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.

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

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

Development and validation of 3-dimensional simulators for penile prosthesis surgery.

BACKGROUND: The acquisition of skills in penile prosthesis surgery has many limitations mainly due to the absence of simulators and models for training. Three-dimensional (3D) printed models can be utilized for surgical simulations, as they provide an opportunity to practice before entering the operating room and provide better understanding of the surgical approach. AIM: This study aimed to evaluate and validate a 3D model of human male genitalia for penile prosthesis surgery. METHODS: This study included 3 evaluation and validation stages. The first stage involved verification of the 3D prototype model for anatomic landmarks compared with a cadaveric pelvis. The second stage involved validation of the improved model for anatomic accuracy and teaching purposes with the Rochester evaluation score. The third stage comprised validation of the suitability of the 3D prototype model as a surgical simulator and for skill acquisition. The third stage was performed at 3 centers using a modified version of a pre-existing, validated questionnaire and correlated with the Rochester evaluation score. OUTCOME: We sought to determine the suitability of 3D model for training in penile prosthesis surgery in comparison with the available cadaveric model. RESULTS: The evaluation revealed a high Pearson correlation coefficient (0.86) between questions of the Rochester evaluation score and modified validated questionnaire. The 3D model scored 4.33 ± 0.57 (on a Likert scale from 1 to 5) regarding replication of the relevant human anatomy for the penile prosthesis surgery procedure. The 3D model scored 4.33 ± 0.57 (on a Likert scale from 1 to 5) regarding its ability to improve technical skills, teach and practice the procedure, and assess a surgeon's ability. Furthermore, the experts stated that compared with the cadaver, the 3D model presented greater ethical suitability, reduced costs, and easier accessibility. CLINICAL IMPLICATIONS: A validated 3D model is a suitable alternative for penile prosthesis surgery training. STRENGTHS AND LIMITATIONS: This is the first validated 3D hydrogel model for penile prosthesis surgery teaching and training that experts consider suitable for skill acquisition. Because specific validated guidelines and questionnaires for the validation and verifications of 3D simulators for penile surgery are not available, a modified questionnaire was used. CONCLUSION: The current 3D model for penile prosthesis surgery shows promising results regarding anatomic properties and suitability to train surgeons to perform penile implant surgery. The possibility of having an ethical, easy-to-use model with lower costs and limited consequences for the environment is encouraging for further development of the models.

Long-term outcomes after plaque excision grafting for Peyronie's disease and subanalysis of patients who undergo the procedure despite preoperative counseling against it.

BACKGROUND: Plaque excision and grafting (PEG) has been recommended for patients with Peyronie's disease (PD) with >60° curvature and/or hinge effect and strong preoperative erections, while placement of an inflatable penile prosthesis (IPP) is recommended when rigidity is suboptimal. Nevertheless, many patients counseled to undergo an IPP decline and insist on proceeding with PEG due to personal preference or desire to avoid an implant. AIM: We aim to review long-term outcomes in patients who underwent PEG for PD at our institution and investigate whether there is any difference in long-term outcomes in patients who undergo PEG despite a recommendation to undergo IPP. METHODS: We conducted a retrospective chart review from 2007 to 2021 on PEG surgery performed at a single tertiary care institution in patients ≥18 years old who had >3 months of follow-up. OUTCOMES: Postoperative information was gathered from the electronic medical record, including postoperative erectile function, patient satisfaction, and the ability to engage in penetrative sexual intercourse. RESULTS: An overall 251 patients underwent PEG with a median follow-up of 12 months (IQR, 6-54). Among these, 54 (22%) were initially advised to undergo IPP but elected for PEG. Patients who underwent PEG despite counseling to undergo IPP reported lower postoperative ability to engage in intercourse (51% vs 76%). Seven (13%) patients initially advised to undergo IPP eventually received an IPP, relative to 7 (4%) initially advised to undergo PEG. CLINICAL IMPLICATIONS: Thorough preoperative assessment of erectile function and penile deformity can guide clinician counseling and manage patient expectations during decision making between PEG surgery and IPP implantation for PD. STRENGTHS AND LIMITATIONS: Limitations of this study include its retrospective nature, high attrition to follow-up, and risk of recall and selection bias. This is a large study with a median follow-up of 12 months, with a high-volume single surgeon who treats patients in a specialized population of complex cases. CONCLUSION: Patients who were initially counseled to undergo IPP due to suboptimal erectile rigidity but elected for PEG had worse postoperative ability to engage in penetrative intercourse, and a higher proportion of these patients eventually received an IPP.

