An Actual Use Study of Tamsulosin in Men with Bothersome Urinary Symptoms in a Simulated Over-the-Counter Setting.

INTRODUCTION: We assessed the ability of men with bothersome urinary symptoms to use an over-the-counter tamsulosin (0.4 mg) product concordant with the information in the proposed drug facts label in a simulated over-the-counter setting. METHODS: Eligibility for this 24-week study was determined by a phone interview. Men who reported not using (nonprescription users) or using (prescription users) a prescription medicine for benign prostatic hyperplasia at screening/baseline reviewed the proposed over-the-counter tamsulosin product. They could then choose to purchase this product and enter the actual use phase. The primary objective was to assess the proportion of nonprescription users compliant with "stop use" directions (performance threshold upper bound of 95% CI 10% or less). Secondary objectives included assessing the proportion of nonRx users compliant with other prespecified instructions on the proposed drug facts label and evaluating adverse events. Analyses were based on outcomes mitigated by a panel of urologists. RESULTS: Of the 4,508 men screened 3,929 were eligible for product review and 1,117 entered the home use phase. Overall 1,074 men (nonprescription users 924, prescription users 150) purchased and used tamsulosin. Mean±SD age was 62.6±10.7 and 66.5±8.8 years, respectively. The primary end point was met, as only 2 of 924 nonprescription users (0.2%, 95% CI 0.0-0.8) reported a "stop use" condition within the first 12 weeks and did not appropriately stop use or initiate contact with a doctor. No unexpected safety concerns were observed. CONCLUSIONS: Results indicate that self-directed use by men interested in using an over-the-counter tamsulosin product was in line with the drug facts label instructions implemented in this study and no unexpected safety concerns were identified.

Over-the-Counter Tamsulosin for Men with Urinary Symptoms: A Simulated Self-Selection Study.

INTRODUCTION: We determined whether consumers who self-select to use tamsulosin for urinary symptoms can make appropriate decisions without health care provider guidance in a simulated over-the-counter setting. METHODS: In a simulated retail setting eligible participants (18 years old or older) reviewed a mock-up of Flomax® over-the-counter packaging and determined whether it was right for them to use tamsulosin capsules (0.4 mg). Per an a priori mitigation procedure 3 urologists reviewed self-reported data, dipstick urinalysis results and AUA-SI (American Urological Association symptom index) scores of men who self-selected tamsulosin as appropriate to use despite information on the drug facts label instructing otherwise. Seemingly incorrect decisions were revised to "appropriate" if deemed well-informed and medically acceptable by 2 or 3 urologists. RESULTS: Overall 619 men and 38 women (mean age 60.9 and 51.6 years, respectively) were enrolled. Of the 470 (75.9%) men who self-selected to use tamsulosin 82 (17.4%) had low health literacy per the REALM (Rapid Estimate of Adult Literacy in Medicine) test and 365 (77.7%) reported seeing a physician at least once a year. Mean AUA-SI total score was 16.5 and 380 (80.9%) men reported urinary symptoms for 1 year or more. The proportions of men who made appropriate self-selection decisions in unmitigated and mitigated analyses were 92.8% (95% CI 90.0-94.9) and 97.9% (95% CI 96.1-99.0), respectively, and findings were similar regardless of health literacy level. Overall 36 of the 38 women (94.7%) made an appropriate decision not to use tamsulosin. CONCLUSIONS: These findings support the potential use of over-the-counter tamsulosin for male urinary symptoms.

Characteristics of men with untreated LUTS interested in over-the-counter tamsulosin.

