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Agency for Health Care Policy and Research (US). AHCPR Quick Reference Guides. Rockville (MD): Agency for Health Care Policy and Research (US); 1992-1996.
This publication is provided for historical reference only and the information may be out of date.
Purpose and Scope
Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in the aging human male. The prevalence of histologically identifiable BPH increases progressively. By age 60, prevalence is greater than 50 percent, and by age 85, approximately 90 percent of men will have microscopic evidence of BPH. About half of these men will eventually have macroscopic enlargement of the gland, and approximately half of those will progress to clinical symptoms of prostatism requiring treatment.
It is estimated that one in every four men in the United States will require treatment for the relief of symptomatic BPH by age 80. More than 300,000 surgical procedures for BPH are currently performed annually in the United States, most commonly transurethral resection of the prostate (TURP).
Like the Clinical Practice Guideline, this Quick Reference Guide for Clinicians applies to men over age 50 with symptoms of prostatism (for example, frequency of urination and a weak stream), but with no significant medical morbidities (such as diabetes) or other known causes of voiding dysfunction (such as urethral stricture or neurogenic bladder). The men to whom this guide applies would not be at increased risk from surgery or the other recognized treatments for BPH. At least two-thirds of the BPH patients in most clinical settings conform to the above patient profile.
If results of the initial evaluation of the patient (see the decision diagram, Figure 2, page 10) are not consistent with the diagnosis of BPH or reveal additional pathologic findings, further diagnostic testing is warranted. Management of these patients is outside the BPH guideline and therefore not covered here. For example, identification of microscopic hematuria in the initial examination clearly warrants further testing while automatically placing the patient outside the diagnostic guideline for BPH, at least temporarily.
Figure
Figure 2: Decision Diagram.
This Quick Reference Guide for Clinicians should preferably be used with the American Urological Association (AUA) Symptom Index, a seven-item self-administered symptom questionnaire for patients (Figure 1, page 4). The AUA Symptom Index quantitatively measures the level of symptoms of prostatism. Use of a standard symptom-scoring instrument is recommended as an integral part of BPH patient management.
The BPH patient will benefit from reading Treating Your Enlarged Prostate: Patient Guide,which is available from AHCPR. It contains information about the prostate, BPH, and the treatment options available
Figure 1: AUA Symptom Index
| Questions to be answered | AUA Symptom Score (Circle 1 number on each line) | ||||||
|---|---|---|---|---|---|---|---|
| Not at all | Less than 1 time in 5 | Less than half the time | About half the time | More than half the time | Almost always | ||
| 1. | Over the past month, how often have you had a sensation of not emptying your bladder completely after you finished urinating? | 0 | 1 | 2 | 3 | 4 | 5 |
| 2. | Over the past month, how often have you had to urinate again less than 2Êhours after you finished urinating? | 0 | 1 | 2 | 3 | 4 | 5 |
| 3. | Over the past month, how often have you found you stopped and started again several times when you urinated? | 0 | 1 | 2 | 3 | 4 | 5 |
| 4. | Over the past month, how often have you found it difficult to postpone urination? | 0 | 1 | 2 | 3 | 4 | 5 |
| 5. | Over the past month, how often have you had a weak urinary stream? | 0 | 1 | 2 | 3 | 4 | 5 |
| 6. | Over the past month, how often have you had to push or strain to begin urination? | 0 | 1 | 2 | 3 | 4 | 5 |
| 7. | Over the past month, how many times did you most typically get up to urinate from the time you went to bed at night until the time you got up in the morning? | 0 (None) | 1 (1 time) | 2 (2 times) | 3 (3 times) | 4 (4 times) | 5 (5 times or more) |
| Sum of 7 circled numbers (AUA Symptom Score): | |||||||
Source: Barry, Fowler, O'Leary, et al., 1992a. Used with permission.
Highlights of Patients Management
Presumptive Diagnosis of BPH
Symptoms of prostatism include frequency of urination, nocturia, urgency, straining to urinate, hesitancy, weak stream, intermittent stream, and a sensation of incomplete emptying. A patient may present with one or more symptoms. Symptoms of prostatism are due to the direct effects of obstruction on urinary flow (for example, weak stream) and to secondary changes in bladder function (such as frequency or urgency of urination).
