Treatment Of Erectile Dysfunction Research Articles

(072) Comparing Risk of Post-Infection Erectile Dysfunction Following SARS Coronavirus 2 Stratified by Acute and Long COVID, Vasopressor Administration, and Hospitalization Status

Abstract Introduction While multiple studies have shown an association between acute COVID-19 infection and subsequent development of erectile dysfunction (ED), no study has yet assessed the risk of developing ED after a diagnosis of long COVID. It is unclear if there is an increased risk of ED in those with long COVID compared to only those diagnosed with acute COVID. In addition, the impact of vasopressor use and hospitalization for an acute COVID infection on ED development is uncertain. Objective This study sought to assess the risk of ED in individuals with acute COVID-19 when compared to individuals with long COVID-19, as well as risk of ED following more severe cases requiring vasopressors and hospitalization. Methods The TriNetX COVID-19 Research Network was queried from December 1st 2020 through June 2023. We included men aged ≥ 18-years old and analyzed cohorts comparing the following 1) men diagnosed with long COVID-19 (ICD-10: U09) were compared to those that were diagnosed with or had positive test for acute COVID-19 but no diagnosis of long COVID. Men were included if they had at least one outpatient follow-up visit 2 weeks after the initial positive test result and excluded if they received a prior ED diagnosis or treatment, prostatectomy, pelvis radiation, or pulmonary hypertension diagnosis at any time. Additional analyses were performed with the same above criteria including men that were and were not hospitalized within 1 month of acute COVID diagnosis and whether men needed vasopressors or not. Cohorts were propensity score matched and compared for differences in new ED diagnosis and/or prescription of phosphodiesterase-5 inhibitors (PDE5i). Variables on which propensity scores were matched are detailed in Table 1. Results A total of 2839 men were included in each cohort after propensity score matching with an average age of 54.5 +/- 16.7 years and 55.1 +/- 17.1 years in the long and acute COVID cohorts, respectively. Men diagnosed with long COVID-19 were more likely to develop ED or be prescribed PDE5i (3.63%) when compared to men with only acute COVID-19 infections (2.61%) [RR 1.39; 95% CI 1.04, 1.87]. There was no statistically significant increased or decreased risk of developing ED or being prescribed PDE5i for individuals who received vasopressors [RR 0.922; 95% CI 0.774,1.098] or were hospitalized [RR 0.933; 95% CI 0.824,1.056]. Conclusions We found that long COVID-19 infection was associated with greater risk for ED diagnosis or PDE5i prescriptions when compared with men diagnosed with only an acute COVID-19 infection, while there was no significantly increased risk for individuals requiring vasopressors or hospitalization. Disclosure No.

(381) Infertility, Erectile Dysfunction, and Hypogonadism Medications in the NFL: A Comprehensive Analysis of the Substance Abuse Policy, Violation Penalties, and Therapeutic Use Exemptions

Abstract Introduction The National Football League (NFL) faces countless challenges in maintaining a fair and competitive playing field while protecting player health. One aspect of concern involves the use of medications to treat infertility, erectile dysfunction (ED), and hypogonadism, which can potentially alter and enhance athletic performance. The NFL's Substance Abuse Policy governs the use of such medications and imposes strict penalties for violations. Several important players have been affected by these rules while attempting treatment for legitimate medical conditions. This project explored the presence of infertility, ED, and hypogonadism treatments among NFL players, assessed the penalties for their misuse, and analyzed the process for obtaining Therapeutic Use Exemptions (TUEs). Objective To provide in-depth analysis of the NFL's Substance Abuse Policy involving medications for infertility, ED, and hypogonadism treatment. Specifically, we evaluated the presence of specific medications in question as compared with the guidelines established by the World Anti-Doping Agency (WADA), examined the penalties associated with misuse, and investigated the procedures for obtaining TUEs. Methods We obtained a copy and conducted a thorough analysis of NFL’s Substance Abuse Policy, focusing on the presence of commonly prescribed medications to treat infertility, ED, and hypogonadism. This was compared to existing WADA guidelines. We then evaluated specific testing procedures and penalties associated with their use. We finally analyzed and delineated the methodology for obtaining a TUE. Results Our analysis of the Substance Abuse Policy revealed 97 prohibited substances encompassing Anabolic/Androgenic Steroids, Protein and Peptide Hormones, Anabolic Agents including Beta-2 Agonists, Anti-Estrogenic Agents, Selective Androgen Receptor Modulators (SARMs). This list was found to be 98% consistent with existing WADA guidelines. Erectile Dysfunction medications were allowed, specifically Viagra, Cialis, and Levitra. Penalties for violating League Policy ranged from fines (calculated using player-specific salary), suspension, bonus forfeiture, and banishment. Regarding TUEs, specifically for hypogonadism, the application process proved to be complex, requiring substantial medical documentation, laboratory testing including FSH, LH, and semen analysis, and expert review. Obtaining a TUE additionally required annual renewal as well as regular serum testing and medical visits. Conclusions The use of medications treating infertility and hypogonadism among NFL players is a valid medical concern. While potential for abuse exists, many players qualify for treatment based on current medical guidelines. The Substance Abuse Policy was comprehensive, including all major infertility and hypogonadism medications while allowing use of common ED medications. Penalties for violations were strict but accompanied by associated review and appeal processes. The TUE system, while complex and time-intensive, provided pathways for players with genuine medical needs to access necessary treatments while maintaining organizational oversight. This study showed the delicate balance maintained by a multi-billion-dollar industry in promoting fair play while simultaneously allowing players to obtain legitimate medical treatments. Further research and collaboration between medical professionals, players, and league officials is needed to further refine this process for future generations. Disclosure No.

