Partner Involvement Reduces Postoperative Care Burden Following Penile Prosthesis Placement.

OBJECTIVE: To determine whether preoperative partner involvement at clinic appointments is associated with deviation from a standardized postoperative care pathway for patients undergoing an inflatable penile prosthesis placement. METHODS: This is a retrospective study of 170 patients undergoing primary inflatable penile prosthesis placement performed by a single surgeon between 2017 and 2020. A standardized postoperative clinical pathway was used, including planned follow-up visits at 2 weeks (for wound check and device deflation) and 6 weeks (for device teaching). Patient characteristics, including demographics, partner involvement, and the number of follow-up visits were obtained from the medical record. Logistic regression modeling was performed to determine whether partner involvement was associated with unanticipated follow-up visits. RESULTS: Partners were involved in preoperative visits for 92 patients (54%). Additional unplanned follow-up visits were observed for 58 patients (34%) between 0 and 6 weeks and for 28 patients (16%) after 6 weeks from surgery. Partner involvement was associated with reduced odds of unanticipated follow-up visits, both between 0 and 6 weeks (odds ratios 0.37, 95% CI 0.18-0.75) and after 6 weeks (odds ratios 0.33, 95% CI 0.13-0.81) in adjusted models. CONCLUSION: Having a patient's partner involved during the preoperative period is associated with a significant reduction in unanticipated follow-up. We would recommend that urologists routinely encourage patients considering the insertion of a penile prosthesis to involve their partners in perioperative visits. Further research needed is needed to determine how to best support patients during surgical decision-making and through the postoperative period.

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

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

A multicenter investigation examining timing of penile prosthesis infection management and responsible organisms.

The purpose of this investigation was to examine the timing of penile prosthesis infection management by different responsible organisms. A retrospective cohort study was performed of patients who underwent penile prosthesis salvage or explant procedures due to a suspected infection between 2001 and 2018. The cohort consisted of 216 patients from 33 different facilities and six countries. The most common primary organisms responsible for device infections included, Gram-positives (31.5%), no growth cultures (30.6%), Gram-negatives (22.2%), fungal (11.6%), and anaerobic organisms (4.2%). Overall, median time to infection was 1.8 (interquartile range [IQR]: 1.0-3.0) months for all patients. Median time to infection management was similar between responsible organisms: 1.0 (IQR: 1.0-2.3) months for Gram-negatives and 2 months for Gram-positives (IQR: 1.0-1.4), fungal (IQR: 1.0-5.0), anaerobes (IQR: 1.0-2.5), and no growth cultures (IQR: 1.0-3.0, p = 0.56). Median time to infection management was significantly shorter among patients who received aminoglycoside/vancomycin prophylaxis (1.5 months, IQR: 1.0-2.5, p < 0.01) compared to other antibiotic groups. Median time to infection management was significantly longer for patients managed with a three-piece inflatable implant salvage procedure (2.8 months, IQR: 1.0-5.0, p = 0.02) compared to other salvage procedures. Conventional wisdom surrounding early versus late penile prosthesis infections should largely be abandoned. More than half of penile prosthesis infections are surgically managed within 2 months of initial device placement.

Multicenter surgical outcomes of penile prosthesis placement in patients with corporal fibrosis and review of the literature.

Penile prosthesis (PP) insertion in the setting of corporal fibrosis can be challenging and a variety of techniques have been described to accomplish this, however the necessity of these maneuvers is debatable. Our objective was to investigate techniques and outcomes of PP placement in patients with corporal fibrosis at tertiary referral centers. Multicenter outcomes of 42 patients (mean age 53.4 ± 1.9 years) with corporal fibrosis who underwent placement of PP over a 10-year period were reviewed. The most common etiology of corporal fibrosis was prior PP explant due to either infection (40.5%) and/or erosion (16.7%). Fourteen patients (33.3%) had a history of priapism, 5 (11.9%) of which had one or more distal surgical penile shunts. Techniques used for PP placement included: sequential dilation (8-12 mm) with standard dilators in 15 (35.7%), dilation with cavernotomes in 25 (59.5%) and limited sharp corporal excision and dilation with cavernotomes in 1 (2.4%). Narrow cylinders were employed in ten patients (23.8%). Major complications occurred in one patient (2.4%) who underwent explant for infection and distal erosion. Most patients with corporal fibrosis can undergo successful placement of a PP using standard dilators or cavernotomes. Sharp corporal excision and other measures are rarely required.

