Intracavernous Research Articles

Investigating the risk factors of penile arterial insufficiency and veno-occlusive dysfunction in patients with erectile dysfunction.

To investigate the risk factors for penile arterial insufficiency (PAI), which is a known cause of erectile dysfunction (ED). Patients who attended our urology clinic complaining of ED for more than 6 months were prospectively enrolled in this study over 1-year period. Patient consent was taken and ethical committee approval. Complete medical history and thorough general and local examination including body mass index (BMI), Peyronie's disease (PD) and penile size measurements (length and girth) were done for all of them. Laboratory tests included testosterone, lipid profile and glycated haemoglobin (HA1c). A penile duplex ultrasound study (PDU) was done for all patients after intracavernosal injection (ICI) with alprostadil. Peak systolic velocity (PSV) and end-diastolic velocity (EDV) were measured after 15 min. Statistical analysis was done using SPSS. A total of 440 patients were enrolled in this analysis. The mean age was 48(23-81), and the mean BMI was 30 (18-51). Older patients had lower PSV (r= -0.361, P= 0.000) and higher EDV (r= 0.174, P= 0.001), and both correlations were highly statistically significant. Diabetics had lower PSV (r= -0.318, P= 0.000) and higher EDV (r= 0.139, P= 0.008), which were also highly statistically significant. Smokers had lower PSV (r= -0.140, P= 0.008) and higher EDV (r= 0.178, P= 0.001), which were highly statistically significant. Men with larger penises measured skin to tip had lower EDV (r= -0.119, P= 0.024), which was less significant. Interestingly, there was neither a significant correlation between BMI and PSV (0.16, P= 0.745) nor a significant correlation between testosterone and PSV (0.029, P= 0.552). Also, there was no correlation between PSV and both dyslipidaemia and penile PD. Ageing, tobacco consumption, DM and hypertension seem to have a negative impact on penile haemodynamics, which was statistically significant. In our patients, there was no statistically significant effect on penile haemodynamics in patients with increased BMI, low testosterone or PD or according to the size of the penis.

Efficacy and Safety of Different Modalities for Treatment of Erectile Dysfunction in Chronic Renal Failure Patients

Background Erectile dysfunction has been found to be significantly more common in men with chronic kidney disease (CKD) than in the general population. Objective of the Study Detection of the safest and most effective medical treatment of erectile dysfunction(ED) in chronic renal failure patients. Patients and Methods . This study was conducted at Ain Shams University Hospitals with a sample size of 60 patients: 15 patients per group. We assessed the improvement in the erectile function through assessment of IIEF (International Index of Erectile Function) score and EHS (Erection Hardness Scale) score pre- and post-administration of the drugs used in the study (oral sildenafil, oral vardenafil, oral tadalafil and intracavernosal injection of alprostadil). Results There is a statistically significant increase in IIEF score post-administration of the drugs used in this study with p value of < 0.001 and a mean difference of 6.92. The mean score of IIEF pre-administration of the drugs used was 8.13 and post-administration was 15.05. There is also a statistically significant difference in EHS score with p value of < 0.001 and mean difference of 1.4. The mean score of EHS pre-administration of the drugs was 1.22 and post-administration was 2.62. From the four drugs used in this study, Alprostadil showed the highest improvement in IIEF and EHS scores. The study also showed a negative correlation between age, duration of haemodialysis and serum creatinine with erectile function. In addition, there was a statistically significant decrease in pre- and- post-treatment IIEF and EHS scores in diabetic cases than in the non-diabetic cases. Conclusion There is high incidence of ED in CKD patients. The drugs used in the study showed improvement in the erectile function with mild side effects. Alprostadil had the best IIEF and EHS scores amongst the four drugs.

Platelet-rich plasma for the treatment of erectile dysfunction: a systematic review of preclinical and clinical studies.

There has been tremendous growth in regenerative medicine during the last decade. For erectile dysfunction (ED), after the inclusion of low-intensity shockwave therapy as a treatment modality for ED management by the European Association of Urology sexual health guidelines, intracavernosal injection of platelet-rich plasma (PRP) has gained popularity between urologists and patients as a novel ED therapeutic modality with initial promising results. However, limited clinical data exist regarding efficacy and safety in patients with ED. Furthermore, despite numerous preclinical studies in other tissues and organs, the mechanism of action for restoring erectile function remains undetermined. This systematic review aims to present the current status of preclinical and clinical evidence regarding the use of PRP as treatment option for ED. A systematic literature search was conducted using PubMed, Cochrane, and ScienceDirect databases, until February 2023 for studies exploring the effect of PRP on ED. We identified 517 articles, 23 of which were included in this review. These were 7 preclinical (of which 1 was a comparative trial and 6 were placebo-controlled randomized controlled trials) and 16 clinical studies (of which 1 was a comparative trial, 5 were randomized trials, and 2 were placebo-controlled randomized controlled trials). Preclinical data support the regenerative role of PRP in erectile tissue, in accordance with existing evidence in other tissues. Randomized clinical studies, as well as the first 2 available randomized, placebo-controlled clinical trials, showed promising efficacy and a lack of any adverse events. As PRP for ED is widely used worldwide, there is an urgent need for high-quality studies with long-term follow-up. Standardization of research protocols, especially on the quality of PRP preparation, is also needed.

