic syndrome and type 2 diabetes mellitus (T2DM) regarding their sexual function. The purpose of this study is to examine the effect of metabolic syndrome and its components on the erectile function of T2DM patients. A cross-sectional study including T2DM patients was conducted from November 2018 until November 2020. Participants were evaluated for the presence of metabolic syndrome and their sexual function was assessed using the International Index of Erectile Function (IIEF) questionnaire. A total of 45 consecutive male patients participated in this study. Metabolic syndrome was diagnosed in 84.4% and erectile dysfunction (ED) in 86.7% of them. Metabolic syndrome was not associated with ED or ED severity. Among metabolic syndrome components, only high-density lipoprotein cholesterol (HDL) was associated with ED [x2 (1, n = 45) = 3.894, p = 0.048; OR = 5.5 (95% CI: 0.890–33.99)] and with the IIEF erectile function scores (median 23 vs. 18, U = 75, p = 0.012). Multiple regression analyses showed that HDL was non-significantly associated with the IIEF erectile function scores. In conclusion, among T2DM patients HDL is associated with ED.

Effect of the new 75-mg orodispersible film of sildenafil on erection and sexual quality of life: insights from an observational study.

The newly devised orodispersible film (ODF) of sildenafil is the first phosphodiesterase type 5 inhibitor (PDE5i) available in a 75-mg dose. This intermediate dose and the particular properties of the ODF formulation can improve the clinical management of erectile dysfunction (ED) patients. We investigated the effects of the sildenafil ODF 75-mg dose on both sexual quality of life and erectile function based on the results from an observational study in daily practice in Italy. This study was a post hoc analysis of results from an observational, real-life study carried out in ED patients at 6 treatment centers in Italy. All subjects were asked to take the prescribed dose of sildenafil ODF at inclusion (visit 1) and to return for a control visit (visit 2) to confirm or adapt the prescribed dose after a minimum of 4weeks. An end of study control visit (visit 3) was performed after additional 4weeks. Erectile function, assessed by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain; sexual quality of life, measured using the sexual quality of life instrument for men (SQoL-M). Among the 36 subjects initially recruited for the 75-mg dose, 5 patients dropped out of the study (2 at visit 2 and 3 at visit 3), none of whom due to treatment inefficacy or serious adverse events. At visit 2, the mean (SD) IIEF-EF scores significantly increased (∆ = 7.97[4.71], P < 0.0001) as SQoL-M scores also did (∆ = 10.76[10.46], P < 0.0001). At visit 3, IIEF-EF and SQoL-M scores were still significantly improved compared to baseline (∆ = 10.64[7.01], P < 0.0001, and ∆ = 18.15[12.32], P < 0.0001, respectively). By ANCOVA, we found no significant effects for age, BMI, previous use of PDE5i, presence of metabolic comorbidities, or smoking habits on study outcomes at both visits 2 and 3. The new 75-mg ODF sildenafil formulation is a safe and effective treatment for ED, significantly improving both erectile function and sexual quality of life in patients undergoing treatment. This is the first study assessing the efficacy of the sildenafil ODF 75-mg dose in a real-life setting. However, the small sample size, possible underlying cultural factors, and limited availability of clinically relevant data may have affected the reliability of our results. The use of the 75 mg ODF formulation for sildenafil represents an effective and safe novel treatment option for ED patients.

Efficacy and safety of platelet-rich plasma (PRP) in erectile dysfunction (ED): a systematic review and meta-analysis.

Erectile dysfunction (ED) is a prevalent condition in aging men. Meanwhile, platelet-rich plasma (PRP), an emerging treatment alternative, has demonstrated potential in mitigating symptoms associated with ED. Our research aimed to explore the safety and effectiveness of employing PRP as a treatment strategy for ED. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocols, our research involved a thorough search across multiple databases: PubMed, Web of Science, Embase, and the Cochrane Controlled Trials Register. To assess the methodological rigor of the studies selected, we applied the modified Jadad scale and the Methodological Index for Non-Randomized Studies (MINORS) scale as evaluation tools. Subsequent to these evaluations, data analysis was conducted. Our analysis included seven non-randomized studies and three randomized controlled trials (RCTs). These studies showed that the International Index of Erectile Function-Erectile Function (IIEF-EF) scores improved significantly after 1, 3, and 6 months of PRP treatment, with increases of 4.05 [95% confidence interval (CI): 2.42, 5.68; P<0.001], 3.73 (95% CI: 2.93, 4.53; P<0.001), and 3.92 (95% CI: 3.00, 4.85; P<0.001) respectively, compared to the baseline scores. Additionally, compared to the placebo group, the PRP group showed significantly higher IIEF-EF scores. PRP treatment also had a beneficial impact on minimal clinically important difference (MCID) and peak systolic velocity (PSV). However, no significant differences were found between the PRP and placebo groups in terms of erectile hardness score (EHS) [mean difference (MD) =0.63; 95% CI: 0.26, 0.99; P<0.001] or visual analog scale (VAS) pain scores (MD =0.24; 95% CI: -0.05, 0.54; P=0.11). Our study results demonstrated significant efficacy and safety of PRP in treating ED. Due to the fact that most of the literature we included was single-arm studies, it was imperative for future research to provide higher-quality evidence for validation.

