Emerging strategies for the prevention of bacterial biofilm in prosthetic surgery.

Penile prosthesis implantation is an effective treatment for erectile dysfunction (ED) with high patient satisfaction and effectiveness. Unfortunately, infections remain a dreaded complication, often necessitating device removal and imposing a substantial healthcare cost. Biofilms are communities of microorganisms encased in a self-produced polymeric matrix that can attach to penile prostheses. Biofilms have been demonstrated on the majority of explanted prostheses for both infectious and non-infectious revisions and are prevalent even in asymptomatic patients. Biofilms play a role in microbial persistence and exhibit unique antibiotic resistance strategies that can lead to increased infection rates in revision surgery. Biofilms demonstrate physical barriers through the development of an extracellular polymeric substance (EPS) that hinders antibiotic penetrance and the bacteria within biofilms demonstrate reduced metabolic activity that weakens the efficacy of traditional antibiotics. Despite these challenges, new methods are being developed and investigated to prevent and treat biofilms. These treatments include surface modifications, biosurfactants, tissue plasminogen activator (tPA), and nitric oxide (NO) to prevent bacterial adhesion and biofilm formation. Additionally, novel antibiotic treatments are currently under investigation and include antimicrobial peptides (AMPs), bacteriophages, and refillable antibiotic coatings. This article reviews biofilm formation, the challenges that biofilms present to conventional antibiotics, current treatments, and experimental approaches for biofilm prevention and treatment.

An evaluation of three validated comorbidity indices to predict short-term postoperative outcomes after prosthetic urologic surgery.

PURPOSE: Commonly used comorbidity indices include the Charlson Comorbidity Index (CCI), Elixhauser/Van Walraven Index (VWI), and modified frailty index (mFI). This study evaluates whether these indices predict postoperative readmissions and complications after inflatable penile prosthesis (IPP) and artificial urinary sphincter (AUS) placement. METHODS: We identified adult males who underwent IPP or AUS placement using the State Inpatient and State Ambulatory Surgery and Services Databases for Florida (2010-2015) and California (2010-2011). CCI, VWI, and mFI scores were calculated for each patient. We extracted 30-day emergency department services, 30-day readmissions, 90-day device complications (e.g., removal, replacement, or infection), and 90-day postoperative complications (excluding device complications). Receiver-operating characteristic curves were constructed and areas under the curve (AUC) were compared between the indices using the VWI as the reference model. We considered an AUC < 0.7 to represent poor predictive power. RESULTS: We identified 4242 IPP and 1190 AUS patients. All three indices had AUCs and 95% confidence intervals less than 0.70 for all outcomes following IPP and AUS placement making these indices poor predictors for postoperative outcomes. There were no significant differences in predicting 90-day postoperative complications between the VWI (AUC = 0.59, 95% CI [0.54-0.63]), CCI (AUC = 0.59, 95% CI [0.54-0.63], p = 0.99), and mFI (AUC = 0.60, 95% CI [0.55-0.66], p = 0.53) for IPPs and VWI (AUC = 0.54, 95% CI [0.47-0.61]), CCI (AUC = 0.50, 95% CI [0.43-0.57], p = 0.30), and mFI (AUC = 0.52, 95% CI [0.43-0.60], p = 0.56) for AUS placements. CONCLUSION: All three comorbidity indices were poor predictors of readmissions and complications following urologic prosthetic surgeries. A better comorbidity index is needed for risk-stratification of patients undergoing these surgeries.

Outcome Measures and Inclusion/Exclusion Criteria in Benign Prostatic Hyperplasia Trials on ClinicalTrials.gov.

INTRODUCTION: For benign prostatic hyperplasia, clinical trials help assess new medical and surgical treatment options. The U.S. National Library of Medicine maintains ClinicalTrials.gov to provide access to prospective trials on diseases. This study investigates registered benign prostatic hyperplasia trials to determine if there are widespread differences in outcome measures and study criteria. METHODS: Interventional research with known study status on ClinicalTrials.gov identified by the keywords "benign prostatic hyperplasia" was examined. Inclusion/exclusion criteria, primary outcomes, secondary outcomes, study status, study enrollment, country of origin, and intervention category were studied. RESULTS: Of the 411 studies identified, International Prostate Symptom Score was the most common study outcome and was the primary or secondary study outcome in 65% of trials. Maximum urinary flow was the second most common study outcome (40.1% of studies). No other outcomes were measured as the primary or secondary outcome for more than 30% of studies. The most common inclusion criteria were a minimum International Prostate Symptom Score (48.9%), maximum urinary flow (34.8%), and minimum prostate volume (25.8%). Among studies using a minimum International Prostate Symptom Score, 13 was the most common minimum (35.3%) and a range of 7-21 was noted. The most common maximum urinary flow for inclusion was 15 mL/s (78 trials). CONCLUSIONS: Among clinicals trials on benign prostatic hyperplasia registered on ClinicalTrials.gov, a majority of studies utilized International Prostate Symptom Score as a primary or secondary outcome. Unfortunately, there were major differences in the inclusion criteria; these dissimilarities between trials may limit comparability of results across trials.