(219) AUTOLOGOUS PLATELET-RICH PLASMA IMPROVES ENDOTHELIAL AND TADALAFIL-INDUCED RELAXATIONS IN CORPUS CAVERNOSUM FROM PATIENTS WITH ERECTILE DYSFUNCTION

Abstract Objectives Available clinical evidence suggests the potential therapeutic use of intracavernosal injections of platelet-rich plasma (PRP) to treat erectile dysfunction (ED). However, the effects of PRP on human cavernosal function have not been elucidated. Our aim was to evaluate the effects of acute exposure to autologous PRP on relaxant capacity of human corpus cavernosum (HCC) from patients with ED. Methods HCC strips were obtained from four ED patients undergoing penile prosthesis insertion and giving informed consent. Previous to intervention, PRP and platelet-poor plasma (PPP) were obtained from patients by apheresis and stored at -20°C until functional procedures. Endothelial relaxation to acetylcholine (ACh) was evaluated before and after 60 min exposure to PRP or PPP (1% v/v) in organ chamber. Relaxant response to the PDE5 inhibitor, tadalafil, was also evaluated in PRP or PPP (1%) treated HCC from the same patient. Results Average age of patients was 67-years-old (range 61-71) while hypertension and smoking history was present in 3/4, diabetes in 2/4, and obesity in 1/4. Mean platelet content in PRP was 1,096x10 9 /L (range 786 to 1,284 x109/L) while negligible platelet content was obtained in any PPP. Exposure to autologous PRP but not PPP significantly enhanced (p<0.0001 by two-factors ANOVA) ACh-induced endothelial relaxations (pEC50 5.75±0.65 vs. 7.16±0.50; Emax 57.3±14.8% vs. 88.5±2.0%; before and after 1%PRP, respectively). Additionally, HCC treated with autologous PRP displayed augmented relaxant responses to tadalafil (p=0.0018 by two-factors ANOVA) with respect to those treated with PPP (pEC50 6.08±0.5 vs. 6.82±0.51 for PPP and PRP, respectively). Conclusions Acute exposure to autologous PRP improves endothelial function and functional response to PDE5 inhibition. These results support the reported clinical improvement of erectile function in patients with ED and suggest that PRP injection might induce a functional effect on cavernosal tissue in addition to the claimed restorative/regenerative effect. Conflicts of Interest None

BMP2 restores erectile dysfunction through neurovascular regeneration and fibrosis reduction in diabetic mice.

The odds of erectile dysfunction are three times more prevalent in diabetes. Severe peripheral vascular and neural damage in diabetic patients responds poorly to phosphodiesterase-5 (PDE5) inhibitors. However, bone morphogenetic protein 2 is known to be involved in angiogenesis. To assess the efficacy of bone morphogenetic protein 2 in stimulating angiogenesis and augmenting nerve regeneration in a mouse model of diabetic-induced erectile dysfunction. The induction of diabetes mellitus was performed by streptozotocin (50mg/kg daily) administered intraperitoneally for 5 successive days to male C57BL/6 mice that were 8weeks old. Eight weeks post-inductions, animals were allocated to one of five groups: a control group, a streptozotocin-induced diabetic mouse group receiving two intracavernous 20μL phosphate-buffered saline injections, or one of three bone morphogenetic protein 2 groups administered two injections of bone morphogenetic protein 2 protein (1, 5, or 10μg) diluted in 20μL of phosphate-buffered saline within a 3-day interval between the first and second injections. The erectile functions were assessed 2 weeks after phosphate-buffered saline or bone morphogenetic protein 2 protein injections by recording the intracavernous pressure through cavernous nerve electrical stimulation. Angiogenic activities and nerve regenerating effects of bone morphogenetic protein 2 were determined in penile tissues, aorta, vena cava, the main pelvic ganglions, the dorsal roots, and from the primary cultured mouse cavernous endothelial cells. Moreover, fibrosis-related factor protein expressions were evaluated by western blotting. Erectile function recovery to 81% of the control value in diabetic mice was found with intracavernous bone morphogenetic protein 2 injection (5μg/20μL). Pericytes and endothelial cells were extensively restored. It was confirmed that angiogenesis was promoted in the corpus cavernosum of diabetic mice treated with bone morphogenetic protein 2 through increased ex vivo sprouting of aortic rings, vena cava and penile tissues, and migration and tube formation of mouse cavernous endothelial cells. Bone morphogenetic protein 2 protein enhanced cell proliferation and reduced apoptosis in mouse cavernous endothelial cells and penile tissues, and promoted neurite outgrowth in major pelvic ganglia and dorsal root ganglia under high-glucose conditions. Furthermore, bone morphogenetic protein 2 suppressed fibrosis by reducing mouse cavernous endothelial cell fibronectin, collagen 1, and collagen 4 levels under high-glucose conditions. Bone morphogenetic protein 2 modulates neurovascular regeneration and inhibits fibrosis to revive the mouse erection function in diabetic conditions. Our findings propose that the bone morphogenetic protein 2 protein represents a novel and promising approach to treating diabetes-related erectile dysfunction.

A novel technique for unilateral dissection of the penile neurovascular bundle to prevent loss of penile sensation during treatment of Peyronie's disease-Initial results of a pilot study.

Plaque incision/excision and grafting are surgical techniques used to treat patients with Peyronie's disease who are refractory to less invasive interventions, have severe penile curvature, or have an hourglass deformity. However, the procedure carries the risk of penile sensory loss because of the need for dissection of the neurovascular bundle (NVB). The aim of this study was to assess the feasibility of a novel technique for unilateral NVB dissection and its ability to preserve penile sensitivity while maintaining adequate correction of the penile curvature. Charts of patients who underwent unilateral NVB dissection during Peyronie's plaque incision/excision and grafting were retrospectively reviewed. All patients received preprocedural intracavernosal injections of TriMix, and the curvature was measured to be >70 degrees. In 3 cases, an incision and minimal excision of the plaque were performed at the point of maximum curvature on the concave side of the curvature. In 3 cases, Tutoplast allografts (Coloplast US, Minneapolis, MN) were used, whereas autografts were used in 2 other cases. All patients were examined at 1, 3, and 6 months after the procedure when curvature and penile sensation were assessed. Five patients underwent this procedure. The mean age of patients was 55 years (45-70 years). All plaques were dorsally located. The mean preoperative curvature was 78 degrees (75-90 degrees). At the 6-month follow-up, all patients had <15 degrees residual curvature and were satisfied with their cosmetic results. Only 1 patient continued with phosphodiesterase-5 inhibitors to improve potency at the 6-month follow-up. All patients reported normal penile glans sensation. Four patients experienced decreased sensation at the site of NVB dissection, but this was only detected when compared with the contralateral side. Only 2 patients reported a difference after 6 months, and only a minor area of involvement was noted. Unilateral NVB dissection is a feasible technique that does not compromise surgical success in curvature correction and helps avoid sensory injury to the penile glans.

