Intracavernous Research Articles

Ablation of IGFBP5 expression alleviates neurogenic erectile dysfunction by inducing neurovascular regeneration.

To investigate the therapeutic potential of eliminating insulin-like growth factor-binding protein 5 (IGFBP5) expression in improving erectile function in mice with cavernous nerve injury (CNI)-induced erectile dysfunction (ED). Eight-week-old male C57BL/6 mice were divided into four groups: a sham-operated group and three CNI-induced ED groups. The CNI-induced ED groups were treated with intracavernous injections 3 days before the CNI procedure. These injections included phosphate-buffered saline, scrambled control short hairpin RNA (shRNA), or shRNA targeting mouse IGFBP5 lentiviral particles. One week after CNI, erectile function was evaluated and the penile tissue was then harvested for histological examination and western blot analysis. Additionally, the major pelvic ganglia (MPG) and dorsal root ganglia (DRG) were cultured for ex vivo neurite outgrowth assays. Following CNI, IGFBP5 expression in the cavernous tissues significantly increased, reaching its peak at day 7. First, ablation of IGFBP5 expression promotes neurite sprouting in MPG and DRG when exposed to lipopolysaccharide. Second, ablating IGFBP5 expression in CNI-induced ED mice improved erectile function, likely owing to increased neurovascular contents, including endothelial cells, pericytes, and neuronal processes. Third, ablating IGFBP5 expression in CNI-induced ED mice promoted neurovascular regeneration by increasing cell proliferation, reducing apoptosis, and decreasing Reactive oxygen species production. Finally, western blot analysis demonstrated that IGFBP5 ablation attenuated the JNK/c-Jun signaling pathway, activated the PI3K/AKT signaling pathway, and increased vascular endothelial growth factor and neurotrophic factor expression. Ablating IGFBP5 expression enhanced neurovascular regeneration and ultimately improved erectile function in CNI-induced ED mice.

PD52-08 Adherence to Intracavernosal Injection Relative to Prescriber Choices and Patient Income: Erratum.

PD52-08 Adherence to Intracavernosal Injection Relative to Prescriber Choices and Patient Income: Erratum.

The feasibility study of shear wave elastography in the diagnosis of erectile dysfunction

The aim of this study was to explore the value of Shear wave elastography (SWE) in evaluating vascular and nonvascular erectile dysfunction. In this study, erectile dysfunction (ED) patients enrolled (n = 114) received SWE and Doppler ultrasonography (PCDU) exams. The peak systolic velocity (PSV) and end-diastolic velocity (EDV) were used as the classification standard. The performance of the SWE was assessed with the receiver operating characteristic curve, sensitivity and specificity. The rigidity alterations of corpus cavernosum penis with age was also investigated. SWE values of corpus cavernosum penis (CCP) before intracavernosal injection (ICI) negatively correlated with age of patients in vascular ED group (r = -0.288, P < 0.05). In erectile or flaccid state, the SWE value of vascular ED was significantly larger than non-vascular ED. When the cut-off value for SWE values of CCP 0.88 m/s in erectile state and 2.32 m/s in flaccid state, the areas under the receiver operating characteristic (ROC) curve were 0.700 (sensitivity: 77.78%, specificity: 60.00%) and 0.612(sensitivity: 68.52%, specificity: 51.67%) in erectile or flaccid state, respectively. This study provides preliminary evidence that SWE in flaccid state could be non-invasive methods used to moderate predict vascular ED.

Safety and efficacy evaluation of intracavernosal injection of platelets rich plasma in treatment of vasculogenic erectile dysfunction

ABSTRACT Objectives The study’s objective is to compare platelet-rich plasma (PRP) injections to placebo in terms of effectiveness and safety for patients with vasculogenic erectile dysfunction (ED). Methods This randomized placebo-controlled clinical trial was done on 50 male patients with organic vasculogenic ED and sexually active in a stable heterosexual relationship for a period of over three months. The patients were randomized into two main groups: Group (A) (n = 25) underwent PRP treatment. Group (B) (n = 25) control underwent placebo treatment. Results The two groups under study differed in a statistically significant way regarding the achievement of minimal clinically important differences (MCID) at 3 months and 24 months. Statistically significant variations existed between the mild subgroup and placebo regarding achieving MCID after 3 months and 24 months. The level of satisfaction was statistically significantly higher in the PRP group. A statistically significant variation was present between the mild subgroup and placebo at 3 months and 24 months in terms of changes from baseline in the erectile function domain of the International Index of Erectile Function (IIEF-EF) questionnaire score in each subgroup. Conclusions PRP is an effective alternative modality of treatment in cases of ED, and they offer an intermediate stage between pharmaceutical therapy and surgical interventions at least in mild and mild to moderate cases where unsatisfactory results or unpleasant side effects compel the patients to abandon all hope on medical treatment.

