Suarez‐Sarmiento, Alfredo

Abstract Introduction Down-sized inflatable penile prosthesis (IPP) cylinders are used in challenging penile fibrosis scenarios, such as after priapism or prior implant infection. Their role in primary penile prosthesis surgery, however, is not well studied. Objective This study aims to identify factors associated with the use of down-sized cylinders in men undergoing primary IPP placement. Methods We conducted a multicenter, retrospective study on men undergoing primary IPP surgery, categorizing them into a down-sized cylinder group (AMS 700 CXR and Coloplast NB) and a standard cylinder group (AMS 700 CX, AMS 700 LGX, and Coloplast Titan). We collected demographic, intraoperative, and postoperative variables and performed a multivariable analysis. Results 4,389 men were included in the study with a mean age of 62.3±10.3 years. Overall, 1,485 (34%) men had diabetes, and 2,131 (49%) had hypertension. Down-sized cylinders were placed in 406 men (174 CXRs, 232 NBs), while standard cylinders were placed in 3,983. Multivariable analysis indicated that down-sized cylinders were more commonly used in men with diabetes (OR 2.6 [1.9, 3.7], p<0.001) and less frequently in men with hypertension (OR 0.5 [0.4, 0.7], p<0.001). A history of priapism did not significantly impact the use of down-sized cylinders (p≥0.152). Sequential dilation was performed more often with the use of down-sized cylinders (OR 4.0 [2.8, 5.7], p<0.001). Down-sized cylinders were associated with an increased rate of non-infectious complications (OR 1.9 [1.3, 2.9], p<0.001), however, there was no significant association with implant infection (OR 2.1 [0.9, 4.6], p=0.07). Non-infectious complications occurred in 44 (25%) men with down-sized cylinders. In the down-sized group, hematomas occurred in 10 (2.5%) men and wound-related complications occurred in 7 (1.7%) men (Table 1). Cylinder-related complications occurred in 7 (1.7%) men with down-sized cylinders. Device-related malfunctions were seen in 8 (2%) men. Conclusions This study demonstrates that down-sized cylinders are more frequently used in men with diabetes and surgeons should be prepared to place down-sized cylinders in these men. Prosthetic urologists are also more likely to use down-sized cylinders in men requiring sequential dilation likely due to fibrosis or more challenging dilations. Down-sized cylinders are associated with a low overall complication rate. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Intuitive Surgical, Fidelis, Urofill, Boston Scientific, Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, Acerus Pharma; Endo Pharma.

Abstract Background 0.05% Chlorhexidine gluconate (CHG) is now commonly used as an antiseptic irrigation for inflatable penile prosthesis (IPP) surgery. Limited in vitro data suggest compatibility of 0.05% CHG with antibiotic impregnated IPP devices; however, very little clinical research exists to guide use of 0.05% CHG in this population. Aim Assess the relationship of 0.05% CHG and antibiotic impregnated IPP infection in a large multi-institutional cohort. Methods We retrospectively reviewed a multi-institutional cohort of patients who underwent antibiotic impregnated IPP implantation. We identified cases using intraoperative 0.05% CHG and an equal number of consecutive control cases without 0.05% CHG use from each center for comparison. The primary outcome was IPP infection requiring explantation. Patient demographics and surgical variables were analyzed using chi-square tests and multivariable logistic regression to identify variables associated with infection. Outcomes The primary outcome was IPP infection requiring device explanation. Results Among 14 participating institutions, 761 cases using an antibiotic impregnated IPP were analyzed. Of these, 348 (45.7%) had 0.05% CHG used during the case. Median follow-up was 4 months (interquartile range 1-12) for the 0.05% CHG group and 8 months (interquartile range 2-21) for the control group. Intraoperative 0.05% CHG utilization was not associated with antibiotic impregnated IPP infection rate (1.9% vs. 2.0%, P = .9). On multivariable analysis, prior IPP infection (OR 6.32, 95% CI 1.32-30.2, P = .021) and prior priapism (OR 10.01, 95% CI 1.18-89.7, P = .039) were associated with increased infection risk. Clinical implications The use of 0.05% CHG irrigation with antibiotic impregnated IPPs was associated with similar infection rates compared to antibiotic irrigation. Strengths and limitations Limitations include the use of a historical comparator cohort which may introduce unknown confounders, practice variation between multiple sites, shorter follow-up in the 0.05% CHG cohort, and the low incidence of IPP infection which may limit statistical power despite a large sample. The major strengths include the large, multi-institutional cohort, and the use of consecutive patients to minimize selection bias. Conclusion 0.05% CHG utilization was not associated with infection rates in antibiotic impregnated IPPs.

