Citations

ABSTRACT Introduction The COVID-19 pandemic has had a significant impact on global health. During uncertain times, priorities amongst patients shifted as many faced health concerns, economic uncertainty, and isolation. Access to general medical care during 2020 was challenging for many Americans who spent the year in quarantine. Without access to care, we hypothesize that patients were less likely to search for treatment options for a non-emergent condition like erectile dysfunction. Objective Herein, we aim to report on Google search trends observed in the pre COVID and post COVID era. Methods Google Trends was analyzed using search terms related to erectile dysfunction between June 2018 and June 2021. The search volume index (SVI), a relative measure of search volume on Google, was obtained for the following terms: erectile dysfunction, viagra, trimix, penile pump, and penile implant. Student t test was used to compare changes in mean SVI for each month compared to the same month one year prior. Results Compared to one year prior, the search for erectile dysfunction remained relatively stable over time with the exception of three months (9% decline Mar 2020, 38% increase Jan 2021, 8% increase Jun 2021). When compared to the preceding year, searches for Viagra declined during 9/37 (24%) months analyzed including Mar-Jun 2020, which coincided with the early part of the COVID-19 pandemic (p<0.05 for all). The only statistically significant increase occurred Oct 2020, a 16% change compared to Oct 2019 (p<0.05). In contrast, search for trimix did not change significantly over time except for an increase of 62% Mar 2021 and 60% Apr 2021 (p<0.05 for all). Search for the term penile pump did not change over time except for a 16 and 10% decline early during the pandemic, Feb and Mar 2020, respectively (p<0.05 for all). Lastly, search for penile implant declined 37% Mar 2020 and 32% Apr 2020 compared to 2019, and increased by 67% May 2021 compared to May 2020 (p<0.05 for all). Conclusions COVID-19 represented a major global health crisis, raising concerns and uncertainties for many. Erectile dysfunction remained a constant source of online interest. Despite limited access to medical care for elective conditions, only a few isolated increases in Google SVI were noted, most of which occurred during 2021 compared to 2020. This may be a reflection of the general public's lack of familiarity with treatments other than phosphodiesterase-5 inhibitors. Disclosure No

ABSTRACT Introduction Introduction:: Chronic scrotal content pain (CSCP) is generally defined by persistent and bothersome pain present for > 3-months. This symptom complex leads to frustration for patients and providers alike, as the underlying etiology varies and in many instances is unknown. Scrotal pain may arise from outside the scrotal contents, as is seen with musculoskeletal conditions involving the hips, lower back, and pelvic musculature. Identifying those patients who have signs or symptoms of a musculoskeletal etiology earlier in their clinical course will allow for a more streamlined treatment pathway and minimize the need for unnecessary referrals. Objective To review historical and examination findings in patients presenting to a tertiary care center for evaluation of chronic testicular pain. Methods We reviewed our clinical experience with referrals for surgical intervention for “chronic testicular pain” at a tertiary care medical center between July 2019 and October 2020. Prior to scheduling an appointment, patients are queried via a list of questions to gather additional information in order to determine whether specialist consultation is indicated. Pertinent information was collected including historical patient data, physical examination findings, laboratory and imaging results, and treatment as recommended by the assessing physician. In addition, we gathered data on the number of prior consults and interventions performed by outside clinicians. The data was summarized to present a cross-sectional representation of patients presenting for CSCP. Results In total, 126 patients were seen for a primary chief complaint of CSCP. Mean patient age was 45 years [standard deviation (SD) 15]. 31 (24%), 55 (44%), and 40 (32%) were self-referred or referred by their primary care provider or a urologist, respectively. 88 patients (70%) had seen at least one prior urologist. 22/126 (17%) reported bilateral testicular pain. 29 patients (24%) had undergone a prior unsuccessful surgical intervention for their pain. On examination, reproducible testicular tenderness was present in only 57 patients (45%), despite 109 patients (87%) stating testicular pain as their primary chief complaint. Digital rectal examination of the pelvic floor musculature was positive for tenderness in 31/126 patients (25%), suggesting a possible pelvic floor contribution. After thorough assessment, musculoskeletal etiologies were suspected to underlie CSCP in 49 patients (39%), prompting additional evaluation and/or referrals. This included 35 patients (28%) who were specifically referred to a pelvic floor physical therapy specialist. Surgery was recommended in 68/126 patients (54%), including microdenervation of the spermatic cord in 22% (after successful diagnostic spermatic cord block), and epididymectomy in 13%. Conclusions CSCP presents with a wide array of concurrent symptoms. The history and physical examination must include assessments for concurrent abdominal, back, hip, and other genital/pelvic pain that may lend towards an alternative non-urologic treatment pathway. Disclosure No