Cosmetic penile enhancement procedures: an SMSNA position statement.

BACKGROUND: Penile cosmetic enhancement procedures have been performed for many years with varying success. However, they have historically been relegated to niche areas of sexual medicine, with limited data, and have not achieved mainstream adoption. More recently, the topic has been increasingly discussed within academic congresses due to availability of novel techniques, therapies, and procedures. Given their distinctive nature, the Sexual Medicine Society of North America (SMSNA) felt that it was pertinent to develop formal position statements to help guide both patients and sexual medicine providers on the current state of the scientific literature and to give recommendations for future research. AIM: The study sought to provide an evidence-based set of recommendations for injection and surgical procedures designed to lengthen, augment, or otherwise cosmetically enhance the penis. METHODS: A review was performed of all scientific literature listed in PubMed from inception through December 2023 relating to penile cosmetic enhancement procedures. Only invasive (injection/surgery) therapies were included due to their distinct risk-benefit profile compared with more conservative treatments (eg, vacuum erection devices, penile traction devices). Similar therapies were categorized, with pertinent data summarized and used to help create relevant position statements. All statements were expert opinion only and were based on analyses of the potential risks and benefits of the specific therapies. OUTCOMES: A total of 6 position statements were issued relating to 5 distinct sexual medicine cosmetic enhancement procedures. RESULTS: A consensus opinion was reached by SMSNA leadership on the state of injection/surgical penile cosmetic enhancement procedures as of 2024. Key topic areas addressed included injectable soft tissue fillers, suspensory ligament division, graft-and-flap procedures, silicone sleeve implants, and sliding/slicing techniques. Distinct recommendations were tailored to each therapy and were based solely on the current state of the literature. It is anticipated that future studies will further inform position statements and will lead to ongoing modifications. CLINICAL IMPLICATIONS: The current position statements provide both patients and clinicians evidence-based, expert recommendations on best practices relating to penile cosmetic enhancement procedures. STRENGTHS AND LIMITATIONS: Strengths include the use of an expert panel of sexual medicine clinicians, consensus design, and summary of existing literature. Limitations include expert opinion and limited research on the topic. CONCLUSION: The current SMSNA position statements provide evidence-based, consensus opinions on the appropriate role for penile augmentation and cosmetic procedures in 2024.

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.

Assessing artificial intelligence responses to common patient questions regarding inflatable penile prostheses using a publicly available natural language processing tool (ChatGPT).

INTRODUCTION: The evolving landscape of healthcare information dissemination has been dramatically influenced by the rise of artificial intelligence (AI) driven chatbots, providing patients with accessible and interactive platforms to obtain knowledge about medical procedures and conditions. Among the various surgical interventions in urology, inflatable penile prosthesis (IPP) is a common treatment for men with erectile dysfunction. As patients increasingly seek comprehensive resources to understand what this procedure entails, AI-based chat technologies, such as ChatGPT, have become more prominent. This study aimed to assess the capacity of ChatGPT to provide accurate and easily understandable responses to common questions regarding the IPP procedure. MATERIALS AND METHODS: Ten frequently asked questions (FAQ) about the IPP procedure were presented to the ChatGPT chatbot in separate conversational sessions without follow up questions or repetitions. An evidence-based approach was employed to assess the accuracy of the chatbot's responses. Responses were categorized as "excellent response not requiring clarification," "satisfactory requiring minimal clarification," "satisfactory requiring moderate clarification," or "unsatisfactory requiring substantial clarification." RESULTS: Upon review, 70% of ChatGPT's answers to questions regarding the IPP procedure were rated as "excellent," not necessitating further clarification. Twenty percent were considered "satisfactory," requiring minimal clarification, notably on the omission of statistical data and the depth of discussion on certain topics. Ten percent of the responses were "unsatisfactory," requiring substantial clarification, including a failure to provide a definitive answer when necessary. CONCLUSIONS: This study reveals that ChatGPT has a substantial capability to produce evidence-based, understandable responses to a majority of common questions related to the IPP procedure. While there is room for improvement, ChatGPT can serve as an advantageous tool for patient education, enhancing preoperative understanding and contributing to informed decision-making during urological consultations for IPP.

