Development of the men's prostate awareness church training: church-based workshops for African American men.

This article describes the development of a spiritually based intervention to increase informed decision making for prostate cancer screening through African American churches. The intervention used spiritually themed health messages, incorporated women as supportive health partners, and included a health information technology component. The Men's Prostate Awareness Church Training Project followed a community-based participatory research process to develop educational materials, and training for 40 community health advisors to implement the 4-part prostate health workshop series that will be implemented in 20 churches. Implications are discussed for designing culturally relevant interventions to reduce prostate cancer disparities impacting African American men.

Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial.

PURPOSE: We recently reported an association between the bother and severity of lower urinary tract symptoms secondary to benign prostatic hyperplasia and the severity of sleep disturbance. However, few studies have examined whether alterations in the severity of urinary symptoms influence the degree of sleep problems over time. MATERIALS AND METHODS: The severity of lower urinary tract symptoms in men enrolled in CAMUS (Complementary and Alternative Medicine for Urological Symptoms), a clinical trial of saw palmetto (Serenoa repens), was evaluated using AUASI (American Urological Association symptom index) and quality of life scores. Sleep disturbance was evaluated by the Jenkins sleep scale at 0, 24, 48 and 72 weeks. Statistical analyses were used to assess the relationship(s) between changes in lower urinary tract symptoms and sleep disturbance. RESULTS: The baseline characteristics of the 339 men (172 placebo arm and 167 saw palmetto arm) enrolled in the CAMUS trial with assessment of sleep disturbance and urinary symptoms were similar. There were no differences between improvements in the severity of sleep disturbance or urinary symptoms between the 2 experimental arms. Combined analyses of the entire cohort revealed significant associations (p <0.001) between the AUASI score and sleep disturbance severity with time. Multivariate analyses demonstrated that improvements in lower urinary tract symptoms other than nocturia were the most significant predictors of improvements in sleep disturbance. Specific analyses adjusting for other baseline characteristics demonstrated that a 3-point improvement in AUASI score was associated with a 0.73-point improvement in the Jenkins sleep scale with time. CONCLUSIONS: Improvements in lower urinary tract symptoms correlate with changes in sleeping abilities with time in men with benign prostatic hyperplasia. While nocturia is significantly associated with sleep disturbance, other changes in overall lower urinary tract symptoms are better predictors of changes in sleep dysfunction.

Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.

CONTEXT: Saw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH); however, recent clinical trials have questioned their efficacy, at least at standard doses (320 mg/d). OBJECTIVE: To determine the effect of saw palmetto extract (Serenoa repens, from saw palmetto berries) at up to 3 times the standard dose on lower urinary tract symptoms attributed to BPH. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, multicenter, placebo-controlled randomized trial at 11 North American clinical sites conducted between June 5, 2008, and October 10, 2010, of 369 men aged 45 years or older, with a peak urinary flow rate of at least 4 mL/s, an American Urological Association Symptom Index (AUASI) score of between 8 and 24 at 2 screening visits, and no exclusions. INTERVENTIONS: One, 2, and then 3 doses (320 mg/d) of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks. MAIN OUTCOME MEASURES: Difference in AUASI score between baseline and 72 weeks. Secondary outcomes included measures of urinary bother, nocturia, peak uroflow, postvoid residual volume, prostate-specific antigen level, participants' global assessments, and indices of sexual function, continence, sleep quality, and prostatitis symptoms. RESULTS: Between baseline and 72 weeks, mean AUASI scores decreased from 14.42 to 12.22 points (-2.20 points; 95% CI, -3.04 to -1.36) [corrected]with saw palmetto extract and from 14.69 to 11.70 points (-2.99 points; 95% CI, -3.81 to -2.17) with placebo. The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo (upper bound of the 1-sided 95% CI most favorable to saw palmetto extract was 1.77 points, 1-sided P = .91). Saw palmetto extract was no more effective than placebo for any secondary outcome. No clearly attributable adverse effects were identified. CONCLUSION: Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00603304.

The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial.