INTRODUCTION: Treatment for lower urinary tract symptoms (LUTS) is often delayed, as it is considered a natural progression of aging. We described baseline demographic and clinical characteristics of men currently not using prescription medications for benign prostatic hyperplasia (BPH) but interested in self-directed use of over-the-counter (OTC) tamsulosin and who had participated in OTC tamsulosin-simulated studies. MATERIALS AND METHODS: Pooled baseline data from four OTC tamsulosin-simulated studies were analyzed for men who were currently not using BPH prescription medication and who believed that OTC tamsulosin was appropriate for use or were interested in purchasing it. Data from the OTC-simulated studies for men using BPH prescription medication and from the BPH registry, which included men diagnosed with BPH, were used for comparison. RESULTS: Overall, 3285 non-prescription-using men (mean age +/- standard deviation [SD], 60.6 +/- 11.6 years) were included. Average American Urological Association Symptom Index (AUA-SI) total score was 17.6; 25.5% reported urinary symptoms for > 5 years. Overall, 46.7% of these men had > 1 visit/year with their physicians. Baseline characteristics of prescription users from the OTC-simulated studies (n = 364; mean age ± SD, 68.3 +/- 9.1 years; mean AUA-SI score, 18.5) and of men from the BPH registry (n = 5042; 64.8 +/- 10 years; 11.6) were similar to those of non-prescription users. CONCLUSIONS: Non-prescription users had long term moderate-to-severe male LUTS, yet remained untreated; self-management may be a viable alternative strategy for this population. Disease characteristics of men not using BPH prescription medication and interested in using OTC tamsulosin were similar to those using BPH medication or diagnosed with BPH.

Is Dipstick Urinalysis Screening Beneficial in Men with Lower Urinary Tract Symptoms?

INTRODUCTION: Dipstick urinalysis is a widely used screening tool in the evaluation of men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). As limited data support the use of dipstick urinalysis, we have used data from three recently published studies to assess clinical outcomes in those who had dipstick urinalysis findings for blood, glucose, and/or leukocytes. METHODS: We analyzed data from three observational studies involving men interested in using over-the-counter tamsulosin: a self-selection study (SSS) and two actual-use studies of 8-week (AUS8) and 24-week (AUS24) durations. Subgroup analyses focused on pooled data from participants not using α-blockers or other prescription medication for LUTS suggestive of BPH (nonRx users) and who had urine dipstick findings. Data from participants using α-blockers (AUS8) or any prescription BPH medications (SSS and AUS24) are presented as reference. RESULTS: Overall, 2488 nonRx users underwent dipstick urinalysis and 680 (27.3%) had positive findings including traces of blood (332; 13.3%), glucose (259; 10.4%), and/or leukocytes (245; 9.8%). Among users of prescription medicines, 21.6% (37/171) in SSS, 27.4% (23/84) in AUS8, and 31.1% (47/151) in AUS24 had urine dipstick findings. The 200 dipstick-positive nonRx users in SSS underwent per protocol urological assessment: 26 (13.0%) had a newly diagnosed condition causing/contributing to urinary symptoms of which 2.9% were identified as medically important conditions. Among nonRx users with or without a dipstick finding, medically important conditions reported included prostate cancer (1.0% vs. 1.0%, respectively) and urolithiasis (1.0% vs. 0.3%, respectively). The proportion of men with dipstick urinalysis findings was similar between men who regularly visited their physician and those who did not. CONCLUSION: Dipstick urinalysis did not markedly increase the detection of undiagnosed medically important conditions that cause/contribute to urinary symptoms, suggesting that this test may not be a very effective screening tool for men with LUTS. FUNDING: Boehringer Ingelheim Pharmaceuticals, Inc.

Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin.

BACKGROUND: Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) are common in men, considerably affecting quality of life. AIMS: The self-directed use of over-the-counter (OTC) tamsulosin (0.4 mg) and potential safety risks were evaluated in an open-label, uncontrolled, exploratory, 8-week OTC-simulated study. METHODS: Men (≥ 18 years) were recruited via mass advertising about bothersome LUTS. In a working retail environment, respondents reviewed the product and decided whether it was appropriate for them to use (self-selection phase). After purchasing the product, participants' ability to use it as directed by the proposed drug facts label (DFL) was assessed (home-use phase). RESULTS: Of 1446 eligible men, 679 completed the self-selection phase, and 73.9% (502/679) self-selected to use tamsulosin correctly according to the DFL. Of 369 participants who purchased tamsulosin and entered the home-use phase, 321 took one or more doses of tamsulosin and participated in at least one telephone interview. In total, 85.4% (274/321) of participants adhered to the 'Stop Use' and 'Directions' instructions in the DFL. Overall, 139 (39.6%) participants experienced one or more adverse events (AEs); 65 (18.5%) were deemed drug-related, including dizziness (11 [3.1%]), ejaculation disorder (6 [1.7%]), and semen volume decrease (6 [1.7%]). No unexpected AEs were reported. CONCLUSIONS: Of the men interested in self-managing their LUTS, a majority had moderate-to-severe LUTS of long duration. Most men were able to appropriately self-select and use tamsulosin in concordance with DFL instructions and directions. No unexpected AEs were reported during self-directed use. With further label refinement, an over-the-counter tamsulosin option might be feasible. TRIAL REGISTRATION: ClinicalTrials.gov NCT01726270.

