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Men's Health, Andrology and Urology - Disease Topic Overview

Andrology and urology are specialties that involve the study, diagnosis and treatment of male reproductive system and urinary tract dysfunction.

The male reproductive system consists of; the scrotum containing the testes, the epididymis and vas deferens connecting the testes to the prostate, the prostate itself, and the urethra connecting the prostate to the final component, the penis.¹

Common non-cancerous disorders of the penis, testes and prostate include; penile inflammation, urethral stricture, penile growths, priapism, Peyronie's disease, testicular torsion, inguinal hernia, epididymitis, hydrocele, varicocele, testicular swelling and benign prostatic hyperplasia.²

Infertility affects approximately 25% of European couples, and male infertility is a factor in 50% of these cases.³ The most common demonstrable cause of male infertility is varicocele (increased scrotal temperature), followed by urogenital infections and immunological factors.³

Prostate and testicular cancers account for 24%4 and 1-2%5 of all newly diagnosed male cancers in the UK respectively. Testicular cancer is most commonly diagnosed in white Caucasian men aged between 20 and 49 years. Worldwide the highest age-standardised incidence rates are found in Western and Northern Europe, specifically Denmark, Germany and Solvenia.⁵ Prostate cancer is the second most common cancer in European men behind lung cancer, with 301,500 new cases diagnosed in 25 EU member states in 2006.⁴

1. Snell R.S. Clinical Anatomy by Regions. Lippincott, Williams and Wilkins. 2007 : 352-355
2. Beers M.H. et al. The Merck manual of medical information. Merck research laboratories. Second home edition. 2003 : 1321-1340.
3. Dohle G.R. et al. EAU Guidelines on Male Infertility. European Urology. November 2005 ; 48 (5) : 703-711
4. Cancer Research UK. Prostate Cancer – UK. Cancer Stats. March 2007 : 1-10
5. Cancer Research UK. Testicular Cancer – UK. Cancer Stats. March 2007 : 1-8

Men's Health
As a disease topic Men's Health covers a broad set of issues affecting men of all ages. Some of the issues requiring greater focus and more thorough dissemination of information amongst the healthcare community, are those that have the potential to go undetected in the early stages. Diseases where early detection and more regular health checks not only improve prognosis and efficacy of treatment outcomes, but also quality of life.

These include:

Erectile Dysfunction (ED)

Erectile dysfunction is characterized by the regular or repeated inability to obtain or maintain an erection. Although not considered a part of the aging process, it is associated with certain physiologic and psychological changes related to age. ED is most common in men between 40-70 years of age. However incidence is also higher amongst men with certain medical conditions which include, diabetes, heart disease, and hypertension. ED can also be a warning sign/symptom of these underlying conditions. ¹

Hypogonadism (low testosterone)

Testosterone is an essential male hormone produced in the testes that plays a crucial role in the health and well being of male bodies. It is responsible for typical male sexual characteristics and is required by all men for a healthy life physically and psychologically.

Low testosterone, clinically known as hypogonadism, consists of decreased functional activity of the testes with diminished production and action of testosterone. Although there is a progressive decline in testosterone levels as men age, hypogonadism can occur in men of any age.

Men with low testosterone are also at increased risk of cardiovascular disease, diabetes and metabolic syndrome and osteoporosis.

For your information, the Mens Health knowledge centre concentrates on the understanding, management and treatment of erectile dysfunction and hypogonadism. The website also provides extensive details on up-coming conferences as well as an extensive library of useful resource. You can also access the knowledge centre via www.menshealthfocus.com.

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What’s in the Men's Health Knowledge Centre?
References

1. McVary, Kevin T. Erectile. In: Kasper DL, Braunwald E, Fauci AS, Hauser SL, Longo DL, Jameson JL et al., editors. Harrison's Internal Medicine. 16th ed. New York: McGraw-Hill; 2005. p. 272-274

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This resource is aimed at physicians who are involved in the diagnosis, treatment and monitoring of men with hypogonadism. It aims to provide a better understanding of the epidemiology and etiology of male hypogonadism, the diagnostic procedures and the available treatment options for hypogonadal men.