Harnessing the regenerative effects of human amniotic stem cells (hAFSCs) on restoring erectile function in a bilateral cavernous nerve crush (BCNC) injury rat model.

Intracavernous (IC) injections of stem cells has been shown to ameliorate cavernous nerve (CN)-induced erectile dysfunction (ED). However, the regenerative effects underlying the recovery of erectile function (EF) in human amniotic fluid-derived stem cells (hAFSCs) remain unclear. In the bilateral cavernous nerve crushing (BCNC) injury rat paradigm, we sought to ascertain the effects of hAFSC treatment on EF recovery during the incipient phase. Three groups of 45 male rats were used in this study: sham (Group 1), saline IC injection after BCNC (Group 2), and hAFSC intracavernous injection (ICI) after BCNC (Group 3). hAFSCs from the fourth passage showed potential to differentiate into trilineage cells. All animals were subjected to EF analysis on the 28th day post-injection and tissues were retrieved for histopathological and immunohistochemical analyses. IC injections of hAFSC significantly improved EF parameters in BCNC-ED rats at 28 days post-injury. AFSC treatment enhanced the smooth muscle condition and increased the smooth muscle/collagen ratio, as evidenced by histological analysis. Immunohistology revealed increased expression of 𝛼-SMA andvWf in the corpus cavernosum and enhanced expression of nNOS in the dorsal penile nerve in BCNC-ED rats (p < 0.05). Western blotting showed that hAFSC treatment significantly increased α-SMA expression in the hAFSC group compared with that in the BCNC group. Electron microscopy revealed significantly elevated myelination in the CN (p < 0.05), maintenance of smooth muscle structures, and restoration of EF in BCNC-ED rats treated with hAFSC. hAFSC treatment increased EF in BCNC-ED rats at a single dose. As BCNC-ED resembles ED caused by radical prostatectomy (RP), this therapy has high potential for ED patients after RP surgery.

Clinical efficacy of intracavernous injection of platelet lysate for erectile dysfunction

BackgroundAmong the emerging treatments for erectile dysfunction (ED), platelet-rich plasma (PRP), known for its ability to enhance tissue repair and regeneration, stands out as a promising therapeutic approach. In this innovative study, we aimed to assess the efficacy of intracavernous injections of platelet lysate (PL), a derivative of PRP, in improving erectile function among ED patients.MethodsWe enrolled twenty-six patients, aged between 35 and 70 years (mean age 51.6 ± 11.3 years), who had been experiencing ED for over six months and had an International Index of Erectile Function-5 (IIEF-5) score of 21 or less. Participants received autologous PL injections intracavernously every two weeks for a total of five administrations. We assessed Erection Hardness Score (EHS) and International Index of Erectile Function-5 (IIEF-5) bi-weekly for 16 weeks and conducted penile Doppler ultrasounds pre- and post-treatment to record peak systolic velocity (PSV) and resistance index (RI).ResultsBefore treatment, the mean EHS was 2.15 ± 0.88 and IIEF-5 was 10.92 ± 5.28. Remarkable improvements were observed post-treatment, with the EHS significantly increasing to 3.15 ± 0.83 (p < 0.05) and IIEF-5 to 17.23 ± 5.26 (p < 0.05). Penile Doppler ultrasound exhibited an increase in both PSV and RI post-treatment, with the rise in RI being statistically significant.ConclusionsOur findings indicate that intracavernous injections of PL substantially enhance erectile function, as evidenced by improvements in EHS, IIEF-5, and the RI of penile Doppler ultrasound, without hemorrhagic events or other adverse reactions apart from temporary pain at the injection site during the 16-week follow-up period. These encouraging results suggest that PL injections are a safe and effective treatment modality for patients with moderate ED, potentially providing a less invasive and more physiologically friendly alternative to current ED management strategies.Trial registrationThe study received approval from the Institutional Review Board of National Taiwan University Hospital (IRB Number 202008061RIPC, date of registration 08/28/2020).

Pain associated with prostaglandin E1-containing intracavernosal injection medication is associated with poor erectile function recovery after radical prostatectomy.

