Effective Treatment For Erectile Dysfunction Research Articles

Exploring novel drug targets for erectile dysfunction through plasma proteome with genome.

Currently, the treatment and prevention of erectile dysfunction (ED) remain highly challenging. This study conducted a systematic druggable genome-wide Mendelian randomization (MR) analysis to identify potential therapeutic targets for ED. A proteome-wide MR approach was employed to investigate the causal effects of plasma proteins on ED. Subsequently, summary data-based MR (SMR) analysis was performed to identify potential drug targets for ED. Enrichment analysis and protein-protein interaction (PPI) networks revealed the functional characteristics and biological relevance of these potential therapeutic targets. Drug prediction and molecular docking studies were conducted to validate the pharmacological activity of these identified targets. Finally, a systematic MR analysis was conducted to assess upstream intervention factors, such as lifestyles and diseases, associated with these targets, providing insights for the prevention and treatment of ED. This study identified several potential therapeutic targets for ED. Proteome-wide MR analysis revealed that 126 genetically predicted plasma proteins were causally associated with ED. SMR analysis indicated that TMEM9 was associated with an increased risk of ED, while MDH1, NQO1, QDPR, ARL4D, TAGLN2, and PPP1R14A were associated with a decreased risk of ED. These potential targets were primarily enriched in metabolic and redox-related biological processes. Molecular docking indicated that the predicted drugs had favorable binding affinities with the proteins, further confirming the pharmacological value of these targets. Finally, 6 plasma proteins (MDH1, NQO1, QDPR, ARL4D, TAGLN2, and TMEM9) could be modulated by lifestyle- and disease-related factors. This study provides new insights into the etiology and potential drug targets of ED and contributes to the development of more effective treatments for ED and reducing the cost of drug development. This is a systematic and extensive study exploring the causal relationship between plasma proteins and ED, which helps to provide a comprehensive perspective to understand the role of potential targets in ED. However, we did not conduct this study in different types of ED or different stages of ED progression. In summary, this study identified 7 plasma proteins causally associated with ED and provided new insights into the etiology and potential drug targets for ED.

The Intra-Meatal Application of Tadalafil Cream Versus Oral Administration Efficacy and Safety: Results from a Randomized, Two-Administration Route, Cross-Over Clinical Trial.

Background: Tadalafil cream, a topically administered phosphodiesterase-5 inhibitor (PDE5), presents a potential alternative to oral PDE5 inhibitors like tadalafil for the treatment of erectile dysfunction (ED). This study evaluates the non-inferiority and potential superiority of tadalafil cream compared to oral tadalafil. Methods: This randomized controlled trial employed a cross-over design with two treatment periods of two weeks each, separated by a one-week washout phase. Thirty-five male participants aged 18-75 with diagnosed ED (International Index of Erectile Function-Erectile function: IIEF-EF score < 26) were randomized to receive either tadalafil cream or oral tadalafil. Tadalafil cream was applied topically, while tadalafil was taken orally. The primary endpoint was IIEF-EF, and secondary endpoints were measured using the International Index of Erectile Function (IIEF) domain scores. Adverse events and treatment preferences were also assessed. Results: Tadalafil cream showed a higher increase in sexual function across all IIEF domains compared to oral tadalafil. The lower bounds of the confidence interval [improvement: final-baseline scores between tadalafil cream and oral tadalafil 0.72 (95% CI -2.72-4.15)] were above the non-inferiority margin of -3.22, confirming tadalafil cream's non-inferiority in the erectile function domain. In the intercourse satisfaction domain, tadalafil cream was superior to oral tadalafil. At the end of the trial, 88.57% of participants preferred tadalafil cream (95% CI 73.26%-96.79%), a result significantly above the non-inferiority margin that indicated superiority (p < 0.001). No systemic adverse events were reported for tadalafil cream, and significant differences in dizziness, headache, nasal congestion, and erythema were observed between the two treatments. Conclusions: Tadalafil cream is a safe and effective treatment for erectile dysfunction, demonstrating non-inferiority and potential superiority over oral tadalafil, with a high patient preference. Its topical administration offers a promising alternative for patients, particularly those with cardiovascular diseases where oral PDE5 inhibitors are contraindicated or less well tolerated.

