Severe ED Research Articles

The relationship between erectile dysfunction and serum adropin level in male patients with type 2 diabetes mellitus

Background: Diabetes Mellitus is a chronic, progressive disease with increasing worldwide prevalence and is a public health problem because of the high cost of treatment and complications. Adropin has been discovered in recent years, and it has been reported to be associated with glucose, lipid metabolism, and endothelial dysfunction. In this study, it was aimed to investigate the relationship between erectile dysfunction and Adropin level in Type 2 diabetic male patients. Methods: Forty patients with type 2 DM with erectile dysfunction and 25 patients with type 2 DM without erectile dysfunction, aged between 40 and 60, who applied to the internal medicine outpatient clinic between November 2019 and March 2020, were included in the prospective study. In addition to routine blood tests in the study groups, Adropin levels were measured using the ELISA method. Results: The study was conducted with 65 men aged 40 and 60 between November 2019 and February 2020. The mean age of the men was 52.71±6.04. The study used 40 (61.5%) Case groups and 25 (38.5%) Control groups. The case group consisted of 12 (18.5%) Mild ED, 20 (30.8%) Moderate ED, and 8 (12.8%) Severe ED, and the control group consisted of Type 2 Diabetes Mellitus Patients without erectile dysfunction. Conclusion: According to our results, serum Adropin levels in Mild ED, Moderate ED, and Severe ED groups were found to be higher than those in Type 2 Diabetes Mellitus patients without erectile dysfunction.

Time-dependent analysis of erectile dysfunction in kidney transplant recipients: insights from four distinct time periods

Background and intentionErectile dysfunction (ED) is an underappreciated clinical condition in men. This study aims to compare the dynamic changes in the distribution of ED among male kidney transplant recipients (mKTRs) in four epochs: end-stage renal disease period (ESRDp), early post-transplant period (EPTP), pre-COVID-19, and post-COVID-19.MethodsGeneral information was gathered through interviews, follow-ups, and medical records. The International Index of Erectile Function Questionnaire-5 was used to assess erectile function. The Mann–Whitney U test and chi-square test were used to analyze differences in ED strength. Univariate and logistic regression analyses were conducted to identify risk factors for ED.ResultsThe database contains 230 mKTRs. In the ESRDp, 17.0% had normal erectile function, 53.5% had mild ED, 18.3% had moderate ED, and 11.3% had severe ED. In the EPTP, the distribution was 38.2% normal, 42.6% mild, 10.8% moderate, and 8.2% severe. In the pre-COVID-19 period, it was 34.3%, 47.3%, 10.4%, and 7.8%, and in the post-COVID-19 period, it was 23.0%, 45.6%, 21.3%, and 10.0%. Overall, erectile function improved after kidney transplant (KT). However, post-COVID-19, the proportion of erectile function significantly decreased compared to EPTP and pre-COVID-19 periods. Risk factors for post-pandemic ED included degree, Generalized Anxiexy Disorder-7, kidney donor type, postoperative time, hypertension and hemoglobin concentration.ConclusionKT improves erectile function in mKTRs within 5 years, but post-SARS-CoV-2 viral infection, ED worsens due to altered risk factors. These findings inform future research for comprehensive ED prevention and management strategies in this population.

Maladaptive exercise in eating disorders: lifetime and current impact on mental health and treatment seeking

BackgroundMany patients with eating disorders report exercise as a central symptom of their illness—as a way to compensate for food intake, prevent weight-gain, and/or reduce negative affect. Previous findings show associations between maladaptive exercise and more severe eating disorder pathology, higher risk for relapse, other co-morbid symptoms, and worse treatment outcome.MethodsIn this study, we included 8252 participants with eating disorders and investigated associations between maladaptive exercise (both lifetime and current) and ED pathology, illness duration, depression, anxiety, self-harm and suicidal ideation, and treatment seeking patterns in individuals with lifetime maladaptive exercise. Participants were included via the Swedish site of the large global study The Eating Disorders Genetics Initiative (EDGI) and completed measures of both lifetime and current symptomatology.ResultsResults indicate that lifetime maladaptive exercise is associated with higher prevalence of lifetime depression and anxiety and with patients more often receiving treatment, although these results need to be investigated in future studies. Current maladaptive exercise was associated with more severe ED symptoms, and higher levels of depression, anxiety, obsessive-compulsive traits, and suicidal ideation.ConclusionsOur findings point to the complexities of exercise as an eating disorder symptom and the need for clearly assessing and acknowledging this, as well as tailoring interventions to treat this symptom to achieve sustainable recovery.

(O-10) CLINICAL PROFILE AND SATISFACTION LEVEL OF PATIENTS UNDERGOING PENILE PROSTHESIS IMPLANTATION AT PEDRO ERNESTO UNIVERSITY HOSPITAL (HUPE/UERJ) 2018-2022

Abstract Introduction Erectile dysfunction (ED) can significantly impact couples' sexual quality of life, with penile prosthesis implants often yielding satisfaction rates of up to 90%. This treatment remains underutilized, less than 5% of refractory ED patients to undergo this therapy. This study aims to assess the satisfaction levels of patients who have undergone penile prosthesis implantation and explore associated factors. Methods We reviewed 48 medical records of patients who underwent penile prosthesis implantation between 2018-2022 and administered satisfaction questionnaires 6 months after the procedure. Results 93% expressed satisfaction post-surgery, with 66% reporting increased libido. Additionally, 83% noted ease in achieving penetration, 75% were content with the prosthesis size, and 95% stated willingness to undergo the surgery again. Common causes of sexual dysfunction were post-radical prostatectomy (45%), followed by diabetes mellitus (22%). Peyronie's disease was the etiology in 6% of cases, and priapism in 2%. The average age was 63 years (range: 27-80), with 20% being obese, 37% having diabetes mellitus, and 56% experiencing systemic arterial hypertension. Approximately 20% of procedures presented complications, surgical wound infection being the most common and prosthesis extrusion the most severe. Discussion Literature identifies predictors associated with satisfaction after penile prosthesis implantation, such as Peyronie's disease, BMI > 30, post-radical prostatectomy, implant type, postoperative complications, and patient age; our study revealed that only 7% expressed dissatisfaction, primarily due to postoperative complications. Conclusion Penile prosthesis implantation proves to be a safe procedure with a high success rate and satisfaction level. Dissatisfaction primarily arises from postoperative complications, emphasizing the importance of offering this therapeutic option to patients with severe ED. Financing No conflict.

