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ABSTRACT: 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.
The Journal of urology 10/2012; · 4.02 Impact Factor
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ABSTRACT: 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.
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.
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.
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 Journal of urology 06/2011; 185(6):2223-8. · 4.02 Impact Factor
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Jeannette Lee,
Gerald Andriole,
Andrew Avins,
E David Crawford,
Harris Foster,
Steven Kaplan,
Karl Kreder,
John Kusek,
Andrew McCullough,
Kevin McVary,
Sreelatha Meleth, Michael Naslund,
J Curtis Nickel,
Leroy Nyberg,
Claus Roehrborn,
O Dale Williams,
Michael Barry
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ABSTRACT: 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.
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.
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 are anticipated in 2011.
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.
Clinical Trials 12/2009; 6(6):628-36. · 1.92 Impact Factor
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ABSTRACT: Pharmacologic treatment of lower urinary tract symptoms from benign prostatic hyperplasia (BPH) commonly includes alpha-blockers (ABs) and 5alpha-reductase inhibitors (5ARIs). Many clinicians use ABs for rapid symptom control and 5ARIs to modify long-term disease progression. The purpose of this study was to assess the clinical impact of delayed 5ARI therapy in patients treated with AB for lower urinary tract symptoms.
Using two nationally representative databases, two retrospective analyses were conducted including patients aged > or =50 years treated for BPH between 2000 and 2007. Clinical outcomes for those using add-on 5ARI therapy early (within 30 days of initiating AB) and late (>30 days after initiating AB) were compared. Likelihood of clinical progression, defined as the presence of acute urinary retention (AUR) and prostate surgery, was assessed over 1 year after AB initiation, and modeled as a function of the treatment cohorts and the following baseline covariates: AUR, BPH stage, Charlson Comorbidity Index, age, and number of unique diagnosis codes, unique non-BPH-related classes of prescriptions filled, and specialty care.
Of 6896 men included in the analyses, approximately 60% initiated 5ARI therapy within 30 days of AB therapy (the early cohort). Patients in the early cohort were less likely to have clinical progression. Each 30-day delay in starting 5ARIs resulted in an increased likelihood of overall clinical progression (average 21.1%), AUR (average 18.6%), and prostate-related surgery (average 26.7%).
These results suggest that delaying 5ARI therapy in men with BPH increases the risk of AUR and prostate surgery.
Confounding factors, such as symptom severity and prostate volume, may have influenced the findings of the study.
Current Medical Research and Opinion 09/2009; 25(11):2663-9. · 2.38 Impact Factor
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Michael Naslund
The Journal of urology 06/2009; · 4.02 Impact Factor
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ABSTRACT: To assess cost differences between dutasteride and finasteride use within the first year of initiating treatment for enlarged prostate (EP) among men aged > or =65 years in a managed care setting.
For this retrospective analysis, medical/pharmacy claims data from July 1, 2003, to June 30, 2006, were analyzed for EP patients aged > or =65 years who were treated with dutasteride or finasteride. Analysis of average monthly costs over each patient's 1-year follow-up period incorporated total charges for EP-related medical care, including physician, inpatient and outpatient hospital care, emergency department, and other ancillary services.
A total of 4498 patients met selection criteria, with comparable demographics between treatment cohorts. Patients taking dutasteride incurred $51 less per month in medical expenses than finasteride-treated patients ($122 vs $173; P <.001), attributable to lower monthly inpatient hospitalization costs ($55.84 vs $70.34), outpatient costs ($22.07 vs $44.25), and physician office visit costs ($40.69 vs $51.10).
Medicare-aged patients treated with dutasteride incurred $51 less per month in medical costs than those treated with generic finasteride, suggesting that the higher price of dutasteride may be offset by decreased medical resource consumption.
The American journal of managed care 06/2008; 14(5 Suppl 2):S167-71. · 2.46 Impact Factor
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ABSTRACT: 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.
The American journal of managed care 05/2008; 14(5 Suppl 2):S148-53. · 2.46 Impact Factor
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ABSTRACT: The objective of this study was to directly assess the likelihood and timing of alpha blocker discontinuation in patients receiving combination therapy with dutasteride or finasteride plus an alpha blocker.
