Inflatable Penile Prosthesis Infection Research Articles

A global, propensity-score matched analysis of patients receiving inflatable penile prostheses and the risk of complications, infections, and re-interventions.

Over 25,000 men undergo inflatable penile prosthesis (IPP) placement yearly to treat erectile dysfunction (ED). Although various comorbidities are hypothesized risk factors for complications, this remains incompletely understood. Our objective was to utilize multi-institutional data to characterize risk for reintervention, complications, and infections in patients with common suspected risk factors undergoing IPP placement. We queried the TriNetX database for adult men who underwent IPP placement from 2003-2023 utilizing Current Procedural Terminology (CPT) codes. We examined the impact of diabetes mellitus (DM), hypertension (HTN), nicotine use, radiation therapy (RT), radical prostatectomy (RP), and urethral surgery [urethroplasty, artificial urinary sphincter (AUS), male urethral sling (MS)] on clinical outcomes defined by International Classification of Diseases 10th Revision (ICD-10) codes. Our primary outcome was need for reintervention based on CPT codes. Secondary outcomes included overall rates of complication and infection utilizing ICD-10 codes. Analytics were performed using TriNetX to calculate risk ratios (RRs) and Kaplan-Meier (KM) survival. We evaluated outcomes overall and for each individual comparison cohort using the remaining demographic variables to perform propensity score matching (PSM). In a total of 11,026 patients there was an overall 13.5% risk of undergoing at least one reintervention, with some undergoing multiple based on CPT codes. KM analysis showed a median IPP survival of 18.2 years and a projected 10- and 20-year survival probability at 70.6% and 48.4% respectively. Overall complication rate was 19.3% with a 5.2% rate of infection based on ICD codes. Patients with history of urethral surgery were at higher risk of both IPP complication and re-intervention. When further analyzing type of re-intervention, patients with a history of smoking, prior RP, and prior AUS/MS placement had higher rates of device removal. Patients with a history of diabetes were less likely to undergo IPP replacement at the time of explant. There were no identified risk factors for IPP infection. This is the largest cohort of patients ever evaluated and can help guide patient selection and counseling. There was a higher rate of IPP complications than previously reported, but this may be due to different reporting parameters. History of prior urethral surgery conferred a higher risk of complications and re-intervention. These results can help guide patient selection and counseling.

Does time of intraoperative exposure to the aerobiome increase microbial growth on inflatable penile prostheses?

Inflatable penile prosthesis (IPP) implantation is a surgical approach for the management of erectile dysfunction (ED). A feared complication is IPP infection, and increased operative time is a risk factor for infection. Exposure of an IPP implant to ambient air in the operating room (OR aerobiome) is thought to contribute to risk of infection from increased operative time, but this is not well-supported. The objective of this study was to evaluate if exposure to the OR aerobiome increased microbial colonization of IPPs. This was an ex vivo study using an uncoated IPP, observing standard surgical sterility and OR conditions. A sterile swab was collected every 30 min for 3 h from each IPP component. Positive controls consisted of swabs exposed to unprepped scrotal skin during in-office vasectomies. All swabs underwent quantitative polymerase chain reaction (qPCR) and next generation sequencing (NGS). Bioinformatic processing was carried out and taxonomic assignment was performed. No microbial growth was detected on any component of the IPPs at any time point, while positive control swabs all detected various skin flora, including bacterial and fungal growth. These findings suggest that exposure to the OR aerobiome does not increase the risk of IPP microbial colonization, at least within a 3-hour period. Further in vivo studies are needed.

Does climate impact inflatable penile prosthesis infection (IPP) risk? Assessment of temperature and dew point on IPP infections.

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. We sought to evaluate the impact of climate on the risk of IPP infections in a large international, multicenter cohort. 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. Our primary outcome was implant infection. A total of 5289 patients with a mean age of 62.2 ± 10.8years 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. These findings provide reassurance to prosthetic urologists that infection reduction strategies do not need to be tailored to local climate. Climate data were not directly recorded for each hospital, but rather based on the monthly averages in the city where the surgery was performed. The climate at time of IPP placement and time of year of surgery is not associated with IPP infection risk.

(020) Does Climate Impact IPP Infection Risk? Assessment of Temperature and Dew Point on IPP Infections

Abstract Introduction Variations in climate have been associated with greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome. Although the pathogenic organisms for inflatable penile prosthesis (IPP) infections are commonly skin flora, limited data exists on the impact of climate on IPP infections. We sought to evaluate the impact of climate on the pathogenic organisms of IPP infections in a large international, multicenter cohort. Objectives To assess whether the time of the year, during which surgery was performed, affected device infections. 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. Additionally, we assessed the effect of temperature, dew point, and humidity on the microorganisms involved in implant infections. Infections were classified as Gram positive, Gram negative, or mixed (including a combination of Gram positive, Gram negative, and/or fungi). A univariate logistic regression analysis was undertaken. Results A total of 5289 patients with a mean age of 62.2 ± 10.8 years received IPP placement. A total of 103 (1.9%) infections were recorded. Overall, 38 (36.9%) infections were caused by Gram positive bacteria. An increase in temperature was associated with a higher risk of infection with Gram positive bacteria (OR: 1.03, 95% CI: 1 to 1.07, p = 0.035). No statistically significant differences were recorded in terms of season (p = 0.19) and month (p = 0.29). Conclusion Higher temperature is associated with greater risk of Gram positive infections whereas lower temperature and dew point were associated with a higher risk of mixed infections. These findings may help surgeons tailor antibiotic prophylaxis based on local climate. Disclosure No.