(147) TOPICAL ADMINISTRATION OF MED3000 GEL SIGNIFICANTLY IMPROVES SELF-ESTEEM AND RELATIONSHIPS IN MEN WITH ERECTILE DYSFUNCTION: RESULTS FROM TWO CLINICAL TRIALS

Abstract Introduction Erectile dysfunction (ED) negatively impacts self-esteem, confidence, relationships, and quality of life while effective treatment of ED improves these measures. MED3000 is a FDA-cleared, topical treatment for ED that has been shown to be effective for the treatment ED, but effects on psychosocial outcomes have not been reported. Objective To assess the effects of MED3000 in men with ED using the Self-esteem and Relationship (SEAR) questionnaire. Methods Two multicenter studies were performed (n = 298 total). Both studies enrolled patients with a clinical diagnosis of ED for &amp;gt;3 months based the National Institutes of Health Consensus Statement. The first (Study 1) had a duration of 12 weeks and the second (Study 2) was 24 weeks. Subjects or their female partners were instructed to apply MED3000 immediately prior to sexual intercourse and subjects were instructed to make at least 4 intercourse attempts in each of the three or six 4-week periods during treatment. Subjects completed the 14-item SEAR questionnaire every 4 weeks for the duration of the study periods. Results for individual scores were combined and transformed into domain and total scores (1-100, higher scores indicate more favorable responses). Results for non-missing data for each 4-week period were combined to provide a mean change from baseline over 12 (Study 1) or 24 (Study 2) weeks. Significance (P &amp;lt; 0.005 with Bonferroni correction) of mean changes from baseline over 12 or 24 weeks were determined with paired t-tests. Results Study 1 enrolled a total of 250 subjects (mean age □ standard deviation (SD) = 46.8□12.5 years, duration of ED = 27.5□36.5 months, 59.2%, 28.0%, and 12.8% with mild, moderate, or severe ED, respectively). Study 2 enrolled 48 subjects (44 White, 4 Black, 46.1□13.5 years old, duration of ED = 28.9□32.3 months, 39.6%, 35.4%, and 25.0% with mild, moderate, or severe ED). In both studies, MED3000 resulted in statistically significant improvements in total scores and for all individual SEAR domains except Overall Relationship Satisfaction in Study 2 (Table 1). Results from both studies indicated that SEAR total and domain score changes from baseline exceeded the minimal clinically meaningful improvement (&amp;gt;10 points) for this measure. At the end of the trial, 81.2% of men in Study 1 and 85.4% in Study 2 felt that sex could be spontaneous. Table 1. SEAR questionnaire results (mean ± SD) Study 1 (N = 250) Study 2 (N = 48) Baseline Change from Baseline over the 12-week Period P-value Baseline Change from Baseline over the 24-week Period P-value Total Score 38.7 ± 15.9 14.7 ± 18.6 &amp;lt; 0.001 44.6 ± 17.5 12.5 ± 16.8 &amp;lt; 0.001 Sexual Relationship and Satisfaction Domain (MCMI &amp;gt;10-point change) 38.1 ± 17.1 15.6 ± 19.9 &amp;lt; 0.001 41.9 ± 19.6 13.8 ± 17.9 &amp;lt; 0.001 Confidence Domain (MCMI &amp;gt;10-point change) 39.4 ± 15.9 13.6 ± 18.9 &amp;lt; 0.001 48.2 ± 16.1 10.8 ± 16.6 &amp;lt; 0.005 Self-esteem Domain (MCMI &amp;gt;10-point change) 38.2 ± 15.4 11.8 ± 17.4 &amp;lt; 0.001 42.6 ± 14.6 11.1 ± 18.3 &amp;lt; 0.001 Overall Relationship Satisfaction Domain (MCMI not defined) 41.9 ± 23.4 17.1 ± 28.1 &amp;lt; 0.001 59.4 ± 27.2 10.1 ± 24.5 0.009 MICI, minimal clinically meaningful improvement. Conclusions Study results from two multicenter trials showed that MED3000 resulted in statistically significant and clinically meaningful improvements in self-esteem and relationships as reflected by SEAR total and domain scores. These findings provide further support for the benefit of MED3000 in men with ED. Disclosure Yes, this is sponsored by industry/sponsor: Futura Pharmaceuticals/Haleon. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Futura and Haleon.