Are Over-the-Counter Alpha Blockers in the Best Interest of Men with Lower Urinary Tract Symptoms?

INTRODUCTION: Lower urinary tract symptoms have a multifactorial etiology, are common in men and increase with age. In view of the unprecedented growth of the aging population worldwide and in the United States, an increase in the number of men with lower urinary tract symptoms is expected in the near future. In contrast, a decline in the number of practicing urologists is projected. Many men do not discuss their lower urinary tract symptoms with health care practitioners or seek treatment. Thus, they remain undiagnosed, untreated or both. For such men, self-treatment with over-the-counter alpha blockers with proven efficacy and safety is an unsubstantiated option. However, use of over-the-counter alpha blockers for the treatment of lower urinary tract symptoms is controversial owing to the multifactorial nature of these symptoms and concerns associated with over-the-counter use of alpha blockers. METHODS: This review summarizes a debate held at the 2015 Annual Meeting of the American Urological Association (May 15-19, 2015, New Orleans, Louisiana) on whether over-the-counter alpha blockers are in the best interest of patients. RESULTS: Concerns about over-the-counter use of alpha blockers for the treatment of lower urinary tract symptoms, including inappropriate self-diagnosis and/or self-treatment by patients; potential for missing an important disease; and failure to adhere with guidelines on the assessment of lower urinary tract symptoms are reviewed, as are corresponding rebuttals supporting use of over-the-counter alpha blockers for the treatment of lower urinary tract symptoms. CONCLUSIONS: Over-the-counter alpha blockers are not yet available. Ongoing studies will determine whether appropriate safety and usage criteria can be achieved.

Phytotherapy for Benign Prostatic Hyperplasia.

INTRODUCTION: The use of complementary and alternative medications for symptomatic benign prostatic hyperplasia is a lucrative business in the USA with revenues reaching close to US$6.4 billion in sales for the 2014 fiscal year. Yet, despite its popularity, the evidence supporting the continued use of phytotherapy for symptomatic benign prostatic hyperplasia (BPH) is questionable and a topic worth investigation given its wide spread use. METHODS: A comprehensive literature search utilizing Medline and PubMed was conducted to identify literature pertaining to phytotherapy for the management of BPH. Agents with at least modest clinical data were selected for in-depth review including Seronoa repens, Pygeum africanum, Secale cereale, and Hypoxis rooperi. RESULTS: Early clinical trials for each of the agents demonstrated mixed efficacy results with many studies pointing to a possible benefit for phytotherapy. On further examination of these studies, significant confounders such as poor product standardization, study design, and follow-up duration were identified. More recent, larger and more soundly constructed studies found no significant benefit for the use of phytotherapy in the treatment of BPH. CONCLUSIONS: Twenty years ago, the urologic community was encouraged by trial results that suggested phytotherapy could effectively treat symptomatic benign prostatic hyperplasia. Since that time, several well-constructed studies have consistently demonstrated that these agents are no more efficacious than placebo, despite being largely safe for ingestion.

Feasibility of an Alternative Option for the Management of Male Lower Urinary Tract Symptoms.

