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Quality Indicators for Benign Prostatic Hyperplasia in Vulnerable Elders Christopher S. Saigal, MD, MPH Key words: benign prostatic hypertrophy; quality of care; treatment and 31 through reference mining. One additional article was included after peer review. enign prostatic hyperplasia (BPH) is a highly prevalent benign neoplasm in older men. Lower urinary tract symptoms (LUTS) associated with BPH include urinary urgency, frequency, nocturia, incomplete emptying, decreased force of urinary s
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  Quality Indicators for Benign Prostatic Hyperplasia inVulnerable Elders Christopher S. Saigal, MD, MPH  Key words: benign prostatic hypertrophy; quality of care;treatment B enign prostatic hyperplasia (BPH) is a highly prevalentbenign neoplasm in older men. Lower urinary tractsymptoms (LUTS) associated with BPH include urinary ur-gency, frequency, nocturia,incomplete emptying,decreasedforce of urinary stream, and urinary incontinence (UI). Theprevalence of these symptoms rises with age. When com-paring men aged 30 to 39 with men aged 70 and older, theprevalence of nocturia more than three times per night risesfrom 3% to 21%, the prevalence of incomplete emptyingrisesfrom6%to22%,andtheprevalenceofaweakurinarystreamrisesfrom0%to57%. 1 UntreatedBPHcanresultinserious clinical sequelae, including acute urinary retention,urinary tract infection (UTI), bladder stone formation,gross hematuria, and rarely, renal failure. Treatment of BPH can often mitigate these outcomes. LUTS associatedwith BPH can have a significant effect on quality of life, 2 which often compels men to seek care; in 2000, the rate of BPH-related physician office visits was 14,473 visits per100,000 adult men. 3 Effective medical and surgical thera-pies are available for BPH treatment. Medication (an alphaadrenergic antagonist, a 5-alpha reductase inhibitor, orboth) is usually the initial treatment, whereas surgery(transurethral resection of the prostate (TURP), open sim-ple prostatectomy, or one of the newer minimally invasivetherapies) is generally reserved for cases of medication fail-ures. National spending related to BPH in 2000 was esti-mated at $1.1 billion, exclusive of medication costs. 3 METHODS A total of 57 articles were considered in this review: oneidentified via a Web search, 24 through a literature search,and 31 through reference mining. One additional articlewas included after peer review. RESULTS Ofthe19 potentialquality indicators(QIs), 13 were judgedvalid using the expert panel process (see the QIs on pagesS464–S487 of this supplement), and six were rejected. OneQI was moved to Urinary Incontinence because of fit withQIs in that condition. The literature summaries that sup-port each of the indicators judged to be valid in the expertpanel process are described. Initial History and Physical Examination 1. IF a male vulnerable elder (VE) complains of new orworsening urinary frequency, urgency, UI, Ã nocturia, de-creased force of stream, feeling of incomplete bladder emp-tying, or postvoid dribbling (LUTS), THEN a historyshould document medications associated with symptoms;neurological conditions that can affect the urological sys-tem; prior urological, neurosurgical, orthopedic, or generalsurgery procedures; whether symptoms are bothersome;and prior treatment; 2. IF a male VE complains of new LUTS, ÃÃ THEN a rectal examination (including prostate size, degree of ten-derness, and nodularity) and abdominal examinationshould be performed; and 3. IF a male VE complains of new or worsening LUTS, THEN a urinalysis (microscopic examination or dipstick)should be performed, as well as a urine culture if theurinalysis demonstrates pyuria or hematuria; BECAUSE BPH is a highly prevalent, sometimes pro-gressive condition in the elderly male population that canresult in avoidable adverse health outcomes; other neuro-logical and postoperative problems can mimic symptomsof BPH, which dietary intake and medication use can alsoexacerbate; prostate cancer and infections of the genitouri-nary tract can occur in men with BPH; and symptom scoreeffectively guide therapy and treatment response. Address correspondence to Christopher S. Saigal, MD, MPH, UCLADepartment of Urology, Box 951738, Los Angeles, CA 90095.E-mail: csaigal@mednet.ucla.eduDOI: 10.1111/j.1532-5415.2007.01330.xFrom the Department of Urology, University of California at Los Angeles,Los Angeles, California. Ã For incontinence, see UI #4. ÃÃ For incontinence, see UI #5 .  