Antibiotic dip and irrigation solutions confer increased antimicrobial efficacy of inflatable penile prosthesis hydrophilic surfaces compared with 0.05% chlorhexidine gluconate.

BACKGROUND: Chlorhexidine gluconate (CHG) (0.05%) has recently been suggested as both a dip for the hydrophilic surface and an irrigation solution in the setting of penile prosthesis (PP) surgery. AIM: The study sought to compare the antimicrobial efficacy of 0.05% CHG with vancomycin and gentamicin (VG) antibiotics as dip and/or irrigation solutions in the setting of a hydrophilic PP surface in vitro. METHODS: Sterile PPs with a hydrophilic coating were obtained. A series of experiments were performed to evaluate the efficacy of normal saline (NS), 0.05% CHG, or VG as dip and/or irrigation solutions to reduce methicillin-sensitive Staphylococcus aureus adhesion to PP surfaces. The 8-mm discs from PPs were incubated in 105 colony-forming units/mL of methicillin-sensitive S aureus for 48 hours, plated, and counted. Disc-diffusion tests were conducted by suspending 6-mm discs for 2 minutes in NS, 0.05% CHG, or VG, then placing them coated side down onto plates streaked with the following organisms: methicillin-sensitive S aureus, S epidermidis, Enterococcus, and Escherichia coli. After 24 hours of growth, zones of inhibition were measured. OUTCOMES: We found average bacterial counts (colony-forming units/mL) and zones of inhibition (mm) following a series of treatment protocols of PP discs. RESULTS: PP discs dipped in VG reduced bacterial adhesion to the implant surface >0.05% CHG (~5.5 log vs ~1.5 log; P < .01). Discs irrigated with either 0.05% CHG or NS removed all dip solution adsorbed to the hydrophilic surface, allowing bacterial growth. VG irrigation adsorbed to the hydrophilic surface even after 0.05% CHG or NS dips, reducing bacterial adherence (~3 log). Dipping and irrigating discs with VG was most effective in reducing adherent bacteria (~5.5 log) and was the only irrigation that showed antimicrobial activity. CLINICAL TRANSLATION: VG, when used both as a prophylactic dip and as an intraoperative irrigation solution for hydrophilic penile implant surfaces, has improved efficacy to 0.05% CHG and NS. STRENGTHS AND LIMITATIONS: This is the first study to compare the use of VG, 0.05% CHG, and NS as prophylactic dips and intraoperative irrigations for hydrophilic penile implant surfaces. Limitations include the use of in vitro studies, which serve as a proxy for in vivo practices and may not be entirely accurate nor translatable clinically. CONCLUSION: We demonstrated the superior efficacy of VG as a combined dip and irrigation solution for hydrophilic penile implant surfaces compared with 0.05% CHG.

Minocycline-rifampin-impregnated penile prosthesis surfaces retain antimicrobial activity following irrigation with 0.05% chlorhexidine gluconate and antibiotic solutions.

