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 stream, and urinary incontinence (UI). The prevalence of these symptoms rises with age. When comparing men aged 30 to 39 with men aged 70 and older, the prevalence of nocturia more than three times per night rises from 3% to 21%, the prevalence of incomplete emptying rises from 6% to 22%, and the prevalence of a weak urinary stream rises from 0% to 57%.1 Untreated BPH can result in serious 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 associated with BPH can have a signicant effect on quality of life,2 which often compels men to seek care; in 2000, the rate of BPH-related physician ofce visits was 14,473 visits per 100,000 adult men.3 Effective medical and surgical therapies are available for BPH treatment. Medication (an alpha adrenergic antagonist, a 5-alpha reductase inhibitor, or both) is usually the initial treatment, whereas surgery (transurethral resection of the prostate (TURP), open simple prostatectomy, or one of the newer minimally invasive therapies) is generally reserved for cases of medication failures. National spending related to BPH in 2000 was estimated at $1.1 billion, exclusive of medication costs.3

RESULTS Of the 19 potential quality indicators (QIs), 13 were judged valid using the expert panel process (see the QIs on pages S464S487 of this supplement), and six were rejected. One QI was moved to Urinary Incontinence because of t with QIs in that condition. The literature summaries that support each of the indicators judged to be valid in the expert panel process are described. Initial History and Physical Examination 1. IF a male vulnerable elder (VE) complains of new or worsening urinary frequency, urgency, UI, nocturia, decreased force of stream, feeling of incomplete bladder emptying, or postvoid dribbling (LUTS), THEN a history should document medications associated with symptoms; neurological conditions that can affect the urological system; prior urological, neurosurgical, orthopedic, or general surgery procedures; whether symptoms are bothersome; and prior treatment; 2. IF a male VE complains of new LUTS, THEN a rectal examination (including prostate size, degree of tenderness, and nodularity) and abdominal examination should 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 the urinalysis demonstrates pyuria or hematuria; BECAUSE BPH is a highly prevalent, sometimes progressive condition in the elderly male population that can result in avoidable adverse health outcomes; other neurological and postoperative problems can mimic symptoms of BPH, which dietary intake and medication use can also exacerbate; prostate cancer and infections of the genitourinary tract can occur in men with BPH; and symptom score effectively guide therapy and treatment response.
For incontinence, see UI #4.

METHODS A total of 57 articles were considered in this review: one identied via a Web search, 24 through a literature search,
From the Department of Urology, University of California at Los Angeles, Los Angeles, California. Address correspondence to Christopher S. Saigal, MD, MPH, UCLA Department of Urology, Box 951738, Los Angeles, CA 90095. E-mail: csaigal@mednet.ucla.edu DOI: 10.1111/j.1532-5415.2007.01330.x

For incontinence, see UI #5 .

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Supporting Evidence Although there are no experimental or observational studies relating the performance of history or physical examination items to subsequent improved outcomes, evaluating the cause of symptoms is a fundamental role of physicians, and other conditions besides BPH can produce similar symptoms. Population-based studies document a signicant prevalence of BPH symptoms in older men. The National Health and Nutrition Examination Survey III demonstrated a prevalence of weak urinary stream of 45% in men aged 60 to 69, which rose to 56% in men aged 70 and older. More than one in ve men aged 70 and older complained of a feeling of incomplete emptying,1 although some older men and physicians may consider LUTS a part of normal aging.4 If untreated, BPH can result in signicant morbidity, including obstructive renal failure, UTI, bladder stones, hematuria, and acute urinary retention. Treatment of BPH can mitigate these outcomes.5 Evaluation of VEs with LUTS must exclude conditions that can mimic BPH, including neurological conditions such as spinal cord injury, vertebral disc herniation, and Parkinsons disease; infectious conditions such as UTI; urological sequelae of cerebrovascular incident; diabetes mellitus; and congestive heart failure. Anatomic abnormalities in the urinary tract (e.g., postoperative scarring) may also cause LUTS. These conditions are prevalent in men with LUTS and increase in frequency as men age. One population-based study estimated prevalence of these conditions to be 9% in men in their seventh decade of life and 33% in men in their eighth decade of life.6,7 Many of these conditions can be uncovered in the medical history or relevant physical examination. Early-stage prostate cancer rarely causes LUTS, but locally advanced disease may cause outlet obstruction; such a lesion is palpable on rectal examination. The American Urological Association (AUA) guidelines recommend a baseline assessment with the AUA Symptom Index, because it is an objective and reliable method to assess symptoms,8 although evidence indicates that two thirds of primary care physicians use the AUA symptom index rarely or never.9 Postvoid Residual 4. IF a male VE presenting with new or worsening UI or complaints of incomplete emptying or LUTS and has neurological disease (e.g., spinal cord injury, multiple sclerosis) or has had a procedure that can affect innervation of the bladder or urethral sphincter mechanism (e.g., spinal surgery), THEN he should have a postvoid residual (PVR) measurement; and UI #7. IF a VE has a PVR greater than 300 cc, THEN he or she should have a serum creatinine within 72 hours and (if no reversible causes are found) be referred to a clinician with urological expertise within 2 months; BECAUSE these men with bladder innervation problems are at risk for urinary retention, which has adverse outcomes that often can be avoided if treated, and an elevated PVR can be associated with renal failure. Supporting Evidence No experimental or observational studies relate the performance of a PVR or urodynamic testing in VEs to subsequent improved outcomes. Patients with complex medical histo-