Safety and Effectiveness of Repeated Botulinum Toxin A Intracavernosal Injections in Men with Erectile Dysfunction Unresponsive to Approved Pharmacological Treatments: Real-World Observational Data.

Intracavernosal injections of botulinum toxin A (BTX/A ic) may be effective for difficult-to-treat erectile dysfunction (ED). This is a retrospective case series study of the effectiveness of repeated off-label BTX/A ic (onabotulinumtoxinA 100U, incobotulinumtoxinA 100U or abobotulinumtoxinA 500U) in men with ED and insufficient response to phosphodiesterase type 5 inhibitors (PDE5-Is) or prostaglandinE1 intracavernosal injections (PGE1 ICIs), defined as an International Index of Erectile Function-Erectile Function domain score (IIEF-EF) < 26 on treatment. Further injections were performed on patients' requests, and the files of men who underwent at least two injections were reviewed. The response to BTX/A ic was defined as the achievement of the minimally clinically important difference in IIEF-EF adjusted to the severity of ED on treatment at baseline. Out of 216 men treated with BTX/A ic and PDE5-Is or PGE1-ICIs, 92 (42.6%) requested at least a second injection. The median time since the preceding injection was 8.7 months. In total, 85, 44 and 23 men received, respectively, two, three and four BTX/A ic. The overall response rate was 77.5%: 85.7% in men with mild ED, 79% for moderate ED and 64.3% for severe ED on treatment. The response increased with repeated injections: 67.5%, 87.5% and 94.7%, respectively, after the second, third and fourth injections. Post-injection changes in IIEF-EF were similar across injections. The time from injection to request for a further injection varied little. Four men reported penile pain at the time of injection (1.5% of all injections), and one experienced a burn at the penile crus. Repeated BTX/A injections combined with PDE5-Is or PGE1-ICIs produced an effective and durable response, with acceptable safety.

The Change of Erectile Function Post Recovery from COVID-19 Infection

Introduction: We assess the correlation between COVID-19 infection and erection and evaluate the effect of aging and comorbidities on the male sexuality of patients with COVID-19 infection. Methods: 100 patients were enrolled and diagnosed with COVID-19 based on reverse transcription-polymerase chain reaction tests of oropharyngeal and nasopharyngeal swabs according to the WHO guidelines. The International Index of Erectile Function (IIEF-5) questionnaire was used to evaluate sexual function. Results: Patients were divided into two groups: the first group of 42 patients <50 years of age with a mean age (±SD) of 35.83 ± 7.8 and the second group of 58 patients ≥50 years of age with a mean age of 58.64 ± 7.7. The mean (±SD) IIEF in the first group pre-COVID-19 infection was 14.2 ± 2.37 while post-COVID-19 was 8.7 ± 2.77, 11.3 ± 2.9, 12.1 ± 3.02 at 1, 3, 6 months, respectively (p < 0.001), while in the second group, the mean (±SD) IIEF pre-COVID-19 infection was 10.04 ± 4.62 while post-COVID was 5.0 ± 2.1, 6.56 ± 2.6, 8.18 ± 2.04 at 1, 3, 6 months, respectively (p < 0.001). On multivariate analysis, old patients infected with COVID-19 and associated with comorbidities such as diabetes mellitus (OR = 8.53, CI = 0.00–2.01), hypertension (OR = 3.908, CI = 0.000–3.07), ischemic heart disease (OR = 2.863, CI = 0.000–2.68), and liver disease (OR = 0.670, CI = 0.000–1.670) were significantly correlated to erectile dysfunction (p < 0.001). Conclusion: COVID-19 significantly affects erection mostly in older patients with comorbidities, leading to subsequent use of oral and intracavernosal injection therapy for erectile dysfunction.

(207) Risk for Priapism after Intracavernosal Injections and Selected Treatments after Index Priapism Encounters

