The incidence of acute urinary retention secondary to BPH is increasing among California men

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1 Prostate Cancer and Prostatic Disease (2013) 16, & 2013 Macmillan Publishers Limited All rights reserved /13 ORIGINAL ARTICLE The incidence of acute urinary retention secondary to BPH is increasing among California men HK Groves 1,2, D Chang 1,3, K Palazzi 1, S Cohen 1 and JK Parsons 1 BACKGROUND: Current epidemiological patterns of adverse events of clinical BPH remain unclear. We investigated trends in acute urinary retention (AUR) associated with BPH in a large, population-based cohort. METHODS: We utilized the California Office of Statewide Health Planning and Development Database to examine emergency room (ER) visits in California among men aged X 50 years from 2007 to Outcomes included AUR for which BPH was the primary diagnosis, AUR for which BPH was a secondary diagnosis and urethral catheterization for AUR. We generated adjusted odds ratios (OR adj ) using multivariate logistic regression to determine longitudinal trends. RESULTS: A total of men presented with a diagnosis of BPH-associated AUR, the unadjusted incidence of which increased from 4.00 per 1000 ER visits in 2007 to 5.23 per 1000 ER visits in 2010 (Po0.001). In adjusted analyses, primary AUR (OR adj ¼ 1.25; 95% confidence interval (CI), ; Po0.001) and secondary AUR (OR adj ¼ 1.80; 95% CI, ; Po0.001) increased 25% and 80%, respectively. Urethral catheterization for primary (OR adj ¼ 1.30; 95% CI, ; Po0.001) and secondary (OR adj ¼ 1.82; 95% CI, ; Po0.001) AUR increased 30% and 82%, respectively. Asian race (Po0.001), Hispanic race (Po0.001) and commercial insurance (Po0.001) were associated with significantly increased risks of AUR and urethral catheterization. CONCLUSIONS: Between 2007 and 2010, the observed incidence of BPH-associated AUR increased substantially in a large and ethnically diverse male population of the United States. Prostate Cancer and Prostatic Disease (2013) 16, ; doi: /pcan ; published online 7 May 2013 Keywords: urinary retention; BPH; incidence; lower urinary tract symptoms; a-blocker; five a-reductase inhibitor INTRODUCTION Clinical BPH affects as many as 75% of men by age 70 years and generates at least $4 billion in treatment costs annually in the United States. 1,2 Clinical BPH usually presents with lower urinary tract symptoms (LUTS), which in older men are independently associated with increased risks of mortality, falls and diminished quality of life. 3 6 Sequelae of advanced BPH, including acute urinary retention (AUR) and renal failure, are associated with significantly increased morbidity and mortality. 7 The most common treatment for BPH is oral therapy. 2 Oral therapy is highly effective for alleviating LUTS and decreasing the risks of AUR, urinary infection, surgery and renal failure. 8,9 The advent of oral therapy transformed BPH from a surgical disease into a chronic medical condition and coincided with a decreased population incidence of adverse events secondary to BPH. 2 However, formal Phase 4 studies of a-blocker and five a-reductase inhibitor therapy were not performed, and longerterm epidemiological trends in adverse events of BPH during the oral therapy era remain unclear. 10 Notably, recent epidemiological data suggest that adverse events of BPH have either increased or persisted in hospitalized patients over the past decade. An analysis of the Nationwide Inpatient Sample observed that hospitalizations in the United States for acute renal failure secondary to BPH increased more than 400% between 1998 and 2008; concomitantly, the frequency of hospitalizations for AUR and urinary infection remained stable. 11 Diagnosis and treatment for BPH occurs primarily in the outpatient setting. 