(099) A Preliminary Investigation on the Incidence of Complications and Patient Contentment Following the Surgical Implantation of Inflatable Penile Prosthesis After Salvage Radical Prostatectomy

Abstract Introduction Erectile dysfunction (ED) is a common complication post salvage radical prostatectomy (RP). Yet, there is scant data in the literature on complication rates and patient satisfaction in those that undergo inflatable penile prosthesis (IPP) insertion post salvage radical prostatectomy (RP) following targeted radiotherapy for treatment of localized prostate cancer. It is understood that these patients have a higher rate of complications as they have experienced both radiation and prostatectomy adverse events which could alter their overall satisfaction after prosthetic surgeries. Objective Our aim is to conduct a preliminary analysis of IPP complication rates and satisfaction rates in patients that had 3-piece IPP implantation following salvage radical prostatectomy. Methods A retrospective chart review from our institutional database was done from 2018 to 2021. The inclusion criteria were patients that had an inserted 3-piece IPP and a history of salvage RP following radiation therapy. Only patients that participated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire at least 6 months from implant date were included. Data on satisfaction, IPP infection rates, mechanical failure rates, and overall complications was also collected. Complications include hematoma, erosion, reservoir hernia. Results A total of 22 patients were included in the study. The median age (IQR) is 65 (64–67) years and the median time (IQR) from RP to IPP insertion is 23 (11–49) months. All patients were approached in a penoscrotal manner with submuscular placement of reservoir (Table 1). The satisfaction rate was high at 91.8% on follow up. Overall complications rate was observed in 2 patients. One patient had a mechanical pump failure at 37.9 months while another patient had signs and symptoms of scrotal wall infection at 15 months. Both devices were easily replaced with no post op complication and remained functional on further follow up. Conclusions In patients that underwent salvage prostatectomy IPP insertion, they reported high satisfaction rates and low complication rates despite the exposure to both prostate cancer treatments adverse events. Further research is needed to confirm the results obtained and to investigate the underlying causes for the observed outcomes. The scientific process is iterative, and the answers obtained from one study often lead to more questions and the need for additional investigations. Disclosure No.

(179) Does Climate Impact IPP Infection Risk? Assessment of Temperature and Dew Point on IPP Infections

Abstract Introduction Variations in climate have been associated with greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome. Although the pathogenic organisms for inflatable penile prosthesis (IPP) infections are commonly skin flora, limited data exists on the impact of climate on IPP infections. Objective We sought to evaluate the impact of climate on the pathogenic organisms 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. Additionally, we assessed the effect of temperature, dew point, and humidity on the microorganisms involved in implant infections. Infections were classified as Gram positive, Gram negative, or mixed (including a combination of Gram positive, Gram negative, and/or fungi). A univariate logistic regression analysis was undertaken. Results A total of 5289 patients with a mean age of 62.2 ± 10.8 years received IPP placement. A total of 103 (1.9%) infections were recorded. Overall, 38 (36.9%) infections were caused by Gram positive bacteria. An increase in temperature was associated with a higher risk of infection with Gram positive bacteria (OR: 1.03, 95% CI: 1 to 1.07, p=0.035). Infections were more frequent as temperature increased with 74.7% of infections occurring when mean ambient temperature was greater than 55□F. No statistically significant differences were recorded in terms of season (p=0.19) and month (p=0.29). Conclusions Higher temperature is associated with greater risk of Gram positive infections These findings may help surgeons tailor antibiotic prophylaxis based on local climate especially when temperatures are over 55□F. Our findings should prompt further studies regarding the impact of climate on infection prevention to further improve IPP outcomes. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: consultant Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, Acerus Pharma, Boston Scientific.

(284) A Preliminary Investigation on the Incidence of Complications and Patient Contentment Following the Surgical Implantation of Inflatable Penile Prosthesis After Salvage Radical Prostatectomy

Abstract Introduction Erectile dysfunction (ED) is a common complication post salvage radical prostatectomy (RP). Yet, there is scant data in the literature on complication rates and patient satisfaction in those that undergo inflatable penile prosthesis (IPP) insertion post salvage radical prostatectomy (RP) following targeted radiotherapy for treatment of localized prostate cancer. It is understood that these patients have a higher rate of complications as they have experienced both radiation and prostatectomy adverse events which could alter their overall satisfaction after prosthetic surgeries. Objective Our aim is to conduct a preliminary analysis of IPP complication rates and satisfaction rate in patients that had 3-piece IPP implantation following salvage radical prostatectomy. Methods A retrospective chart review from our institutional database was done from 2018 to 2021. The inclusion criteria were patients that had an inserted 3-piece IPP and a history of salvage RP following radiation therapy. Only patients that participated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire at least 6 months from implant date were included. Data on satisfaction, IPP infection rates, mechanical failure rates, and overall complications was also collected. Complications include hematoma, erosion, reservoir hernia. Results A total of 22 patients were included in the study. The median age (IQR) is 65 (64-67) years and the median time (IQR) from RP to IPP insertion is 23 (11-49) months. All patients were approached in a penoscrotal manner with submuscular placement of reservoir (Table 1). The satisfaction rate was high at 91.8% on follow up. Overall complications rate was observed in 2 patients. One patient had a mechanical pump failure at 37.9 months while another patient had signs and symptoms of scrotal wall infection at 15 months. Both devices were easily replaced with no post op complication and remained functional on further follow up. Conclusions In patients that underwent salvage prostatectomy IPP insertion, they reported high satisfaction rates and low complication rates despite the exposure to both prostate cancer treatments adverse events. Further research is needed to confirm the results obtained and to investigate the underlying causes for the observed outcomes. The scientific process is iterative, and the answers obtained from one study often lead to more questions and the need for additional investigations. Disclosure No.