Abstract Introduction Priapism remains a challenging consult for urologists. Proper understanding of the risk of priapism after intracavernosal injections (ICI) and management trends for patients with priapism may help urologists facing this issue. Objective To describe rates of priapism and patient demographics after ICI and management trends after a diagnosis of priapism using a global database. Methods TriNetX is a collaborative research enterprise which collects real-time data from almost 89 million patients located in 58 healthcare organizations across the globe and analyzes patient data from 20 years back to present (2002-2022). We queried TriNetX for all adult patients receiving ICI or presenting for priapism, using Common Procedural Terminology (CPT) and International Classification of Diseases-10 (ICD-10) codes. The index event was defined as usage of ICI or incidence of priapism. We performed descriptive statistics to describe rates of priapism after ICI within 3 days and between 4 and 90 days after injection and described demographic differences between patients presenting with priapism after ICI and those who did not. We evaluated treatment options for priapism at 1 week, 90 days, 1 year, and 5 years after the initial event. We also described rates of additional priapism episodes within 1 year and 5 years after index priapism encounter. Analyses were run on June 28th, 2022. Results There were 26104 usages of ICI and 17545 recorded instances of priapism. Of patients receiving ICI, 4% and 1.6% had priapism at 3 days and between 4 and 90 days, thus most patients presented with priapism near-immediately. Patients presenting with priapism after ICI tended to be younger (46.4 years vs 57.4 years, p&amp;lt;0.01) and had a disproportionate prevalence of mood disorders (20% vs 14%, p&amp;lt;0.01), pain disorders (16% vs 12%, p&amp;lt;0.01) and sickle cell disease (6% vs &amp;lt;1%, p&amp;lt;0.01). They were less likely to have comorbidities such as diabetes (14% vs 22%, p&amp;lt;0.01), hypertension (33% vs 40%, p&amp;lt;0.01) or a history of prostate cancer (13% vs 25%, p&amp;lt;0.01) and less likely to have taken phosphodiesterase 5 inhibitors such as sildenafil (30% vs 35%, p&amp;lt;0.01) or tadalafil (29% vs 38%, p&amp;lt;0.01) in the past. The most common treatment for priapism was irrigation and/or injection of medications (11.3% same day, Table 1). The prevalence of implants for patients experiencing priapism steadily increased throughout the various timepoints, but overall remained low. Conclusions Priapism remains an infrequent problem that is difficult to study given the relative rarity of presentation. By utilizing a global data set, we are to describe rates of priapism after ICI and treatments for priapism. For patients prescribed ICI, proper counseling of the risks of priapism is important to reduce damaging long term consequences if the condition does occur. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast.

(493) Utilization of Intracavernosal Injection and Penile Ultrasound in the Evaluation of Erectile Dysfunction and Peyronie’s Disease

Abstract Introduction Intracavernosal injections (ICI) and penile duplex Doppler ultrasound (DDUS) play a diagnostic role for patients with erectile dysfunction (ED) and Peyronie’s disease (PD). They can help to identify vascular and anatomical changes that may guide medical and surgical management; however, contemporary utilization rates of ICI and penile DDUS have not recently been described. Here we use a multicenter database to determine utilization of ICI and penile DDUS in patients with ED and PD. Objective To evaluate the rates of ICI and penile DDUS in patients with ED and PD using a global database. Methods TriNetX is a research network of real-time data from 58 Healthcare Organizations globally. Using the International Classification of Diseases Tenth Edition (ICD-10) codes, we queried the network for adult men with ED (N52) being medically treated with phosphodiesterase (PDE)-5 inhibitors from 2002 - 2022. This included sildenafil, tadalafil, vardenafil, and avanafil. Current Procedural Technology (CPT) codes were utilized to identify patients who received penile DDUS (93980, 93981) and penile prosthesis (54400, 54401, 54405). ICD-10 codes were utilized to query the network for those with PD (N48.6) from 2002 – 2022. We then used CPT codes to search within this cohort for those who had ICI (54235) excluding patients that also had penile DDUS (93980, 93981). We separately queried for patients that had penile DDUS (93980, 93981). Finally, we queried for patient who received either evaluation method and had injection therapy (54200), penile plication (54360), or plaque excision +/− grafting (PEG) (54110, 54111, 54112). The analysis was run on June 30, 2022. Results The cohort with ED on a PDE-5 inhibitor in the TriNetX database included 613,323 patients. The cohort had a mean age of 63 +/− 13 years and racial demographics of 18% black and 70% white. 8,540 patients (1.4%) had a penile DDUS and 868 (0.1%) went on to penile prosthesis (Figure 1A). A second study cohort included 46,743 patients with Peyronie’s disease with a mean age of 62 +/− 13 years and racial demographics of 8% black and 73% white. ICI was performed in 2,960 (6.3%) PD patients: 568 (1.2%) then underwent injection therapy, 1,128 (2.4%) penile plication, and 142 (0.3%) PEG (Figure 1B). Penile DDUS was performed in 4,972 (10.7%) patients with PD: 955 (2.0%) then underwent injection treatment, 474 (1.0%) penile plication, and 255 (0.5%) PEG (Figure 1B). Conclusions For ED, penile DDUS is used in a low percentage of evaluations. For PD, penile DDUS is used more commonly than ICI only. After evaluation with penile DDUS, the most common therapy is injection. After an evaluation with ICI only, the most common therapy is penile plication. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific and Coloplast.

(352) Erection Hardness Score (EHS) Correlates With Resistive Index but Not Cavernosal Artery Dilation During Penile Doppler for Erectile Dysfunction and Peyronie's Disease

Abstract Introduction Penile Doppler Ultrasound (PDU) is a non-invasive diagnostic test used to assess organic erectile dysfunction (ED) and Peyronie’s disease and characterize functional changes in penile blood flow. Quantitative measurements taken during penile Doppler testing include changes in cavernosal artery diameter, the velocity of blood flow in the cavernosal artery in systolic and diastolic phases, and a calculated resistive index. It remains poorly understood which of these parameters best predict response to intracavernosal injection therapy and how they are influenced by comorbidities such as age, diabetes, smoking, hypertension, and obesity. Objective The objective of this study is to assess which parameters best predict response to intracavernosal trimix injection and determine the utility of measuring cavernosal artery diameter during penile Doppler testing. Methods This study is a single institutional retrospective cross-sectional review of men undergoing workup for organic ED and/or Peyronie's disease who elected to undergo penile Doppler testing. Only patients who received a standardized 30-1-10 trimix injection were included. Dosing was determined based on age and risk factors using a nomogram, and redosing was performed if the erection quality was below subjective optimal erection quality at home. Baseline cavernosal artery and plaque imaging were performed, and repeat measurements were obtained at 10 minutes following trimix injection. Results 93 men were included in the study with a median age of 59 (IQR 51-67). 47% carried a diagnosis of Peyronie's, 41% had hypertension, 29% were obese, and 30% were smokers. 40% met the criteria for venous leak (RI &amp;lt;0.8). Erectile hardness scale (EHS) scores of 1-4 were documented in 5, 21, 61, and 5 patients, respectively. Linear regression demonstrated no significant relationship between the change in cavernosal artery diameter and trimix dose, resistive index, comorbidities or other Doppler parameters measured. There was no direct relationship between the EHS scores and cavernosal artery dilation. However, there was a statistically significant relationship between EHS and age (p=0.004), trimix dose (p=0.008), and resistive index (p=0.001) on univariate regression. A multivariable model containing age, comorbidities, and these parameters correctly explained 31% of the variance demonstrated (p=0.001). Conclusions Provider-determined EHS scores were directly proportional to patient age, trimix dose, and resistive indices but not to changes in cavernosal artery diameter. Our findings suggest that this measurement may be safely omitted during the evaluation of organic ED and Peyronie’s Disease without changes in diagnostic or management pathways. Disclosure No