Factors affecting post-vasectomy semen analysis compliance in home- and lab-based testing.

INTRODUCTION: We used a home-based (HB) post-vasectomy semen analysis (PVSA) between 2014 and 2017, but we have since reverted to local lab-based (LB) testing. In this study, we compared PVSA compliance rates in HB and LB test settings and describe factors that may influence completion rates. METHODS: We retrospectively identified patients who underwent vasectomy at our institution. Surgeons X and Y performed vasectomies from 2014-2017 using a HB immunochromatographic PVSA kit. From 2017-2020, surgeon X used a local LB PVSA. We collected data on PVSA completion status and patient demographics to perform two analyses. HB testing was examined by assessing all patients who had a vasectomy from 2014-2017. Another compared HB and LB testing by looking at surgeon X vasectomies from 2014-2017 and 2017-2020. RESULTS: We identified 285 patients who underwent vasectomy from 2014-2017 and were assessed with HB testing. Compliance with PVSA was 35% with HB PVSA. Age at vasectomy, number of children, and surgeon influenced PVSA completion in the 2014-2017 cohort. Surgeon X PVSA completion was 29% for the HB (n=136) testing cohort and 46% for the LB (n=201) cohort (odds ratio 0.47, 95% confidence interval 0.29-0.74). Again, more children decreased PVSA completion. CONCLUSIONS: Compliance with PVSA testing was inadequate in both test settings, although it was significantly higher in local LB setting. Based on these findings, the convenience of HB testing appears to decrease compliance with PVSA, although surgeon factors may be influential. These findings may help surgeons identify factors that improve PVSA compliance rates.

Differences in sexual adverse events for premature ejaculation medications from a public federal database.

American Urological Association (AUA) guidelines recommend selective serotonin reuptake inhibitors (SSRI) as first-line pharmacotherapy for premature ejaculation (PE). While previous studies have described sexual adverse events (AE) associated with each medication, there is limited data directly comparing rates of specific sexual AEs across SSRIs. This study investigates the Food and Drug Administration Adverse Event Reporting System (FAERS) database for reports of monotherapy use of fluoxetine 20 mg, paroxetine 20 mg, sertraline 50 mg, and sertraline 100 mg in males from January 2004-June 2021. We examined 2608 reports from patients using SSRIs for PE or other psychiatric conditions. The average number of AEs was significantly different (p < 0.01) with paroxetine 20 mg having the highest (5.1 AEs/case report). Changes in libido was the most common sexual AE for fluoxetine 20 mg (6.7% of reports), paroxetine 20 mg (4.2%), and sertraline 50 mg (7.2%) while orgasm disorder was the most reported for sertraline 100 mg (3.9%). The SSRIs had different rates of changes in libido, erection disorder, orgasm disorder, and other sexual dysfunction (outside those listed). The SSRIs also differed in the rates of fatigue, ear/hearing changes, headache, and psychological AEs. The differences in specific AEs warrant future studies to determine true differences that would affect patient counseling.

Partial Component Exchange of a Non-Infected Inflatable Penile Prosthesis is Associated With a Higher Complication Rate.

OBJECTIVE: To describe the infectious and non-infectious complications in men undergoing Inflatable penile prosthesis (IPP) revision with partial and complete component exchange for mechanical malfunction. METHODS: We performed a multicenter retrospective cohort study of patients who underwent IPP revision. Men undergoing procedures for implant infection were excluded. Patients were divided into those who had complete exchange of the entire device or partial exchange of only one or 2 components. Infectious and non-infectious complications were compared between groups. RESULTS: Three hundred sixty-eight men had complete exchange of the entire device and 85 had partial component exchange. Men undergoing partial exchange had a significantly higher infection rate (7.1% vs 2.2%, P = .031). The partial exchange group also was more likely to receive antifungals (51.8 vs 16.6%, P < .001), have a modified salvage washout (77.4 vs 60.2%, P = .004), and less likely to receive vancomycin and gentamicin (63.5 vs 83.7%, P < .001). Time to revision was significantly shorter in the partial exchange group (44.9 vs 168.2 months, P < .001). Mean follow-up was slightly longer in the complete exchange group (18.3 vs 13.0 months). In multivariable analysis, partial exchange surgery, vancomycin and gentamicin prophylaxis, modified salvage washout, and antifungal prophylaxis were no longer associated with postoperative infections. The partial exchange group had greater rates of non-infectious complications (21.2% vs 9.5%, P = .005) such as pump malfunction and tubing breakage. CONCLUSION: Patients undergoing partial component revision had more infectious and non-infectious complications. These findings suggest that partial component exchange increases complications in men undergoing IPP revision.