PURPOSE: Bothersome lower urinary tract symptoms, including nocturia, significantly impact general health related quality of life in men, as does sleep disturbance. However, few groups have examined the relationship between urinary symptom severity and sleep disturbance. MATERIALS AND METHODS: Men enrolled in a clinical trial of saw palmetto (Serenoa repens) were studied at baseline. Lower urinary tract symptom severity, as determined by the American Urological Association symptom index and quality of life scores, and the degree of sleep disturbance were determined by the Jenkins sleep scale. Analysis was done, adjusting for baseline characteristics, to identify predictors of severe sleep disturbance. RESULTS: A total of 366 men with a mean ± SD age of 60.9 ± 8.3 years who had moderate-severe lower urinary tract symptoms (mean American Urological Association symptom index score 14.58 ± 4.6 points) and a mean Jenkins sleep score of 7.3 ± 4.7 points were included in analysis. Overall there were significant associations between the American Urological Association symptom index score and sleep disturbance severity. Multivariate analysis revealed that obstructive and irritative symptoms were significantly associated with severe sleep disturbance. Further analysis showed that lower serum prostate specific antigen and post-void residual urine volume were also significantly associated with the degree of sleep disturbance. CONCLUSIONS: Lower urinary tract symptom severity is a risk factor for severe sleep disturbance in men. While nocturia was significantly associated with sleep disturbance, other lower urinary tract symptoms were also independent predictors of sleep dysfunction.

The economic impact of delaying 5-alpha reductase inhibitor therapy in men receiving treatment for symptomatic benign prostatic hyperplasia.

BACKGROUND: Pharmacologic treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia often includes alpha-blockers and 5-alpha reductase inhibitors. Many clinicians use alpha-blockers for rapid symptom control, later adding 5-alpha reductase inhibitors to modify long-term disease progression. Delaying the addition of these medications has been shown to result in reduced clinical outcomes. The economic impact of this practice has not been widely studied or reported to date. OBJECTIVE: The objective of this study was to assess the economic impact of delaying initiation of concomitant 5-alpha reductase inhibitor therapy (≥30 days) in patients receiving alpha-blockers for lower urinary tract symptoms. METHODS: Using 2 nationally representative databases (Integrated Health Care Information Solutions and PharMetrics), 2 retrospective analyses were conducted involving 2636 and 4260 men, respectively, aged ≥50 years treated for benign prostatic hyperplasia between 2000 and 2007. Economic outcomes (ie, the cost of therapy and the use of healthcare resources) were compared for adding 5-alpha reductase inhibitor therapy early (within <30 days of initiating an alpha-blocker) versus delaying these medications (≥30 days after initiating an alpha-blocker). RESULTS: In the Integrated Health Care Information Solutions analysis, patients in the early add-on therapy group (n = 1572) had lower benign prostatic hyperplasia-related medical costs in the posttreatment period than those in the delayed-therapy group (n = 1064), $349 versus $618 (P <.0001). Similar trends were seen in the PharMetrics analysis-the medical costs in the early add-on therapy group (n = 2604) and delayed group (n = 1656) were $344 versus $449, respectively (P <.001). Pharmacy costs were $1068 for the early-treatment cohort and $989 for the delayed-treatment cohort for the Integrated Health Care Information Solutions database, yielding total costs of $1417 and $1606, respectively, for a $189 savings per patient over the initial year of treatment (P <.0001). In the PharMetrics analysis, pharmacy costs were $1391 for the early-treatment cohort and $1237 for the delayed-treatment cohort, resulting in total cost of $1735 and $1686, respectively, yielding $59 in additional costs per patient annually for those treated early (P = .8645). CONCLUSION: These results suggest that patients receiving 5-alpha reductase inhibitor therapy within 30 days after initiating alpha-blocker treatment have lower benign prostatic hyperplasia-related medical costs than those who start combination treatment later. The increase in pharmacy costs associated with early initiation of 5-alpha reductase inhibitor therapy resulted in total costs that were similar or significantly lower than those of delayed combination users.

Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia.

