Citations

ABSTRACT Introduction Peyronie's Disease (PD) is characterized by a fibrous scar of the tunica albuginea. PD is typically imaged with 2D ultrasound. We propose a classification system of these ultrasound findings in the evaluation of PD. Objective The purpose of this study is to establish a functional, reproducible sonographic classification system for evaluating PD and to examine the relationship between PD grading and curvature, duration of PD, and vascular erectile status. Methods In our study, 395 patients with PD underwent intracavernous injection with an erectile agent (ICI) followed by Color Doppler Duplex Ultrasound (CDDU). All CDDU studies were performed by a single examiner and all PD grading was done by two independent reviewers using saved images. CCDU findings including peak systolic velocities (PSV) and resistive indices (RIs) were recorded. PD grades of 2D images were classified into three grades: Grade 1 acoustic shadowing without calcification; Grade 2 focal microcalcifications of the tunica, pillars, or septal fibers; Grade 3 confluent calcification of the dorsal, septal, ventral tunica albuginea. Results There were 250 patients classified with Grade 1 (63%) sonographic changes, 75 with Grade 2 (19%), and 70 with Grade 3 (18%). Neither median age nor body mass index (BMI) of the cohorts were significantly different: Grade 1 (59.3 yr), Grade 2 (59 yr) and Grade 3 (60.3 yr), p = 0.711; BMI 27.6, 28.2, 27.7, p = 0.813. Medical risk factors for erectile dysfunction, including hypertension, heart disease, diabetes mellitus, hyperlipidemia, smoking history, and history of prostate surgery were not statistically different for the three cohorts. Most patients had previously used PDE5-Inhibitors (293/395). History and or physical findings of Dupuytren's palmar contracture was noted in 30/395 (7.6%) of men. The median duration of PD was not significantly different in the three cohorts (12, 12, 14 months p = 0.639). Neither CDDU diagnoses (Table 1) nor curvature varied by sonographic grades (Table 2). Conclusions The scar resulting from PD seals together the outer longitudinal and inner circular layers of the tunica albuginea causing deformity of the erect shaft. PD plaques are usually palpable and associated with focal thickening of the tunica. On 2D ultrasound, the typical appearance is an acoustic shadow. Most of our patients presented with Grade I acoustic shadowing and no calcifications 250/395 (63%); on the other hand, 19% had acoustic plaque shadowing and additional findings of focal tunica or deep microcalcifications and 18% had confluent calcification of the dorsal, septal or ventral tunica. We propose a unique and reproducible classification system. This grading system based on grayscale ultrasound of Peyronie's plaques may serve as a paradigm for diagnosis, didactics and integrated research. Disclosure Work supported by industry: no, by N/A.

ABSTRACT Introduction Intracavernosal injections (ICI) are a well-established treatment option with great success rates for men with erectile dysfunction. Unfortunately, the anticipation of pain with injections remains a significant barrier to the use of ICI. Objective This study aims to utilize a standardized verbal pain scale to examine the perception of pre- and post-injection pain in men who are undergoing their first injection with an intracavernosal erectile agent. Thus, inclusion criteria required no previous penile injection of any type, including but not limited to erectile medications and collagenase. Methods We determined a prospective pre-post observational study would be best to examine men undergoing their first ICI. Men who had no previous history of intracavernosal injection of any kind were asked to predict the pain associated with their first ICI with a score of zero to ten. Patients then received a 10 microgram (mcg) injection of prostaglandin E1 (PGE1). Immediately after they received their injection, they were asked to rate the pain they perceived with the injection on the same scale (0-10). The same physician administered pre- and post-injection scales in a standardized fashion. Results A total of 17 of men were asked to rate their pain as discussed in the Methods Section. The average age of men sampled was 61.8 years of age. On review of history, 64.7% of men were found to have used some type of PDE-5 inhibitor before visiting our clinic. The majority of men we saw had erectile dysfunction (70.6%) and/or Peyronie's Disease (58.8%). The average pre-injection prediction pain score was 5.29 +/- 1.90; the average post-injection perceived pain score was 1.21 +/- 0.81. Thus, there was an average decrease of over 4 points in predicted pain versus perceived pain. A two-sample t-test was performed; in addition, a Wilcoxson Signed Rank Test was performed. Both tests showed statistical significance in the difference between pre- and post-injection pain scores (p <0.001). Conclusions We found that patients who are undergoing ICI for their first time have a significantly higher prediction of pain versus perception of pain after the injection. We have utilized this data in our clinic to explain to patients that while the majority of patients predict high pain scores associated with injection, the vast majority of patients report very minimal pain associated with the injection. Patients can be more open-minded to ICI therapy which could help aid them with their erectile status; this can particularly be helpful in patients who want to avoid surgery and in patients who are not good surgical candidates. Disclosure Work supported by industry: no, by N/A.