(O-03) DORSAL VENOUS LEAK LIGATION IN PATIENTS WITH ERECTILE DYSFUNCTION. REPORT OF 60 PATIENTS WITH 12-MONTH FOLLOW-UP

Abstract Objective Penile dorsal venocclusive dysfunction is recognized as a cause of erectile dysfunction in some young patients with no other risk factors. The objective of this study is to report the results of a surgical technique in patients who presented ED before the age of 40, with follow-up up to 12 months after treatment. Materials and Methods A descriptive study was carried out in a retrospective cohort of medical records with 60 patients who met the inclusion criteria, evaluated, and underwent standardized ligature surgery by the same surgeon between 01/2014 and 04/2022. The group underwent a symptom score (International Index of Erectile Function-5), before surgery, 3, 6 and 12 months after. The results of the IIFE-5 before and after surgery were related to the different degrees of erectile dysfunction (severe, moderate, and mild); additionally they were divided into three groups according to criteria defined by the IIFE-5 as successful, moderate, and poor. The diagnosis of venous leaks was made by penile Doppler ultrasound, recording venous leaks and degree of penile fibrosis. The study protocol was approved by the Research Committee of the Pablo Tobon Uribe Hospital in Medellín. Results The age of onset of erectile dysfunction was between 14-39 years, mean 23.9; the mean age of the patients who consulted was 31.5 years. The time of evolution of the disease before attempting surgery varied between 2 months and 21 years (average 9.5 years). The result of the preoperative IIFE-5 was: Severe ED: n=6 (10%) and moderate ED: n=54 (90%), there were no preoperative mild ones. Postoperative outcomes at 12 months were: moderate ED n=13 (21.6%); mild ED n=25 (41.6%) and without ED n=22 (36.6%), after the intervention. Additionally, according to the internal analysis of IIFE-5: n=39 (65%) was successful; n=9 (15%) moderate and n=12 (20%) poor. Conclusions Ligation of penile dorsal venous leaks has good medium and long-term results in terms of erection quality and patient satisfaction. Financing No conflicto.

Impact of low-intensity extracorporeal shockwave therapy on vascular parameters and sexual function in patients with arteriogenic erectile dysfunction.

Previous published studies have shown an improvement of penile hemodynamic parameters after low-intensity extracorporeal shockwave therapy (Li-ESWT). However, the clinical significance of these findings remains unclear, and definitive selection criteria for Li-ESWT based on preexisting comorbidities have yet to be established. This was an observational study of 113 patients with ED, evaluated between January 2019 and December 2021 in Andrology Unit at the Department of Urology and Renal Transplantation, University of Foggia (Foggia, Italy). Penile dynamic Doppler was performed to evaluate vascular parameters and 5-item version of the International Index of Erectile Dysfunction (IIEF-5) questionnaire was administered to assess the severity of ED. This was repeated 1 month after treatment. Patients with a peak systolic velocity (PSV) <30 cm s -1 were considered eligible for Li-ESWT. Our protocol consisted of 8 weekly sessions with 1500 strokes distributed in 5 different locations along the penis. After treatment, a significant mean (±standard deviation [s.d.]) PSV increase of 5.0 (±3.4) cm s -1 was recorded and 52/113 (46.0%) patients reached a PSV >30 cm s -1 at posttherapeutic penile dynamic Doppler. A clinically significant IIEF-5 score improvement was observed in 7 patients, 21 patients, and 2 patients with mild-to-moderate, moderate, and severe pretreatment ED, respectively. No different outcomes were assessed based on smoking habits, previous pelvic surgery, or use of oral phosphodiesterase-5 inhibitor (PDE5i). On the other side, only 1 (6.7%) in 15 patients with diabetes mellitus showed an IIEF-5 score improvement after Li-ESWT. Shockwave treatment determined a significant increase in PSV and correlated IIEF-5 improvement in ED patients. This advantage seemed particularly evident for moderate ED and was not affected by smoking habits, previous pelvic surgery, and use of PDE5i. Conversely, diabetic patients did not benefit from the treatment.

(160) Prospective Evaluation of Proximal Decompression for the Management of Refractory Ischemic Priapism

Abstract Introduction A prolonged undesired erection of the penis that is often unrelated to sexual arousal is referred to as priapism. Over 95% of people who experience priapism are ischemic, which causes blood to become stuck in the corpora, increase hypoxia, hypercarbia, and acidosis that resemble compartment syndrome, and hinders penile venous outflow. IP is a urological emergency due to the risk of cavernosal fibrosis and consequent permanent ED. Injections of α-agonist and corporal irrigation/aspiration are the main forms of treatment for short-duration priapism, with distal shunting as a last resort. Patients with refractory and/or prolonged ischemic priapism (PIP) find their strategy more challenging. There is a low probability that irrigation/aspiration procedures, α-agonist injections, and distal shunting will work for people who have priapism that lasts longer than 24 hours. Objective This study was conducted on 21 male patients with refractory and\or prolonged IP to evaluate the outcomes of proximal decompression in the management of those patients. The primary end point was to assess priapism resolution in the patients. While the secondary end point was to assess erection recovery in those patients and their ability to perform sexual intercourse. Methods Patients’ information had been collected from the hospital data and connection with them had been through phone calls and hospital follow-up visits. Results Among the current study patients, the most detected etiology was tramadol intake (23.8%), followed by THC addiction and idiopathic ischemic priapism, while the least common were papaverine injection and hematological disorder (4.8%). 23.8% of the patients had twice aspirations, while 33.3% had a once. 14.3% of the patients had T shunt. 33.3% had bilateral PSD, and the other 66.7% had unilateral PSD. In the present study the decompression was successful in all the patients, where all the patients showed resolution of priapism, however 57.1% were able to perform sexual intercourse. The mean duration to achieve complete detumescence after surgery in this study was 24.2 ± 8.4 days. 33.3% had no complications, 52.4% had edema, while 14.3% had wound infection. The mean baseline IIEF score of the present study patients was 22.6 ± 2.2 (most of the patients (75%) hadn’t erectile dysfunction, 9.5% had mild erectile dysfunction and 4.8% had mild to ED), which was decreased after 3 months of the surgery (7.7 ± 2.8). Three months post-operatively severe ED was detected in 52.4% of the patients, 33.3% had moderate ED and 14.3% had mild to moderate ED. Six months after surgery the erectile dysfunction improved, where the mean IIEF score was 12.2 ± 5.0. Mild ED was detected in 23.8 %, Mild to moderate ED in 33.3 %, Moderate ED in 19 % and Severe ED in 23.8 %. The difference between the IIEF scores at base line, 3 months postoperatively and 6 months postoperatively was statistically significant. Conclusions Penoscrotal decompression (PSD) is a simple, safe, highly effective, and easily reproducible procedure for resolution of RIP with glans preservation in addition to more satisfactory erectile function outcomes to a certain extent Disclosure Yes, this is sponsored by industry/sponsor: alexandria main university hospital Clarification: Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: alexandria main university hospital.