Intracavernosal injection therapy is often used as second-line therapy for erectile dysfunction associated with radical prostatectomy when therapy with phosphodiesterase-5 inhibitors has failed, but prostaglandin E1-containing vasoactive agents are associated with penile pain in some men. To define the incidence of pain with prostaglandin E1-containing intracavernosal injectionmixtures for erectile dysfunction associated with radical prostatectomy when therapy with phosphodiesterase-5 inhibitors has failed, and whether painwasa predictor of erectile function recovery. Men who underwent radical prostatectomy andwerecommencedonintracavernosal injection within 12 months of radical prostatectomy were included. A pain visual analog scale (0-10) was used to assess the degree of pain. Erectile function recovery was defined asthe International Index of Erectile Function domain score ≥24using phosphodiesterase-5 inhibitors at 24months. The study included 566 patients, mean age was 58±14 (42-74) years. Duration post-radical prostatectomy at intracavernosal injection training was 3.5±3.5m. Nerve sparing status: bilateral 76%, unilateral 13%, and non-nerve sparing 11%. Incidence of pain with intracavernosal injection per nerve sparing status: bilateral 10% of patients, unilateral 32%, non-nerve sparing 92% (p<0.001). Median visual analog scale in those experiencing pain: bilateral 4 (interquartile range 3, 5), unilateral 5.5 (interquartile range 3, 6), non-nerve sparing 7 (interquartile range 3, 9) (p<0.001). Phosphodiesterase-5 inhibitors success at 24months (no pain vs. pain): bilateral 70%vs. 40% (p<0.001), unilateral 50%vs. 28% (p<0.001), non-nerve sparing 10%vs. 0% (p<0.001). On multivariate analysis, predictors of failure to respond to phosphodiesterase-5 inhibitors at 24months post-radical prostatectomy included baseline erectile function, increasing age, incomplete nerve-sparing surgery, and presence of pain. The presence of penile pain with intracavernosal injection is associated with poorer erectile function recovery post-radical prostatectomy. Incidence of pain is high in men with non-nerve sparing radical prostatectomy; older patient age, poorer nerve sparing, poor baseline erectile function, and the presence of penile pain with prostaglandin E1-containing intracavernosal injection medication, were predictive of poor erectile function recovery using phosphodiesterase-5 inhibitors at 24months.

The potential role of intracavernosal injection of platelet-rich plasma for treating patients with mild to moderate erectile dysfunction: A GRADE-Assessed systematic review and meta-analysis of randomized controlled trials.

Platelet-rich plasma (PRP) has shown positive effects on enhancing erectile function in animal studies. Human clinical trials are limited and provide contradictory results. This review aims to conduct a meta-analysis of the available Randomized controlled trials (RCT) to assess the efficacy of PRP in males with ED. A systematic review was carried out following the Cochrane Handbook of Intervention and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and registered in PROSPERO (CRD42023441655). A total of three RCTs were included in the analysis for a total of 221 patients with mild to moderate ED. The patients receiving PRP reported significantly better improvement of IIEFEF score during 1,3- and 6-months follow-up compared to the placebo group (mean difference [MD] 2.66, 95% confidence interval [CI] 1.48 to 3.83, p < 0.01; MD 2.11, 95%CI 0.13 to 4.09, p = 0.04; MD 2.99, 95%CI 1.79 to 4.19, p < 0.01). The pooled analysis indicated that attainment of minimally clinical important difference (MCID) was significantly higher in patients receiving PRP compared to the placebo group during one and 6-month follow-up (odds ratio [OR] 5.51, 95%CI 1.2 to 254, p = 0.03; OR 5.64, 95%CI 2.05 to 15.55, p < 0.01; respectively). Encouragingly, no major AEs were reported in all three trials in the PRP and placebo groups (p = 0.99). This review highlights the potential role of PRP in providing short-term improvement of erectile function parameters for up to 6 months in mild to moderate ED patients. Future RCTs with longer-duration follow-ups and more standardized treatment protocols are necessary to gain sufficient details on PRP's long-term effectiveness and safety.

Discrepancy Between Patient vs Provider Assessment of Erection Quality

ObjectiveTo characterize the discrepancy between patients’ and providers’ assessments of erection rigidity and its association with patient characteristics and penile ultrasound parameters. MethodsPatients presenting for penile doppler ultrasound between July 2022 and October 2023 were reviewed retrospectively. After intracavernosal injection, patients and providers independently rated erection rigidity from 1 to 10 prior to ultrasound. We defined discrepancy as a difference of 2 out of 10 or greater between the two assessments. Chi-squared and Mann Whitney U tests were used for hypothesis testing. Results65/297 (22%) of patients demonstrated a discrepancy in perceived erection quality. 58/65 (89%) of these patients rated their erections lower than their providers. There was a higher incidence of ED as the primary diagnosis in the discrepant group as compared to the concordant group (p=0.01). The discrepant group also showed a higher resistive index on penile ultrasound (p=0.04), with no difference in peak systolic velocity, end diastolic velocity, or other clinical variables between the two groups. ConclusionDiscrepancy in perceived erection rigidity was mainly driven by lower patient perception, although these patients had noninferior penile hemodynamics to their peers. These findings underscore the influence of subjective perception of virility on sexual function. It is critical for clinicians to identify patients with poor perception of erectile function out of proportion to physiologic abnormalities. Thoughtful counseling about treatment goals and expectations, emphasizing functional outcomes, and adjunctive treatments such as sex therapy or psychotherapy are critical to therapeutic success in this population.