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

PURPOSE: Our aim was to determine if the AUA-recommended prophylaxis (vancomycin + gentamicin alone) for primary inflatable penile prosthesis surgery is associated with a higher infection risk than nonstandard regimens. MATERIALS AND METHODS: We performed a multicenter, retrospective study of patients undergoing primary inflatable penile prosthesis surgery. Patients were divided into those receiving vancomycin + gentamicin alone and those receiving any other regimen. A Cox proportional-hazards model was constructed adjusted for major predictors. A subgroup analysis to identify the appropriate dosage of gentamicin was also performed. RESULTS: A total of 4,161 patients underwent primary inflatable penile prosthesis placement (2,411 received vancomycin + gentamicin alone and 1,750 received other regimens). The infection rate was similar between groups, 1% vs 1.2% for standard vs nonstandard prophylaxis. In the multivariable analysis, vancomycin + gentamicin (HR: 2.7, 95% CI: 1.4 to 5.4, P = .004) and diabetes (HR: 1.9, 95% CI: 1.03 to 3.4, P = .04) were significantly associated with a higher risk of infection. Antifungals (HR: 0.08, 95% CI: 0.03 to 0.19, P < .001) were associated with lower risk of infection. There was no statistically significant difference in infection rate between weight-based gentamicin compared to 80 mg gentamicin (HR: 2.9, 95% CI: 0.83 to 10, P = .1). CONCLUSIONS: Vancomycin + gentamicin alone for antibiotic prophylaxis for primary inflatable penile prosthesis surgery is associated with a higher infection risk than nonstandard antibiotic regimens while antifungal use is associated with lower infection risk. A critical review of the recommended antimicrobial prophylactic regimens is needed. Prospective research is needed to further elucidate best practices in inflatable penile prosthesis antimicrobial prophylaxis.

Subcoronal Incision for Inflatable Penile Prosthesis Does Not Risk Glans Necrosis.

PURPOSE: Glans vascular compromise had previously been considered a rare but devastating complication of the subcoronal incision for inflatable penile prosthesis surgery. Here, we describe the largest series of subcoronal implants to date to assess contemporary complication rates. MATERIALS AND METHODS: A retrospective review of subcoronal prosthesis placements by a single surgeon from Seoul, South Korea, was performed. Patients were randomly assigned either Coloplast Titan or AMS 700 device per institutional practice. RESULTS: A total of 898 patients who underwent subcoronal implants from May 2015 to March 2022 were analyzed. Median follow-up was 41 months (IQR 40). Preoperative patient comorbidities included diabetes (36.6%) and Peyronie's disease (4%). The most common complication was transient distal penile edema (74.7%). Transient incisional paresthesia (20.6%) was more common in patients with diabetes (31.9% vs 13.9%, P < .01). Five cases (0.5%) of distal penile skin necrosis were reported in patients who had previously been circumcised. Of these, 3 were managed successfully with wet-to-dry dressing, 1 required skin grafting, and 1 required device explant. Device infection without incisional compromise occurred in 2 cases (0.2%). There were no instances of glans necrosis or ischemia observed in this cohort. Of the first-time implants (817, 90.9%), most (62.3%) were successfully completed under local anesthetic alone, with the remainder of surgeries completed with the addition of adjunctive conscious sedation. CONCLUSIONS: Subcoronal incision for first-time or revision penile implant surgery is not a risk factor for glans ischemia or necrosis and can be safely completed under local anesthetic with or without conscious sedation.

Initial safety outcomes for the Rigicon Infla10® inflatable penile prosthesis.

OBJECTIVE: To analyse data from patient information forms (PIFs) submitted to the manufacturer of a new three-piece inflatable penile prosthesis (IPP), the Rigicon Infla10®, to summarize early outcomes. METHODS: A retrospective review of PIFs from 319 patients implanted with the IPP between 6 January 2019 and 31 December 2021 was performed to assess device durability and rates of reoperation for infection, mechanical failure or medical reasons. RESULTS: The mean ± sd (range) follow-up was 21.2 ± 11 (5-36) months and the mean ± sd patient age was 58.5 ± 8.7 years. Of the total, 4.4% of devices required removal or revision. Complications included mechanical failure (2.5%) and component migration (0.7%). No infections were observed in this series. One patient (0.4%) required revision for inadequate straightening of Peyronie's disease. Three patients (0.9%) requested device removal because of dissatisfaction. A total of 95.6% of the Rigicon Infla10 devices were free from explant or revision 21 months after the original implant date. Kaplan-Meier analysis showed the rates of cumulative survival of the device at 12, 24, 36 months were 95.6%, 94.7% and 93.7%, respectively. CONCLUSIONS: The vast majority of the early Rigicon Infla10 IPPs implanted prior to January 2022 were included in this retrospective analysis of volunteered PIFs. These early results demonstrate initial durability from reoperation equivalent to that of other contemporary devices.

