Penile Prosthesis Infection Research Articles

Perioperative infection prevention during inflatable penile prosthesis surgery: a narrative review.

Penile prostheses are an option for the management of erectile dysfunction (ED). Over the years penile prosthesis surgery has become increasingly safe owing to improvements such as antibiotic usage, coated devices, and surgical techniques. However, infection remains a dreaded complication during prosthesis surgery. Efforts to minimize risk of infection in the perioperative period have been extensively studied. Herein, we performed a narrative review on preoperative, intraoperative, and postoperative strategies for infection prevention during placement of a penile prosthesis with a comparison of infection prevention strategies to other surgical fields. A literature review was performed using PubMed and Google Scholar. Studies evaluating perioperative management of penile prosthesis infection were included. The following search terms were used to for our literature search: penile prosthesis, inflatable penile prosthesis, infection, prevention, perioperative management. Articles were graded based on the 2011 Oxford Centre for Evidence Based Medicine (OCEBM) guidelines and a table was generated with each intervention discussed and its level of evidence based on current literature. Optimization of patient's comorbid conditions can help reduce risk during prosthesis operations. Monitoring and optimizing a patient's glycemic control has been investigated, but the current literature does not necessarily support a strict hemoglobin A1c (HbA1c) or pre-operative blood glucose level. Surgical field preparation using chlorhexidine-based solutions has been shown to be superior to iodine-based solutions. Appropriately selected peri-operative antibiotics have also been shown to reduce infection risk. Intraoperatively, the use of coated devices in addition to a 'no touch' technique have been shown to significantly reduce the risk of inflatable penile prosthesis (IPP) infection. Post operatively, available evidence of antibiotic use has not been demonstrated to be effective in reducing infection rates. Surgical infection following placement of an IPP is a devastating and morbid complication with infection rate up as high as 1-3% in virgin cases and 7-18% in revision cases. While perioperative techniques exist and have reduced risk of infection, more prospective data is needed to evaluate the clinical significance of these different approaches. More research in these areas, along with future options such as nanoparticles, antibiotic coated suture, and next generation sequencing (NGS) for bacterial pathogens, may shed light on further ways to optimize infection reduction strategies for prosthesis surgery.

Narrative review of immediate salvage for penile prosthesis infection.

Implantation of a penile prosthesis is a reliable option for men with erectile dysfunction (ED) refractory to less invasive therapies. While the frequency of penile prosthesis infections have decreased, they remain a devastating complication. Herein we discuss why immediate salvage surgery is an essential technique for the management of implant infections. We will also describe the relevant advancements to this technique. We conducted a narrative review via computer based search of PubMed for all relevant articles on penile prosthesis infection management, including guidelines, case series, reviews, and expert opinions. Search terms used included: "inflatable penile prosthesis", "IPP", "penile prosthesis", "salvage", "treatment", "delayed", "immediate". Only English peer-reviewed publications were included. Historically, patients who presented with penile prosthesis infections were exclusively managed with complete removal of the prosthesis without replacement. Although this strategy is safe, it hastens immediate ED and corporal fibrosis, resulting in loss of penile length and increased difficulty with subsequent prosthesis replacement. Previous case series have reported successful treatment of localized penile prosthesis infections with nonsurgical treatment, but the role of conservative treatment remains limited. The current standard of immediate salvage entails removal of the infected prosthesis and washout followed by immediate replacement with a new penile prosthesis. This technique has been demonstrated to be safe and effective, thus allowing patients to resume intercourse and maintain penile length. Immediate salvage surgery is safe and effective, and has emerged as the preferred strategy for the management of most patients with a penile prosthesis infection.

The Management of Inflatable Penile Prosthesis Erosion and Infection following Iatrogenic Aspiration

The Management of Inflatable Penile Prosthesis Erosion and Infection following Iatrogenic Aspiration

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.