Development of a North American coordinated registry network for surgical treatment of benign prostatic hyperplasia.

PURPOSE: To create a prospective, multicenter coordinated registry network (CRN) of robust "real world" data for benign prostatic hyperplasia (BPH) that links surgical practices to objective and subjective outcomes of patients who undergo surgery for the improvement in lower urinary tract symptoms (LUTS) secondary to BPH. METHODS: We gathered a group of BPH experts from various institutions to identify the minimum core data elements needed to assess BPH procedures. To achieve consensus on the data elements, we used a Delphi method adaptation, in which a series of surveys were answered by the expert panel individually and anonymously. Survey results were collected and analyzed. Questions for the following round were based on response analysis from the prior survey. This process was repeated until consensus was achieved. RESULTS: Participation rates in the first and second rounds were 100% and 90%, respectively. The expert panel reached consensus on 148 data elements out of the 182 proposed, capturing patient medical and surgical history, procedure, discharge, short- and long-term follow-up, device factors, surgery, and surgeon factors. CONCLUSION: We have successfully developed a set of core data elements to support the study of BPH surgical therapies by gathering an expert panel on BPH and using the Delphi method. These data elements influence provider decisions about treatment and include important outcomes related to efficacy and safety.

Evolution of healthcare costs for lower urinary tract symptoms associated with benign prostatic hyperplasia.

PURPOSE: With the ubiquity of lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) in older men, costs related to this highly prevalent disease are likely significant but not well defined. With this study, we hoped to define costs related to LUTS/BPH care. METHODS: We utilized the Optum© de-identified Clinformatics® Data Mart Database (CDM) for privately insured male enrollees aged 40-64 years with LUTS/BPH (N ≈ 100,300 annually) and the Centers for Medicare and Medicaid Services Medicare 5% Sample for male beneficiaries aged 65 + years with LUTS/BPH (N ≈ 147,800 annually). Annual LUTS/BPH-related expenditures from 2004 to 2013 were age standardized and calculated overall and by age and service location. RESULTS: The Medicare cohort demonstrated a 23% increase in total costs over the study period with a 28% decrease in CDM costs. Decreases in inpatient hospital charges (45% for Medicare, 55% for CDM) were offset by increasing hospital-based outpatient fees (120% for Medicare, 87% for CDM). Overall, we estimated a total cost of at least $1.9 billion for treatment of men with LUTS/BPH for 2013. Per person expenditures increased with age within cohorts with an average per-person cost of $269 (CDM) and $248 (Medicare) in 2013. CONCLUSION: The distribution of healthcare expenditures for LUTS/BPH shifted across practice settings from 2004 to 2013, with increasing outpatient relative to inpatient expenditures. Total direct costs for LUTS/BPH in 2013 were at least $1.9 billion, not accounting for indirect costs or certain unmeasured populations.

Erectile dysfunction and prostate diseases are the predominant Google search terms amongst men's health topics.

Patients are becoming increasingly active consumers of health information on the internet with urologic concerns being no exception. Our objective was to explore online search trends for topics related to men's health and identify information-seeking patterns related to news and media coverage of these topics. We used Google Trends ( http://google.com/trends ) to explore search trends for various search terms related to men's health in the United States over a 5-year period. Search queries provided graphs depicting search volume as a function of time, geographical data, and related topics and queries. Isolated spikes in search volume were further explored to identify a related event. Erectile dysfunction was the most-searched topic over the last 5 years in the United States. Prostate cancer and benign prostatic hyperplasia were the second and third most-searched topics, respectively. Other popular topics involved symptoms or pathologies of the testicles and penis. Most topics had relatively stable search volumes, with the exceptions of premature ejaculation and Peyronie's disease. Several observed spikes in search volume were attributable to singular events, mostly in the form of online article publications or social media posts. We believe it may be helpful for providers to stay informed of cultural events relating to medical conditions to anticipate patient concerns.

Poor clinical guideline adherence and inappropriate testing for incident lower urinary tract symptoms associated with benign prostatic hyperplasia.