(235) False Negative Penile Duplex Sonography: Results of Cavernovenous Leakage Surgery in 41 Patients with Normal End-Diastolic Velocity. The Need for Venous Leak Hemodynamic Criteria Re-Evaluation?

Abstract Introduction In cavernovenous leakage (CVL), blood entering corpora cavernosa escapes too early due to abnormal venous network, for erections to develop or maintain. CVL diagnosis relies on persisting blood flow velocity in cavernosal arteries at the end of diastole (EDV), with a consensus 5 cm/s cut-off value at pharmacologically-challenged penile duplex sonography (PC-PDS). Objective We present clinical, hemodynamic characteristics, and response to surgery of 41 patients with severe ED resistant to PDE5Is, with EDV5 cm/s at PC-PDS, considered non pathologic, but with CVLs identified by gold standard pharmacologically-challenged penile CT-cavernography. Methods Prospectively collected data from 41 consecutive patients with ED resistant to PDE5Is, with cavernosal artery EDV5 cm/s (Group A), were compared to data from 130 patients with EDV&amp;gt;5 cm/s (Group B). CVLs in Group A were detected by PC-PDS on deep dorsal vein or penile superficial veins after intracavenosal injection of Prostaglandin E1 plus Papaverine. All patients had refused a penile implant and underwent CVL intervention consisting in open surgery and embolization during the same procedure. Inter-group comparison used a T-test of means, pre- and post-operative data comparison a paired t-test. Results Patients in Group A were younger than in Group B (mean age 38.2±14.0 and 45.9±11.6 years, respectively, p&amp;lt;.0022). Pharmacologic Erection Hardness Score (EHS) was higher (2.9±.7 vs. 2.4±.6, p&amp;lt;.0001), EDV velocity was less (1.6±2.2 vs. 15.1±2.2 cm/s, p&amp;lt;.0001) in Group A than B, respectively. Pre-operative IIEF5 score was higher in Group A than in B (13.3±5.3 and 9.4±4.8, respectively, p&amp;lt;.0181). Other pre-operative erection parameters were otherwise similar in the two groups (morning erection EHS and frequency, masturbation and sexual intercourse EHS, percentage of successful penetration (p&amp;lt;.498, .543, .682, .510, .289, respectively). Patients in Group A and B responded similarly to surgery, with a similar pharmacologic EHS increase at systematic three-month post-operative PC-PDS (0.77±.94 vs. .81±.67, p&amp;lt;.80). Mixing Group A and B 171 patients, at the end of the 29.8±20.4-month follow-up, a significant improvement on all clinical parameters was observed: IIEF-5 score had increased from 9.7±5.1 to 15.5±6.0 (p&amp;lt;.0001), clinical EHS during sexual intercourse from 2.0±.7 to 3.3±.7 (p&amp;lt;.0001), penetration success rate from 22.3±31.7 to 70.1±37.2% (p&amp;lt;.0001), mean EHS during masturbation from 2.11±.67 to 3.04±.75 (p&amp;lt;.0001), morning erection EHS from .95±1.24 to 2.12±1.37 (p&amp;lt;.0001), before and after surgery, respectively. There was no statistically significant difference between Group A and B regarding all these parameters, demonstrating similar clinical responses to surgery. Conclusions Patients with EDV5 cm/s may have CVL evidenced by PC-PDS flow analysis directly on veins, and gold standard PC-PCTC. Their erection disability is severe. They respond well to combined open and embolization surgery, a confirmation that they suffer CVL. EDV criterium misses CVL in as much as one patient out of four with actual CVL in our series. Since false negative diagnosis has severe, life-long, patient and partner implications, hemodynamic criteria for CVL diagnosis should be debated in the field of sexual medicine. Disclosure No.

(307) Prevalence of Sexual Dysfunction and Pursuit of Sexual Medicine Evaluation Among Male Physicians