(161) Is there a Difference in Inflatable Penile Prosthesis Mechanical Failure and Infections Rates in Relation to Prostate Cancer Treatment Modality (Radiation Therapy vs Radical Prostatectomy)

Abstract Introduction Inflatable Penile Prosthesis (IPP) implantation as a treatment for ED has high satisfaction rates in the general population; however, there is limited literature on quantification of complication rates as stratified by ED etiology. Objective Our aim was to compare mechanical failure and infection rates in patients undergoing IPP implantation for ED following Radical Prostatectomy (RP) versus radiation therapy (RT) for prostate cancer. Methods A retrospective chart review from our institutional database was conducted to identify 405 patients who underwent IPP placement at our institution from 2015–2019, then selecting for those whose etiology of ED was following RP or RT. To prevent crossover confounding; patients with history of pelvic radiation or salvage radiotherapy were excluded from the RP group and patients with history of RP were excluded from the RT group. Data was obtained from 75 patients who met criteria for inclusion: 44 patients in the RP group and 31 patients in the RT group. Mechanical failure, infection rates, mean EDITS scores and additional survey questions were compared between the radiation and RP groups. Results Patient demographic information and IPP complication and satisfaction rates are listed below in Table 1 and Figure 1. There was a statistically significant difference in number of patients experiencing IPP complications, 19.4% (n=6) of patients in the RT cohort and 4.5% (n=2) in the RP cohort, respectively. There was no statistically significant difference found in stratified complications- infection rates, device erosion rates, mechanical failure rates, or device removal and/or replacement rates between the two groups. The RP cohort had a significantly higher mean Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire score versus the RT cohort, 91.58 to 76.02, respectively. Conclusions These preliminary findings, while requiring large-scale follow up, suggest that there is a higher rate of IPP related complications in patients with device placement following RT for prostate cancer versus RP. Disclosure No.

(025) Laparoscopic Assisted Reservoir Removal of an Infected Inflatable Penile Prosthesis in a Patient with Ipsilateral Inguinal Hernia Mesh Implant

Abstract Introduction Infection is a devastating complication of penile prosthesis implantation ranging from 0.33 to 11.4%. 1 Although a salvage procedure is an option in case of infection, the rule of thumb is to remove all device components. 2 Special considerations and pre-operative planning are essential for better outcome in the management of such condition. We are presenting a video case presentation demonstrating the use of laparoscopic assisted approach to aid in the extraction of the reservoir of an infected penile prosthesis from a patient who had ipsilateral inguinal hernia mesh implant Objective To demonstrate the feasibility and efficacy laparoscopic assisted approach in the removal of difficult to extract inflatable penile prosthesis (IPP) reservoir. Methods A 72-year-old gentleman with past medical history of Diabetes and hypertension presented to our clinic 3 weeks after an IPP insertion that was done in another center. He was complaining of right inguinal bulge and scrotal pain. The bulge developed suddenly without any preceding event. Examination confirmed a prosthesis reservoir herniation in to the right groin. Plan CT abdomen& pelvis confirmed the diagnosis. In three days, the herniated reservoir was managed by inguinal exploration, repositioning of the same reservoir in the right Retzius space and posterior inguinal canal wall repair using a mesh. The patient was discharged on post-operative day 1 in a stable condition, but unfortunately, he developed persistent scrotal pain that progressed into an overt scrotal infection over the early follow up period. During the examination, a scrotal collection was observed, swap was taken from the draining pus and results showed moderate growth of pseudomonas aeruginosa. On the other hand, the inguinal scar showed good healing with no tenderness, indicating the presence of an intact and non-infected inguinal mesh. Therefore, the decision was made to remove all components of the prosthesis without removing the mesh. Considering the anticipated challenges associated with removing the reservoir of the IPP through a scrotal approach, a decision was made to incorporate an additional laparoscopic-assisted abdominal approach for reservoir removal. Results Removal of the IPP cylinders and pump was performed through a scrotal incision, then a laparoscopic assisted abdominal approach was used successfully to remove the reservoir. After the IPP explant procedure, patient had an uneventful smooth recovery at the two and four weeks follow up visits, he was advised to use Vacuum erection device (VED) to alleviate possible penile fibrosis/shortening. A penile prosthesis reimplantation procedure was planned in a 6 months period Conclusions Laparoscopic assisted approach for penile prosthesis reservoir extraction is a feasible and safe technique that can be used in anticipated cases of difficult reservoir extraction. Pre-operative assessment, planning and counselling are crucial in obtaining a favorable outcome in such complex cases. Disclosure No.

