Society of Urologic Prosthetic Surgeons' Coding and Billing Position Statement on Ancillary/Adjunct Penile Prosthesis Surgical Procedures: Part I.

OBJECTIVE: To create a society position statement on common adjunct penile prosthesis (PP) procedures. While the Medicare Current Procedural Terminology code book lists descriptions of procedures, it is very brief and lacks detail in the small subspecialty of prosthetic urology. At educational/research meetings, wide variation was found in how experts in prosthetic urology code the same procedures, and need for a standardized format in billing common ancillary surgery was voiced. METHODS: A subcommittee within the Society of Urologic Prosthetic Surgeons developed a survey assessing coding options for several procedures commonly adjunct to PP placement, which was distributed in the fall of 2022. The results of the survey were used to develop consensus statements on coding adjunct PP procedures; statements were distributed among society membership and meetings for approval. RESULTS: Thirty members replied to the survey; demographics were obtained as follows: 73% were trained in a fellowship, 50% identified as university/academic practitioners, and 50% in community/private practice; and 63% respondents place more than 50 implants annually. Only 1 of the 30 respondents stated confidence in coding for these ancillary procedures. Specifically, differences in how to code curvature correction procedures were observed throughout the survey results. CONCLUSION: Only 1 in 30 prosthetic urologists expressed confidence in coding and billing of adjunct PP procedures, further confirming the need for a society position statement. Therefore, we generated a consensus society position statement on common surgeries that are adjunct to PP placement.

Effects of a Novel Oral Testosterone Undecanoate on Ambulatory Blood Pressure in Hypogonadal Men.

BACKGROUND: Testosterone replacement therapies may increase blood pressure (BP) with chronic use but the mechanism is not clear. TLANDO™ is a new oral testosterone undecanoate (TU) under development for the treatment of male hypogonadism. METHODS: We studied the effects of the TU at 225 mg twice daily on ambulatory BP (ABP) and heart rate, in 138 men with hypogonadism (mean age, 54 years, 79% white, 48% with hypertension). Ambulatory BP and heart rate and hematologic assessments were obtained at baseline and following 4-months of therapy. RESULTS: Changes from baseline in ambulatory 24-hour, awake, and sleep systolic BP (SBP) of 3.8 (P < 0.001), 5.2 (P < 0.001), and 4.3 mmHg (P = 0.004) were observed post-treatment, respectively. Lesser changes in the diastolic BP (DBP) were observed (1.2 (P = 0.009), 1.7 (P = 0.004), and 1.7 mmHg (P = 0.011) for 24-hour, awake, and sleep, respectively). Hematocrit and hemoglobin were increased by 3.2% and 0.9 g/dL (P < 0.001), respectively. In those men in the top quartile of changes in hematocrit (range of 6% to 14%), the largest increases in ambulatory SBP (mean, 8.3 mmHg) were observed, whereas the changes in ambulatory SBP in the lower 3 quartiles were smaller (mean, 1.9, 3.3, and 2.1 mmHg in 1st, 2nd and 3 rd quartiles, respectively). CONCLUSION: These data demonstrate that small increases in ABP occurred following 4 months of the oral TU. For those men whose hematocrit rose by >6%, BP increases were of greater clinical relevance. Hence, hematocrit may aid in predicting the development of BP increases on testosterone therapy. CLINICALTRIALS.GOV IDENTIFIER: NCT03868059.

Peyronie's disease: new paradigm for the treatment of a unique cause of erectile dysfunction.

