Helo, S

ABSTRACT Introduction Penile length loss and erectile dysfunction (ED) are common post-prostatectomy. Recent results from a randomized, controlled study (RCT) of RestoreX penile traction therapy (RxPTT) demonstrated preserved erectile function and penile length improvements in men post-prostatectomy. Objective To report outcomes of the open label phase (6-9 month time point) of the previously noted RCT comparing efficacy of RxPTT to control in men post-prostatectomy. Methods A randomized, controlled trial (NCT03500419) has been completed of 82 men post-prostatectomy. Men were randomized 1-month post-prostatectomy to no therapy (control, n=27) or RxPTT (n=55) for 5 months. Participants then entered an open label phase for 3 months. Assessments included stretched penile length (corona), standardized (International Index of Erectile Function [IIEF]), and non-standardized questionnaires. Comparisons were performed of men who utilized traction at least 15 minutes daily for both phases to men who were originally control and continued with no treatment (as-treated analysis). Analyses were also performed of men who crossed over from control to >15 min daily (crossover to treatment) and those who were originally in the treatment group and continued with >15 min daily use during the open label phase (ongoing treatment). Results Of the 82 men enrolled (mean age 58.6), 55 had 6-month, and 42 had 9-month data available to review. Baseline characteristics (IIEF scores, penile length) were similar between cohorts. In the as-treated analysis (no treatment n=7, RxPTT x 8 months n=12, respectively), differences were as noted: IIEF-EFD (-8 vs -0.5, p=0.19), IIEF-OFD (-3 vs -2, p=0.86), IIEF-SD (-1 vs 0.5, p=0.09), IIEF-ISD (-3 vs -0.5, p=0.31), IIEF-OSD (-2 vs 0, p=0.29), penile length (-0.1 vs +1.8 cm, p<0.01), PDE5 use (86% vs 75%, p=0.57), intracavernosal injection use (86% vs 17%, p<0.01). Comparing men who did not use therapy at any time (n=7) to those who crossed over to RxPTT during the open label phase (n=8) demonstrated the following results: IIEF-EFD (-8 vs -6, p=0.49), IIEF-OFD (-3 vs -1, p=0.90), IIEF-SD (-1 vs 0, p=0.55), IIEF-ISD (-3 vs -1, p=0.45), IIEF-OSD (-2 vs -1, p=0.51), penile length (-0.1 vs +0.69 cm, p=0.39). Men who crossed over from RxPTT to no treatment (n=10) had relatively preserved improvements compared to those who continued with RxPTT during the open label phase (n=12) compared to baseline, respectively: IIEF-EFD (0 vs -0.5, p=0.95), IIEF-OFD (-3.5 vs -2, p=0.97), IIEF-SD (0 vs 0.5, p=0.18), IIEF-ISD (0 vs -0.5, p=0.87), IIEF-OSD (0 vs 0, p=0.66), penile length (+1.8 vs +1.8, p=0.99). Conclusions Although sample size and statistical power are limited, results from the open label phase confirm earlier findings of preserved sexual function and penile length in men treated with RxPTT compared to controls. Men who crossed over from controls to treatment experience benefits, although not as significant as those who were treated beginning at 1 month post-prostatectomy. Men who stopped therapy after 6 months demonstrated stable improvements from baseline, suggesting a preserved effect of RxPTT even after discontinuing use. If validated with external series, these findings would represent a significant advancement in the prevention of sexual dysfunction post-prostatectomy. Disclosure No

ABSTRACT Introduction Erectile dysfunction (ED) is a known precursor and sequelae to diagnosed cardiovascular disease (CVD). ED AUA guidelines recommend evaluating standard CV risk factors including serum lipids and penile doppler to help stratify CV risk, but few patients are referred for further evaluation. Plasma ceramides are metabolic byproducts that are novel predictors of adverse cardiovascular events resulting from unstable atherosclerotic plaque. CVD risk conferred by ceramide levels has been shown to be independent of conventional risk factors such as LDL and hsCRP levels. Thus, Plasma MI-Heart Ceramide is a new test that useful for evaluating shorter term major adverse cardiovascular events (MACE) in the next 1 to 5 years. Objective We sought to evaluate the utility of ceramide levels in ED patients Methods We initiated ceramide testing in all patients with ED in late 2019 (in addition to lipids and Hgba1c). We queried our electronic medical record for ceramide levels and men with a diagnosis of ED. Ceramide levels stratified patients in normal, moderate, high, and very high risk. Twenty eight patients additionally had penile duplex ultrasound (DUS). Left and right peak systolic velocity values were averaged and a value of <25 cm/s was defined as penile arterial insufficiency. Results 245 men with ED and ceramide levels were analyzed. 44% (n=107) were normal, 42% (n=103) were moderate risk, 12% (n=29) were high risk and 2% (n=6) were very high risk. As result of their ceramide and office evaluation, 42% (15/35) of high/very high risk patients were referred for cardiac evaluation. Comparing ceramide scores in men with penile arterial insufficiency (16.7 cm/sec) vs patients without (43.2 cm/sec), we found no significant difference (p=1). Similarly, when comparing DUS results between ceramide risk categories, we found no significant differences (p=1). Conclusions One in 7 men presenting to an ED clinic had a high or very high ceramide risk. DUS results did not correlate with ceramide risk. Patients undergoing DUS (even without arterial insufficiency) may benefit from additional ceramide testing and possible cardiac referral. Further study is warranted to optimize utility of ceramide in men with ED and potentially decrease peri-procedural IPP cardiac morbidity. Disclosure No

