AUA White Paper on the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults.

INTRODUCTION: Medication related problems are common but may be preventable outcomes of prescribing choices. Risks associated with medications in the older adult population are greater due to changes in physiological function with age or disease. Older adults and those with significant comorbidities are often excluded from the clinical trials used to develop medications. In 2012 the American Geriatrics Society published the most recent update of the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Several medications included in sections of the Beers Criteria are frequently used in clinical urology, including nitrofurantoin, alpha-1 blocker medications, and antimuscarinic anticholinergic medications for the treatment of urge incontinence and overactive bladder. We describe the challenges and considerations that are useful in prescribing medications for geriatric patients. METHODS: A literature review was performed targeting publications from 2003 to 2013 on the topics of the Beers Criteria, potentially inappropriate medications and specific urological medications included in the current version of the Beers Criteria. An expert panel was convened to evaluate this information and create this white paper with the purpose of educating the urological community on these issues. RESULTS: The rationale for the creation and implementation of the Beers Criteria and its implications for urological practice are reviewed. Careful examination of the Beers Criteria can help clinicians avoid potentially inappropriate prescribing choices for their geriatric patients. We also identified that the HEDIS® high risk medications list of potentially inappropriate medications has been implemented as a negative quality indicator, even though this was not an original purpose of the Beers Criteria. In other words, decisions of denial of coverage and/or requirements for preauthorization are being made using the Beers Criteria as justification by third party payers and other entities. CONCLUSIONS: The Beers Criteria were developed to improve prescribing practices for older adult patients to reduce or avoid potential risks and complications. We encourage clinicians to educate themselves about the Beers Criteria recommendations and associated initiatives that are aimed at improving the care of older adult patients. Urologists should have a key role in the development, evaluation, implementation and analysis of practice measures and the resulting policies.

An evaluation of the pharmacokinetics and pharmacodynamics of the histrelin implant for the palliative treatment of prostate cancer.

Seventeen patients with advanced prostate cancer were studied to evaluate the pharmacokinetics and pharmacodynamics of a hydrogel implant designed to deliver histrelin at a constant rate (50 microg/d) for 1 year. Serum histrelin levels were collected during the 52-week implantation period and after a second implant. Testosterone suppression was the primary pharmacodynamic endpoint, with treatment success defined as serum testosterone less than 50 ng/dL. The histrelin subdermal implant delivered constant histrelin levels, with mean serum histrelin of approximately 0.265 ng/mL over 52 weeks. At the end of 52 weeks, mean histrelin concentrations were 0.128 +/- 0.0652 ng/mL. Patients achieved chemical castration (testosterone less than 50 ng/mL) by week 4. In patients who had the first implant removed and received a new implant at the end of the first 52 weeks, testosterone suppression was not interrupted. The hydrogel implant provided consistent delivery of histrelin over 1 year and effectively suppressed testosterone in men with prostate cancer.

Use of a temporary prostatic stent after transurethral microwave thermotherapy reduced voiding symptoms and bother without exacerbating irritative symptoms.

OBJECTIVES: To evaluate the ability of a temporary prostatic stent (Spanner [Sp]) to manage voiding symptoms, irritative symptoms, and bother after transurethral microwave thermotherapy (TUMT) for prostatic obstruction. METHODS: Patients were randomized to the Sp (n = 100) or standard of care (SOC, n = 86) after TUMT with 3 to 10 days of routine catheterization. We evaluated International Prostate Symptom Score (IPSS) voiding subscore, IPSS irritative subscore, voiding diary data, and Benign Prostatic Hyperplasia Impact Index (BII) 7 to 10 days before TUMT and repeated them 1, 2, 4 (stent removal), 5, and 8 weeks after stent insertion. RESULTS: After 1 week of stent use, the Sp group experienced significantly greater improvements in the IPSS voiding subscore (Sp = -4.9 versus SOC = -2.3, P = 0.002) and individual voiding symptoms assessed by the IPSS (intermittency, weak stream, and straining) and voiding diary data (stream strength, and strain). After 2 weeks, the Sp group showed a trend toward greater improvements in IPSS voiding (P = 0.059) and irritative (P = 0.058) subscores and reported significantly less bother (BII, Sp = -2.1 versus SOC = -1.1, P = 0.033). After stent removal, the Sp group reported significantly greater improvements in the IPSS irritative subscore (5 weeks: Sp = -4.0 versus SOC = -2.7, P = 0.029; 8 weeks: Sp = -5.0 versus SOC = -4.0, P = 0.050), individual voiding (stream strength and dysuria), and irritative (frequency and urgency) symptoms and bother (5 weeks: Sp = -4.0 versus SOC = -2.3, P = 0.002; 8 weeks: Sp = -5.0 versus SOC = -3.1, P = 0.001). CONCLUSIONS: The Spanner, a temporary prostatic stent, improved voiding symptoms and bother without exacerbating irritative symptoms. Improvements in symptoms and bother were sustained after stent removal.