(262) Salvage Penile Prosthetic Surgery, Unique Surgical Technique. Institutional Experience

Abstract Introduction `-Penile prosthesis surgery represents the end-stage treatment for erectile dysfunction. It is conventionally used only in cases of erectile dysfunction refractory to pharmacological treatments. -Penile prothesis surgery is associated with a high satisfaction rate and a low complication profile. However, it must be appreciated that the complications of surgery can have devastating consequences on a patient's quality of life and satisfaction and include infection, prosthesis malfunction, penile corporal perforation and penile length loss. -This study discusses the diagnosis and management of infected penile prosthesis with highlighting special intra-operative surgical technique that might be a valuable step in Salvage penile prosthetic surgery Objective Since its introduction in 1996 Mulcahy salvage has significantly improved outcomes for the removal and replacement of infected penile prostheses. Long-term follow up data of Mulcahy salvage show an infection-free rate of 82%. In our study we evaluated the Salvage Penile Prosthetic Surgery Cases done in our tertiary institution since (2000 up to date) and introduce the unique surgical technique that resulted in reduction the re-infetion rate. Methods This is a retrospective, institutional review Results total of 13 Salvage penile prosthetic surgeries done in our tertiary center since between 2000 and 2023 out of them only one case developed reinfection and ended with penile prosthesis removal. Therefor, the rate of re-infection is 8% comparing with latest successe rate of Mulcahy technique (18%) We applied surgical step intra- operative that might be the underling reason of decreasing the the reinfection rate that will be presented in details. Conclusions This retrospective analysis of salvage procedures and replacement of infected penile prosthesis with malleable prosthesis shows a high infection-free rate. Disclosure No.

(131) Predictors of Success with Early Antibiotic Therapy for Penile Implant Infection: Patients from a Prospective Randomized Study Comparing DNA Sequencing versus Traditional Cultures

Abstract Introduction Traditional culture is the current standard-of-care to determine therapeutic antibiotics for patients suffering from penile prosthesis (PP) infections. However, approximately 30% to 50% of PPs removed for infection are culture negative. Next-generation sequencing (NGS) of DNA has proven to be beneficial in its thorough analysis of biofilm composition. However, there are no existing clinical measures for identifying presenting characteristics of patients of successful or failed antibiotic treatments. Objective The purpose of this early dataset is to identify patient characteristics predicting success or failure with early antibiotic therapy in the setting of penile implant infection. Methods Upon institutional review board approval, adult men undergoing treatment for mild to moderate clinical (non-systemic) PP infection are enrolled after providing informed consent. Enrollees are randomized into one of two analytic arms – traditional culture or NGS. Traditional culture and NGS samples are collected upon clinical presentation prior to initiation of antibiotics. Patients are started on set empiric antibiotics and randomized to traditional culture or NGS. Patients follow up within ten days of antibiotic initiation and at six months complete a safety and compliance questionnaire which assesses symptoms, device function, and patient satisfaction. Results Of the 8 patients enrolled in the study, 4 eventually underwent device explantation due to worsening infection within 7 days of initiating empiric antibiotic treatment. The other 4 patients went on to the next step in the protocol. In evaluating these 2 groups: if there was penile shaft tenderness (2/4) this required PP removal prior to 7 days; while if there was no penile tenderness, the patient ended up with the device surviving at least 10 days. Patients on the NGS arm included those that survived the entire 6-month period. Currently, there are 11 active sites already participating; more patients and more centers are being enrolled in the study. Conclusions Penile shaft tenderness was a more common presentation in patients who failed early antibiotic treatment for penile implant infection. Recruitment of additional patients to this prospective, randomized controlled trial will help to identify additional favorable presentations of penile implant infection in addition to comparing the utility and outcomes of NGS and culture. Disclosure Yes, this is sponsored by industry/sponsor: Microgen Dx. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Microgen Dx.

(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.