Unveiling the Hidden Perils: A Comprehensive Review of Fungal Infections in Inflatable Penile Prosthesis Surgery

Inflatable penile prosthesis (IPP) surgery is an effective treatment for erectile dysfunction (ED), but infections pose a significant threat to its success. Current guidelines lack antifungal recommendations, despite rising fungal infection rates post-IPP surgery. This review examines epidemiology, risk factors (including diabetes mellitus, immunosuppression, and obesity), and pathogenesis, highlighting the role of biofilm formation in device contamination. Clinical manifestations vary from acute to delayed, with fungal biofilms presenting challenges in diagnosis. Prophylactic strategies, including broad-spectrum antibiotics and antifungals, are crucial, with evidence suggesting a 92% reduction in infections. With fungal infections showing lower salvage rates, management involves culture-guided treatment, irrigation, and oral antibiotics. Future research aims to understand biofilm mechanisms and develop biomaterials to reduce infection rates. Implementing antifungal therapy, along with standard practices like the no-touch technique and antibiotic dips, is crucial in preventing IPP infections.

(287) INTRACAVERNOSAL BOTULINUM TOXIN USE IN THE TREATMENT OF ERECTILE DYSFUNCTION: A PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED STUDY

Abstract Introduction Erectile dysfunction (ED) is a significant public health issue that greatly impacts patients’ quality of life. Its prevalence increases with age and is associated with several risk factors, including diabetes, hypertension, hypercholesterolemia, smoking, sedentary lifestyle, obesity, and hypogonadism. These factors often lead to vascular endothelial alterations, resulting in atherosclerosis, arterial obstruction, and reduced penile blood flow. Traditional treatments for ED focus on vasodilators to facilitate erections. In the 1980s, intracavernosal injections of vasoactive drugs became prevalent, and the 1990s saw a revolution with the introduction of phosphodiesterase-5 (PDE5) inhibitors, such as sildenafil. Despite their effectiveness, about 30% of patients do not respond adequately to these treatments, prompting the search for more effective alternatives. Botulinum toxin (BT), known for its muscle relaxation properties, emerges as a promising candidate. Preliminary studies, including those by Ghanem (2018) and El-Shaer (2021), show promising results for intracavernosal BT in ED treatment, though further research is needed. Objective The primary objective of this study is to determine the safety and efficacy of intracavernosal botulinum toxin application in the treatment of erectile dysfunction. Specifically, the study aims to assess the improvement in erectile function in patients with ED refractory to standard treatments and evaluate the occurrence of any adverse events associated with BT use. Methods This prospective, double-blind, randomized study involves evaluating botulinum toxin (study drug) versus placebo, alongside standard ED treatments. The study includes male patients aged 18 and above, with an International Index of Erectile Function (IIEF-5) score of 21 or less, and currently undergoing at least one form of standard ED treatment. Exclusion criteria include urogenital neoplasms, radical prostatectomy, testosterone levels below 350 ng/ml, diagnosed depression on antidepressants, genital tract anatomical alterations, and insufficient sexual activity for analysis. Participants will be randomly assigned to either the BT or placebo group. The active treatment involves injecting 100 units of botulinum toxin, diluted in 4 ml of 0.9% saline, into the penile base and distal shaft, with a penile base tourniquet applied for 20 minutes. The placebo group will receive 0.9% saline injections. Patients will be monitored for 12 months, with evaluations at 1, 3, 6, and 12 months post-treatment. These evaluations include the IIEF-5 score, penile length (CRT max), and blood tests. After 6 months, the blind will be lifted, allowing placebo group patients to opt for BT treatment, and active group patients to receive another BT dose if desired. Results Initial findings from the study indicate that of the 15 patients treated, 8 have shown improvements in their IIEF-5 scores. However, it is important to note that the study is still blinded, and we do not yet know which patients receives botulinum toxin and which received the placebo. As such, the observed improvements cannot yet be attributed to the botulinum toxin treatment. The study will continue the 6-month mark, at which point the blind will be lifted, allowing for a more precise evaluation of the treatment’s efficacy. To date, the treatment has been well-tolerated, with no severe adverse events reported, aligning with previous research on the safety and efficacy of BT for ED. Conclusions This study provides evidence supporting the uso of intracavernosal botulinum toxin as a safe and effective treatment for erectile dysfunction, particularly in patients who do not responde to conventional therapies. The results indicate improvements in erectile function and minimal adverse effects, suggesting that BT could become a valuable addition to the current ED treatment options. Further research with larger sample sizes and longer follow-up periods is necessary. Disclosure No.

