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Unlabelled: Study Type - Therapy (outcomes research) Level of Evidence 2c. What's known on the subject? and What does the study add? It is known that benign prostatic hyperplasia is a common condition affecting most men by the age of 80 years. There are multiple treatment options available, including both medical and surgical interventions. However, what is not known is how affective the different types of interventions are in the general population. Previous studies have focused on centre-specific data. What is unique about our study is that it is a prospective cross-section analysis of a community cohort of men. Through this study we were able to assess the outcomes in the general population as opposed to in a high-volume surgical centre. Our findings show that in this community medical management was poor at symptomatic improvement, whereas surgical intervention produced the best improvement., Objective: • To describe the use and symptomatic outcomes of different therapies for lower urinary tract symptoms (LUTS) in a community-based population of men followed for 17 years., Patients and Methods: • Data from a randomly selected cohort of 2184 men, aged 40-79 years in 1990, from Olmsted County, Minnesota, USA were included in the study. Participants completed a questionnaire similar to the American Urological Association Symptom Index (AUASI) and reported on incontinence. • Men were followed biennially through 2007 (median follow-up: 13.7 years; Q1, Q3: 8.8, 15.7). Medical and surgical treatments for LUTS were reported on biennial questionnaires and abstracted from community medical records., Results: • Overall, 610 (28%) men received medical or surgical therapy for treatment of LUTS. Patients undergoing vaporization and transurethral resection of the prostate (TURP) had the highest pre-intervention AUASI scores (P < 0.001) and the most rapid increase in scores over time (P= 0.002) compared with those treated with medications or no therapy. After intervention, symptom progression slowed in all treatment groups. • However, the greatest improvement in AUASI score (median % change) was observed in the TURP group: -27.45%. The TURP group also reported a significant decrease in incontinence after surgery (% change): TURP: -22.58%., Conclusion: • All therapies were effective at slowing the progression of LUTS, but only TURP patients reported a significant decrease in both LUTS and incontinence after therapy., (© 2012 MAYO FOUNDATION. BJU INTERNATIONAL © 2012 BJU INTERNATIONAL.)