Understanding the Complex Relationship between Diabetes, HbA1c Levels, and Penile Prosthesis Infections: A Comprehensive Analysis and Clinical Implications

Understanding the Complex Relationship between Diabetes, HbA1c Levels, and Penile Prosthesis Infections: A Comprehensive Analysis and Clinical Implications

Rigicon disposable Furlow insertion tool has the potential to decrease infection rates after inflatable penile prosthesis implantation.

Furlow insertion tool is frequently used during the insertion of the inflatable penile prosthesis cylinders inside the corporal bodies. Although these devices are completely disassembled and separately sterilized after each operation, the residual blood clots and tissues after inadequate cleaning may become the primary sources of penile prosthesis infection. In order to minimize the risk of infection, Rigicon, Inc. (NY, USA) has developed the first disposable Furlow insertion tool. Head-to-head comparison studies with conventional and disposable Furlow insertion tools are necessary to confirm if there is a significant difference in post-implant infection rates.

(113) Hydrophilic Inflatable Penile Prothesis (HC-IPP) Discs Inoculated With Aerobic and Anaerobic Bacteria and Fungal Species Dipped in 0.05% Chlorhexidine Gluconate (CHG) Irrigation Solution and Irrigated With the Device to Evaluate Real World Situations

Abstract Introduction Hydrophilic-coated implants have significantly decreased penile prosthesis infection (PPI) since their release in 2001. However, the microbial spectrum of PPI has significantly changed. Based on recent Next Generation Sequencing literature, gram negative and fungal species are now included in the three most common organisms isolated. The Titan (Coloplast, Minneapolis, MN, USA) implant enables surgeons to choose a dipping solution according to their local biogram and preference. Irrisept (Irrimax, Lawrenceville, GA, USA) is 0.05% chlorhexidine gluconate (CHG) solution and has an extensive profile for microbial kill, including many aerobic, anaerobic, and fungal species known to cause PPI. Objective Evaluate microbial reduction on HC-IPP material dipped and irrigated with 0.05% CHG irrigation device using a validated microbiological study design: microbial contamination with microbial reduction counts following treatment. Methods An In-Vitro evaluation of the ability of an irrigation device to reduce transient bacterial contamination from a Test Substrate - pre-cut discs prepared from a HC-IPP material. Seven common PPI microorganisms - Bacteroides fragilis (A TCC #25285), Candida albicans (A TCC #10231), Enterococcus faeca/is (A TCC #29212), Escherichia coli (A TCC #25922), Pseudomonas aeruginosa (ATCC #27853), Staphylococcus aureus (ATCC #29213) and Staphylococcus epidermidis (ATCC #12228) were used for this evaluation. For each challenge species, three discs of the implant material (i.e., carriers) were pre-conditioned by immersion in 0.9% Sodium Chloride Irrigation, USP (Baseline Controls), and six discs were pre-conditioned by immersion in the test irrigation solution, (Irrisept®; Test Carriers). The pre-conditioned carriers were allowed to dry for approximately 10 minutes prior to contamination with a suspension of each test strain. Following a 2-to-3-minute drying period at room temperature, the three contaminated Baseline Carriers were evaluated for viable microbial recoveries. Three of the contaminated and dried Test Carriers were evaluated for viable microbial recoveries with no additional treatment (Pre- Rinse Test Carriers). The three remaining Test Carriers were evaluated following a rinsing procedure using 200cc of Wound Irrigation Device/Solution (Post-Rinse Test Carriers) at three time points, mimicking an in-vivo practice. Results Table 1 presents the Initial population (CFU/mL), Mean Baseline Control Recovery (normal saline log10) and the mean Post-Exposure Recovery (0.05% CHG log10), and Mean Post-Exposure Reduction (0.05% CHG log10) following three separate 150cc irrigations (one full bottle/disk with 0.05% CHG irrigation device. (lrrisept 450mL [Lot #21HDB982]). Conclusions Dipped and irrigated HC-IPP material discs with the irrigation device containing 0.05% CHG results in clinically significant log10 reductions in tested microbial strains. All previous studies on this subject matter have used zone of inhibition (ZOI) testing only. This microbiological methodology is superior as it is quantitative not qualitative, and can evaluate bactericidal, viricidal and fungicidal activity. Disclosure Yes, this is sponsored by industry/sponsor: Irrimax Corporation, Coloplast Corporation Clarification Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Irrimax.