(370) Overview of Nonclinical Studies of LIB-01, a Novel Promising Oral Drug Under Development for Treatment of Erectile Dysfunction

Abstract Introduction LIB-01 is a novel molecule being developed as an oral drug for the treatment of erectile dysfunction (ED). It is a semi-synthetic analog, developed based on research on active compounds identified in root bark that had been used for treatment of male sexual disability since time immemorial. Objective In preparation for clinical development, a number of nonclinical studies on erectile function were conducted in normal and diabetic rats with ED. Studies to investigate the mechanism supporting the pro-erectile effect of LIB-01 were also conducted. A summary of the results from the nonclinical research program is presented. Methods Erectile response elicited by electrical stimulation of the cavernous nerve (ES CN) in anaesthetized rats was assessed. Intracavernous and arterial blood pressures were monitored according to a standardized experimental procedure. Mechanism of action studies were conducted with rat cavernosal tissue samples using immunohistochemistry and in ex vivo/organ chamber experiments. The isometric tension studies were conducted on cavernosal strips from LIB-01 treated and untreated Wistar rats. Cavernosal strips from untreated rats were incubated with either LIB-01 or DMSO (control) and then pre-contracted by phenylephrine (PHE). Concentration- or frequency response curves were performed on PHE pre-contracted strips in 3 consecutive steps: (i) cumulative addition of increasing acetylcholine (ACh) concentrations, (ii) electrical field stimulation (EFS) with increasing frequencies, and (iii), cumulative addition of increasing sodium nitroprusside (SNP) concentrations. Results A statistically significant pro-erectile facilitatory effect of LIB-01 has been repeatedly evidenced in all the studies conducted in anaesthetized control Wistar rats, by oral or subcutaneous administration of LIB-01 at 15 mg/kg/d, with an effect in the similar range as iv sildenafil 0.3mg/kg, when compared. The pro-erectile effect of LIB-01 was not acute, instead, the effect gradually increased and remained for at least 7 days post treatment. In addition, LIB-01 significantly improved erectile responses in anaesthetized diabetic Goto-Kakizaki ED rats compared to vehicle-treated rats, demonstrating the pro-erectile effect of LIB-01 in a robust validated pathophysiological rat model of type 2 diabetes. Immunohistochemistry experiments on cavernosal tissue from LIB-01 treated normal rats showed that neither CD31 nor nNOS expression was altered, thus likely ruling out any effect of LIB-01 on cavernosal micro-vascularization or cavernosal nNOS. Furthermore, only at a high concentration (10-5 M) was there a slight increase in the endothelium dependent relaxations induced by ACh compared to vehicle while LIB-01 did not exert any effect neither on endothelium-independent relaxations induced by SNP nor on nitrergic relaxation induced by EFS of untreated cavernosal strips exposed ex-vivo to different concentrations of LIB-01. Conclusions LIB-01 is a novel molecule which displays a significant pro-erectile effect in anesthetized normal rats as well as in diabetic rats with ED. The pro-erectile effect of LIB-01 is not acute, instead, the effect gradually increases and remains for at least 7 days post-treatment. Results from several mechanistic studies lead to postulate that the mechanism of LIB-01 does not recruit the NO-cGMP pathway thereby differing from phosphodiesterase type 5 inhibitors. A first-in-human clinical trial with LIB-01 is planned to start in 2023. Disclosure Yes, this is sponsored by industry/sponsor: Dicot AB. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Dicot AB.

(164) Potential Savings with Use of Cost Plus Pharmacy for Medical Treatment of Erectile Dysfunction

Abstract Introduction With its stated goal “to end ridiculous drug prices,” the Mark Cuban Cost Plus Drug Company (MCCPDC) launched in January 2022 with over 100 generic prescription drugs available to be mailed directly to patients without the involvement of health insurance. To promote drug cost transparency, all drugs are priced at the cost to manufacture the drug with a 15% administrative markup, a $3 pharmacist fee, and a $5 shipping fee. Prior research has focused on the theoretical savings MCCPDC could offer if Medicare purchased drugs at MCCPDC prices with studies reporting a potential $3.3 billion in savings for Medicare. Prescription drug spending is continuing to rise in the United States and providers are increasingly considering patient’s out-of-pocket costs. MCCPDC touts a transparent, consistent pricing model, but it is unclear if this pricing model will actually translate to cost savings for patients. Objective We sought to analyze if Mark Cuban Cost Plus Drug Company (MCCPDC) can offer savings directly to patients compared with other mail-order pharmacies, local pharmacies (based on zip code of our urology clinic) and with patients using health insurance to fill prescriptions for their sildenafil, vardenafil and tadalafil. Methods Out of the approximately 100 generic drugs available on MCCPDC website, we analyzed the 3 drugs that are prescribed to treat erectile dysfunction. We analyzed drug prices of 30 and 90-day prescriptions at the same dose of each medication. Using Good Rx prescription drug search engine, we compared the drug prices of the cheapest mail order and local in person pharmacies near our zip code. We also included prices for the recently started telemedicine company Roman. To compare if MCCPDC could offer savings to patients using health insurance to fill their prescriptions, we extracted the out-of-pocket drug costs for patients from the 2020 Medical Expenditure Panel Survey (MEPS; a national survey that compiles data from both the pharmacy and the survey respondent to determine the exact cost of each prescription filled during that year) and the 2020 Medicare Part D spending data. Medicare Part D spending data was used to estimate the out-of-pocket cost for each medication, which is approximately a 25% copayment for Medicare prescriptions. Results MCCPDC offered the lowest direct-to-consumer price on sildenafil and tadalafil 90-day prescriptions (Table 1). MCCPDC saved patients approximately $10 per sildenafil and tadalafil prescription compared with the next cheapest option. We found additional, although smaller, savings at 30-day prescriptions for sildenafil and tadalafil. MCCPDC was not the cheapest option for vardenafil. Compared with Roman, MCCPDC offered cheaper prescriptions for sildenafil and tadalafil by over $300 and $900, respectively. Conclusions MCCPDC can offer significant cost savings to patients, especially considering the high number of sildenafil and tadalafil prescriptions each year. The transparency and consistency in pricing with MCCPDC can be utilized by providers when counseling patients on medical therapy options for erectile dysfunction. Disclosure No.