(335) Unconsummated Marriage: Findings and Outcomes of Ccouples Visiting an Andrology Clinic

Abstract Introduction Failure to have a penetrative peno-vaginal intercourse among the heterosexual married couples is termed as unconsummated marriage (UCM). Unheard in most western countries, UM is often seen in culturally conservative countries like India where majority still don't have sexual encounters prior to marriage. Nonconsummation is most commonly due to erectile dysfunction (ED, vaginismus or forced marriage. The management requires an aggressive early treatment otherwise some even end up in divorce. Objective To report the clinical characteristics and outcomes of males visiting Andrology clinic seeking treatment for UCM Methods This is a retrospective study of 62 male patients seeking treatment for UCM who presented to the andrology clinic from Jan 2018 to May 2022. All were subjected through detailed clinical history including patient demographics, physical examination and necessary investigations. Wherever possible, the female partner was also involved for discussion and if found abnormal during clinical history was referred to the female reproductive medicine specialists. Results Of the 62 male patients, majority (56, 90%) complained erectile dysfunction as the cause for UCM. Other causes being lack of anatomical knowledge of intercourse (2/62), vaginal pain while attempting penetration (4/62), performance anxiety (5/62) and forced marriage (4/62). There was overlap of more than 1 cause in few patients. The mean duration of UCM was 12.6 months (range 2-128 months). Of the 62 patients, 13 had master’s degree and 42 had bachelor’s degree. Among the 56 patients with ED, 22/56 had already received sildenafil or/and tadalafil from primary care physician with no success. Dual therapy (simultaneous on-demand sildenafil and daily tadalafil) helped 23/56 males to consummate their marriage. Six males didn’t come for follow-up after 2 visits and even refused to answer our questions on phone. Two males did not seek any further treatment for ED after oral medications failed and proceeded with assisted reproductive techniques to conceive for social reasons. Of the four females with vaginismus, 3 successfully consummated following vaginal dilator therapy and psychosexual counselling, but the remaining 1 proceeded with intrauterine insemination to conceive. Consummation was achieved in 6 men who received intra-cavernosal injection of reconstituted 20mcg alprostadil. Three men consummated following penile prosthesis placement (2 semirigid and 1 inflatable). Two couples divorced as the wives wanted “natural” erections from their husbands and not “medicated” erections. Three couples were in the process of divorce. Twelve of the 62 men were accompanied by their parents or in-laws in their first or second clinical visit. Conclusions As against the usual assumption, UCM is commonly seen even among the well-educated class. UCM should be considered as an andrological emergency and timely intervention is required to prevent termination of marriage. When oral medications and counselling doesn’t work, do not hesitate to start on intra-cavernosal injections and occasionally may be a penile implant surgery. Due to social and familial concerns, few may decide to seek assisted reproductive techniques to conceive without sexual intercourse and the same may be considered. Disclosure No

(124) Investigating the Risk Factors of Penile Arterial Insufficiency and Veno-occlusive Dysfunction In Patients with Erectile Dysfunction

Abstract Introduction It was reported that a more generalized peripheral atherosclerotic process is associated with a severer penile arterial insufficiency (PAI), and this in turn was correlated well with decreased blood supply in more important arteries like the coronary and carotid arteries. Objective We investigated the risk factors for PAI which is a known cause of erectile dysfunction (ED Methods Patients who attended our urology clinic complaining of ED for more than 6 months, were prospectively enrolled in this study in one year period. Patient consent was taken and ethical committee approval. Complete medical history and thorough general and local examination including body mass index (BMI), Peyronie’s disease (PD) and penile size measurements (length and girth) were done for all of them. Laboratory tests included testosterone, lipid profile, and glycated haemoglobin (HbA1c). Penile duplex ultrasound study (PDU) was done for all patients after intra-cavernosal injection (ICI) with Alprostadil. peak systolic velocity (PSV) and end diastolic velocity (EDV) were measured after 15 minutes. Statistical analysis was done using SPSS. Results A total of 440 patients were enrolled in this analysis. The mean age was 48 (23-81), and the mean BMI was 30 (18-51). Older patients had lower PSV (r=-0.361, P=0.000) and higher EDV (r=0.174, P=0.001) and both correlations were highly statistically significant. Diabetics had lower PSV (r=-0.318, P=0.000) and higher EDV (r=0.139, P=0.008) which were also highly statistically significant. Hypertensive patients had lower PSV (r=-0.296, P=0.000) which was highly statistically significant. Smokers had lower PSV (r=-0.140, P=0.008) and higher EDV (r=0.178, P=0.001) which were highly statistically significant. Men with larger penises measured skin to tip, had lower EDV (r=-0.119, P=0.024) which was less significant. Interestingly there was neither significant correlation between BMI and PSV (0.16, p=0.745) nor significant correlation between testosterone and PSV (0.029, p=0.552). Also, there was no correlation between PSV and both dyslipidaemia and penile PD. Conclusions Our study highlights key risk factors - Increased age, tobacco consumption, DM and hypertension - are factors that have a statistically significant negative impact on penile haemodynamics. Of these, tobacco consumption, good diabetic control and hypertension are potentially modifiable and should form part of any treatment plan for erectile dysfunction. Other risk factors – increased BMI, low testosterone, PD and penile size – had no statistically significant impact on penile hemodynamics. This allows for targeted advice that can be given to patients who present with this very common problem. Ultimately, good vascular health goes hand in hand with good erectile function. Disclosure No