Abstract Introduction While the epidemiology of male sexual dysfunction in the general population is well studied, little is known regarding the prevalence of sexual dysfunction in male physicians and their likelihood of seeking treatment. Objective To characterize the prevalence of sexual dysfunction, evaluation patterns, and barriers to treatment among male physicians. Methods Between June 2022 and October 2022, male physicians were invited to complete a questionnaire regarding sexual function. Surveys were disseminated electronically via social media and professional medical societies using Qualtrics (Provo, UT). Results 235 responses were included in the final analysis. The mean age of respondents was 36.3 ± 7.4 years. 27 (11.5%) reported having seen a doctor for sexual health. Of these 27,11 (40.7%) saw a physician for erectile dysfunction, 8 (29.6%) for low libido, 6 (22.2%) for premature ejaculation, 2 (7.4%) for delayed ejaculation, and 9 (33.3%) for some other concern. An additional 29 (13.9%) respondents considered establishing care for sexual issues but didn’t, mostly due to being too busy (N=18, 62.1%). Of the 56 respondents who had either seen or thought about seeing a physician for sexual health issues, the mean IIEF score was 24.4 ± 8.7 with 18 (32.1%) qualifying as having at least mild ED and 7 (12.5%) having severe ED (Table 2). 46 (19.6%) respondents reported having taken medication to improve erectile function. Only 12 (5.1%) respondents reported having ever been diagnosed with low testosterone. Among the 56 respondents who had either seen or thought about seeing a physician for sexual health issues, those who worked more hours (&amp;gt;60 hours per week) were least likely to see a physician (7.2%) compared to those working the fewest hours (33.3%), p=0.02. Conclusions In a cohort of young male physicians, 25.4% had seen or considered seeing a doctor for sexual health concerns, and nearly 1 in 5 had taken medication for erectile dysfunction. Given the highly demanding work schedules, occupational stress, and a variety of other factors associated the medical profession, male physicians appear to be at higher risk for sexual dysfunction than the general population. Moreover, male physicians face significant and unique barriers in access to care for sexual dysfunction. Disclosure No.

(231) Low-Intensity Extracorporeal Shockwave Therapy Twice Per Week for Six Weeks May Result in Transient Subjective Improvements in Erectile Function

Abstract Introduction Low-intensity extracorporeal shockwave therapy (LiESWT) has been reported to result in subjective improvements in erectile function, but the ideal patient population and treatment protocol have not yet been established. Objective We aimed to assess improvements in International Index of Erectile Function – Erectile Function domain (IIEF-EF) scores following treatment with LiESWT of 1500 shocks of 0.2mJ/mm2 per treatment, twice a week for six weeks. We hypothesized that LiESWT results in subjective improvements of erectile function. Methods Patients were prospectively enrolled in a clinical trial examining changes in erectile function following LiESWT. The study was powered to detect a change in IIEF-EF scores of 5 points. Patients received 12 bi-weekly LiESWT treatments of 0.2mJ/mm2 at 5Hz, 1500 shocks delivered per treatment using the Storz Duolith T-Top Ultra shockwave device. Patients completed IIEF-EF, Sexual Encounter Profile (SEP) questions two and three, Global Assessment Questions (GAQ), and Erection Hardness Score (EHS) questionnaires prior to initiation of treatments and following completion of treatments at 1-2 weeks, 4-6 weeks, 3 months and 6 months post-treatment. Changes in questionnaire responses were compared to baseline responses. Data were analyzed using single variant one-tailed T-tests and one-tailed Fisher’s exact test. Values are reported as means ± standard error. Results Twenty-five patients completed all five study visits. Mean pre-treatment IIEF-EF score was 14.24 ± 1.21. Mean IIEF-EF scores increased to 15.80 ± 1.46 1-2 weeks following treatment (Study Time #2), 16.12 ± 1.46 4-6 weeks following treatment (Study Time #3), 18.12 ± 1.57 3 months following treatment (Study Time #4), and 16.36 ± 1.86 6 months following treatment (Study Time #5), though results only reached significance at Study Time #4 (p=0.016) and results were not sustained. Changes in IIEF-EF scores following treatment were evaluated by baseline ED severity (normal IIEF-EF 26-30, N=1; mild IIEF-EF 22-25, N=2; mild-moderate IIEF-EF 17-21, N=7; moderate IIEF-EF 11-16, N=10; severe IIEF-EF 6-10, N=5. Patients with IIEF-EF scores 11-21 reported significant improvements in IIEF-EF scores at all time points (Figure 1). Mean pre-treatment EHS score was 2.1±0.14. There was no significant improvement in EHS score following treatment at any time point, and no differences when analyzed based on pre-treatment ED severity. Similarly, no changes in SEP or GAQ positive response rates were noted following treatment. Conclusions Our results suggest that LiESWT using 1500 shocks per treatment with energy of 0.2mJ/mm2 twice per week for 6 weeks may transiently improve subjective erectile function as measured using IIEF-EF questionnaires, particularly for patients with mild-moderate to moderately severe ED, consistent with other studies. However, improvements may not be sustained 6 months following treatment. Disclosure No.

(015) The Association Between Prostate Volume and Erectile Function Recovery Following Radical Prostatectomy

Abstract Introduction The relationship between prostate volume (PV) and erectile function recovery (EFR) after radical prostatectomy (RP) has not been well studied. Objective We aimed to evaluate PV as a predictor of EFR 24 months after RP. Methods We included men who underwent RP with surgeon-reported nerve-sparing score (NSS) and 2-year follow up who had documentation of pre-RP PV on MRI and baseline functional erections (pre-RP IIEF-EFD scores ≥ 24). Demographics, ED-related comorbidities, pathological features, PDE5i use, and total testosterone (T) levels were recorded. At 12 months post-RP, patients scored PDE5i use 0-3; 0 never, 1 sometimes, 2 regularly, 3 routinely. NSS on each side (R/L) was scored on a 1-4 scale: 1 complete preservation, 2 near-complete preservation, 3 partial resection, 4 complete resection. Scores of 1 or 2 indicate nerve-sparing and scores of 3 or 4 indicate non-nerve-sparing. We then classified overall NS status as bilateral, unilateral, or non-spared. At 24 months post-RP, EFD score ≥ 24 defined functional erections, ≤ 10 severe ED. Multivariable analysis (MVA) evaluated predictors of EFD score ≥ 24 as well as EFD ≤ 10 after RP; patient age, number of comorbidities, baseline EF, NSS, PDE5i use, and PV were analyzed. Results 1741 men were included. Median age was 60 (55, 65) years. 36% had ≥ 2 comorbidities. Median PV was 33 (26, 44) mL with 12% having PV ≥ 60 mL. Median pre-RP IIEF-EFD score was 29 (27, 30). Grade group 1, 2, 3, 4 and 5 comprised 12%, 68%, 15%, 2%, and 3% of the cohort, respectively. NSS: bilateral (82%), unilateral (15%), non-spared (3%). Median PDE5i use score within 4 weeks of the 12 month post-RP visit was 1 (0, 1); reported PDE5i use was 44% never, 39% sometimes, 13% regularly, and 4% routinely. At 24 months post-RP, median EFD was 22 (9, 28), and 56% had EFD &amp;lt; 24. Men with post-RP EFD &amp;lt; 24 had greater PV (41 ± 26 mL) vs men with EFD ≥ 24 (36 ± 17 mL, p&amp;lt;0.001). 67% of the men with EFD &amp;lt; 24 had a PV ≥ 60 mL vs 33% of men with EFD ≥ 24 (p=0.02). On MVA, predictors of EFD ≥ 24 included bilateral NS, age and PV. Predictors of EFD ≤ 10 included bilateral NS and age. At 24 months post-RP, neither routine PDE5i use nor a higher comorbidity index were predictive of EF outcome. Conclusions Among men with functional erections pre-RP, larger PV is associated with a poorer EFR at 24m post-RP independent of degree of nerve-sparing, age, and PDE5i use. Disclosure No.