(O-01) PREDICTORS OF INTRACAVERNOSAL INJECTION THERAPY IN MEN WITH ERECTILE DYSFUNCTION

Abstract Introduction &amp; Objective Oral phosphodiesterase type 5 inhibitors (PDE5i) and intracavernosal injections (ICI) are effective treatments for erectile dysfunction (ED). However, the risk factors associated with the transition from oral therapy to ICI use remain less established. We aimed to identify predictive factors contributing to the progression from oral PDE5i to ICI therapy. Methods Retrospective chart review was conducted on patients presenting with erectile dysfunction at our clinic. Patients initiating therapy before clinical documentation or without follow-up were excluded. Statistical analysis utilized chi-square test, two-tailed student's t-test, and multivariable logistic regression performed in R. Results Among 259 men treated for ED, 61% (158) reported subjective improvement with oral PDE5i therapy alone, while 18% (46) initiated ICI therapy. Table 1 summarizes demographic information and cardiovascular risk factors. Men progressing to ICI had higher rates of hypertension (54.3% vs. 28.4%, p=0.0015), type 2 diabetes mellitus (32.6% vs. 11.4%, p=0.0013), and a history of radical prostatectomy (26.1% vs. 3.8%, p&amp;lt;0.001) compared to those satisfied with oral therapy. Significant predictors for ICI progression on multivariate analysis were history of radical prostatectomy (OR 19.4, [95% CI, 1.42-678.88]) and diabetes mellitus (OR 8.6, [95% CI, 1.36-76.49]). Two patients (4.3%) experienced priapism as a complication of ICI use. Among the patients using ICI, 54% (25/46) reported satisfaction with their erections. Conclusions Cardiovascular risk factors and a history of radical prostatectomy were more prevalent among patients progressing from oral therapy to ICI in our cohort. These findings may guide early counseling on ED treatment progression for patients with these predictive factors. Financing No conflict.

(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 &amp;lt; 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.

(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.

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.

Pharmacokinetics comparison of vardenafil as administered by an intranasal spray formulation vs a 10-mg oral tablet.

