Infectious Adverse Events Following the Placement of a Penile Prosthesis: A Systematic Review.

INTRODUCTION: Infection remains a prominent concern following penile implantation. Recognition of the risk factors for infection may help to guide surgeons toward reducing the risk of prosthetic contamination. AIM: To gain a further understanding of infectious adverse events following penile prosthesis, we performed a systematic literature review. METHODS: As part of the 2018 American Urological Association Erectile Dysfunction Clinical Guidelines and with the support of the American Urological Association, we performed a comprehensive review of the PubMed, Embase, and Cochrane databases to search for eligible articles published between January 1, 1965, and July 20, 2016, to identify articles reporting infectious adverse events following prosthesis placement. MAIN OUTCOME MEASURE: The main outcome measure was infectious adverse events following penile prosthesis placement. RESULTS: Ninety-one articles reporting infectious adverse events representing 97 study arms were identified. Prosthetic infection rates ranged from 0% to 24.6% across all series. Inflatable penile prostheses displayed a wider range (0-24.6%) than malleable devices (0-9.1%); the most frequently reported infection rate for inflatable devices was 5% or less. With the advent of device coatings and improved surgical techniques, infectious adverse events have decreased. Infections among diabetic patients also decreased throughout the reviewed body of literature, with the most recent series reporting rates consistent with those of non-diabetic patients. Furthermore, no glycosylated hemoglobin cutoff was found to infer increased or decreased risk of prosthesis infection. CONCLUSION: Overall penile prosthetic infectious adverse events have decreased as surgical techniques have improved and the use of antimicrobial coating has gained in popularity. These advances have demonstrated significant benefits for all patients, particularly diabetic patients who experience infection rates similar to those of non-diabetic patients in recent reports. Further technological advancements for the prevention of biofilm formation is warranted. Mahon J, Dornbier R, Wegrzyn G, et al. Infectious Adverse Events Following the Placement of a Penile Prosthesis: A Systematic Review. Sex Med Rev 2020;8:348-354.

Etiology of Erectile Dysfunction and Duration of Symptoms in Patients Undergoing Penile Prosthesis: A Systematic Review.

INTRODUCTION: Inadequate treatment of men with erectile dysfunction (ED) subjects them and their partners to lost quality of life, yet little is known about the cause and duration of symptoms that lead to penile prosthesis (PP) placement. AIM: We performed a systematic review addressing cause and duration of symptoms before implantation. METHODS: We searched PubMed, Embase, and Cochrane for articles published between January 1, 1965-July 20, 2016, reporting on PP for ED. Studies were assessed for quality. Body of evidence strength was categorized in accordance to American Urological Association (AUA) categorization: grade A (well-conducted, highly-generalizable randomized controlled trials (RCTs) or exceptionally strong observational studies with consistent findings), grade B (RCTs with some weaknesses of procedure/generalizability or moderately strong observational studies with consistent findings), or grade C (RCTs with serious deficiencies of procedure/generalizability, have small sample sizes, or other problems that potentially confound interpretation). This review was performed as part of the 2018 AUA ED Clinical Guidelines, with the support of the AUA. MAIN OUTCOME MEASURES: Cause and duration of symptoms before PP were assessed. RESULTS: We reviewed 113 articles constituting 150 study arms. All studies were observational (body of evidence strength grade C). Of these arms, only 19 reported on ED duration. Mean duration was 56 months for men undergoing inflatable penile prosthesis (IPP) placement (38.7 months for those after prostatectomy) and 72 months for those undergoing malleable penile prosthesis placement. Diabetic patients undergoing IPP had mean ED duration of 75 months. Among arms reporting on IPPs, causes of ED were vascular disease (47 arms; range 2.9-62.0%; mean 31.9%), diabetes (61 arms; range 12.8-77.8%; mean 28.3%), and pelvic surgery or trauma (49 arms; range 0.5-49.7%; mean 20.3%). CONCLUSION: Nearly all men undergoing PP have ED of organic causes, whereas diabetic patients and patients receiving malleable penile prosthesis have the longest ED duration. Factors driving this relative delay require additional investigation. Post-prostatectomy IPP placement is offered relatively late, on average. Bajic P, Mahon J, Faraday M, et al. Etiology of Erectile Dysfunction and Duration of Symptoms in Patients Undergoing Penile Prosthesis: A Systematic Review. Sex Med Rev 2020;8:333-337.