(247) Complication Rates After Penile Prostheses In Men with History of Priapism – A Retrospective Claims Database Cohort Analysis

Abstract Introduction Penile prostheses can be placed in men with a history of priapism who develop erectile dysfunction, or as initial management of acute ischemic priapism. However, little is known about long-term complications associated with prostheses in these men. Objective To assess the risk of penile prosthesis complications in men with a history of priapism. Methods We searched the TriNetX insurance claims database to create a cohort of men ages ≥16 years old with 1) a diagnosis of priapism (ICD-10: N48.4), 2) a diagnosis of erectile dysfunction (ICD-10: N52), and 3) had undergone prosthesis placement (insertion of penile prosthesis inflatable and self-contained [CPT: 54401], insertion of semi-rigid penile prosthesis [CPT 54400], or insertion of multiple component inflatable penile prosthesis [CPT: 54405]). Three complications were assessed: penile prosthesis infection (ICD-10: T83.61), penile prosthesis mechanical breakdown (ICD-10: T83.410A), and penile prosthesis displacement or migration (ICD-10: T83.420). Rates of and duration to IPP removal (CPT: 54415-17, 54406, 54410-11) were also assessed. To compare rates of complications, the priapism cohort was compared to a cohort of men with a diagnosis of erectile dysfunction and prosthesis placement but without a history of priapism or corpora cavernosal irrigation, matched by age, race, diabetes status, and obesity (E66). When assessing risk of prosthesis complications, we utilized 1:1 greedy nearest-neighbor propensity score matching to control for confounding variables. Results A total of 665 men were identified with a diagnosis of priapism and erectile dysfunction who subsequently received a penile prosthesis. A control group of 31,345 patients with erectile dysfunction and a penile prosthesis but without priapism or history of irrigation was identified, and ultimately 660 men in the case and control cohorts were matched by age, race, diabetes status, and obesity. Men of with a history of priapism were more likely to experience penile prosthesis infection (5.0% vs 2.7%; Risk Ratio (RR): 1.83, 95% Confidence Interval (CI) 1.04-3.22) and mechanical breakdown of the prosthesis (7.3% vs 3.8%, RR: 1.92, 95%CI 1.20-3.08). There was no difference in the rate of penile prosthesis displacement or migration (3.5% vs 2.4%, RR: 0.76, 95%CI 0.77-2.70). Overall rates of penile prosthesis explantation were higher in men with a history of priapism 14.6% vs 8.4% (RR: 1.73, 95%CI 1.27-2.36). Rates of early explantation (within 6 months of placement) were similar between the two groups, 3.3% vs 2.9% (RR: 1.16, 95%CI 0.63-2.11). Rate of explantation of semi-rigid prostheses were significantly higher in men with a history of priapism, 27% vs 9.6% (RR: 2.54, 95%CI 1.62-3.93). Of the 17 men undergoing explantation of semi-rigid prosthesis with history of priapism, only 4 men (23%) went on to have a 3-piece penile prosthesis placed. Conclusions In this US claims-based database comparison between prosthetic complications in men with and without a history of priapism, men with priapism were more likely to experience infection, mechanical breakdown and explantation. There was no difference in rate of device displacement or migration, or in timing of device explantation. This real-world data provides context for counseling men with priapism who undergo prosthesis placement. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Urogen Pharma, Janssen Global Services, Regeneron Pharmaceuticals