(390) A Preliminary Analysis of Outcomes and Complication Rates for Patients Undergoing Inflatable Penile Prosthesis Implantation following Intracavernosal Injection Therapy With or Without Concurrent Anticoagulation

Abstract Introduction Medications, namely antiplatelets (AP) and anticoagulation (AC), are effective at avoiding fatal vascular complications and prolonging the lives of our patients. As such, more and more men seeking treatment for erectile dysfunction (ED) also take blood thinners. This is an interaction we must better understand to provide safe, individualized care to our patients and minimize peri-operative morbidity. Currently, there is no published information on whether differences exist in the escalation of treatment for patients with erectile dysfunction and on AC. A previous study has demonstrated no statistically significant difference in complications between AC and non-AC groups while on ICI, despite there being a higher rate of absolute bleeding events for AC patients. Objective To compare outcomes and complication rates in patients undergoing IPP implantation following ICI therapy with or without concurrent anticoagulation. Methods A retrospective observational study was undertaken. Electronic patient records from January to September 2021 were reviewed. Included patients were those who had either currently or previously utilized ICI therapy for ED treatment. ICI therapy surveys and Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) questionnaire were obtained. 85 patients met the inclusion criteria; 43 concurrently using AC during ICI therapy and 42 with no AC use. Patients who were unable to completely stop their AC medications a week before surgery due to cardiovascular concerns or recommendations, underwent bridging with a shorter half life and reversible AC. Extra measures taken during the IPP for such patients, including meticulous hemostasis, compression dressing and drain insertion. Additional data regarding IPP implantation as well as any complications or infections experienced following IPP surgery which were compared between the AC and no AC groups. Results Patient demographics, IPP implantation information and subsequent complication rates are listed below in Table 1. There was no statistically significant difference in the rate of patients who underwent IPP placement between the AC and no AC cohorts. Moreover, there was also no statistically significant difference in median time from date of initial ICI usage to time of IPP placement as well as median time from IPP placement to last follow-up. Among the 12 total patients who underwent IPP placement, none experienced any complications, including infection, mechanical failure, device removal or revision at any time point up to last follow-up (longest was 18 months). No statistically significant differences in EDITS score between both groups was observed. Conclusions These preliminary findings, while requiring large-scale follow up, show that there is no statistically significant difference in rate of patients opting for IPP surgery following initiation of ICI therapy regardless of concomitant AC usage as well as the rate of complications following IPP implantation. Lastly, there is no drawbacks in performing such procedure in this specific cohort of patients, provided that all necessary measures are taken into consideration to minimize bleeding complications. Disclosure No.

(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.

(318) Factors Influencing Compliance with Trimix, an Intracavernosal Injection for Erectile Dysfunction: A Retrospective Analysis

Abstract Introduction Trimix, an intracavernosal injection therapy, is an effective treatment for erectile dysfunction. However, patient compliance with Trimix use is crucial for treatment success, and factors influencing compliance are not well understood. Objective This retrospective analysis aimed to identify factors that influence compliance with Trimix therapy among patients with erectile dysfunction. Additionally, the study aimed to investigate the impact of comorbidities, specifically diabetes and prostate cancer, on the duration of Trimix treatment. Methods Patient data from pharmacy records between 2017 and 2022 was analyzed. Custom Python code was used to calculate the duration of Trimix use based on the first and last prescription refill events. A comprehensive chart review was conducted to collect additional patient-related data, including demographics and comorbidities. Cox Proportional Hazards Regression models were employed to assess the effects of predictor variables on the duration of Trimix use. Simple linear regression was used to compare the presence of diabetes, prostate cancer, or both on time spent on Trimix treatment. Results The analysis included a total of 4,072 patients. Age was identified as a significant predictor of Trimix therapy discontinuation, with every additional year of age associated with an increased hazard ratio of 1.007 (p < 0.001). Preferred language also emerged as a significant predictor, with patients preferring Spanish exhibiting a higher hazard ratio of 1.163 compared to patients preferring English (p = 0.004). In terms of comorbidities, the presence of prostate cancer significantly differed from other organic causes of erectile dysfunction on time spent on Trimix treatment (p = 0.002), resulting in 80 fewer days of Trimix treatment. Conclusions This retrospective analysis revealed that age and preferred language are important factors influencing compliance with Trimix therapy. Older patients and those preferring Spanish were more likely to discontinue Trimix treatment. Additionally, the presence of prostate cancer significantly impacted the duration of Trimix treatment. These findings emphasize the need for age-specific counseling, language-concordant interventions, and tailored approaches to address comorbidities such as prostate cancer. Understanding these factors is vital for optimizing treatment adherence and efficacy in patients with erectile dysfunction. Disclosure No.