Penile prostheses harbor biofilms driven by individual variability and manufacturer even in the absence of clinical infection.

BACKGROUND: Culture-based studies have shown that penile prostheses harbor biofilms in the presence and absence of infection, but these findings have not been adequately validated using contemporary microbiome analytic techniques. AIM: The study sought to characterize microbial biofilms of indwelling penile prosthesis devices according to patient factors, device components, manufacturer, and infection status. METHODS: Upon penile prostheses surgical explantation, device biofilms were extracted, sonicated, and characterized using shotgun metagenomics and culture-based approaches. Device components were also analyzed using scanning electron microscopy. OUTCOMES: Outcomes included the presence or absence of biofilms, alpha and beta diversity, specific microbes identified and the presence of biofilm, and antibiotic resistance genes on each prosthesis component. RESULTS: The average age of participants from whom devices were explanted was 61 ± 11 years, and 9 (45%) of 20 had a diagnosis of diabetes mellitus. Seventeen devices were noninfected, and 3 were associated with clinical infection. Mean device indwelling time prior to explant was 5.1 ± 5.1 years. All analyzed components from 20 devices had detectable microbial biofilms, both in the presence and absence of infection. Scanning electron microscopy corroborated the presence of biofilms across device components. Significant differences between viruses, prokaryotes, and metabolic pathways were identified between individual patients, device manufacturers, and infection status. Mobiluncus curtisii was enriched in manufacturer A device biofilms relative to manufacturer B device biofilms. Bordetella bronchialis, Methylomicrobium alcaliphilum, Pseudoxanthomonas suwonensis, and Porphyrobacter sp. were enriched in manufacturer B devices relative to manufacturer A devices. The most abundant bacterial phyla were the Proteobacteria, Actinobacteria, and Firmicutes. Glycogenesis, the process of glycogen synthesis, was among the predominant metabolic pathways detected across device components. Beta diversity of bacteria, viruses, protozoa, and pathways did not differ among device components. CLINICAL IMPLICATIONS: All components of all penile prostheses removed from infected and noninfected patients have biofilms. The significance of biofilms on noninfected devices remains unknown and merits further investigation. STRENGTHS AND LIMITATIONS: Strengths include the multipronged approach to characterize biofilms and being the first study to include all components of penile prostheses in tandem. Limitations include the relatively few number of infected devices in the series, a relatively small subset of devices included in shotgun metagenomics analysis, and the lack of anaerobic and other expanded conditions for culture. CONCLUSION: Penile prosthesis biofilms are apparent in the presence and absence of infection, and the composition of biofilms was driven primarily by device manufacturer, individual variability, and infection, while being less impacted by device component.

Effect of 0.05% chlorhexidine gluconate in water on the hydrophilic inflatable penile prosthesis: biocompatibility, adherence, and dip time.