A temporary intraurethral prostatic stent relieves prostatic obstruction following transurethral microwave thermotherapy.

PURPOSE: The Spanner, a novel prostatic stent, was evaluated for safety, efficacy and patient tolerance when used to relieve prostatic obstruction following transurethral microwave thermotherapy. MATERIALS AND METHODS: Following transurethral microwave thermotherapy and routine post-procedure Foley catheterization at 1 of 9 clinical sites 186 patients meeting study criteria were randomized to receive a Spanner (100) or the standard of care (86). Baseline evaluations included post-void residual urine, uroflowmetry, International Prostate Symptom Score and International Prostate Symptom Score quality of life question. These evaluations were repeated at visits 1, 2, 4, 5 and 8 weeks after randomization (Spanner insertion) with the addition of the Spanner satisfaction questionnaire, ease of use assessment and adverse events recording. The Spanner was removed after 4 weeks, at which time the Spanner and standard of care groups underwent cystourethroscopy. RESULTS: At the 1 and 2-week visits the Spanner group showed significantly greater improvements from baseline in post-void residual urine, uroflowmetry and International Prostate Symptom Score compared to the standard of care group. The Spanner group experienced significantly greater improvements in quality of life at the 5 and 8-week visits. Patient satisfaction with the Spanner exceeded 86%. Cystourethroscopy findings in the Spanner and standard of care groups were comparable and adverse events associated with previous stents were rare. CONCLUSIONS: The Spanner is a safe, effective and well tolerated temporary stent for severe prostatic obstruction resulting from therapy induced edema after transurethral microwave thermotherapy. It may be a needed addition to the armamentarium for managing bladder outlet obstruction in a broad group of urological patients.

An eight-month clinical study of LA-2575 30.0 mg: a new 4-month, subcutaneous delivery system for leuprolide acetate in the treatment of prostate cancer.

OBJECTIVES: To investigate the safety, efficacy, and pharmacokinetics of a new 4-month subcutaneous depot of leuprolide acetate in patients with prostate cancer. METHODS: Ninety patients diagnosed with adenocarcinoma of the prostate were enrolled in an open-label, multicenter study. LA-2575 30.0 mg was administered subcutaneously once every 4 months for 8 months. The primary efficacy parameter was a serum testosterone level of 50 ng/dL or less. The pharmacokinetics of leuprolide acetate were analyzed in the first 24 enrolled patients. The values are reported as the mean +/- standard error. RESULTS: Of 90 enrolled patients, 82 (91%) completed the 8-month study. Eight patients voluntarily withdrew from the study for the following reasons: nonmedical reasons (n = 3), treatment-related adverse events (n = 3), disease progression (n = 1), and cardiovascular disease (n = 1). By day 28, 85 (94%) of the 90 patients had achieved a serum testosterone level less than 50 ng/dL. At study completion, 88 (98%) of the 90 patients had a testosterone value less than the castrate level (mean 12.4 +/- 0.8 ng/dL), with 81 (90%) at less than 20 ng/dL. From baseline to month 6, the mean luteinizing hormone level had decreased from 7.51 +/- 0.69 mIU/mL to 0.12 +/- 0.02 mIU/mL. The mean prostate-specific antigen level had decreased 90% from 13.2 +/- 2.0 ng/mL at baseline to 1.3 +/- 0.3 ng/mL at 8 months. No clinically significant flare reactions were observed. The most common treatment-related adverse event was mild hot flashes. CONCLUSIONS: LA-2575 30.0-mg depot consistently produced and maintained safe and effective suppression of serum testosterone, with total serum testosterone concentrations well below the medical castrate level of less than 50 ng/dL.