An assessment of current penile prosthesis reimbursement guidelines for insurance plans nationwide.

A lack of uniformity exists for insurance payer coverage for all categories of penile prostheses (PP). We sought to determine common insurance coverage criteria and barriers to implantation across common insurance plans from healthcare referral regions (HRR) nationwide. Coverage criteria and stipulations were reviewed regarding erectile dysfunction (ED) etiology, ED duration, contributing comorbid conditions, medications, drug use, diagnostic tests, use of procedures and prior interventions. Seventy of 100 plans included coverage criteria. 36.1% provided coverage only in cases of gender dysphoria. 27.7% required documentation of trial, contraindication or intolerance to pharmacologic therapy, with varying descriptors of what this entailed. 13.8% required at least consideration of prior pharmacologic therapy. 4.2% required trial or contraindication to classic second-line therapies. 25.0% stated that ED must be organic. Psychogenic ED was covered by 12.5% of plans. Eleven plans required at least 6 or 12 months of symptoms. Laboratory evaluation to rule out hypogonadism or hyperprolactinemia was required by five plans. Insurance coverage criteria for PP placement were highly variable by state and plan. Coverage is provided for PP implantation in most cases for ED of organic etiology following failure of pharmacologic therapy when contributing comorbidities are optimally managed.

Immediate preoperative blood glucose and hemoglobin a1c levels are not predictive of postoperative infections in diabetic men undergoing penile prosthesis placement.

Defining the risks associated with diabetes mellitus in patients undergoing penile prosthesis implantation remains controversial. Our study aims to assess whether preoperative hemoglobin a1c and preoperative blood glucose levels are associated with an increased risk for postoperative infection in diabetic men. We performed a retrospective review of 932 diabetic patients undergoing primary penile prosthesis implantation from 18 high-volume penile prosthesis implantation surgeons throughout the United States, Germany, Belgium, and South Korea. Preoperative hemoglobin a1c and blood glucose levels within 6 h of surgery were collected and assessed in univariate and multivariate models for correlation with postoperative infection, revision, and explantation rates. The primary outcome is postoperative infection and the secondary outcomes are postoperative revision and explantation. In all, 875 patients were included in the final analysis. There were no associations between preoperative blood glucose levels or hemoglobin a1c levels and postoperative infection rates; p = 0.220 and p = 0.598, respectively. On multivariate analysis, a history of diabetes-related complications was a significant predictor of higher revision rates (p = 0.034), but was nonsignificant for infection or explantation rates. We conclude preoperative blood glucose levels and hemoglobin a1c levels are not associated with an increased risk for postoperative infection, revision, or explantation in diabetic men undergoing penile prosthesis implantation.

Impact of Antimicrobial Dipping Solutions on Postoperative Infection Rates in Patients With Diabetes Undergoing Primary Insertion of a Coloplast Titan Inflatable Penile Prosthesis.