Oral vardenafil (VDF) tablet is an effective treatment for erectile dysfunction (ED), but intranasal administration with a suitable formulation can lead to a faster onset of action and offer more convenient planning for ED treatment. The primary purpose of the present pilot clinical study was to determine whether intranasal VDF with an alcohol-based formulation can result in more "user-friendly pharmacokinetics" as compared with oral tablet administration. This single-dose randomized crossover study was conducted in 12 healthy young volunteers receiving VDF as a 10-mg oral tablet or 3.38-mg intranasal spray. Multiple blood concentrations were obtained, and VDF concentrations were determined with a liquid chromatography-tandem mass spectrometry assay. Pharmacokinetic parameters following each treatment were compared and adverse events assessed. Pharmacokinetic parameters were obtained: apparent elimination rate constant, elimination half-life, peak concentration, peak time, total area under the curve, and relative bioavailability. Although mean apparent elimination rate constant, elimination half-life, peak concentration, and total area under the curve were similar between intranasal and oral administration, the median peak time from intranasal was much shorter (10vs 58minutes, P < .001, Mann-Whitney U test). The variability of the pharmacokinetic parameters was also less with intranasal than oral administration. The relative bioavailability of intranasal to oral was 1.67. Intranasal VDF caused transient but tolerable local nasal reactions in 50% of subjects. Other adverse events (eg, headache) were similar between the treatments. The incidence of adverse events was, however, significantly less in the second treatment after initial exposure to VDF. No serious adverse events were noted. Intranasal VDF potentially offers a more timely and lower dose for the treatment of ED in patients who can tolerate the transient local adverse reactions. The strength of this study is its randomized crossover design. Because the study was conducted in 12 healthy young subjects, the results may not reflect those observed in elderly patients who may be likely taking VDF for ED. Nevertheless, the changes of pharmacokinetic parameters in the present study are likely a reflection of the differences between intranasal and oral administration of the formulations. Our study indicated that the present VDF formulation, when administered intranasally, can achieve a more rapid but similar plasma concentration with only about one-third dose when compared with the oral administration.

Advanced hydrogels: New expectation for the repair of organic erectile dysfunction.

Organic erectile dysfunction (ED) is a type of sexual disorder in men that is usually associated with illness, surgical injury, normal aging and has a high incidence across the globe. And the essence of penile erection is a neurovascular event regulated by a combination of factors. Nerve and vascular injury are the main causes of erectile dysfunction. Currently, the main treatment options for ED include phosphodiesterase type 5 inhibitors (PDE5Is), intracorporeal injections and vacuum erection devices (VEDs), which are ineffective. Therefore, it is essential to find an emerging, non-invasive and effective treatment for ED. The histopathological damage causing ED can be improved or even reversed with hydrogels, in contrast to current therapies. Hydrogels have many advantages, they can be synthesized from various raw materials with different properties, possess a definite composition, and have good biocompatibility and biodegradability. These advantages make hydrogels an effective drug carrier. In this review, we began with an overview of the underlying mechanisms of organic erectile dysfunction, discussed the dilemmas of existing treatments for ED, and described the unique advantages of hydrogel over other approaches. Then emphasizing the progress of research on hydrogels in the treatment of 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.

2022. Evaluation of Antimicrobial Prophylaxis and Infectious Outcomes in Penile Prosthetic Implants at VA Long Beach Healthcare System

Abstract Background Penile prosthetic implants (PPI) offer an effective treatment for erectile dysfunction. The risk of postoperative infection in primary PPI is estimated at 0.33-11.4% and up to 18% in revision surgery. The most common causative organisms include Escherichia coli and coagulase negative Staphylococcus. The AUA guidelines recommend perioperative antibiotics for no more than 24 hours. However, a survey of urologists revealed that the majority used oral antibiotics for 5-14 days after surgery. There have been increasing reports of anaerobic and fungal infections, but the AUA guidelines do not recommend antimicrobial prophylaxis against these organisms. Methods This is a retrospective, chart review, quality-improvement study. Veterans who had a PPI procedure between May 1999 to July 2021 were included. Patients with only removal of the prosthesis were excluded. For patients who had multiple procedures, only the most recent procedure was considered. Data collection included demographics, pertinent medical history (history of polysubstance abuse, homelessness, smoking, chronic immunosuppression, anticoagulation, diabetes, HIV, spinal cord injury, Peyronie’s disease or priapism), prior PPI, relevant labs (BMP, A1C), microbiologic results, and medications prescribed. Results 176 patients underwent a PPI-related procedure between May 1999 and July 2021. 137 patients were included in this study. 14 patients (10.2%) experienced a PPI infection. For all patients, the average total duration of antimicrobial prophylaxis was 11.8 days. Mean duration of antimicrobial therapy after procedure was 12.4 days and 10.5 days for the infection and no infection group, respectively (p-value 0.118). The most common antibiotic combination was vancomycin and gentamicin. There were no statistically significant difference in patient risk factors between infection and no infection groups, but the most common risk factors were smoking and prior implant. Gram positive organisms were most commonly isolated. There were no incidences of fungal infections. 2.2% incidence of AKI and 1.5% incidence of antimicrobial resistance were observed. Conclusion Further evaluation of the necessity of prolonged duration of antimicrobial prophylaxis and antifungal prophylaxis should be evaluated. Disclosures All Authors: No reported disclosures.

