Tables 1. Serum PSA concentration in patients with histologically confirmed BPH .... 2. Comparative PSA values for BPH and organ-confined prostate 3. Ability of PSA to distinguish organ-confined prostate cancer 4. Distribution of subjects' global ratings of the bothersomeness 6. Inability of eight urodynamic parameters to separate obstruction 7. Symptomatic improvement based on pretreatment Qmax; statistically significant difference in probability for treatment success below or above Qmax cutoff value of 15 mL/sec 8. Diagnostic specificity and sensitivity of flowrate recording using 9. Urodynamic variables used to predict outcome after surgery 11. Adverse effects due to intravenous administration of contrast 12. Incidence of significant findings in series using IVU and US 14. Combined analysis of adverse events during alpha blocker 85 93 15. Percentages of adverse events in ≥0.5% of patients (phase III finasteride studies only) ... 94 16. Analysis of immediate surgical complications 96 17. Combined analysis of rates of epididymitis and urinary tract infection during followup 98 18. Probability of becoming impotent following surgical treatment for BPH 101 19. Probability of retrograde ejaculation following treatment for BPH .. 20. Combined analysis: stress and total incontinence bladder neck contracture ... 22. Five-year projected treatment failure rates 23. Combined analysis of perioperative mortality 103 106 108 112 121 24. Relative risk and 95% CI of 5-year mortality following TURP, 25. Age-adjusted cumulative risk of death (per 100) after surgery 26. Average individual direct costs of treatment for BPH 28. Hospital stay for Medicare patients (1989) 126 127 129 132 132 29. Outcomes as ranked by 38 proxy judges, listed in descending order of importance 136 3. Mean pre- and posttreatment Qmax for various BPH treatment modalities 78 4. Postvoid residual urine status for various BPH treatment modalities .. 80 5. Mean pre- and posttreatment amount of postvoid residual urine for various BPH treatment modalities 81 6. Percentage of patients experiencing changes in globally assessed BPH symptom status following treatment 84 7. Percent improvement in symptom score following different BPH treatments 87 8. Prevalence of impotence by age category in the general population and in men with BPH ... 100 9. Probability of perioperative mortality following TURP 123 10. Probability of perioperative mortality following: (1) balloon dilation, (2) open surgery-all modalities, (3) TUIP, and (4) TURP 124 11. Treatment choices of proxy judges, stratified by BPH symptom severity .. 137 12. Treatment choices of patients, stratified by BPH symptom severity... 138 13. View of treatment options by patients, stratified by BPH symptom severity. 139 Benign prostatic hyperplasia (BPH), as the most common benign neoplasm in the aging human male, has a high prevalence that increases progressively with age. The prevalence of histologically identifiable BPH for 60-year-old males is greater than 50 percent. By age 85, the prevalence is approximately 90 percent. About one-half of the men with microscopic evidence of BPH will eventually have macroscopic enlargement of the gland (Isaacs, 1990), and approximately one-half of those men will develop clinical symptoms of prostatism. An estimated one in every four men in the United States will be treated for the relief of symptomatic BPH by age 80 (Barry, 1990, 1991). Over 300,000 surgical procedures for BPH, mostly transurethral resection of the prostate (TURP), are performed annually in the United States (Holtgrewe, Mebust, Dowd, et al., 1989). TURP is the second most common surgical procedure performed in the Medicare population, second only to cataract surgery. The resulting related cost is estimated to be in excess of $2 billion per year (Holtgrewe, Mebust, Dowd, et al., 1989). BPH is a noncancerous enlargement of the prostate gland. Four conditions are interrelated with the disease process of BPH: (1) anatomic prostatic hyperplasia, (2) the presence of symptoms commonly referred to as prostatism, (3) the urodynamic presence of obstruction, and (4) the response of the bladder (detrusor) muscle to obstruction (Hald, 1989). Some patients have all four conditions and therefore are most likely to have the disease that physicians consider as BPH. Other patients may have anatomic hyperplasia and urodynamic evidence of obstruction without symptoms of prostatism. They are said to have "silent" prostatism. The dominant risk factors for the development of BPH are increasing age and the presence of androgens. The etiology of the disease remains poorly understood. Long-term outcome data regarding the natural history and treatment of BPH are lacking, and indicators to aid in the proper timing of treatment for BPH are sparse. Because of these uncertainties, there is significant geographic variation in BPH treatment patterns, both among small areas in the United States and among developed countries worldwide. This guideline is intended to identify the most effective methods for diagnosing BPH and to identify and describe the most appropriate treatments for BPH based on patient preference and clinical need. A central tenet of the recommendations in this