ABSTRACT Introduction Penile prosthesis (PP) implantation with concurrent straightening maneuvers is the gold standard surgical therapy for men with Peyronie's Disease (PD) and concurrent medication-refractory ED. Satisfaction rates exceed 80-90% in modern series. PD is characterized by other bothersome effects on penile morphology (i.e. penile shortening) that also negatively impact patient satisfaction with PP. We hypothesized that men with both PD+ED would report lower overall satisfaction with PP implantation compared to those with ED alone. Objective To compare patient outcomes in a cohort of patients undergoing PP implantation for ED with and without concurrent PD. Methods We identified all patients who underwent PP implantation by a single surgeon between May 2012 and August 2019 (n=354). A retrospective chart review was performed to evaluate pertinent clinical demographics and surgical outcomes. A survey was mailed to all patients in July 2019. This included validated ED questionnaires (IIEF, EDITS, and QOLSP) and clinician-derived questions to evaluate subjective outcomes. Survey results were compared between those patients with and without a history of PD, using two-sample student t- and chi-squared tests (p-value < 0.05 considered significant). Results 79 patients completed the survey (response rate 22%), including 38 (48%) with PD+ED. Mean survey follow-up duration was 45.5 (SD 19.5) months. There was no significant difference in patient demographics amongst those patients who did and did not respond to the survey. Amongst survey respondents, the mean preoperative IIEF-EF score was significantly higher for patients with PD+ED (10.2; SD 9.1) compared to those with ED alone (3.9; SD 5.0, p=0.003). Respondents with a history of both PD+ED were also less likely to have previously used oral therapy and intracavernosal injection to treat ED prior to PP implantation (p<0.009). For those respondents with PD+ED, mean preoperative curvature was 59O (SD 43). Adjunctive straightening maneuvers at the time of PP implantation included manual modeling (87%), plication (5%), and incision/grafting (50%). Overall, device infection occurred in 4/79 patients (5%), and mechanical malfunction occurred in 3/79 (4%). 87% of all survey respondents felt their ED was “very much” or “much” improved. 80% stated they would recommend PP to a friend. 60% reported postoperative penile length loss, but only 35% were “dissatisfied” with current length and only 20% were dissatisfied with penile girth. In those with PD+ED, 91% were satisfied with the degree of penile straightening. There was no significant difference in patient-reported outcomes pertaining to length, girth, and overall satisfaction between those with and without PD. The mean follow-up IIEF-EF was 27.4 (SD 5.7), mean EDITS was 18 (SD 8), and mean QOLSP was 55 (SD 15). Once again, there was no significant difference in these outcomes based on the presence of PD. Conclusions PP results in high rates of patient satisfaction. The presence of concurrent PD, even amongst those requiring adjunctive maneuvers, does not appear to significantly impact patient outcomes. While there are inherent limitations to a survey-based study including reporter bias, these results support the use of PP and concurrent straightening as an excellent treatment option for men with PD and ED. Disclosure Yes, this is sponsored by industry/sponsor: This project was funded by an investigator-initiated grant from Coloplast Corporation. Clarification: Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast Corporation (Dr. Laurence Levine - consultant); Boston Scientific (Dr. Laurence Levine - Consultant)