Global trends in prevalence, treatments, and costs of penile prosthesis for erectile dysfunction in men

ABSTRACT Introduction Penile prosthesis is a durable and effective treatment for erectile dysfunction (ED). Even as other treatment options for ED have been brought to market, penile prosthetic surgery remains a mainstay for urologists treating ED. No systematic study has yet summarized the global trends in penile prosthetic surgery. Objective To systematically review studies of trends in penile prosthetic surgery to determine global movements in implantation rates, malleable vs inflatable prosthetic surgery, inpatient vs outpatient implantation surgery, the proportion of men with ED undergoing penile prosthetic surgery, and prosthetic cost. Methods A systematic review of MEDLINE, EMBASE, Cochrane Library, and ClinicalTrials.gov was performed for studies assessing trends in penile prosthetic surgeries and costs associated with penile prosthetic device and inclusive surgical costs. Results Twenty-seven studies were identified during the systematic review, comprising 447,204 penile prosthetic surgeries reported from 1988 to 2019. Trend analysis demonstrates that rates of penile prosthetic surgery dramatically declined in the late 1980s and early1990s but has demonstrated modest growth since the mid-2000s. Outpatient inflatable penile prosthetic surgery has strongly trended upward. Penile prostheses device costs have matched the rate of inflation, but inclusive surgical cost has radically outpaced inflation. Growth has mainly been seen in the United States, with a more modest global growth. Conclusion Penile prosthesis remains a viable option for the treatment of ED. Trends such as outpatient surgery and inflatable penile prosthesis placement may be driving the recent steady growth of penile prosthetic surgeries but surging inclusive surgical cost may present a barrier for some patients without insurance coverage. Disclosure Work supported by industry: no.

Global Trends in Prevalence, Treatments, and Costs of Penile Prosthesis for Erectile Dysfunction in Men

ABSTRACT Introduction Penile prosthesis is a durable and effective treatment for erectile dysfunction (ED). Even as other treatment options for ED have been brought to market, penile prosthetic surgery remains a mainstay for urologists treating ED. No systematic study has yet summarized the global trends in penile prosthetic surgery. Objective To systematically review studies of trends in penile prosthetic surgery to determine global movements in implantation rates, malleable vs inflatable prosthetic surgery, inpatient vs outpatient implantation surgery, the proportion of men with ED undergoing penile prosthetic surgery, and prosthetic cost. Methods A systematic review of MEDLINE, EMBASE, Cochrane Library, and ClinicalTrials.gov was performed for studies assessing trends in penile prosthetic surgeries and costs associated with penile prosthetic device and inclusive surgical costs. Results Twenty-seven studies were identified during the systematic review, comprising 447,204 penile prosthetic surgeries reported from 1988 to 2019. Trend analysis demonstrates that rates of penile prosthetic surgery dramatically declined in the late 1980s and early1990s but has demonstrated modest growth since the mid-2000s. Outpatient inflatable penile prosthetic surgery has strongly trended upward. Penile prostheses device costs have matched the rate of inflation, but inclusive surgical cost has radically outpaced inflation. Growth has mainly been seen in the United States, with a more modest global growth. Conclusions Penile prosthesis remains a viable option for the treatment of ED. Trends such as outpatient surgery and inflatable penile prosthesis placement may be driving the recent steady growth of penile prosthetic surgeries but surging inclusive surgical cost may present a barrier for some patients without insurance coverage. Disclosure No

Impact of atorvastatin on erectile dysfunction: A meta-analysis and systematic review.