Repair of penile prosthesis-induced impending erosion using xenograft during simultaneous inflatable penile prosthesis replacement.

Penile prosthesis (PP)-induced impending erosion is a rare complication that has not been well characterized. This study evaluates the role of prosthesis sizing and of the safety of xenograft windsock repair (AlloDerm, Tutoplast, ArthroFLEX) of impending erosion. This was a retrospective review of xenograft use during inflatable penile prosthesis (IPP) replacement. Patient demographics, prior PP characteristics, and xenograft-augmented IPP characteristics were obtained. Paired-samples t tests were used to compare the PP cylinder size, rear tip extender size, and calculated PP length between the most recent prior PP and the xenograft-augmented IPP. Complications and follow-up data were obtained. The primary outcome was comparing the corporal body and device measurements between the PP presenting with impending erosion and the implanted xenograft-augmented IPP. The secondary outcome was evaluating the incidence of subsequent explantation. A total of 24 patients underwent xenograft repair with simultaneous IPP replacement from 2012 to 2022. The median number of prior PP was 1 (interquartile range, 1-2.75). The median time between the most recent prior PP and xenograft-augmented IPP placement was 21(interquartile range, 14-79) months. The prior PP was significantly longer at the time of explantation compared with the measured corporal body length in both the left (21.4cm vs 20.1cm; P < .01) and right (21.4cm vs 20.1cm; P < .01) sides. However, there was no significant difference in length between the xenograft-augmented IPP length at the time of implantation and measured corporal body length in both the left (20.1cm vs 20.0cm; P = .67) and right (20.2cm vs 20.1cm; P = .56) sides. A total of 16 (66.7%) cases required bilateral xenograft corporal body use. Only 1 (4.2%) patient had an IPP infection requiring explantation within 90days of xenograft-augmented IPP placement. A total of 2 (8.3%) patients had device malfunction and 1 (4.2%) patient had impending erosion recurrence requiring removal/replacement of their initial xenograft-augmented IPP in a median time of 56months from placement. PP oversizing may increase risk of PP-induced impending erosion, which is a delayed process. This is the largest retrospective study of xenograft use during IPP replacement for impending erosion but does not have a control cohort. This study is limited by its retrospective nature, limited follow-up, and absence of a treatment comparison. PP-induced impending erosion may be due to PP oversizing but can be successfully repaired with xenograft windsock during simultaneous IPP replacement.

(419) In Vivo Next Generation Sequencing Identifies More Isolates vs. Standard Culture During Revision Inflatable Penile Prosthesis Insertion: A Single Center Experience

Abstract Introduction The presence of biofilm at the inflatable penile prosthesis (IPP) component sites, which resists eradication, likely increases postoperative infection rates in revision surgery. The microbiome of (IPP) revision surgery has been shown to be increasingly complex and the weak microbe Staph epidermidis is no longer prevailing and was previously considered the major causative agent for overt infections. Furthermore, next generation sequencing (MicrogenDx, Lubbock, TX, USA) has been used recently to demonstrate that in certain scenarios such as mechanical malfunction, erosion, and infection, specific microbes dominate. Due to the disastrous complications with postoperative IPP infection, it is paramount to provide additional evidence for increased utilization of next generation sequencing over traditional cultures during IPP revision surgery. This will serve to guide postoperative treatment if necessary. Objective We investigated a cohort of IPP revision patients receiving intraoperative low concentration chlorhexidine (CHG) lavage to see whether next generation sequencing or traditional cultures of the pump space reveals more isolates. Methods A total of 31 patients with indwelling IPPs underwent revision surgery for both infectious and noninfectious reasons between May 2021 and March 2022 by a single, high volume implant surgeon who solely uses 0.05% CHG dip and irrigation. Once the pump capsule was entered, swabs were taken from the pump space and sent for traditional culture and next generation sequencing. All cultures were obtained prior to irrigation with 0.05% chlorhexidine (CHG) solution (Irrimax corporation, Lawrenceville, GA, USA). All patients received perioperative clindamycin, gentamicin, and fluconazole. Results 1 patient was excluded due to missing next generation sequencing results. Of the 30 remaining patients, 4 presented with infectious and 26 with noninfectious etiologies. 93% (28/30) patients had negative traditional cultures prior to irrigation with 0.05% CHG; however, 21% (6/28) of these patients had isolates on next generation sequencing. Only 7% (2/30) had positive preop irrigation cultures and isolates on next generation sequencing. Both of these patients presented with infection. 1 of these patients had a concordant next generation sequencing result. However, the other patient had multiple isolates. The traditional culture showed only pseudomonas a. On NGS, it was the third most abundant on NGS at only 4% compared to the most and second most abundant being E. coli at 83% and Klebsiella p. at 12%. Conclusions These results suggests that a greater number of isolates are obtained using next generation sequencing compared to traditional cultures during IPP revision surgery. Consequently, this may lead to better prevention and/or better guide treatment of postoperative IPP infection in the setting of IPP replacement. Although, further studies are needed prior to universally adopting this modality. Disclosure Yes, this is sponsored by industry/sponsor: MicrogenDx. Clarification Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: MicrogenDx.