(549) Case Report of an IPP Reservoir Salvage Following Infection

Abstract Introduction Inflatable penile prosthesis (IPP) infections are rare and devastating. IPP infections are treated with either explant or salvage, the latter with either a malleable or inflatable device. Isolated component infections are very rare in the literature. This is the first description of successful treatment of an isolated IPP reservoir infection, with preservation and eventual reuse of the patient’s uninfected pump and cylinders. Objective To report a case of successful IPP salvage after an isolated reservoir infection. Methods This is a case study of IPP reservoir explant and eventual reimplant in a 51-year-old male, with preservation of the implant pump and cylinders. Past medical history is notable for HIV, hypertension, and hyperlipidemia. The patient had a Coloplast Titan IPP placed penoscrotally in November 2020 for treatment of post-prostatectomy erectile dysfunction. The reservoir was placed ectopically in the patient’s right high submuscular space. Results In January 2021 the patient underwent emergent exploratory laparoscopic washout and drain placement at a different hospital for perforated appendicitis. The IPP reservoir was not encountered during this procedure. In March 2021 he presented to that same hospital with recurrent fevers and right lower quadrant pain. CT showed increased peritoneal stranding and thickening surrounding the IPP reservoir as well as multiple small, complex loculated fluid collections suspicious for abscesses external to the reservoir. There was no evidence of infection of the pump or cylinders on imaging or physical exam. He was transferred to Dartmouth-Hitchcock Medical Center for further care. Conservative treatment with intravenous vancomycin, Zosyn, and fluconazole yielded no change after 48 hours. Three days after initial presentation, the reservoir was explanted during a collaborative procedure with general surgery, during which the appendix remnant was also removed. Intraoperatively the penile prosthesis reservoir was encased in a dense rind that was incised and drained. Copious purulent material was sent for culture, which showed multi-organism aerobic and anerobic bacteria. The reservoir was removed and the remnant tubing to the pump was clamped. The abdomen was irrigated repeatedly with saline, dilute betadine, vancomycin, gentamicin, Zosyn, and amphotericin. The prothesis tubing was cut as low as possible, capped, and wrapped with a paste of vancomycin mixed with Zosyn and amphotericin. There were no intraoperative complications. The patient was discharged two days later. At his one-week postoperative visit, he was readmitted for interventional radiology drain placement due to abdominal abscess recurrence. Once the recurrent abscess had resolved, he underwent successful radiation treatment for recurrent prostate cancer. In March 2022, the reservoir was successfully replaced into the left high submuscular space via counter incision and the dormant cylinders and pump were reconnected. The patient continues to do well, with no signs of recurrent infection and with excellent device function. He is satisfied with the result of surgery. Conclusions To our knowledge this is the only case of isolated IPP reservoir infection successfully treated with reservoir explant and eventual replacement. The original IPP pump and cylinders were preserved without issue and eventually reused. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast.

(443) A Randomized Prospective Evaluation of Next-generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Prostheses: Impact of Microbial Identification on Outcomes

Abstract Introduction Traditional culture is the current standard-of-care to determine therapeutic antibiotics for patients suffering from penile prostheses (PP) infections. However, approximately 50% of PPs removed for infection are culture negative. Next-generation sequencing (NGS) of DNA has proven to be beneficial in its thorough analysis of biofilm composition and determination of the relative abundance of specific microbes. In this prospective, multicenter, single-blinded, randomized controlled trial, we hypothesize that the use of NGS will lead to better therapeutic strategies that will result in improved patient outcomes by determining the microbial composition of infected PP. Objective We present our early results from our prospective study that compares outcomes of microbial identification between NGS versus culture for clinically infected PP. Methods Upon institutional review board approval, adult men undergoing treatment for mild to moderate PP infection are enrolled after providing informed consent. Enrollees are randomized to one of two analytic arms – traditional culture or NGS, using Captivate by ClinCapture. Patients with severe infection requiring urgent explantation are excluded. Traditional culture and NGS samples are collected upon clinical presentation prior to initiation of antibiotics. Specimens of infected fluid were collected, stored in sterile packaging, and transported for both traditional culture at the institutional laboratory and NGS testing (MicroGenDX, Lubbock, TX). Patients are started on set empiric antibiotics and randomized to traditional culture or NGS. Patients with a positive culture or NGS result will receive treatment-specific antibiotics, while patients with negative results continue empiric antibiotics for two weeks. For patients randomized to the NGS arm, positive results will undergo central infectious disease (ID) review, and antibiotics initiated based on their recommendations. Patients will follow up within ten days of antibiotic initiation and at six months to complete a safety and compliance questionnaire which assesses symptoms, device function, and patient satisfaction. Results To date, two patients have been enrolled. The first patient was randomized to the culture arm and presented with mild tenderness and drainage around the scrotal pump area for five days but remained afebrile. His culture resulted as Citrobacter koseri. He started empiric treatment with amoxicillin-clavulanate which was changed to ciprofloxacin based on culture results. The second patient was randomized to the NGS arm and presented with four days of bloody and purulent drainage from the scrotal pump area. Although he was afebrile, he had moderate tenderness, swelling, and erythema in his scrotum. NGS identified multiple organisms (data remains blinded). He was started on empiric trimethoprim-sulfamethoxazole but was treated successfully with a course of cefdinir and doxycycline per ID. Both patients had primary implants and did not require device removal. On the post-treatment questionnaire, both patients reported that their devices were working and endorsed high satisfaction rates. Conclusions This is the first prospective, randomized controlled trial comparing the utility and outcomes of NGS and culture for the identification of microbes in clinically infected PP. Currently, recruitment is ongoing. We hope that this trial will demonstrate a clinical benefit of NGS in characterizing distinct microbiomes of infected PP to tailor antimicrobial therapy. 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