BACKGROUND: Rates of infection after inflatable penile prosthesis range from 1% to 3%; however, a new surgical irrigation solution is Food and Drug Administration cleared as antimicrobial wound lavage and appears to be safe for patients and noncaustic during hydrophilic inflatable penile prosthesis (hIPP) dipping and irrigation. AIM: To evaluate if 0.05% chlorhexidine (CHG) lavage is caustic to the hIPP coating and if dip adherence is dependent on time. METHODS: Preconnected hIPP devices were tested at a Coloplast research and development laboratory. The devices were soaked in the 0.05% CHG lavage solution or normal saline for 1, 15, 30, and 60 minutes. Subsequently, all parts were dried for 15 minutes in a 35 °C oven. A Congo red dye test was performed following a Coloplast-validated and Food and Drug Administration-cleared test method to ensure product reliability. Implants were then visually inspected for deleterious effects as well as dip coverage. In addition, we evaluated 0.05% CHG lavage solution vs previously published hIPP dipping solutions. OUTCOMES: 0.05% CHG lavage does not appear to damage the hIPP coating, and adherence of this solution is not dependent on dip time. RESULTS: All components of the preconnected hydrophilic IPPs were tested for coating adherence and defects. All tested IPPs achieved a "satisfactory" coating, meaning a uniform coat without flaking or clumping. Furthermore, there were no noticeable caustic effects or differences in coating adherence between the normal saline-soaked control and 0.05% CHG-coated arms with increasing dip time. A review of the literature for 0.05% CHG lavage solutions vs previously published hIPP dipping solutions revealed that it may have some advantages over previously reported antibiotic solutions. CLINICAL IMPLICATIONS: This study serves as a foundation to introduce 0.05% CHG lavage to the urologic literature as a potentially new "magic bullet" irrigation. STRENGTHS AND LIMITATIONS: Major strengths of the study are that it is the first study of its kind to address the question of what dip duration should be used and whether it is scientifically reproducible. A limitation is the in vitro model, thus needing validation in a clinical setting. CONCLUSION: 0.05% CHG does not appear to negatively affect the hIPP coating or differ in adherence with increasing dip time; however, long-term device performance has not been verified.

Predictors of hinge effect in patients with Peyronie's disease.

BACKGROUND: Patients with Peyronie's disease present with a variety of penile deformities. Those with hinge effect can experience bothersome buckling of the erection and instability during penetrative sex; however, the actual characteristics and clinical implications are not fully understood. AIM: To determine the factors that cause hinge effect and to assess the role on surgical intervention. METHODS: This retrospective review included 1223 consecutive patients who were examined by a single surgeon and had a complete penile duplex evaluation with curvature and hinge assessment. Baseline demographics, penile duplex findings, and clinical outcomes were used to assess for predictors of hinge effect. OUTCOMES: Analyses were performed to assess preoperative predictors of hinge effect and surgical intervention. RESULTS: Hinge effect was observed at the time of penile duplex Doppler examination in 33% of patients. Circumferential girth discrepancy at point of indentation (odds ratio [OR] 1.82; P < .001), rigidity of erection (OR, 0.82; P = .002), and degree of primary curvature (OR, 1.03; P < .001) predicted the presence of hinge effect. When controlling for rigidity, a girth discrepancy >1 cm did appear to be associated with a hinge. CLINICAL IMPLICATIONS: Circumferential girth discrepancy >1 cm, regardless of erectile rigidity, can be associated with hinge effect. STRENGTHS AND LIMITATIONS: As a strength, this study included the largest cohort of patients with Peyronie's disease, all of whom were examined in a rigorous and uniform manner via the same operative counseling. However, the study is limited by its retrospective nature and potential for selection and observer bias, given that the treating physician was also assessing all penile deformities as well as performing operative intervention. CONCLUSIONS: The presence of hinge effect can cause instability of erections during penetrative sex. Multiple factors may predispose patients to a hinge effect, including the quality of erection and severity of curvature. But when controlling for rigidity, a girth discrepancy >1 cm did appear to be associated with a hinge. While many factors, such as baseline erectile dysfunction and severity of curvature, are important in determining the optimal surgical intervention, assessing for preoperative hinge effect also influenced the surgical approach.

Penetrative anal intercourse may require high axial loading forces.

BACKGROUND: Despite increases in the lifetime prevalence of anal intercourse, little is known about the safety of inflatable penile prosthesis use during anal intercourse or the forces required for anal penetration. AIM: We sought to determine the force required for anal penetration. METHODS: A digital force gauge device was secured to a silicone phallus with a length and girth representative of the average male phallus in the United States and inserted into the anal canal of 6 male participants for a total of 5 measurements per participant. The maximum axial forces on insertion were recorded. Participants then completed a survey eliciting demographic information and past experience with receptive anal intercourse. OUTCOMES: The outcome measure was the force recorded during insertion of a force gauge device into the anal canal. RESULTS: The median maximal force recorded on anal penetration was 26.5 N (2.7 kg; range: 16.1-51.7 N or 1.64-5.27 kg). Participants who engaged in receptive anal intercourse more than once per month tended to use lesser median maximal forces (25.7 N or 2.62 kg) than participants who engaged less frequently in receptive anal intercourse (41.6 N or 4.24 kg). CLINICAL IMPLICATIONS: Compared with the forces required for vaginal penetration, anal penetration forces may cause additional mechanical stress to the phallus. STRENGTHS AND LIMITATIONS: While the study is limited primarily in its small sample size and in the use of a single device for anal penetration with a set size and rigidity, the resulting findings presented here are to our knowledge the first reported data pertaining the force required for anal penetration. CONCLUSION: As the forces required for anal penetration exceeded those for vaginal penetration, clinicians may need to carefully counsel patients on the safe use of an inflatable penile prosthesis for anal intercourse.