(358) Responder Analysis from a Multicentered Survey of Men’s Perception who underwent Low Intensity Extracorpeal Shock Wave Therapy (LIESWT), as a Novel and Experimental Intervention for the Treatment of Erectile Dysfunction (ED)

Abstract Introduction Low-intensity extracorporeal shock wave therapy (LI-ESWT) is an experimental, non-FDA approved yet novel treatment modality that has recently been developed for treating erectile dysfunction (ED). The basic science hypothesis concerning the mechanism of action is that LI-ESWT causes microtrauma at the cellular level which may stimulate the release of angiogenic factors, and cause neovascularization of the treated tissue. Completed research report improvement in erectile functioning, decreased reliance on phosphodiesterase inhibitor medication as well as the regained ability to attain and maintain natural or spontaneous erections. We report here a preliminary responder analysis of men who had LIESWT as part of their erectile dysfunction treatment paradigm. Objective We report here the preliminary responder analysis results of an internet based, random retrospective survey on past users of this novel technology for the treatment of ED. Methods A random survey was sent to a convenience sample from 10 national centers (Hawaii, Washington (2), Portland, Utah, Oklahoma (2), Arizona, California, Oregon) to men who had completed 6 sessions of LIESWT for the treatment of ED. The internet-based survey examined patient perception and experience of this intervention. We present the responders analysis ( n=47). All procedures were performed by sexual medicine health care professionals after a detailed and comprehensive history, physical examination, and laboratory/hormonal assessment. Results Surveys were completed anonymously over the course of a 2-week period by men who had undergone 6 sessions of LIESWT. 28% of participants were aged 50-59; whereas 63 percent were over the age of 60. Other adjunctive treatments included erectile dysfunction (ED) medication, testosterone replacement therapy (TRT), previous plasma rich protein injections and Intracavernosal injections. 83% of those who got the procedure noticed an improvement within the first 5 weeks. 89% of responders noticed an improvement in erection firmness whereas 81% noticed an improvement in quality of erections. 77% of responders noticed an improvement in their level of sexual satisfaction and 72% noticed an improvement in sexual pleasure. 60% noticed an improvement in the overall quality of the orgasm. Overall, the procedure was well tolerated with &amp;lt;0.5% (3/670 procedures) adverse events reported (1 pain in penis, 1 “knot in penis” and 1 pain in the head) reported. Overall, 65% of LIESWT users would recommend this procedure to a friend. Conclusions LIESWT is a novel and experimental intervention for the treatment of ED. While it shows excellent promise, most data contain some shortcomings, including: small numbers, limited follow-p, and various non-standardized protocols. Results from a double-blind, randomized, control trial confirm that LI-ESWT may result in significant clinical improvement of erectile function and a shift towards improvement in penile hemodynamics without any adverse effects. Our participant responder analysis demonstrates that LIESWT improves erectile function and other sexuality parameters. Further larger, randomized sham-controlled, and comparative clinical trials are warranted before LI-ESWT may be considered new standard of care for men with vasculogenic ED. Disclosure No

(165) Role of Penile Veno-occlusive Dysfunction in Peyronie’s Disease Patients with Erectile Dysfunction

Abstract Introduction The incidence of Peyronie's disease (PD) is 4% in the U.S. male population. Many PD patients also suffer from erectile dysfunction (ED). The etiology of ED incidence in PD men is not known, although veno-occlusive dysfunction (VOD) is often suggested. It is important to appreciate the influence of VOD in PD patients with ED, especially in regard to successful PD treatment. Objective The main objective of this study is to assess the penile hemodynamic response to intracavernous injection (ICI) of a vasoactive agent in order to evaluate the incidence of VOD in PD patients with or without ED. Methods A total of 333 men, diagnosed either with PD (n=202) or ED (n=68) or both PD and ED (n=63), visiting our Andrology clinic were included in this study. Initial ED was determined by using the International Index of Erectile Function (IIEF) score, whereas patients with penile curvature ≥30° were categorized as having PD. Penile color duplex Doppler ultrasound (CDDU) data was retrospectively collected from these patients, and parameters such as peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI) were used for analysis. RI (=PSV-EDV/PSV) was calculated, and VOD was confirmed when PSV ≥30 cm/sec, EDV ≥6 cm/sec, and RI &amp;lt;0.8 based on previously published guidelines for standardization of penile CDDU parameters. Statistical analysis was performed using MedCalc statistical software version 20.019 (MedCalc Software bv, Ostend, Belgium). Results Table 1 summarizes the CDDU results of all 333 patients. Age of the study subjects was 55.6 ± 11.3 years, with no difference between groups. Incidence of penile VOD was higher in patients with ED without PD (58.8%) or with PD (52.4%) compared to PD alone (44.6%). RI values of PD patients without ED were higher (&amp;gt;0.8) compared to PD patients with ED having VOD (&amp;lt;0.7) (P&amp;lt;0.001). Conclusions The current study results indicate that lower RI values suggest a higher incidence of VOD in PD patients. VOD plays an important role in the onset of ED in men with PD. Furthermore, this demonstrates the importance of performing CDDU and diagnosing the presence of VOD in further understanding the pathophysiology of PD. Disclosure No

