Modgil, Vaibhav

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 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 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.

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 We 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 4,398 cases. These cases were divided into two distinct groups based on BMI: less than 30 (n = 2,260) and greater than or equal to 30 (n = 2,138). 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 with 1858 (86.9%) compared to 1919 (84.9%) for <30 BMI group, (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, the IPP industry may need to consider device specific alterations with pump tubing length 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.

Abstract Introduction Inflatable penile prosthesis (IPP) surgery is a well-established treatment for erectile dysfunction (ED). There is little information in the literature regarding the utilization of perioperative antimicrobial prophylaxis in primary and revision IPP surgeries. Objective We investigated the patterns of perioperative antimicrobial prophylaxis among a large multinational cohort of primary and revision IPP surgeries. Methods We conducted a retrospective analysis of 5,400 patients (4,187 primary IPP patients and 849 revision IPP patients) from our Prosthetic Urology Multi-Institutional Partnership (PUMP) institutions. Usage data for intravenous (IV), preoperative oral, and postoperative oral antimicrobials were analyzed. We specifically assessed patient profiles, antimicrobial selection, and antimicrobial duration. Multivariate statistical analyses were conducted to identify significant variations between primary and revision surgeries. Results For patients undergoing primary IPP placement, 81.9% received IV antibiotics for <24 hours whereas 18.1% received IV antibiotics for >24 hours. Preoperative oral antimicrobials were used in 59.4% of patients and 99.4% received postoperative oral antimicrobials. The overall infection rate for primary implants was 2%. Notably, quinolone administration shows a higher postoperative infection rate (11.4%) compared to gentamicin (1.9%), cephalosporin (0%), and vancomycin (1.0%). Multivariable regression analysis identifies factors such as a history of infection, diabetes, and priapism as predictors for postoperative infections. Furthermore, the study finds that perioperative antifungal use is associated with a decreased risk of infection. Conclusions This study provides valuable insights into the patterns of perioperative antimicrobial prophylaxis. Duration, type, and route of antibiotics given preoperatively or postoperatively do not affect postoperative infection rates among high volume prosthetic urologists. Giving IV antibiotics for more than 24 hours does not affect postoperative infection. Perioperative antifungals are a protective factor. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.

Objectives To evaluate the pre‐ and intraoperative variables that impact the integrity of the corporal bodies over time after inflatable penile prosthesis (IPP) placement, as predictors of intraoperative corporal perforation and delayed cylinder complications have not been well characterized. Patients and Methods We retrospectively reviewed a 16‐centre multi‐institutional database of IPP surgeries performed by experienced implanters from 2016 to 2021. Poor corporal integrity (PCI) was defined as intraoperative (iPCI) corporal complications or postoperative (pPCI) corporal complications. Multivariable analysis was performed to identify independent predictors of PCI, iPCI, and pPCI. Primary outcomes included intra‐ and postoperative corporal complications. Results We identified 5153 patients for analysis from 5406 IPP cases, finding 152 (2.95%) cases of PCI. On multivariable analysis, predictors of PCI included revision IPP surgery (odds ratio [OR] 8.16, 95% confidence interval [CI] 5.15–12.92; P < 0.001), sequential dilatation (OR 2.12, 95% CI 1.32–3.39; P = 0.002), coronary artery disease (CAD)/peripheral vascular disease (PVD) (OR 1.81, 95% CI 1.18–2.77; P = 0.006), older age (OR 1.02, 95% CI 1.01–1.04; P = 0.013), and corporal scarring (OR 1.58, 95% CI 1.0–2.5; P = 0.049). Predictors of iPCI included revision IPP surgery (OR 7.34, 95% CI 4.18–12.88; P < 0.001), corporal scarring (OR 2.77, 95% CI 1.64–4.69; P < 0.001), radiation therapy (OR 2.25, 95% CI 1.0–5.04; P = 0.049), and older age (OR 1.03, 95% CI 1.0–1.05; P = 0.025). Revision IPP surgery (OR 7.92, 95% CI 3.69–17.01; P < 0.001), sequential dilatation (OR 3.4, 95% CI 1.61–7.19; P = 0.001), CAD/PVD (OR 2.98, 95% CI 1.56–5.72; P = 0.001), and history of priapism (OR 3.59, 95% CI 1.08–11.99; P = 0.038) were predictive of pPCI. Conclusion Coronary artery disease/PVD, being of older age, having corporal scarring, undergoing IPP revision surgery and sequential dilatation were predictive risk factors for complications associated with PCI. Identifying patients who are at risk of having PCI may improve patient‐specific counselling, consideration of referral to more experienced implanters, and surgical planning to potentially promote longer‐term device viability.

