Thomas Rhodes

Natural History of Prostatism: Risk Factors for Acute Urinary Retention

PURPOSE We determined the occurrence of and risk factors for acute urinary retention in the community setting. MATERIALS AND METHODS A cohort of 2,115 men 40 to 79 years old was randomly selected from an enumeration of the Olmsted County, Minnesota population (55% response rate). Participants completed a previously validated baseline questionnaire that assessed symptom severity, and voided into a portable urometer to measure peak urinary flow rates. A 25% random subsample underwent transrectal sonographic imaging of the prostate to determine prostate volume. Followup was performed through a retrospective review of community medical records to determine the occurrence of acute urinary retention in the subsequent 4 years. RESULTS During the 8,344 person-years of followup 57 men had a first episode of acute urinary retention (incidence 6.8/1,000 person-years, 95% confidence interval [CI] 5.2, 8.9). Among men with no to mild symptoms (American Urological Association symptom index score 7 or less) the incidence of acute urinary retention increased from 2.6/1,000 person-years among men 40 to 49 years old to 9.3/1,000 person-years among men 70 to 79 years old. By contrast, rates increased from 3.0/1,000 person-years for men 40 to 49 years old to 34.7/1,000 person-years among men 70 to 79 years old among men with moderate to severe symptoms (American Urological Association symptom index score greater than 7). Men with depressed peak urinary flow rate (less than 12 ml. per second) were at 4 times the risk of acute urinary retention compared with men with urinary flow rates greater than 12 ml. per second (95% CI 2.3, 6.6). Men with an enlarged prostate (greater than 30 ml.) experienced a 3-fold increase in risk (95% CI 1.0, 9.0, p = 0.04). CONCLUSIONS Lower urinary tract symptoms, depressed peak urinary flow rates, enlarged prostates and older age are associated with an increased risk of acute urinary retention in community dwelling men. These findings may help to identify men at increased risk of acute urinary retention in whom closer evaluation may be warranted.

Metabolic Syndrome and 10-Year Cardiovascular Disease Risk in the Hoorn Study

Background—Different definitions of the metabolic syndrome have been proposed. Their value in a clinical setting to assess cardiovascular disease (CVD) risk is still unclear. We compared the definitions proposed by the National Cholesterol Education Program Adult Treatment Panel III (NCEP), World Health Organization (WHO), European Group for the Study of Insulin Resistance (EGIR), and American College of Endocrinology (ACE) with respect to the prevalence of the metabolic syndrome and the association with 10-year risk of fatal and nonfatal CVD. Methods and Results—The Hoorn Study is a population-based cohort study. The present study population comprised 615 men and 749 women aged 50 to 75 years and without diabetes or a history of CVD at baseline in 1989 to 1990. The prevalence of the metabolic syndrome at baseline ranged from 17% to 32%. The NCEP definition was associated with about a 2-fold increase in age-adjusted risk of fatal CVD in men and nonfatal CVD in women. For the WHO, EGIR, and ACE definitions, these hazard ratios were slightly lower. Risk increased with the number of risk factors. Elevated insulin levels were more prevalent in subjects with multiple risk factors, but metabolic syndrome definitions including elevated insulin level were not more strongly associated with risk. Conclusions—The metabolic syndrome, however defined, is associated with an approximate 2-fold increased risk of incident cardiovascular morbidity and mortality in a European population. In clinical practice, a more informative assessment can be obtained by taking into account the number of individual risk factors.

Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations

UNLABELLED Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains and measures that should be considered in clinical trials of treatments for acute and chronic pain in children and adolescents. Consensus was refined by consultation with the international pediatric pain community through announcement of our recommendations on the Pediatric Pain List and inviting and incorporating comments from external sources. There was consensus that investigators conducting pediatric acute pain clinical trials should consider assessing outcomes in pain intensity; global judgment of satisfaction with treatment; symptoms and adverse events; physical recovery; emotional response; and economic factors. There was also agreement that investigators conducting pediatric clinical trials in chronic and recurrent pain should consider assessing outcomes in pain intensity; physical functioning; emotional functioning; role functioning; symptoms and adverse events; global judgment of satisfaction with treatment; sleep; and economic factors. Specific measures or measurement strategies were recommended for different age groups for each domain. PERSPECTIVE Based on systematic review and consensus of experts, core domains and measures for clinical trials to treat pain in children and adolescents were defined. This will assist in comparison and pooling of data and promote evidence-based treatment, encourage complete reporting of outcomes, simplify the review of proposals and manuscripts, and facilitate clinicians making informed decisions regarding treatment.