Peyronie's Disease is an incurable condition of the tunica albuginea of the penis associated with scarring, plaque formation, and penile deformity on erection. It is often associated with erectile dysfunction. Recent data have supported a familial and genetic predisposition to this chronic condition. The etiology of Peyronie's Disease is unknown, but is likely associated with multiple micro traumas to the erect penis in men who are susceptible to the scarring typical of Peyronie's Disease. The treatment of Peyronie's Disease has improved over the past decade as a result of animal studies and the approval of new medications. In the acute phase of the condition, phosphodiesterase type 5 inhibitors have been shown to have some benefit and are supported by animal studies demonstrating reduced fibrosis of the penis in animal models of Peyronie's Disease. In the stable phase of the disease, newer injectable agents have shown great promise. Collagenase clostridium histolyticum is approved for the treatment of Peyronie's plaques by direct injection into the scarred tissue with data showing satisfactory safety and efficacy. Surgical procedures for penile straightening have been refined with improved outcomes in the past decade. For those men with erectile dysfunction and Peyronie's Disease, penile implants can restore erectile function and form. As a result of the new understanding of the risk factors for Peyronie's Disease and recent advances in treatment options, the algorithm for the treatment of Peyronie's Disease has improved outcomes for patients and their partners.

Artificial urinary sphincter: current status and future directions.

Urge urinary incontinence (UUI) is one of the most troublesome complications of surgery of the prostate whether for malignancy or benign conditions. For many decades, there have been attempts to reduce the morbidity of this outcome with variable results. Since its development in the 1970s, the artificial urinary sphincter (AUS) has been the "gold standard" for treatment of the most severe cases of UUI. Other attempts including injectable bulking agents, previous sphincter designs, and slings have been developed, but largely abandoned because of poor long-term efficacy and significant complications. The AUS has had several sentinel redesigns since its first introduction to reduce erosion and infection and increase efficacy. None of these changes in the basic AUS design have occurred in the past three decades, and the AUS remains the same despite newer technology and materials that could improve its function and safety. Recently, newer compressive devices and slings to reposition the bladder neck for men with mild-to-moderate UUI have been developed with success in select patients. Similarly, the AUS has had applied antibiotic coating to all portions except the pressure-regulating balloon (PRB) to reduce infection risk. The basic AUS design, however, has not changed. With newer electronic technology, the concept of the electronic AUS or eAUS has been proposed and several possible iterations of this eAUS have been reported. While the eAUS is as yet not available, its development continues and a prototype device may be available soon. Possible design options are discussed in this review.

Infection Retardant Coatings Impact on Bacterial Presence in Penile Prosthesis Surgery: A Multicenter Study.

OBJECTIVE: To investigate patients for positive culture rates with or without infection retardant coatings (IRC) penile prostheses (PPs) and to examine changes in culture positive isolates found in patients presenting overt clinical infection. METHODS: Cultures were obtained from PPs immediately upon surgical exposure of the pump. 236 patients were broken down into 2 groups, with each further divided into 2 groups. The noninfected group included 208 patients: 133 with uncoated PPs and 75 with IRC implants. The infected group included 28 patients: 16 with uncoated PP and 12 with IRC inflatable penile prostheses (IPP). Additionally, sensitivity to the combination of tetracycline and rifampin were evaluated on all cultures. RESULTS: In the noninfected group, culture positive isolates were found in 85 patients with uncoated PP's and in 32 patients with IRC implants [P value = 0.0003]. Cultures positive for Staphylococcus genus were found in 75 uncoated PP patients, while 20 patients with IRC implants had an isolate of this genus. In the infected group, culture positive isolates were found in 7 patients with uncoated PP and 6 patients with IRC IPPs [P value = 1.000]. Positive cultures for Staphylococcus genus were found in 6 patients with uncoated PP, while 3 patients with IRC IPP had an isolate of this genus. All bacterial isolates were sensitive to the combination of tetracycline and rifampin. CONCLUSION: Positive bacterial cultures have been shown to be present on clinically uninfected IPPs at time of revision surgery. Culture isolates grown from patients with IRC IPPs reveal a nontraditional bacterial profile: fewer cultured isolates of Staphylococcus genus.

The Availability and Acquisition of Illicit Anabolic Androgenic Steroids and Testosterone Preparations on the Internet.