Objective: To conduct a study to determine whether diabetes treatment is associated with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) and progression in black and white men. Diabetes has been associated with BPH and LUTS in aging men., Methods: Using the Olmsted County Study of Urinary Symptoms and Health Status among Men and the Flint Men's Health Study, we examined how the use of medical therapy (eg, insulin regimens, oral hypoglycemics) related to changes in LUTS severity, maximal urinary flow rate measured by uroflowmetry, prostate volume determined by transrectal ultrasonography, and serum prostate-specific antigen concentrations., Results: Of the 2226 men participating in the Olmsted County Study of Urinary Symptoms and Health Status among Men and the Flint Men's Health Study, 186 men reported a history of diabetes, 76.9% of whom were treated with medical therapy. Overall, the men with diabetes had significantly greater odds of moderate/severe LUTS (age- and race-adjusted odds ratio 1.37, 95% confidence interval 1.00-1.87) compared with those without diabetes. However, among the diabetic men, those not taking medication had greater odds of moderate/severe LUTS than those taking medication. This association among men not taking medication was seen for 5 of the 7 individual symptoms. The prostate volume and prostate-specific antigen level were not significantly associated with diabetes treatment. No significant differences were observed for the annual change in BPH characteristics by diabetes treatment status., Conclusion: These findings suggest that the presence of diabetes and subsequent poor glycemic control might be less related to prostate growth and more to the dynamic components of lower urinary tract function. Additional evaluations of the associations between glycemic control and BPH progression are warranted., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: To determine the distribution of longitudinal changes in serum prostate-specific antigen (PSA) levels from a population-based sample of men., Patients and Methods: In this prospective cohort study, a random sample of Olmsted County, Minnesota, men aged 40 to 79 years in 1990 were followed up biennially from January 1, 1990, through August 29, 2007. Serum PSA levels were determined at each examination, and men were censored for follow-up with a diagnosis of prostate cancer or treatment for benign prostatic hyperplasia. The empirical distributions of annual percent change and annual absolute change in serum PSA level were calculated and tabulated, including the median and 75th and 95th percentiles., Results: For men with PSA measurements 2 years apart, the median annual percent change in serum PSA level was 4.83% and the 95th percentile was about 49.76%. The variability in estimated annual change decreased with increasing time between assessments, with a 95th percentile of 21.82% after 8 or more years between assessments. Although the median absolute change per year increased with increasing age, the median percent change per year was fairly consistent across age groups., Conclusion: These data demonstrate that, with shorter intervals between assessments, greater variability should be expected. These distributions should prove helpful to patients and clinicians in interpreting changes in serum PSA levels observed in typical clinical practices., (Copyright © 2012 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Purpose: We provide cross-sectional normative data on [-2]proenzyme-prostate specific antigen from the Olmsted County Study of Urinary Symptoms and Health Status among Men, and the Flint Men's Health Study. We also describe associations with clinical urological measures and the risk of prostate cancer diagnosis., Materials and Methods: Measurements of [-2]proenzyme-prostate specific antigen were obtained from 420 white men from Olmsted County, Minnesota, and 328 black men from Genesee County, Michigan. Cross-sectional associations between [-2]proenzyme-prostate specific antigen and prostate enlargement/elevated prostate specific antigen were assessed. Cox proportional hazard models were used to assess associations between [-2]proenzyme-prostate specific antigen and the incident diagnosis of prostate cancer., Results: Baseline [-2]proenzyme-prostate specific antigen was slightly higher in black men at a median of 6.3 pg/ml (25th, 75th percentiles 4.1, 8.9) than in white men at a median of 5.6 pg/ml (25th, 75th percentiles 3.9, 7.7, respectively, p = 0.01). Baseline [-2]proenzyme-prostate specific antigen was highly predictive of biopsy confirmed prostate cancer in the Olmsted County Study cohort. Relative to men in the [-2]proenzyme-prostate specific antigen lower quartile those in the upper quartile were at almost eightfold increased risk for prostate cancer (HR 7.8, 95% CI 2.2-27.8) after adjusting for age and baseline prostate specific antigen., Conclusions: In these cohorts of community dwelling black and white men [-2]proenzyme-prostate specific antigen was much lower than in previous studies. These data suggest that [-2]proenzyme-prostate specific antigen may help identify prostate cancer in men with serum prostate specific antigen in an indeterminate range, although the reference ranges for white and black men may differ slightly., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We describe cross-sectional associations of benign prostate specific antigen with clinical urological measures and examined the risk of future urological outcomes in 2 population based cohorts of black and white men, respectively., Materials and Methods: Two population based cohort studies were established to characterize the natural history of and risk factors for prostate disease progression in white and black male residents of Olmsted County, Minnesota, and Genesee County, Michigan, respectively., Results: The benign prostate specific antigen distribution was similar in black men at a median of 32.9 pg/ml (25th, 75th percentiles 17.3, 68.0) and white men at a median of 32.2 pg/ml (25th, 75th percentiles 16.6, 68.9, respectively). However, it was much lower than in previous reports. For Olmsted County men in the upper quartile of benign prostate specific antigen there was a fifteenfold increased risk of prostate cancer (HR 14.6, 95% CI 3.1-68.6) and a twofold higher risk of treatment for benign prostatic hyperplasia (HR 2.2, 95% CI 1.2-4.2) after adjusting for age. After additional adjustment for baseline prostate specific antigen the association between benign prostate specific antigen and prostate cancer risk was attenuated but remained almost ninefold higher for men in the upper quartile of benign prostate specific antigen (HR 8.7, 95% CI 1.8-42.4). The twofold higher risk of treatment for benign prostatic hyperplasia also remained after adjusting for baseline prostate specific antigen for men in the upper benign prostate specific antigen quartile (HR 1.9, 95% CI 0.9-4.0)., Conclusions: Results suggest that increased benign prostate specific antigen may help identify men with prostate cancer and those at risk for benign prostatic hyperplasia treatment., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: To determine if polymorphisms in the cyclooxygenase 2 (COX-2) enzyme gene (prostaglandin synthase 2; PTGS2) were associated with development of benign prostate enlargement (BPE), and whether associations were modified by use of nonsteroidal anti-inflammatory drugs (NSAIDs)., Materials and Methods: Participants were men residing in Olmsted County, MN, who were between 40 and 79 years of age in 1990 (N= 356). Prostate volume was measured by transrectal ultrasound and men reported all the medications that they were taking at the time of the examination. Men were followed biennially for 16 years. Ten tagging single nucleotide polymorphisms (SNPs) in the PTGS2 gene were typed using the Illumina GoldenGate(TM) Assay. Associations between SNPs and development of BPE (volume >30 mL) were assessed by Cox proportional hazards models. Models were also stratified by NSAID use., Results: We observed significant associations between four polymorphisms in the PTGS2 gene and development of BPE (all P < 0.05). These associations were not observed among men who used NSAIDs., Conclusion: Variants in the PTGS2 gene may increase the risk of prostate enlargement, but the increased risk may be minimized by use of NSAIDs., (© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.)