ries that can affect bladder innervation who have LUTS may be at higher risk for treatment failure because of misdiagnosis. Clinical opinion is that they may also be at higher risk for urinary retention. VEs with such complex histories and a large PVR (measured immediately after the patient voids uisng bladder ultrasound or straight catheterization) may be at even higher risk of failure with therapy directed at the prostate itself, although indirect evidence for the risk of a high PVR only exists for failure of watchful waiting as a strategy.10 In the Medical Therapy of Prostatic Symptoms Trial, which followed approximately 3,000 men with BPH for a mean of 4.5 years, 1% of subjects developed incontinence.11 Although specic data do not exist to document the risk for overow incontinence if an elder complains of incontinence or incomplete emptying, PVR testing is a relatively quick and inexpensive way to identify a potentially serious and correctable problem. If an elder complains of UI or feels that he cannot empty his bladder completely, the PVR should be checked to exclude overow incontinence. Men in retention with overow are at higher risk for UTI and renal deterioration. For patients with elevated PVR, a serum creatinine measurement can help establish the degree of renal impairment, if any, related to obstruction. Unfortunately, no data exist to support the creation of a binary criterion for high PVR. AUA guidelines refer to a PVR of greater than 350 cc as large, and note that within the range of residuals from 0 to 300 cc of urine, PVR does not predict response to therapy.12

Urological Trauma 5. IF a male VE presenting with new or worsening LUTS has a history of lower tract urological surgery or urethral trauma (including traumatic catheterizations), THEN he should be referred to a urologist within 2 months, BECAUSE urological surgery or trauma can result in strictures or bladder neck contractures that mimic the symptoms of BPH but do not respond to treatment for BPH. Supporting Evidence Although no experimental or observational data relate referral to a urologist in this situation to subsequent improved outcomes, VEs who have had transurethral surgery or open surgery involving the prostate or urethra, as well as those who have a history of urethral trauma, are at risk for anatomic obstruction from scarring. Such scarring can produce LUTS that mimic those produced by BPH. For example, 2.8% to 9.8% of patients who undergo TURP experience bladder neck contracture.13,14 Elders who have had internal urethrotomies in the past are at high risk for recurrence; one study documented a 45% recurrence rate over 3 years.15 Recurrence rates are lower for elders who have undergone open urethroplasty (18%).16 Evaluation of Hematuria 6. IF a male VE has new microhematuria (43 red blood cells/high-powered eld) and a negative urine culture (or has 1 positive and 1 negative urinalysis), THEN a repeat urinalysis should be performed within 1 month; and

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7. IF a male VE has unexplained gross hematuria or microhematuria (43 red blood cells/high-powered eld on 2 of 3 urinalyses) and a negative urine culture, THEN he should have serum creatinine, upper urological tract imaging, and referral to a urologist or nephrologist within 3 months; BECAUSE renal and bladder cancer may cause hematuria.

