PRACTICE Matters 1

Matters PRACTICE PRACTICE Matters

• Symptomatic benign prostatic hyperplasia (BPH)

is one of the most common medical conditions in

older men.

• As many as 40% of men in their 70s have lower

urinary tract symptoms attributed to BPH.

• In the United States, treatment of BPH exceeds

2 billion dollars a year.

• Treatment of BPH accounts for 1.7 million office

visits a year.

• BPH therapy results in more than 200,000

prostatectomies annually.

• Treatment options include lifestyle modification,

device and surgical therapies and pharmaceutical

and plant extracts.

• VA sponsored research has led to important

advances in, and continues to focus on, the

treatment and management of BPH.

DIAGNOSIS

AND

MANAGEMENT

OF BENIGN

PROSTATIC

HYPERPLASIA

A publication of the Management Decision and Research Center

A program within the Department of Veterans Affairs Health Services Research and Development Service

JULY, 1998 VOL. 3 ISSUE 1
2 PRACTICE Matters

TREATMENT GOALS

Treatment goals in the vast majority of men

diagnosed with benign prostatic hyperplasia

(BPH) are to relieve the bothersome

irritative (urgency, frequency, and nocturia) and

obstructive (weak stream, hesitancy, intermittency and

incomplete emptying) symptoms. Treatment options

include lifestyle modification, pharmaceutical and

phytotherapeutic (plant extract) preparations, and

device and surgical therapies.

Indications for and type of treatment recommended

are based on many factors including:

• severity of voiding symptoms

• degree of bother and patient dissatisfaction related

to symptoms

• complications due to BPH (urinary retention, recurrent urinary tract infection, renal insufficiency,

gross hematuria, bladder calculi)

• underlying medical conditions

SYMPTOMS AND DIAGNOSIS

Lower urinary tract symptoms due to BPH are

related to abnormalities in bladder emptying

(weak urinary stream, incomplete bladder emptying,

straining or dribbling) and/or bladder filling (urgency,

frequency, night time disturbance). Symptoms of BPH

can be due to either an enlarged prostate and/or due

to increased smooth muscle tension of the prostate

and bladder.

Quantitative assessment of voiding symptoms is

obtained by using easily administered standardized and

validated urologic symptom and bother scales such as

the American Urologic Association Symptom Index

and the BPH Impact Index Scales. These questionnaires determine the degree of bother and symptom

severity. The severity of symptoms and degree of

bother are the major factors in determining treatment

options.

Regardless of symptom severity or bother, men

should be referred for urologic evaluation if they have

any of the following conditions believed to be due to

BPH:

• recurrent urinary tract infections

• urinary incontinence

• urinary retention

• renal insufficiency

• bladder stones or hematuria.

Men with BPH symptoms are not at greater risk

for having prostate cancer than men without symptoms. Because prostate specific antigen (PSA) levels

are increased with prostate enlargement, routine prostate cancer screening with PSA testing in men with

BPH symptoms will result in an increased number of

falsely abnormal tests requiring additional evaluation.

PSA testing for detection of prostate cancer in men

with BPH symptoms is considered optional. Rather

than routinely ordering a PSA test, doctors should

inform patients of the known risks and uncertain benefits of prostate cancer screening. If routine PSA testing is performed, the assessment of the percentage of

“free or unbound” PSA can help differentiate whether

elevations in PSA levels are due to BPH or prostate

cancer. This may reduce unnecessary biopsies and

additional tests.

THERAPIES

Watchful Waiting

Watchful waiting consists of teaching patientsvarious lifestyle changes and behavioral techniques including: taking extra time to urinate, urinating prior to taking long trips or going to bed, avoiding excess fluids, alcohol, caffeine, cold or allergy

medications as well as switching prescriptions or adjusting dosages of medications such as diuretics and

anticholinergics. This approach has proven beneficial in men with all degrees of symptom severity and

should be considered first line therapy.

Medical Management

Medical management provides several new drugs

which can provide relief for BPH symptoms.