ABSTRACT Introduction The prevalence of erectile complaints in the US is estimated to be more than 50%. Most of the time ED complaints are evaluated and treated in the primary care setting. However, when first line measures are not efficient, patients are referred to general Urologists or to a specialized center. Objective The primary aim of this study is to describe the characteristics of patients referred to a tertiary center for evaluation of erectile complaints not responding to traditional first line therapies and, or patients with an associated complaint of penile deformity (rule out Peyronie's Disease/PD). Methods We retrospectively analyzed a cohort of patients between 2005 and 2019, detailing primary complaints, sexual histories, self-assessment scores, medical history and results of in office intracavernous injection followed by Color Doppler Duplex Ultrasound (CDDU). CDDU findings were recorded following injection of low dose alprostadil (10-20 mcg) and again after a period of privacy and visual sexual stimulation. CDDU findings including peak systolic velocities (PSV), and resistive indices (RIs) were recorded. Arterial insufficiency (AI) was defined as either a post-stimulation PSV < 25 (severe) or a PSV 25-34.9 with RI ≥ 0.9 (moderate). Cavernous venous occlusion disease (CVOD) was defined as post-stimulation PSV ≥35 with RI < 0.9. Vascular normal was defined as post-stim PSV ≥ 35 with RI ≥ 0.9. Results A total of 1490 patients with a median age of 60 (range, 18 – 88), median BMI of 28.4 (range, 15.9 – 56.8) and median Sexual Health Inventory for Men (SHIM) score of 10 (range, 0-25). In our cohort, 257/1489 (17.3%) patients had heart disease, 656/1489 (44.1%) patients had hypertension, 520/1489 (34.9%) patients had diabetes, and 203/1488 (13.6%) patients had a past medical history of hypertriglyceridemia. Smoking history was present in 853/1478 (57.7%) of patients and complaint of PDE-5 failure was made by 945/1201 (78.7%) patients who reported using it. 900 patients (60.4%) had a complaint of penile deformities and ED, 461 (30.9%) had a complaint of ED only, and 129 (8.7%) had a complaint of PD only. Prostate surgery history was noted in 316 men: radical retropubic prostatectomy 108, robotic assisted prostatectomy 134 and endoscopic resection or enucleation 74. Following CDDU we confirmed 767 (51.5%) patients with both ED and PD, 351 (23.6%) with ED only, and 310 (20.8%) PD only. We found 62 men (4.2%) had normal vascular erectile response to low dosage PGE1 (diagnosed as psychogenic ED vs. post-prostatectomy neurogenic ED). Among the 351 patients with ED only on Doppler, 132 (37.6%) had AI, 124 (35.3%) had CVOD, and 95 (27.1%) had a mixed vascular diagnosis. Among patients with vascular ED on diagnoses by CDDU, 73/351 (20.8%) had heart disease, 192/349 (55.0%) had smoking history, 273/311 (87.8%) complained of PDE5-inhibitor failure, 130/351 (37.0%) had diabetes, and median SHIM score was 7 (range 1-25). Conclusions This summary describes the characteristics in 1490 men who presented for evaluation of erectile complaints and or complaints of penile deformity to a tertiary care center. Patients referred to Urologists have complex ED, defined as refractory to PDE5-Inhibitors, associated with penile deformities, and multiple medical / surgical risk factors. Disclosure No

ABSTRACT Introduction Erectile dysfunction (ED) is a common consequence of Diabetes Mellitus (DM). The medical literature is inconclusive as to which DM related morbidities improve with better glycemic control. Surgical literature often associates infection outcomes with DM and with glycemic control. There is limited research on the relationship between Hemoglobin A1c and severity of vascular ED. Objective To evaluate the relationship between hemoglobin A1c (HbA1c) and severity of vascular ED in men with DM diagnosed with vascular ED by penile color duplex Doppler ultrasound (CDDU). Methods We retrospectively analyzed patients with a history of DM who underwent intracavernous injection followed by CDDU at our institution between 2005 and 2019. CDDU findings including peak systolic velocities (PSV), primary diagnosis after CDDU, and resistive indices (RIs) were recorded. Doppler diagnosis was based on post stimulation PSV and RI. Arterial Insufficiency (AI) was classified as PSV < 25 cm/s (severe), or (moderate) PSV 25-34.9 cm/s with RI ≥ 0.90. Corporal veno-occlusive disease (CVOD) was classified as PSV ≥ 35 cm/s with RI < 0.90. Mixed ED was classified as PSV 25-34.9 cm/s with RI < 0.90. HbA1c