BACKGROUND: Modern-day penile prostheses use infection retardant coating to decrease rates of postoperative infection, subsequently reducing explantation and revision rates as well. The Coloplast Titan models are dipped into antimicrobial solutions right before implantation, and the components used for dipping can be tailored toward the patient. AIM: To compare infection, explantation, and revision rates among different dipping solutions used before implantation for patients with diabetes receiving a Coloplast Titan implant. METHODS: We systematically reviewed 932 patients with diabetes receiving a primary penile implant across 18 different centers from the period April 2003 to August 2018. Of those patients, 473 received a Coloplast device, whereas 459 received an AMS device. Data regarding the type of antimicrobial solution used before implantation were recorded for 468 patients receiving a Coloplast Titan, including whether or not they suffered a postoperative infection and if they underwent explantation and/or revision. Outcome rates were compared using Fisher's exact and Pearson's chi-square tests, and logistic regression modeling was performed to account for covariates. OUTCOMES: The main outcome measures of this study were postoperative infection, explantation, and revision rates. RESULTS: Of the total 932 patients reviewed, 33 suffered a postoperative infection. Of 468 patients receiving Coloplast implants, there was a 3.4% infection rate. The most commonly used antibiotic combination before dipping was vancomycin + gentamicin (59.0%). There was a significantly lower rate of postoperative infection, explantation, and revision when vancomycin + gentamicin was used than those associated with the use of all other dipping solutions ([1.4% vs 6.4%; P = .004], [1.1% vs 8.3%; P < .001], and [2.5% vs 12.5; P < .001], respectively). After adjusting for age, body mass index, preoperative blood glucose level, and hemoglobin A1c, the use of other dips was an independent predictor of postoperative infection (odds ratio: 0.191; P = .049). The inclusion of rifampin in the dipping solution trended toward being a significant risk factor for infection (P = .057). Including antifungals in the dipping solution did not affect infection (P = .414), explantation (P = .421), or revision (P = .328) rates. CLINICAL IMPLICATIONS: Vancomycin + gentamicin was the most efficacious combination of antibiotics used for dipping in terms of preventing postoperative infection and subsequent explantation and revision. STRENGTHS AND LIMITATIONS: Data were sampled across multiple institutions providing a large sample that may be more representative of the population of interest. A key limitation of the study was its retrospective nature, which prevented us from controlling certain variables. CONCLUSION: The use of rifampin did not provide the same type of protection, possibly representing a shift in resistance patterns of common bacteria responsible for device infection. Towe M, Huynh LM, Osman MM, et al. Impact of Antimicrobial Dipping Solutions on Postoperative Infection Rates in Patients With Diabetes Undergoing Primary Insertion of a Coloplast Titan Inflatable Penile Prosthesis. J Sex Med 2020;17:2077-2083.

A Multicenter Investigation Examining American Urological Association Recommended Antibiotic Prophylaxis vs Nonstandard Prophylaxis in Preventing Device Infections in Penile Prosthesis Surgery in Diabetic Patients.

PURPOSE: American Urological Association (AUA) antibiotic prophylaxis recommendations may be insufficient for covering organisms commonly found in penile prosthesis infections. In this study we assess the difference between AUA recommended antibiotic prophylaxis and nonstandard prophylaxis in preventing device infections in penile prosthesis surgery performed in diabetic patients. MATERIALS AND METHODS: A multicenter, retrospective cohort study of diabetic patients undergoing primary penile prosthesis surgery was performed between April 2003 and August 2018. Eighteen institutions from the United States, Europe and Korea contributed. The association between antibiotic prophylaxis type and postoperative penile prosthesis infections, device explantations and revision surgeries was assessed. RESULTS: Standard AUA antibiotic prophylaxis was followed in 48.6% (391) of cases while nonstandard prophylaxis was used in 51.4% (413). Common nonstandard antibiotic prophylaxis included vancomycin-gentamycin-fluoroquinolone, clindamycin-fluoroquinolone, and vancomycin-fluoroquinolone among other combinations. Patients who received AUA prophylaxis had significantly more postoperative device infections (5.6% vs 1.9%, p <0.01) and explantations (8.3% vs 2.0%, p <0.001) compared to those who received nonstandard prophylaxis. Patients who received AUA prophylaxis had significantly higher odds of a postoperative device infection (OR 2.8, 95% CI 1.1-7.3) and explantation (OR 3.6, 95% CI 1.4-9.1) compared to those who received nonstandard prophylaxis. CONCLUSIONS: Diabetic men with erectile dysfunction who received standard AUA prophylaxis for penile prosthesis surgery had significantly greater odds of experiencing a postoperative device infection and device explantation compared to patients who received nonstandard prophylaxis. Our study provides a strong rationale for a prospective investigation to establish the most appropriate prophylaxis strategy in penile prosthesis surgery.