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.

AUA-Recommended Antibiotic Prophylaxis for Primary Penile Implantation Results in a Higher, Not Lower, Risk for Postoperative Infection: A Multicenter Analysis. Reply.

You have accessJournal of UrologyLetters to the Editor1 Mar 2023AUA-Recommended Antibiotic Prophylaxis for Primary Penile Implantation Results in a Higher, Not Lower, Risk for Postoperative Infection: A Multicenter Analysis. Reply.is a reply to letterAUA-Recommended Antibiotic Prophylaxis for Primary Penile Implantation Results in a Higher, Not Lower, Risk for Postoperative Infection: A Multicenter Analysis. Letter. David W. Barham, Nikolaos Pyrgidis, Martin S. Gross, Jay Simhan, and Faysal A. Yafi David W. BarhamDavid W. Barham * E-mail Address: [email protected] University of California, Irvine-Orange, California More articles by this author , Nikolaos PyrgidisNikolaos Pyrgidis University Hospital, LMU Munich-Munich, Germany More articles by this author , Martin S. GrossMartin S. Gross Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire More articles by this author , Jay SimhanJay Simhan University of California, Irvine-Orange, California More articles by this author , and Faysal A. YafiFaysal A. Yafi University of California, Irvine-Orange, California More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003150AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail To the Editor: We appreciate the thought-provoking comment by Garman and Trock. As the authors correctly state, the findings of the present study should be interpreted with caution due to some important limitations relevant to its retrospective design, confounding factors, and inherent selection bias.1 Indeed, most baseline characteristics displayed statistically significant differences between patients undergoing treatment with vancomycin plus gentamicin vs other regimens. Nevertheless, we provide, to our knowledge, the largest study focusing on postoperative inflatable penile prosthesis infections in the published literature. Moreover, Garman and Trock raise some issues relevant to the applied statistical analysis and interpretation of the data which merit further clarification. Given that it is desirable to have a minimum of 10 events per variable (EPV) or even 20 EPV, they suggest that, with a total of 47 events, 5 or even fewer variables should have been included in the multivariable Cox proportional hazards model. However, it should be highlighted that this “1 in 10 rule” is only a rule of thumb that may be too conservative. Based on the previous notion, systematic discounting of results, in particular statistically significant associations, from any model with 5-9 EPV does not appear to be justified.2 In our study we included 8 variables, and thus a total of 5.9 EPV. As stated in our methods, these parameters were selected based on both clinical (age, diabetes, BMI, immunosuppression, prior pelvic radiotherapy) and statistical significance (perioperative antibiotic prophylaxis, antifungal prophylaxis, device manufacturer) in the univariate analysis. Of note, we also intended to control for other important variables such as race, Charlson comorbidity index and intraoperative approach, but these were not included in the multivariable Cox proportional hazards model to avoid overfitting and to remain over 5 EPV. Garman and Trock indicate that the variable selection for the multivariable Cox proportional hazards model should not have been based on clinical significance, but solely on statistical criteria to eliminate potential sources of confounding. They suggest putting variables “in a regression model and then add[ing] each of the other variables individually to identify the potential source of confounding.” In other words, they suggest performing automated selection methods (using backward elimination, forward selection, or both methods, ie, stepwise selection) to select the best model in many steps according to statistical criteria. These methods seem at first the “panacea” to all modeling problems. After all, it would be ideal to leave the selection of the most “correct” model to a statistical program. Nevertheless, automated selection methods have been criticized. By performing repeated testing and comparisons with automated selection methods, the probability of type I error increases substantially. Accordingly, the “correct” model after automated selection may not provide clinical utility, since, in this way, important risk factors may be excluded.3 It should be stressed that the current guidelines were not based on urological literature and recent work has questioned the efficacy of these recommendations.4-6 Although our study builds upon this knowledge, the limitations of our study should serve as a charge to the prosthetic urology community to improve our understanding of antimicrobial prophylaxis. There are certainly a number of barriers to performing prospective studies on penile prosthesis infections; however, if we want to overcome the limitations of our current literature, we must begin this process.