• alpha blockers including terazosin, doxazosin, and

tamsulosin improve both urinary symptoms and

flow measures by reducing smooth muscle tone

from alpha receptor stimulation in the prostate and

the bladder. A large VA Cooperative Trial demonstrated that men with BPH treated with alpha
PRACTICE Matters 3

blockers had clinically and statistically significant

improvement in urologic symptoms and flow rates

compared to finasteride or placebo. The main side

effects from alpha blockers are dizziness (25%),

lethargy (15%) and low blood pressure (8%). Because of their proven effectiveness and lower cost,

alpha blockers are considered the treatment of

choice for pharmacological management of men

with symptomatic BPH.

• 5 alpha reductase inhibitors (finasteride) decrease

mechanical obstruction from hyperplastic tissue by

suppressing formation of dihydrotestosterone and

subsequently reducing prostate size. The treatment

effectiveness is directly proportional to prostate

size. A minority of men with BPH symptoms have

very large prostates and moderate to severe symptoms. In these men, treatment with finasteride has

been shown to improve urinary symptoms and flow

measures. Additionally, finasteride reduces the risk

of acute urinary retention or the need for surgery

by about 6 in 100 compared to placebo. The main

adverse effects of finasteride are impotence and loss

of libido, occurring in 5-10% of men.

Alternative Therapies

Phytotherapeutic compounds (plant extracts) are

readily available as over the counter health supplements.

The most widely used preparation for BPH is an extract from the ripe fruit of the saw palmetto plant, Serenoa repens. The therapeutic mechanism of action is not

known but it is the first line pharmacologic therapy for

symptomatic BPH in Europe. A recent systematic review of 18 randomized trials determined the safety and

efficacy of saw palmetto with either placebo or

finasteride. The results indicate that saw palmetto improves urinary symptoms and flow measures more than

placebo. Compared to finasteride, saw palmetto provides similar improvement in urinary symptoms and

flow measures. It appears to be a safe and relatively

inexpensive option for men with mild to moderate BPH

symptoms. The long term effectiveness of saw palmetto

is not established and it has not been adequately compared to alpha blockers.

Device Therapies

The potential advantages of minimally invasivedevice therapies over transurethral resection of

the prostate (TURP) include: use in an outpatient

setting under local anesthesia, fewer serious

complications and reduced costs. Minimally invasive

therapies for BPH treatment include:

• prostatic stents

• microwave therapy

• high frequency ultrasound, and

• transurethral needle ablation

Randomized trials have compared the effectiveness

of several of these minimally invasive therapies to

TURP. In appropriately selected individuals they appear to provide similar improvements in urinary symptoms and flow measures. Therefore, these minimally

invasive therapies may be preferable in certain high

risk patients or those men desiring less invasive treatment approaches.

Surgical Management

TURP is considered the gold standard therapy andthe treatment of choice for improving urologic

symptoms and flow measures in men with severe

symptoms or complications related to BPH. A VA Cooperative Trial demonstrated that TURP was more

effective than watchful waiting particularly among

men with more bothersome disease. There were no

differences in impotence and incontinence rates between men treated with and without surgery.

Alternate surgical procedures include:

• transurethral incision of the prostate

• laser prostatectomy and

• transurethral electro vaporization

For appropriate patients these surgical treatments

can provide similar improvement in urinary symptoms

with reduced risk of bleeding and/or other complications and can usually be performed on an out-patient

basis.
4 PRACTICE Matters

B

CLINICAL VIEWPOINT

enign prostatic hyperplasia, often referred to

as “prostatism” by urologists, is extremely

common in the aging male, affecting an estimated 14,000,000 men over the age of 50. The simplest and most effective tool available to evaluate this

clinical problem is the American Urologic Association Symptom and Bother Score (AUASS). This instrument asks patients a series of seven questions,

which have a range of answers scored from 0-5. Zero

means the patient is completely asymptomatic, and

five means that they have the severest possible symptoms. The sum total of all seven responses gives the

patient’s final AUASS.