JAGS 55:S253–S257, 2007 r 2007, Copyright the Authors Journal compilation r 2007, RAND Corporation 0002-8614/07/$15.00  Supporting Evidence Although there are no experimental or observational stud-ies relating the performance of history or physical exam-ination items tosubsequent improved outcomes, evaluatingthe cause of symptoms is a fundamental role of physicians,and other conditions besides BPH can produce similarsymptoms.Population-basedstudiesdocumentasignificantprevalence of BPH symptoms in older men. The NationalHealthandNutritionExaminationSurveyIIIdemonstrateda prevalence of ‘‘weak urinary stream’’ of 45% in men aged60 to 69, which rose to 56% in men aged 70 and older.Morethanoneinfivemenaged70andoldercomplained of a feeling of incomplete emptying, 1 although some oldermen and physicians may consider LUTS a part of normalaging. 4 Ifuntreated,BPHcanresultinsignificantmorbidity,including obstructive renal failure, UTI, bladder stones,hematuria, and acute urinary retention. Treatment of BPHcanmitigatetheseoutcomes. 5 EvaluationofVEswithLUTSmust exclude conditions that can mimic BPH, includingneurologicalconditionssuchasspinal cordinjury,vertebraldisc herniation, and Parkinson’s disease; infectious condi-tions such as UTI; urological sequelae of cerebrovascularincident; diabetes mellitus; and congestive heart failure.Anatomic abnormalities in the urinary tract (e.g., postop-erativescarring)mayalsocauseLUTS.Theseconditionsareprevalent in men with LUTS and increase in frequency asmen age. One population-based study estimated prevalenceof these conditions to be 9% in men in their seventh decadeof life and 33% in men in their eighth decade of life. 6,7 Many of these conditions can be uncovered in the medicalhistory or relevant physical examination. Early-stage pros-tate cancer rarely causes LUTS, but locally advanced dis-ease may cause outlet obstruction; such a lesion is palpableon rectal examination. The American Urological Associa-tion (AUA) guidelines recommend a baseline assessmentwith the AUA Symptom Index, because it is an objectiveand reliable method to assess symptoms, 8 although evi-dence indicates that two thirds of primary care physiciansuse the AUA symptom index rarely or never. 9 Postvoid Residual 4. IF a male VE presenting with new or worsening UI orcomplaints of incomplete emptying or LUTS and has neu-rological disease (e.g., spinal cord injury, multiple sclerosis)or has had a procedure that can affect innervation of thebladder or urethral sphincter mechanism (e.g., spinal sur-gery), THEN he should have a postvoid residual (PVR)measurement; and UI #7. IF a VE has a PVR greater than 300cc, THEN he orshe should have a serum creatinine within 72 hours and (if no reversible causes are found) be referred to a clinicianwith urological expertise within 2 months; BECAUSE these men with bladder innervation prob-lems are at risk for urinary retention, which has adverseoutcomes that often can be avoided if treated, and anelevated PVR can be associated with renal failure. Supporting Evidence No experimental or observational studies relate the perfor-manceofaPVRorurodynamictestinginVEstosubsequentimproved outcomes. Patients with complex medical histo-ries that can affect bladder innervation who have LUTSmay be at higher risk for treatment failure because of mis-diagnosis.Clinicalopinionisthattheymayalsobeathigherrisk for urinary retention. VEs with such complex historiesand a large PVR (measured immediately after the patientvoids uisng bladder ultrasound or straight catheterization)may be at even higher risk of failure with therapy directedat the prostate itself, although indirect evidence for the riskofahighPVRonlyexistsforfailureofwatchfulwaitingasastrategy. 10 In the Medical Therapy of Prostatic Symptoms Trial,which followed approximately 3,000 men with BPH for amean of 4.5 years, 1% of subjects developed inconti-nence. 11 Although specific data do not exist to documentthe risk for overflow incontinence if an elder complains of incontinence or incomplete emptying, PVR testing is a rel-atively quick and inexpensive way to identify a potentiallyseriousandcorrectableproblem.IfaneldercomplainsofUIor feels that he cannot empty his bladder completely, thePVR should be checked to exclude overflow incontinence.Men in retention with overflow are at higher risk for UTIand renal deterioration.For patients with elevated PVR, a serum creatininemeasurement can help establish the degree of renal impair-ment, if any, related to obstruction. Unfortunately, no dataexist to support the creation of a binary criterion for ‘‘high’’PVR. AUA guidelines refer to a PVR of greater than 350ccas ‘‘large,’’ and note that within the range of residuals from0 to 300cc of urine, PVR does not predict response totherapy. 