Mechanical indications for inflatable penile prosthesis revision: analysis and implications for revision surgery.

BACKGROUND: Despite technical advancements, inflatable penile prostheses (IPPs) are inherently at risk of mechanical failure given their nature as hydraulic devices. AIM: To characterize IPP component failure location at the time of device revision and stratify by manufacturer: American Medical Systems (Boston Scientific [BSCI]) and Coloplast (CP). METHODS: A retrospective review of penile prosthesis cases from July 2007 to May 2022 was conducted, identifying men who underwent revision surgery. Cases were excluded if documentation did not denote the cause of failure or the manufacturer. Mechanical indications for surgery were categorized by location (eg, tubing, cylinder, or reservoir leak; pump malfunction). Nonmechanical revisions were excluded (component herniation, erosion, or crossover). Categorical variables were assessed with Fisher exact or chi-square analysis; Student t-test and Mann-Whitney U test were used for continuous variables. OUTCOMES: Primary outcomes included specific location of IPP mechanical failure among BSCI and CP devices and time to mechanical failure. RESULTS: We identified 276 revision procedures, 68 of which met inclusion criteria (46 BSCI and 22 CP). Revised CP devices were longer than BSCI devices (median cylinder length, 20 vs 18 cm; P < .001). Log-rank analysis revealed a similar time to mechanical failure between brands (P = .096). CP devices failed most often due to tubing fracture (19/22, 83%). BSCI devices had no predominant site of failure. Between manufacturers, tubing failure was more common in CP devices (19/22 vs 15/46 for BSCI, P < .001), while cylinder failure was more common among BSCI devices (10/46 vs 0/22 for CP, P = .026). CLINICAL IMPLICATIONS: The distribution of mechanical failure is significantly different between BSCI and CP devices; this has implications regarding the approach to revision surgery. STRENGTHS AND LIMITATIONS: This is the first study to directly compare when and where mechanical failure occurs in IPPs and to compare the 2 main manufacturers head-to-head. This study would be strengthened by being repeated in a multi-institutional fashion to provide more robust and objective evaluation. CONCLUSION: CP devices commonly failed at the tubing and rarely elsewhere, while BSCI devices showed no predominant failure site; these findings may inform decision making regarding revision surgery.

Delayed placement of an inflatable penile prosthesis is associated with a high complication rate in men with a history of ischemic priapism.

BACKGROUND: Corporal fibrosis is known to result from prolonged priapism; however, the impact of the timing of penile prosthesis placement after priapism on complication rates is poorly understood. AIM: We sought to evaluate the impact of timing of inflatable penile prosthesis (IPP) placement on complications in men with a history of ischemic priapism. METHODS: We performed a multicenter, retrospective cohort study of patients with a history of priapism undergoing IPP placement by 10 experienced implantation surgeons. We defined early placement as ≤6 months from priapism to IPP. We identified a 1:1 propensity-matched group of men without a history of priapism and compared complication rates between men who had early placement, late placement, and no history of priapism. OUTCOMES: Our primary outcome was postoperative noninfectious complications, and secondary outcomes included intraoperative complications and postoperative infection. RESULTS: A total of 124 men were included in the study with a mean age of 50.3 ± 12.7 years. A total of 62 had a history of priapism and 62 were matched control subjects. The median duration of priapism was 37 (range, 3-168) hours and the median time from ischemic priapism to IPP placement was 15 months (range, 3 days to 23 years). Fifteen (24%) men underwent early (≤6 months) IPP placement at a median time of 2 months (range, 3 days to 6 months) following the ischemic priapism event. The remaining 47 (76%) underwent placement >6 months following priapism at a median time of 31.5 months (range, 7 months to 23 years). The complication rate in the delayed placement group was 40.5% compared with 0% in the early placement group and control group. Cylinder-related complications such as migration or leak accounted for 8 (57%) of 14 of the postoperative noninfectious complications. Full-sized cylinders were used in all patients who had a cylinder related complication. CLINICAL IMPLICATIONS: Priapism patients should be referred to prosthetic experts early to decrease complication rates in those needing an IPP. STRENGTHS AND LIMITATIONS: This is a multicenter study from experienced prosthetic urologists but is limited by the retrospective nature and small number of patients in the early placement group. CONCLUSION: IPP complication rates are high in men with a history of ischemic priapism, especially when implantation is delayed beyond 6 months.

