Azad, Babak Kazemzadeh

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.

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 <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.

Abstract Introduction High medication costs for vaginal estrogen may create a barrier for patients seeking treatment for numerous urinary and vaginal symptoms and lead to poor medication adherence. The Mark Cuban Cost Plus Drug Company (CPD) and GoodRx tools offer patients a method to purchase prescription medications at a discount, which may lead to improved medication adherence and decreased national expenditures on such medications. Objective To compare the pricing of vaginal estrogen as advertised by retail pharmacies, Medicare, and discount listings through CPD and GoodRx. Methods A review of publicly available data from CPD and GoodRx was performed to obtain listed retail and discounted prices for Estrace (topical), Vagifem (tablet), and Premarin (topical). GoodRx prices were obtained using prices from Costco, CVS, Walgreens, and Walmart pharmacies in the most from populous zip code from each of the 3 most populous U.S. states: California, New York, and Texas. Prices were adjusted to account for dosage and prescribed quantity to estimate an average cost per dosage unit ($/adu). The Medicare Part D Drug Spending and Utilization data from 2021 were used to report the average spending per dosage unit and total expenditure for each of the listed medications. These data were compared to create an estimate of average national savings after use of CPD and/or GoodRx. Results Average spending per dosage unit for Estrace, Vagifem, and Premarin was lesser when discount tools were used (0.50 $/adu, 3.75 $/adu, and 4.30 $/adu respectively), compared to Medicare pricing (6.14 $/adu, 20.95 $/adu, and 10.10 $/adu respectively) or retail pricing (3.14 $/adu, 10.19 $/adu, and 5.43 $/adu respectively). When adjusted for total dosage units, use of CPD over Medicare pricing for the three medications would result in a combined annual national saving of $64.2M. Use of either CPD or GoodRx compared to retail pricing would similarly result in a combined annual national saving of $39.2M. Conclusions The utilization of CPD and GoodRx in the prescription of vaginal estrogen led to a substantial national average cost savings when compared to retail and Medicare pricing. CPD and GoodRx may offer a way to decrease the cost burden for patients seeking treatment for urinary and vaginal symptoms and significantly reduce national expenditures on medications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: The utilization of CPD and GoodRx in the prescription of vaginal estrogen led to a substantial national average cost savings when compared to retail and Medicare pricing. CPD and GoodRx may offer a way to decrease the cost burden for patients seeking treatment for urinary and vaginal symptoms and significantly reduce national expenditures on medications.

Abstract Introduction The Mark Cuban Cost Plus Drug Company (CPD) is an online retailer launched in January 2022 that sells generic prescription medications directly to consumers at cost of ingredients and manufacturing plus a fixed 15% margin in addition to a small pharmacy dispensing fee and shipping fee. GoodRx is an online tool which offers coupons redeemable at pharmacies for discounts on prescription medications. The combination of these two tools offers physicians a way to provide prescription medications to patients at lower costs, which may lead to improved medication adherence and lower medication expenditures nationally. Objective To compare the cost of various erectile dysfunction medications when purchased through retail pharmacies, reimbursed through Medicare, or obtained utilizing CPD and GoodRx. Methods A review of publicly available data from CPD and GoodRx was performed to obtain average retail and discounted prices for generic sildenafil, tadalafil, and vardenafil. GoodRx prices were obtained using prices from Costco, CVS, Walgreens, and Walmart pharmacies in the most from populous zip code from each of the 3 most populous U.S. states: California, New York, and Texas. Prices were adjusted to account for dosage and prescribed quantity to estimate an average cost per dosage unit ($/adu). The Medicare Part D Drug Spending and Utilization data from 2021 were used to report the average spending per dosage unit and total expenditure for each of the listed medications. These data were compared to create an estimate of average national savings after use of CPD or GoodRx. Results Average spending per dosage unit for sildenafil, tadalafil, and vardenafil was less when GoodRx or CPD were used (0.28 $/adu, 0.31 $/adu, and 6.17 $/adu respectively), compared to Medicare pricing (2.14 $/adu, 8.08 $/adu, and 27.84 $/adu respectively) or retail pricing (0.52 $/adu, 2.82 $/adu, and 8.35 $/adu respectively). When adjusted for total dosage units, use of CPD over Medicare pricing for the three medications would result in a combined annual national saving of $149M. Use of either CPD or GoodRx compared to retail pricing would similarly result in a combined annual nation saving of $40M. Conclusions The utilization of CPD and GoodRx in the prescription of common erectile dysfunction medications may lead to significant reductions in pricing compared to retail and Medicare estimates. Knowledge of these prescription tools may lead to significant reductions in national expenditures on medications and decreased cost burden for patients seeking treatment. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Advisory board and speaker for Coloplast; consultant for Cynosure; advisory board and speaker for Halozyme; intellectual property with Masimo; advisory board for Promescent; consultant for Sprout; advisory board for Xialla.

Abstract Introduction High medication costs for vaginal estrogen may create a barrier for patients seeking treatment for numerous urinary and vaginal symptoms and lead to poor medication adherence. The Mark Cuban Cost Plus Drug Company (CPD) and GoodRx tools offer patients a method to purchase prescription medications at a discount, which may lead to improved medication adherence and decreased national expenditures on such medications. Objective To compare the pricing of vaginal estrogen as advertised by retail pharmacies, Medicare, and discount listings through CPD and GoodRx. Methods A review of publicly available data from CPD and GoodRx was performed to obtain listed retail and discounted prices for Estrace (topical), Vagifem (tablet), and Premarin (topical). GoodRx prices were obtained using prices from Costco, CVS, Walgreens, and Walmart pharmacies in the most from populous zip code from each of the 3 most populous U.S. states: California, New York, and Texas. Prices were adjusted to account for dosage and prescribed quantity to estimate an average cost per dosage unit ($/adu). The Medicare Part D Drug Spending and Utilization data from 2021 were used to report the average spending per dosage unit and total expenditure for each of the listed medications. These data were compared to create an estimate of average national savings after use of CPD and/or GoodRx. Results Average spending per dosage unit for Estrace, Vagifem, and Premarin was lesser when discount tools were used (0.50 $/adu, 3.75 $/adu, and 4.30 $/adu respectively), compared to Medicare pricing (6.14 $/adu, 20.95 $/adu, and 10.10 $/adu respectively) or retail pricing (3.14 $/adu, 10.19 $/adu, and 5.43 $/adu respectively). When adjusted for total dosage units, use of CPD over Medicare pricing for the three medications would result in a combined annual national saving of $64.2M. Use of either CPD or GoodRx compared to retail pricing would similarly result in a combined annual national saving of $39.2M. Conclusions The utilization of CPD and GoodRx in the prescription of vaginal estrogen led to a substantial national average cost savings when compared to retail and Medicare pricing. CPD and GoodRx may offer a way to decrease the cost burden for patients seeking treatment for urinary and vaginal symptoms and significantly reduce national expenditures on medications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Advisory board and speaker for Coloplast; consultant for Cynosure; advisory board and speaker for Halozyme; intellectual property with Masimo; advisory board for Promescent; consultant for Sprout; advisory board for Xialla.