BACKGROUND: 0.05% Chlorhexidine gluconate (CHG; Irrisept [IrriMax]) is a commercial wound irrigation solution approved by the Food and Drug Administration that has seen recent adoption in the field of prosthetic urology; however, no study has evaluated whether 0.05% CHG is compatible with the minocycline-rifampin-impregnated surface (InhibiZone) of the AMS 700 penile prosthesis (Boston Scientific). AIM: To evaluate whether 0.05% CHG alters the antibiotic efficacy of the minocycline-rifampin-impregnated penile prosthesis surface. METHODS: Discs (8 mm) were taken by a punch biopsy (Sklar) from sterile penile prosthesis reservoirs whose surfaces had been impregnated with rifampin and minocycline. Discs (n = 10) were suspended in 0.05% CHG, vancomycin and gentamicin, or normal saline for 2 minutes to simulate intraoperative irrigation. Discs were then rinsed in normal saline to remove any unbound solution and incubated with methicillin-sensitive Staphylococcus aureus for 48 hours. Adherent surface bacteria were suspended by shaking in a 0.3% Tween 20 solution, serially diluted, plated onto 3M PetriFilms, and counted. Kirby-Bauer disc diffusion assays were conducted to generalize findings across various organisms. OUTCOMES: Outcomes included (1) bacterial adherence to the implant surface measured as bacterial counts (in colony-forming units per milliliter) and (2) bacterial growth reduction measured as zones of inhibitions (in millimeters). RESULTS: Incubation of implant surfaces in 0.05% CHG did not alter recovered bacterial counts as compared with normal saline and vancomycin/gentamycin. Similarly, within a single bacterial species, 0.05% CHG and vancomycin/gentamycin did not alter zone-of-inhibition measurements in Kirby-Bauer disc diffusion studies. CLINICAL TRANSLATION: This study demonstrates in vitro that 0.05% CHG may be used directly on the minocycline-rifampin-impregnated surface without altering the antibiotic efficacy of the coating. STRENGTHS AND LIMITATIONS: Strengths include that this is the first study to evaluate if 0.05% CHG affected the minocycline-rifampin-impregnated surface. Limitations include the use of in vitro studies, which serve as a proxy for in vivo practices and may not be entirely accurate or translatable in a clinical setting. CONCLUSION: 0.05% CHG does not alter the antimicrobial activity of the minocycline-rifampin-impregnated surface as compared with vancomycin/gentamycin and normal saline in vitro; however, its efficacy in clinical practice remains to be evaluated.

Study Protocol for a Randomized Controlled Trial of Low Intensity Shockwave Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction: "SHARP-ED TRIAL".

Introduction: Erectile Dysfunction (ED) is a common challenge post Radical Prostatectomy (RALP), affecting men's sexual health after undergoing definitive cancer therapy. Despite employing nerve-sparing techniques, ED remains a prevalent issue in this population. Studies indicate that approximately 70%-85% of men experience varying degrees of ED following RALP. The existing treatment landscape for post-RALP-ED presents limitations, and a discernible knowledge gap persists. To address this, our study aims to investigate the efficacy of Shockwave Therapy (SWT) as a potential intervention for managing ED after RALP. Methods: This prospective, randomized, sham-controlled clinical trial aims to recruit 189 eligible patients post-RP and assess the effects of SWT. Comprehensive screening, including medical history, physical examinations, and biochemical evaluations, will be conducted to confirm eligibility. The intervention involves utilizing a device to administer focal shockwaves targeted at cavernosal tissue. Safety measures include continuous monitoring for adverse events and rigorous reporting protocols. The primary endpoint assesses changes in participants' ability to engage in penetrative intercourse from baseline to study completion, while secondary endpoints encompass various measures of erectile function, including questionnaire-based assessments, ultrasound parameters, and clinical outcomes. Results: Statistical analysis, encompassing ANOVA for continuous variables and Fisher's exact test for categorical ones, will evaluate demographic characteristics, baseline data, and primary as well as secondary outcomes for statistical significance. Detailed analysis of trends, subgroup comparisons, and treatment effects will provide a comprehensive understanding of the impact of SWT on post-RP ED. Conclusion: This study protocol represents a rigorous investigation into the potential therapeutic role of SWT in managing post-RP ED. The outcomes from this study aim to contribute valuable insights into the efficacy, safety, and potential improvements in erectile function following SWT, providing significant guidance for future interventions aimed at addressing this challenging condition affecting men's health and quality of life.

Perioperative risk predictors for gender affirming surgery in the NSQIP database.