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

BACKGROUND: Penile prosthesis (PP)-induced impending erosion is a rare complication that has not been well characterized. AIM: This study evaluates the role of prosthesis sizing and of the safety of xenograft windsock repair (AlloDerm, Tutoplast, ArthroFLEX) of impending erosion. METHODS: 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. OUTCOMES: 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. RESULTS: 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 (21.4 cm vs 20.1 cm; P < .01) and right (21.4 cm vs 20.1 cm; 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 (20.1 cm vs 20.0 cm; P = .67) and right (20.2 cm vs 20.1 cm; 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 90 days 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 56 months from placement. CLINICAL IMPLICATIONS: PP oversizing may increase risk of PP-induced impending erosion, which is a delayed process. STRENGTHS AND LIMITATIONS: 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. CONCLUSION: PP-induced impending erosion may be due to PP oversizing but can be successfully repaired with xenograft windsock during simultaneous IPP replacement.

Shaeer's infrapubic technique for penile prosthesis implantation through a single midline corporotomy: A single-center pilot study.

BACKGROUND: With the infrapubic approach (IPA) for penile prosthesis implantation, lateral corporotomies carry the risk of injury to the laterally coursing dorsal nerves. AIM: We sought to describe for the first time Shaeer's IPA, a modification of the IPA whereby malleable penile prosthesis cylinders are implanted through a single midline corporotomy in the bed of the deep dorsal vein, anatomically off the course of the dorsal nerves of the penis. METHODS: We compared semirigid penile prosthesis implantation via the single midline corporotomy IPA (IPA-S, n = 11) to the classic IPA with laterally placed dual corporotomies (IPA-D, n = 11) and to the penoscrotal approach (PSA; n = 13). Shaeer's IPA is performed through an infrapubic incision. A 3- to 5-cm length of the deep dorsal vein is stripped. A single 3- to 5-cm midline corporotomy is cut along the bed of the vein. Dilation, sizing, and implantation are performed through the single corporotomy on either side of the midline septum. Patients are discharged the same day and are allowed to bend the implant after 2 weeks and to commence intercourse after 3 weeks. OUTCOMES: Operative time, postoperative satisfaction, International Index of Erectile Function 5 (IIEF-5), and possible complications were recorded. RESULTS: There were no statistically significant differences in age, postimplantation IIEF-5, or satisfaction between the 3 groups. Average operative time for the IPA-S group was 21.8% shorter than that for the IPA-D group, and 34.5% shorter than for the PSA group. Those differences were statistically significant. No complications were recorded in the IPA-S group. Infection occurred in 1 PSA case, and partial hypoesthesia in 1 IPA-D case. CLINICAL IMPLICATIONS: The midline corporotomy confers an anatomical advantage that may help avoid nerve injury, thereby increasing the safety of the IPA. STRENGTHS AND LIMITATIONS: The main limitation of this study is the limited sample number, considering that this is a pilot study. CONCLUSION: The Shaeer's Midline-Corporotomy IPA is a minimally invasive technique for implantation of a semirigid penile prosthesis, with an anatomical advantage that may decrease the possibility of dorsal nerve injury.

Subcoronal inflatable penile prosthesis implantation: indications and outcomes.