(314) MED3000, A CLINICALLY PROVEN, FAST-ACTING TOPICAL PRODUCT FOR ERECTILE DYSFUNCTION WITH THE PROSPECT OF BEING THE FIRST GLOBALLY AVAILABLE OTC TREATMENT FOR ED

Abstract Objectives To assess the effectiveness, onset of action and safety of MED3000 gel over a 24-week treatment period in male patients clinically diagnosed with ED. Methods 100 male patients clinically diagnosed with ED were randomised into two treatment groups, 50 to MED3000 and 50 to Tadalafil (5mg) in 11 Investigational sites in USA, Poland Georgia and Bulgaria. Results Both Co-Primary end points were achieved (P&amp;lt;0.001) (1) Mean IIEF-EF change from baseline at 24 weeks (2) Minimal clinically important difference (MCID) exceeded at 24 weeks). 61% of MED3000 users exceeded the MCID at 24 weeks The mean IIEF score at weeks 4, 8, 12, 16, 20, 24 was 4.59, 5.20, 5.12, 5.83, 5.57 5.73 Secondary Endpoint 10 minute onset of action FDA agreed standard for achieving a 10 minute onset of action was achieved. A key differentiator from PDEi's Effective in Mild, Moderate and Severe ED MED3000 also delivered a clinically meaningful outcome over 24 weeks in accordance with the Rosen 2, 5 and 7 criteria (Rosen et al 2011)1 in mild, moderate and severe ED subjects Adverse Events (&amp;lt;2 incidences) are detailed in figure 1. Reference 1 – Rosen RC et al “Minimal clinically important differences in the erectile function domain in the International Index of Erectile Function Scale Eur Urol 2011;60(5):1010-6 Conclusions MED3000 has been shown to deliver a clinically meaningful response and is fast-acting. It was also shown to be clinically effective in mild, moderate and severe ED. Results were generally consistent with a previously conducted clinical study used for European approval MED3000 was shown to have minimal adverse events. Its “drug-free” formula provides a further margin of safety with no propensity for adverse drug interactions. This profile makes it suitable for OTC use. FDA filing for marketing authorisation as a De Novo medical device occured in October 2022. Conflicts of Interest Professor David Ralph is a consultant to FMD Tim Holland and Ken James are employees of FMD The study was funded by FMD (Not for promotional purposes in the US).

(126) Long-term Functional Outcomes for Men with Priapism Secondary to Recreational Use of Intracavernosal Injectables: A Multi-center Follo- up Study

Abstract Introduction Ischemic priapism is a urologic emergency which results in permanent erectile dysfunction if not managed immediately. There is a dearth of studies evaluating long term erectile function after episodes or treatment for priapism. Objective We evaluated the functional outcomes of a larger, multi-institutional population of men with priapism due to recreational use of ICIs. Methods Men who presented with ischemic priapism due to recreational use of ICIs to Cedars-Sinai Medical Center (Los Angeles, CA), University of California at San Francisco (San Francisco, CA), and Jackson Memorial Hospital (Miami, FL) from January 2010 to December 2018 were contacted via telephone. All participants completed the five-item international index of erectile function (IIEF-5). Results A total of 19 men aged 24 – 59 (mean 47.9) were recruited from the 3 sites. Mean follow up was 77.2 months (+/− 27.6). 17 men (89%) were white; the one man was Asian (5.5%) and one man was Hispanic (5.5%). Seven men (37%) had been diagnosed with ED prior to their priapism episode however none of the men had a prescription for ICIs. Four men (21%) required no intervention at all, eleven men (58%) required phenylephrine irrigation alone, four men (21%) required distal shunting. No men required proximal shunting. None of the men had no ED, 31.6% had mild ED, 36.8% had mild-moderate ED, 26.3% had moderate ED, and 5.3% had severe ED. Mean IIEF-5 for the population was 13.4 (+/− 3.9). Strengths of our study included the large population size give the relative rarity of this condition as well as the geographic diversity of our population. Limitations include our low overall recruitment rate and lack of objective measures of erectile function prior to priapism. Conclusions Men who suffer ischemic priapism secondary to recreational use of ICIs appear to retain some erectile function following their priapism episode. Nevertheless, 100% report some level of ED. This is likely due a combination of adequate erectile function at baseline and expeditious treatment of priapism in a minimally invasive manner. Disclosure No

(410) Multiple Slit Incisions with Tachosil® Grafting for Treatment of Peyronie’s Disease and ED

Abstract Introduction Plaque incision or partial excision with collagen fleece grafting and IPP implantation is a well-established treatment for severe penile curvatures associated with ED. Nevertheless, multiple plaque incisions combined with Tachosil® grafting may have added advantages. Objective We demonstrate step-by-step the treatment of a case of severe ED with an over 60 degree dorsal curvature mainly on the left side and an hour glass indentation on the right side of the penile shaft. We highlight the advantages of multiple plaque incisions and Tachosil® grafting combined with IPP implantation for these specific cases. Methods After IPP implantation via the penoscrotal approach, the neurovascular bundle was mobilized. For the left sided curvature we underwent multiple deep transverse slits starting from and around the point of maximum curvature using a low energy cutting current (20 to 30 Watts). Our transverse incisions were complimented with the modeling technique. For the right sided waist formation we underwent longitudinal slits. The area of incisions was covered by a Tachosil® graft. Results The multiple horizontal incisions led to a vertical release thus straightening of the curved penile shaft. Longitudinal slits led to a horizontal release, therefore expanding and obliterating of the waist formation. Conclusions The multiple slit technique together with Tachosil® grafting may have added advantages compared to the conventional plaque incision/excision utilizing the same graft. The smaller defects created by the multiple tunical incisions may avoid potential cylinder protrusion, facilitate better sealing of the collagen fleece, lower the incidence of hematoma and/or infections and allow complimentary modeling of the penis. Moreover, complex deformities may also be treated simultaneously with success. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast.