Abstract Introduction Down-sized inflatable penile prosthesis (IPP) cylinders are useful in cases with substantial penile fibrosis such as history of priapism or prior infection. Although down-sized IPP cylinders have a clear role in fibrotic corpora, their role in primary implant cases is unclear. Objective To identify factors associated with the use of down-sized cylinders in men undergoing primary IPP placement. Methods We conducted a retrospective analysis of 4,389 patients undergoing primary IPP placement from our multicenter database. Patients were categorized by down-sized (AMS 700 CXR, Coloplast NB) vs. standard sized cylinders (AMS 700 CX, AMS 700 LGX, Coloplast Titan). We collected demographic, intraoperative, and postoperative data. A multivariable analysis was performed to identify factors associated with use of down-sized cylinders Results A total of 4,389 men undergoing primary inflatable penile prosthesis (IPP) placement were included in the study, with a mean age of 62.3 ± 10.3 years. Among them, 1,485 (34%) had diabetes and 2,131 (49%) had hypertension. A total of 406 down-sized cylinders and 3,983 standard cylinders were implanted. Non-infectious complications occurred more frequently with the use of down-sized cylinders (odds ratio [OR] = 2.0, p < 0.001). Specifically, non-infectious complications were reported in 44 out of 185 men (23.8%) with down-sized cylinders, compared to 192 out of 2,727 men (10.9%) with standard cylinders. Cylinder complications constituted 13.9% and 13.0% of the non-infectious complications in the down-sized and standard cylinder groups, respectively. Conclusions The rate of cylinder-related complications were similar between the down-sized cylinder and standard cylinder groups. Urologists should be prepared to place down-sized cylinders during IPP placement in diabetic men and in men requiring serial dilation due to fibrosis. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Intuitive Surgical, Fidelis, Urofill, Boston Scientific, Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, Acerus Pharma; Endo Pharma.

Abstract Introduction Glans ischemia and subsequent necrosis is a rare but devastating complication of inflatable penile prosthesis (IPP) placement. Differentiating true glans ischemia from severe ecchymosis is often difficult to distinguish, yet it remains paramount given the glans ischemia principle: “when in doubt, take it out.” Objective We present several clinical scenarios and associated postoperative images wherein there was concern for post-IPP glans ischemia based on initial clinical examination. In addition, we review pertinent clinical factors that can be used to help distinguish between greater than “average” glans ecchymosis and true ischemia. Methods We present four cases from 2025 and describe clinical factors likely responsible for increased glans discoloration. Results Traditional risk factors for glans ischemia are constrictive IPP wrap, vasculopathy, use of prolonged large bore catheters, and concomitant surgery (circumcision, distal counter-incision, urethral/neurovascular bundle mobilization). Case 1 was a patient with a history of radiation for prostate malignancy who had notably hypervascular corpora intraoperatively. On postoperative day (POD) #1, the urethral meatus was ecchymotic along with patchy ecchymosis throughout the glans. The Kerlix wrap can be seen around the penile shaft up to the corona. Removing the constrictive wrap and increasing room lighting revealed a well-vascularized glans with spotty ecchymosis likely from passage of the Keith needles during deployment. Case 2 was another patient examined on POD1 after uneventful IPP placement under local anesthesia. Note the similar level of ecchymosis involving the scrotum. Case 3 is another patient examined POD1 from a penoscrotal IPP that required multiple firing attempts with the Keith needle. Again, multifocal areas of patchy ecchymosis are interspersed with areas of normal appearing glans. The patient’s skin color was also similar in appearance to the areas of ecchymosis, requiring careful attention to detail to differentiate. Finally, Case 4 is an image on POD0 after uneventful IPP. The patient required several Keith needle passes because Furlow tool severed suture. Notably, decision was made to leave the penile implant in place in all cases. The penile wrap and/or catheter was removed and lighting was optimized to evaluate for clinical change. No patient reported paresthesia or pain out of proportion to the clinical examination. All glans were warm to the touch. Rates of glans bruising at POD3 for 298 implants performed since 2024 under local anesthesia, with bruising scored 0-4, were as follows: 0: 3.7% 1: 48.7%, 2: 25.5% 3: 21.1% 4: 0.3%. This demonstrates high rates of glans bruising with local anesthesia. We speculate that the increased rate of glans bruising may be attributed to the aggressive nature of the local anesthesia block, which can result in vasodilation and ecchymosis due to needle trauma and increased vascular permeability. Conclusions IPP cylinder deployment requiring multiple Keith needle punctures, constrictive post-op penile wrap, hypervascular corpora, exam/images with poor lighting, extensive bruising in other areas, and IPPs performed under local anesthesia appear may contribute to glans discoloration that mimics ischemia. A detailed physical exam and close clinical monitoring are essential when postoperative glans discoloration is observed. Disclosure No