(505) New Findings Regarding Independent Predictors of Poor Corporal Integrity in Penile Implant Recipients: A Multicenter International Investigation

Abstract Introduction Predictors of intraoperative corporal perforation and delayed cylinder complications in inflatable penile prosthesis (IPP) placement have not been well-delineated in the literature. Inflatable penile prosthesis (IPP) can offer high satisfaction rates of patients, but this procedure is not without complications that can be encountered intraoperatively and postoperatively. Particularly, predictors of intraoperative corporal perforation and delayed cylinder complications in IPP placement have not been well-delineated in the literature. Objective We evaluated our retrospective multi-institutional database of IPP surgeries performed by expert implant surgeons to identify risk factors that are predictive of the development of these non-infectious complications. Methods IPP cases performed by sixteen international implanters from 2016-2021 were identified. All primary and revision cases were included. Salvage cases for infection were excluded. Demographic characteristics, intraoperative variables, and postoperative outcomes were assessed. Poor corporal integrity (PCI) was defined as intraoperative corporal complications (proximal and/or distal perforation of the corpora, corporal crossover) or postoperative corporal complications (cylinder erosion, extrusion, impending erosion, or deformity). Risk factor analysis and multivariate analysis were performed to identify predictors of PCI. Results A total of 5406 IPP cases across 16 separate institutions were assessed. There were 163 (3.0%, mean age 64) cases of PCI. Of the 156 complications that occurred, 101 (64.7%) occurred intraoperatively, while 55 (35.3%) occurred postoperatively. The rates of diabetes (p=0.669), vascular disease (p=0.054), and history of intracavernosal injections (p=0.111) all had no statistically significant effect on corporal integrity. Patients with PCI tended to have hypertension (p=0.045), current smoking (p=0.03), history of IPP infection (p&amp;lt;0.001), and history of shunt for priapism (p&amp;lt;0.001). On multivariate analysis, predictors of PCI include hypertension (OR 1.64 (1.09-2.47), p=0.018), history of IPP infection (OR 4.41 (2.52-7.84), p&amp;lt;0.001), and age (OR 1.02 (1.00-1.04), p=0.027). Obesity was found to be protective (OR 0.63 (0.42-0.95), p=0.027). Conclusions Our multicenter analysis found that hypertension, current smoking, history of IPP infection and age were risk factors for complications associated with poor corporal integrity. Recognizing these risk factors preoperatively can allow for improved patient-specific counseling and changes in surgical strategy to potentially prevent these complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific.

PD42-04 BLOOD THINNERS: DO THEY NEED TO BE HELD FOR IPP SURGERY?

You have accessJournal of UrologyCME1 Apr 2023PD42-04 BLOOD THINNERS: DO THEY NEED TO BE HELD FOR IPP SURGERY? Niki Parikh, Reza Roshandel, Ryan Griggs, Gerard Henry, Paul Perito, Coral Gables, Saint Helena, and Tobias Kohler Niki ParikhNiki Parikh More articles by this author , Reza RoshandelReza Roshandel More articles by this author , Ryan GriggsRyan Griggs More articles by this author , Gerard HenryGerard Henry More articles by this author , Paul PeritoPaul Perito More articles by this author , Coral GablesCoral Gables More articles by this author , Saint HelenaSaint Helena More articles by this author , and Tobias KohlerTobias Kohler More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003352.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Inflatable penile prosthesis (IPP) placement on active anticoagulation (AC) is controversial. Techniques utilized to decrease complications include use of malleable implant, partial inflation of IPP for hemostasis, and placement of drain; however risk and benefits must be weighed. We sought to assess outcomes of IPP in men on AC in a multi-institutional study. METHODS: Data from 3 high-volume implant centers was retrospectively analyzed. Demographics, comorbidities, secondary procedures, drain placement/output, and complications were recorded. Aspirin was excluded as it is not routinely held. Center 1 utilizes a penoscrotal approach without drain placement, center 2 a penoscrotal approach with drain placement (removal when output <50 mL/8 hours), and center 3 an infra-pubic approach with drain for 3 days. RESULTS: 202 patients were continued on AC throughout surgery. 112 patients were on clopidogrel, 35 warfarin, 38 apixaban, 1 enoxaparin, 15 rivaroxaban, and 1 on combination therapy with clopidogrel and enoxaparin. AC requirement included peripheral vascular disease (55%), CHF (11%), cardiac stents (11.6%), DVT/PE/history of thrombosis (7%), atrial fibrillation (11%), cardiac valves (2.2%), stroke (1.3%), and preventive (0.9%). Nine patients on AC (3.98%) experienced complications including 4 significant events (1.9%): 1 major retropubic bleed requiring transfusion, 3 IPP infections and 5 minor events: 3 minor hematomas, 1 minor wound dehiscence and 1 CT negative stroke event. Drain outputs for center 3 averaged 113 ml, 81 ml, and 30 ml of output per day respectively with a total average output average of 223 ml and experienced no hematomas nor infections. Drain output for center 2 averaged 121 ml with the majority or patients having the drain for only one day. Drain output was significantly higher than historical non-AC controls (121 vs. 72 ml p=.001) but there was no difference in hematoma rate. Three hematomas and 1 infection occurred in this group. AC type, revision surgery, scrotoplasty, or reservoir technique did not affect outcomes nor drainage (p>.05). Complication rate (IPP infection and hematoma rate) where not different when compared to large cohorts from respective institutions. CONCLUSIONS: In high-volume implant centers, major complication rate of 1.9% occurred in IPP patients on AC. Although IPP is feasible in this patient population, drain for 3 days and submuscular reservoir placement may be indicated. In most, elective IPP surgery should be delayed until it is safe to discontinue anticoagulation. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1112 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Niki Parikh More articles by this author Reza Roshandel More articles by this author Ryan Griggs More articles by this author Gerard Henry More articles by this author Paul Perito More articles by this author Coral Gables More articles by this author Saint Helena More articles by this author Tobias Kohler More articles by this author Expand All Advertisement PDF downloadLoading ...