A clinical study of 22.5 mg. La-2550: A new subcutaneous depot delivery system for leuprolide acetate for the treatment of prostate cancer.

PURPOSE: The safety, efficacy and pharmacokinetics of a unique 3-month subcutaneous depot of leuprolide acetate were investigated in patients with prostate cancer. MATERIALS AND METHODS: This open label, noncomparative, 6-month multicenter study enrolled 117 patients diagnosed with adenocarcinoma of the prostate. LA-2550 (22.5 mg. depot) (Atrix Laboratories, Fort Collins, Colorado) was administered subcutaneously once every 3 months. The primary efficacy parameter was serum testosterone 50 ng./dl. or less. Pharmacokinetics were analyzed in a subset of 22 patients. RESULTS: Of the 117 enrolled patients 111 (98%) completed the 6-month study. Five patients withdrew for nontreatment related events and 1 was withdrawn because he received less than a full dose of the study drug. By day 28, 98% of patients had serum testosterone 50 ng./dl. or less and 84% had achieved 20 ng./dl. or less. By day 35 all patients had 50 ng./dl. or less testosterone. A patient with a breakthrough response after testosterone suppression on day 49 (112 ng./dl.) regained suppression (27 ng./dl.) 14 days after the second injection (day 98). At study completion all patients had 50 ng./dl. or less testosterone (mean plus or minus standard error of mean 10.1 +/- 0.07) and 104 of the 111 (94%) had 20 ng./dl. or less. From baseline to month 6 mean luteinizing hormone decreased from 9.2 +/- 1.1 to 0.08 +/- 0.01 mIU/ml. and mean prostate specific antigen decreased more than 98%. No flare reactions were observed and patient assessments of bone pain and urinary symptoms were unchanged. The most common treatment related adverse event was hot flashes, which were mild in 57% of cases, moderate in 12% and severe in 0%. CONCLUSIONS: LA-2550 (22.5 mg. depot) produced and maintained safe and effective suppression of serum testosterone to well below the medical castrate level of 50 ng./dl. or less.

2003 American Urological Association Gallup survey: physician practice patterns, cryosurgery/brachytherapy, male infertility, female urology and insurance/professional liability.

PURPOSE: The Health Policy Survey and Research Committee of the American Urological Association and the Gallup Organization have performed 10 surveys of American urologists since 1992 for the purpose of assessing demographics and practice patterns. The results of the 2003 survey are presented. MATERIALS AND METHODS: A random sample of 510 urologists who have completed urological residencies was interviewed by telephone in February 2003. Major content areas were physician practice patterns, cryosurgery/brachytherapy, male infertility, female urology and insurance/ professional liability. RESULTS: Urologists are older, staying in practice longer and planning to retire later than ever before. Urologists are also seeing more patients in the office every year. Most urologists treat male infertility and female voiding dysfunction. CONCLUSIONS: American urologists are older, working harder and planning on continuing to do so for longer than in any year sampled in the last decade.

2001 American Urological Association Gallup Survey: changes in physician practice patterns, satisfaction with urology, and treatment of prostate cancer and erectile dysfunction.

PURPOSE: The Health Policy Survey and Research Committee of the American Urological Association and the Gallup organization have performed 9 surveys of American urologists since 1992 for the purpose of assessing demographics and practice patterns. The results of the 2001 survey are presented. MATERIALS AND METHODS: A random sample of 507 urologists was interviewed in February and March 2001. Major content areas were physician practice patterns, cryosurgery/brachytherapy, prostate specific antigen, erectile dysfunction, Medicare and the Internet. RESULTS: Membership in the American Urological Association continues to increase among American urologists. The number of patients seen weekly in the office also continues to increase. While age at retirement has not changed significantly, most urologists are satisfied with the specialty and increasing numbers are using the Internet. CONCLUSIONS: Minimally invasive procedures such as brachytherapy for prostate cancer continue to proliferate and there is evidence that the specialty of urology is continuing to become more office based. The demand for urological services appears to be continuing to increase.