Erectile Dysfunction: AUA Guideline.

PURPOSE: The purpose of this guideline is to provide a clinical strategy for the diagnosis and treatment of erectile dysfunction. MATERIALS AND METHODS: A systematic review of the literature using the Pubmed, Embase, and Cochrane databases (search dates 1/1/1965 to 7/29/17) was conducted to identify peer-reviewed publications relevant to the diagnosis and treatment of erectile dysfunction. Evidence-based statements were based on body of evidence strength Grade A, B, or C and were designated as Strong, Moderate, and Conditional Recommendations with additional statements presented in the form of Clinical Principles or Expert Opinions. RESULTS: The American Urological Association has developed an evidence-based guideline on the management of erectile dysfunction. This document is designed to be used in conjunction with the associated treatment algorithm. CONCLUSIONS: Using the shared decision-making process as a cornerstone for care, all patients should be informed of all treatment modalities that are not contraindicated, regardless of invasiveness or irreversibility, as potential first-line treatments. For each treatment, the clinician should ensure that the man and his partner have a full understanding of the benefits and risk/burdens associated with that choice.

Testosterone Pellet Implantation Practices: A Sexual Medicine Society of North America (SMSNA) Member Questionnaire.

INTRODUCTION: There has been renewed interest in the use of subcutaneous testosterone pellets for the treatment of hypogonadism since the introduction of Testopel in 2008 by Slate Pharmaceuticals (Durham, NC, USA). Manufacturer guidelines recommend using two to six pellets; however, in the clinical setting, this is deemed insufficient. This has produced a wide variety of testosterone pellet usage that is not fully understood. AIM: To better understand subcutaneous testosterone pellet implantation practices among members of the Sexual Medicine Society of North America (SMSNA). METHODS: A 19-item questionnaire was emailed to the 687 members of the SMSNA. Of the 19 questions, 17 were multiple choice and two required write-in responses. Usage patterns, satisfaction rates, and complication rates were investigated. MAIN OUTCOME MEASURES: Data regarding indications for initiating treatment with Testopel, initial dosage, follow-up of testosterone levels and dose titration, patient tolerance and satisfaction, technique of implantation, and procedural complications were collected. RESULTS: Eighty-seven survey responses were received (12.9%). At initiation of Testopel therapy, 80.5% of respondents would implant at least 10 pellets, whereas only 4.6% would place six to seven pellets and 3.4% would implant fewer than six pellets. Many respondents would determine the starting dose based on some combination of baseline testosterone level and weight, although 24.1% described using a standard starting dose for all patients. All respondents would check testosterone levels within 3 months of initiating therapy, with the vast majority (72.4%) doing so at 1 month. Subsequent dosing of Testopel was not changed in most patients, with 41.4% and 26.4% of respondents reporting that 60% to 80% and 80% to 100% of patients, respectively, remained on their initial dose. Most respondents would re-implant pellets at a 3-month (21.8%) or 4-month (43.7%) interval. High patient satisfaction was described by respondents, with 56.3% finding patients to be satisfied "most times" and 34.5% "almost always." CONCLUSION: This study provides insight into the usage of Testopel among members of the SMSNA. We found that the vast majority of specialists use at least 10 pellets at initial implantation, with limited need for subsequent dose adjustments, good durability of response, and high patient satisfaction and tolerability.

Adult-Onset Hypogonadism.