PURPOSE: We determine if men with self-reported lower urinary tract symptoms can make a correct decision to use an over-the-counter alpha-1 blocker. Furthermore, we assess the frequency of medically significant conditions presenting with urinary symptoms in these consumers. MATERIALS AND METHODS: Subjects reviewed a mock-up of an over-the-counter product for male lower urinary tract symptoms (part 1). Subjects who selected the product underwent urine dipstick testing and male subjects completed the AUA Symptom Index (part 2). Urological assessment was conducted in women; in men younger than 45 years; men 45 years old or older who reported "Do Not Use" symptoms listed on the over-the-counter label; who had glucose, leukocytes and/or blood in their urine; or had an AUA-SI score of 20 or greater. RESULTS: Of the 1,967 subjects enrolled 1,953 completed part 1 (men/women 1,697/256), 1,311 (1,294/17) entered part 2 and 1,289 (1,274/15) were evaluated. Frequently reported baseline medical conditions were hypertension (45.8%/46.7%) and dyslipidemia (36.4%/60.0%). Lower urinary tract symptoms were present for more than 3 years in 47.6% of men and 40% of women. Mean AUA-SI score was 18.9. Urine dipstick results were positive in 20.9% of men. Overall 729 men and 12 women underwent urological assessment, and 517 (70.9%) men had urologist confirmed lower urinary tract symptoms while 200 (27.4%) did not. Newly diagnosed medically significant conditions causing/contributing to lower urinary tract symptoms were identified in 21 (2.9%) men and 2 (16.7%) women. CONCLUSIONS: Most men correctly selected the over-the-counter product for the management of lower urinary tract symptoms/benign prostatic hyperplasia, while most women correctly deselected to use the product. Since few men had undiagnosed medically significant conditions causing/contributing to urinary symptoms, the risk of harm due to incorrect selection was low.

Complementary and alternative medications for benign prostatic hyperplasia.

INTRODUCTION: The use of complementary and alternative medications has become a multi-million dollar business in the United States and comprises more than half of all filled prescriptions for benign prostatic hyperplasia (BPH) in Europe. For the practicing urologist, understanding the phytotherapeutic agents available, their proposed mechanism of action, the research supporting their use, and their safety profiles has become increasingly important as more patients inquire into their use. MATERIALS AND METHODS: A comprehensive literature search was conducted to identify pertinent articles pertaining to alternative and complementary treatment options for the management of BPH. Treatments demonstrating adequate clinical data, including Serona repens, Pygeum africanum, and Secale cereal, were selected for in depth review. RESULTS: Small clinical trials for each of the agents demonstrated mixed results while larger more soundly constructed studies found no significant benefit for the use of phytotherapy in the treatment of BPH. CONCLUSIONS: Based on the available literature, there is no evidence that phytotherapy significantly improves symptoms of BPH against placebo, despite being largely safe for ingestion. In patients with mild BPH symptoms who are reluctant to take standard pharmaceutical medications may try these agents provided that the patient understands their current limitations. Those with moderate or severe BPH should be discouraged from alternative and complementary treatments.

The evaluation and treatment of nocturia: a consensus statement.

What's known on the subject? and What does the study add? Nocturia is currently defined by the International Continence Society (ICS) as the complaint that an individual has to wake at night one or more times to void. It is, however, an underreported, understudied, and infrequently recognized problem in adults. Many factors may contribute to nocturia which are treatable, yet patients do not seek care or the condition may not be identified by providers. This paper aims to help healthcare providers better serve patients who are experiencing nocturia by summarizing current research, clinical approaches, and treatment options. The results of the conference provide a balanced evaluation of the full treatment armamentarium capable of meeting the needs of patients with the manifold causes of nocturia such as nocturnal polyuria, overactive bladder, or benign prostatic hyperplasia.

Familial testicular torsion.

PURPOSE: Isolated reported cases of familial torsion yield modest information on incidence, genetics or clinical features. We present what is to our knowledge the largest series of familial torsion, including the first 3 generation case and a review of the literature. MATERIALS AND METHODS: Since 2006, we have questioned the presence of a positive family history in all patients with torsion at the initial consultation. We compiled data on familial relationship, laterality, age and outcomes of the proband and affected relatives. We collected previously published cases to better understand clinical features and genetics. RESULTS: Eight of 70 boys (11.4%) with torsion had affected family members. Another 2 families were included from a historical perspective. One relative was affected in 7 families, 2 were affected in 2 and 3 were affected in 1. First degree relatives were most commonly affected. In 1 family torsion occurred in 3 consecutive generations. Despite a family history 50% of patients experienced testicular loss. Brothers were affected in each of the 10 previously reported cases. In 3 families fathers were also affected. There were 3 sets of monozygotic twins. We noted laterality concordance 5 times and discordance 6 times. Age at torsion in probands was adolescence except in 2 with neonatal torsion. No clear inheritance mode was found. CONCLUSIONS: Familial torsion occurs in about 10% of probands and can affect multiple relatives and generations. A positive family history may be useful for torsion diagnosis and management. Relatives of affected patients need education on the signs and symptoms of torsion, and the importance of early presentation to improve outcome.