Atorvastatin may be an effective treatment for erectile dysfunction (ED). The purpose of this meta-analysis was to determine whether atorvastatin therapy is effective in the treatment of ED. All published research on atorvastatin in the treatment of ED patients in EMBASE, PubMed, Web of Science and Cochrane were investigated till 30 October 2021. A meta-analysis of randomized controlled trials (RCTs) was done to investigate the efficacy of atorvastatin and placebo in the treatment of ED. Moreover, we also performed a meta-analysis based on single-arm trials (SATs) to explore the atorvastatin treatment on the efficacy of ED. In a meta-analysis based on RCTs, the weighted mean difference of the change of International Index for Erectile Function-5 (IIEF-5) score in the atorvastatin treatment group with or without treatment was 4.53 (95 per cent confidence interval [CI] of 3.28-5.79) higher than in the control group. In an SAT-based meta-analysis, the ES of the change in IIEF-5 score in the atorvastatin treatment group before and after treatment was 3.22 (95 per cent CI of 1.32-5.12). Atorvastatin is an effective therapeutic drug for patients with ED. However, we expect that more multicentre clinical trials will be conducted to support this assertion.

Ex vivo Akt inhibition reverses castration induced internal pudendal artery and penile endothelial dysfunction

AimsAndrogen deprivation therapy is a common prostate cancer treatment which causes men to have castrate levels of testosterone. Unfortunately, most testosterone deficient patients will suffer severe erectile dysfunction (ED) and have no effective ED treatment options. Testosterone deficiency causes endothelial dysfunction and impairs penile vasodilation necessary to maintain an erection. Recent evidence demonstrates testosterone activates androgen receptors (AR) and generates nitric oxide (NO) through the Akt-endothelial NO synthase (eNOS) pathway; however, it remains unknown how castration impacts this signaling pathway. Materials and methodsIn this study, we used a surgically castrated rat model to determine how castration impacts ex vivo internal pudendal artery (IPA) and penile relaxation through the Akt-eNOS pathway. Key findingsUnlike systemic vasculature, castration causes significant IPA and penis endothelial dysfunction associated with a 50% AR reduction. Though testosterone and acetylcholine (ACh) both phosphorylate Akt and eNOS, castration did not affect testosterone-mediated IPA and penile Akt or eNOS phosphorylation. Surprisingly, castration increases ACh-mediated Akt and eNOS phosphorylation but reduces the eNOS dimer to monomer ratio. Akt inhibition using 10DEBC preserves IPA eNOS dimers. Functionally, 10DEBC reverses castration induced ex vivo IPA and penile endothelial dysfunction. SignificanceThese data demonstrate how castration uncouples eNOS and provide a novel strategy for improving endothelial-dependent relaxation necessary for an erection. Further studies are needed to determine if Akt inhibition may treat or even prevent ED in testosterone deficient prostate cancer survivors.

MP27-08 CLINICAL CORRELATES AND ECONOMIC CONSEQUENCES OF EMPLOYER BENEFIT EXCLUSION FOR PENILE PROSTHESIS IMPLANTATION FOR ERECTILE DYSFUNCTION