(261) Response to Intralesional Collagenase Clostridium Histolyticum Therapy in Men with Peyronie’s Disease is Independent of Baseline Testosterone Levels

Abstract Introduction Testosterone plays an important role in collagen metabolism, TGF-β1 expression, and wound healing, all critical factors in the pathogenesis of Peyronie’s disease (PD). While evidence is mixed, some clinical studies have suggested an association between PD and hypogonadism. Objective We seek to investigate whether baseline total serum testosterone (tT) influences response to intralesional collagenase clostridium histolyticum (CCh) for PD. Methods A retrospective review of patients undergoing CCh injections was conducted at a single institution. Only patients with available tT levels within one year of initial CCh injection were included. Curvature was assessed after in-office intracavernosal injection of vasodilatory agents or patient-provided photograph. Data was collected on baseline demographic characteristics, hypogonadal status, tT, number of CCh cycles, and pre- and post-treatment degree of curvature. Hypogonadism was defined as a tT &amp;lt;300ng/dL, or a documented diagnosis. Results A total of 36 men were included. The mean age was 58.2 years old (SD 10.4) and the mean BMI was 26.8 (SD 3.2). The mean pre-treatment tT was 459.2 ng/dL (SD 144.0), and 14 (39.9%) were hypogonadal. Of hypogonadal men, 5 (35.7%) were receiving hormonal replacement therapy, 4 on testosterone and 1 on clomiphene. Thirty (83.3%) men experienced some degree of erectile dysfunction. The mean pre-treatment curvature was 47.6° (SD 14.2) and the mean post-treatment curvature was 27.8°(SD 10.7), for a mean improvement of 19.9° (40.1%) after an average of 4 cycles (2-8) (Table 1). Baseline tT was not associated with baseline rigidity (β=-0.01; R2=0.02; p=0.41). However, hypogonadal status was significantly associated with more severe curvature, 54.6° among hypogonadal men compared to 43.2° among eugonadal men (p=0.03); however, baseline curvature and tT were not significantly associated (β=-0.03; R2=0.09; p=0.08). On linear regression analysis, tT did not significantly predict improvement in degrees (β=-0.02; R2=0.06; p=0.14; Figure 1) or percent (β=0.0; R2=0.05; p=0.18; Figure 2). Similarly, improvement in neither degrees nor percent differed significantly by hypogonadal status (p=0.14 and p=0.69, respectively). Number of cycles did significantly predict greater improvement in curvature on both univariate and multivariate analyses (β=5.7; R2=0.34; p&amp;lt;0.01). Conclusions While hypogonadism is associated with more severe curvature, neither total testosterone nor hypogonadism is associated with degree of improvement after CCh treatment. Men should be offered CCh therapy according to guidelines independent of gonadal status. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast Clarus Therapeutics Antares Pharma Acerus.

(257) Ultrasound Classification System for Peyronie's Disease

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 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 intracavernosal 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. Ultrasound 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%). All groups had similar median ages and body mass index (BMI): 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. Additionally, medical and surgical risk factors for erectile dysfunction were similar across the three groups; these included hypertension, heart disease, diabetes mellitus, hyperlipidemia, smoking history, and history of prostate surgery. 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 across the three groups (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 for Peyronie's Disease. This grading system is based on grayscale ultrasound of Peyronie’s plaques may serve the purpose of diagnostic evaluation, didactic teaching and integrated research. Disclosure No

(202) Exploring Erectile Hemodynamics in Men Complaining of Hard-Flaccid Syndrome (HFS)

Abstract Introduction There is increasing awareness of a condition, vernacularly termed HFS, in which men complain of subjective and palpable abnormalities in the flaccid penis (hardness, heaviness) often associated with erectile dysfunction (ED). Objective We attempted to define erectile hemodynamic profiles in this population. Methods The study population consisted of (i) males ≥18 years of age (ii) who presented with self-diagnosed HFS (iii) who underwent comprehensive history and examination (including genital and lower extremity neurological) and (iv) penile duplex Doppler ultrasound (PDDU). PDDU was performed using redosing of vasodilators. PSV ≥35 cm/s and EDV ≤3 were considered normal. Patients with Peyronie’s disease or a history of intracavernosal injection therapy were excluded. Results 88 men were analyzed. Mean age was 28 ± 12 years. Median number of vascular comorbidities was zero (0, 1). 66 (75%) had a history of depression or anxiety, 60 of whom had used pharmacotherapy for such at some time and 40 were actively using anxiolytics or anti-depressants at time of evaluation. No patient had a history of neurological conditions and neurological exam was normal in all. Mean duration of symptoms was 14 ± 20 months. Median number of prior physician consultations was 1 (1,4). All complained of impaired erectile function, 50% being incapable of having penetrative sexual relations. 91% had or were using PDE5 inhibitors. On examination all patients had a hypertonic flaccid penis with excellent stretch on traction. At PDDU, median number of penile injections was 2 (1, 3). 50% of men required phenylephrine reversal. All patients had normal PSV with 2/88 having abnormal EDV values, both of whom required reversal. Mean PSV was 45 ± 35 cm/s, mean EDV was 2 ± 11 cm/s. No patient had elevated echogenicity on B-mode scanning. Conclusions In this analysis, all men presenting with self-reported HFS had normal hemodynamics and an absence of fibrosis, suggesting the absence of vascular or gross cavernosal smooth muscle structural changes. Disclosure No

(121) Validation of a Digital Rigidometer for the Evaluation of Erection Hardness During In-office Rigidity Assessment in Patients with Erectile Dysfunction

