Faculty Bibliography

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.

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.

The traditional inflatable penile prosthesis (IPP) reservoir placement is below the transversalis fascia in the space of Retzius. In 2002, Dr. Steve Wilson described ectopic reservoir placement, thereby providing a safe and effective alternative for implant surgeons. This new approach obviated the need for a second incision and decreased operative times during surgery. In the manuscript, he also described the introduction of a reservoir lock-out valve, which prevents autoinflation of the penile implant. The development of lockout valves and flat reservoirs has contributed to the early success and feasibility of submuscular placement techniques. Thirteen years after Dr. Wilson's pivotal study, this technique should be in the armamentarium of all urologic prosthetic surgeons. Accordingly, in certain subsets of patients, ectopic/ submuscular reservoir site placement should be considered a safe, effective alternative to standard reservoir placement in the space of Retzius.

OBJECTIVE:To examine the safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for the treatment of Peyronie's disease (PD), using a pooled safety analysis of patients who received at least one dose of CCH in any of six clinical studies. PATIENTS AND METHODS/METHODS:Patients from six clinical studies, including three randomised, double-blind, placebo-controlled studies and three open-label safety and efficacy studies, were included if they had received at least one dose of 0.58 mg CCH. Adverse events (AEs), including treatment-emergent AEs, treatment-related AEs, and serious AEs (SAEs), were characterised. Potential immunogenicity-related AEs were evaluated through examination of increased anti-AUX-I and anti-AUX-II antibody levels, AEs, and reported terms possibly associated with immunological or hypersensitivity events. RESULTS:Overall, 85.8% of 1 044 pooled patients reported at least one treatment-related AE. The most frequently reported (≥25.0% of patients) treatment-related AEs included penile haematoma (82.7% had the verbatim 'penile bruising'), penile pain, and penile swelling. Most patients (75.2%) had mild- or moderate-severity treatment-related AEs, and 14.2% had no treatment-related AEs. Nine patients (0.9%) had treatment-related SAEs: five with penile haematoma and four with corporal rupture. There was no association between AEs and anti-AUX-I or anti-AUX-II antibody levels across treatment cycles, and no systemic hypersensitivity reactions occurred. CONCLUSIONS:This pooled safety analysis shows that although non-serious and serious treatment-related AEs can occur after CCH treatment for PD, most were non-serious and the SAEs were manageable. Providers should be prepared to manage possible SAEs.

PURPOSE/OBJECTIVE:The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of Peyronie's disease. MATERIALS AND METHODS/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.

Introduction: Medical malpractice and prostate cancer screening are important issues in the current landscape of health care. We identified factors contributing to litigation in the diagnosis of prostate cancer. Methods: We used the Westlaw® database to search for jury verdict reports using the term medical malpractice combined with prostate cancer with dates ranging from January 2000 to December 2013. Each case was examined for trial year, patient age, prostate specific antigen at alleged breach of duty and at diagnosis, defendant specialty, alleged cause of malpractice, whether there was metastasis, the outcome of cases that went to trial or were otherwise settled, and the plaintiff award. Results: The initial search produced 256 results, which was narrowed to 106 cases. Of these cases 64.1% went to trial, including 66.2% that were decided for the defendant. The mean out of court settlement was $945,000, significantly lower than the mean plaintiff verdict award of $2.1 million (p = 0.0009). Primary care physicians (74.1%) were the most commonly named defendants, followed by urologists (19.6%). The most common cause was failure to perform an initial prostate specific antigen test (26.8%), followed by failure to follow elevated prostate specific antigen (22.3%). Conclusions: Causes of malpractice revolved mostly around prostate specific antigen testing. Primary care physicians and urologists must continue to educate patients to minimize malpractice claims made in this setting. It will be important to follow data to see trends following recent guidelines.