(363) A Global Survey of Sexual Dysfunction Management Among Urologists and Sexual Medicine Experts

Abstract Introduction Understanding and addressing sexual dysfunction is of paramount importance to enhance the overall well-being and quality of life of individuals worldwide. While significant progress has been made in the field of sexual medicine, variability in practice patterns among healthcare professionals remains a potential barrier to optimal patient care. To bridge this knowledge gap and identify the prevailing trends in sexual dysfunction management, we conducted an international survey targeting urologists specializing in Andrology, Sexual Medicine, and related fields. Objective This international survey aimed to assess male and female sexual dysfunction management practices among sexual medicine physicians across to globe to identify variability in practice patterns. Methods A survey was distributed globally to urologists specializing in Andrology, Sexual Medicine, and related fields who are members of International Society for Sexual Medicine (ISSM) or affiliated regional societies (SMSNA, ESSM, MESSM, APSSM, SASSM, SLAMS, ISSWSH, SIU). Demographic information (age, gender, specialty, and practice setting) and treatment approaches for male and female sexual dysfunction were collected. Respondents also reported the percentage of their practice dedicated to sexual dysfunction and whether treatments were covered by health insurance. Results A total of 200/3000 practitioners participated, with 101 (50.7%) identifying as urologists. The majority were male (72.9%) and worked in private practice or community hospitals (32.7%) or a mixture of both (34.2%). Male sexual dysfunction was treated by 71.4% of respondents, with 25.7% dedicating 75-100% of their practice to it. Female sexual dysfunction was treated by 36.9% of respondents, with 64% dedicating 0-25% of their practice to it. Health insurance covered 25-49% of their care for 41.2% of respondents, predominantly provided by private companies (45.9%). The most common treatments for erectile dysfunction were oral medications (86.5%), injections (61.7%), and inflatable penile prostheses (45.1). For Peyronie's disease, oral therapies (59.1%) and penile traction therapy (34.4%) were most frequently offered, while surgical treatment for Peyronie's disease was offered by 58.2% of respondents, with penile prostheses being the primary choice (79.7%). Regarding female sexual dysfunction, 58.4% of respondents offered treatments for genitourinary syndrome of menopause/atrophic vaginitis, with vaginal estrogen being the most common choice (50%). For dyspareunia due to vaginismus/hypertonic pelvic floor dysfunction, 50.3% of respondents offered treatment, with pelvic floor exercise/physiotherapy being the most recommended (66%). Conclusions This study provides valuable insights for healthcare professionals, policymakers, and researchers regarding the current landscape of sexual dysfunction management. The results underscore the importance of continuous efforts to develop comprehensive and individualized approaches, ensuring that both male and female patients receive effective and accessible care for their sexual health concerns. By addressing issues related to insurance coverage and fostering interdisciplinary collaboration, the medical community can collectively work towards improving sexual well-being and quality of life for patients worldwide. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Advisory board and speaker for Coloplast; consultant for Cynosure; advisory board and speaker for Halozyme; intellectual property with Masimo; advisory board for Promescent; consultant for Sprout; advisory board for Xialla.

(126) Application of HIFEM Therapy Improves Orgasmic, Urinary and Erectile Function by Stimulation of Pelvic Floor Muscles

Abstract Introduction The weak pelvic floor in men contributes to various urological disorders. Treatment can be accomplished by strengthening the pelvic floor muscles (PFM) through pelvic floor muscle training. Nevertheless, such development of PFM is time-consuming and heavily dependent on the subject's ability to perform selective muscle contractions. An advantageous approach is the targeted stimulation of PFM which can be accomplished via electromagnetic stimulation. Particularly, the pelvic floor muscles can be non-invasively and selectively stimulated via the HIFEM field. This results in the natural development and rehabilitation of PFM, which, among other functions, plays a vital role in facilitating orgasmic, urinary and erectile function. Objective The aim of this study is to assess the safety and efficacy of the HIFEM pelvic procedure for the treatment of erectile dysfunction. Methods In this study, 28 males with a median age of 56 (30-72 years) were enrolled. The treatment was composed of ten weekly 28-minute sessions. Outcome measurements were collected via questionnaires and ultrasound imaging prior to and after the last treatment. To assess changes in erectile and sexual function, and prostate-related symptoms, the International Index of Erectile Function (IIEF) and International Prostate Symptom Score (IPSS) were used. Transverse B-Mode ultrasound video scans were recorded along the long axis of the penile shaft from the tip to the base with the penis in a flaccid state. A linear transducer was used, the depth was set at 2 cm, and the frame rate was approximately 30 frames per second. Separate video recordings of the left and right cavernosum were taken. The ultrasound scans were processed by the Morphometrix cloud-based algorithm. Adverse events were monitored during the study. Results All evaluation methods proved the efficiency of treatment on a statistically significant level. A significant improvement was detected in the majority (4 of 5) of the domains of IIEF, with the overall score improvement from a baseline value of 45.14±2.42 to 48.75±2.86 (+3.61 points). The most exceptional improvement was found in Sexual desire (+18.78%; p=1.06x10-3), Erectile dysfunction (+13.03%; p=5.7x10-4), and Orgasmic function (+10.69%; p=7.04x10-5) domains. The mean difference in the total score of the IPSS questionnaire reached -3.04 points (p=5.1x10-6), exceeding the corresponding minimal clinical difference (MIC=3 points). Overall, subjects, on average, shifted from moderately symptomatic (9.57±1.37 points) to mildly symptomatic (6.54±0.91 points). An increase in vascularity of both cavernosal was measured within 57% of patients who underwent ultrasound examination; specifically, a significant improvement was recorded in tissue segment count (TSC; +104%; p=1.17x10-4) and density (TSD; +81% p=2.20x10-3), pointing to better blood flow and delivery in examined tissues. No adverse event was observed. Conclusions The therapy administering HIFEM technology of the pelvic floor for selective PFM stimulation demonstrated significant improvement of erectile and orgasmic function and urinary symptoms. The questionnaire results corresponded with ultrasound measurements using a novel algorithm, identifying positive changes in the penile vascular system. Overall, the treatment may be considered a safe and a possible first-line solution for male patients suffering from dysfunctions linked to weakened pelvic floor muscles. Further investigation is needed. Disclosure Yes, this is sponsored by industry/sponsor: BTL. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: AFFIRM Science.

