Yang, D

ABSTRACT Background 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 Work supported by industry: no.

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