MP62-18 NEW FINDINGS REGARDING INDEPENDENT PREDICTORS OF POOR CORPORAL INTEGRITY IN A LARGE SERIES OF PENILE IMPLANT RECIPIENTS: A MULTICENTER INTERNATIONAL INVESTIGATION

You have accessJournal of UrologyCME1 Apr 2023MP62-18 NEW FINDINGS REGARDING INDEPENDENT PREDICTORS OF POOR CORPORAL INTEGRITY IN A LARGE SERIES OF PENILE IMPLANT RECIPIENTS: A MULTICENTER INTERNATIONAL INVESTIGATION Chrystal Chang, Zafardjan Dalimov, David Barham, Daniel Swerdloff, Hossein Sadeghi-Nejad, Robert Andrianne, Mike Hsieh, Martin Gross, Georgios Hatzichristodolou, Maxime Sempels, Daniar Osmonov, Aaron Lentz, Paul Perito, James Hotaling, Koenraad Van Renterghem, Sung Hun Park, Jonathan N. Warner, Faysal A. Yafi, and Jay Simhan Chrystal ChangChrystal Chang More articles by this author , Zafardjan DalimovZafardjan Dalimov More articles by this author , David BarhamDavid Barham More articles by this author , Daniel SwerdloffDaniel Swerdloff More articles by this author , Hossein Sadeghi-NejadHossein Sadeghi-Nejad More articles by this author , Robert AndrianneRobert Andrianne More articles by this author , Mike HsiehMike Hsieh More articles by this author , Martin GrossMartin Gross More articles by this author , Georgios HatzichristodolouGeorgios Hatzichristodolou More articles by this author , Maxime SempelsMaxime Sempels More articles by this author , Daniar OsmonovDaniar Osmonov More articles by this author , Aaron LentzAaron Lentz More articles by this author , Paul PeritoPaul Perito More articles by this author , James HotalingJames Hotaling More articles by this author , Koenraad Van RenterghemKoenraad Van Renterghem More articles by this author , Sung Hun ParkSung Hun Park More articles by this author , Jonathan N. WarnerJonathan N. Warner More articles by this author , Faysal A. YafiFaysal A. Yafi More articles by this author , and Jay SimhanJay Simhan More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003320.18AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Inflatable penile prosthesis (IPP) offers high satisfaction rates for patients, but this procedure is not without complications that can be encountered either intraoperatively or postoperatively. Particularly, predictors of intraoperative corporal perforation and delayed cylinder complications in IPP placement have not been well-delineated. We hypothesize that preoperative and intraoperative variables may impact the integrity of the corporal bodies long-term and thus implant viability. METHODS: We retrospectively reviewed a large, multi-institutional collaborative study of IPP surgeries performed by expert implanters from 2016-2021. All primary and revision cases were included. Salvage cases for infection were excluded. Demographic characteristics, intraoperative variables, and postoperative outcomes were assessed. PCI was defined as intraoperative corporal complications (proximal and/or distal perforation of the corpora, corporal crossover) or postoperative corporal complications (cylinder erosion, extrusion, impending erosion, or deformity). Risk factor analysis and multivariate analysis were performed to identify independent predictors of PCI. RESULTS: After excluding salvage cases for infection, we identified 5,153 patients undergoing IPPs, of which 149 were diagnosed with PCI. The rates of diabetes (p=0.19), immunosuppression (p=0.79), priapism (p=0.06), history of radiation (p=0.29), and prior use of intracavernosal injections (p=0.19) all had no significant effect on corporal integrity. Patients with PCI were more likely to have active coronary artery disease (CAD) or peripheral vascular disease (PVD) (p=0.02), be current smokers (p=0.003), and have a history of IPP infection (p<0.001). On multivariate analysis, predictors of PCI included older age (OR 1.02 (1.00-1.04), p=0.03), CAD/PVD (OR 1.58 (1.06-2.35), p=0.025) and history of IPP infection (OR 5.82 (3.27-10.34), p<0.001). Obesity (OR 0.582 (0.40-0.86), p=.006) and non-Caucasian race (OR 0.60 (0.41-0.88), p=0.01) were found to be protective. CONCLUSIONS: Our multicenter analysis found that CAD/PVD, current smoking, and history of IPP infection were risk factors for complications associated with poor corporal integrity. Recognizing these risk factors preoperatively can allow for improved patient-specific counseling and changes in surgical strategy to potentially promote longer term device viability. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e869 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Chrystal Chang More articles by this author Zafardjan Dalimov More articles by this author David Barham More articles by this author Daniel Swerdloff More articles by this author Hossein Sadeghi-Nejad More articles by this author Robert Andrianne More articles by this author Mike Hsieh More articles by this author Martin Gross More articles by this author Georgios Hatzichristodolou More articles by this author Maxime Sempels More articles by this author Daniar Osmonov More articles by this author Aaron Lentz More articles by this author Paul Perito More articles by this author James Hotaling More articles by this author Koenraad Van Renterghem More articles by this author Sung Hun Park More articles by this author Jonathan N. Warner More articles by this author Faysal A. Yafi More articles by this author Jay Simhan More articles by this author Expand All Advertisement PDF downloadLoading ...