Regional Variation in Penile Prosthesis Utilization among Medicare Patients with Erectile Dysfunction.

OBJECTIVE: To characterize penile prosthesis surgery utilization and assess for regional differences in the use of this procedure across the United States. MATERIALS & METHODS: We examined penile prosthesis surgeries (inflatable and semirigid implants) in Medicare beneficiaries with erectile dysfunction (ED) for the years 2006 through 2014. Adjusted utilization rates were calculated per 1000 beneficiaries accounting for age and race. Utilization rates were examined nationally and by hospital referral region (HRR). RESULTS: The national adjusted rate of penile prosthesis surgery declined from 5.41 per 1000 beneficiaries in 2006 to 3.74 per 1000 beneficiaries in 2014. The number of beneficiaries diagnosed with ED outpaced the number of patients undergoing surgery. Regional variation was observed; a 12-fold difference in 2014 (1.9/1000 in Norfolk, VA to 24.2/1000 in Miami, FL). Adjustment of 2014 data by urology provider density reduced variation between HRRs, and as a result a 3.5-fold difference was observed. Over 60% of HRRs performed 0 to <11 surgeries. CONCLUSION: The rate of penile prosthesis surgery is declining amongst Medicare beneficiaries with ED. Significant regional variation exists in the utilization of penile prosthesis surgery. This variation may be explained by a series of urologist and patient-specific factors, including provider density. Penile prosthesis surgery in Medicare beneficiaries is likely highly dependent on where these patients seek care.

A Review of Economic Evaluations of Erectile Dysfunction Therapies.

INTRODUCTION: Erectile dysfunction (ED) is a common and costly urologic condition with increasing prevalence as men age. Cost-effectiveness of ED therapies and whether cost-effectiveness varies for different populations of men remains underexplored. AIM: To review and summarize available published data on the economic evaluation of ED therapies and to identify gaps in the literature that still need to be addressed. METHODS: All relevant peer-reviewed publications and conference abstracts were reviewed and incorporated. RESULTS: There are a number of medical and surgical treatment options available for ED. The economic evaluation of phosphodiesterase-5 inhibitors, particularly sildenafil, has been well described. However, minimal research has been conducted to assess the cost-effectiveness of intracavernosal injections, intraurethral suppositories, penile prosthesis surgery, vacuum erection devices, and other emerging therapies in men with different causes of ED. CONCLUSION: Available economic evaluations of ED therapies are dated, do not reflect present-day physician, pharmaceutical, and device costs, fail to account for patient comorbidities, and may not be generalizable to today's ED patients. Substantial research is needed to evaluate the cost-effectiveness of ED treatments across different patient populations, countries, and reimbursement systems. Rezaee ME, Ward CE, Brandes ER, et al. A Review of Economic Evaluations of Erectile Dysfunction Therapies. Sex Med Rev 2019;8:497-503.

Updates in penile prosthesis infections.

Inflatable penile prostheses are an important tool in the treatment of medically refractory erectile dysfunction. One of the major complications associated with these prostheses is infections, which ultimately require device explanation and placement of a new device. Over the past several decades, significant work has been done to reduce infection rates and optimize treatment strategies to reduce patient morbidity. This article reviews the current state of knowledge surrounding penile prosthesis infections, with attention to the evidence for methods to prevent infection and best practices for device reimplantation.

Multicenter Investigation of Fungal Infections of Inflatable Penile Prostheses.