Addressing the need for preclinical study of penile prosthesis infection: a new animal model and narrative review.

Erectile dysfunction (ED) is a common condition in men, and many patients refractory to conservative treatment may undergo penile prostheses (PPs) placement. The primary concern following PP implantation is device infection. Although antibiotic and hydrophilic coatings have reduced the incidence of inflatable PP (IPP) infections, there remains room for improvement. Optimization of PP outcomes requires a practical in vivo model to better understand mechanisms of infection and to test new infection control strategies. We aimed to describe a new rabbit model which contains a functional IPP and review previously reported animal PP models. An IPP was placed into rabbit flanks and cycled for functionality testing. Rabbits were evaluated for signs of pain and distress over 14 days. Separately, narrative review methodology was utilized to search the PubMed and Scopus databases for all publications through March 21, 2023, which studied PP within an in vivo setting. Three independent reviewers ultimately selected 12 papers from 1992-2021 for inclusion. Several animal studies highlighted the initial functionality or feasibility of devices for ED before their introduction in the clinical setting. There are several subsequent studies aimed at optimizing the type of antibiotic use or coating material using segments of PP material in an in vivo setting. However, the literature lacks a contemporary animal model containing a functional IPP. Our novel rabbit model offers a safe, practical way to implant a functioning IPP and investigate new perioperative infection prevention and treatment strategies before trials in the clinical setting. Animal models have played a key role in testing medical devices, including PPs, prior to their clinical introduction. Our review uncovered no modern animal studies involving placement of a functional PP. A new animal model can facilitate study of evolving microorganism profiles, novel methods to enhance antibiotic delivery, and proposed treatment options.

Overcoming barriers to immediate penile implant salvage surgery: a narrative review.

Since immediate salvage (IS) surgery for infected penile prosthesis (PP) was introduced nearly 30 years ago, an abundance of evidence has emerged in support of its use. IS remains underutilized by the modern urologist despite its distinct advantages. While some medical literature proposes reasons for the underuse of IS, no comprehensive review attempts to address the numerous factors limiting its implementation. Our objective is to analyze the barriers to IS surgery for infected PP with the goal of expanding utilization of this technique through a practical and standardized approach for treating urologists. A narrative review of available English, peer-reviewed, medical literature relevant to the barriers to IS was completed. Searches were expanded to include literature from surgical specialties in general if hypothesized barriers were incompletely described in available PP publications. The major barriers that are likely contributing to the low rates of IS for PP surgery can be broadly classified into three major categories: institutional/systemic, medical/surgical, and patient preference. Institutional/systemically driven barriers include surgeon comfort with PP surgery, low national availability of urologists, inaccessibility of prosthetics or critical ancillary staff at the time of patient presentation and limited operating room (OR) access. Medical/surgical barriers primarily relate to reinfection fears, perceived contraindications to IS, and overall patient stability at the time of presentation. Patient preference factors inhibiting IS involve loss of trust in the medical team, psychosocial distress, dissatisfaction with the initial device prior to infection and anxiety regarding postoperative recovery. Many of the identified barriers can be overcome with increased surgical training, improved patient and surgeon understanding of PP infection, or precautionary planning. Of the factors that contribute to low utilization of IS, many are misunderstood or unknown. Recognition of these barriers may equip urologists to provide better care to patients with prosthesis infection.