A phase IV prospective evaluation of the safety and efficacy of extended release testosterone pellets for the treatment of male hypogonadism.

INTRODUCTION: Men with hypogonadism exhibit decreased serum testosterone levels and may experience a constellation of clinical symptoms, including decrease in muscle mass, loss of sexual desire, impotence, and infertility. While previous studies have shown that implantation of extended release testosterone pellets can provide therapeutic levels of testosterone over several months, additional data are needed to establish this approach as the standard of care for male hypogonadism. AIM: To evaluate the safety and efficacy of testosterone pellets over 6 months as a treatment for male hypogonadism in a clinical practice setting. METHODS: A phase IV, single center, open-label study designed to assess the safety and efficacy of subcutaneous insertion of 8 to 12 testosterone 75 mg pellets (450 mg to 900 mg), during a single implantation procedure in hypogonadal men. Subjects who successfully completed the protocol were allowed to enroll in an extension study that included another implantation and 6 months of follow-up. MAIN OUTCOME MEASURES: Safety was determined by investigator-reported adverse events, changes in vital signs, physical exam findings, and laboratory tests. Efficacy was based on serum laboratory tests, physical exams, implantation site evaluations, and vital signs. Secondary objectives were to assess patient preference for testosterone pellets and to maintain optimal total testosterone. RESULTS: Mean testosterone significantly increased and luteinizing hormone (LH) levels significantly decreased from pre-implantation values at weeks 1, 4, and 12, and had returned to pre-implantation levels by week 24. Prostate-specific antigen levels remained unchanged for the duration of the study. Improvements in several symptoms of hypogonadism were determined with multiple questionnaires. Implanted testosterone pellets were generally well tolerated. CONCLUSION: Implanted testosterone pellets can normalize testosterone and LH levels and improve symptoms for at least 3 months and up to 6 months in men with hypogonadism, and should be considered as a therapeutic option for hypogonadal men.

New findings in localized and advanced prostate cancer: AUA 2011 review.

The 2011 American Urological Association (AUA) annual meeting took place in Washington, DC, USA, on May 14-19. It is the largest gathering of urologists in the world, providing unparalleled access to groundbreaking research, new guidelines and the latest advances in urologic medicine. The opportunity to exchange knowledge among urologists on a worldwide level was provided by participation of more than 80 countries in this scientific meeting. As one of the most important subjects, there were more than 500 presented studies in prostate cancer. In this review we will highlight some of the findings and the clinical significance of a few of these abstracts concerning prostate cancer staging and markers.

The effect of changes in Medicare reimbursement on the practice of office and hospital-based endoscopic surgery for bladder cancer.

BACKGROUND: Procedures performed in the office offer potential cost savings. Recent analyses suggest, however, that a fee-for-service system may incentivize subscale operations and, thus, contribute to excessive spending. The authors of this report sought to characterize changes in the practice of office-based and hospital-based endoscopic bladder surgery after 2005 increases in Medicare reimbursement. METHODS: All office and hospital-based endoscopic surgeries that were performed in a faculty practice from 2002 through 2007 were identified using billing codes for procedures, diagnoses, and procedure locations and then analyzed using the chi-square test and logistic regression. Costs were estimated based on published Medicare reimbursements for office and hospital-based surgeries. RESULTS: In total, 1341 endoscopic bladder surgeries were performed, including 764 in the office and 577 in the hospital. After 2005, the odds ratio (OR) for office surgery occurring among all cystoscopies and for surgery occurring in the office versus the hospital was 2.01 (95% confidence interval [CI], 1.71-2.37) and 2.29 (95% CI, 1.83-2.87), respectively. Among all treated lesions that were associated with a diagnosis of bladder cancer and nonbladder cancer, the OR for a procedure occurring in the office versus the hospital was 1.36 (95% CI, 1.07-1.73) and 1.99 (95% CI, 1.52-2.60), respectively. The likelihood of repeat surgery on the same lesion increased after 2005 (OR, 2.86; 95% CI, 1.46-5.62), and the likelihood of an office surgery leading to a bladder cancer diagnosis at the next visit declined (OR, 0.29; 95% CI, 0.16-0.51). The overall estimated expenditure increased by 50%. CONCLUSIONS: After 2005, more bladder lesions were identified and treated in the office. In a single group practice, office treatment of bladder cancer did not fully explain this new practice pattern, suggesting a lowered threshold for office intervention.

Clomiphene citrate and enclomiphene for the treatment of hypogonadal androgen deficiency.

Hypogonadism has a number of important clinical consequences related to androgen deficiency and impaired spermatogenesis. The cause of this condition is multifactorial and can result from hypothalamic, pituitary or gonadal dysfunction as well as factors that affect hormonal signaling along the hypothalamic-pituitary-gonadal axis. While testosterone replacement is the most common treatment, it can paradoxically lead to infertility, and may be a less physiologic therapy for patients with secondary hypogonadism due to pituitary dysfunction. Clomiphene citrate, and its derivatives, may allow for restoration of gonadal function by restoring physiologic pituitary function in a subset of patients with hypogonadism.

Skin preparation for the prevention of surgical site infection: which agent is best?

Procedural and surgical site infections create difficult and complex clinical scenarios. A source for pathogens is often thought to be the skin surface, making skin preparation at the time of the procedure critical. The most common skin preparation agents used today include products containing iodophors or chlorhexidine gluconate. Agents are further classified by whether they are aqueous-based or alcohol-based solutions. Traditional aqueous-based iodophors, such as povidone-iodine, are one of the few products that can be safely used on mucous membrane surfaces. Alcohol-based solutions are quick, sustained, and durable, with broader spectrum antimicrobial activity. These agents seem ideal for longer open surgeries with the potential for irrigation or surgical spillage, such as cystoprostatectomy, radical prostatectomy, and retroperitoneal lymph node dissection.