Timing and causative organisms associated with modern inflatable penile prosthesis infection: an institutional retrospective.

The advent of antibiotic-coated devices has reduced the rate of inflatable penile prosthesis (IPP) infections; however, this may have altered microbial profiles when infections do occur. To describe the timing and causative organisms behind infection of infection retardant-coated IPPs in the context of our institution's perioperative antimicrobial protocols. We retrospectively reviewed all patients undergoing IPP placement at our institution from January 2014 to January 2022. In all patients, perioperative antibiotic administration was congruent with American Urological Association guidelines. Boston Scientific devices are impregnated with InhibiZone (rifampin and minocycline), and all Coloplast devices were soaked in rifampin and gentamicin. Intraoperative irrigation was performed with betadine 5% irrigation prior to November 2016 and with vancomycin-gentamicin solution afterward. Cases involving prosthesis infection were identified, and variables were extracted from the medical record. Descriptive and comparative statistics were tabulated to identify clinical characteristics, including patient comorbidities, prophylaxis regimen, symptom onset, and intraoperative culture result. We previously reported an increased infection risk with Betadine irrigation and stratified results accordingly. The primary outcome was time to infectious symptoms, while the secondary outcome was description of device cultures at the time of explantation. A total of 1071 patients underwent IPP placement over 8 years with an overall infection rate of 2.6% (28/1071). After discontinuation of Betadine, the overall infection rate was significantly lower at 0.9% (8/919) with a relative riskof16.9 with Betadine (P < .0001). Primary procedures represented 46.4% (13/28). Of 28 patients with infection, only 1 had no identified risk factors; the remainder included Betadine at 71% (20/28), revision/salvage procedure at 53.6% (15/28), and diabetes at 50% (14/28). Median time to symptoms was 36days (IQR, 26-52); almost 30% of patients had systemic symptoms. Organisms with high virulence, or ability to cause disease, were found in 90.5% (19/21) of positive cultures. Our study revealed a median time to symptoms of just over 1month. Risk factors for infection were Betadine 5% irrigation, diabetes, and revision/salvage cases. Over 90% causative organisms were virulent, demonstrating a microbial profile trend since antibiotic coating development. The large prospectively maintained database is a strength along with the ability to follow specific changes in perioperative protocols. The retrospective nature of the study is a limitation as well as the low infection rate, which limits certain subanalyses from being performed. IPP infections present in a delayed manner despite the rising virulence of infecting organisms. These findings highlight areas for improvement in perioperative protocols in the contemporary prosthetics era.

Immediate salvage with inflatable penile prosthesis in an infected field: A contemporary multi-institutional cohort

ABSTRACT Introduction Contemporary management of inflatable penile prosthesis (IPP) infections involves removal and replacement to minimize corporal fibrosis and penile shortening. Many urologists prefer a malleable prosthesis (MP) followed by staged conversion to IPP, a technique thought to improve outcomes by allowing treatment of the infection while maintaining intracorporeal volume. A staged procedure involves additional surgery with associated risks. Previous studies suggest an 18% infection risk of placing a second device in a non-infected, revision setting, and that infection risk increases with each subsequent procedure. Objective Our study aims to delineate whether immediate IPP salvage in an infected field yields similar complication rates to the staged approach. Methods Retrospective review at 5 institutions from February 2010 to October 2020 identified patients with IPP infection who underwent IPP salvage. Demographic, laboratory, operative, and microbiology data were collected. Emphasis was placed on the salvage operative technique, duration of antibiotics, and post-salvage complications. Results 19 patients underwent immediate salvage with IPP in the setting of a suspected infection. Average age at initial implantation was 59.9 years. Median time from initial implant to presentation with infectious symptoms was 2.4 months, and revision was performed a median of 1.5 days after presentation and initiation of antibiotics. Intraoperative complications were rare (5.3%), and post-salvage complications were 21.1%, including 1 cylinder herniation and 3 post salvage infections (15.8%). Only 1 post-salvage infection showed concordance with initial cultures while 1 was discordant and the third showed no growth (Table 1). Fisher's exact test showed diabetes, purulence in the operative field, use of drain, or washout type were not associated with infection post-salvage. Conclusions Immediate IPP salvage in the setting of an acutely infected field shows a complication profile not exceeding published data in the staged revision setting. Although staged MP-IPP salvage has been favored by many surgeons, the complication profile may be equivalent to immediate IPP salvage, and the risks of a subsequent operation should be considered. Disclosure Work supported by industry: no.