BACKGROUND: Fungal infections of inflatable penile prostheses (IPPs) are inadequately understood in the literature. AIM: To review a multi-institution database of IPP infections to examine for common patient and surgical factors related to IPP fungal infections. METHODS: This is a retrospective Institutional Review Board-approved analysis of 217 patients at 26 institutions who underwent salvage or device explant between 2001 and 2018. Patient data were compiled after an extensive record review. OUTCOMES: 26 patients (12%) with fungal infections were identified. RESULTS: 23 of 26 patients (83%) with a fungal IPP infection were either diabetic or overweight. 15 patients had undergone primary IPP implantation, and the other 11 had previously undergone an average of 1.7 IPP-related surgeries (range 1-3; median 2). The average age at implantation was 63 years (range 31-92; median 63). 18 of the 26 patients with fungal infection had diabetes (69%), with a mean hemoglobin A1c (HbA1c) value of 8.4 (range 5.8-13.3; median 7.5). Twenty-two patients (85%) were overweight or obese. The mean body mass index for all patients was 30.1 kg/m2 (range 23.7-45 kg/m2; median 28.4 kg/m2), and that for diabetic patients was 30.8 kg/m2 (range 24.1-45 kg/m2, median 29.7 kg/m2). Ninety-one percent of implants were placed with intravenous antibiotics, consistent with current American Urological Association guidelines: an aminoglycoside plus first- or second-generation cephalosporin or vancomycin or ampicillin/sulbactam or piperacillin/tazobactam. 65% (17 of 26) of infected IPPs had only fungal growth in culture. No patient had concomitant immunosuppressive disease or recent antibiotic exposure before IPP implantation. CLINICAL IMPLICATIONS: More than two-thirds of the fungal infections occurred in diabetic patients and 85% occurred in overweight or obese patients, suggesting that antifungal prophylaxis may be appropriate in these patients. STRENGTHS & LIMITATIONS: This is the largest series of fungal infections reported to date in the penile prosthesis literature. The overall number of such cases, however, remains small. CONCLUSION: Fungal infections represent 12% of all penile prosthesis infections in our series and were seen mostly in diabetic or overweight patients, who may benefit from antifungal prophylaxis. Gross MS, Reinstatler L, Henry GD, et al. Multicenter Investigation of Fungal Infections of Inflatable Penile Prostheses. J Sex Med 2019;16:1100-1105.

Infection Prevention Considerations for Complex Penile Prosthesis Recipients.

PURPOSE OF REVIEW: The purpose of this review is to critically analyze and summarize recent studies in the area of penile prosthesis surgery outcomes with a focus on infection prevention in high-risk patients. RECENT FINDINGS: Reduction of surgical time in complex prosthesis surgery may reduce infection risk. Concomitant implant surgery is not associated with increased infection risk. Certain immunocompromised patients may be more likely to have penile implant infections, but these may not include patients with well-controlled HIV, well-controlled diabetes, or transplant recipients. Substance abuse is correlated with increased risk of infection after penile implant surgery. Careful patient selection and preoperative optimization can reduce infection risk in spinal cord injury patients. In the last 5 years, there have been several important studies investigating the risk of penile prosthesis infection in complex patients, clarifying which patient categories are at increased risk and how that risk can be mitigated.

Bibliometric Analysis of Erectile Dysfunction Publications in Urology and Sexual Medicine Journals.