Palpable prostate enlargement is common. However, prostate size does not correlate with symptom severity or the degree of obstruction. Other presumptive diagnostic hallmarks include patient age of 50 or over and the absence of other known causes of symptoms of prostatism such as urinary tract infection, neurogenic bladder dysfunction, urethral stricture, and prostate cancer (all of which can produce prostatism-like symptoms).
Complications of BPH
Long-standing BPH can, although not frequently, result in urinary retention (complete inability to urinate requiring catheterization), renal insufficiency, urinary tract infections, gross hematuria, or bladder stones.
No known clinical variables (history, examination, test, and procedure results) reliably predict which untreated patients will have a complication. Patients should be monitored for these complications, particularly if they follow a strategy of watchful waiting or are treated with drugs or balloon dilation.
Diagnostic Evaluation
Initial Evaluation
The following are recommended in the initial evaluation of all patients presenting with prostatism, with the exception of testing for prostate- specific antigen (PSA) (which is optional)
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 also be helpful in determining the frequency and nature of the complaints.
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.
Measurement of PSA is optional in the initial evaluation. Testing for PSA increases the detection rate for prostate cancer over DRE alone and tends to detect cancer at an earlier stage. However, the PSA test does not discriminate well between patients with symptomatic BPH and those with prostate cancer, particularly if the cancers are pathologically localized and curable. There is significant overlap in PSA values between BPH and cancer patients. Also, there is a lack of consensus regarding the evaluation of minimally elevated PSAs. The test may trigger additional evaluation, including ultrasound and biopsy of the prostate. In addition, there is no evidence yet whether PSA testing will or will not lead to a decrease in morbidity and mortality from prostate cancer.
Symptom Assessment
For quantification of symptoms by using a symptom questionnaire, the preferred instrument is the self-administered AUA Symptom Index (Figure 1, page 4). It consists of seven questions relating to symptoms of prostatism. Some patients need help completing such a questionnaire, especially if there is a language barrier or if the patient cannot read. The AUA instrument, however, is particularly easy to administer.
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 Index should be used in treatment planning and periodically in followup. The AUA Symptom Index, however, should not be used as the sole means of diagnosing BPH, because the symptoms are not specific for BPH.
Additional Diagnostic Tests
Several additional diagnostic tests, discussed below, are available to assess patients with BPH. Data are insufficient to demonstrate the value of these tests in routine patients for confirming the diagnosis of BPH and predicting the results of treatment. Moreover, the definition of normal and abnormal test values is uncertain. Results from these tests thus do not define BPH, and their use is not mandatory prior to a decision to treat.
Some tests may, nevertheless, be useful in selected patients if the diagnosis is uncertain following the initial evaluation. Other tests may be useful if the patient and physician choose an invasive treatment option such as balloon dilation or surgery.
Optional Tests
The following tests are optional after 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 diminished and who are less likely to benefit from therapy.
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 strategy. PVR is poorly reproducible for a given patient. However, for patients who elect nonsurgical treatments (including watchful waiting), PVR may be helpful in monitoring the course of the disease as it may detect worsening bladder function. If possible, PVR should be measured noninvasively.
Pressure-flow studies, although invasive, are particularly helpful in patients whose history and/or examination suggest primary bladder dysfunction (for example, from neurologic disease) as the cause for symptoms of prostatism. They are also 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.
Urethrocystoscopy is optional during later evaluation if invasive treatment is being planned.
Tests Not Recommended in Routine Cases
Imaging of the upper urinary tract by ultrasonography or intravenous urography is not recommended for the typical BPH patient. It should be reserved for patients with urinary tract complications of BPH or patients who have concomitant urinary tract disease or abnormalities (for example, hematuria, urinary tract infection, renal insufficiency, previous urinary tract surgery, or a history of urinary tract stones).
Filling cystometry (cystometrography or CMG) is not recommended in the evaluation of typical patients with symptoms of prostatism. It may be useful in the evaluation of patients with suspected neurologic diseases or to determine why individual patients fail to improve after prostate surgery. However, pressure-flow studies are a superior alternative in these circumstances. In patients with suspected primary bladder or neurologic lesions and who cannot urinate (retention), filling cystometry may be useful.