BACKGROUND: Benign prostatic hyperplasia (BPH), a common condition among older men, confers its morbidity through potentially bothersome lower urinary tract symptoms. Treatments for BPH include drugs such as alpha-adrenergic receptor blockers and 5-alpha reductase inhibitors, minimally invasive therapies that use heat to damage or destroy prostate tissue, and surgery including transurethral resection of the prostate. Complementary and alternative medicines are gaining popularity in the US. Two phytotherapies commonly used for BPH are extracts of the fruit of Serenoa repens, the Saw palmetto dwarf palm that grows in the Southeastern US, and extracts of the bark of Pygeum africanum, the African plum tree. PURPOSE: The objective of the Complementary and Alternative Medicines for Urological Symptoms (CAMUS) clinical trial is to determine if phytotherapy is superior to placebo in the treatment of BPH. METHODS: CAMUS was originally designed as a 3300-participant, four-arm trial of S. repens, P. africanum, an alpha-adrenergic blocking drug, and placebo with time to clinical progression of BPH, a measure of long-term efficacy, as the primary endpoint. Before enrollment started, a randomized, double-blind, placebo-controlled, single institution clinical trial showed that S. repens at the usual dose did not demonstrate any benefit over placebo with respect to symptom relief at 1 year. Consequently, the focus of CAMUS shifted from evaluating long-term efficacy to determining if any short-term (6-18 months) symptom relief could be achieved with increasing doses of S. repens, the phytotherapy most commonly used in the US for BPH. RESULTS: Results are anticipated in 2011. CONCLUSIONS: Trial design occurs in an environment of continually evolving information. In this case, emerging results from another trial suggested that a study of long-term efficacy was premature, and that an effective dose and preparation of S. repens had to be established before proceeding to a long-term clinical trial.

5-Alpha reductase inhibitors in men with an enlarged prostate: an evaluation of outcomes and therapeutic alternatives.

This article presents background information and highlights key findings from a managed care perspective related to enlarged prostate (EP) in Medicare-eligible patients. This article does not provide a comprehensive review of EP but instead attempts to increase the current understanding of EP through discussion of its prevalence in men aged > or =65 years, its associated economic burden, and some available treatment options. This supplement includes 3 additional articles, all of which present data from a naturalistic, managed care setting. The article by Fenter et al assesses differences in outcomes between elderly EP patients treated with finasteride and those treated with dutasteride in relation to the risks of acute urinary retention and prostate-related surgery. Issa et al conduct a comparative analysis of the combined use of alpha-blockers and 5-alpha reductase inhibitors to treat EP. The final article compares medical costs incurred within the first year of initiating treatment for EP patients receiving finasteride versus dutasteride. This supplement is intended to assist managed care formulary decision makers in evaluating key clinical and economic data that differentiate dutasteride and finasteride within the Medicare-aged population. Although the information presented is not designed to illustrate the superiority of one product over the other, it answers important questions in relation to treating EP in elderly men and raises substantial issues beyond medication costs.

Transurethral needle ablation versus transurethral resection of the prostate for the treatment of symptomatic benign prostatic hyperplasia: 5-year results of a prospective, randomized, multicenter clinical trial.

PURPOSE: We report the 5-year efficacy and safety of transurethral needle ablation of the prostate (TUNA) compared to transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 121 men 50 years or older with LUTS secondary to BPH a minimum of 3 months in duration were enrolled in this prospective, randomized clinical trial at 7 medical centers across the United States. Of the participants 65 (54%) were randomly selected to receive TUNA and 56 (46%) were selected to receive TURP. International Prostate Symptom Score, quality of life, peak urinary flow rate, post-void residual urinary volume, and prostate size and configuration were evaluated before the procedure and then annually for 5 years after the procedure. Adverse events were also recorded throughout the study. RESULTS: Improvement from baseline for TUNA and TURP retained statistical significance at each interval for International Prostate Symptom Score, quality of life and peak flow rate. Post-void residual volume was statistically significant at all time points for TURP and at year 5 for TUNA. The TURP group reported 41% retrograde ejaculation, while the TUNA group reported none. The incident of erectile dysfunction, incontinence and stricture formation was also greater in TURP than in TUNA cases with significantly fewer adverse events for TUNA than for TURP. CONCLUSIONS: The results of this study demonstrate stable treatment outcomes after 5 years of followup and suggest that TUNA is an attractive treatment option for men with LUTS due to BPH.