In August 2015, an expert colloquium commissioned by the Sexual Medicine Society of North America (SMSNA) convened in Washington, DC, to discuss the common clinical scenario of men who present with low testosterone (T) and associated signs and symptoms accompanied by low or normal gonadotropin levels. This syndrome is not classical primary (testicular failure) or secondary (pituitary or hypothalamic failure) hypogonadism because it may have elements of both presentations. The panel designated this syndrome adult-onset hypogonadism (AOH) because it occurs commonly in middle-age and older men. The SMSNA is a not-for-profit society established in 1994 to promote, encourage, and support the highest standards of practice, research, education, and ethics in the study of human sexual function and dysfunction. The panel consisted of 17 experts in men's health, sexual medicine, urology, endocrinology, and methodology. Participants declared potential conflicts of interest and were SMSNA members and nonmembers. The panel deliberated regarding a diagnostic process to document signs and symptoms of AOH, the rationale for T therapy, and a monitoring protocol for T-treated patients. The evaluation and management of hypogonadal syndromes have been addressed in recent publications (ie, the Endocrine Society, the American Urological Association, and the International Society for Sexual Medicine). The primary purpose of this document was to support health care professionals in the development of a deeper understanding of AOH, particularly in how it differs from classical primary and secondary hypogonadism, and to provide a conceptual framework to guide its diagnosis, treatment, and follow-up.

Evidence-Based Management Guidelines on Peyronie's Disease.

INTRODUCTION: Despite recent advances in our knowledge and treatment strategies in Peyronie's Disease (PD), much remained unknown about this disease. AIM: To provide a clinical framework and key guideline statements to assist clinicians in an evidence-based management of PD. METHODS: A systematic literature search was conducted to identify published literature relevant to PD. The search included all relevant articles published up to June 2015, including preclinical studies and published guidelines. References used in the text were assessed according to their level of evidence, and guideline recommendations were graded based on the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Owing to the paucity of larger series and randomized placebo-controlled trials with regard to surgical intervention, guideline statements are provided as clinical principle or expert opinion. MAIN OUTCOME MEASURES: This literature was discussed at a panel meeting, and selected articles with the highest evidence available were used to create consensus guideline statements for the Fourth International Consultation on Sexual Medicine guidelines on PD. RESULTS: In addition to existing Third International Consultation on Sexual Medicine guidelines on PD, seven new summary recommendations were created. CONCLUSION: A greater understanding of the scientific basis of PD is greatly needed to address our understanding of the pathophysiology, clinical epidemiology, psychosocial, and diagnostic assessment as well as treatment strategies.

Peyronie's Disease: AUA Guideline.

PURPOSE: The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of Peyronie's disease. MATERIALS AND METHODS: A systematic review of the literature using the PubMed®, EMBASE® and Cochrane databases (search dates 1/1/1965 to 1/26/15) was conducted to identify peer-reviewed publications relevant to the diagnosis and treatment of PD. The review yielded an evidence base of 303 articles after application of inclusion/exclusion criteria. RESULTS: The systematic review was used to create guideline statements regarding treatment of PD. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high quality evidence; high certainty), B (moderate quality evidence; moderate certainty), or C (low quality evidence; low certainty). Evidence-based statements of Strong, Moderate, or Conditional Recommendation were developed based on benefits and risks/burdens to patients. Additional consensus statements related to the diagnosis of PD are provided as Clinical Principles and Expert Opinions due to insufficient published evidence. CONCLUSIONS: There is a continually expanding literature on PD; the Panel notes that this document constitutes a clinical strategy and is not intended to be interpreted rigidly. The most effective approach for a particular patient is best determined by the individual clinician and patient in the context of that patient's history, values, and goals for treatment. As the science relevant to PD evolves and improves, the strategies presented here will be amended to remain consistent with the highest standards of clinical care.

Office-based management of impotence and Peyronie's disease.

Erectile dysfunction (ED) impacts more than 50% of men older than 40 years; Peyronie disease (PD) affects up to 10% of men, with an adverse impact on normal sexual function and overall well-being. ED can also be the first sign of other underlying disease. The office-based evaluation of ED and PD is the first step in the management of these devastating conditions of men's health. New and exciting nonsurgical therapies are now available to help treat these conditions and restore sexual function and quality of life.

North American consensus document on infection of penile prostheses.