Some men have rapid increases in benign prostatic enlargement and lower urinary tract symptoms (LUTS), and it is not clear how sex steroid hormones contribute to the rates of change in these urologic outcomes. Therefore, the authors conducted a population-based cohort study of 648 men residing in Olmsted County, Minnesota, from 1990 to 2007, to examine associations between baseline sex steroid hormones, the rate of change in these hormones, and the rates of change in LUTS, maximum urinary flow rate, and prostate volume. Annual changes in hormone levels and urologic outcomes were calculated using mixed-effects regression models. Associations between hormone variables and rates of change in urologic outcomes were assessed with linear regression models. Higher baseline estradiol levels and rapid declines in estradiol over time were associated with rapid increases in LUTS and rapid decreases in maximum flow rate. Lower baseline bioavailable testosterone levels and more rapid declines in bioavailable testosterone were associated with more rapid increases in prostate volume. These results suggest that both absolute sex steroid hormone levels and the rates at which the levels change may be important in the development of urologic conditions in aging men.

Objective: To determine whether statin use is associated with a decreased risk of developing benign prostatic enlargement (BPE) and lower urinary tract symptoms (LUTS)., Subjects and Methods: We conducted a retrospective, population-based cohort study of 2447 men, 40-79 years of age, residing in Olmsted County, MN, USA, in 1990, and followed these men biennially through 2007. Cox proportional hazard models were used to assess associations between statin use and new onset of moderate/severe LUTS (American Urological Association Symptom Index score >7), a decreased maximum urinary flow rate (<12 mL/s) or BPE (prostate volume >30 mL)., Results: Statin use was inversely associated with new onset of LUTS (Hazard ratio (HR) 0.39; 95% confidence interval (CI) 0.31-0.49), a decreased maximum flow rate (HR 0.53; 95% CI 0.34-0.82) and BPE (HR 0.40; 95% CI 0.23-0.69) after adjustment for baseline age and body mass index, diabetes, hypertension, coronary heart disease, smoking, alcohol use, activity level and non-steroidal anti-inflammatory use. The longest duration of statin use was associated with the lowest risk of developing each outcome (all tests for trend: P < 0.001)., Conclusion: In this study, statin use was associated with a 6.5- to 7-year delay in the new onset of moderate/severe LUTS or BPE. While men typically take statin medications to prevent coronary heart disease events and related outcomes, these data suggest that men who use statins may also receive urologic benefits., (© 2010 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. JOURNAL COMPILATION © 2010 BJU INTERNATIONAL.)