Прямая перкутанная рентгенэндоваскулярная окклюзия вен простатического сплетения

In this work, we developed and introduced into clinical practice direct percutaneous X-ray endovascular occlusion of the veins of the prostatic plexus. Indications for this operation were a decrease in the quality of life associated with erectile dysfunction, the presence of proximal pathological venous drainage from the corpora cavernosa of the penis, lack of sufficient effect from taking of inhibitors phosphodiesterase type 5, refusal to use intracavernosal injections, refusal to undergo penile prosthetics, absence or low quality of visualization of the deep dorsal vein of the penis when using antegrade approaches to the prostatic plexus (transdorsal) as well as the complex anatomy of the pelvic veins when using retrograde approaches to the prostatic plexus (transfemoral and transcubital). The advantage of this technique was safety, extremely low morbidity and minimal hospitalization time. Keywords: venogenic erectile dysfunction, x-ray endovascular occlusion of the veins of the prostatic plexus

The value of shear wave elastography combined with red blood cell distribution width in evaluating arterial erectile dysfunction

PurposeA retrospective study was conducted to determine the value of shear wave elastography (SWE) and red blood cell distribution width (RDW) in the diagnosis of various forms of erectile dysfunction (ED).MethodsWith the method of Nocturnal Penile Tumescence and Rigidity (NPTR) and the screening method of Color Duplex Doppler Ultrasound (CDDU), hematological data were collected from 131 individuals, among whom 24 are with psychogenic ED, 48 are with non-arterial ED(NAED) and 59 are with arterial ED(AED) with erectile dysfunction. SWE value of penile corpus cavernosum(CCP) and cavernous arterial flow velocity were measured before (flaccid state) and after (erect state) intracavernous injection (ICI) in all patients.ResultsAmong the AED patients and other types of ED patients, there were statistically significant differences in the abridged five-item International Index of Erectile Function (IIEF-5), red blood cell distribution width-coefficient of variation (RDW-CV), red blood cell distribution width-standard deviation (RDW-SD), and SWE values (all P < 0.01). In the AED patients, the IIEF-5 scores had a significant negative relationship with RDW-CV, RDW-SD, and SWE values, with SWE values having the strongest correlation. (p < 0.001, r=-0.638).ConclusionThe combination of RDW level and SWE value demonstrated the greatest performance in diagnosing AED, according to the receiver-operator characteristic(ROC) curve analysis (AUC = 0.870, p < 0.0001, cut-off value of 0.75, sensitivity of 74.6%, specificity of 91.7%).RDW and SWE value may develop into an incredibly simple, practical tool for predicting and diagnosing AED.Trial registrationretrospectively registered.

Pharmacological Treatments for Erectile Dysfunction in Diabetic Patients: Efficacy, Safety, and Emerging Therapies

Men with diabetes mellitus, particularly those with type 2 diabetes (T2DM), are known to experience erectile dysfunction (ED), a condition whose prevalence has risen to 75% in recent years. The pathophysiology of ED in diabetic patients involves vascular impairment, neuropathy, hormonal dysregulation, and chronic hyperglycemia, all of which contribute to endothelial dysfunction, reduced nitric oxide availability, and nerve damage. Phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, tadalafil, and vardenafil, are the first-line pharmacological treatments for ED, though their efficacy is reduced in diabetic patients due to the extent of vascular and neurological damage. Other treatments, including testosterone replacement therapy (TRT), intracavernosal injections, and vacuum erection devices (VEDs), provide alternatives for patients unresponsive to PDE5 inhibitors. Emerging therapies such as low-intensity extracorporeal shockwave therapy (LI-ESWT) and regenerative medicine approaches, including stem cell and platelet-rich plasma (PRP) injections, show potential in improving erectile function in diabetic patients. Glycemic control plays a critical role in both preventing ED and enhancing the efficacy of treatments by improving vascular function and reversing nerve damage. This review was conducted through an extensive analysis of current literature on pharmacological and emerging treatments for ED in diabetic patients. In conclusion, integrating traditional pharmacotherapy with emerging treatments and emphasizing glycemic control holds promise for optimizing ED management in diabetic patients. Keywords: Erectile Dysfunction (ED), Diabetes Mellitus (T2DM), Phosphodiesterase Type 5 (PDE5) Inhibitors, Testosterone Replacement Therapy (TRT), Glycemic Control