BACKGROUND: The American Urological Association makes recommendations for evaluation and testing for lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) to help primary care providers and specialists identify LUTS/BPH and harmful related conditions including urinary retention and prostate or bladder cancer. Our understanding of provider adherence to these Guidelines is limited to single-site or nonrepresentative settings. METHODS: We analyzed two insurance claims databases: the Optum® de-identified Clinformatics® Data Mart database for privately insured males aged 40-64 years (N ≈ 1,650,900 annually) and the Medicare 5% Sample for males aged ≥65 years (N ≈ 546,000 annually). We calculated the annual prevalence of LUTS/BPH and comorbid bladder cancer and bladder stones from 2004 to 2013. We additionally examined LUTS/BPH incidence and adherence to testing guidelines in a cohort of men newly diagnosed with LUTS/BPH in 2009. RESULTS: While LUTS/BPH prevalence and incidence increased with increasing age, evaluation testing became less common. Urinalysis was the most common testing type but was performed in <60% of incident patients. Serum prostate-specific antigen (PSA) was the second most common test across age groups (range: 15-34%). Prevalence of comorbid bladder cancer (range: 0-4%), but not bladder stones (range: 1-2%), increased with increasing age. CONCLUSIONS: Although older men were at greater risk of LUTS/BPH than younger men, they were less likely to undergo testing at diagnosis. Recommended testing with urinalysis was poor despite higher prevalence of bladder cancer in older men and a standard recommendation for urinalysis since 1994. Providers should be more cognizant of AUA Guidelines when assessing LUTS/BPH patients.

Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment.

PURPOSE: Surgical therapies for symptomatic bladder outlet obstruction (BOO) due to benign prostatic hyperplasia (BPH) are many, and vary from minimally invasive office based to high-cost operative approaches. This Guideline presents effective evidence-based surgical management of male lower urinary tract symptoms secondary/attributed to BPH (LUTS/BPH). See accompanying algorithm for a detailed summary of procedures (figure[Figure: see text]). MATERIALS/METHODS: The Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, Cochrane Library, and AHRQ databases to identify eligible studies published between January 2007 and September 2020, which includes the initial publication (2018) and amendments (2019, 2020). The Team also reviewed articles identified by Guideline Panel Members. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, information is provided as Clinical Principles and Expert Opinions (table[Table: see text]). RESULTS: Twenty-four guideline statements pertinent to pre-operative and surgical management were developed. Appropriate levels of evidence and supporting text were created to direct urologic providers towards suitable and safe operative interventions for individual patient characteristics. A re-treatment section was created to direct attention to longevity and outcomes with individual approaches to help guide patient counselling and therapeutic decisions. CONCLUSION: Pre-operative and surgical management of BPH requires attention to individual patient characteristics and procedural risk. Clinicians should adhere to recommendations and familiarize themselves with criteria that yields the highest likelihood of surgical success when choosing a particular approach for a particular patient.

Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management.

PURPOSE: Benign prostatic hyperplasia (BPH) is a histologic diagnosis describing proliferation of smooth muscle and epithelial cells within the prostatic transition zone. The prevalence and severity of lower urinary tract symptoms (LUTS) in aging men are progressive and impact the health and welfare of society. This revised Guideline provides a useful reference on effective evidence-based management of male LUTS/BPH. See the accompanying algorithm for a summary of the procedures detailed in the Guideline (figures 1 and 2[Figure: see text][Figure: see text]). MATERIALS AND METHODS: The Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, Cochrane Library, and AHRQ databases to identify eligible English language studies published between January 2008 and April 2019, then updated through December 2020. Search terms included Medical Subject Headings (MeSH) and keywords for pharmacological therapies, drug classes, and terms related to LUTS or BPH. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, information is provided as Clinical Principles and Expert Opinions (table 1[Table: see text]). RESULTS: Nineteen guideline statements pertinent to evaluation, work-up, and medical management were developed. Appropriate levels of evidence and supporting text were created to direct both primary care and urologic providers towards streamlined and suitable practices. CONCLUSIONS: The work up and medical management of BPH requires attention to individual patient characteristics, while also respecting common principles. Clinicians should adhere to recommendations and familiarize themselves with standards of BPH management.

National Trends in the Management of Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

PURPOSE OF REVIEW: To gain an understanding of current practices in the management of lower urinary tract symptoms (LUTSs) in the setting of benign prostatic hyperplasia (BPH). Including both medication therapy and emerging minimally invasive options including peri-procedure considerations, expected outcomes, and value-based considerations. RECENT FINDINGS: Medical therapy, primarily alpha blockers (ABs), and 5 alpha reductase inhibitors (5-ARI) remain the most commonly utilized intervention for LUTS associated with BPH. Several minimally invasive surgical treatments (MISTs) have emerged to provide efficacious and durable results, while largely sparing men from the sexual adverse effects of more invasive surgical options. The introduction of value-based health care has led to more cost-conscious medical care and is poised to influence the landscape of LUTS associated with BPH treatment. As the population-based and societal needs continue to influence medical care for men with LUTS associated with BPH, a paradigm shift in management is expected.