Key points

Historically, the practicing urologist has received classic surgical training. This has usually involved 1 to 2 years of general surgery and 3 to 4 years of urology residency, often times with a research component. The amount of out patient clinical experience may vary by program, with most educational instruction being based within the operating room. When a chief resident matriculates into clinical practice, he or she may spend upward of 50% of the time in the clinic setting. Urology represents a hybrid specialty, where most patients seen are symptom driven and may not have a defined diagnosis. There is a cognitive requirement to properly evaluate and determine an appropriate treatment plan for every patient, pending the result of the work-up. Currently, depending on the number of providers in the practice, geographic area, and scope of practice, accounting for some of the variables, the revenues generated from the nonsurgical portion of a practice may range from 30% to 65% of collections.

Medicine, in general, is changing rapidly. Most practices are faced with continued decreases in reimbursement, rising group overhead, and sweeping health insurance reform at the federal level that threatens the very existence of independent community practice. The field of urology has been morphing with regard to its historical clinical and practice patterns. The pharmaceutical management of benign prostatic hyperplasia has reduced the number of surgical interventions. The advent of minimally and noninvasive procedures continues to grow and the number of “open cases” is diminishing in training programs and in practice. There is an increasing amount of time now required for office therapeutics, because many of the treatments that have evolved can be delivered and administered in an outpatient setting. The busy urology practice is now in the position to deliver many novel and unique therapies across multiple disease states. As a result, clinicians can provide state-of-the-art care in a clinic setting and potentially reduce the overall costs of health care delivery. This article reviews some of these potential new opportunities available to the practicing urologist.

Hormone-replacement therapy

As the life expectancy in the United States has significantly increased over the past century, men have increasingly encountered hypogonadism as they age. The Nobel Prize was awarded to Butenandt and Ruzicka in 1939 for their work in isolating testosterone. In men, testosterone is produced primarily by the testes with smaller amounts produced by the adrenal glands. Testosterone is converted to dihydrotestosterone by 5α-reductase and within androgen target cells. About 98% of circulating testosterone is bound, of this approximately 30% is bound to sex hormone-binding globulin and the rest is bound to albumin and other serum proteins; the remainder represents free testosterone. Bioavailable testosterone is made up by free testosterone and that which is bound to albumin.

There are several different assays used for measuring testosterone with different normal ranges for each. Measuring testosterone levels is not an exact science because circulating testosterone levels can be affected by many factors including medical conditions, diurnal variation, changes in SHBG, age, body mass index, and more. The definition of hypogonadism is controversial and to this point the American Urological Association released a white paper titled “The Laboratory Diagnosis of Testosterone Deficiency” in 2013. The position statement at the end of this document is as follows:

Based on the extensive review of published data and input from professional organizations, the members of this panel believe that, for now, diagnosis of hypogonadism should be based as much on the presence of signs and symptoms as on serum T measurement. Based on overall poor quality of T testing in most clinical laboratories and age bias of published reference ranges, no patient should be denied coverage for treatment based solely on payer defined cut-off points if need for such treatment is established by a health professional. The AUA works closely with regulatory and professional agencies to improve assay performance and normal range, and as literature accumulates, this position will be reevaluated.

Symptoms of hypogonadism include decreased libido, fatigue, erectile dysfunction (ED), decreased muscle mass, irritability, decreased motivation, and hot flashes. Men are becoming increasingly aware of hypogonadism as a diagnosis and of treatment options for this condition. This is caused in part by increased advertising in many communities by nonurologic practitioners.

Testosterone replacement can be administered in several different forms. Oral preparations are available but are rarely used in the United States because much of the drug undergoes first-pass metabolism by the liver and carries with it a higher incidence of primary hepatoma. Testosterone can be administered by intramuscular injections and there are different formulations for this available. Testosterone cypionate injection is available in two strengths: 100 and 200 mg/mL. The half-life of testosterone cypionate is approximately 8 days. Ninety percent of a dose is excreted in the urine, 6% in the feces, and inactivation of testosterone occurs mostly in the liver. Testosterone cypionate, 100 and 200 mg/mL, is manufactured in 10-mL multidose vials. Intramuscular (IM) injections of testosterone cypionate should be administered in the gluteus. Dosing varies based on patient’s symptoms and serum testosterone levels. In general, 50 to 400 mg can be administered every 2 to 4 weeks for testosterone replacement in hypogonadal men.

Testosterone can also be applied topically. Testosterone gels available include Androgel, Testim, Fortesta, and Axiron. In addition, there is the once daily transdermal patch (Androderm). Testopel is a testosterone pellet, manufactured by Slate pharmaceuticals, that is implanted into the subcutaneous (SC) fat in the outer quadrant of the hip. This requires a short procedure in the clinic every 3 to 6 months. Each pellet contains 75 mg of testosterone.

There are several contraindications for use of testosterone replacement common to all methods and formulations of replacement therapy, including allergy or hypersensitivity to the drug; males with breast cancer; history or suspicion of prostate cancer; women who are or may become pregnant; and patients with serious cardiac, hepatic, or renal disease.

Men receiving replacement testosterone therapy should have hemoglobin/hematocrit checked periodically given the risk of polycythemia. Lipid panels should be checked regularly because of risk of hyperlipidemia while on replacement therapy and serum testosterone levels should be checked to assess efficacy of treatment. Baseline complete blood count and lipid panel should be checked before initiating testosterone-replacement therapy.