(307) EXPERT OPINIONS ON INTRACAVERNOSAL INJECTIONS AND THEIR LINK TO PEYRONIE’S DISEASE AND PENILE FIBROSIS: A SURVEY OF SUPS, GURS, AND SMSNA MEMBERS

Abstract Introduction The development of penile curvature is recognized as a potential adverse effect of intracavernosal injection (ICI) therapy. Literature often cites Peyronie’s disease as a possible consequence of ICI therapy. However, despite this widespread belief, there is a notable lack of data supporting a causal relationship between intracavernosal injection therapy and the onset of Peyronie’s disease. Objective To assess the current opinions of experts in sexual medicine, reconstructive urology, and prosthetic urology regarding the association between intracavernosal injection therapy and the development of Peyronie’s disease and penile fibrosis. Methods A 20-question survey was digitally distributed to the listservs of members of the Society of Urologic Prosthetic Surgeons (SUPS), Society of Genitourinary Reconstructive Surgeons (GURS) and the Sexual Medicine Society of North America (SMSNA). Responses were collected over an 8-month period allowing for up to three reminder emails to be sent from the participating societies. Results were then analyzed for descriptive statistics. Results A total of 100 surveys were completed. 70% of respondents completed fellowships with the most common being GURS. Respondents’ years in practice were evenly distributed with 49% above and 51% below ten years in practice. Overall, 68% of respondents stated that they counsel patients that ICI can cause Peyronie’s disease and 57% stated that they believe ICI causes corporal fibrosis. When looking at respondent demographics, 70% of fellowship trained respondents stated that they counsel patients that ICI can cause Peyronie’s compared to 57% of non-fellowship trained respondents. This was in contrast to priapism for which 40% of respondents stated that they counsel their patients that priapism may result in Peyronie’s disease with no significant difference in respondents’ completion of a fellowship. Conclusions The belief that ICI can cause Peyronie’s disease remains prevalent but not unanimous members of SMSMNA, GURS and SUPS. Urologists who have completed a fellowship are more likely to counsel patients on the risk of Peyronie’s and penile fibrosis with the use of ICI. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific and Coloplast.

(222) MANAGEMENT OF A RETAINED NEEDLE - A COMPLICATION OF INTRACAVERNOSAL INJECTION THERAPY

Abstract Introduction Intracavernosal injections (ICI) is a well-established treatment for erectile dysfunction with common complications including priapism, penile ecchymosis and injection site pain. A rarer complication is breakage and retention of the needle inside the penis during self-injection, with only 16 cases reported in the literature from 1991 to 2023. Objective To report a case of needle breakage and retention as a complication of ICI and describe the optimal management of retained needle in the penis. Methods A 69-year-old male with a history of erectile dysfunction on TriMix presented to the Urology Department after half of his ICI needle broke off in the right side of his penis following self-injection. He denied having any pain or discomfort but reported that a small nodule had formed at the site. On physical examination, a nodule was palpated at the right base of his penis. He underwent pelvic X-ray and penile ultrasound, noting a 4-5 mm foreign body in the right base of the penis without gas in the soft tissue. As the retained needle was not significantly affecting him, he decided not to proceed with intervention and continued with ICI on the contralateral side. He began noticing burning pain at the site of injection, with development of a hard nodule that self-resolved each time. Due to worsening erectile function, he returned to clinic one year later to discuss inflatable penile prosthesis placement, where he inquired about removal of the retained needle. A small, nontender nodule was still noted at the right base of the penis. Results The patient underwent penile exploration in the operating room, revealing an obvious inflammatory fibrous nodule at the right base of the penis corresponding to the location of the needle on previous ultrasound. There was also a similar, smaller nodule contralaterally where the patient had continued ICI. Ultrasound guidance was used intraoperatively to identify the needle, then a spinal needle was used to triangulate with the needle fragment. The penis was sharply dissected along the spinal needle with iris scissors until the 4 mm needle fragment was identified and removed in its entirety. Dissection then began to excise the inflammatory nodule. However, despite attempts to completely mobilize Buck’s fascia and the nerves, the neurovascular bundles were quite adherent to the nodule from an inflammatory reaction and thus it was unable to be excised. A small possible corporotomy was then identified and repaired using 2-0 PDS. Injectable saline was then used to induce an erection and confirm no defects in the corpora. The patient recovered well post-operatively without any complications, and the nodules were noted to be much smaller at his one-month postoperative visit. Conclusions ICI needle breakage and entrapment in the penis is a rare complication. The diagnosis of needle retention includes imaging such as pelvic radiographs or penile ultrasound to locate the needle. While less invasive approaches can be attempted for removal, they may be less effective and cause further damage to surrounding tissue. Surgical exploration under ultrasound guidance is a safe and effective approach to needle removal. Disclosure No.