A retrospective analysis of the PharMetrics Integrated Medical and Pharmaceutical Database (Watertown, Mass) was conducted to assess differences in alpha blocker discontinuation rates for patients initiated on 5-alpha reductase inhibitor (5ARI) therapy. The database is nationally representative, encompassing more than 45 million patients from 85 managed healthcare plans. Male patients aged >50 years with a diagnosis of enlarged prostate (EP) who were receiving alpha blocker therapy and who began 5ARI treatment (dutasteride or finasteride) between January 1, 1999, and March 1, 2005, were included. Patients were studied for up to 12 months to evaluate the likelihood and timing of alpha blocker discontinuation.
Overall, 56.7% of the patients remained on alpha blocker therapy for 6 months. At 1 year, more dutasteride patients had discontinued alpha blocker therapy (48.9% remained on alpha blocker) than finasteride patients (58.7% remained on alpha blocker). After controlling for background covariates, dutasteride patients were 19.9% more likely to discontinue alpha blocker therapy over 365 days.
Patients with EP who are taking an alpha blocker and 5ARI in combination for urinary symptom relief discontinue their alpha blocker 19.9% earlier when taking dutasteride than when taking finasteride. The ability to discontinue alpha blocker therapy earlier could reduce the costs of pharmacotherapy while continuing to provide an adequate level of symptom control and disease modification, which may result in cost savings to healthcare plans.
The American journal of managed care 03/2007; 13 Suppl 1:S17-22. · 2.46 Impact Factor
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ABSTRACT: 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).
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.
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.
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.
The Journal of Urology 07/2004; 171(6 Pt 1):2336-40. · 3.75 Impact Factor
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ABSTRACT: Patients undergoing prostate brachytherapy (PB) as monotherapy are often selected on the basis of favorable pretreatment factors. However, intermediate and high-risk prostate cancer patients are commonly offered PB as monotherapy without the addition of external beam radiotherapy (EBRT) or hormonal therapy. This series reports the outcome of patients undergoing PB as monotherapy who were stratified into low, intermediate, and high-risk groups with extended follow-up.
A total of 102 patients with clinically localized prostate cancer underwent PB alone as monotherapy. EBRT or hormonal therapy was not part of their initial treatment. Prostate-specific antigen (PSA) relapse-free survival (PRFS) was determined in accordance with the American Society for Therapeutic Radiology and Oncology consensus statement. Patients were stratified as at favorable risk (Stage T1-2a, pretreatment PSA < or =10.0 ng/mL, and Gleason score < or =6), intermediate risk (one prognostic indicator with a higher value), or unfavorable risk (> or =2 indicators with higher values). The median follow-up period for patients in this series was 7 years (range 2.1-9.7). The median age at treatment was 71 years (range 54-80), and the median prescribed dose of (125)I was 145 Gy.
Forty patients experienced a biochemical relapse at a median of 1.9 years (range 0.4-4.2). The 5-year actuarial PRFS rate for patients with favorable, intermediate, and unfavorable risk was 85%, 63%, and 24%, respectively (p <0.0001). All but 1 patient had the relapse within the first 5 years of treatment. When stratifying patients on the basis of their pretreatment PSA level, the 5-year PRFS rate for men with a PSA < or =10 ng/mL vs. >10 ng/mL was 78% vs. 35%, respectively (p = 0.0005). Furthermore, the 5-year PRFS rate for men with a Gleason score of < or =6 vs. > or =7 was 74% vs. 33%, respectively (p = 0.0001). No difference was found between Stage T1-T2a and Stage T2b or higher (64% vs. 54%, respectively; p = 0.353).
On the basis of risk stratification, PB as monotherapy produces comparable PRFS to EBRT and surgery at 7 years of follow-up. PB as monotherapy is particularly ineffective in patients with unfavorable risk factors, and additional therapy is warranted.
International Journal of Radiation OncologyBiologyPhysics 07/2002; 53(3):588-94. · 4.11 Impact Factor