INTRODUCTION: Gender affirming surgeries (GAS), such as phalloplasty (PLPs) and vaginoplasty (VGPs), are important aspects of medical care for transgender patients. Here, we aim to better characterize patient demographics and surgical outcomes for PLPs and VGPs using the National Surgical Quality Improvement Program (NSQIP). We hypothesized that frailty indices would be predictive of perioperative PLP and VGP risk and outcomes for PLPs and VGPs. MATERIALS AND METHODS: Primary GAS, specifically PLPs and VGPs performed from 2006-2020 were identified in NSQIP. Baseline frailty was based on NSQIP's modified frailty index (mFI) and preoperative morbidity probability (morbprob) variable. RESULTS: Fifty-eight PLPs and 468 VGPs were identified. The overall 30-day complication rate for PLP was 26%, with 17% of total patients experiencing minor complications and 16% experiencing major complications. The overall, minor, and major complication rates for VGP were 14%, 7%, and 9% respectively. Readmissions and reoperations occurred in 7% PLP and 5% VGP patients. No deaths occurred in either group within 30 days. The mFI scores were not predictive of 30-day complications or LOS. NSQIP morbprob was predictive of 30-day complications for both PLP (OR 4.0, 95% CI 1.08-19.59, p = 0.038) and VGP (OR 2.39, 95% CI 1.46-3.97, p = 0.0005). NSQIP's morbprob was also predictive of extended LOS for PLP patients (6.3 ± 1.3 days, p = 0.03). CONCLUSIONS: This study describes patient characteristics and complication rates of PLPs and VGPs. The NSQIP preoperative morbprob is an effective predictor of surgical complications and is better than the mFI.

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

Background and Objective: 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. Methods: 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. Key Content and Findings: 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. Conclusions: 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.

Society of Urologic Prosthetic Surgeons' Coding and Billing Position Statement on Ancillary/Adjunct Penile Prosthesis Surgical Procedures: Part I.

OBJECTIVE: To create a society position statement on common adjunct penile prosthesis (PP) procedures. While the Medicare Current Procedural Terminology code book lists descriptions of procedures, it is very brief and lacks detail in the small subspecialty of prosthetic urology. At educational/research meetings, wide variation was found in how experts in prosthetic urology code the same procedures, and need for a standardized format in billing common ancillary surgery was voiced. METHODS: A subcommittee within the Society of Urologic Prosthetic Surgeons developed a survey assessing coding options for several procedures commonly adjunct to PP placement, which was distributed in the fall of 2022. The results of the survey were used to develop consensus statements on coding adjunct PP procedures; statements were distributed among society membership and meetings for approval. RESULTS: Thirty members replied to the survey; demographics were obtained as follows: 73% were trained in a fellowship, 50% identified as university/academic practitioners, and 50% in community/private practice; and 63% respondents place more than 50 implants annually. Only 1 of the 30 respondents stated confidence in coding for these ancillary procedures. Specifically, differences in how to code curvature correction procedures were observed throughout the survey results. CONCLUSION: Only 1 in 30 prosthetic urologists expressed confidence in coding and billing of adjunct PP procedures, further confirming the need for a society position statement. Therefore, we generated a consensus society position statement on common surgeries that are adjunct to PP placement.

Evaluating the management trends for priapism and assessing the risk of priapism after in-office intracavernosal injections: a cross-sectional analysis.

We describe the management trends of patients suffering from any priapism and evaluate the risks of developing priapism after intracavernosal injections (ICI) performed in office. We queried TriNetX for two separate male adult cohorts - those presenting with any priapism based on International Classification of Disease code, N48.3 (priapism) and those who underwent ICI in office based on Current Procedural Terminology code, 54235 (injection of corpora cavernosa with pharmacologic agent[s]). We evaluated treatment options for these patients after any priapism and described demographic risks for developing priapism after ICI performed in office. There were 17,545 priapism encounters and 26,104 usages of ICI in the office. Most common treatment for any priapism was corporal irrigation/injection of medications (11.3%). Patients presenting with priapism after ICI were younger (age > 65 years, OR 0.44 [95% CI 0.38-0.51], p < 0.01) and had a higher prevalence of mood disorders (20% vs 14%), behavioral disorders (7% vs 2%) and sickle cell disease (6% vs <1%). They were less likely to have diabetes (14% vs 22%), hypertension (33% vs 40%), prostate cancer (13% vs 25%) or have taken sildenafil or tadalafil (29-30% vs 35-38%). For patients administering ICI, proper screening and counseling of priapism is important to reduce complications.

Androgens and Urethral Health: How Hypogonadism Affects Postoperative Outcomes of Patients Undergoing Artificial Urinary Sphincter or Inflatable Penile Prosthesis Placement.