Objectives: To measure prostate volume doubling times (PVDTs) for a large sample of community men followed serially by transrectal ultrasonography (TRUS), and to determine whether specific characteristics are associated with a rapid PVDT., Subjects and Methods: A subsample of 446 subjects from a larger cohort of American white men aged 40-79 years were evaluated biennially for a median (range) follow-up of 10 (3-14) years. Mixed-effects regression models were used to estimate prostate growth rates and PVDT for subjects with three or more or with five or more serial biennial TRUS PV measurements., Results: The median (25-75th percentile) PVDT was 32.6 (24.6-44.0) years. The average annual increase in PV was 2.2%. The PVDT distribution was constant in men of all age groups studied (r < 0.001, P = 0.99). The factor most strongly associated with PVDT was baseline transition zone volume (r = -0.55, P < 0.001). Baseline total prostate-specific antigen (PSA) level, free PSA and total PV were also significantly inversely associated with PVDT (r = -0.30, -0.44 and -0.32, respectively, all P < 0.001). Age, baseline anthropomorphic measurements, hormone levels and specific lifestyle characteristics were not significantly correlated with PVDT., Conclusion: These data indicate that PVDT might be a useful future measure of benign prostatic growth. They provide a basis to forecast PV at 10, 20, or 30 years later, after one baseline TRUS measurement of prostate volume, and can be presented in a simple nomogram.

Purpose: Ultrasonically measured intravesical prostatic protrusion may be a promising noninvasive method of assessing bladder outlet obstruction. Previous investigations of this technique focused on patients with acute urinary retention and symptomatic men identified in urology clinics, which may not reflect the distribution of intravesical prostatic protrusion in community dwelling men., Materials and Methods: In 2006 a total of 322 white men residing in Olmsted County, Minnesota underwent transrectal ultrasound examination which permitted direct measurement of intravesical prostatic protrusion. Cross-sectional associations between lower urinary tract symptoms/benign prostatic enlargement and intravesical prostatic protrusion were measured. Rapid increases in lower urinary tract symptoms/benign prostatic enlargement measures as predictors of severe intravesical prostatic protrusion were also assessed., Results: Overall 10% of these men had an intravesical prostatic protrusion of 10 mm or greater. Greater intravesical prostatic protrusion was weakly correlated with greater prostate volume (r(s) = 0.28), higher obstructive symptoms (r(s) = 0.18) and lower peak urinary flow rate (r(s) = -0.18). Men with the most rapidly growing prostate before intravesical prostatic protrusion measurement were 3 times more likely to have an intravesical prostatic protrusion of 10 mm or greater. Men with an intravesical prostatic protrusion of 10 mm or greater were more likely to use medications for lower urinary tract symptoms/benign prostatic enlargement compared to those with an intravesical prostatic protrusion less than 10 mm (adjusted OR 2.95, 95% CI 1.23-7.06)., Conclusions: These population based data provide reference ranges for future studies of intravesical prostatic protrusion as a predictor of adverse urological outcomes. Intravesical prostatic protrusion is significantly correlated with greater prostate volume, higher obstructive symptoms and lower peak urinary flow rate, suggesting that it may have clinical usefulness in predicting the need for treatment.

OBJECTIVE To determine the normal values for the presumed circle area ratio (PCAR) in a group of community-based men, and to determine whether PCAR is associated with specific urological outcomes. PATIENTS AND METHODS The study was a cross-sectional analysis among 328 Caucasian men (94% participation) residing in Olmsted County, Minnesota, USA. The PCAR was measured during prostatic ultrasonography. Lower urinary tract symptoms (LUTS) were measured using the American Urologic Association Symptom Index. The peak urinary flow rate was measured by a uroflowmeter, and the postvoid residual volume (PVR) was assessed using the BladderScan(TM) BVM 6500 (Verathon, Bothell, WA, USA). Correlations between PCAR and presence of LUTS, peak urinary flow rate, and PVR were determined using Spearman correlation coefficients. Unadjusted and adjusted odds ratios (ORs) were calculated using logistic regression to determine the associations between PCAR thresholds and categorical urological outcomes. RESULTS The median (interquartile range) PCAR was 0.85 (0.81-0.88). After adjusting for age and total prostate volume, men who had PCARs of >0.90 were more likely to have elevated overall and obstructive symptom scores (OR 2.95, 95% confidence interval 1.39-6.25, and 3.47, 1.63-7.39, respectively). CONCLUSION PCAR might add further information beyond total prostate volume when predicting the development of obstructive LUTS.