Abstract Introduction Inflatable penile prosthesis (IPP) surgery is a well-established treatment for erectile dysfunction (ED). There is little information in the literature regarding the utilization of perioperative antimicrobial prophylaxis in primary and revision IPP surgeries. Objective We investigated the patterns of perioperative antimicrobial prophylaxis among a large multinational cohort of primary and revision IPP surgeries. Methods We conducted a retrospective analysis of 5400 patients (4187 primary IPP patients and 849 revision IPP patients) from our Prosthetic Urology Multi-Institutional Partnership (PUMP) institutions. Usage data for intravenous (IV), preoperative oral, and postoperative oral antimicrobials were analyzed. We specifically assessed patient profiles, antimicrobial selection, and antimicrobial duration. Multivariate statistical analyses were conducted to identify significant variations between primary and revision surgeries. Results For patients undergoing primary IPP placement, 81.9% received IV antibiotics for &lt;24 hours whereas 18.1% received IV antibiotics for &gt;24 hours. Preoperative oral antimicrobials were used in 59.4% of patients and 99.4% received postoperative oral antimicrobials. The overall infection rate for primary implants was 2%. Notably, quinolone administration shows a higher postoperative infection rate (11.4%) compared to gentamicin (1.9%), cephalosporin (0%), and vancomycin (1.0%). Multivariable regression analysis identifies factors such as a history of infection, diabetes, and priapism as predictors for postoperative infections. Furthermore, the study finds that perioperative antifungal use is associated with a decreased risk of infection. Conclusions This study provides valuable insights into the patterns of perioperative antimicrobial prophylaxis. Duration, type, and route of antibiotics given preoperatively or postoperatively do not affect postoperative infection rates among high volume prosthetic urologists. Giving IV antibiotics for more than 24 hours does not affect postoperative infection. Perioperative antifungals are a protective factor. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.

Abstract Background Variations in climate have been associated with a greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome; however, limited data exist on the impact of climate on inflatable penile prosthesis (IPP) infections. Aim We sought to evaluate the impact of climate on the risk of IPP infections in a large international, multicenter cohort. Methods We performed a multi-institutional, retrospective study of patients undergoing IPP surgery. We then evaluated whether the month or season, during which surgery was performed, affected device infections. Implant infections were defined as infections requiring device explantation. A univariate logistic regression analysis was undertaken. Outcomes Our primary outcome was implant infection. Results A total of 5289 patients with a mean age of 62.2 ± 10.8 years received IPP placement. There was a fairly even distribution of implants performed in each season. A total of 103 (1.9%) infections were recorded. There were 32 (31.1%) IPP infections in patients who underwent surgery in the summer, followed by 28 (27.2%) in the winter, 26 (25.2%) in the spring, and 17 (16.5%) in the fall. No statistically significant differences were recorded in terms of season (P = .19) and month (P = .29). The mean daily temperature (P = .43), dew point (P = .43), and humidity (P = .92) at the time of IPP placement was not associated with infection. Clinical Implications These findings provide reassurance to prosthetic urologists that infection reduction strategies do not need to be tailored to local climate. Strengths and Limitations Climate data were not directly recorded for each hospital, but rather based on the monthly averages in the city where the surgery was performed. Conclusion The climate at time of IPP placement and time of year of surgery is not associated with IPP infection risk.

Abstract Introduction Intracavernosal injection (ICI) therapy for erectile dysfunction (ED) carries a risk of corporal fibrosis, potentially making placement of an inflatable penile prosthesis more difficult. Prostate cancer treatment may also induce corporal fibrosis. Objective To assess whether a history of ICI or prostate cancer treatment is associated with complications following IPP placement. Methods A retrospective cohort study of primary IPP cases from 2016–2021 across 16 institutions. Patients were stratified by history of ICI and between-group differences in risk factors were assessed. Multivariable logistic regression was used to assess for predictors of intraoperative complications, postoperative non-infectious complications and postoperative infection. Results A total of 2540 patients met inclusion criteria of which 781 (30.8%) had a history of ICI. Patients with a history of ICI tended to be older (mean 63 vs 64 years, p=0.002) and were more likely to have history of radical prostatectomy (21.0% vs. 32.1%, p&lt;0.001) and/or radiation (5.51% vs 10.9%, p&lt;0.001). On multivariable regression, a history of ICI, prostatectomy, and radiation were all significant predictors of intraoperative complications (OR 2.11, p=0.03; OR 2.27, p=0.03; OR 2.40, p=0.04, respectively). A history of ICI and patient age were predictors of non-infectious postoperative complications (OR 1.44, p=0.02, OR 1.02, p=0.004 respectively)). None of the variables were significant predictors of infection. Conclusions In men undergoing IPP placement, a history of ICI is associated with an increased risk of both intraoperative and postoperative, non-infectious complications. Prostate cancer treatment with radiation or surgery is independently associated with increased risk of intraoperative complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: D.O. has served as a consultant for Coloplast, Intuitive Surgical, and Fidelis. P.P. has served as a consultant for Coloplast, Boston Scientific, and Urofill. M.S. has served as a consultant for Boston Scientific and Coloplast. J.S. has served as a consultant for Boston Scientific and Coloplast. F.A.Y. has served as a consultant for Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, and Acerus Pharma. M.S.G. has served as a consultant for Coloplast. The other authors disclose no conflicts.