Inflatable penile prosthesis infection successfully managed by non-operative novel treatment strategies: A case report

ABSTRACT Introduction IPP infections occur in approximately 1% of cases. The fundamental principle for treatment has always been surgical removal of all components. Explantation/reimplantation surgery, however, may be unsuccessful, require additional surgeries, and/or result in poor patient satisfaction, reduced penile sensation, and decreased penile length. A patient presented 4 weeks post-op with an obvious IPP infection. Culture of scrotal drainage prior to antibiotic administration grew serratia marcescens, enterococcus faecalis, and citrobacter freundii. The patient was informed explanation was required, but he refused and requested we “do what we can” first. He was made aware of the lack of data supporting non-operative strategies for IPP infection. Objective To present, likely for the first time, non-operative strategies including IV/oral antibiotics, low intensity shockwave therapy (LiSWT), and immune therapy can result in successful IPP infection treatment. Methods A 49 yo with a 14 year history of ED underwent insertion of an 20 cm Titan IPP (Coloplast) with submuscular reservoir placement. Four weeks post-op he presented with fever (101°F), elevated WBC (15,400), purulent drainage from a swollen, tender scrotum, and tenderness of all IPP components. We discussed non-operative management. He was admitted for broad spectrum IV antibiotics/antifungal agents: Vancomycin, Piperacillin and Tazobactam, and Fluconazole. After 6 days of IV antibiotics the patient became afebrile, WBC normalized (8,000) but he developed mildly abnormal renal and liver function tests. He was discharged on oral Levofloxacin daily for 30 days. Grayscale ultrasound showed fluid around the pump and scrotal tubing with significant device tenderness and scrotal drainage through two small sinus tracts confirming persistent infection. We assessed the degree of purulent scrotal drainage on gauze kept on the scrotum for 10 hour periods. LiSWT (Urogold 100 MTS, parabolic unfocused probe OPP 155, energy flux density 0.13 mJ/mm2, Hz 3.0, total shocks 6,600/treatment) was administered to the device components and scrotum for two weeks daily, then twice weekly x 2 weeks and then weekly x 4 weeks. Concomitantly he received immune therapy via subcutaneous peptide administration and ozone blood dialysis twice weekly x2 weeks and then weekly x 4 weeks. Results The patient progressively improved, remaining afebrile, with WBC (5,000) and liver and renal function tests normalized at 1 week. Scrotal drainage stopped at 2 weeks and scrotal sinus tracts healed. There was no pain/tenderness of device components or scrotum at 2.5 weeks. There was no skin fixation to any device component. The patient could easily inflate/deflate the device to full rigidity/flaccidity without pain at 3 weeks and intercourse with orgasm at 5 weeks. Grayscale ultrasound at 4 weeks showed absent fluid around the device components. Conclusions This is the first case report of successful management of an infected IPP using non-operative novel treatments. The effect of immune therapy is to enhance immune response to infection. Concerning the management of infection with LiSWT, it has been shown to have anti-infective properties, upregulate/recruit anti-bacterial/microbial peptide LL37, increase local blood flow, possibly inhibit biofilm, and result in salvage of infected breast and hip prostheses. Disclosure Work supported by industry: no.

Immediate Salvage with Inflatable Penile Prosthesis in an Infected Field: A Contemporary Multi-institutional Cohort

ABSTRACT Introduction Contemporary management of inflatable penile prosthesis (IPP) infections involves removal and replacement to minimize corporal fibrosis and penile shortening. Many urologists prefer a malleable prosthesis (MP) followed by staged conversion to IPP, a technique thought to improve outcomes by allowing treatment of the infection while maintaining intracorporeal volume. A staged procedure involves additional surgery with associated risks. Previous studies suggest an 18% infection risk of placing a second device in a non-infected, revision setting, and that infection risk increases with each subsequent procedure. Objective Our study aims to delineate whether immediate IPP salvage in an infected field yields similar complication rates to the staged approach. Methods Retrospective review at 5 different institutions from February 2010 to October 2020 identified patients with IPP infection who underwent IPP salvage. Patient demographic, laboratory, operative, and microbiology data were collected. Emphasis was placed on the salvage operative technique, duration of antibiotics, and post-salvage complications. Results Overall, 19 patients underwent immediate salvage with IPP in the setting of a suspected infection. Average age at initial implantation was 59.9 years. Median time from initial implant to presentation with infectious symptoms was 2.4 months, and revision was performed a median of 1.5 days after presentation and initiation of antibiotics. Intraoperative complications were rare (5.3%), and post-salvage complications were 21.1%, including 1 cylinder herniation and 3 post salvage infections (15.8%). Only 1 post-salvage infection showed concordance with initial cultures while 1 was discordant and the third showed no growth (Table 1). Fisher's exact test showed diabetes, purulence in the operative field, use of drain, or washout type were not associated with infection post-salvage. Conclusions Immediate IPP salvage in the setting of an acutely infected field shows a complication profile not exceeding published data in the staged revision setting. Although staged MP-IPP salvage has been favored by many surgeons, the complication profile may be equivalent to immediate IPP salvage, and the risks of a subsequent operation should be considered. Disclosure No

Penile prosthesis salvage: a historical look at the Mulcahy technique and a review of the latest literature.

Historically, management of inflatable penile prosthesis infection was explantation of the device with delayed reimplantation at a later date. In 1991, this paradigm was challenged when early attempts at washout and immediate salvage proved successful. The clinical experiences and data generated over the past 30 years have allowed implanters to refine their salvage procedures to improve patient outcomes. In this article, we review the original Mulcahy technique for salvage and discuss updates to this protocol based on recent data.