OBJECTIVE: To determine the role of androgens in penile and urethral health, we sought to understand what impact hypogonadism may have on artificial urinary sphincter (AUS) and inflatable penile prosthesis (IPP) outcomes. We hypothesize that patients with hypogonadism are at increased risk of reinterventions, complications, and infections. METHODS: We queried the TriNetX Global Database in March 2023 for patients receiving an AUS or IPP, looking at lifetime reintervention, complication, and infection rates. We conducted multiple comparisons: (1) eugonadal patients against hypogonadal patients, (2) hypogonadal patients on testosterone replacement therapy (TRT) against hypogonadal patients not on TRT, and (3) hypogonadal patients on TRT against eugonadal patients. RESULTS: Hypogonadal patients undergoing AUS had more complications (33.5% vs 28.3%), higher reintervention rates (27.7% vs 24.3%) and higher infection rates (7.3% vs 6.8%), albeit none reaching significance. Hypogonadal patients undergoing IPP had significantly higher infection rates (6.3% vs 4.4%, RR 1.5 (1.04, 2.04)) and reintervention rates (14.9% vs 11.9%, RR 1.3 (1.04, 1.61)), but not complication rates (21.9% vs 18.9%). When comparing patients with hypogonadism on TRT vs off TRT, there was not a significant difference in reinterventions, or complications, in AUS and IPP patients, but there were significantly more infections in IPP patients (7.0% vs 3.9%, RR 1.9 (1.002, 3.5)). CONCLUSION: Hypogonadal patients have more reinterventions, complications, and infections following urologic implant surgery, to varying levels of significance. TRT may not be completely protective to improve tissue health but with many limitations that should be explored in further research.

Oxycodone prescription after inflatable penile prosthesis has risks of persistent use: a TriNetX analysis.

We sought to evaluate the impact of Oxycodone prescriptions on short-term patient outcomes and long-term Oxycodone use following inflatable penile prosthesis (IPP) placement. We queried the TriNetX research database for all adult patients undergoing IPP. Cohorts included opioid naïve patients prescribed postoperative Oxycodone against propensity score-matched patients without a prescription. We compared return visits to the emergency department (ED) within 14 and 90 days of surgery, a diagnosis of opioid abuse or dependence disorder 6 months or later after surgery and persistent Oxycodone use 9-15 months after surgery. After matching, there were 2433 patients in each group. There was an increase in 90-day ED visits based on receipt of Oxycodone (6.8% of patients vs 5.0%, risk ratio (RR) 1.4 95% confidence interval (CI) [1.1, 1.7]). Groups had similar 14-day ED visits (3.7% of patients vs 2.9%, RR 1.3, 95% CI [0.95, 1.7]). Patients prescribed Oxycodone (5.1% of patients vs 2.7%, RR 1.9, 95% CI [1.4, 2.6]) were more likely to have persistent Oxycodone use at 9-15 months. There were low instances of diagnosis of opioid dependence or abuse for both groups limiting comparison. Oxycodone prescription after IPP has risks of persistent use and withholding Oxycodone does not appear to increase postoperative healthcare utilization.

Characterizing the biofilm of artificial urinary sphincters (AUS).

Background: There is a paucity of data regarding the bacterial colonization on artificial urinary sphincter (AUS) devices following revision surgery. We aim to evaluate the microbial compositions of explanted AUS devices identified on standard culture at our institution. Methods: Twenty-three AUS devices explanted were included in this study. During revision surgery, aerobic and anaerobic culture swabs are taken from the implant, capsule, fluid surrounding the device, and biofilm, if present. Culture specimens are sent to the hospital laboratory for routine culture evaluation immediately upon case completion. Differences in number of microorganism species detected across samples (richness) against demographic variables were determined through backwards selection of all variables using analysis of variance (ANOVA). We assessed the prevalence (how many times each species occurred) of microbial culture species. Statistical analyses were performed using the statistical package in R (version 4.2.1). Results: Cultures reported positive results in 20 (87%) cases. Coagulase-negative staphylococci were the most commonly identified bacteria among explanted AUS devices (n=16, 80%). Among two of the four infected/eroded implants, more virulent organisms such as Escherichia coli and fungal species such as Candida albicans were identified. The mean number of species identified amongst culture positive devices was 2.15±0.49. The number of unique bacteria identified per sample was not significantly associated with demographic variables including race, ethnicity, age at revision, smoking history, duration of implantation, etiology for explantation, and concomitant medical comorbidities. Conclusions: The majority of AUS devices removed for non-infectious reasons harbor organisms on traditional culture at the time of explantation. The most commonly identified bacteria in this setting is coagulase-negative staphylococci, which may be a result of bacterial colonization introduced at the time of implant. Conversely, infected implants may harbor microorganisms with higher virulence including fungal elements. Bacterial colonization or biofilm formation on implants may not necessarily equate to clinically infected devices. Future studies with more sophisticated technology, such as next-generation sequencing or extended cultures, may evaluate microbial compositions of biofilm at a more granular level to understand its role in device infections.