Abstract Introduction The evaluation of erectile function should include the measurement of axial rigidity, since it is one of the key factors in the pathophysiology, diagnosis and treatment of ED. This assessment is usually performed following in-office intracavernosal injections of vasoactive agents during Doppler ultrasound studies, curvature assessments or simply prior to initiation of intracavernosal pharmacotherapy. In this scenario, the Erectile Hardness Score (EHS) is the most common validated tool to evaluate penile rigidity. Although highly reproducible, EHS is still based on the examiner’s subjective perspective and might eventually lead to conflicting results. Objective The aim of the present study was to assess the diagnostic accuracy of a digital rigidometer in comparison to the EHS scale to allow for a more detailed rigidity assessment using an objective measure of penile axial load. Methods First we performed a controlled experiment using a digital dynamometer coupled to a 3D-printed tip to assess the maximal load applied to the Pfizer’s Erection Hardness Meter (Figure 1). Three urologists with expertise on the management of ED performed 2 different measures of axial rigidity on each shaft corresponding to the EHS scale in order to suggest a 4-grade classification range. Then, a sample of patients was analyzed during in-office erectile tests performed by 2 different urologists using redosing protocols of vasoactive agents from February to June 2022. Coefficients of variation were calculated using analysis of variance (ANOVA) and t-test was performed to compare the interval data. ROC curves were used to estimate the diagnostic accuracy of the digital rigidometer in comparison to the EHS. P values below 0.05 were considered significant. Results Mean axial load supported by each shaft of the Pfizer’s Erection Hardness Meter was: EHS 1: 0.51 ± 0.05 Kg; EHS 2: 0.75 ± 0.05 Kg; EHS 3: 1.2 ± 0.13 Kg; and EHS 4: 2.5 ± 0.51 Kg. The following coefficients of variations were found: EHS 1: 10.1%, EHS 2: 6.85%, EHS 3: 11.2%, and EHS 4: 20.4%. Distribution of different measures is shown in Figure 2. A total of 30 men with mean age of 54.5 ± 15.5 years were included in the analysis. The mean IIEF-EFD was 16.3 ± 5.1. During erection assessment 3 (10%) presented erection EHS 2, 7 (23.3%) EHS 3, and 20 (66.6%) EHS 4. The mean dose of trimix was 0,35 ml and 50% required sympathomimetic medication for erection reversion after the procedure. The digital rigidometer had an AUC of 0.91 (95% CI 0.78-1.00, p=0.0005) to discriminate EHS&amp;gt;3 (Figure 3). The best cuff value for that purpose is 1.2 Kg, yielding a sensitivity of 85.7% and specificity of 88.9%. Conclusions The digital rigidometer tested in the present study appears to provide reproducible measures of axial penile rigidity that might be useful in clinical practice. It has demonstrated interesting diagnostic properties for the in-office assessment of erectile rigidity in comparison to the EHS, in which the cutoff of 1.2 Kg is the one with the best diagnostic properties. An objective measurement of penile axial rigidity can contribute to both clinical and research environment. Disclosure No

(343) Predictors of Corporo-venocclusive Dysfunction (CVOD) in Men with Bilateral Nerve-sparing Radical Prostatectomy (RP)

Abstract Introduction Nerve-sparing status (NSS) during RP is a significant predictor of erectile function recovery (EFR). Poor nerve sparing is associated with collagenization of cavernosal smooth muscle and CVOD development with typically poor response to PDE5 inhibitors (PDE5i) and intracavernosal injection therapy (ICI). Objective This study aimed to define factors predictive of CVOD in men with bilateral NS RP. Methods Study population consisted of (i) men who underwent bilateral NS (defined by the surgeon using an institutional grading system) RP (ii) with poor response to PDE5i and ICI (iii) ≥2 years post-RP (iv) who underwent penile duplex Doppler ultrasound (DUS) (v) using a vasoactive agent redosing schedule. CVOD diagnosis was made with end-diastolic velocity (EDV) values ≥5 cm/sec bilaterally. ADT and radiation therapy were exclusions. We used multivariable modeling to define factors predictive of CVOD. Factors included in the model: patient age, history of diabetes, history of obstructive sleep apnea, number of vascular comorbidities, baseline EF, peri-RP total testosterone (T) level, and total T at DUS (within 3 months). Results 201 men with a mean age of 66 ± 7 years. 25% of the patients reported 3 or more vascular comorbidities, 17% had diabetes, 36% obstructive sleep apnea, 39% were current or former smokers. Mean baseline PSA and pre-RP total T was 6.7 ± 6 ng/mL and 410 ± 211 ng/dL, respectively. Median baseline EFD score was 24 (13, 29). 49% of the men had an erection less than penetration rigidity during the DUS procedure with a mean total dose administered of 87 ± 21 units of trimix. 69% received 100 units. CVOD was diagnosed in 76%. Mean total T at DUS was 386 ± 177 ng/dL. 32% had low T. Significant predictors of CVOD after RP in men with BL NSS were: OSA (OR = 3.8, 95% CI = 1.7-8.7), ≥ 3 vascular comorbidities (OR = 5.0, 95% CI = 1.7-14.8), age at the time of DUS (per 10 years increase, OR = 1.9, 95% CI = 1.2-3.0), and pre-RP EF domain score (per 1 unit increase, OR = 0.93, 95% CI 0.88-0.98). There was a signal that in a larger sample size, diabetes may be a significant predictor of CVOD in this group of patients (OR = 2.7, 95% 0.9-8.0). Conclusions Baseline clinical comorbidities pre-RP have a significant impact on EFR post-RP, in particular, the presence of venous leak. Despite BL NSS, older patients, men with OSA, higher number of comorbidities pre-RP, and lower pre-RP EF increased the likelihood of developing CVOD post-RP. Disclosure No