You have accessJournal of UrologySexual Function/Dysfunction: Evaluation I (MP27)1 Sep 2021MP27-08 CLINICAL CORRELATES AND ECONOMIC CONSEQUENCES OF EMPLOYER BENEFIT EXCLUSION FOR PENILE PROSTHESIS IMPLANTATION FOR ERECTILE DYSFUNCTION Sirikan Rojanasarot, Samir Bhattacharyya, and Arthur L. Burnett Sirikan RojanasarotSirikan Rojanasarot More articles by this author , Samir BhattacharyyaSamir Bhattacharyya More articles by this author , and Arthur L. BurnettArthur L. Burnett More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002024.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Employed men with erectile dysfunction (ED) covered by employer-sponsored health insurance (ESHI) often have limited access to penile prosthesis implantation (PPI). This study quantified the clinical correlates and economic consequences of the benefit exclusion by examining the prevalence and comorbid correlations of ED among men with ESHI; the population size of ED men affected by the issue; and the economic impact of work productivity loss due to benefit exclusion for PPI. METHODS: A cost-consequence analysis was developed to quantify the impact of employer exclusion for PPI. The analysis was selected as it displays results in natural units of effect, including the number of men affected and the days and costs of work productivity lost, enabling clinicians and decision makers to select the most relevant components to them. IBM MarketScan Commercial data from 2010-2018 were analyzed to determine the prevalence and comorbid correlations of ED. The American Community Survey and published literature were used to estimate the number of ED men with ESHI affected by benefit exclusion for PPI. The economic impact of work productivity loss due to ED was calculated using National Occupational Employment and Wage Estimates and converted into 2019 US dollars. RESULTS: The prevalence rates of ED among men with ESHI increased from 1.6% in men aged 18-24 years to 24.6% in men aged 55-64 years (Figure). Most ED men were ≥45 years of age (78.5%), had a Charlson Comorbidity Index of 0 (76.1%). Common comorbidities were hyperlipidemia (48.0%) and hypertension (46.4%). An estimated 1.29 million men with ESHI in 2019 were affected by benefit exclusion for PPI. Men with ED had an additional 283 hours/year of work impairment compared to men without ED, resulting in an annual indirect mean cost of $7,270. An average US company with 5,000 employees that excluded PPI from their plan could lose $1.28 million of work productivity due to additional work impairment from ED. CONCLUSIONS: The extent of men with ED affected by benefit exclusion for PPI as well as economic impact of work productivity loss due to this exclusion issue are substantial. Removing benefit exclusion for PPI may improve patient access to effective ED treatment and reduce the burden of ED on both patients and employers . Source of Funding: Boston Scientific © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e474-e474 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sirikan Rojanasarot More articles by this author Samir Bhattacharyya More articles by this author Arthur L. Burnett More articles by this author Expand All Advertisement Loading ...

Endocrine contribution to the sexual dysfunction in patients with advanced chronic kidney disease and the role of hyperprolactinemia.

In this study, we investigated the prevalence of sexual dysfunction among males with advanced chronic kidney disease and the effect of treating hyperprolactinemia among these patients. In this prospective study, patients were assessed with history, physical examination, hormonal assessment, and two questionnaires, IIEF and AIPE. Patients with hyperprolactinemia received treatment with cabergoline 0.5mg once per week for 6months and were re-evaluated. A total of 102 patients were included in this study, 75 (73.53%) were on hemodialysis, 13 (12.75%) on peritoneal dialysis and 14 (13.73%) on medical treatment alone. Ninety (88.24%) patients had premature ejaculation, 85 (83.33%) had anything from mild-to-moderate-to-severe erectile dysfunction. The incidence of hypogonadism and hyperprolactinemia was 34.4%. Patients treated with cabergoline (n=26) showed a significant increase in LH levels (p=.003) and a significant decrease in prolactin levels (p=.003). Testosterone levels and the incidence of erectile dysfunction or premature ejaculation did not improve significantly. There is a high incidence of sexual dysfunction among patients. Treatment of hyperprolactinemia is effective in correcting prolactin levels, but does not improve erectile dysfunction or premature ejaculation. Therefore, treating hyperprolactinemia is not an overall effective treatment for erectile dysfunction in these patients.

Two Piece Inflatable Penile Prosthesis Surgery: Operative Steps

The placement of a penile prosthesis has been considered the most reliable and effective treatment for erectile dysfunction in men with failed medical treatment. The 2-piece system eliminates a need for separate reservoir making the surgery easy for the treating surgeon/urologist. We report the use of this two-piece prosthesis in a 50-year-old patient with erectile dysfunction and describe the surgical steps of the same.