A global, propensity-score matched analysis of patients receiving artificial urinary sphincters and the risk of complications, infections, and re-interventions.

Background: Artificial urinary sphincters (AUS) are the gold standard treatment for patients with stress urinary incontinence. However, risk factors for implant infection, complication, or re-intervention (removal, repair, replacement) are incompletely understood. We sought to understand the impact of various patient factors on the risk of device failure by leveraging a large, multi-national research database. Methods: We queried the TriNetX database for all adult patients undergoing AUS. We evaluated the impact of age, body mass index, race, ethnicity, diabetes (DM), smoking history, history of radiation therapy (RT), history of radical prostatectomy (RP) and history of urethroplasty on select clinical outcomes. Our primary outcome was the need for re-intervention defined by current procedural terminology (CPT) codes. Secondary outcomes included overall device complication rate and infection rate defined by international classification of diseases (ICD) codes. Analytics were performed on TriNetX which calculated risk ratios (RR) and Kaplan-Meier (KM) survival. We evaluated our outcomes first on the entire population and then repeated analyses for each individual comparison cohort using the remaining demographic variables to perform propensity score matching (PSM). Results: The overall rates of AUS re-intervention, complication and infection were 23.4%, 24.1% and 6.4%, respectively. KM analysis showed median AUS survival (no need for re-intervention) at 10.6 years and projected 20-year survival probability at 31.3%. Patients with a history of smoking or urethroplasty were at higher risk of AUS complication and re-intervention. Patients with DM or a history of RT were at higher risk of AUS infection. Patients with a history of RT were at higher risk of AUS complication. All risk factors besides race showed a difference in device removal itself. Conclusions: To our knowledge, this represents the largest series to follow patients with an AUS. About one-quarter of AUS patients needed re-intervention. Multiple demographics place patients at increased risk of re-intervention, infection, or complication. These results can help guide patient selection and counseling with the goal of reducing complications.

A narrative review on surgical treatment options for male stress urinary incontinence.

Background and Objective: Stress urinary incontinence (SUI) can occur due to a variety of etiologies. For male patients specifically, SUI is typically thought of as iatrogenic secondary to intrinsic sphincter deficiency occurring after prostate surgery. Given the noted negative impact that SUI can have on a man's quality of life, multiple treatment options have been developed to improve symptoms. However, there is no "One-Size-Fits-All" approach to management of male SUI. In this narrative review, we sought to highlight some of the various procedures and devices available to treat men with bothersome SUI. Methods: This narrative review gathered primary resources through Medline search, and secondary resources by cross-referencing citations used in articles of interest. We started our investigation by searching for previous systematic reviews on male SUI and treatments for male SUI. Furthermore, we reviewed societal guidelines, such as the American Urological Association and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction guidelines and the recently published European Urological Association guidelines. Our review focused on English-language full-length manuscripts when available. Key Content and Findings: We present multiple surgical options for men with SUI. This review focuses on surgical options including 5 fixed male slings, 3 adjustable male slings, 4 artificial urinary sphincters (AUS), and an adjustable balloon device. This review includes treatment options from across the globe, although not all included devices are available in the United States. Conclusions: A great variety of treatment options exist for men with SUI, although not all Federal Drug Administration (FDA) approved. Shared decision making is paramount to generate the greatest satisfaction for patients.