(196) Reconstruction of Complex Midline Septal Corporal Defect in a Distal Crossover Penile Implant Cylinder: A Step-by-step Demonstration of Surgical Technique

Abstract Introduction Inflatable penile prosthesis (IPP) placement is a common and effective treatment for erectile dysfunction. Around 20,000 procedures are performed annually. Complications can arise after the procedure, with non-infectious complications occurring in approximately 4% of cases. One rare non-infectious complication is complete cylinder crossover, which can happen due to variable windows in the corporal septum. Objective This case report presents a complex distal septal defect caused by distal cylinder crossover and its repair using Tutoplast graft. Methods The patient, a 59-year-old African American male, had a history of prostate cancer and underwent robotic-assisted laparoscopic prostatectomy in 2018. He received an IPP in September 2020. In 2022, the patient experienced painful leftward penile curvature during erections and incomplete deflation of the penile prosthesis. A physical examination revealed crossover of the right prosthesis cylinder to the left. After a thorough discussion of the risks and benefits, the patient opted for surgical revision and reconstruction of the penile prosthesis. The procedure involved a right corporotomy, septal corporal reconstruction using a 5 × 2 cm Tutoplast graft, and redirection of the uninfected, functioning cylinder into the neocorporal space. Results The surgery was successfully completed without any complications, and the IPP functioned well at the end of the procedure. During the 6-week clinic follow-up, the patient reported proper cycling of the device, excellent erectile function, the ability to orgasm, and minimal pain. Conclusions In conclusion, our case demonstrates that Tutoplast graft, along with appropriate seating and redirection of the displaced cylinder without replacing the functional hardware, is a viable surgical approach for IPP revision, even in complex cases involving septal defects. Disclosure No.

(287) A Patient's Journey with Erectile Dysfunction: Prediction Progression to Penile Implant

Abstract Introduction Inflatable penile prosthesis (IPP) is seen as the gold standard for surgical treatment for ED, specifically for patients that are not amenable to lifestyle changes or oral medications. Objective This study aims to explore which patients progress to seeking treatment with an IPP along their journey with erectile dysfunction. Methods This retrospective study identified patients with ED as a chief complaint during the primary visit or follow-up from 2009-2022. If patients eventually progressed to treatment with IPP, data was collected to find common features and analyzed. Results Of our cohort of 361 men presenting with erectile dysfunction (ED), 21 men progressed to the placement of an inflatable penile prosthesis (IPP). 20 men classified as non-Hispanic, with 13 white, 6 African American/black, and 1 Asian males. Only 1 man was Hispanic. 5 men had either hypertension (n = 11), hyperlipidemia (n = 10), or DM (n = 3), with 6 having both hypertension and hyperlipemia, 1 with hypertension and diabetes, and 1 with hypertension, hyperlipidemia, and diabetes. Median age of the group at surgery was 76 years (IQR: 71 – 82), with median time from initial presentation to surgery of 12 (IQR = 11.5-27.5) months. N = 10 men had trialed oral phosphodiesterase inhibitor type 5 (PDE-5i) therapy, and 7 men failed intracavernosal injection (ICI) therapy. 8 men had been treated for hypogonadal symptoms with testosterone replacement therapy (TRT). Of patients who had data available on their reason for IPP placement, indications included were Peyronie’s disease inhibiting intercourse (8/21), longstanding ED refractory to medical therapy (4/21), post-prostatectomy ED (4/21), history of priapism requiring surgical intervention (1/21), and history of spinal cord tumor (1/21). Among those treated with IPP, the median patient waited almost 1 year from initial presentation following failure with PDE5i, ICI, and TRT. 17/21 men reported satisfaction after IPP treatment. In those who progressed to IPP, the majority of indications were organic forms of ED (Peyronie’s disease, neurogenic, surgery). Conclusions Only 5.8% of men in this cohort went on to proceed with an IPP. In summary, our results indicate that IPP is best suited for those presenting with organic ED who have failed more conservative management techniques. Further studies are needed to assess why so few men go on to proceed with an IPP and wait an average of 2 years. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast Investor: Sprout.