The lifetime prevalence of anabolic androgenic steroids (AAS) use in the United States is over 1%. Recent reports have suggested AAS can easily be obtained over the Internet without a prescription, but this has been poorly studied. This study focused on determining the availability and ease of purchase for AAS, testosterone, and other non-AAS therapies on the Internet from the perspective of a typical consumer. A Google search was performed and the top-ranking sites offering AAS for sale were individually evaluated for selection of AAS offered, the purchasing process, and additional consumer information to support AAS use. The current results revealed that 87% of sites offered commonly used forms of AAS, injectable testosterone, and non-AAS hormone therapies. Seventy-five percent offered at least one postcycle recovery agent and 62% offered at least one erectile dysfunction medication. No site required a prescription for purchase of any substance, 75% accepted common forms of payment including credit card, and all sites were supplied by unregulated international pharmacies providing shipment to home addresses with disclaimers that consumers are liable to local laws. Seventy-five percent of sites provided specific cycle and stacking recommendations, 62% provided postcycle recovery information, but only one site offered information on non-AAS alternatives. In conclusion, AAS, injectable testosterone, and other non-AAS therapies are readily available and remarkably easy to purchase on the Internet without a prescription. It is of paramount importance that clinicians are aware of this considerable public health problem given the detrimental physiologic effects including infertility and sexual dysfunction.

Failure of the inflatable penile prosthesis due to abnormal folding of a low-profile reservoir - A selected case from an overall series and systematic review.

We present a case from a running series of inflatable penile prosthesis failure due to improper folding of the Conceal™ reservoir. The Conceal™ Low-Profile reservoir gained popularity due to claims of improved cosmesis and ease of implantation. As the number of patients receiving this and other low-profile reservoirs increases, it is imperative to review and document any novel complications. While the Conceal™ reservoir may be preferred in ectopic placement, it may be more prone to fluid lockout facilitated by conformational change. Our review did not identify prior reports of improper folding, which we believe is unique to these low-profile reservoirs.

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.

Testosterone and Cardiovascular Disease.

Testosterone (T) is the principal male sex hormone. As men age, T levels typically fall. Symptoms of low T include decreased libido, vasomotor instability, and decreased bone mineral density. Other symptoms may include depression, fatigue, erectile dysfunction, and reduced muscle strength/mass. Epidemiology studies show that low levels of T are associated with more atherosclerosis, coronary artery disease, and cardiovascular events. However, treating hypogonadism in the aging male has resulted in discrepant results in regard to its effect on cardiovascular events. Emerging studies suggest that T may have a future role in treating heart failure, angina, and myocardial ischemia. A large, prospective, long-term study of T replacement, with a primary endpoint of a composite of adverse cardiovascular events including myocardial infarction, stroke, and/or cardiovascular death, is needed. The Food and Drug Administration recently put additional restrictions on T replacement therapy labeling and called for additional studies to determine its cardiac safety.

Testosterone deficiency in the aging male.

Treatment for hypogonadism is on the rise, particularly in the aging population. Yet treatment in this population represents a unique challenge to clinicians. The physiology of normal aging is complex and often shares the same, often vague, symptoms of hypogonadism. In older men, a highly prevalent burden of comorbid medical conditions and polypharmacy complicates the differentiation of signs and symptoms of hypogonadism from those of normal aging, yet this differentiation is essential to the diagnosis of hypogonadism. Even in older patients with unequivocally symptomatic hypogonadism, the clinician must navigate the potential benefits and risks of treatment that are not clearly defined in older men. More recently, a greater awareness of the potential risks associated with treatment in older men, particularly in regard to cardiovascular risk and mortality, have been appreciated with recent changes in the US Food and Drug Administration recommendations for use of testosterone in aging men. The aim of this review is to provide a framework for the clinician evaluating testosterone deficiency in older men in order to identify correctly and treat clinically significant hypogonadism in this unique population while minimizing treatment-associated harm.

Reduced Resident Work Hours in Urology: The History and Impact of Duty Hour Restrictions.