(338) Factors Associated with Sexual Inactivity in Patients Diagnosed with Benign Prostatic Hyperplasia

Abstract Introduction Benign prostatic hyperplasia is a common pathology in patients over 40 years of age, with an important role in male sexual health due to its association with sexual dysfunction, with an elevated proportion of patients with sexual inactivity. Objective The objective of this study is to evaluate the factors associated with sexual activity in patients over 40 years of age with a diagnosis of benign prostatic hyperplasia Methods A retrospective cross-sectional study of 331 patients with a confirmed diagnosis of benign prostatic hyperplasia between January 2021 and November 2021. Both sociodemographic and clinical data were evaluated to associate them to the IIEF questionnaire15 Results Of the 331 patients diagnosed with BPH, 68.5% had erectile dysfunction: severe ED 119 (36%) moderate ED 14.2%, Mild/moderate ED 10.6% andMild in 7.9%. Of the 226 patients with ED, only 50 patients (22.1%) treated their erectile dysfunction. In addition, 33.2% had low sexual desire and the overall prevalence of sexual inactivity in more than 1 month was 43%. Sexual inactivity was classified: in 1-3 months: 29, 5%, 3-6 months 15.4%, 12% more than 6 months and 42.9% more than 12 months. The independent predictors related variables of sexual inactivity were: age over 60 years (PR 1.5), not having a sexual partner (PR 3.2), IEEF-15 (Erectile dysfunction RP 9.2) dissatisfaction with the partner (PR 4.9), low sexual desire (PR 2.9), and lack of confidence (PR 2.5), Severity of IPSS (RP 1.7) and urethral catheter carrier (RP 2.4) Conclusions Sexual inactivity is common in patients diagnosed with BPH and is associated with age and sexual desire. Independently lack of confidence, erectile dysfunction, not having a sexual partner or dissatisfaction with the partner. Of the specific variables related to prostatic hyperplasia, the only ones related were being a carrier of urethral catheter and IPSS severity, the latter associated with decreased sexual frequency and erectile dysfunction. Cardiovascular risk factors had no independent association unlike what was found in other studies. Disclosure No

Auxins seem promising as a tuning method for balancing sugars with acidity in grape musts from cv. Tempranillo, but not defoliation or application of magnesium to leaves

Global warming boosted by climate change affects grape quality, with increasing total soluble solids (TSS) content and decreasing total acidity (TA). However, current wine preferences increasingly include moderate alcohol content, higher acidity and the preservation of primary aromas reminiscent of grapes. Therefore, we hypothesised that applying phytohormones or mineral nutrients to leaves or carrying out defoliation can improve grape must properties in the face of climate warming and in accordance with current oenological trends. The effects of these three viticultural strategies were assessed independently from one another during three growing seasons in a Vitis vinifera L. cv. Tempranillo vineyard in northern Spain. Specifically, three 1-naphtaleneacetic acid (NAA) treatments, two early defoliations (ED; moderate and severe) and two foliar fertilisations with magnesium (Mg) were applied. Treatment with NAA was the most encouraging strategy for decreasing must TSS while increasing TA: it had slight effects on TSS in general and also slight effects on TA when applied close to veraison. The effects of the Mg treatments and moderate ED had null to slightly adverse effects. Finally, severe ED was clearly counter-productive. This study contributes to understanding the effects of both auxin and early defoliation treatments on grape must TSS, acidity and even yeast assimilable nitrogen (YAN) at harvest time. The favourable effects of NAA application are shown to be consistent though slight. Therefore, according to these results, the application of auxins may be an adequate choice for balancing sugars with acidity in grape musts. However, the results also suggest that more research needs to be undertaken to better characterise the effects of auxin treatments on grape must properties at harvest. In particular, different types of auxins, rates, concentrations and number of applications should be tested in the quest for more marked effects.

Management of erectile dysfunction and premature ejaculation: The perspective of Spanish urologists. Results of the PANDORA Project (Part II)

IntroductionED and PE are the most common male sexual dysfunctions, although they remain underdiagnosed and undertreated. AimTo ascertain how a group of Spanish urologists currently address ED and PE. MethodsDescriptive study based on a self-designed questionnaire about the clinical practice in ED and PE upon diagnosis, treatment and monitoring, patient–physician relationship and the role of the patient's partner. ResultsThe survey was completed by 188 experienced urologists. Most patients went to the urologist's office without a previous diagnosis (92% of the urologists found <10 PE-diagnosed patients in public settings). The diagnosis of ED and/or PE was mainly carried out by the current urologist and not by another professional, particularly in private centres as opposed to public centres (78.8% vs 57.0% for ED; 82.0% vs 62.6% for PE). Most urologists believed that these disorders are underdiagnosed and deemed them as general health issues. 38% of urologists acknowledged using validated questionnaires to diagnose ED. PE was considered a subjective problem rather than a true disease and the use of PRO-based diagnosis of PE was not generally accepted (14%). Treatment options of both disorders were chosen as expected. Referral to the andrologist is usually scheduled in moderate-to-severe PE or severe ED. The cohort seemed to be mostly neutral (50%–75% for ED and 40%–55% for PE) regarding patient reluctancy to talk about their sexual problem. Patients’ partners play an important role in helping men seeking treatment. ConclusionUrologists should show more proactivity during anamnesis and routine visits to improve management of ED and PD.