2 Further epidemiological studies of adverse events of BPH identified in outpatient venues, therefore, would inform BPH treatment and health policy by providing insight into current population trends in BPH severity. AUR, which occurs in B3% of BPH patients followed for 5 years, 8 is a readily measurable outcome and a robust marker of advanced BPH. Therefore, we evaluated trends in the incidence of AUR among men with BPH presenting to California emergency rooms (ERs). MATERIALS AND METHODS Study population: the California Office of Health Planning and Development ER database The State of California Office of Statewide Health Planning and Development (Healthcare Quality and Analysis Division) provides ER discharge data for the years The State of California government requires all licensed ERs to submit data on all discharged patients every 6 months. These records thus comprise a 100% sample of all non-federal (that is, non-veterans Administration) ER discharges in the state of California. All data are de-identified and include demographic information, including age, gender, race, information on primary and concomitant diagnoses recorded and procedures performed, discharge information (for example, hospital admission and death) and administrative information (for example, payer information). As individual patients are not identified in this multicenter registry report, the need for consent and institutional review board approval was waived at the University of California San Diego. 1 Division of Urologic Oncology, Section of Urology, Department of Surgery, UC San Diego Moores Cancer Center, VA San Diego Medical Center, La Jolla, CA, USA; 2 University of California, San Diego School of Medicine, La Jolla, CA, USA and 3 UC San Diego Health System, San Diego, CA, USA. Correspondence: Dr JK Parsons, Division of Urologic Oncology, UC San Diego Moores Cancer Center, 3855 Health Sciences Drive 0987, La Jolla, CA , USA. k0parsons@ucsd.edu Received 14 January 2013; revised 20 February 2013; accepted 23 February 2013; published online 7 May 2013

2 Case selection We performed a cross-sectional analysis from 2007 to 2010 for men X 50 years of age and identified BPH patients using ICD-9 codes ( , and ). We used ICD-9 codes , and for urinary retention. We excluded men with a diagnosis of urinary strictures (598.8), neurogenic bladder (344.61, ), presence of neuropacemaker or other electronic device (V45.89), bladder cancer ( , V10.51), prostate cancer (185, V10.46) and kidney cancer (189.0, V10.52). We began our analysis in 2007 to avoid potential confounding from a diagnostic coding change for BPH that occurred in October Outcomes: AUR and urethral catheterization The primary outcomes were BPH-associated AUR and urethral catheterization for BPH-associated AUR. We classified AUR into two different categories to distinguish encounters for which BPH was the presenting problem from those in which BPH occurred in the setting of another disorder. Primary AUR (BPH was the presenting problem) consisted of a primary code of AUR with an associated BPH code in a secondary position or a primary code of BPH with an associated AUR code in a secondary position. Secondary AUR (BPH occurred with another disorder) consisted of AUR and BPH codes in secondary positions. To examine urethral catheterization, we identified urinary catheter insertion occurring with primary and secondary AUR using CPT codes 51701, and for insertion of urethral catheter. Exposure variables included insurance status, race, age and diabetes mellitus (identified by ICD-9 code ). We determined three categories for insurance status based on the expected source of payment variable: commercial insurance, Medicare and limited (which included Medicaid and other assistance programs). Statistical analysis We tested statistical significance of the outcome variable for bivariate analysis using w 2 -test and two-tailed significance of Pp0.05. Demographic variables were compared with ER patients without BPH-associated AUR and between primary AUR and secondary AUR. Median age was compared using Mann Whitney s U-test. We performed multivariate analysis using binary logistical regression adjusted for age, race, diabetes and insurance status, and was expressed as the odds ratio with 95% confidence interval (CI). We determined the significance of the year-to-year trend using a linear time model and expressed as P-trend. The year-to-year trend in AUR incidence among subsets of Black, White, Asian and Hispanic men with commercial insurance and men with limited insurance were compared using multivariate logistic regression to assess for homogeneity. We also compared year-to-year trends in primary AUR incidence with secondary AUR incidence among elderly patients (older than 85 years) and younger patients (age years) to examine the relationship between age and AUR subtype. All analyses were performed using Stata v 11.1 (StataCorp, College Station, TX, USA). RESULTS Analytic cohort We included ER visits in this analysis (Figure 1). The median age of the final analytic cohort was 61 years (interquartile range 54 73). Men with primary AUR (median 74 years, interquartile range 64 82, Po0.001) and secondary AUR (median 75 years, interquartile range 65 83, Po0.001) were significantly older than men without AUR. Of all ER visits during the period of study, 0.46% included a diagnosis of BPH-associated AUR. The incidence of AUR steadily increased from 2007 to 2010 (Table 1). Primary AUR occurred four times as often as secondary AUR. Compared with non-aur ER encounters, men with AUR were less likely to be Black, more likely to be Hispanic and more likely to be insured by Medicare (Table 1). Acute urinary retention On multivariate analysis, there was a 36% increase in the incidence of overall AUR in 2010 compared with that in The incidence of primary AUR increased 25%, whereas the incidence of Eligible (n= 3,839,108) --Men > 50 years old presenting to the ER Analyzed (n= 3,724,016) Excluded (n=115,092) -- Neurogenic bladder (n= 1,928) -- Malignant neoplasm of bladder, kidney, or prostate (n= 25,126) -- History of malignancy of bladder, kidney or prostate (n= 52,726) -- Urethral stricture (n= 303) -- Post procedure state (n= 37,454) Figure 1. Composition of the analytic cohort: the California Office of Statewide Health Planning and Development (OSHPD) emergency room (ER) database, secondary AUR increased 80%. Variables associated with increased risk of AUR included older age, Hispanic and Asian race and commercial insurance. Diabetes was associated with decreased risk of overall, primary and secondary AUR (Table 2). Urethral catheterization Primary AUR and secondary AUR were associated with urethral catheterization in 64% and 44% of cases, respectively. On multivariate analyses, there were significant increases in the incidence of urethral catheterization for primary (30%) and secondary (82%). Older age, Hispanic and Asian race and commercial insurance were associated with increased risk; diabetes and African American race was associated with decreased risk (Table 3). Sensitivity analyses To examine potential residual confounding by age, we performed subset analyses to examine the increase of primary and secondary AUR among the elderly. Among men older than 85 years, the incidence of primary AUR increased 22% (adjusted odds ratio (OR adj ¼ 1.22; 95% CI, ), whereas the incidence of secondary AUR increased 201% (OR adj ¼ 2.01; 95% CI, ). Findings among the youngest age category men aged years were similar to those for the primary analysis (data not shown). We also performed sensitivity analyses to test for homogeneity of the trend in increasing incidence of AUR among demographic subsets. There were no significant differences in the rates of increased incidence among Black and White race or among limited and commercial insurance (data not shown). DISCUSSION In this study, one of the largest population analyses to date of BPH complications, we observed substantial increases in both incident AUR and urethral catheterization for AUR among a large and ethnically diverse male population of the United States. Commercial insurance coverage and Hispanic and Asian race were each associated with increased risks of AUR and urethral catheterization. Collectively, our results suggest that the incidence of BPHassociated AUR is increasing in California and, consistent with recent data among BPH patients hospitalized for acute renal failure, 11 could indicate a rising incidence and prevalence of clinically advanced BPH in the US population. Prior studies of longitudinal trends in AUR indicated a decreasing incidence from the 1990s through the early 2000s; after 2000, rates generally stabilized. From 1994 to 2000, according to observational data from the Urologic Diseases of America Project, the number of men presenting to ERs with BPH as the primary diagnosis decreased by 34%. 2 Similarly, the 261 & 2013 Macmillan Publishers Limited Prostate Cancer and Prostatic Disease (2013),