(240) Evaluation of Factors Associated with Reoperation Rates for Penile Prosthetic Implantation in Erectile Dysfunction: A Medicare Analysis

Abstract Introduction As the prevalence of erectile dysfunction (ED) in the U.S. continues to rise due to an aging population, the use of penile prostheses (PP) to treat refractory ED is expected to increase. In 2017, Onyeji et al analyzed a New York state surgical database and found that the highest quartile implanters had lower re-operation rates in long-term follow-up. Due to a higher risk of infection and morbidity in PP reoperations, compared to primary surgery, minimizing PP reoperations is important. Objective This study evaluates the association between patient/clinical characteristics and reoperation rates at 90-days and 1-year among men undergoing PP implantation using a national database. Methods This retrospective claims data analysis used the 100% Medicare Standard Analytical Files (SAF) to identify men aged ≥65 who received PP (malleable and inflatable) between 2017 and 2020. The patients were required to have a continuous enrollment 1-year pre- and post-index PP encounter. The outcomes of interest were reoperation rates (defined as removal, repair, and removal and replacement of PP with or without infection) at 90 days and 1 year following initial implantation. Multivariable logistic regression was used to examine the relationship between reoperation rates and patient demographics and comorbidities: age, geographic region, race (White, Black, and Others [American Indian, Asian, Hispanic, Other, Unknown]), urbanization, baseline Charlson Comorbidity Index (CCI) and comorbidities (diabetes and prostate cancer therapy), primary diagnosis at the index PP implantation, type of index PP procedure, and prosthetic surgeon procedure volume. Urbanization was categorized as urban vs rural based on patient’s county of residence and the 2013 National Center for Health Statistics Urban-Rural Classification Scheme for Counties. The prosthetic surgeon procedure volume was split into low (1-24 surgeries) and high-volume (≥25 surgeries) based on the 2022 PP International Consensus Forum definition. Results This study included 12,350 patients who underwent PP implantation. Nearly 50% were aged 65-69 years, 77.2% White, 82.6% in urban areas, and 56.2% had a CCI score of 0 (Table 1). Most of these men (96.0%) received an inflatable PP and 91.2% had ED as their primary diagnosis. The overall reoperation rates at 90-day and 1-year post-implant were 2.19% and 6.15%, respectively. Logistic regression found that low-volume implanters were associated with a 34% (OR 1.34; 95% CI 1.01, 1.78) and 35% (OR 1.35; 95% CI 1.14, 1.60) higher odds of reoperation at 90-day and 1-year post-implant, respectively, compared to high-volume implanters. Men with a baseline CCI of 0 had 19% higher odds of 1-year reoperation (OR 1.19; 95% CI 1.01, 1.40) compared to their counterparts with a CCI of ≥1. Black patient race was associated with 35% lower odds of 90-day reoperation compared to White patients (OR 0.65; 95% CI 0.43, 0.99) but this difference did not persist at 1-year of follow-up. Conclusions This study highlights that higher case volume reduces the risk of reoperation in the short to medium term, consistent with state-specific data of long-term follow-up. The impact of race and comorbidities warrants further evaluation to optimize patient counseling as they seek surgical treatment of ED. Disclosure Yes, this is sponsored by industry/sponsor: Boston Scientific. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast, BK Medical.

(282) Longitudinal Impact of Inflatable Penile Prostheses on Patients’ Body Image and Sexual Satisfaction

Abstract Introduction Inflatable penile prostheses (IPP) are used in a multitude of urologic disorders including Peyronie’s disease and medication-refractory erectile dysfunction. The IPP procedure is performed by inserting a penile pump to help generate and maintain penile erections. Objective To analyze self-perceptions and body dysmorphia of patients who have had an IPP placement. Methods An electronic survey was delivered through REDCap to patients who had undergone an IPP placement and who were identified using diagnosis codes associated with the procedure within the 06/01/2007 - 09/01/2022 observation interval. The survey asked each patient about their comfort with their penis’s appearance and usage in sexual settings, with answer choices corresponding to a five-point Likert-Scale in addition to a free-form response section. T-tests were utilized to compare mean respondent scores before and after IPP placement using SPSS software. Results 436 surveys were sent out, and 69 responses were received (15.83%). When asked about comfort with their penis’s appearance, the respondents had a slight, non-significant increase after IPP (T-value = -0.771, p = .221). In response to inquiring about the patient’s ease using their penis in sexual relationships, patients reported an increase due to their IPP placement (T-value = -3.00, p = .0016). When reverse coded, patients demonstrated a great decrease in concern about their penis in social situations after the IPP procedure (T-value = -3.88, p = .00008). The total score of all questions before and after IPP placement increased by an average of 15.1% (T-value = -3.21, p = .00082). 44.78% of respondents noted a positive change in how the IPP changed how they view themselves and their body; 40.30% noted neutral change and 14.93% noted a negative change. In response to how the IPP has affected sexual and romantic relations, 68.66% reported a positive difference after IPP, 16.42% were neutral, and 14.93% reported a negative difference. Conclusions Our data demonstrate that IPPs have a stronger impact on sexual function, as opposed to body image; however, the vast majority of patients felt a positive or neutral change of how they view themselves and their bodies post-IPP. These findings support the continued use of IPPs in patients who are non-responsive to previous erectile dysfunction treatments. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Larry Lipshultz: AbbVie (Consultant) American Medical Systems/Boston Scientific (Speaker) Augmenta LLC (Stockholder) Aytu BioScience (Consultant) Contraline, Inc. (Consultant) Endo Pharmaceuticals (Consultant/Speaker) Inherent Biosciences (Advisor) Lipocine (Consultant); Mohit Khera: Consultant- AbbVie, Halozyme, Clarus, Metuchen, Acerus, Boston Scientific, Coloplast, Endo.

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.