Urethrocystoscopy is not recommended as a procedure to determine the need for treatment. It is optional for patients electing invasive therapy (surgery or balloon dilation) in order to assess prostate size and configuration. Urethrocystoscopy may be performed prior to scheduling or in the operating room prior to the procedure. The advantage of urethrocystoscopy prior to scheduling is that the patient can be informed of the results and can participate in the final decision on treatment (for example, surgery as opposed to balloon dilation, transurethral incision of the prostate as opposed to transurethral resection of the prostate). Transabdominal bladder/prostate ultrasonography, but not intravenous urography, can provide the same information on prostate size and configuration noninvasively.
Treatment
Asymptomatic patients with prostate enlargement due to BPH generally do not require treatment. For those patients who have specific complications due to BPH (see page 2), prostate surgery is usually the most appropriate form of treatment. All other patients should, in consultation with their physicians, decide on the treatment after understanding the likely outcomes of each potential treatment.
The depth of information needed will vary from patient to patient. To make a treatment decision, the patient needs to consider how bothered he is by his symptoms and his attitude toward the likely benefits and risks of each treatment option. The health care provider can help guide the patient in making the most appropriate treatment decision.
Watchful Waiting
Watchful waiting is an appropriate treatment strategy for the majority of patients. The probability of disease progression or the development of BPH complications is uncertain. Until research defines these probabilities, patients treated by watchful waiting should be monitored periodically by reassessment of symptom level, physical findings, routine laboratory testing, and optional urologic diagnostic procedures. No studies define the optimal interval for followup. Annual followup is reasonable, but supported only by subjective judgment.
Surgery
Of all treatment options, prostate surgery offers the best chance for symptom improvement. However, surgery also has the highest rates of significant complications. Transurethral resection of the prostate (TURP) is the most commonly used surgical treatment for BPH. Transurethral incision of the prostate (TUIP), a procedure of almost equivalent efficacy, is limited to prostates whose estimated resected tissue weight (if done by TURP) would be 30 grams or less. TUIP can be performed in ambulatory settings or during a 1-day hospitalization. Open prostatectomy is typically performed on patients with very large prostates.
Given proper patient selection, benefits are probably equivalent for each surgical procedure, but complication rates differ between the procedures. Open prostatectomy, for example, has greater incisional morbidity and a longer recovery time than other procedures. TUIP has the lowest morbidity and ejaculatory disturbance rates. Given that prostates of men undergoing surgery average less than 30 grams of resected weight, TUIP is an underutilized procedure
Surgery need not be a treatment of last resort for most patients; that is, patients need not undergo other treatments for BPH before they can have surgery.
However, recommending surgery on the ground that a patient's surgical risk will only increase with age is inappropriate. BPH progresses slowly and quite variably among patients.
Balloon Dilation
Balloon dilation of the prostatic urethra is clearly less effective than surgery for relieving symptoms but is associated with fewer complications. Recent studies suggest that improvement may be temporary, with recurrence of symptoms within 2 years. At present, balloon dilation is a reasonable treatment option for patients with smaller prostates and no middle lobe enlargement. However, TUIP can be performed in the same patients with superior efficacy, with similar morbidity, and in similar outpatient settings.
Alpha Blockers
Alpha-1-adrenergic receptor blockers (such as doxazosin, prazosin, and terazosin) relax smooth muscle of the bladder neck and prostate. In the average patient, they cause a small increase in peak urinary flowrate (Qmax) and a small but perceptible reduction in symptoms. Approved by the Food and Drug Administration (FDA) for treating hypertension, alpha blockers are also widely used by physicians for treating BPH. The FDA has recently approved terazosin to treat BPH. Other alpha blockers are under FDA review for BPH treatment.
Titration of dose is necessary. Long-term efficacy has not been determined. Side effects include orthostatic hypotension, dizziness, tiredness, and headache. The nonselective alpha blocker phenoxybenzamine is not recommended because of a higher incidence of side effects. Also, there is no evidence that alpha blockers reduce BPH complication rates or the need for future surgery.