ABSTRACT Introduction Congenital penile curvature is a relatively uncommon condition characterized by penile angulation. Similar to Peyronie's Disease (PD), this condition has historically been managed with various surgical techniques. Given the efficacy of Collagenase Clostridium Histolyticum (CCH) in men with PD, our team has elected to treat men with CPD with CCH injections. Objective To describe outcomes of CPD men treated with CCH injections and to compare against a traditional PD cohort. Methods A prospective database has been maintained of all men undergoing CCH injections by our team since Jan 2014. The specific CCH administration protocol has been modified over time and currently includes combined use of RestoreX traction therapy, sildenafil, 0.9 mg of CCH diluted into 0.7 ml, injections performed at the point of maximal curvature, and aggressive manual modeling. Curvatures were measured in two planes (dorsal and lateral), with the combined measure reported as a composite. Outcomes were reported based on the most recent curvature assessment obtained minus baseline. Men were included if they received at least one series of CCH injections and had at least one baseline and follow-up curvature assessment available. Results A total of 272 men comprised the current cohort, with 23 exhibiting CPD and 249 PD. Mean age was higher in PD men (57.4 vs 38.4, p<0.0001), and mean PD duration was 18 months in PD men. Median baseline curvature was non-statistically higher in PD (65 vs 55 degrees, p=0.06). Baseline curvature directions for PD and CPD, respectively were: dorsal (82% vs 35%, p<0.0001), lateral (58% vs 78%, p<0.05), ventral (11% vs 35%, p<0.01). Following treatment with CCH, median curvature improvement was similar between cohorts, with 20 degrees (IQR 5, 35) for PD and 20 degrees (IQR 5, 30) for CPD, p=0.62. Percentage improvement from baseline was non-statistically higher in PD men (33% vs 29%, p=0.99). Conclusions Treatment of CPD men with CCH is a viable therapeutic option and provides similar benefits to those observed in men with PD. Disclosure No

ABSTRACT Introduction Peyronie's disease (PD) is a connective tissue disorder of the penile tunica albuginea, that can often cause penile deformity, pain, sexual dysfunction, and shortening. Therapies available include penile traction, oral medications, intralesional therapy, and surgical management. Many patients undergo multiple therapies for this disease due to poor satisfaction or lack of subjective improvement. Objective We thus sought out to delineate which patients were more likely to undergo a second therapy. Methods A cohort of 385 men who underwent therapy for Peyronie's disease from 2014-2018 were analyzed. A univariate analysis of patient demographics, subjective complaints, IIEF score parameters, primary treatments, and secondary treatment approaches was conducted. Results Of the 385 men identified, 29 patients ultimately decided to undergo a secondary treatment approach with 14 patients undergoing penile traction therapy, 7 intralesional therapy (Xiaflex) and 9 surgical therapy (5 penile plication, 2 insertion of inflatable penile prosthesis, and 2 grafting). 17 patients initially underwent surgery for PD with 23.53% of these patients undergoing a second line therapy (p<0.0469). 148 patients initially underwent Xiaflex injections with 12.16% of these patients undergoing a second line therapy (p<0.0227). Patients with poor orgasmic function as determined by IIEF questionnaire (median scores 8 vs 2, p<0.0420), men with greater objective curvature (median curvature 45 vs 35, p<0.0220), and men with greater stretched penile length (13.5 cm vs 12 cm, p=0.0284) were also more likely to undergo secondary therapy. Table 1 shows all factors associated with increased likelihood for secondary therapy. Conclusions Peyronie's disease is often a complex condition to treat due to the mental, emotional, and physical toll this disease takes on patients. It is helpful to determine which patients could likely require secondary therapy as this may help guide patient counseling and further management. Disclosure No