Abstract Introduction Glans ischemia and subsequent necrosis is a rare but devastating complication of inflatable penile prosthesis (IPP) placement. Differentiating true glans ischemia from severe ecchymosis can be difficult but is critical, particularly in light of the adage, “when in doubt, take it out.” However, post-operative glans discoloration can be misleading and result in premature device explantation. Objective To present clinical cases and identify distinguishing features between true glans ischemia and pronounced post-operative ecchymosis, with emphasis on risk factors and evaluation techniques. Methods A retrospective case series was conducted on four IPP patients in 2025 who presented with significant glans discoloration concerning for ischemia. Key operative variables, physical exam findings, and postoperative images were reviewed. Additionally, a prospective database of 298 implants placed under local anesthesia since 2024 was analyzed for glans bruising severity on postoperative day (POD) 3, using a 0–4 scale. Results Common ischemia risk factors included tight circumferential wrap (e.g., Coban), vasculopathy (e.g., prior arterial bypass), prolonged catheterization, and concomitant procedures. Case 1: History of pelvic radiation with ecchymotic meatus and glans. Improved after wrap removal and better lighting. Case 2: Extensive ecchymosis and discoloration of glans and scrotum noted on POD1 after uneventful IPP under local. Case 3: Patchy glans discoloration after multiple Keith needle passes. Skin tone complicated assessment. Case 4: Severe glans bruising immediately post-op following multiple needle passes due to suture breakage. In all cases, the glans was warm, well-perfused, and not painful out of proportion to appearance. No patients required explantation. Glans bruising rates in 298 implants under local anesthesia were: 0 (3.7%), 1 (48.7%), 2 (25.5%), 3 (21.1%), 4 (0.3%), notably higher than with general anesthesia. Key Clinical Indicators: Favors Hematoma: • Vascular corpora • Small/no catheter • Bruising elsewhere • Wrap excluded glans • No blistering • No paresthesias • Glans warm to touch Favors Ischemia: • Avascular corpora • Large indwelling catheter • Minimal bruising elsewhere • Coban wrap on shaft • Blistering present • Pain or paresthesias • Glans cold to touch Conclusions Significant glans bruising can mimic ischemia, particularly in IPPs placed under local anesthesia. Factors such as multiple Keith needle passes, tight wrapping, and poor photographic lighting may contribute to this diagnostic confusion. Warm, non-painful glans with widespread ecchymosis are reassuring. Avoiding premature explantation requires thorough clinical assessment, device unwrapping, and close patient monitoring. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: UroFill, Coloplast, Boston Scientific, Rigicon