OBJECTIVE: To issue a consensus document on the prevention, management, and research of infection associated with penile prostheses, as neither professional associations nor governmental entities have issued guidelines that are specific to this infection. METHODS: Sixteen North American experts on infection of penile prostheses were identified and assembled to select and discuss certain issues related to infection of penile prostheses. After performing an extensive search of clinically important issues in published reports, the 16 experts met twice in person to finalize the selection, discuss the issues that were deemed most important, and issue pertinent recommendations. RESULTS: Although many subjects relevant to infection of penile prostheses were initially identified, the experts selected 10 issues as currently being the most important issues and for which there exists some support in the published data. The examined issues involved prevention, management, or research of infections associated with penile prostheses. CONCLUSION: In the absence of pertinent guidelines, the consensus document issued by experts in the field of prosthetic urology is anticipated to improve the quality of patient care, streamline the prevention and management of infected penile prostheses, and stimulate collaborative research. Although this consensus document could serve as best practice recommendations, the lack of adherence to these recommendations would not indicate improper care.

Tadalafil is efficacious and well tolerated in the treatment of erectile dysfunction (ED) in men over 65 years of age: results from Multiple Observations in Men with ED in National Tadalafil Study in the United States.

INTRODUCTION: Erectile dysfunction is increasingly common with advancing age, yet sexual activity and intimacy are important to elderly men. AIM: To assess the efficacy and tolerability of tadalafil in men over the age of 65 years. METHOD: In this multicenter open-label study, 188 men (mean age = 71.6 years) who were over age 65 and did not have diabetes mellitus or clinical depression received tadalafil 20 mg, taken on demand, for up to 12 weeks. MAIN OUTCOME MEASURES: Efficacy was assessed using the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP). Psychosocial outcomes were evaluated using the Psychological and Interpersonal Relationship Scale (PAIRS). RESULTS: Tadalafil treatment significantly improved all domains of the IIEF from baseline, including the erectile function (EF) domain (change = 8.8, end point = 21.6; P < 0.001). Mean per-patient percentage of "yes" responses to SEP questions concerning successful penetration (SEP2; change = 33.5%, end point = 73.5%; P < 0.001) and successful intercourse (SEP3; change = 39.6%, end point = 59.6%; P < 0.001) also improved significantly from baseline. Forty percent of the patients with baseline EF scores < 26 had normal EF (IIEF-EF domain scores > or = 26) at end point, and 81% reported improved erections in the Global Assessment Questionnaire. At least 56% of attempts at sexual intercourse were successfully completed (SEP3) at all time intervals up to 36 hours after tadalafil administration. The patients also experienced significant improvement in both the sexual self-confidence and spontaneity domains of the PAIRS. Tadalafil was well tolerated, with < 5% of the patients discontinuing because of adverse events. CONCLUSION: Tadalafil 20 mg was effective and well tolerated in elderly men with ED.

Holmium: yttrium aluminium garnet laser lithotripsy for symptomatic Kock pouch calculi.

Kock first described continent ileostomy for fecal diversion in 1969 as an alternative procedure to conventional ileostomy. Later, this procedure was replaced by restorative proctocolectomy with ileal pouch anal anastomosis as the procedure of choice. The main reasons for its virtual abandonment include technical difficulty, high morbidity, and the need for a stoma. To our knowledge, this report is the first published case of successful enterolith destruction and retrieval from a Kock pouch, using a Holmium: yttrium aluminium garnet laser. This outpatient procedure can avoid the morbidity and cost of a laparotomy.

Single-blind, multicenter, placebo controlled, parallel study to assess the safety and efficacy of intralesional interferon alpha-2B for minimally invasive treatment for Peyronie's disease.