3 262 Table 1. Characteristics of men presenting to non-federal California ERs with and without BPH-associated AUR: the California OSHPD ER database, Demographics of analytic cohort Total ER patients All AUR Primary AUR Secondary AUR Variable N (%) N/1000 ER visits N/1000 ER visits N/1000 ER visits Calendar year Age (%), years (58.8) 1.92 (24.8) a 1.58 (26.5) a 0.35 (19.2) a,b (18.8) 7.44 (30.5) 5.92 (31.7) 1.52 (26.7) (14.8) 9.14 (29.6) 6.85 (28.9) 2.29 (31.7) 85 þ (7.7) 9.03 (15.2) 5.91 (12.9) 3.12 (22.5) Race (%) White (64.2) 4.44 (61.3) a 3.33 (60.1) a 1.11 (64.9) a,b Black (10.4) 2.72 (6.08) 2.06 (6.0) 0.66 (6.2) Hispanic (18.0) 5.71 (22.1) 4.44 (22.5) 1.27 (20.7) Asian (4.1) 7.61 (6.7) 6.31 (7.3) 1.30 (4.8) Other (3.4) 5.37 (3.9) 4.28 (4.1) 1.10 (0.1) Insurance (%) Limited (28.4) 2.29 (14.0) a 1.83 (14.7) a 0.46 (11.9) a,b Commercial (27.8) 3.55 (21.3) 2.86 (22.5) 0.69 (17.6) Medicare (43.8) 6.84 (64.6) 5.09 (62.9) 1.75 (70.4) Diabetes Mellitus (%) (13.9) 3.89 (11.9) a 2.81 (11.2) a 1.08 (14.1), NS b Urethral Catheter (%) (2.4) (58.9) a (63.6) a (43.6) a,b Abbreviations: AUR, acute urinary retention; ER, emergency room; OSHPD, Office of Statewide Health Planning and Development; NS, not significant. a w 2 -Test comparing AUR subtype with ER patients without BPH-associated AUR. Significant Po0.001 level. b w 2 -Test comparing primary AUR with secondary AUR. Significant Po0.001 level. Hospital Episode Statistics database in England showed that primary AUR incidence decreased by 7% between 1998 and 2003 although, notably, the incidence of recurrent AUR increased by 20%. 12 Finally, between 1998 and 2008, hospitalizations for AUR in the United States remained stable. 11 Although Canadian investigators observed a substantial rise in the percentage of TURP patients presenting with AUR from 1988 (22.9%) to 2008 (42.9%), this result most likely reflected changes in the types of patients undergoing TURP rather than changes in population incidence. 13 To the best of our knowledge the present analysis is the first to describe incident AUR after 2008 and, within the context of prior studies, suggests a U-shaped AUR incidence curve with a steady decrease in the 1990s, a nadir in the early 2000s and a substantial increase after There are at least three potential explanations for these observations. First, these data could indicate an increase in the number of men with clinically advanced BPH, possibly resulting from the aging population. Alternatively, increasing numbers of BPH patients may now be presenting with clinically advanced disease after prolonged medical suppression of LUTS. The rapid transition to medical therapy during the 1990s occurred in the absence of randomized clinical trials comparing surgery with medication, models analyzing the import such a paradigm shift might have on future BPH population trends, or longer-term Phase 4 studies of medication utilization in a community. 10 A large proportion of BPH patients now undergo treatment in the primary care setting, and most of these patients receive a-blocker monotherapy. 14,15 Both the Medical Therapy of Prostate Symptoms and a combination of Avodart and Tamsulosin trials demonstrated that a-blocker monotherapy is inferior to five a-reductase inhibitor alone or to combination therapy in preventing AUR, 8,9 and five a-reductase inhibitor prescription rates are inversely and a-blocker prescription rates are directly associated with risk of BPH surgery. 16 It is possible that a-blocker monotherapy masks LUTS while allowing for subclinical biological progression, delaying the clinical onset of late-stage BPH without altering its longer-term natural history or reducing the overall incidence of adverse sequelae. The positive association of commercial insurance coverage with increased risk of AUR in this cohort supports this interpretation; patients with commercial insurance coverage presumably had greater access to oral BPH medications. Second, rather than reflecting actual changes in AUR incidence, these data may instead indicate alterations in claimsbased diagnostic coding aimed at increasing reimbursements. 17,18 As the similar patterns in AUR and urethral catheterization suggest cases in which bladder drainage was clinically indicated, temporal changes in claims-based data would likely represent a correction in rather than a misrepresentation of estimates of actual disease prevalence, with providers submitting claims (that is, for urethral catheterization) that previously had not been captured in the billing process. In this scenario, incidence would be expected to eventually stabilize at a new, higher frequency. The insurance status association is consistent with this interpretation, as providers would be more motivated to seek additional reimbursement for patients with commercial insurance coverage. Finally, these results may reveal evolutions in the management of AUR. It is possible, for example, that health care providers over time are more aggressively diagnosing and treating AUR, or that Prostate Cancer and Prostatic Disease (2013), & 2013 Macmillan Publishers Limited