(017) COST-EFFECTIVENESS MODELING OF IMPLANTABLE PROSTHESIS AS A FIRST-LINE OPTION FOR ERECTILE DYSFUNCTION MANAGEMENT

Abstract Introduction Erectile dysfunction (ED) rates in the United States have increased over the past several decades due to multiple factors, including an aging population and rising rates of diabetes and peripheral vascular disease. Implantable penile prostheses (IPP) are highly effective for refractory ED, however, insurance coverage is variable and often requires demonstration of both failed oral and injectable therapy. Delayed IPP placement in high-risk patients is likely to reduce quality of life metrics as well as increase costs associated with failed pharmacological trials. Objective We aimed to evaluate the quality associated life years (QALY) and the cost per QALY of direct IPP placement for PDE5 inhibitor-resistant ED. Methods A literature review was conducted to gather probability functions of success and complications associated with PDE5 inhibitors, intracavernosal injection (ICI), and IPP, as well as costs and QALYs associated with each therapy. TreeAge was used to generate a Markov model, which evaluated two separate strategies: 1) a standard pathway, in which all patients would be trialed on PDE5 inhibitors and ICI for 1 to 6 months each, and 2) a direct-to-IPP pathway, in which patients would immediately be offered an IPP. Each model was run for 10 000 iterations for 10 years per iteration. The standard pathway was run for 9 scenarios, in which each population would have a varying response rate to PDE5 inhibitors and ICI (10% to 90% response). Cumulative QALY, costs, and the incremental cost-effectiveness ratio (ICER) of each strategy were calculated. Results The standard pathway model considered 10% to 90% response rates to traditional medical management, resulting in average 10-year costs ranging between $22 914 and $44 187. In comparison, the direct-to-IPP group had average 10-year costs of $17 750 (Fig. 1). The ICERs for the standard pathway compared to the direct-to-IPP approach ranged linearly from -$34 221 to -$45 595 (from 10% to 90% medical management success). Average total QALY for a 10-year period ranged from 6.99 (90% medical management success) to 7.61 (direct-to-IPP). Conclusions In this analysis, we sought to quantify the cost-effectiveness of the prevailing management strategy for erectile dysfunction compared to an IPP-first strategy. We found that the ICER of medical management compared to a direct-to-IPP strategy ranged from -$34 K to -$46 K, indicating that medical management was both more costly and less effective in providing patients with ED quality of life. While it is unreasonable to suggest that IPP should be a first-line treatment for all patients with erectile dysfunction, these data are informative for counseling in populations particularly susceptible to high rates of erectile dysfunction, such as those with diabetic neuropathy, a history of radical prostatectomy, or peripheral vascular disease. In these populations, counseling directly on penile prosthesis before PDE5 inhibitors or ICI trials could be both cost-effective and fit within the current American Urological Association guideline statements. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Gregory Joice MD is a consultant for Boston Scientific.

(047) INNOVATIVE PRIAPISM SIMULATION TRAINER IMPROVES RESIDENT COMFORT WITH BEDSIDE AND OPERATIVE MANAGEMENT

Abstract Introduction Priapism, a prolonged and often painful penile erection, represents a urological emergency that necessitates immediate intervention. The complexity and infrequency of this condition pose significant challenges for urology residents in acquiring the necessary skills for effective bedside and operative management. This scarcity of practical experience underscores the pressing need for alternative training models. Simulation-based training provides a risk-free environment for trainees to practice, refine, and master the requisite skills for managing priapism. To date there is no commercially available priapism simulation training model. Objective This objective of this project was to develop a priapism training model, test it with a group of urology trainees, and assess pre- and post-training comfort with bedside and operative priapism management. Methods A low-cost high-fidelity priapism trainer was developed using a silicone-based material to mimic the structure and resistance of natural tissues to needles and scalpels (Fig. 1). Long party balloons filled with salt served as the dilated corpora during casting. Once set, the salt was drained and the hollow balloons attached to IV tubing and elevated bags of red-colored saline. Each training model was secured to a threaded bolt and baseplate to provide stability. These single-use trainers were utilized during a regional AUA training resident training course which included a priapism case presentation where trainees practiced penile aspiration, pharmacologic injection, and distal (or T) shunting. As part of novel training model improvement, users completed an anonymous REDCap survey before and after the session regarding priapism management experience and comfort. Wilcoxon ranked sum tests were used to compare groups on nonparametric continuous data. Results Thirty-three residents (1 PGY1, 16 PGY2, 14 PGY3, 2 PGY4) completed the priapism training survey as part of the regional course. On a 1 to 5 Likert scale corresponding to “not at all comfortable” to “very comfortable”, the average comfort level in managing a patient with priapism increased from 3.6 to 4.3 from pre- to post-training, respectively (p = .004). Mean estimated number of priapism procedures performed over the past year was aspiration/irrigation 4.9 (±4.3), intracavernosal injection 4.8 (±4.4), distal penile shunt 0.6 (±1.0), and placement of acute penile prosthesis 0.2 (±0.6). Only 15.2% of participants had previously attended a hands-on simulation for the management of priapism. Comfort level with each of bedside and operative priapism procedure was increased post-training (Fig. 2). Average impact on priapism knowledge and skills was 4.2 (moderate to major increase) and change in clinical practice as a result of attending training was 3.9 (moderate to significant impact). All participants would recommend this simulated priapism training to their colleagues. Conclusions An innovative priapism simulation trainer improves resident comfort level with overall priapism management across a broad group of trainees. Comfort level was also improved across all bedside and operative management techniques surveyed. The trainees noted a moderate to significant impact in their clinical practice as a result of the training session. Future studies will look to increase resident exposure to the priapism model, both early year urology and non-urology (eg, emergency medicine) residents. Disclosure No.