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

ABSTRACT Introduction Congenital penile curvature is common and presents with varying levels of severity. The curvature may present during infancy or post-pubertal. Historically, treatment has consisted of surgical correction, typically with penile plication or complex grafting procedures. Most pediatric urologists recommend surgical management for penile curvature (PC) based on curvature severity, with previous work identifying ≥ 30° as a common threshold to recommend correction. Objective To assess adult patients’ opinions on willingness to consider surgical correction for PC in order to determine if this aligns with pediatric urologists’ opinions. Methods In this cross-sectional study, a survey was administered to adult patients and their partners (> 18 years of age) in general adult urology clinics at 3 geographically separate institutions. The survey consisted of unlabeled images of penis models with varying degrees of PC (range 10-90°). Respondents were asked to select the images they would want surgically corrected for themselves or their partners. Univariable and multivariable analyses were performed to identify demographic variables associated with willingness to consider correction (p-values < .05 considered significant). Results Response rate was 77% (300/388). The majority (80%) of participants chose to surgically correct PC, however 20% chose to not surgically correct any degree of PC. Most participants were male (70%), married (62%), heterosexual (92%), and did not work in healthcare (80%) (Table 1). Among those who endorsed willingness to surgically correct PC, the average threshold for correction was 40.5° (SD 25.3). On univariable analysis, there was a significant difference in willingness to undergo PC correction based on gender, age groups, sexual orientation, and region (Table 1). Male patients were more likely to consider surgery at a lower degree of PC compared to females (36.6° vs 50.6°, p<.001). Those who identified as heterosexual also had a lower threshold for correction compared to those identifying as LGBTQ (39.6° vs 56.4°, p=.015). Midwestern residents endorsed an average threshold for correction of 21.5° compared to other regions varying between 40° to 60° (p<.001). Regionality differences remained true on multivariable analysis when accounting for all demographic features (p<.001). Conclusions In surveying adult patients, we identified an average PC threshold of 40° beyond which surgical correction was desired. Females and LGBTQ+ participants had a higher threshold for surgical correction, but when accounting for all demographic factors, only residence in the Midwest US was associated with a lower threshold for correction. Disclosure No

ABSTRACT Introduction Collagenase Clostridium Histolyticum (CCH) is commonly injected at the point of maximal curvature (POMC) for Peyronie's Disease (PD). However, many providers only evaluate the POMC at baseline and do not reassess during CCH injections. As PD plaques often extend over an extended region, it is currently unknown how much the POMC may change throughout a course of CCH treatment. Objective We sought to evaluate for changes in POMC between series among men undergoing CCH injections. Methods A prospective database has been maintained of PD men undergoing CCH injections at two institutions. POMC assessments were obtained prior to each series of injections after pharmacologic erection and were measured from the coronal margin to POMC. An analysis was performed comparing changes in POMC throughout the CCH course, including associated baseline demographic and disease characteristics. Results A total of 445 men (mean age 55.9, mean PD duration 30.6 months) underwent CCH injections from Jan 2014 through Feb 2021. The mean baseline composite curvature was 63.7° (SD 23.7), and the mean distance to curvature was 3.1 cm. Among men who completed 4 series of CCH injections, the mean improvement was 21° (SD 20.6) or 31.7% (SD 33%). In reviewing changes in POMC, the largest change observed at any point within the CCH series was a median 1 cm (IQR 0.5, 2 cm; range 0, 9.5 cm). Compared to baseline, 58% of men experienced a POMC change of 1 cm or greater, 25% 2 cm or greater, and 12% 3 cm or greater during the course of CCH treatment. Age, duration of PD, and baseline curvature were not associated with changes in POMC, although the POMC itself was associated with extent of changes, with proximal curves more likely to experience more notable changes compared to distal ones (p<0.0001). The total improvement in curve was also variably associated with change in POMC, with those experiencing greater improvements noted to have larger change in POMC (p<0.05 for changes in composite curvature and p=0.07 for percent change from baseline). These findings would suggest significant evolution of the POMC during a course of CCH, particularly among men with mid shaft or proximal curves and among those with greater curve improvements. Findings would support a role for repeat curvature assessments prior to each series of CCH injections. Conclusions Based on data from a prospective, two-institution series of PD men undergoing CCH injections, the POMC changes by ≥1 cm in the majority of men. Given the small volume injected with each CCH series, the clinical relevance of these findings and their impact on injector protocols merit further investigation. Disclosure No