Treatment of erectile dysfunction by intracavernosal administration of mesenchymal stem cells in patients with diabetes mellitus.

The purpose of study is to assess and analyse the effectiveness of their use in the treatment of erectile dysfunction in patients with diabetes mellitus. The literature search was conducted using systematic methods and analysis in databases such as Web of Science, Scopus, PubMed, Elsevier, and Springer, with 41 sources included for further review. The study highlights microangiopathic and neuropathic links as key factors in erectile dysfunction development in diabetic patients, stemming from endothelial dysfunction and conductivity disturbances. Mesenchymal stem cell therapy from bone marrow, adipose tissue, and umbilical cord mitigates pathogenic impact through regenerative and anti-apoptotic effects. Due to this, most studies indicate high efficacy of the treatment and rapid therapeutic action through intracavernosal administration. Some studies suggest an increase in the body's receptor sensitivity to other drugs, such as sildenafil. From the perspective of further research on this issue, standardising the preparation of stem cells and the treatment method using a large sample size is essential to introduce such a method as an extremely promising therapy for this delicate issue in men into practical medicine. The practical value of the study lies in the systematisation of information on different sources of mesenchymal stem cells for treating erectile dysfunction.

Satisfaction assessment study in patients (and their partners) with/without Peyronie’s disease and penile prosthesis implantation

Introduction and objectiveAmong the many treatments for erectile dysfunction, implantation of a penile prosthesis has been associated with high patient satisfaction rates. However, patients with coexistent Peyronie’s disease (PD) and refractory erectile dysfunction and/or severe deformities may show different results. The aim of our study was to assess and to compare the level of satisfaction, with an inflatable penile prosthesis (IPP), in men with/without coexistent PD. Material and methodsA survey study based on a five-item satisfaction questionnaire was submitted to all those live patients implanted in the period 1992–2022 at our center (n=570) and their partners. Ninety-two percent of implants were inflatable devices. Surgeries were mainly performed by two surgeons. The main outcome measure used was the level of patient and partner satisfaction with sexual intercourse after IPP. ResultsOf the 570 eligible patients, 479 (84%) completed the survey (393 Non-PD: GROUP 1; 70 non-complex PD-Group 2; 16 complex PD). Eighty-six per cent of patients in Group 1 reported satisfactory sexual intercourse (very or moderately satisfied). Non-complex PD implanted patients (Group 2) reported a global 81% satisfactory sexual intercourse (very or moderately satisfied) (p>0.05). However, when we evaluated the PD subgroup of patients with severe PD who require incision/excision/grafting at the time of implant (Group 3: n=20), only 61% reported satisfactory sexual intercourse (p<0.01) with predominance of moderately satisfied patients over very satisfied: 78% vs. 22%). Additionally, 84% (Group 1), 80% (Group 2) and 54% (Group 3) of partners reported satisfactory intercourses, respectively (p<0.01). Overall, 84% of Group 1 implants and 79% of Group 2 reported that they would undergo the procedure again if the IPP failed (p>0.05; ns). Only 50% of Group 3 patients would do it again. With regard to cosmetic aspects, 48% of the Group 3 implant reported penile shortness or soft glans as the main causes of their dissatisfaction. Only 2.4% of total PP patients expressed difficulty in manipulating the device. ConclusionThe presence of PD alone may not impact PP patient and partner satisfaction, but patients with more severe baseline deformity who require incision/grafting may be less satisfied with outcomes including penile length and glans sensation.

Identification and validation of new fatty acid metabolism-related mechanisms and biomarkers for erectile dysfunction.

Erectile dysfunction (ED) is a common condition affecting middle-aged and elderly men. The study sought to investigate differentially expressed fatty acid metabolism-related genes and the molecular mechanisms of ED. The expression profiles of GSE2457 and GSE31247 were downloaded from the Gene Expression Omnibus database and merged. Differentially expressed genes (DEGs) between ED and normal samples were obtained using the R package limma. Gene Ontology and Kyoto Encyclopedia of Genes and Genomes enrichment analyses of DEGs were conducted using the R package clusterProfiler. Fatty acid metabolism-related DEGs (FAMDEGs) were further identified and analyzed. Machine learning algorithms, including Lasso (least absolute shrinkage and selection operator), support vector machine, and random forest algorithms, were utilized to identify hub FAMDEGs with the ability to predict ED occurrence. Coexpression analysis and gene set enrichment analysis of hub FAMDEGs were performed. Fatty acid metabolism-related functions (such as fatty acid metabolism and degradation) may play a vital role in ED. In total, 5 hub FAMDEGs (Aldh2, Eci2, Acat1, Acadl, and Hadha) were identified and found to be differentially expressed between ED and normal samples. Gene set enrichment analysis identified key pathways associated with these genes. The area under the curve values of the 5 hub FAMDEGs for predicting ED occurrence were all >0.8. Our results suggest that these 5 key FAMDEGs may serve as biomarkers for the diagnosis and treatment of ED. The strengths of our study include the use of multiple datasets and machine learning algorithms to identify key FAMDEGs. However, limitations include the lack of validation in animal models and human tissues, as well as research on the mechanisms of these FAMDEGs. Five hub FAMDEGs were identified as potential biomarkers for ED progression. Our work may prove that fatty acid metabolism-related genes are worth further investigation in ED.

Safety, tolerability, and pharmacokinetics of aildenafil citrate tablets, a novel oral PDE5 inhibitor, in healthy Chinese volunteers after multiple-dose administration.