4 Table 2. OR adj with 95% CI of BPH-associated AUR among men presenting to non-federal California ERs: the California OSHPD ER database, AUR Variable All AUR Primary AUR Secondary AUR OR adj (±95% CI) P-value OR adj (±95% CI) P-value OR adj (±95% CI) P-value Calendar year 2007 (reference) ( ) ( ) ( ) o ( ) o ( ) o ( ) o ( ) o ( ) o ( ) o0.001 P-trend o0.001 o0.001 o0.001 Age (years) (reference) ( ) o ( ) o ( ) o ( ) o ( ) o ( ) o þ 5.57 ( ) o ( ) o ( ) o0.001 Race White (reference) Black 0.93 ( ) ( ) ( ) 0.98 Hispanic 1.65 ( ) o ( ) o ( ) o0.001 Asian 1.60 ( ) o ( ) o ( ) 0.3 Other 1.46 ( ) o ( ) o ( ) Insurance Limited (reference) Commercial 1.34 ( ) o ( ) o ( ) Medicare 1.03 ( ) ( ) ( ) 0.63 Diabetes mellitus Non-diabetic (reference) Diabetic 0.72 ( ) o ( ) o ( ) Abbreviations: AUR, acute urinary retention; CI, confidence interval; ER, emergency room; OD adj, adjusted odds ratio; OSHPD, Office of Statewide Health Planning and Development. Adjusted for race, age, race, insurance status, and concurrent diagnosis of diabetes. P-value indicates significance of year-to-year trend in an adjusted linear time model. AUR patients previously catheterized in clinic are increasingly being sent to the ER. This latter interpretation raises issues related to resource utilization and the appropriateness of sending AUR patients to the ER for further procedures. Notably, the insurance status association is not consistent with this interpretation, as providers would presumably be more apt to send underfunded, rather than funded, patients to the ER. We also found that the increases in incident secondary AUR cases for which the primary diagnosis was non-urologic, but the patient had a concomitant diagnosis of BPH were greater in magnitude than those for primary AUR, with an 80% adjusted increase in risk from 2007 to As older age was more strongly associated with secondary AUR, and BPH patients with concomitant diagnoses of COPD and cardiac disease are at increased risk of AUR, 19,20 a likely explanation is an aging population with a higher prevalence of both BPH and comorbid conditions. With the global population aging, these data portend a growing burden of AUR and associated health care costs in this setting, particularly as Foley catheter insertion is already a considerable source of morbidity that affects estimated tens of thousands of US men annually. 21,22 In this cohort, the higher risk of AUR for Hispanic and Asian men, and the lower risk for African American men, may indicate differences in community prevalence of advanced BPH among these groups. However, prior published data on associations of BPH and race have been conflicting, likely due, at least in part, to differences in clinical definitions of BPH and LUTS. 26 In addition, insurance status and treatment seeking may also have influenced these observations. The inverse associations of AUR with diabetes conflict with prior studies supporting increased risks of BPH 27 and BPH with urinary retention 20 with a diagnosis of diabetes. It is possible that in this case diabetic men with BPH and urinary retention were less likely to be evaluated in the ER. A major strength of this study is the large and ethnically diverse analytic cohort. California is the most populous state in the United States, with a population approaching 40 million individuals ( Both its size and high proportion of non-white residents contribute to the robustness and external validity of the findings. Moreover, the analytic cohort included a nearly 100% sample of all California ER visits during this time period. A potential limitation of this analysis is that it did not incorporate detailed patient-level data, including BPH medication use, surgical history or ER bladder-scan data. Still, there is no evidence to suggest that variations in patient-level parameters would have been differential by year with respect to the primary study outcomes. It is also possible that misclassification bias, secondary to inaccurate coding by providers, occurred. To limit the potential for BPH misclassification bias, we stratified AUR by primary and secondary BPH and, importantly, AUR incidence significantly increased in both categories. Moreover, it is highly unlikely that inaccurate coding for BPH systematically generated an apparent association of year with incident AUR. In conclusion, between 2007 and 2010, the incidences of BPH-associated AUR and urethral catheterization increased & 2013 Macmillan Publishers Limited Prostate Cancer and Prostatic Disease (2013),