12 Urological Trauma 5.IF amaleVEpresentingwithneworworseningLUTShasa history of lower tract urological surgery or urethral trau-ma(includingtraumaticcatheterizations), THEN heshouldbe referred to a urologist within 2 months, BECAUSE uro-logical surgery or trauma can result in strictures or bladderneck contractures that mimic the symptoms of BPH but donot respond to treatment for BPH. Supporting Evidence Although no experimental or observational data relatereferral to a urologist in this situation to subsequent im-proved outcomes, VEs who have had transurethral surgeryor open surgery involving the prostate or urethra, as well asthose who have a history of urethral trauma, are at risk foranatomic obstruction from scarring. Such scarring can pro-duce LUTS that mimic those produced by BPH. For exam-ple, 2.8% to 9.8% of patients who undergo TURPexperience bladder neck contracture. 13,14 Elders who havehad internal urethrotomies in the past are at high risk forrecurrence; one study documented a 45% recurrence rateover 3 years. 15 Recurrence rates are lower for elders whohave undergone open urethroplasty (18%). 16 Evaluation of Hematuria 6. IF a male VE has new microhematuria ( 4 3red bloodcells/high-powered field) and a negative urine culture (orhas 1 positive and 1 negative urinalysis), THEN a repeaturinalysis should be performed within 1 month; and S254 SAIGAL OCTOBER 2007–VOL. 55, NO. S2 JAGS  7. IF a male VE has unexplained gross hematuria or mi-crohematuria ( 4 3 red blood cells/high-powered field on 2of 3 urinalyses) and a negative urine culture, THEN heshould have serum creatinine, upper urological tract imag-ing, and referral to a urologist or nephrologist within 3months; BECAUSE renal and bladder cancer may cause hema-turia. Supporting Evidence No experimental or observational studies relate improvedoutcomes to the performance of any of these laboratorytests, but an indirect argument exists that, if these tests arenot performed, the possibility of urological malignancymay be overlooked. VEs with LUTS should have UTI ruledout with a urinalysis and urine culture. In elders with LUTSwho have gross hematuria or microhematuria and a neg-ative urine culture, the presence of upper or lower tractmalignancy should be evaluated, per AUA guidelines onBPH. 12 In older men who are at risk for urological disease,the prevalence of microscopic hematuria is as high as21%. 17 Microhematuria examinations, as described above,demonstrated urological malignancy in 4% and 25% of community-based and referral populations, respectively,with a rate of detection of other genitourinary abnormal-ities as high as 25%. 18 AUA guidelines on microscopichematuria mandate upper tract imaging with computed to-mography, ultrasound, or intravenous pyelogram (withmagneticresonanceimagingasasecondarytest),followedbycystoscopy. Cystoscopy is performed after upper tract imag-ing so that retrograde studies may be performed if a ureterallesion is seen on initial imaging. The interval between serialurinalyses should be o 1 month, based on the observationthat patients with a window longer than 3 months betweendiagnosis of muscle invasive bladder cancer and radical cyst-ectomy had worse progression-free survival. 19 PSATesting 8.IF amaleVEreceivesascreeningprostatespecificantigen(PSA) test, THEN the chart should document a discussionoftheprosandconsofthetest, BECAUSE theharmsofPSAscreening may outweigh the benefits in the VE population. Supporting Evidence The value of PSA testing in reducing mortality fromprostate cancer is still being examined. One recent popu-lation-based case-control study demonstrated an odds ratiofor metastatic disease of 0.66 (95% confidence interval(CI) 5 0.45–0.93)inasymptomaticmenscreenedwithPSA,implying that PSA screening reduces risk for metastasis andperhaps subsequent mortality. 20 The odds ratio for menaged 60 to 84 was 0.67 (95% CI 5 0.41–1.09), althoughbecause of the indolent nature of many prostate cancers,organizations that advocate for PSA screening (such as theAUA and the American Cancer Society) do so only for menwith a life expectancy of longer than 10 years. In men notdestined to die of their prostate cancer, treatment can resultin needless morbidity and anxiety. A nested case-controlstudy from 10 New England Veterans Affairs Medical Cen-ters failed to find a relationship between PSA screening andall-cause or cause-specific mortality. 21 In a study of 223consecutively diagnosed Swedish men with localized pros-tate cancer followed for a mean of 21 years, the rate of cause-specific mortality for men after 10 years was only 18per 1,000 person-years, and the rate of progression to met-astatic disease was 15 per 1,000 person-years. However,these rates more than doubled in men followed for morethan 15 years. 