(061) CASE SERIES: PERSISTENCE OF FUNCTIONAL PENILE CAVERNOSAL TISSUE FOLLOWING EXPLANT OF PENILE PROSTHESIS

Abstract Introduction Placement of a penile prosthesis is a safe, reliable treatment for erectile dysfunction. Unfortunately, regardless of patient satisfaction, some prostheses must be removed for select indications. It is widely believed that after explant of a penile prosthesis, patients will have no chance of penetrative intercourse without another penile prosthesis. Implantation of a penile prosthesis disrupts the inner corporal cavernosal sinusoidal tissue, and it is believed that remaining tissue cannot attain meaningful erections. However, we have observed several patients with varying degrees of persistent erectile function following explant, challenging this dogma. Objective We present a series of patients who pursued medical management of erectile dysfunction following penile prosthesis explant. Methods We identified all patients at our practice that underwent explant of penile prosthesis and wished for salvage of erectile function from June 2023 to December 2023. Chart review was performed to abstract demographic and clinical data. Descriptive statistics were not applicable. Results Following explant of penile prosthesis, 4 patients were motivated to continue management of erectile dysfunction. Three of these patients underwent penile duplex ultrasonography, results in Table 1. Arterial sufficiency is demonstrated in each ultrasound. One patient progressed to salvage medical management with intracavernosal injections and attained functional erections. Conclusions The patients identified demonstrate evidence of functional, viable corporal cavernosal tissue several years following penile prosthesis placement. Our data presents both objective and subjective evidence of successful erectile potential. This is a small case series with short-term follow up, but these results directly counter the current paradigm-some patients can experience efficacious medical management of erectile dysfunction following explant of penile prosthesis. Further investigation with larger patient cohorts is warranted to better define treatment options for patients’ sexual health following prosthesis explantation. Disclosure No.

(268) PREDICTORS FOR USE OF ADVANCED ERECTILE DYSFUNCTION THERAPY FOLLOWING ROBOTIC ASSISTED RADICAL PROSTATECTOMY

Abstract Introduction Despite improvements in nerve-sparing techniques offered by Robotic Assisted Laparoscopic Radical Prostatectomy (RARP), nearly all patients undergoing this procedure will demonstrate some degree of erectile dysfunction (ED) thereafter. Emerging data indicate that older age and pre-surgical hypogonadism correlate with worsened post-surgical erectile dysfunction. Objective Herein, we sought to determine real world outcomes of erectile dysfunction therapy as they related to patient age, pre-surgical testosterone level, and testosterone replacement therapy (TRT) at time of RARP. Methods We identified patients undergoing RARP by a single surgeon at our institution from 2015-2023. We then collected demographics, pre-surgical total testosterone levels, type of erectile dysfunction therapy (none [No Tx], phosphodiesterase 5 inhibitor [PDE5], or intracavernosal injection [ICI]) and TRT use for each patient. Data were analyzed using GraphPad Prism Software. We performed statistical analysis using One-way ANOVA for comparison of multiple groups followed by Tukey’s post-test. P values less than 0.05 were deemed significant. Results We identified a total of 179 patients undergoing RARP (mean age 64 +/- 7 years) who had pre-operative testosterone levels measured (mean testosterone level 396 +/- 299 ng/dL). 74 patients (41%) were found to have untreated hypogonadism. 42 patients (23%) were found to already be receiving testosterone therapy pre-procedurally. Younger patients and those with a higher natural pre-surgical total testosterone level were more likely to proceed with erectile dysfunction therapy (Table 1). Interestingly, while patients on no testosterone therapy were more likely to utilize either no ED therapy or PDE5, those on testosterone therapy were considerably more likely to utilize more invasive ED therapy, namely ICI (Table 2). Conclusions Younger age, higher pre-RARP testosterone levels, and Testosterone Replacement Therapy as controlled for by a single surgeon’s operative technique correlate with a patient’s use of erectile dysfunction therapy. Knowledge from this study will aid the urologist in identifying those patients most likely to seek and benefit from post-RARP erectile dysfunction therapy. Disclosure No.