PD26-06 THE ASSOCIATION BETWEEN INSOMNIA, INSOMNIA MEDICATIONS, AND ERECTILE DYSFUNCTION

You have accessJournal of UrologyCME1 Apr 2023PD26-06 THE ASSOCIATION BETWEEN INSOMNIA, INSOMNIA MEDICATIONS, AND ERECTILE DYSFUNCTION Federico Belladelli, Shufeng Li, Chiyuan A. Zhang, Francesco Del Giudice, Frank Glover, Wade Muncey, Nicolas Serranio, Satvir Basran, Francesco Montorsi, Andrea Salonia, and Michael Eisenberg Federico BelladelliFederico Belladelli More articles by this author , Shufeng LiShufeng Li More articles by this author , Chiyuan A. ZhangChiyuan A. Zhang More articles by this author , Francesco Del GiudiceFrancesco Del Giudice More articles by this author , Frank GloverFrank Glover More articles by this author , Wade MunceyWade Muncey More articles by this author , Nicolas SerranioNicolas Serranio More articles by this author , Satvir BasranSatvir Basran More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , Andrea SaloniaAndrea Salonia More articles by this author , and Michael EisenbergMichael Eisenberg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003304.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Due to its importance for health, quality and duration of sleep has been investigated. Insomnia, characterized by difficulty in falling asleep, staying asleep, or poor-quality sleep. Itaffects up to one third of adults and may impact male sexual function. In addition, the treatments for insomnia, which operate through manipulations of the central nervous system, may also affect sexual function. The current study investigated the risk of ED in patients diagnosed with and treated for insomnia. METHODS: We utilized the IBM® MarketScan® (2007 to 2016) Commercial and Medicare Supplemental Databases (v 2.0, DOI: 10.57761/ray7-1g16) Age- and enrollment date- matched controls were selected among patients without insomnia diagnosis. Cox proportional hazard models were applied to calculate the risk of incident ED (i.e. diagnosis alone, or diagnosis and treament with PDE5i , intracavernous injection (ICI)/urethral suppositories, and penile prosthesis) after the diagnosis or treatment of insomnia while adjusting for relevant comorbidities. RESULTS: In total, 182,534 men with an insomnia diagnosis were identified with a median age of 49. An additional 356,575 men diagnosed and treated for insomnia were identified with a median age of 51. The median (SD) follow-up time for patients diagnosed and diagnosed & treated for insomnia were 2.8 and 2.5 years. Men with insomnia were more commonly smokers and had a higher number of office visits and comorbidities, compared to controls (p<0.001). On adjusted analysis, both untreated and treated insomnia were associated with ED diagnosis [OR (95% CI): 1.58 (1.54-1.62) and 1.66 (1.64-1.69), respectively; p<0.001]. Similarly, men with treated insomnia had a higher odds of having ED treated with PDE5i [OR (95% CI): 1.52 (1.49-1.55); p<0.001] and ICI [OR (95% CI): 1.32 (1.14-1.54); p<0.001] when compared to controls. In contrast, men with untreated insomnia did not have higher odds of having ED treated with PDE5i [OR (95% CI): 0.97 (0.95-1.001); p<0.001] or ICI [OR (95% CI): 0.84 (0.67-1.07); p=0.02]. CONCLUSIONS: In the current report, a consistent association between insomnia and ED diagnosis was identified. Men with untreated insomnia were not prescribed PD5i or ICI for their ED. However, men with pharmacologic insomnia treatments for insomnia were more often prescribed treatments for ED suggesting that insomnia treatment may exacerbate erectile dysfunction in men. However, more severe insomnia requiring treatment leads to more severe ED is also possible. Given the prevalenec of insomnia, future studies are warranted to delineate the association between insomnia and its treatment with erectile function. Source of Funding: Data for this project were accessed using the Stanford Center for Population Health Sciences Data Core. The PHS Data Core is supported by a National Institutes of Health National Center for Advancing Translational Science Clinical and Translational Science Award (UL1TR003142) and from Internal Stanford funding. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e737 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Federico Belladelli More articles by this author Shufeng Li More articles by this author Chiyuan A. Zhang More articles by this author Francesco Del Giudice More articles by this author Frank Glover More articles by this author Wade Muncey More articles by this author Nicolas Serranio More articles by this author Satvir Basran More articles by this author Francesco Montorsi More articles by this author Andrea Salonia More articles by this author Michael Eisenberg More articles by this author Expand All Advertisement PDF downloadLoading ...