22 Mortality in VEs is approximately 25% at3 years, meaning that a minority of VEs will survive 10years. 23 Furthermore, predicting who is likely to surviveand who is likely to die is imprecise. Still, some documen-tation from the ordering physician that an asymptomaticVEhastheexpectationofsufficientremaininglifetobenefitfrom the test seems advisable.Men with palpable advanced disease on rectal exam-inationmaybenefitfromhormonaltherapytorelieveoutletobstruction, and men with suspected metastatic disease(e.g., bone pain or pathological fracture) will benefit fromhormonal therapy for pain relief and prevention of bonelesion progression. In these settings, PSA testing is appro-priate as the first step in establishing the diagnosis and fol-lowing response to treatment. Because these clinicalsituations are rare in this population, harms of PSA testingmay outweigh benefits. Thus, this QI refers only to PSAtesting performed for screening purposes. Under such cir-cumstances, providers should document a discussion of theprosandconsoftestingsothatpatientsreceive thetestonlyiftheyhave anadequatelife expectancyand understandthecontroversy concerning the value of the test. Referral to a Urologist 9. IF a male VE with presumed BPH has bladder stones,urinary retention ( 4 1 episode), UTI, or renal failure withhydronephrosis, THEN the patient should be referred to aurologist, BECAUSE these conditions may require surgicaltreatment. Supporting Evidence There have been no randomized, controlled trials (RCTs) toassess whether surgical treatment is superior to medicalmanagementfortheseconditions,butphysiologyandexpertconsensus suggest that theseverity of these complications of BPH mandate definitive treatment. Although they are rel-atively rare events in the United States, population-baseddatafromOlmsteadCountyindicatethata60-year-oldmanwith a moderate to severe AUA Symptom Index (SI) scorewould have a 14% chance of retention in the following 10years. The Medical Therapy of Prostatic Symptoms Trialreported recurrent UTI, bladder stone, renal failure, andhematuria as extremely rare or absent, although these clin-ical data may not be representative of community experi-ence. 11 A retrospective series examining indications forsurgery in 3,000 subjects found that hematuria was the sur-gical indication in 12% of cases. 24 Although renal failuresecondarytoBPHisrare,elderspresentingwithrenalfailuredue to outlet obstruction should have definitive therapy torelieve the obstruction. One review on the topic concludedthat a relationship between BPH and renal failure existedandthatsurgerywaseffectiveatimprovingrenalfunction. 25 Treatment of Mild BPH Symptoms 10.IF amale VEwithBPHhasanAUASIscore of7orless,the symptoms are not bothersome, and the patient is not QUALITY INDICATORS FOR BPH IN VULNERABLE ELDERS S255 JAGS OCTOBER 2007–VOL. 55, NO. S2  known to have bilateral hydronephrosis, bladder stones,hematuria attributable to the prostate, or UTI, THEN he should not be prescribed medications or surgery forBPH, BECAUSE potential harms of treatment may exceedbenefits. Supporting Evidence Based on its expert panel review of the literature, the AUArecommends avoiding treatment of mild obstructive symp-toms, because these symptoms do not affect quality of life. 12 The expert panel concluded that the potential harmsof treatment for this group outweighed the benefits of ther-apy. The panel came to the same conclusion regarding anyVE with LUTS who is not ‘‘bothered’’ by symptoms,althoughinpractice,because‘‘bother’’isoneoftheprimarydrivers for patients to seek care for LUTS, such situationsshould be rare. 26 Watchfulwaitingcanbeaneffectivestrategy.OneRCTcompared watchful waiting and lifestyle advice (reducecaffeineandalcohol)withprostatectomy.The‘‘failure’’ratein the watchful waiting arm was 6 per 100 person years;mean symptom scores in men on watchful waiting de-creased almost 25%, emphasizing the waxing and waningnature of LUTS. 27 Treatment of Moderate to Severe BPH Symptoms 11. IF a male VE with BPH has moderate to severe symp-toms (or an AUA SI score 4 7) that are bothersome, THEN the medicalrecord shoulddocument thattreatment optionswere discussed (e.g., medical, surgical, watchful waiting), BECAUSE each of these strategies has been found to beeffective in managing symptoms of BPH. Supporting Evidence Asconcludedbyonereview,nospecificlevelofsymptomsisan absolute indication for any one particular treatment forLUTS attributed to BPH. 28 Shared decision-making princi-ples should guide treatment of BPH, 28 and the patientshould have all options presented to him. Several large re-views support the effectiveness of alpha-adrenergic antag-onists over placebo in reducing symptoms, 28–30 althougheachagentseemstobecomparablewithothersinitsclassinterms of efficacy. A large RCTsupported the use of finaste-ride (especially in combination with alpha-blockers) in pre-venting progression of BPH symptoms (defined as anincrease above baseline of at least 4 points on the AUA SI,acute urinary retention, UI, renal insufficiency, or recurrentUTI). 