was recorded at time of assessment. Among our cohort of 1490 men who had CDDU, 520 had DM: 130 with CDDU diagnosis of ED, 270 with CDDU diagnosis of ED + Peyronie's disease (PD), 94 with PD alone and 26 with normal vascular erections on CDDU and no PD. The 130 patients with DM diagnosed with ED without presence of PD were included in our analysis. We used a Kruskal-Wallis rank sum test to evaluate the overall association between HgA1c and CDDU diagnosis (AI, CVOD, and mixed ED). Spearman rank correlation tests were used to explore the relationship of HbA1C with PSV and RI. Results Among the 130 men with DM + ED without PD, the median age was 61 y (range 20-79 y), 76 (58%) had hypertension, 37 (28%) had heart disease, median BMI was 30.7 kg/m2 (range 21.2-48.9 kg/m2), and median HgbA1C was 7.0 (range 5.0-11.0). PDE-5 inhibitor use was reported in 119/129 (92.2%) and among those who reported using it 108/119 (90.8%) reported PDE-5 inhibitor failure. CDDU diagnoses were 53 (40.8%) AI, 44 (33.8%) CVOD, and 33 (25.4%) mixed vascular (25%). The median (interquartile range) HbA1c was 7.0 (6.1-7.8) in men with AI, 7.1 (6.3-8.0) in men with CVOD, and 6.7 (6.1-7.0) in men with mixed ED. We did not find evidence of a relationship between HbA1c and severity of vascular ED (Kruskal-Wallis test P = 0.25). We also did not find evidence of a correlation of HbA1c with either post-stimulation PSV (Spearman rank correlation = 0.04, P=0.68) or RI (Spearman rank correlation = -0.03, P = 0.79). Conclusions Median HbA1c did not vary with the vascular diagnosis of men with DM + ED (AI vs. CVOD vs. Mixed Vascular). DM is a significant risk factor for ED and HbA1c is used to monitor and advise patients. We found no predictive relationship between HbA1c and type of vascular ED as defined by CDDU. Disclosure No

ABSTRACT Introduction Intracavernosal injections (ICI) are a well-established treatment option with great success rates for men with erectile dysfunction. Unfortunately, the anticipation of pain with injections remains a significant barrier to the use of ICI. Objective This study aims to utilize a standardized verbal pain scale to examine the perception of pre- and post-injection pain in men who are undergoing their first injection with an intracavernosal erectile agent. Thus, inclusion criteria required no previous penile injection of any type, including but not limited to erectile medications and collagenase. Methods We determined a prospective pre-post observational study would be best to examine men undergoing their first ICI. Men who had no previous history of intracavernosal injection of any kind were asked to predict the pain associated with their first ICI with a score of zero to ten. Patients then received a 10 microgram (mcg) injection of prostaglandin E1 (PGE1). Immediately after they received their injection, they were asked to rate the pain they perceived with the injection on the same scale (0-10). The same physician administered pre- and post-injection scales in a standardized fashion. Results A total of 17 of men were asked to rate their pain as discussed in the Methods Section. The average age of men sampled was 61.8 years of age. On review of history, 64.7% of men were found to have used some type of PDE-5 inhibitor before visiting our clinic. The majority of men we saw had erectile dysfunction (70.6%) and/or Peyronie's Disease (58.8%). The average pre-injection prediction pain score was 5.29 +/- 1.90; the average post-injection perceived pain score was 1.21 +/- 0.81. Thus, there was an average decrease of over 4 points in predicted pain versus perceived pain. A two-sample t-test was performed; in addition, a Wilcoxson Signed Rank Test was performed. Both of these tests showed statistical significance in the difference between pre- and post-injection pain scores (p <0.001). Conclusions We found that patients who are undergoing ICI for their first time have a significantly higher prediction of pain versus perception of pain after the injection. We have utilized this data in our clinic to explain to patients that while the majority of patients predict high pain scores associated with injection, the vast majority of patients report very minimal pain associated with the injection. Patients can be more open-minded to ICI therapy which could help aid them with their erectile status; this can particularly be helpful in patients who want to avoid surgery and in patients who are not good surgical candidates. Disclosure No