The Association Between Hemoglobin A1c Levels and Inflatable Penile Prosthesis Infection: Analysis of US Insurance Claims Data

BackgroundThe association between elevated hemoglobin A1c (HbA1c) levels and the risk of postoperative infection after penile prosthesis surgery remains controversial. AimTo examine the association between HbA1c levels and penile implant infections in men undergoing inflatable penile prosthesis (IPP) surgery for erectile dysfunction using a large insurance claims database. MethodsThis was a retrospective review using Optum's de-identified Clinformatics Data Mart Database. Male subjects 18 years and older with available laboratory data undergoing IPP insertion between 2003 and 2018 were included. Administrative diagnosis and procedural codes were used to assess subsequent penile implant revision surgery status for either infectious or noninfectious causes. Associated conditions were controlled for such as smoking status, hyperlipidemia, hypertension, obesity status, and Peyronie's disease. OutcomesThe main outcomes were risk of revision for infection and time to revision. ResultsA total of 2,363 individuals underwent initial IPP insertion and had available HbA1c data with a mean HbA1c of 6.9%. The overall IPP infection revision rate was 3.9% and the highest rate of 12.1% was seen in the highest HbA1c group (>10%). After adjusting for demographic and health factors, a higher HbA1c level was associated with a higher risk of revision for infection, with every 1 point increase in HbA1c conferring an increased risk of infection requiring revision by 29% (95% CI 17–42%). When infections did occur, they happened sooner in men with HbA1c > 10.0% with an average of 1.3 months vs 3.5 months in the HbA1c < 6.0% group. Clinical ImplicationsThese findings provide insight into the potential relationship between HbA1c levels and postoperative risk of infection after penile prosthesis surgery and may aid in clinical decision-making. Strengths and LimitationsStrengths include the large sample size, length of data coverage, and real-world analysis of surgeries done across the United States. Limitations include the reliance on insurance claims data, the retrospective study design, and lack of additional relevant clinical variables that may impact infection rates. ConclusionsWhile the overall risk of penile prosthesis infection remains modest, the current report notes an increased risk of infection for diabetic men with poor glycemic control.Chen T, Li S, Eisenberg ML. The Association Between Hemoglobin A1c Levels and Inflatable Penile Prosthesis Infection: Analysis of US Insurance Claims Data. J Sex Med 2021;18:1104–1109.

Penile Implant Infection: Experience With Expanded Salvage Criteria and a Shortened Course of Postoperative Antibiotics.

IntroductionThe preferred treatment for inflatable penile prosthesis (IPP) infection includes antibiotic therapy, device removal, and immediate replacement. While this is an accepted procedure, the delivery and length of postoperative antibiotics are not standardized. Furthermore, historical salvage criteria may be overly restrictive given the new salvage techniques.AimOur aim is to determine if an expanded salvage criteria and shorter course of antibiotics demonstrate acceptable IPP infection rates.MethodsWe retrospectively reviewed 466 consecutive IPP cases from a single surgeon between March 2014 and March 2019. Salvage and reinfection were determined by current procedural terminology codes, and the final cohort was individually reviewed for integrity. Demographic, operative, and culture data from each patient were obtained. All patients were discharged on oral antibiotics after initial salvage. Patients were not excluded for exposed hardware, immunosuppression, tissue necrosis, severe diabetes, or corporal purulence. Owing to the small sample size, only descriptive statistics were used to describe the final cohort.Main Outcome MeasuresThe main outcome measures were classification of microorganisms cultured at the time of salvage and salvage failure rate.ResultsA total of 26 cases of IPP infections (6%) were identified. The median (interquartile ratio) age and body mass index were 62 (58–66) and 32 (28–34), respectively. During initial salvage, gross purulence was noted in 9 patients (35%), and 22 patients (84%) had a malleable prosthesis placed. The most prescribed postoperative antibiotic was Bactrim/Augmentin with a median (interquartile ratio) antibiotic duration of 14 days (11–14). After IPP salvage, 2 patients (8%) developed a reinfection while on oral antibiotics. One of those patients was immunosuppressed, and the other was infected with Candida glabrata.ConclusionExpanded salvage criteria and postoperative oral antibiotic duration of at least 14 days demonstrated an acceptable infection rate. This suggests that a longer antibiotic therapy may not be necessary.Chandrapal J, Harper S, Davis LG, et al. Penile Implant Infection: Experience With Expanded Salvage Criteria and a Shortened Course of Postoperative Antibiotics. Sex Med 2020;8:383–387.

Multicenter investigation on the influence of climate in penile prosthesis infection.

The purpose of this study is to investigate the relationship between inflatable penile prosthesis (IPP) infection, time of year, climate, temperature and humidity. This is a retrospective IRB-approved analysis of 211 patients at 25 institutions who underwent salvage procedure or device explant between 2001 and 2016. Patient data were compiled after an extensive review of all aspects of their electronic medical records. Climate data were compiled from monthly norms based on location, as well as specific data regarding temperature, dew point, and humidity from dates of surgery. Rigorous statistical analysis was performed. We found that penile prosthesis infections occurred more commonly in June (n = 24) and less frequently during the winter months (n = 39), with the lowest number occurring in March (n = 11). One-hundred thirty-nine infections occurred at average daily temperatures greater than 55 °F, compared to 72 infections at less than 55 °F. The incidence rate ratio for this trend was 1.93, with a p-value of <0.001. Humidity results were similar, and fungal infections correlate with daily humidity. Infected implants performed in the fall and summer were over 3 and 2.3 times, respectively, more likely to grow Gram-positive bacteria compared to implants performed in spring (p = 0.004; p = 0.039). This was consistent across geographic location, including in the Southern hemisphere. We found trends between climate factors and IPP infection like those seen and proven in other surgical literature. To our knowledge these data represent the first exploration of the relationship between temperature and infection in prosthetic urology.