Inflammation may play a role in the development of benign prostatic hyperplasia and/or lower urinary tract symptoms (LUTS). Higher levels of C-reactive protein (CRP) may therefore be associated with the development of these outcomes. The authors examined the association of CRP levels measured in 1996 with rapid increases in prostate volume, prostate-specific antigen levels, and LUTS as well as rapid decreases in peak flow rates (through 2005) in a population-based cohort of men residing in Olmsted County, Minnesota. Men with CRP levels of > or =3.0 mg/L were more likely to have rapid increases in irritative LUTS (odds ratio (OR) = 2.14, 95% confidence interval (CI): 1.18, 3.85) and rapid decreases in peak flow rates (OR = 2.54, 95% CI: 1.09, 5.92) compared with men with CRP levels of <3.0 mg/L. CRP levels were not significantly associated with rapid increases in prostate volume, obstructive LUTS, or prostate-specific antigen levels. Associations were attenuated after adjusting for age, body mass index, hypertension, and smoking history (irritative LUTS: OR = 2.00, 95% CI: 1.04, 3.82; peak flow rate: OR = 2.45, 95% CI: 0.73, 8.25). These results suggest that rapid increases in irritative LUTS and rapid decreases in peak flow rates may be due to inflammatory processes.

Background: Previous reports have suggested an inverse relationship between smoking and surgery for benign prostatic hyperplasia (BPH). We hypothesized that acute urinary retention (AUR), an adverse outcome of this disease and indication for surgical treatment, may be related to smoking., Methods: Study subjects were randomly selected from Olmsted County men aged 40-79 identified through the Rochester Epidemiology Project. Of the 3,854 eligible men, 2,089 (54%) completed a questionnaire that included the American Urological Association Symptom Score and assessed smoking status. Community medical records were examined for occurrence of AUR with documented catheterization in the subsequent 10 years and occurrence of BPH surgery. Proportional hazard models were used to assess the relationship between baseline smoking status and subsequent retention., Results: In the 18,307 person-years of follow-up, 114 men had AUR. When compared to 727 never-smokers, there was a trend among the 336 current smokers to be at lower risk (Relative risk (RR) = 0.62, 95% Confidence Interval (CI) = 0.33, 1.18) whereas the 1,026 former smokers were at similar risk to non-smokers (RR = 1.0, 95%CI = 0.67, 1.46). Among men with moderate-severe symptoms at baseline, current smokers were at lower risk of retention compared to non-smokers (RR = 0.65, 95%CI = 0.22, 1.91) but the association approached the null among those with none-mild symptoms (RR = 0.91, 95% CI = 0.40, 2.06)., Conclusions: Community-dwelling men who currently smoke may be at a modestly reduced risk of AUR. The magnitude of this association is sufficiently small that it seems unlikely that this explains a sizable proportion of the inverse association between smoking and surgically treated BPH., (2009 Wiley-Liss, Inc.)

Objectives: To determine whether physician-diagnosed prostatitis was associated with later development of benign prostatic hyperplasia (BPH)-associated events in a longitudinal, population-based sample of 2447 men residing in Olmsted County, Minnesota., Methods: Medical records were reviewed for physician diagnosis of prostatitis and subsequent diagnoses of BPH, enlarged prostate, prostatism, and acute urinary retention. Records were also reviewed for medical or surgical treatments for BPH. Odds ratios were calculated to assess the associations between physician-diagnosed prostatitis and later development of development of BPH-associated events., Results: Physician-diagnosed prostatitis was associated with a 2.4-fold increased odds of receiving a later diagnosis of prostatism, enlarged prostate, or BPH (OR: 2.44, 95% CI: 1.48, 4.01). Prostatitis was also associated with a 70% increased odds of requiring later treatment for BPH (OR: 1.69, 95% CI: 1.28, 2.22), and a non-significant increased odds of acute urinary retention (OR: 1.33, 95% CI: 0.89, 1.99)., Conclusions: Physician-diagnosed prostatitis was associated with an increased risk of later onset of several BPH-associated events. Physician-diagnosed prostatitis may therefore be an early marker or a risk factor for development of later prostatic or urologic problems.