ABSTRACT Introduction Peyronie's Disease (PD) can coexist with erectile dysfunction (ED). International guidelines recommend that management of PD include an assessment of each patient's ability to initiate and sustain erection. PD causes significant stress to the patient and his partner; that distress may limit their ability to assess adequacy of penile rigidity. Further complicating evaluations based on history is the fact that PDE5-Inhibitor use is common. Objective The primary aim of this study is to non-invasively assess vascular erectile integrity in the setting of PD. Methods 1490 patients who underwent intracavernous injection (ICI) followed by Color Doppler Duplex Ultrasound (CDDU) at our institution were retrospectively analyzed. CDDU findings were recorded following injection of low dose alprostadil (10-20 mcg) and again after a period of privacy and visual sexual stimulation. CCDU findings including peak systolic velocities (PSV), and resistive indices (RIs) were recorded. Arterial insufficiency (AI) was defined as either a post-stimulation PSV < 25 cm/sec (severe AI) or a PSV 25-34.9, RI ≥ 0.9(mild AI). Cavernous Venous Occlusion Disease (CVOD) was defined as post-stimulation PSV ≥ 35 cm/sec with RI < 0.9. Mixed was defined as post-stimulation PSV 25-34.9 with RI < 0.9. Vascular normal was defined as post-stim PSV ≥ 35 with RI ≥ 0.9. Results Our cohort of 1490 patients included 900 (60.4%) with a complaint of both PD + ED; 461 (30.9%) with complaint of ED only and 129 (8.7%) with complaint of PD only. Following ICI with PGE1, 310 men were found to have PD and 767 were found to have PD + ED. Patients with a CDDU confirmed diagnosis of PD alone were younger (median: 56.9 vs. 60.8 y, p < 0.001), less likely to have hypertension [103/310 (33.2%) vs. 365/767 (47.6%), p < 0.001], less likely to have used PDE-5 inhibitor [219/310 (70.6%) vs. 616/767 (80.3%), p < 0.001], and less likely to have failed to a PDE-5 inhibitor [142/219 (64.8%) vs. 484/616 (78.6%, p < 0.001]. Diabetes was slightly more common in men with PD + ED compared to PD [270 (35.2%) vs. 94 (30.3%), p = 0.063], but not statistically significant. CDDU diagnoses for men with ED + PD were: AI 262/767 (34.2%), CVOD 305/767 (39.8%), mixed vascular ED 200/767 (26.1%). By definition all men with PD alone were vascular normal. Self-assessments by SHIM scores were abnormal in both groups ED + PD and PD [median(interquartile range): 10 (5 – 17) vs. 14 (8 – 20), p< 0.001]. Conclusions By history alone, patients with ED + PD vs. PD only can't reliably be identified. This is likely related to the distress caused by PD and the tendency to physicians to treat or patients to self-medicate all erectile complaints with PDE5-Inhibitors. For non-invasive treatments distinguishing between ED + PD vs. PD is not critical. Before any patient is triaged to surgical intervention an evidence-based assessment of vascular erectile integrity should be performed. In our cohort of men, Doppler analysis demonstrated that at least 6 out of 10 PD patients have some form of vascular ED. Disclosure No

ABSTRACT Introduction Peyronie's Disease (PD) is a well described pathology affecting up to 5-10% of men. The presence and extent of penile calcifications is an important determinant in disease management. Calcifications have a variety of clinical presentations ranging from microcalcifications to calcified plaques. Calcified plaques were excluded from past Xiaflex clinical trials. Calcified plaques may necessitate plaque excision and grafting (E&G) sometimes combined with inflatable penile prosthesis (IPP) placement, which is more complex than plaque incision and grafting. Peyronie's Disease guidelines recommend color duplex Doppler ultrasound (CDDU) primarily to rule out Erectile Dysfunction. PD pathology such as corporal septal involvement, multifocal calcifications, and circumferential corporal calcification can be difficult to assess on penile ultrasound (PUS) due to acoustic shadowing and device limitations. We describe a series of patients in whom non-contrast CT scan was used to further define calcified or complicated pathology. Objective To describe the role of non-contrast CT scan of the penis for anatomic evaluation and surgical planning in patients with complicated calcified Peyronie's disease. Methods 23 male patients with a diagnosis of PD were evaluated by a single surgeon at a single academic institution between 2017 and 2021. All patients underwent color doppler ultrasound (CDDU) examination with artificial erection via intracavernosal alprostadil injection and were evaluated based on erectile function, plaque dimension, hourglass deformity, plaque septal involvement, and suspected calcification status. Patients with CDDU examination concerning for significant calcification or complexity proceeded to non-contrast CT scan for calcific confirmation and for 3-dimensional evaluation of their PD plaque prior to surgical discussion. Complexity was defined as concern for multifocal calcified plaques (>2), partial/complete circumferential corpus cavernosum involvement, or septal involvement. Results All 23 patients had concerning findings on initial examination for calcified plaque. 