PURPOSE: We investigated the efficacy and safety of intralesional interferon alpha-2b for the treatment of Peyronie's disease. MATERIALS AND METHODS: A total of 117 consecutive patients with a mean age of 55.1 years who had Peyronie's disease were enrolled in a single-blind, multicenter, placebo controlled, parallel study to determine the efficacy and safety of intralesional interferon alpha-2b therapy (Schering, Kenilworth, New Jersey), including 62 who received placebo and 55 who received interferon alpha-2b. Saline (10 ml) in controls and interferon alpha-2b (5 x 10(6) U) were administered biweekly for 12 weeks. Each patient was evaluated for penile curvature, plaque size and density, penile pain, erectile function and penile hemodynamics before and after study completion. Improvement in these parameters was statistically compared between the groups. RESULTS: A total of 53 patients in the control arm and 50 in the interferon alpha-2b arm completed the study. Improvement in penile curvature, plaque size and density, and pain resolution was significantly greater in patients treated with interferon alpha-2b vs placebo. The increase in mean International Index of Erectile Function scores was not significantly different between the groups. Penile blood flow improvement was observed in interferon alpha-2b treated patients but not in those who received placebo. The decrease in the number of penile vascular pathologies was significantly higher in interferon alpha-2b cases. Side effects, mostly flu-like symptoms, which were frequently noted in patients on interferon alpha-2b, were mild to moderate in degree and of short duration. CONCLUSIONS: This single-blind, multicenter, placebo controlled, parallel study demonstrates that intralesional interferon alpha-2b at a dose of 5 x 10(6) units biweekly for 12 weeks is effective and safe as minimally invasive therapy for Peyronie's disease.

Surgical technique to maintain penile length after insertion of an inflatable penile prosthesis via infrapubic approach.

INTRODUCTION: The aim of this study was to provide an overview of the principal author's experience in maintaining penile length after implantation of a three-piece inflatable penile prosthesis (IPP). For many patients with erectile dysfunction, who choose surgical treatment, loss of penile length after implantation of an IPP is a common concern. In the principal author's experience, release of the suspensory ligament during IPP implant surgery can maintain penile length, alleviating this concern. METHODS: After implantation with an IPP, the principal author released the patient's suspensory ligament. Main Outcome Measures. The main outcome measure was patient satisfaction with penile length after IPP surgery. A second outcome measure was a substudy measuring the patient's penile length after IPP implantation both before and after suspensory ligament release. RESULTS: From August 1997 through September 2002, the principal author implanted a total of 303 Alpha 1 IPPs into men who suffered from erectile dysfunction (ED). All had their suspensory ligament released. Postoperative complications were minimal and for the most part transitory. Ninety-three percent reported satisfaction with IPP performance, penile length, and willingness to undergo the IPP surgery again. None of the patients reported penile shortening, with some of them reporting an increase in penile length, as compared with preoperative measurements. CONCLUSION: Release of the suspensory ligament appears to maintain or even increase penile length, with a minimum of complications, and a high degree of patient satisfaction.

Long-term results of multimodal therapy for chronic prostatitis/chronic pelvic pain syndrome.

PURPOSE: Chronic prostatitis/chronic pelvic pain syndrome is a prevalent and multifactorial condition. Many patients have the condition for years despite conventional therapies. We assess the outcomes of multimodal therapy in patients with long-standing chronic prostatitis/chronic pelvic pain syndrome. MATERIALS AND METHODS: A total of 53 patients with chronic prostatitis treated at our clinic with a minimum followup of 6 months were assessed by the National Institutes of Health-Chronic Prostatitis Symptom Index and by a global assessment score. Treatments included antibiotics, prostatic massage, anti-inflammatory phytotherapy, alpha-blockers and neuromuscular agents. RESULTS: Mean age patient was 45 years and median symptom history was 3.5 years. Based on localizing cultures, and microscopy of urine and prostatic fluid 13% of the cases were category II, 41% were category IIIa and 46% were category IIIb. Mean followup from the last visit was 417 days (range 185 to 1,247). Mean changes +/- SE from the initial to the final score on the National Institutes of Health-Chronic Prostatitis Symptom Index were 10.4 +/- 3.3 to 5.9 +/- 4.4 for pain, 4.2 +/- 2.9 to 2.0 +/- 2.7 for urinary, 8.2 +/- 2.9 to 4.7 +/- 3.4 for quality of life and 22.7 +/- 6.6 to 13.2 +/- 9.5 for total score (p <0.0001). Based on a global subjective assessment 43 of the patients (80%) were better, 8 were the same and 3 were worse. At final assessment 39% of the patients were on no therapy, 22% were on an alpha-blocker, 37% were on quercetin, 13% were on neuromuscular agents and 9% were on antibiotics. CONCLUSIONS: An approach using stepwise therapy with antibiotics, anti-inflammatories and neuromuscular agents can be successful in the majority of patients with long-standing chronic prostatitis.