In 1990-2002, the authors conducted a population-based cohort study of 2,447 Caucasian men in Olmsted County, Minnesota, to determine whether daily users of nonsteroidal antiinflammatory drugs (NSAIDs) were at lower risk than nondaily NSAID users of developing benign prostatic hyperplasia. Participants completed validated questionnaires during a home visit, including information about daily NSAID use. A random subset of 634 men also participated in a clinical evaluation including transrectal ultrasonography and assessment of serum prostate-specific antigen levels. Examinations and questionnaires were repeated biennially through 2002. Benign prostatic hyperplasia measures included development of moderate/severe urinary symptoms (American Urological Association Symptom Index score >7), low maximum urinary flow rate (<12 ml/second), prostate volume >30 ml, or prostate-specific antigen level >1.4 ng/ml. After adjustment for age, daily NSAID use was inversely associated with onset of moderate/severe urinary symptoms (hazard ratio (HR) = 0.73, 95% confidence interval (CI): 0.64, 0.82), low maximum flow rate (HR = 0.51, 95% CI: 0.43, 0.61), increased prostate volume (HR = 0.53, 95% CI: 0.41, 0.68), and elevated prostate-specific antigen level (HR = 0.52, 95% CI: 0.40, 0.68). In age-specific analyses, inverse associations between NSAID use and urinary measures tended to be stronger in the oldest age groups, although this interaction was statistically significant for only obstructive symptoms and treatment. Results suggest that NSAID use may prevent or delay development of benign prostatic hyperplasia.

Objective: To determine whether measures of transitional zone volume (TZV) are more strongly associated than total prostate volume with longitudinal urologic outcomes., Methods: In 1990, 2,115 randomly selected Caucasian men from Olmsted County, Minnesota (USA) completed validated questionnaires during a home visit. A 25% subsample underwent clinical evaluation that included transrectal ultrasonography, assessment of serum prostate-specific antigen levels, and maximum urinary flow rates. Examinations and questionnaires were repeated biennially through 2004. TZV measures were taken at the fifth through eighth visits. Men with at least one TZV measurement were included in this study (n=336)., Results: Changes in TZV correlated weakly with changes in peak urinary flow rate and urinary symptoms. After accounting for age and change in total prostate volume, change in TZV added no information to models that predict changes in urinary symptoms and peak urinary flow rates. Men who experienced the most rapid annual changes in TZV were not more likely to experience more rapid changes in urinary symptoms or maximum flow rate., Conclusion: Tracking changes in TZV over time may be unlikely to provide a good surrogate measure for the development of benign prostatic hyperplasia.

Purpose: We characterized how longitudinal changes in PSA, prostate size, maximum urinary flow rates and lower urinary tract symptoms track together over time., Materials and Methods: In 1990, 2,115 white men, randomly selected from the Olmsted County, Minnesota population, completed validated questionnaires during a home visit by a study assistant. A 25% random subsample underwent clinical evaluation including transrectal ultrasonography, serum PSA and assessment of maximum urinary flow rates. Examinations and questionnaires were repeated biennially through 2002. Longitudinal changes in these measurements were estimated with 2-stage models. Annualized changes were correlated and also dichotomized at various percentiles and examined in age adjusted logistic regression models predicting symptom increases in the upper 80th percentile., Results: Correlations between changes in prostate volume, PSA levels, maximum flow rates and urinary symptoms were modest (age adjusted Spearman correlation coefficients: volume and symptoms 0.08, p = 0.06; PSA and symptoms 0.06, p = 0.20; maximum flow rate and symptoms -0.08, p = 0.05). However, PSA and prostate volume annual increases in the upper 80th percentile were each associated with an approximately 2-fold increased risk of symptom changes in the upper 80th percentile. As PSA and prostate volume changes increased from the 50th to the 90th percentiles, the odds of having symptoms in the upper 80th percentile also increased., Conclusions: While overall correlations among changes in each of these variables were modest, men with more rapid annual increases in PSA levels and prostate volumes were also likely to have more rapid increases in urinary symptoms.