The Effect of Autologous Temporal Fascia Graft on Erectile Function and Psychometric Properties in Peyronie's Disease Patients.

The aim of this study is to evaluate the results of the surgical technique used by the authors on Peyronie's disease (PD) patients who underwent surgical treatment with a temporalis fascia autograft. Patients with normal erectile functions and > 60° penile curvature who underwent surgical treatment with temporalis fascia autografts were included in this retrospective study. The patients were recruited between January 2017 and May 2021. Preoperative assessment included the International Index of Erectile Function erectile function (IIEF-EF) score, penile duplex and penile curvature angle measurement. Postoperative self-reports, penile deformity, IIEF-EF scores and the Patient Global Impression of Improvement (PGI-I) questionnaire were assessed every three months. Twenty-two patients with a mean age of 52.09 ± 6.61 years were included in the study, and no major complications developed in any case. Postoperative assessment revealed curvature relapse in seven patients (31.8%), although no intervention was performed on five patients with < 20° curvature. Six patients experienced a postoperative decrease in penile length and erectile function was completely preserved in 68.18%. The mean level of satisfaction with surgery measured using the visual analogue scale was 79.13 ± 21.23. The temporalis fascia graft, thin and durable graft, is a highly successful therapeutic option in the surgical treatment of PD patients and a good alternative in terms of its cosmetic and functional results.

Effectiveness and safety of the radial pressure waves for the treatment of erectile dysfunction. A randomized clinical trial

ABSTRACT Introduction The current management of vasculogenic erectile dysfunction is based mainly on getting an erection firm enough for sexual intercourse with pharmacologic treatment. Some studies have shown that shock waves improve erectile function and could be a way to treat the endothelium in the corpora cavernosa. Radial wave therapy is commercialized as an option for the management of erectile dysfunction. However, the mechanism of action of the radial waves differs substantially from shock waves, so the evidence gathered for shock wave therapy cannot be extrapolated, and are very few clinical trials with the radial wave. Objective To assess the efficacy and safety of radial wave therapy compared with sham therapy for the treatment of primary erectile dysfunction. Methods This was a randomized, double-blind, sham-controlled clinical trial. Eighty patients with moderate erectile dysfunction, without sickle cell anemia, anticoagulation treatment, comorbidities, or conditions associated with secondary erectile dysfunction were included. Patients were randomized 1:1 to one of two arms: 6 weekly sessions of radial wave therapy (RW group) or 6 weekly sessions of sham therapy (control group). The parameters for radial wave therapy were 1 weekly session, 4,000 pulses in the body of the penis in a sweeping technique and 2,000 pulses in the perineal area (bilateral ischiocavernosus and bulbospongiosus muscles) at 2.4 Bar and a frequency of 17 Hz. The sham therapy group received 6 weekly sessions under the same parameters of radial wave therapy, using an internal bar in the handpiece of the equipment to prevent the patient from receiving the wave. All patients received sildenafil 20 mg. The efficacy and safety were assessed at 6 and 10 weeks after randomization. The primary outcome was the mean change in the International Index of Erectile Function - Erectile Function (IIEF-EF) domain score at 6 weeks after randomization. An intention-to-treat analysis was performed. Results Eighty men were randomized. The average baseline IIEF-EF score was 16.3 +/- 3.2, and the median baseline erection hardness score (EHS) was 3 (range, 1 to 3). At 6 weeks after randomization, the average change in the IIEF-EF score was 3.4 (95% confidence interval [CI] 1.5-5.2) in the RW group and 4.2 (95% CI 2.5-5.9) in the control group (p = 0.742). A total of 36.8% of the patients in the sham therapy arm and 41.7% of the wave therapy arm increased the EHS by at least 1 point at week 6 after the end of treatment (p = 0.671). At week 10, this proportion was 26.3% and 30.6%, respectively, for each group (p = 0.686). There were no changes in the dose of sildenafil in any of the groups. Non-serious adverse events occurred in two (5%) patients after radial wave therapy, and in one (2.5%) patient after sham therapy. Conclusions No difference was found in this study between men with erectile dysfunction treated with radial waves and men treated with placebo sham therapy.

Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial

IntroductionRadial wave therapy is commercialized as an option for the management of erectile dysfunction. However, the mechanism of action of the radial waves differs substantially from shock waves, so the evidence gathered for shock wave therapy cannot be extrapolated, and there are very few clinical trials with the radial wave. AimTo assess the efficacy and safety of radial wave therapy compared with sham therapy for the treatment of moderate and mild to moderate erectile dysfunction. MethodsA randomized, double-blind, sham-controlled clinical trial was realized. Eighty patients with moderate erectile dysfunction, without sickle cell anemia, anticoagulation treatment, comorbidities, or conditions associated with secondary erectile dysfunction were included. The efficacy and safety were assessed at 6 and 10 weeks after randomization. Patients were randomized 1:1 to 1 of 2 arms: (i) 6 weekly sessions of radial wave therapy (RW group) or (ii) 6 weekly sessions of sham therapy (control group). All patients received sildenafil 25 mg. OutcomeThe primary outcome was the mean change in the International Index of Erectile Function - Erectile Function (IIEF-EF) domain score at 6 weeks after randomization. ResultsEighty men were randomized. The average baseline IIEF-EF score was 16.3 (Standard Deviation - SD 3.2), and the median baseline Erection Hardness Score (EHS) was 3 (IQR 1). At 6 weeks after randomization, the mean change in the IIEF-EF score was 3.4 (95% confidence interval [CI] 1.5-5.2) in the RW group and 4.2 (95% CI 2.5-5.9) in the control group. No differences were observed between groups (P value =.742). No change was observed in the median EHS score in the evaluations. No serious adverse events occurred in 2 (5%) patients after radial wave therapy, and in 1 (2.5%) patient after sham therapy. Clinical ImplicationsKnowledge of the effectiveness of radial waves protocols used for the treatment of moderate erectile dysfunction, helps doctors and patients in making decisions about the use of this therapy. Strengths & LimitationsOne strength is conducting the study with high methodological standards to minimize risk biases. Our results are limited to the evaluation of 1 specific protocol in moderate and mild to moderate erectile dysfunction. ConclusionsNo difference was found in this study between men with moderate and mild to moderate erectile dysfunction treated with radial waves and men treated with placebo sham therapy. Studies with different protocols of radial waves are necessary.Sandoval-Salinas C, Saffon JP, Martínez JM, et al. Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial. J Sex Med 2022;19:738–744.

Surgical outcomes after collagenase Clostridium histolyticum failure in patients with Peyronie\u2019s disease in a multicenter clinical study

In the present study we aimed to investigate the surgical outcomes of patients with persistent penile curvature (PC) after Collagenase Clostridium histolyticum (CCH) intraplaque injections. Data from 90 patients with persistent PC after CCH in a multicentre study from 6 andrological centres were retrospectively reviewed. Three standardized surgical techniques were performed. Group 1: plaque incision grafting (PIG) with penile prosthesis implant (PPI); Group 2: PIG without PPI; Group 3: Nesbit technique. Hospital stay, operative time, postoperative complications and PC persistency/recurrence (> 20°) were evaluated. Overall satisfaction and functional outcomes were assessed through International Index of Erectile Function-Erectile Function (IIEF-EF), Peyronie’s Disease Questionnaire (PDQ), Female Sexual Function Index (FSFI) administered pre and 3 months postoperatively. Of all, 25 (27.8%) patients received grafting procedure + PPI (Group 1), 18 (20.0%) patients belonged to Group 2, and 47 (52.2%) to Group 3. Bovine pericardium graft and collagen fleece have been used in in 22 (51.2%) and 21 (48.8%) patients, respectively. Median penile length after surgery was 13.0 cm (IQR 12.0–15.0). After surgery, Group 1 showed higher increase in penile length after surgery and better improvements in terms of PDQ-PS. In contrast, both IIEF-EF and FSFI scores did not differ among groups. Overall, 86 (95.6%) did not report any complication. 4 (4.4%) patients had PC recurrence; of those, 2 (8.0%), 1 (5.6%) and 1 (2.1%) cases were observed in Group 1, Group 2 and Group 3, respectively. In case of persistent PC after CCH, surgical correction by grafting with or without concomitant PPI or Nesbit technique emerged as a technically feasible, effective and safe procedure, with no significant postoperative complications.

Low intensity extracorporeal shockwave Therapy shifts PDE5i nonresponders to responders.

ABSTRACTTo evaluate the efficiency of an energy density of 0.05mj/mm2 of low intensity extracorporeal shockwave therapy (Li-ESWT) on erectile dysfunction (ED) patients.A total of 45 ED patients met the inclusion criteria, including 7 PDE5i responders and 38 nonresponders. All the patients have already been delivered 10000 shockwaves of total seven treatment points twice a week for 4 weeks. Simultaneously, questionnaires of International Index of Erectile Function-Erectile Function (IIEF-EF), Erectile Hard Score (EHS) and Minimal Clinical Important Differences (MCID) were evaluated for the efficiency and safety at 8th and 16th weeks.The changes in the IIEF-EF score by MCID suggested that Li-ESWT treatment was effective in 22 PDE5i nonresponders patients (58%) at 8th week. Then at 16th week the number of patients who were effectively treated increased to 27 (71%). Among PDE5i responders, 5 patients (71%) were effective base on MCID at 16th week. Among PDE5i nonresponders 22 patients (58%) achieved erection hard enough for vaginal penetration and increased to 27 (71%) patients at 16th week (EHS ≥3). Moreover, even 3 patients achieved EHS 4 in PDE5i nonresponders at 16th week. Among PDE5i responders, 4 of 7 patients reached EHS of 4 from EHS 3 at 16th week. Apart from this, Li-ESWT treatment was also effective in 9 patients (24%) in PDE5i nonresponders without follow-up PDE5i.Energy flux density (EFD) of 0.05 of Li-ESWT could improve the erectile function of ED patients with PDE5i response. In addition, EFD of 0.05 of Li-ESWT treatment could turn PDE5i nonresponders to responders.