Finasteride
The drug finasteride was approved in 1992 by the FDA for treatment of BPH. Finasteride is a 5-alpha reductase inhibitor that blocks conversion of testosterone to dihydrotestosterone, the major intraprostatic androgen in men. The drug is taken orally once a day. It can reduce the size of the prostate. It causes a small average increase in Q[max], and for some men a small yet perceptible reduction in symptoms. Six months or more are required for maximal effects. Long-term efficacy has not been documented.
Side effects are mainly sexually related and include decreased libido, ejaculatory dysfunction, and impotence. Finasteride also lowers serum PSA approximately 50 percent. How this affects the utility of PSA as a cancer-detection tool is unknown. As with alpha blockers, there is currently no evidence that finasteride reduces BPH complication rates or the need for future surgery.
New Technologies
Emerging technologies for treating BPH include lasers, coils, stents, thermal therapy, and hyperthermia. The BPH panel reviewed these new therapies but found the data currently insufficient to permit conclusions regarding the safety and efficacy of these modalities in routine practice. Laser prostatectomy appears promising, but its benefits and risks relative to TURP and TUIP are uncertain and long-term effectiveness has not yet been demonstrated.
Decision Diagram: Management of BPH
The decision diagram is provided as a framework for diagnosis and treatment (Figure 2). It is not intended as a rigid pathway that must be followed in all cases. Individual patients will present in whom deviations from these policies are appropriate. In such circumstances, the health care provider should exercise clinical judgment and act in the patient's best interest.
The terms recommended, optional, and not recommended indicate degrees of desirability for specific diagnostic interventions. The terms standard, guideline, and option indicate intended degrees of flexibility for treatment policies. Patients with prostate enlargement without symptoms of prostatism should not be evaluated for BPH treatment, but reassessed periodically.
1. Initial Evaluation (Recommended)
Detailed history
Urinary tract symptoms, prior urinary tract surgery/other treatment. Medical disease, to evaluate fitness for BPH treatments.
Physical examination
Includes focused neurologic examination as well as digital rectal examination.
Digital rectal examination (DRE)
Prostate size and/or palpable abnormalities. Anal sphincter tone.
Urinalysis
Dipstick (including test of bacteriuria, hematuria, and/or pyuria) or examination of the spun sediment.
Creatinine
Elevated value suggests need for upper urinary tract imaging, preferably by ultrasonography.
PSA
Optional.
2. Prostate Surgery (Guideline)
There is a treatment-policy guideline for surgery if any of these urinary tract conditions are present secondary to BPH.
3. Quantitative Symptom Assessment
Ask patient to complete AUA Symptom Index questionnaire (Figure 1) (Recommended). Put completed AUA form in medical record.
4. Mild Symptoms (Symptom Score = 0-7)
Offer watchful waiting only (Standard). Reassure patient. Reassess periodically. Risks outweigh benefits for all treatments except watchful waiting. Most patients prefer watchful waiting.
5. Moderate Symptoms (Symptom Score = 8-19) to Severe Symptoms (Symptom Score = 20-35)
Offer treatment options (Guideline).
Provide the patient with a copy of Treating Your Enlarged Prostate: Patient Guide (Guideline).
Discuss treatment options, including benefits and risks, after patient reads the Patient Guide (Guideline).
Moderate symptoms: Wide variation in patient preferences. A substantial number of patients prefer watchful waiting.
Severe symptoms: More patients prefer surgery to other treatment options. There is still a wide variation in patient preferences overall.
6. Diagnostic Tests: To Confirm BPH Diagnosis (Optional)
Uroflowmetry, pressure-flow studies, postvoid residual urine (PVR) volume, if cause of symptoms is uncertain after the initial evaluation.
Consider pressure-flow studies if peak flowrate is normal (>15 mL/sec), if patient is at higher risk for a primary bladder problem (known neurologic disease), or in patients for whom a distinction between prostatic obstruction, detrusor instability, and/or impaired detrusor contractility might affect the choice of therapy.
7. Offer Treatment Alternatives
Educate patient about each treatment option; give him a copy of Treating Your Enlarged Prostate: Patient Guide (Guideline).