(322) PATIENT OUT-OF-POCKET COSTS FOR GUIDELINE-RECOMMENDED TREATMENTS FOR ERECTILE DYSFUNCTION: A MEDICARE COST MODELING ANALYSIS

Abstract Introduction Patient out-of-pocket (OOP) cost represents a barrier to accessing treatment for erectile dysfunction (ED). Many physicians have limited insight into the costs and insurance coverage of the treatment options that they recommend. Objective We sought to evaluate OOP costs incurred by men with ED covered by Fee-for-Service Medicare. Methods The 2018 American Urological Association (AUA) guidelines were used to identify recommended ED treatments. Coverage policies were obtained from the Medicare Coverage Database. OOP costs were retrieved from the 2023 CMS Final Rule. For treatments not covered by Medicare, OOP costs were extracted from GoodRx® or published literature and inflated to 2022 dollars. Annual prescription costs were calculated using a published estimate of 52.2 instances of sexual intercourse per year. The estimated number of Medicare patients with ED (n = 254,650) was used to evaluate healthcare system implications. Results Medicare has established coverage for inflatable penile prostheses (IPP; strong recommendation), non-coverage for vacuum erection devices (VED; moderate recommendation) and phosphodiesterase type-5 inhibitors (PDE5i; strong recommendation), and no existing policies for intracavernosal injections (ICI; moderate recommendation), intraurethral alprostadil (IA; conditional recommendation), or extracorporeal shock wave therapy (ESWT; conditional/investigational recommendation; Table 1). Annual IA prescription is associated with the highest patient OOP cost ($4,022), followed by annual ICI prescription ($3,947), one ESWT treatment course ($3,445), IPP ($1,600; inpatient deductible), annual PDE5i prescription ($696), and one VED ($213; Fig. 1). Among PDE5i, avanafil is associated with the highest annual OOP cost ($3,455), followed by vardenafil ($2,102), tadalafil ($723), and sildenafil ($459). One-year projections demonstrate IA is associated with the highest national healthcare OOP cost ($1.02 billion), followed by ICI ($1.0 billion), ESWT ($877 million), IPP ($407 million), PDE5i ($177 million), and VED ($54 million). Conclusions PDE5i and IPP are cost-effective options with strong guideline recommendations. Better understanding of patient financial burden may improve shared decision making with patients who suffer from ED. Disclosure Yes, this is sponsored by industry/sponsor: Boston Scientific. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.

(044) ASSESSING THE EFFICACY OF INTRAURETHRAL BIMIX GEL AS AN ADJUNCT THERAPY IN 55 ERECTILE DYSFUNCTION PATIENTS

Abstract Introduction Erectile dysfunction can affect men from ages 40 to 70, with a range of 30% to 50% of the population experiencing this inability to achieve and sustain an erection (1). Erectile dysfunction can have a myriad of problems with risk factors such as obesity, smoking, and age, to name a few. The traditional treatments for ED are oral therapy, injections, and penile prostheses, but in some cases, these may not be effective. Objective To evaluate the effectiveness of intraurethral Bimix gel as an adjunct to therapy in 56 patients diagnosed with ED. Methods A retrospective chart review of patients who were prescribed intraurethral Bimix gel for a diagnosis of ED as an adjunct following primary therapy were selected. This yielded a total of 55 patients with a mean age of 61 (range, 25-85) years. The patients were prescribed intraurethral Bimix gel because of their unsatisfactory response to oral therapy. The efficacy of the gel was evaluated by comparing the Sexual Health Inventory for Men (SHIM) scores before and after the treatment with a Wilcoxon signed rank test. Results The mean SHIM score prior to intraurethral Bimix gel was 9.62 (range, 0-24), and following the Bimix gel administration was 11.93 (range, 1-25) (p &amp;lt; 0.001). The patients had a favorable response to the intraurethral Bimix gel therapy. This therapy offers a good alternative to patients and an easier mode of administration for patients who are wary of intracavernosal injections. One of the common side effects reported was a mild burning sensation at the administration site during the application and absorption period. There were no other adverse effects. Conclusions Intraurethral Bimix gel is a good alternative adjunct to primary oral therapy for erectile dysfunction which can be used together with the initial therapy or as a booster during the act of sexual intercourse as a salvage option.