Hormone-replacement therapy

As the life expectancy in the United States has significantly increased over the past century, men have increasingly encountered hypogonadism as they age. The Nobel Prize was awarded to Butenandt and Ruzicka in 1939 for their work in isolating testosterone. In men, testosterone is produced primarily by the testes with smaller amounts produced by the adrenal glands. Testosterone is converted to dihydrotestosterone by 5α-reductase and within androgen target cells. About 98% of circulating testosterone is bound, of this approximately 30% is bound to sex hormone-binding globulin and the rest is bound to albumin and other serum proteins; the remainder represents free testosterone. Bioavailable testosterone is made up by free testosterone and that which is bound to albumin.

There are several different assays used for measuring testosterone with different normal ranges for each. Measuring testosterone levels is not an exact science because circulating testosterone levels can be affected by many factors including medical conditions, diurnal variation, changes in SHBG, age, body mass index, and more. The definition of hypogonadism is controversial and to this point the American Urological Association released a white paper titled “The Laboratory Diagnosis of Testosterone Deficiency” in 2013. The position statement at the end of this document is as follows:

Based on the extensive review of published data and input from professional organizations, the members of this panel believe that, for now, diagnosis of hypogonadism should be based as much on the presence of signs and symptoms as on serum T measurement. Based on overall poor quality of T testing in most clinical laboratories and age bias of published reference ranges, no patient should be denied coverage for treatment based solely on payer defined cut-off points if need for such treatment is established by a health professional. The AUA works closely with regulatory and professional agencies to improve assay performance and normal range, and as literature accumulates, this position will be reevaluated.

Symptoms of hypogonadism include decreased libido, fatigue, erectile dysfunction (ED), decreased muscle mass, irritability, decreased motivation, and hot flashes. Men are becoming increasingly aware of hypogonadism as a diagnosis and of treatment options for this condition. This is caused in part by increased advertising in many communities by nonurologic practitioners.

Testosterone replacement can be administered in several different forms. Oral preparations are available but are rarely used in the United States because much of the drug undergoes first-pass metabolism by the liver and carries with it a higher incidence of primary hepatoma. Testosterone can be administered by intramuscular injections and there are different formulations for this available. Testosterone cypionate injection is available in two strengths: 100 and 200 mg/mL. The half-life of testosterone cypionate is approximately 8 days. Ninety percent of a dose is excreted in the urine, 6% in the feces, and inactivation of testosterone occurs mostly in the liver. Testosterone cypionate, 100 and 200 mg/mL, is manufactured in 10-mL multidose vials. Intramuscular (IM) injections of testosterone cypionate should be administered in the gluteus. Dosing varies based on patient’s symptoms and serum testosterone levels. In general, 50 to 400 mg can be administered every 2 to 4 weeks for testosterone replacement in hypogonadal men.

Testosterone can also be applied topically. Testosterone gels available include Androgel, Testim, Fortesta, and Axiron. In addition, there is the once daily transdermal patch (Androderm). Testopel is a testosterone pellet, manufactured by Slate pharmaceuticals, that is implanted into the subcutaneous (SC) fat in the outer quadrant of the hip. This requires a short procedure in the clinic every 3 to 6 months. Each pellet contains 75 mg of testosterone.

There are several contraindications for use of testosterone replacement common to all methods and formulations of replacement therapy, including allergy or hypersensitivity to the drug; males with breast cancer; history or suspicion of prostate cancer; women who are or may become pregnant; and patients with serious cardiac, hepatic, or renal disease.

Men receiving replacement testosterone therapy should have hemoglobin/hematocrit checked periodically given the risk of polycythemia. Lipid panels should be checked regularly because of risk of hyperlipidemia while on replacement therapy and serum testosterone levels should be checked to assess efficacy of treatment. Baseline complete blood count and lipid panel should be checked before initiating testosterone-replacement therapy.

Erectile dysfunction

The incidence of ED increases with age and the prevalence of ED has increased in the United States alongside increasing life expectancies. In the Massachusetts Male Aging Study, which surveyed men between 40 and 70 years of age in the Boston area, Feldman and colleagues demonstrated a 52% prevalence of ED and that the prevalence of complete ED increased from 5% to 15% between subject ages 40 and 70 years old. In their analysis of the US adult male population, Selvin and colleagues found the overall prevalence of ED in men greater than or equal to 20 years of age at 18.4%, with prevalence positively related to age, hypertension, cardiovascular risk factors, diabetes, and lack of physical activity.

The most important component of evaluation of a patient with ED is a thorough history and physical examination. Evaluation often includes the use of questionnaires, examples of which include the International Index of Erectile Function, the Erectile Dysfunction Inventory for Treatment Satisfaction, and the Brief Males Sexual Function Inventory. These questionnaires are also often used to monitor patient response to treatment.

Nonsurgical interventions for ED include lifestyle changes, pelvic floor muscle therapy, oral PDE5-inhibitor therapy, and use of a vacuum-erection device. Dr Giles Brindley, famous for presentation of his research results at the 1983 American Urological Association annual meeting, demonstrated the success of intracavernosal injection of phenoxybenzamine. Options for intracavernosal injection therapy include papaverine; alprostadil; papaverine + phentolamine (Bi-Mix); and papaverine + phentolamine + alprostadil (Tri-Mix). Initiation of therapy with intracavernosal injection requires initial administration in clinic for patient education and to ascertain the effective dosing.

Advanced prostate cancer