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Prostate Cancer
Prostate cancer is the most frequently diagnosed non-cutaneous malignancy in men, accounting for one in five male cancers.¹ The introduction of prostate-specific antigen (PSA) screening, has led to an increase in the detection of asymptomatic prostate cancer, and subsequently an increase in incidence and survival rates.^1,2

There are only three well established risk factors for prostate cancer; age, family history and ethnicity.³ In contrast to many other types of tumour, smoking, alcohol and a sedentary lifestyle are not currently thought to be involved in the development of prostate cancer.⁴

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Prostate cancer is the most frequently diagnosed non-cutaneous malignancy in men, accounting for one in five male cancers.¹ The introduction of prostate-specific antigen (PSA) screening, has led to an increase in the detection of asymptomatic prostate cancer, and subsequently an increase in incidence and survival rates.^1,2

There are only three well established risk factors for prostate cancer; age, family history and ethnicity.³ In contrast to many other types of tumour, smoking, alcohol and a sedentary lifestyle are not currently thought to be involved in the development of prostate cancer.⁴

Classification of prostate cancer can take two forms; histological classification is used to generate a Gleason score,⁵ while the spread of the disease is classified using the tumour-node-metastasis (TNM)system.³

The majority of prostate cancer diagnoses are made following screening as most patients are asymptomatic.^3,6 However further investigations should be conducted if a patient presents with symptoms. Numerous management options are available dependent on the stage at which a patient presents with prostate cancer, however as most men do not die from prostate cancer it is important to determine which patients will benefit from therapy.^5,7

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What’s in the Prostate Cancer Knowledge Centre
References

1. Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P. Estimates of the Cancer Incidence and Mortality in Europe in 2006. Ann Oncol. 18:581-92; 2007
2. World Health Organization. The Global Burden of Disease: 2004 Update. Geneva: WHO; 2004
3. European Association of Urology. Guidelines on Prostate Cancer, 2010.
4. Grönberg H. Prostate Cancer Epidemiology. Lancet. 361:859-64; 2003
5. Kirby RS, Patel MI. Fast facts: prostate cancer (5th ed). Health Press Ltd: Oxford; 2008.
6. American Urological Association. Prostate-specific antigen best practice statement: 2009 update; 2009
7. Coleman MP, Quaresma M, Berrino F; CONCORD Working Group. Cancer survival in five continents: a worldwide population-based study (CONCORD). Lancet Oncol. 9:730-56; 2008

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SGLT2-Inhibitors eCME Webcast

The eCME webcast entitled SGLT2-Inhibitors: Assessing the Evidence and the Potential Impact on Future Clinical Practice is ACCME/EACCME accredited. This activity has been designed to inform healthcare professionals on Type 2 Diabetes Mellitus and the role of SGLT2-Inhibitors in the treatment of this disease.

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Type 2 Diabetes Mellitus affects approximately 20.66 million people across the UK, France, Germany, Spain and Italy¹. This leads to many complications including macrovascular and microvascular disease. Glycaemic control in diabetes is particularly important in reducing these complications; a 1% fall in HBA1C results in a 37.5% and 42.5% reduction in microvascular and peripheral vascular disease respectively².

There are numerous treatments for Type 2 Diabetes Mellitus. These act on receptors within various organs including the pancreas, muscle, adipose tissue, gastrointestinal tract and liver. A new class of drugs, SGLT2-Inhibitors act on the kidney, which itself plays an important role in glycaemic control.

The eCME webcast entitled SGLT2-Inhibitors: Assessing the Evidence and the Potential Impact on Future Clinical Practice is ACCME/EACCME accredited. This activity has been designed to inform healthcare professionals on Type 2 Diabetes Mellitus and the role of SGLT2-Inhibitors in the treatment of this disease. To access the eCME accredited webcast click here.

References
1. IDF Diabetes Atlas 2010. http://www.idf.org/atlasmap/atlasmap.
2. Stratton, I. et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000; 321: 405-412.

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NX 1207 (Recordati/Nymox) starts Phase III trial for BPH - 21-02-2012

Recordati and Nymox Pharmaceutical Corporation announced the start of activities aimed to the preparation of a European Phase III clinical trial for NX-1207, following the successful completion of a Scientific Advice meeting with the European Medicines Agency. NX-1207, is a Phase III investigational drug from Nymox and is currently in clinical development in the United States for the treatment of Benign Prostatic Hyperplasia (BPH). The pivotal controlled clinical trial will assess the efficacy and safety of a single TRUS-guided intraprostatic injection of NX-1207 in patients with lower urinary tract symptoms (LUTS) associated with BPH not adequately controlled by medical therapy.The drug is injected by a urologist in an office setting directly into the zone of the prostate where the enlargement occurs and involves little or no pain or discomfort. NX-1207 has successfully completed a series of blinded controlled multi-center U.S. clinical trials where a single dose of NX-1207 has been found to improve the signs and symptoms of BPH, with improvements about double those reported for currently approved BPH drugs, and without the side effects associated with those drugs, which can include sexual problems and blood pressure changes. Follow-up studies have shown evidence of long lasting benefit with a significant proportion of men reporting maintained improvement in BPH symptoms without other treatments for up to 7½ years.