11 Similarly, reviews have documented the effective-ness of surgical procedures such as TURP or open pros-tatectomy in reducing symptoms. 28 Reviews of evidenceregarding newer, minimally invasive technologies such astransurethral microwave thermotherapy and transurethralneedle ablation of the prostate also conclude that theyreduce symptoms scores, although their long-term efficacyis unclear. 28,31,32 Patients selecting these interventions mayrequire re-treatment at higher rates than if they had chosenTURP. Preoperative Urinalysis 12.IF amaleVEhassurgeryforBPH, THEN aurinalysisora urine culture should have been done within 6 weeksbefore surgery and treated, if necessary, BECAUSE of therisk of urosepsis during transurethral procedures. Supporting Evidence UTI is the most common postoperative complication of TURP and can lead to significant postoperative morbidityand cost. 33 One prospective RCT of subjects undergoingTURPwithorwithoutpreoperativeantibioticsdocumented62 of 308 subjects with a positive urine culture beforeTURP. In those not randomized to preoperative antibiotics,the postoperative UTI rate was 87%. 34 VEs are at higherrisk for morbidity after UTI because of multiple medicalproblems. ACKNOWLEDGMENTS We recognize the support of Michael Barry and PaulShekelle. Patricia Smith provided technical assistance. Financial Disclosure: The ACOVE project was sup-ported by a contract from Pfizer Inc to RAND. Dr. Christo-pher S. Saigal has received grant funding from the NationalInstitutes of Diabetes and Digestive and Kidney Diseases. Author Contributions: Dr. Saigal was involved in thestudy concept and design, acquisition of data, analysis andinterpretation of data, and preparation of the manuscript. Sponsor’s Role: The funding source had no role in thedesign, analysis, or interpretation of the study or in thepreparation of the manuscript for publication. REFERENCES 1. Platz EA, Smit E, Curhan GC et al. Prevalence of and racial/ethnic variation inlower urinary tract symptoms and noncancer prostate surgery in U.S. men.Urology 2002;59:877–883.2. O’Leary MP. Quality of life and alpha-blocker therapy: An important con-sideration for both the patient and the physician. Urology 2002;59(2 Suppl 1):7–11.3. WeiJT,CalhounEA,JacobsenSJ.Benignprostatichyperplasia.In:LitwinMS,Saigal CS, eds. Urologic Diseases in America. U.S. Department of Health andHuman Services, PublicHealth Service, National Institues ofHealth,NationalInstituteofDiabetesandDigestiveandKidneyDiseases.Washington,DC:U.S.Government Publishing Office, 2004; NIH Publication No. 04-5512 45–69.4. Collins MF, Friedman RH, Ash A et al. Underdetection of clinical benignprostatic hyperplasia in a general medical practice. J Gen Intern Med 1996;11:513–518.5. Anderson JB, Roehrborn CG, Schalken JA et al. The progression of benignprostatic hyperplasia: Examining the evidence and determining the risk. EurUrol 2001;39:390–399.6. GadesNM,JacobsonDJ,GirmanCJetal.Prevalenceofconditionspotentiallyassociated with lower urinary tract symptoms in men. BJU Int 2005;95:549–553.7. Dull P, Reagan RW Jr, Bahnson RR. Managing benign prostatic hyperplasia.Am Fam Physician 2002;66:77–84.8. Barry MJ, Fowler FJ Jr, O’Leary MP et al. The American Urological Asso-ciation symptom index for benign prostatic hyperplasia. The MeasurementCommittee of the American Urological Association. J Urol 1992;148:1549–1557, discussion 1564.9. Collins MM, Barry MJ, Bin L et al. Diagnosis and treatment of benign pros-tatic hyperplasia. Practice patterns of primary care physicians. J Gen InternMed 1997;12:224–229.10. Flanigan RC, Reda DJ, Wasson JH et al. 5-year outcome of surgical resectionand watchful waiting for men with moderately symptomatic benign prostatichyperplasia: A department of veterans affairs cooperative study. J Urol1998;160:12–16, discussion 16–17.11. McConnell JD, Roehrborn CG, Bautista OM et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 2003;349:2387–2398.12. AUA guideline on management of benign prostatic hyperplasia (2003). Chap-ter 1: Diagnosis and treatment recommendations. J Urol 2003;170(2 Part 1):530–547.S256 SAIGAL OCTOBER 2007–VOL. 55, NO. S2 JAGS
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