Insulin-like Growth Factor I, Insulin-like Growth Factor Binding Protein 3, and Urologic Measures of Benign Prostatic Hyperplasia

Laboratory studies suggest that insulin-like growth factor I (IGF-I) promotes prostatic growth. The authors evaluated the association between benign prostatic hyperplasia and IGF-I and its binding protein IGFBP-3 in community-dwelling men to determine whether this laboratory finding is manifest at the population level. Participants (n = 471) were Olmsted County, Minnesota, Caucasian males aged 40-79 years in 1990. Urologic measures were assessed from the International Prostate Symptom Score, peak urinary flow rates, prostate volume, and serum prostate-specific antigen (PSA), and serum IGF-I and IGFBP-3 levels were measured. After adjustment for age, the relative odds (odds ratios) of an abnormal urologic measure in men with high versus low serum IGF-I levels were 0.98 (95% confidence interval (CI): 0.66, 1.45) for a symptom score of >7, 1.14 (95% CI: 0.72, 1.80) for a peak urinary flow rate of <12 ml/second, 1.11 (95% CI: 0.72, 1.72) for a prostate volume of >30 ml, and 0.71 (95% CI: 0.46, 1.09) for a PSA level of >1.4 ng/ml. A low IGFBP-3 level was associated with an enlarged prostate (odds ratio = 1.72, 95% CI: 1.05, 2.82), after simultaneous adjustment for IGF-I and age, but not with other urologic measures. These data do not provide evidence for an association between benign prostatic hyperplasia and serum IGF-I.

Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations.

&NA; There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected. These findings could reflect a true lack of efficacy or methodological and other aspects of these trials that compromise the demonstration of efficacy. There is substantial variability among chronic pain clinical trials with respect to important research design considerations, and identifying and addressing any methodological weaknesses would enhance the likelihood of demonstrating the analgesic effects of new interventions. An IMMPACT consensus meeting was therefore convened to identify the critical research design considerations for confirmatory chronic pain trials and to make recommendations for their conduct. We present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials. Increased attention to and research on the methodological aspects of confirmatory chronic pain clinical trials has the potential to enhance their assay sensitivity and ultimately provide more meaningful evaluations of treatments for chronic pain.

Longitudinal prostate growth rates during 5 years in randomly selected community men 40 to 79 years old.

PURPOSE We estimate the rate of prostate growth in randomly selected healthy community dwelling men. MATERIALS AND METHODS Prostate volume in an age stratified random sample of 631 white male residents of Olmsted County, Minnesota 40 to 79 years old without prior prostate surgery or prostate cancer was measured up to 4 times by transrectal ultrasound during a followup period of almost 7 years. RESULTS Estimated prostate growth rates increased with increasing age. However, the estimated average annual change was 1.6% across all age groups. Estimated prostate growth rates were high depending on baseline prostate volume with higher growth rates for men with larger prostates. CONCLUSIONS While there is wide variability in prostate growth rates on an individual level, prostate volume appears to increase steadily at about 1.6% per year in randomly selected community men.

A Population-Based Study of Daily Nonsteroidal Anti-inflammatory Drug Use and Prostate Cancer

OBJECTIVE To investigate the association between daily use of nonsteroidal anti-inflammatory drugs (NSAIDs) and prostate cancer. PATIENTS AND METHODS Subjects were 50- to 79-year-old white men randomly selected in January 1990 from the Olmsted County, Minnesota, community (n=1362) from among participants in a longitudinal study of lower urinary tract symptoms. At the beginning of the study, all medications that were used daily, including prescription and nonprescription NSAIDs, were ascertained by trained interviewers. Men who developed a histologically proved diagnosis of prostate cancer during a median of 66 months (maximum, 6 years) of follow-up were identified from a complete review of the community medical record. RESULTS Twenty-three (4%) of 569 NSAID users and 68 (9%) of 793 nonusers developed prostate cancer during follow-up (P=.001). The relative odds of prostate cancer were 0.45 (95% confidence interval [CI], 0.28-0.73) in NSAID users compared with nonusers. This inverse association with NSAID use increased with increasing age at study onset. Thus, the relative odds of prostate cancer among NSAID users were 0.9 (95% CI, 0.4-2.2) in men aged 50 to 59 years, 0.4 (95% CI, 0.2-0.8) in men aged 60 to 69 years, and 0.2 (95% CI, 0.1-0.5) in men aged 70 to 79 years compared with similarly aged men who did not use NSAIDs. CONCLUSION The study findings suggest that daily use of NSAIDs may be associated with a lower incidence of prostate cancer in men aged 60 years or older. The stronger effect among older men suggests that NSAIDs may prevent the progression of prostate cancer from latent to clinical disease.