Review benefits and risks of each option.
Assess patient attitudes toward each treatment option.
Help patient to assess treatment options and select one.
8. Watchful Waiting
Periodic (probably annual) reassessment: review symptoms (AUA Symptom Index), physical findings, laboratory testing (Guideline).
Uroflowmetry and postvoid residual urine determination (Optional).
9. Optional Testing to Plan an Invasive Procedure, Not Used to Determine Need for Treatment
Urethrocystoscopy or transabdominal bladder/prostate ultrasonography to help surgeon plan prostate surgery or balloon dilation by determining prostate size and configuration.
Assessment of Treatment Outcomes
Introduction
The number ranges on the Balance Sheet (Figure 3) are 90-percent confidence intervals for the likelihood that a given outcome will follow a given treatment. A wide range indicates that there is considerable uncertainty regarding the likelihood of the outcome.
Figure 3: Balance Sheet for BPH Treatment Outcomes
| Surgical Options | Nonsurgical Options | ||||||
|---|---|---|---|---|---|---|---|
| Direct treatment outcomes | Balloon dilation | TUIP | Open surgery | TURP | Watchful waiting | Alpha blockers | Finasteride |
| Chance for improvement of symptoms (90% confidence interval) | 37-76% | 78-83% | 94-99.8% | 75-96% | 31-55% | 59-86% | 54-78% |
| Degree of symptom improvement (percent reduction in symptom score) | 51% | 73% | 79% | 85% | Unknown | 51% | 31% |
| Morbidity/complications associated with surgical or medical treatment (90% from BPH confidence interval), progression about 20% of all complications assumed to be significant | 1.78-9.86% | 2.2-33.3% | 6.98-42.7% | 5.2-30.7% | 1-5% complications from BPH progression | 2.9-43.3% | 13.6-18.8% |
| Chance of dying within 30-90 days of treatment (90% confidence interval) | 0.72-9.78% (high-risk/elderly patients) | 0.2-1.5% | 0.99-4.56% | 0.53-3.31% | 0.8% | chance of death <= 90 days for 67-year-old man | |
| Risk of total urinary incontinence (90% confidence interval) | Unknown | 0.06-1.1% | 0.34-0.74% | 0.68-1.4% | Incontinence associated with aging | ||
| Need for operative treatment for surgical complications in future (90% confidence interval) | Unknown | 1.34-2.65% | 0.6-14.1% | 0.65-10.1% | 0 | ||
| Risk of impotence (90% confidence interval) | No long-term followup available | 3.9-24.5% | 4.7-39.2% | 3.3-34.8% | About 2% of men age 67 become impotent per year. Long-term data on alpha blockers are not available. | 2.5-5.3% (also decreased volume of ejaculate) | |
| Risk of retrograde ejaculation (percent of patients) | Unknown | 6-55% | 36-95% | 25-99% | 0 | 4-11% | 0 |
| Loss of work time (days) | 4 | 7-21 | 21-28 | 7-21 | 1 | 3.5 | 1.5 |
| Hospital stay (days) | 1 | 1-3 | 5-10 | 3-5 | 0 | 0 | 0 |
Explanation of Balance Sheet Table
Line 1: Likelihood that given patient will experience some symptom improvement; likelihood of improvement is greater if pretreatment symptoms are more severe.
Line 2: Expected amount of improvement (for patients who improve).
Line 3: Likelihood that given patient will have treatment complications or adverse events.
Line 4: Likelihood that given patient will die due to any causes within 3 months of treatment.
Line 5: Likelihood that given patient will experience total incontinence due to the treatment.
Line 6: Likelihood that given patient will require surgical correction for a late complication of BPH treatment such as bladder neck contracture or urethral stricture.
Line 7: Likelihood that a patient who was potent prior to treatment will experience impotence following treatment.
Line 8: Likelihood that a patient who was potent before treatment and still potent after treatment will experience retrograde ejaculation following treatment.
Line 9: Estimated number of days a given patient may miss from work during first year of treatment.
Line 10: Estimated number of days spent in hospital.
AHCPR Publication No. 94-0583.
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