5 264 Table 3. OR adj with 95% CI of urethral catheterization for BPH-associated AUR among men presenting to non-federal California ERs: the California OSHPD ER database, Urethral catheterization Variable All AUR þ urethral catheterization Primary AUR þ urethral catheterization Secondary AUR þ urethral catheterization OR adj (±95% CI) P-value OR adj (±95% CI) P-value OR adj (±95% CI) P-value Calendar year 2007 (reference) ( ) o ( ) ( ) ( ) o ( ) o ( ) o ( ) o ( ) o ( ) o0.001 P-trend o0.001 o0.001 o0.001 Age (years) (reference) ( ) o ( ) o ( ) o ( ) o ( ) o ( ) o þ 5.38 ( ) o ( ) o ( ) o0.001 Race White (reference) Black 0.81 ( ) o ( ) o ( ) Hispanic 1.51 ( ) o ( ) o ( ) o0.001 Asian 1.78 ( ) o ( ) o ( ) Other 1.35 ( ) o ( ) o ( ) 0.40 Insurance Limited (reference) Commercial 1.69 ( ) o ( ) o ( ) o0.001 Medicare 1.26 ( ) o ( ) o ( ) Diabetes mellitus Non-diabetic (reference) Diabetic 0.70 ( ) o ( ) o ( ) Abbreviations: AUR, acute urinary retention; CI, confidence interval; ER, emergency room; OD adj, adjusted odds ratio; OSHPD, Office of Statewide Health Planning and Development. Adjusted for race, age, race, insurance status and concurrent diagnosis of diabetes. P-value indicates significance of year-to-year trend in an adjusted linear time model. substantially in a large and ethnically diverse male population of the United States. Potential explanations which merit further study include an increased population prevalence of clinically advanced BPH, temporal changes in provider billing procedures and alterations in practice patterns for management of AUR. CONFLICT OF INTEREST The authors declare no conflict of interest. REFERENCES 1 Saigal CS, Joyce G. Economic costs of benign prostatic hyperplasia in the private sector. J Urol 2005; 173: Wei JT, Calhoun E, Jacobsen SJ. Urologic diseases in America project: benign prostatic hyperplasia. J Urol 2005; 173: Engstrom G, Henningsohn L, Steineck G, Leppert J. Self-assessed health, sadness and happiness in relation to the total burden of symptoms from the lower urinary tract. BJU Int 2005; 95: Taylor BC, Wilt TJ, Fink HA, Lambert LC, Marshall LM, Hoffman AR et al. Prevalence, severity, and health correlates of lower urinary tract symptoms among older men: the MrOS study. Urology 2006; 68: Parsons JK, Mougey J, Lambert L, Wilt TJ, Fink HA, Garzotto M et al. Lower urinary tract symptoms increase the risk of falls in older men. BJU Int 2009; 104: Kupelian V, Fitzgerald MP, Kaplan SA, Norgaard JP, Chiu GR, Rosen RC. Association of nocturia and mortality: results from the Third National Health and Nutrition Examination Survey. J Urol 2011; 185: Armitage JN, Sibanda N, Cathcart PJ, Emberton M, van der Meulen JH. Mortality in men admitted to hospital with acute urinary retention: database analysis. BMJ 2007; 335: McConnell JD, Roehrborn CG, Bautista OM, Andriole Jr GL, Dixon CM, Kusek JW et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Eng J Med 2003; 349: Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Nandy I et al. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol 2010; 57: Parsons JK. Commentary on BPH and public health--have we lost the forest through the trees? J Urol 2008; 179(5 Suppl): S Stroup SP, Palazzi-Churas K, Kopp RP, Parsons JK. Trends in adverse events of benign prostatic hyperplasia (BPH) in the USA, 1998 to BJU Int 2012; 109: Cathcart P, van der Meulen J, Armitage J, Emberton M. Incidence of primary and recurrent acute urinary retention between 1998 and 2003 in England. J Urol 2006; 176: Izard J, Nickel JC. Impact of medical therapy on transurethral resection of the prostate: two decades of change. BJU Int 2011; 108: Wei JT, Miner MM, Steers WD, Rosen RC, Seftel AD, Pasta DJ et al. Benign prostatic hyperplasia evaluation and management by urologists and primary care physicians: practice patterns from the observational BPH registry. J Urol 2011; 186: Prostate Cancer and Prostatic Disease (2013), & 2013 Macmillan Publishers Limited

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