Abstract Introduction Inflatable penile prosthesis (IPP) implantation is a common and effective surgical treatment for erectile dysfunction. However, the presence of comorbidities and the use of anti-thrombotic therapy (AT) can complicate surgical decision-making. Due to the correlation between erectile dysfunction and cardiovascular disease, the preoperative comorbidities of surgical patients are important to examine. Objective The goal of this study was to assess the outcomes of IPP implantation in men on active AT therapy compared to a non-AT therapy cohort. Methods A retrospective analysis from 2015 to 2023 was conducted using data from three high-volume implant centers. The study focused on men who underwent three-piece IPP placement. Demographics, comorbidities, secondary procedures, drain information, and complications were recorded. The three centers each have different techniques and approaches to the surgery. Center 1 utilizes a penoscrotal approach, never places a drain, and places the reservoir in an ectopic location. Center 2 utilizes an infra-pubic approach, places a drain which remains in place for 3 days, and utilizes various reservoir locations depending on patient profile. Lastly, center 3 utilizes a penoscrotal approach, places a drain with removal when output is less than 50 mL over 8 hours, and places the reservoir in an ectopic location. Outcomes were analyzed using multivariate and univariate analysis. Results A total of 210 patients on active AT therapy and 128 non-AT patients were included. The AT and non-AT groups showed significant differences in baseline comorbidities, with the AT group exhibiting higher rates of cardiovascular disease, hypertension, and thrombosis (p<0.05). Among patients on anti-thrombotic therapy, 27.6% required revision surgeries and had increased rates of ectopic reservoir placement compared to the non-AT group (p<0.001). Despite these differences, there were no statistically significant variations in overall complication rates between the two groups. Drain output was notably higher in the AT cohort on postoperative days 1 (mean 110.5 cc vs 60 cc, p<0.001) and 2 (mean 78 cc vs 20 cc, p<0.001); however, hematoma rates remained comparable between both groups (p=0.667). Importantly, neither the type of anti-thrombotic therapy nor the surgical approach used appeared to influence postoperative outcomes. Eleven patients (5.2%) experienced complications in the AT arm and 5 patients (3.9%) experienced complications in the non-AT arm (p=0.793). Conclusions IPP implantation is feasible and safe in men on active anti-thrombotic therapy when performed in high-volume centers with appropriate perioperative management. Further studies with larger cohorts and longer follow-up are needed to refine protocols and determine long-term outcomes for these high-risk patients. Disclosure No

Abstract Introduction Obesity, defined as an elevated Body Mass Index (BMI) >30, is a prevalent public health concern with far-reaching implications for various medical procedures and outcomes. In the context of inflatable penile prosthesis placement (IPP), where patient well-being and surgical success are of paramount importance, the impact of obesity on postoperative and intraoperative complications warrants thorough investigation. Objective Our study aimed to investigate the impact of BMI on both postoperative and intraoperative complications in an international, multi-institutional cohort of patients who underwent IPP placement. Methods We performed a retrospective chart review of 4398 cases. These cases were divided into two distinct groups based on BMI: less than 30 (n = 2260) and greater than or equal to 30 (n = 2138). The study assessed various surgical factors as well as complications, including overall complications, corporal scarring, incontinence, intraoperative complications, proximal perforation, distal perforation, proximal crossover, distal crossover, and urethral injury. Results Our analysis revealed that there were no statistically significant differences in intraoperative or postoperative complications between the two BMI categories. Notably, proximal corporal measurement was significantly higher for >30 BMI group (9.55 +/−2.18) compared to <30 BMI group (9.14 +/−2.19), (p = < 0.001). The incidence rates for overall complications (30.2% vs. 28.7%; p = 0.164), corporal scarring (18.2% vs. 16.7%; p = 0.36), incontinence (3.53% vs. 3.13%; p = 0.076), intraoperative complications (1.94% vs. 1.68%; p = 0.253), and specific complications all exhibited no significant differences. Similarly, post-operative complications, including both non- infectious (6.99% vs. 6.22%; p = 0.215) and infectious (2.61% vs. 1.87%; p = 0.165) complications, did not significantly vary between BMI categories. Conclusions Our findings indicate that BMI does not exert a statistically significant influence on postoperative and intraoperative complications in the context of high-volume prosthetic urology. In the absence of any other differences between patients of differing BMIs, surgeons may need to be mindful of pump tubing length concerns in obese patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.