INTRODUCTION: The ACGME first mandated duty hour restrictions for resident physicians in 2003, setting a limit of 80 hours per week. While the goals of this and later reforms were to improve patient care and safety, the outcomes have been mixed. In this review we report on the history of duty hour regulations and how these changes have impacted resident and patient outcomes. METHODS: A literature search was performed, and articles discussing surgical training, resident duty hours, resident wellness and patient outcomes were reviewed. RESULTS: After implementation of duty hour restrictions in 2003, the Harvard Work Hours Health and Safety Group published 3 hallmark studies that suggested duty hour restrictions were associated with improved outcomes. A recently published systematic review reported mixed results from the growing body of research. While 71% of the reviewed studies reported improvement in resident wellness, only 4% illustrated an improvement in resident education, 19% reported improved patient safety outcomes and 13% demonstrated improved patient morbidity. CONCLUSIONS: Resident duty hour restrictions were based on a body of evidence illustrating that fatigue and sleeplessness negatively impact decision making, resident wellness and patient care. While initial outcomes suggested that these regulations resulted in better resident and patient outcomes, more recent evidence suggests otherwise. There is very little urology specific evidence addressing these matters.

Special considerations for placement of an inflatable penile prosthesis for the patient with Peyronie's disease: techniques and patient preference.

Placement of an inflatable penile prosthesis (IPP) is the mainstay of surgical treatment for patients with Peyronie's disease (PD) and concomitant medication-refractory erectile dysfunction. Special considerations and adjunctive surgical techniques during the IPP procedure are often required for patients with PD to improve residual penile curvature, as well as postoperative penile length. The surgical outcomes and various adjunctive techniques are not significantly different from one another, and selection of the appropriate technique must be tailored to patient-specific factors including the extent of the deformity, the degree of penile shortening, and preoperative patient expectations. The aims of this review were to assess the current literature on published outcomes and surgical techniques involving IPP placement in the treatment of PD. Patient satisfaction and preferences are reported, along with the description and patient selection for surgical techniques that include manual penile modeling, management of refractory curvature with concurrent plication, and correction of severe residual curvature and penile shortening with tunica release and plaque incision and grafting. A thorough description of the available techniques and their associated outcomes may help guide surgeons to the most appropriate choice for their patients.

Analysis of the clinical safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for adults with Peyronie's disease (PD).

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: 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.

Low testosterone has a similar prevalence among men with sexual dysfunction due to either Peyronie's disease or erectile dysfunction and does not correlate with Peyronie's disease severity.

INTRODUCTION: Low testosterone (T) has been suggested as a risk factor for Peyronie's disease (PD) that may correlate with disease severity. Low T is common in men with sexual dysfunction but its role in the pathogenesis of PD remains unclear. AIM: The aim of this study was to compare the prevalence of low T (<300 ng/dL) in patients presenting with PD or erectile dysfunction (ED), as well as disease severity between men with PD and either low T or normal T (≥300 ng/dL). METHODS: Retrospective review of 300 men with either PD or ED was conducted. Men were excluded for combined PD and ED, psychogenic ED, or prior T use. For men with PD, plaque size, degree of curvature, and surgical correction rate were compared. MAIN OUTCOME MEASURES: The main outcome measures were (i) mean T levels in men with PD or ED and (ii) plaque size, degree of curvature, and surgical correction rates among men with PD and either low T or normal T. RESULTS: Eighty-seven men with PD and 98 men with ED were identified. Men with PD had mean total T and free T of 328 ng/dL and 11.5 ng/dL, while men with ED had mean levels of 332 ng/dL and 12.1 ng/dL, respectively (P > 0.05). Of PD men, 52.9% had low T, compared with 45.9% of men with ED (P = 0.35). T levels did not correlate with plaque size or degree of curvature in the PD group (P > 0.05). CONCLUSIONS: Men with sexual dysfunction characterized by either PD or ED had similarly low T levels, and low T did not correlate with PD severity or surgical correction rate. The comparable prevalence of low T in men with PD or ED suggests the high rate of low T in PD men may be related to a common process among men with abnormal erectile physiology and not specifically causative in plaque formation.