9 of 23 (39.1%) patients had exam findings of an hourglass deformity. On CT evaluation, calcification was confirmed in 22 of 23 patients (95.7%). Plaque dimensions on CT scan ranged from 0.4 × 0.2 × 0.5 cm to 4.0 × 2.0 × 1.7 cm. Many of these measurements were approximations due to circumferential calcified plaque. This classic “gull-wing” appearance (Figure 1) was noted in 6 of 23 (26%) patients. 12 of 23 (52.2%) of patients had septal involvement on CT (Figure 2). 8 of 23 patients (34.8%) had significant multifocal disease (Figure 3). 8 of 23 patients (34.8%) decided to proceed with surgical correction via E&G (n = 3), IPP with E&G (n =1), or via IPP with manual remodeling via the Wilson technique (n = 4). Conclusions Non-contrast penile CT scan for evaluation of calcified Peyronie's disease allows for increased accuracy of surgical planning especially when evaluating for multifocal disease, circumferential plaque and/or septal involvement. These elements are critical in being able to provide accurate surgical recommendations and post operative discussions. Disclosure No

ABSTRACT Introduction Peyronie's Disease (PD) is characterized by a fibrous scar of the tunica albuginea. PD is typically imaged with 2D ultrasound. We propose a classification system of these ultrasound findings in the evaluation of PD. Objective The purpose of this study is to establish a functional, reproducible sonographic classification system for evaluating PD and to examine the relationship between PD grading and curvature, duration of PD, and vascular erectile status. Methods In our study, 395 patients with PD underwent intracavernous injection with an erectile agent (ICI) followed by Color Doppler Duplex Ultrasound (CDDU). All CDDU studies were performed by a single examiner and all PD grading was done by two independent reviewers using saved images. CCDU findings including peak systolic velocities (PSV) and resistive indices (RIs) were recorded. PD grades of 2D images were classified into three grades: Grade 1 acoustic shadowing without calcification; Grade 2 focal microcalcifications of the tunica, pillars, or septal fibers; Grade 3 confluent calcification of the dorsal, septal, ventral tunica albuginea. Results There were 250 patients classified with Grade 1 (63%) sonographic changes, 75 with Grade 2 (19%), and 70 with Grade 3 (18%). Neither median age nor body mass index (BMI) of the cohorts were significantly different: Grade 1 (59.3 yr), Grade 2 (59 yr) and Grade 3 (60.3 yr), p = 0.711; BMI 27.6, 28.2, 27.7, p = 0.813. Medical risk factors for erectile dysfunction, including hypertension, heart disease, diabetes mellitus, hyperlipidemia, smoking history, and history of prostate surgery were not statistically different for the three cohorts. Most patients had previously used PDE5-Inhibitors (293/395). History and or physical findings of Dupuytren's palmar contracture was noted in 30/395 (7.6%) of men. The median duration of PD was not significantly different in the three cohorts (12, 12, 14 months p = 0.639). Neither CDDU diagnoses (Table 1) nor curvature varied by sonographic grades (Table 2). Conclusions The scar resulting from PD seals together the outer longitudinal and inner circular layers of the tunica albuginea causing deformity of the erect shaft. PD plaques are usually palpable and associated with focal thickening of the tunica. On 2D ultrasound, the typical appearance is an acoustic shadow. Most of our patients presented with Grade I acoustic shadowing and no calcifications 250/395 (63%); on the other hand, 19% had acoustic plaque shadowing and additional findings of focal tunica or deep microcalcifications and 18% had confluent calcification of the dorsal, septal or ventral tunica. We propose a unique and reproducible classification system. This grading system based on grayscale ultrasound of Peyronie's plaques may serve as a paradigm for diagnosis, didactics and integrated research. Disclosure No