Alternative therapies for the treatment of chronic prostatitis.

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent disease for which there is no standardized therapy. Traditional treatments have included antibiotics, α-blockers, and anti-inflammatories, but those have not proven to be efficacious therapies through many clinical trials. Alternative therapies, such as phytotherapy, acupuncture, and pelvic floor physical therapy, have grown in popularity for the treatment of CP/CPPS. As clinicians continue to explore these alternative therapies, there is an accumulation of strong evidence demonstrating the success of these alternative therapies.

Management of prostate cancer in HIV-positive patients.

Improved medical therapy for HIV-positive patients has helped delay the progression of HIV to AIDS and reduce AIDS deaths. This dramatically prolonged survival has resulted in increased detection of non-AIDS-defining malignancies, such as prostate cancer, in people with HIV. Reported prostate cancer incidences in HIV-positive men compared with the general population vary in different studies; however, its incidence in the general population has generally increased over time, owing to the widespread use of PSA testing and increased life expectancy. In the highly active antiretroviral therapy (HAART) era, evidence indicates that PSA kinetics and prostate cancer behavior are similar in HIV-positive and HIV-negative patients. Current American Urological Association (AUA) guidelines recommend screening of all men aged >or=40 years with a life expectancy >10 years, and HIV-positive patients should be included in this recommendation. Treatment options for HIV-positive patients with prostate cancer should include all those offered to the general population. Long-term treatment outcomes in HIV-positive patients remain uncertain; however, early results suggest response rates similar to those in HIV-negative patients.

Educating patients about lifestyle modifications for prostate health.

Benign prostatic hyperplasia (BPH) and other prostatic diseases share many observational and mechanistic features with cardiovascular disease. Both BPH and cardiovascular disease increase significantly with age and affect a disproportionate number of men from racial/ethnic minority populations. Pharmacotherapy and surgical options are the treatments most often discussed in the medical literature for the 2 conditions, and these treatments have demonstrated remarkable effectiveness, regardless of the severity of the condition. Obesity, lack of physical activity, dyslipidemia, diabetes mellitus, higher blood pressure, a heart-unhealthy diet, and other factors that increase the risk for cardiovascular disease also appear to be associated with increased risk for BPH. However, the potential for lifestyle changes to prevent or reduce the severity of BPH, especially as an adjunct to conventional treatments, has not received significant attention, even in recent specialty treatment guidelines. Because lifestyle changes may affect the risk for developing BPH or its progression, clinicians are in need of guidelines they can use to educate patients about the potential links between increased risk of cardiovascular disease and increased risk or greater severity of BPH. Patients need to know that a heart-healthy lifestyle is also a prostate-healthy lifestyle. This article provides educational and lifestyle recommendations that may favorably affect BPH and improve overall health in men.

Cranberry juice for the prevention and treatment of urinary tract infections.

There is widespread belief that cranberry juice can treat urinary tract infections (UTIs). There is no conclusive evidence from either in vitro or in vivo studies to confirm this. However, there is strong in vitro and in vivo evidence confirming the hypothesis that UTIs can be prevented by decreasing bacterial adherence to uroepithelial cells. For people with recurrent uncomplicated UTIs, routine utilization of cranberry products may offer an alternative methodology to antibiotic prophylaxis.

Treatment of benign prostatic hyperplasia in patients with cardiovascular disease.

Pharmacological management is the most common therapeutic approach for patients with benign prostatic hyperplasia and alpha-adrenoceptor antagonists are the most commonly prescribed initial treatment. Although all of the alpha-adrenoceptor antagonists produce similar improvements in symptom scores and urinary flow rates, they have different adverse effect profiles, especially with respect to the cardiovascular system. The older alpha-adrenoceptor antagonists, terazosin and doxazosin, were initially approved for the treatment of hypertension and are associated with higher rates of dizziness, syncope and hypotension than the newer agents, tamsulosin and alfuzosin. The older alpha-adrenoceptor antagonists are also involved in more interactions and have a greater number of precautions concerning their usage with other cardiovascular medications. Of the newer alpha-adrenoceptor antagonists, tamsulosin has a lower rate of dizziness than alfuzosin. However, both of these agents are superior to doxazosin and terazosin in that no dose escalation or titration is needed for them.