Aildenafil citrate is a potent and selective inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase type 5, developed for the treatment of erectile dysfunction (ED). This study aimed to assess the pharmacokinetics, safety, and tolerability of aildenafil citrate tablets after multiple doses in healthy Chinese males. Twenty participants were divided into 2 groups, 10 participants each. Participants were administered multiple doses of aildenafil citrate tablets at 30and 60mg. The safety evaluation was based on clinical symptoms and adverse events. Concentrations of aildenafil and its key metabolites (M1, M5, and M12) in human serum were measured by liquid chromatography-tandem mass spectrometry. Pharmacokinetic analysis showed rapid absorption and elimination of aildenafil, with a median time to maximum serum concentration of 1hour and mean terminal half-lives of 2.75and 3.26hours in the respective dose groups. The mean maximum concentration was proportional to the aildenafil dose in the range of 30to 60mg, although the area under the curve was not proportional for serum concentration vs time 0 to the last measurable time point (24 hours). Multiple doses of aildenafil were well tolerated, with 60.0% of men experiencing treatment-emergent adverse events, notably myalgia and fatigue, particularly in the 60-mg group. Aildenafil citrate tablets demonstrated favorable tolerability with once-daily administration over the clinical dose range. The occurrence of myalgia and fatigue was more prevalent in the 60-mg group. From a pharmacokinetic perspective, optimal administration of aildenafil citrate tablets appears to be 1hour before sexual intercourse in men with ED. This study presents robust safety and pharmacokinetic data at expected therapeutic doses, unaffected by clinical factors. The efficacy of aildenafil citrate tablets warrants further validation in individuals with ED. Aildenafil citrate tablets exhibited good tolerability in healthy Chinese males following multiple doses at 30and 60mg. The 60-mg group showed an increased incidence of myalgia and fatigue, suggesting the need for heightened clinical vigilance. The mean maximum concentration, but not the area under the curve, displayed dose proportionality within the 30- to 60-mg dose range, and no significant drug accumulation was observed with repeated daily administration. CTR20192473 (http://www.chinadrugtrials.org.cn).

A real-world pilot study assessing treatment satisfaction with avanafil in patients with erectile dysfunction.

Avanafil is a second-generation phosphodiesterase type 5 (PDE5) inhibitor, and offers a rapid onset of action (15minutes). Its real-world data, including treatment satisfaction, are still lacking. The study sought to investigate the treatment outcomes of avanafil and the factors impacting treatment satisfaction in a real-world setting. Between November 2021 and February 2023, erectile dysfunction (ED) patients prescribed avanafil were consecutively enrolled in this phase 4, open-label, cross-sectional, observational study. At each follow-up visit (4-week intervals), participants completed a questionnaire for assessing the use and treatment-emergent adverse events of avanafil, ED severity, and treatment satisfaction. The outcome measures included the Sexual Health Inventory for Men (SHIM), and Erectile Dysfunction Inventory of Treatment Satisfaction. Among 234 patients enrolled, 112 (47.9%) patients had follow-up visits and answered the questionnaire. Treatment with avanafil significantly improved the mean SHIM total score from 10.2 ± 5.6 at baseline to 17.5 ± 6.2 (P < .001). Of the patients treated with avanafil, 71.4% (n = 80 of 112) reported a >4-point improvement in the SHIM total score, and 33.1% (n = 37 of 112) reported normal erectile function. The proportion of patients satisfied with avanafil treatment (defined as Erectile Dysfunction Inventory of Treatment Satisfaction index score ≥60) was 87.5%. Several physical factors (younger age, lower waist circumference, and lower level of low-density lipoprotein), and sexual function factors (shorter duration of ED, higher SHIM total score at baseline, PDE5 inhibitor treatment naive, and acquired premature ejaculation) tended to contribute to satisfaction with avanafil treatment. Treatment-emergent adverse events occurred in 41.1% of patients, and all were mild in severity. This study identifies the factors associated with treatment satisfaction of avanafil, which may ultimately lead to better treatment outcomes. This is the first study to provide real-world evidence of avanafil for ED treatment, and validated questionnaires were used to assess erectile function and treatment satisfaction. However, the limitations of this study include single-center observational study design, small sample size, and short-term follow-up. Avanafil is an effective treatment for ED, and satisfaction rate is high in an outpatient setting. The awareness of identified factors related to patient satisfaction may improve treatment outcomes.

Preoperative counseling for penile implant surgery: standardized approach in a high-volume center of excellence.

Shared-decision making is crucial in today's society. Although penile prosthesis surgery has had significant improvements regarding technique and materials over the last few decades - with the highest satisfaction rate in erectile dysfunction treatment at present time -, dissatisfaction can occur because of bad preoperative counseling with the creation of unrealistic expectations. This paper includes a small narrative review regarding the most important preoperative variables to be discussed in the preoperative setting. Literature search was conducted in December 2023 using PubMed. Additionally, our own standardized flowchart for preoperative counseling was added. The most important aspects of preoperative counseling include a description of the pathophysiology of erectile dysfunction as well as alternative treatments. Information should be given about which implant categories exist. Additionally, some information about the procedure itself as well as the financial aspect should be communicated. The most frequent and most important complications should be illustrated. Last but not least, the patient's expectations should be evaluated. Our added standardized flowchart with figure acts as a practical guideline for professionals as well as for patients. Our standardized approach for preoperative counseling emphasizes reasonable postoperative expectations aiming for a well-informed patient with high postoperative satisfaction. Our general strategy is to underpromise and overdeliver.