Vitaros(Apricus BioScience) for Erectile Dysfunction rights update - 17-02-2012

Apricus BioScience has licensed, via subsidiary NextMed, the German rights to its erectile dysfunction drug,Vitaros,to Sandoz AG. The drug is approved in Canada where it is marketed by Abbott Labs and has a Complete Response Letter from the FDA where the drug is to be marketed by Warner Chilcott. The drug is filed in the EU and will be marketed in Italy by Bracco SpA.

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Prostate Cancer - Qatar (Prostate CA)

The goal will be to identify genes that are associated with prostate cancer and gene profiles that are associated with differing prognoses in individuals who have prostate cancer.

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Latest Journal Publications

Experimental and Therapeutic Medicine

It has been suggested that various cytokines are associated with the pathophysiology of prostate carcinoma (Pca). We profiled ten cytokines (IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IFN-γ and TNF-α) in the serum levels of 11 patients with organ-confined Pca, 15 with advanced Pca without cachexia, 8 with advanced Pca with cachexia (cachexia group) and 5 healthy males as controls. Cytokines were measured using a highly sensitive fluorescence microsphere system. Compared to the control group, serum levels of all cytokines were significantly higher in the cachexia group, and six cytokines (IL-1β, IL-2, IL-8, IL-12, TNF-α and IFN-γ) were significantly higher in the group with advanced Pca without cachexia. In the group with organ-confined Pca, only IL-1β and IL-12 levels were significantly higher compared to the control group. In the cachexia group, levels of all cytokines apart from TNF-α were significantly higher compared to the group with organ-confined Pca, and levels of four cytokines (IL-2, IL-4, IL-8 and IL-10) were significantly higher compared to the group with advanced Pca without cachexia. These results indicate that i) an aberrance imbalance of cytokine production was associated with the pathophysiology of Pca and cachexia, ii) cytokine profiles in Pca patients were distinct by disease stage, and iii) IL-1β and IL-12 may be applicable as early diagnostic indicators.

Experimental and Therapeutic Medicine

Lymphoma, particularly non-Hodgkin's lymphoma, may occur in sites other than the lymph nodes, i.e., extranodal lymphoma, which occurs in approximately 40% of total lymphoma cases. However, simultaneous detection of multiple extranodal involvements at presentation is quite uncommon. Here, we report a rare case of a 55-year-old Chinese man with non-Hodgkin's lymphoma of the left testicle and bilateral adrenals as determined by 18F-FDG PET/CT imaging. FDG PET/CT has been successfully employed for lymphoma diagnosis, initial staging, restaging and therapy follow-up. It is useful for assessing both nodal and extranodal involvements. In the present case of lymphoma with involvement of the testicle and bilateral adrenals, 18F-FDG PET/CT played an important role in the diagnosis and assessment of therapeutic response.

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Ampio Pharma has developed an oral rapid-dissolving tablet form of the centrally acting opioid analgesic, tTramadol as a therapy for premature ejaculation. Tramadol is used in many countries for the treatment of moderate to severe pain.In a Phase III ,604 patient European trial Ampio Pharma reported positive summary results from in which the 62mg dose of Zertane (oral rapidly dissolving tramadol) showed a 2.4-fold increase in median intravaginal ejaculatory latency time compared with placebo (p<0.001). Daewoong Pharmaceuticals will market the drug in South Korea. Ampio is seeking market-by-market alliances for the drug.

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The FDA has approved Cialis (tadalafil) tablets, the PDE 5 inhibitor marketed for erectile dysfunction ,from Eli Lilly Company, for once daily use for the treatment of men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH). The FDA also approved Cialis for once daily use for a separate indication for the treatment of the signs and symptoms of BPH. This means Cialis is now approved for three indications: ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions. "Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians," said Claus Roehrborn , MD, chairman, Department of Urology , The University of Texas Southwestern Medical Center and clinical trial investgator .

Cialis Phase III study in Benign Prostatic Hyperplasia is reported in Jo.Sexual Medicine Men's Health, Andrology and Urology Page

A pivotal Phase III study of Cialis (tadalafil) tablets 5 mg from Eli Lilly and Company for once daily use met its co-primary endpoints, significantly improving measures of both erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both conditions. The study is available online in The Journal of Sexual Medicine . It is one of three efficacy and safety studies included in the supplemental new drug application Lilly submitted to the FDA last year seeking approval for Cialis in the treatment of the signs and symptoms of BPH and the treatment of both ED and the signs and symptoms of BPH (ED+BPH). This approval has now been granted.