ABSTRACT Introduction The efficacy and safety of collagenase clostridium histolyticum (CCH) for the treatment of Peyronie's disease (PD) were demonstrated in two phase 3, randomized, double-blind, placebo-controlled studies. CCH injections were administered in up to 4 treatment cycles at 6-week intervals; each cycle included two injections 1-3 days apart. Objective To evaluate incremental changes in penile curvature over the course of CCH treatment in men with PD. Methods A post hoc analysis was conducted using pooled data from the 2 placebo-controlled trials. Change from baseline and from the previous penile curvature measurement were calculated after each of the 4 treatment cycles (Weeks 6, 12, 18, and 24). For all patients, treatment included penile plaque modeling. For CCH vs placebo, mean percentage change in penile curvature was compared using a two-sample t-test; percentage of patients classified as treatment responders (defined as curvature reduction ≥20%) was compared using Fisher's exact test. Results The population included 832 adult men (CCH [n=551]; placebo [n=281]) who received ≥1 injection of study medication. At baseline, mean ± standard deviation (SD) penile curvature was 50.6±14.7 degrees in the CCH group and 50.4±14.1 degrees in the placebo group. Compared with baseline, the mean ± SD percentage change in penile curvature was -12.8±20.3% for CCH vs -6.2±18.8% for placebo after the first treatment cycle, -22.6±23.5% vs -10.6±23.1% after the second, -29.9±25.0% vs -14.6±24.0% after the third, and -33.1±28.0% vs -16.6±25.5% after the fourth (all P<0.001 vs placebo; Figure 1A). Comparing change from the previous measurement (ie, incremental change from previous treatment cycle [eg, between first and second; second and third, etc]), mean ± SD percentage reduction in penile curvature was 11.1±21.8% vs 5.0±16.4% after the second treatment cycle (P<0.001 vs placebo), 9.6±21.8% vs 3.9±17.0% after the third (P<0.001) and 6.3±23.0% vs 2.0±17.2% after the fourth (P=0.009; Figure 1B). The percentage of patients with ≥20% reduction in penile curvature since the previous measurement (cycle) was 29.9% for CCH group vs 18.3% for the placebo group after the first treatment cycle (P=0.0003), 29.1% vs 16.9% after the second (P=0.0002), 25.2% vs 12.8% after the third (P<0.0001), and 20.2% vs 10.9% after the fourth (P=0.001). For patients with a response after 2 treatment cycles (CCH [n=219]; placebo [n=77]), 40.2% of the CCH-treated patients vs 19.5% of the placebo-treated patients had an additional reduction of ≥20% after completing 4 treatment cycles (P=0.001). In patients with <20% reduction after the initial 2 treatment cycles (CCH [n=205]; placebo [n=168]), 29.8% of patients in the CCH group were classified as treatment responders after completing the fourth injection cycle (versus 20.8% of placebo-treated patients; P=0.057). Conclusions Data support that incremental benefits were obtained from each of the 4 CCH treatment cycles administered to men with Peyronie's disease. Results would suggest benefits with performing a full series of 4 CCH injections, even among men who are initial non-responders. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals Inc. Clarification Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals Inc.