document is that the patient should be at the center of the decisionmaking process regarding the diagnosis and treatment of his BPH. Diagnosis of BPH Initial Evaluation In the initial evaluation of all patients with prostatism, the following are recommended: ■ A detailed medical history focusing on the urinary tract, previous surgical procedures, general health issues, and fitness for possible surgical procedures, in order to identify other causes of voiding dysfunction and comorbidities that may complicate treatment. For some patients, a "voiding diary" may help in determining the frequency and nature of the complaints. ■ A physical examination, including a digital rectal examination (DRE) and a focused neurologic examination. ■ Urinalysis by dipstick testing or microscopic examination of sediment to rule out urinary tract infection and hematuria. ■ Measurement of serum creatinine to assess renal function. In the initial evaluation, measurement of prostate-specific antigen (PSA) is optional. Testing for PSA increases the detection rate for prostate cancer over DRE alone and may detect the cancer at an earlier stage. However, there is significant overlap in PSA values between BPH and prostate cancer patients. As a result, the PSA test does not discriminate well between patients with symptomatic BPH and those with prostate cancer. Also, there is a lack of consensus regarding the evaluation of minimally elevated PSAs, as many of these tests will be "false positives" in patients symptomatic for BPH. This may lead to unnecessary prostate biopsies. In addition, there is no direct evidence as yet whether the increased diagnosis of prostate cancer through PSA testing will lead to a decrease in morbidity and mortality from the disease. Symptom Assessment The panel believes that quantification of symptom severity is an important step in the evaluation of men with prostatism. For objective quantification of symptoms, the recommended instrument is the self-administered American Urological Association (AUA) Symptom Index, which consists of seven questions relating to symptoms of prostatism. Some patients need help understanding and completing such questionnaires. The AUA instrument, however, is generally considered easy to administer and score. In the AUA scoring system, symptoms are classified as mild (0 to 7), moderate (8 to 19), or severe (20 to 35). The AUA symptom score is recommended for use in treatment planning and periodically in followup. Additional Diagnostic Tests Several specific diagnostic tests, discussed below, are available to further assess patients with a presumptive diagnosis of BPH. Data are insufficient to demonstrate the value of these tests for verifying the diagnosis and predicting the results of treatment. Moreover, the optimal thresholds to define normal and abnormal test values are uncertain. Test results thus do not accurately define the severity of BPH. Use of the tests is not mandatory prior to a decision to treat typical patients with a high probability of BPH based on the recommended evaluation. These specific tests, nevertheless, may be valuable if the diagnosis is less certain following the initial evaluation. Other tests may be useful if the patient and physician select more invasive treatment options such as balloon dilation and surgery. The following tests are optional following the initial evaluation: ■ Uroflowmetry is a test that may be useful in patients with symptoms of prostatism because it will identify those whose maximum flowrate is not markedly diminished. These patients are less likely to have bladder outlet obstruction and may respond less well to therapy. Pressure-flow studies, while invasive, may be useful in patients whose history and/or examination suggest primary bladder dysfunction (for example, from neurologic disease) as the cause for symptoms of prostatism. Pressure-flow studies may be especially useful in patients for whom a distinction between prostatic obstruction and impaired detrusor contractility might affect the choice of therapy. However, pressure-flow studies may or may not be useful in the workup of the usual patient with symptoms of prostatism. ■ Postvoid residual urine (PVR) measurement has not been proven useful in predicting the need for or response to treatment, although patients with large residual urines may have a higher likelihood of failing a watchful waiting treatment strategy. PVR measurements are poorly reproducible for a given patient. However, for patients who elect nonsurgical treatments (including watchful waiting), PVR may be useful in monitoring the course of the disease as PVR measurement may detect worsening obstruction. Repeat measurements should be considered before making treatment decisions based on PVR values. If possible, PVR should be measured noninvasively. ■ Urethrocystoscopy is optional during later evaluation if invasive treatment is being planned. The following tests are not recommended: ■ Imaging of the upper urinary tract by ultrasonography or intravenous urography is not recommended for the typical BPH patient. It should be reserved for BPH patients who have concomitant urinary tract disease or abnormalities (for example, hematuria, urinary tract infection, renal |