TREATMENT FOR BENIGN PROSTATIC HYPERPLASIA AMONG COMMUNITY DWELLING MEN: THE OLMSTED COUNTY STUDY OF URINARY SYMPTOMS AND HEALTH STATUS

PURPOSE We describe treatments for benign prostatic hyperplasia (BPH) among men participating in the Olmsted County study of urinary symptoms and health status among men during 10,000 person-years of followup. MATERIALS AND METHODS A cohort of 2,115 men 40 to 79 years old was randomly selected from an enumeration of the Olmsted County, Minnesota population (55% response rate). Participants completed a previously validated baseline questionnaire to assess symptom severity and voided into a portable urometer. A 25% random subsample underwent transrectal sonographic imaging of the prostate to determine prostate volume and measurement of serum prostate specific antigen. Followup included retrospective review of community medical records and completion of a biennial questionnaire to determine the occurrence of medical and surgical treatment for BPH in the subsequent 6 years. RESULTS During more than 10,000 person-years of followup 167 men were treated, yielding an overall incidence of 16.0/1,000 person-years. There was a strong age related increase in risk of any treatment from 3.3/1,000 person-years for men 40 to 49 years old to more than 30/1,000 person-years for those 70 years old or older. Men with moderate to severe symptoms (American Urological Association symptom index greater than 7), depressed peak urinary flow rates (less than 12 ml. per second), enlarged prostate (greater than 30 ml.) or elevated serum prostate specific antigen (1.4 ng./ml. or greater) had about 4 times the risk of BPH treatment than those who did not. After adjustment for all measures simultaneously an enlarged prostate (hazard ratio 2.3, 95% confidence interval [CI] 1.1, 4.7), depressed peak flow rate (hazard ratio 2.7, 95% CI 1.4, 5.3) and moderate to severe symptoms (hazard ratio 5.3, 95% CI 2.5, 11.1) at baseline each independently predicted subsequent treatment. CONCLUSIONS While repeat contact and availability of urological measurements during the study period may have influenced treatment decisions in this cohort, the data demonstrate that treatment is common in elderly men with nearly 1 in 4 receiving treatment in the eighth decade of life. Furthermore, these data suggest that men with moderate to severe lower urinary tract symptoms, impaired flow rates or enlarged prostates are more likely to undergo treatment, with increases in risk of similar magnitude to those associated with adverse outcomes, such as acute urinary retention.

Correlation between prostate size estimated by digital rectal examination and measured by transrectal ultrasound

OBJECTIVES To correlate prostate size estimates performed by single or multiple examiners through digital rectal examination (DRE) with volume measured by transrectal ultrasound (TRUS) and to propose measures for predicting prostate volume using DRE estimates in clinical settings. METHODS Data from four sources were analyzed: (1) the Olmsted County community study of 397 patients examined by a single urology nurse, with TRUS measurements done by multiple examiners; (2) a community study in Stirling, Scotland, involving 480 patients with DRE and TRUS performed by one urologist; (3) baseline data from the Veterans Affairs Cooperative Study No. 359 in 1222 patients with DRE and TRUS measurements by multiple personnel at 31 centers; and (4) a clinical series of 100 men with DRE and TRUS by a single urologist. RESULTS DRE estimates and TRUS volumes were significantly correlated (r = 0.4 to 0.9), but prostate size was underestimated by 25% to 55% for men with a prostate volume over 40 mL, depending on the study, with greater variability for studies involving multiple examiners. In one study that assessed prostate dimensions by DRE, posterior surface area (SA) correlated with overall TRUS volume (r = 0.4). According to receiver operating characteristic curves, SA showed a 70% and 76% chance of correctly identifying men with prostate volume greater than 30 or 40 mL, respectively; those with larger prostates were best distinguished by SA greater than 7 cm2 (sensitivity greater than 0.74, specificity greater than 0.50). CONCLUSIONS DRE underestimates prostate size, particularly if TRUS volume is greater than 30 mL. However, DRE estimates may help identify prostates likely to be larger than certain cutpoints by TRUS. Posterior SA may be useful as a preliminary assessment when prostate size is an important predictor of therapeutic response.

Sexual Function of Men Ages 40 to 79 Years: The Olmsted County Study of Urinary Symptoms and Health Status Among Men

OBJECTIVES: Knowledge of male sexual function is somewhat limited because of a lack of current population‐based data. This study provides information on sexual function and satisfaction in a population‐based sample of men.