BACKGROUND: While implantation of an inflatable penile prosthesis (IPP) is commonly performed via infrapubic or penoscrotal approaches, the subcoronal (SC) approach for IPP implantation may safely and reliably allow for additional reconstructive procedures through a single incision. AIM: The aim of this study is to report outcomes, including complications, of the SC approach and to determine common characteristics of patients undergoing the SC approach. METHODS: A retrospective chart review from May 11, 2012, to January 31, 2022, was performed at a single, tertiary care institution to identify patients with IPP implantation via the SC approach. OUTCOMES: Postoperative information was reviewed and extracted from all clinic notes available following the date of IPP implantation in the electronic medical record, detailing any complications including wound complications, need for revision or removal, device malfunction, and infections. RESULTS: Sixty-six patients had IPP implantation via the SC approach. Median follow-up duration was 29.4 (interquartile range 14.9-50.1) months. One (1.8%) patient had a simple wound complication. Two (3.6%) experienced postoperative infection of the prosthesis, which resulted in explantation of the device. One of these infected prostheses later experienced partial glans necrosis. Revision for mechanical failure or unsatisfactory cosmetic result was performed in 3 (7.3%) IPPs placed via a SC incision. CLINICAL IMPLICATIONS: The SC approach for implantation of IPP is safe and feasible with low complication and revision rates. It offers urologists an alternative to the classic infrapubic and penoscrotal approaches, both of which would require a second incision for additional reconstructive procedures required to adequately address deformities associated with severe Peyronie's disease. Therefore, urologists who treat these specialized populations of men may benefit from having the SC approach in their array of techniques for IPP implantation. STRENGTHS AND LIMITATIONS: The limitations of this study include its retrospective nature, risk of selection bias, lack of comparison groups, and sample size. This study reports on early experience with the SC approach performed by a single high-volume reconstructive surgeon, who treats a specialized population of patients requiring complex repair during implantation of an IPP, particularly those with Peyronie's disease. CONCLUSION: The SC incision for IPP implantation has low rates of complications and remains our approach of choice for IPP implantation in patients with severe Peyronie's disease, including curvatures >60°, severe indentation with hinge, and grade 3 calcification, which are unlikely to respond adequately to manual modeling alone.

Lightweight macroporous mesh can be used for corporal reconstruction during penile prosthesis surgery.

BACKGROUND: Options to reinforce or reconstruct the corpora cavernosa during penile prosthesis surgery are limited. Synthetic grafts may confer a higher infection risk. Lightweight macroporous mesh is a promising alternative due to better integration and tissue ingrowth. AIM: The study sought to report the first experience of using lightweight mesh to reinforce or reconstruct the corpora. METHODS: The medical records of all patients undergoing insertion or revision of penile prosthesis between May 2016 and May 2021 were reviewed retrospectively. Patient characteristics, management, and outcomes were extracted in which mesh was used for corporal reconstruction. Poliglecaprone-25/polypropylene mesh (UltraPro) was used in all cases. The surgical technique and alternatives were summarized. OUTCOMES: The outcomes were infection rate, postoperative complications by Clavien-Dindo classification, and patient-reported outcomes. RESULTS: Mesh was required during penile prosthesis surgery in 21 men (median age 56 [range, 18-74] years). Reasons for reconstruction were severe corporal fibrosis (n = 6), impending erosion (n = 6), crossover/perforation (n = 6), congenital corporal agenesis (n = 2), and excision of Peyronie's plaque. All but 2 patients (with corporal agenesis) presented for revision penile prosthesis surgery with a median number of previous revision attempts of 2 (range, 1-5). Two (10%) patients required explant after a mean follow-up of 23 ± 8.7 months. One man developed infection of the device 2 years after surgery, translating to an infection rate of 5% despite a high prevalence of diabetes (25%) in this cohort. Another required explantation due to debilitating chronic pain after 3 months. Further revision surgery for stiction syndrome was required in a third patient. Finally, another man was not satisfied with the position of the pump within the scrotum or the axial rigidity of the device, despite a second opinion suggesting no issues with the device. All men were sexually active following surgery. CLINICAL IMPLICATIONS: A lightweight mesh can be considered to reinforce or reconstruct the corpora cavernosa in complex cases in which there are no alternative techniques available. STRENGTHS AND LIMITATIONS: This is the first study using a lightweight macroporous mesh for revision penile prosthesis surgery. This was a well-characterized cohort of patients. A larger cohort with 5-year follow-up would be preferable. CONCLUSION: These early results suggest that a lightweight macroporous mesh may be an acceptable synthetic graft for corporal reconstruction. Poliglecaprone-25/polypropylene mesh may be ideal because it is partially absorbable, easy to handle, and not bulky.