Supporting Evidence No experimental or observational studies relate improved outcomes to the performance of any of these laboratory tests, but an indirect argument exists that, if these tests are not performed, the possibility of urological malignancy may be overlooked. VEs with LUTS should have UTI ruled out with a urinalysis and urine culture. In elders with LUTS who have gross hematuria or microhematuria and a negative urine culture, the presence of upper or lower tract malignancy should be evaluated, per AUA guidelines on BPH.12 In older men who are at risk for urological disease, the prevalence of microscopic hematuria is as high as 21%.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 abnormalities as high as 25%.18 AUA guidelines on microscopic hematuria mandate upper tract imaging with computed tomography, ultrasound, or intravenous pyelogram (with magnetic resonance imaging as a secondary test), followed by cystoscopy. Cystoscopy is performed after upper tract imaging so that retrograde studies may be performed if a ureteral lesion is seen on initial imaging. The interval between serial urinalyses should be o1 month, based on the observation that patients with a window longer than 3 months between diagnosis of muscle invasive bladder cancer and radical cystectomy had worse progression-free survival.19 PSA Testing 8. IF a male VE receives a screening prostate specic antigen (PSA) test, THEN the chart should document a discussion of the pros and cons of the test, BECAUSE the harms of PSA screening may outweigh the benets in the VE population. Supporting Evidence The value of PSA testing in reducing mortality from prostate cancer is still being examined. One recent population-based case-control study demonstrated an odds ratio for metastatic disease of 0.66 (95% condence interval (CI) 5 0.450.93) in asymptomatic men screened with PSA, implying that PSA screening reduces risk for metastasis and perhaps subsequent mortality.20 The odds ratio for men aged 60 to 84 was 0.67 (95% CI 5 0.411.09), although because of the indolent nature of many prostate cancers, organizations that advocate for PSA screening (such as the AUA and the American Cancer Society) do so only for men with a life expectancy of longer than 10 years. In men not destined to die of their prostate cancer, treatment can result in needless morbidity and anxiety. A nested case-control study from 10 New England Veterans Affairs Medical Centers failed to nd a relationship between PSA screening and all-cause or cause-specic mortality.21 In a study of 223 consecutively diagnosed Swedish men with localized pros-

tate cancer followed for a mean of 21 years, the rate of cause-specic mortality for men after 10 years was only 18 per 1,000 person-years, and the rate of progression to metastatic disease was 15 per 1,000 person-years. However, these rates more than doubled in men followed for more than 15 years.22 Mortality in VEs is approximately 25% at 3 years, meaning that a minority of VEs will survive 10 years.23 Furthermore, predicting who is likely to survive and who is likely to die is imprecise. Still, some documentation from the ordering physician that an asymptomatic VE has the expectation of sufcient remaining life to benet from the test seems advisable. Men with palpable advanced disease on rectal examination may benet from hormonal therapy to relieve outlet obstruction, and men with suspected metastatic disease (e.g., bone pain or pathological fracture) will benet from hormonal therapy for pain relief and prevention of bone lesion progression. In these settings, PSA testing is appropriate as the rst step in establishing the diagnosis and following response to treatment. Because these clinical situations are rare in this population, harms of PSA testing may outweigh benets. Thus, this QI refers only to PSA testing performed for screening purposes. Under such circumstances, providers should document a discussion of the pros and cons of testing so that patients receive the test only if they have an adequate life expectancy and understand the controversy concerning the value of the test.

Referral to a Urologist 9. IF a male VE with presumed BPH has bladder stones, urinary retention (41 episode), UTI, or renal failure with hydronephrosis, THEN the patient should be referred to a urologist, BECAUSE these conditions may require surgical treatment. Supporting Evidence There have been no randomized, controlled trials (RCTs) to assess whether surgical treatment is superior to medical management for these conditions, but physiology and expert consensus suggest that the severity of these complications of BPH mandate denitive treatment. Although they are relatively rare events in the United States, population-based data from Olmstead County indicate that a 60-year-old man with a moderate to severe AUA Symptom Index (SI) score would have a 14% chance of retention in the following 10 years. The Medical Therapy of Prostatic Symptoms Trial reported recurrent UTI, bladder stone, renal failure, and hematuria as extremely rare or absent, although these clinical data may not be representative of community experience.11 A retrospective series examining indications for surgery in 3,000 subjects found that hematuria was the surgical indication in 12% of cases.24 Although renal failure secondary to BPH is rare, elders presenting with renal failure due to outlet obstruction should have denitive therapy to relieve the obstruction. One review on the topic concluded that a relationship between BPH and renal failure existed and that surgery was effective at improving renal function.25 Treatment of Mild BPH Symptoms 10. IF a male VE with BPH has an AUA SI score of 7 or less, the symptoms are not bothersome, and the patient is not