PD11-03 THE USE OF PHOSPHODIESTERASE 5 INHIBITORS IS NOT ASSOCIATED WITH OCULAR ADVERSE EVENTS

You have accessJournal of UrologyCME1 Apr 2023PD11-03 THE USE OF PHOSPHODIESTERASE 5 INHIBITORS IS NOT ASSOCIATED WITH OCULAR ADVERSE EVENTS Federico Belladelli, Shufeng Li, Chiyuan A. Zhang, Francesco Del Giudice, Frank Glover, Wade Muncey, Nicolas Serranio, Satvir Basran, Francesco Montorsi, Andrea Salonia, and Michael Eisenberg Federico BelladelliFederico Belladelli More articles by this author , Shufeng LiShufeng Li More articles by this author , Chiyuan A. ZhangChiyuan A. Zhang More articles by this author , Francesco Del GiudiceFrancesco Del Giudice More articles by this author , Frank GloverFrank Glover More articles by this author , Wade MunceyWade Muncey More articles by this author , Nicolas SerranioNicolas Serranio More articles by this author , Satvir BasranSatvir Basran More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , Andrea SaloniaAndrea Salonia More articles by this author , and Michael EisenbergMichael Eisenberg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003251.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Phosphodiesterase-5 inhibitors (PDE5i) are the first-line line treatment for men with ED. The use of PDE5I has recenty been linked to several ocular side effects, such as serous retinal detachment (SRD), retinal vascular occlusion (RVO), and ischemic optic neuropathy (ION). However, the risk factors for major ocular events and ED overlap suggesting that the association may not be causative. The current study investigated the risk for SRD, RVO, and ION in patients using PDE5Is. METHODS: We utilized the IBM® MarketScan® (2007 to 2016) Commercial and Medicare Supplemental Databases (v 2.0, DOI: 10.57761/ray7-1g16). Cox proportional hazard models were applied to calculate the risk of ocular events after the diagnosis and or treatment of ED (i.e. PDE5i, penile injection/urethral suppositories, penile prosthesis placement) while adjusing for relevant comorbidities. As a further analysis, the use of PDE5i in men with BPH was also examined. RESULTS: In total, 1,565,006 men with an ED diagnosis were identified. Among them, 525,624 (33.6%) were treated with a PDE5i. In total, 1,806,803 men with a BPH diagnosis were observed during the study period with 141,607 (7.8%) treated with a PDE5i. On adjusted analysis, PDE5i use was not consistently associated with SRD, ION, and any ocular event when compared to ED diagnosis and other ED treatments. However, men who received a penile prosthesis had a higher risk of ocular events RVO (HR: 2.36; 95% CI: 1.81–3.09). In addition, PDE5i use was associated with SRD, RVO, and ION in the BPH cohort. In fact, BPH patients using 5a reductase/alpha blocker or prostatectomy had the highest risk of ocular events. CONCLUSIONS: In the current report, no consistent association with PDE5i use and adverse ocular events (i.e. SRD, RVO, and ION) was identified. For erectile dysfunction, men requiring more invasive treatment of ED (i.e. men with more severe ED who required more invasive treatments) carried the highest risk of adverse ocular events. The link between PDE5i use and ocular events is consistent with biases related to common risk factors suggesting patient counseling about this association is unnecessary. Source of Funding: Data for this project were accessed using the Stanford Center for Population Health Sciences Data Core. The PHS Data Core is supported by a National Institutes of Health National Center for Advancing Translational Science Clinical and Translational Science Award (UL1TR003142) and from Internal Stanford funding. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e333 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Federico Belladelli More articles by this author Shufeng Li More articles by this author Chiyuan A. Zhang More articles by this author Francesco Del Giudice More articles by this author Frank Glover More articles by this author Wade Muncey More articles by this author Nicolas Serranio More articles by this author Satvir Basran More articles by this author Francesco Montorsi More articles by this author Andrea Salonia More articles by this author Michael Eisenberg More articles by this author Expand All Advertisement PDF downloadLoading ...

PD26-10 PREDICTING ERECTILE FUNCTION PRESERVATION AFTER PROSTATE CANCER TRIPLE THERAPY

You have accessJournal of UrologyCME1 Apr 2023PD26-10 PREDICTING ERECTILE FUNCTION PRESERVATION AFTER PROSTATE CANCER TRIPLE THERAPY Samantha L. Thorogood, Jose M. Flores, Nicole Benfante, James A. Eastham, Craig E. Grossman, Michael Zelefsky, and John P. Mulhall Samantha L. ThorogoodSamantha L. Thorogood More articles by this author , Jose M. FloresJose M. Flores More articles by this author , Nicole BenfanteNicole Benfante More articles by this author , James A. EasthamJames A. Eastham More articles by this author , Craig E. GrossmanCraig E. Grossman More articles by this author , Michael ZelefskyMichael Zelefsky More articles by this author , and John P. MulhallJohn P. Mulhall More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003304.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Men with prostate cancer initially treated with radical prostatectomy (RP) who later undergo radiation (RT) and androgen deprivation therapy (ADT) in the adjuvant or salvage setting are at high risk for erectile dysfunction; however, this risk is not well quantified. We aimed to identify predictors of erectile function (EF) preservation this cohort treated with “triple therapy” (TTX). METHODS: We included men who underwent RP and subsequent adjuvant or salvage RT+ADT aka TTX but excluded men treated with ADT pre-RP. We extracted data on pre-RP ED-related comorbidities, total testosterone (T) levels, cancer and treatment characteristics, and sexual function. We analyzed International Index of Erectile Dysfunction (IIEF) Erectile Function Domain (EFD) score and phosphodiesterase 5 inhibitor (PDE5i) use documented pre-RP, 12 months (m) post-RP, and 12 m and 24 m post-TTX. PDE5i use was scored on a Likert scale of 0-3 (0: never; 3: routinely). NSS of each side (R/L) was scored on a 1-4 scale: 1 complete vs 2 near complete preservation (both considered nerve-sparing) and 3 partial vs 4 complete resection (both considered non-nerve-sparing). We then classified overall NS status as bilateral, unilateral, or not-spared. Multivariable analysis (MVA) was performed to define factors associated with EFD scores ≤10 (severe ED) and ≥24 (functional erections) at 24 m after TTX completion. RESULTS: We analyzed 163 men with a mean age of 63 years. 47% had ≥2 comorbidities. Median (IQR) total T 361 (26, 456) ng/dL. 18% had pre-RP T<300. 50% had bilateral NS. Median time between RP and start of RT was 18 (9, 34) m. Median duration of ADT: 4 (3, 6) m; 66% received >3 m ADT. Median EFD pre-RP=26 (17, 30) vs 6 (2, 20) at 24 m post-TTX. Mean difference in EFD pre-RP vs 24 m post-TTX was 11 (95% CI 9-12, p<0.0001). 18% had EFD≤10 pre-RP vs 62% at 24 m post-TTX. 60% had EFD≥24 pre-RP vs 15% at 24 m post-TTX. On MVA (Table 1), pre-RP EFD and bilateral NS were found to be significantly (p<0.05) associated with both EFD≤10 and EFD≥24. Age, ≥2 comorbidities, time between RP and RT, duration of ADT, and routine PDE5i use were not significant predictors in either model. CONCLUSIONS: This analysis identified pre-RP EF and surgeon-reported NS score as the only significant predictors of severe ED and functional recovery of erections 24 m after completion of TTX. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e738 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Samantha L. Thorogood More articles by this author Jose M. Flores More articles by this author Nicole Benfante More articles by this author James A. Eastham More articles by this author Craig E. Grossman More articles by this author Michael Zelefsky More articles by this author John P. Mulhall More articles by this author Expand All Advertisement PDF downloadLoading ...