INTRODUCTION: Scientific literature has experienced a significant growth in the number of authors per publication each year. Erectile dysfunction (ED) is one of the most common urologic conditions, accounting for over 2.9 million outpatient visits per year. Given the prevalence of ED and the large literature base available on this condition, bibliometric analysis of the ED literature could provide urologists and sexual medicine specialists with a better understanding of publication trends in this topic area. AIM: The purpose of this study was to investigate trends in authorship, citations, and impact score for ED original and review articles published in urology and sexual medicine journals. METHODS: We analyzed ED original research and review articles indexed in MEDLINE between January 1, 2006, and December 31, 2016. Descriptive statistics were used to evaluate the mean number of authors for articles by journal type and time period (2006 vs 2016). Linear regression was used to examine the relationship between number of authors, number of citations, and relative citation ratio (RCR). MAIN OUTCOME MEASURE: The primary outcomes of interest included mean number of authors, citations, and RCR per manuscript by journal type and time period. RESULTS: A total of 3,516 articles were analyzed, 2,938 (83.6%) original and 578 (16.4%) review articles. The mean number of authors among ED publications increased from 4.8 in 2006 to 6.4 in 2016, a 34.4% increase. Original articles had a greater mean number of authors compared to review articles (6.0 vs 4.3, P < .001). The mean number of authors for original articles significantly increased from 5.0 in 2006 to 7.0 in 2016 (P < .001), an increase of 38.9%. A positive linear relationship was observed between mean number of authors and number of citations per manuscript (r = 0.015, P < .01) as well as RCR (r = 0.37, P < .0001). The largest authorship increases were observed in European Urology (78.8%), BJU International (78.6%), and Journal of Sexual Medicine (58.1%). CLINICAL IMPLICATIONS: Authorship trends should be taken into consideration when urologists and sexual medicine experts review ED articles for the purpose of informing patient care. STRENGTH AND LIMITATIONS: Primary strengths include a large literature base spanning multiple years for analysis and a systematic literature search to identify relevant ED literature. Findings are limited to ED literature published in the urology and sexual medicine journals analyzed. CONCLUSION: The number of authors per ED manuscript has significantly increased over time, most notably among original research articles. Increasing authorship was associated with more citations and higher RCR in the ED literature. Rezaee ME, Johnson HA, Munarriz RM, et al. Bibliometric Analysis of Erectile Dysfunction Publications in Urology and Sexual Medicine Journals. J Sex Med 2018;15:1426-1433.

Multicenter Investigation of the Micro-Organisms Involved in Penile Prosthesis Infection: An Analysis of the Efficacy of the AUA and EAU Guidelines for Penile Prosthesis Prophylaxis.

INTRODUCTION: Penile prosthesis infections remain challenging despite advancements in surgical technique, device improvements, and adoption of antibiotic prophylaxis guidelines. AIM: To investigate penile prosthesis infection microbiology to consider which changes in practice could decrease infection rates, to evaluate current antibiotic prophylaxis guidelines, and to develop a proposed algorithm for penile prosthesis infections. METHODS: This retrospective institutional review board-exempt multi-institutional study from 25 centers reviewed intraoperative cultures obtained at explantation or Mulcahy salvage of infected three-piece inflatable penile prostheses (IPPs). Antibiotic usage was recorded at implantation, admission for infection, and explantation or salvage surgery. Cultures were obtained from purulent material in the implant space and from the biofilm on the device. MAIN OUTCOME MEASURES: Intraoperative culture data from infected IPPs. RESULTS: Two hundred twenty-seven intraoperative cultures (2002-2016) were obtained at salvage or explantation. No culture growth occurred in 33% of cases and gram-positive and gram-negative organisms were found in 73% and 39% of positive cultures, respectively. Candida species (11.1%), anaerobes (10.5%) and methicillin-resistant Staphylococcus aureus (9.2%) constituted nearly one third of 153 positive cultures. Multi-organism infections occurred in 25% of positive cultures. Antibiotic regimens at initial implantation were generally consistent with American Urological Association (AUA) and European Association of Urology (EAU) guidelines. However, the micro-organisms identified in this study were covered by these guidelines in only 62% to 86% of cases. Antibiotic selection at admissions for infection and salvage or explantation varied widely compared with those at IPP implantation. CONCLUSION: This study documents a high incidence of anaerobic, Candida, and methicillin-resistant S aureus infections. In addition, approximately one third of infected penile prosthesis cases had negative cultures. Micro-organisms identified in this study were not covered by the AUA and EAU antibiotic guidelines in at least 14% to 38% of cases. These findings suggest broadening antibiotic prophylaxis guidelines and creating a management algorithm for IPP infections might lower infection rates and improve salvage success. Gross MS, Phillips EA, Carrasquillo RJ, et al. Multicenter Investigation of the Micro-Organisms Involved in Penile Prosthesis Infection: An Analysis of the Efficacy of the AUA and EAU Guidelines for Penile Prosthesis Prophylaxis. J Sex Med 2017;14:455-463.