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known to have bilateral hydronephrosis, bladder stones, hematuria attributable to the prostate, or UTI, THEN he should not be prescribed medications or surgery for BPH, BECAUSE potential harms of treatment may exceed benets.

before surgery and treated, if necessary, BECAUSE of the risk of urosepsis during transurethral procedures.

Supporting Evidence Based on its expert panel review of the literature, the AUA recommends avoiding treatment of mild obstructive symptoms, because these symptoms do not affect quality of life.12 The expert panel concluded that the potential harms of treatment for this group outweighed the benets of therapy. The panel came to the same conclusion regarding any VE with LUTS who is not bothered by symptoms, although in practice, because bother is one of the primary drivers for patients to seek care for LUTS, such situations should be rare.26 Watchful waiting can be an effective strategy. One RCT compared watchful waiting and lifestyle advice (reduce caffeine and alcohol) with prostatectomy. The failure rate in the watchful waiting arm was 6 per 100 person years; mean symptom scores in men on watchful waiting decreased almost 25%, emphasizing the waxing and waning nature of LUTS.27 Treatment of Moderate to Severe BPH Symptoms 11. IF a male VE with BPH has moderate to severe symptoms (or an AUA SI score 47) that are bothersome, THEN the medical record should document that treatment options were discussed (e.g., medical, surgical, watchful waiting), BECAUSE each of these strategies has been found to be effective in managing symptoms of BPH. Supporting Evidence As concluded by one review, no specic level of symptoms is an absolute indication for any one particular treatment for LUTS attributed to BPH.28 Shared decision-making principles should guide treatment of BPH,28 and the patient should have all options presented to him. Several large reviews support the effectiveness of alpha-adrenergic antagonists over placebo in reducing symptoms,2830 although each agent seems to be comparable with others in its class in terms of efcacy. A large RCT supported the use of nasteride (especially in combination with alpha-blockers) in preventing progression of BPH symptoms (dened as an increase above baseline of at least 4 points on the AUA SI, acute urinary retention, UI, renal insufciency, or recurrent UTI).11 Similarly, reviews have documented the effectiveness of surgical procedures such as TURP or open prostatectomy in reducing symptoms.28 Reviews of evidence regarding newer, minimally invasive technologies such as transurethral microwave thermotherapy and transurethral needle ablation of the prostate also conclude that they reduce symptoms scores, although their long-term efcacy is unclear.28,31,32 Patients selecting these interventions may require re-treatment at higher rates than if they had chosen TURP. Preoperative Urinalysis 12. IF a male VE has surgery for BPH, THEN a urinalysis or a urine culture should have been done within 6 weeks

Supporting Evidence UTI is the most common postoperative complication of TURP and can lead to signicant postoperative morbidity and cost.33 One prospective RCT of subjects undergoing TURP with or without preoperative antibiotics documented 62 of 308 subjects with a positive urine culture before TURP. In those not randomized to preoperative antibiotics, the postoperative UTI rate was 87%.34 VEs are at higher risk for morbidity after UTI because of multiple medical problems. ACKNOWLEDGMENTS We recognize the support of Michael Barry and Paul Shekelle. Patricia Smith provided technical assistance. Financial Disclosure: The ACOVE project was supported by a contract from Pzer Inc to RAND. Dr. Christopher S. Saigal has received grant funding from the National Institutes of Diabetes and Digestive and Kidney Diseases. Author Contributions: Dr. Saigal was involved in the study concept and design, acquisition of data, analysis and interpretation of data, and preparation of the manuscript. Sponsors Role: The funding source had no role in the design, analysis, or interpretation of the study or in the preparation of the manuscript for publication. REFERENCES
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