• Mild symptoms are defined as a score of ≤ 7

• moderate symptoms from 8-19, and

• severe symptoms from 20-35.

Therapeutic intervention is generally predicated on

these scores as follows.

• mild symptoms managed by watchful waiting

• moderate symptoms with alpha adrenergic receptor blockers or 5-alpha reductase inhibitors (which

are generally used only for glands ≥ 40 grams), and

Continued on page 5

EVIDENCE SUGGESTS:

• Initial BPH evaluation should consist of a history,

physical examination including digital rectal examination, urinalysis and creatinine. Prostate specific

antigen testing for the purpose of early detection

of prostate cancer is optional. Rather than screening all men for prostate cancer, doctors should inform patients of the known risks and potential benefits of screening, diagnosis and treatment.

• Quantitative symptom assessment using validated

questionnaires should be performed to determine

symptom severity and degree of bother.

• Men with mild symptoms should be treated with

watchful waiting and lifestyle management.

• Phytotherapy with saw palmetto may be a safe and

effective alternative therapy for men with mild to

moderate BPH symptoms.

• Alpha blockers are the preferred pharmacologic

therapy for improving urinary symptoms and flow

measures regardless of prostate size. Combination

therapy with finasteride provides no greater improvement in symptoms or flow measures than alpha blockers alone.

• Men with moderate to severe symptoms should be

offered treatment options that include pharmacologic, surgical and device therapies. Men with more

severe symptoms and/or a higher degree of bother

are more likely to benefit from surgical or device

therapies.

• Finasteride is useful in improving symptoms and

preventing urinary retention and the need for surgical intervention in men with large prostates who

have moderate to severe symptoms.

• Urology referral should be made for urinary retention or any of the following: recurrent urinary

tract infection, incontinence, hematuria, bladder

stones or renal insufficiency.

• Incorporating shared decision making in the diagnosis and management of benign and malignant

prostate conditions has been shown to improve

patients’ knowledge and satisfaction and has influenced treatment decisions.

Acknowledgments

This Diagnosis and Management of Benign Prostatic Hyperplasia issue of VA Practice Matters was

written by Timothy J. Wilt, M.D., M.P.H. of the

VA Cochrane Review Group in Prostatic Diseases and Urologic Malignancies and the Minneapolis/VISIN 13 Center for Chronic Disease

Outcomes Research. Other major contributors/

reviewers were: Carol M. Ashton, M.D., M.P.H.,

Associate Director, Houston Center for Quality

of Care and Utilization Studies; John G.

Demakis, M.D., Director, VA Health Services

Research and Development Service; Brian J.

Miles, M.D., Associate Professor, Baylor College

of Medicine; Ronald J. Gebhart, M.D., Chief

Consultant, Primary and Ambulatory Care;

Claus G. Roehrborn, M.D., The University of

Texas, Southwestern Medical Center, Department of Urology. The issue was edited by

Geraldine McGlynn, M.Ed. and Elaine Alligood,

M.L.S. of VA’s Management Decision and Research Center.
PRACTICE Matters 5

CLINICAL VIEWPOINT

Continued on page 5

• severe symptoms with a trial of alpha blockers or

surgical intervention

However, all men with moderate symptoms do not

by definition require treatment. If a patient is not

bothered by his symptoms then watchful waiting can

be entertained. Virtually all men with severe symptoms will pursue and require medical/surgical therapy.

The evaluation of symptomatic benign prostatic

hyperplasia remains somewhat controversial. Urologists strongly recommend a PSA in all patients. As

listed by the American Cancer Society, the symptoms

of BPH are also the symptoms of prostate cancer.

When men seek an evaluation of their prostate, they

are also seeking reassurance that they do not have

prostate cancer. A PSA should not be performed without a patient’s consent, but should always be offered.

Furthermore, digital rectal exams should always be

performed. Although the AHCPR lists postvoid residual and creatinine levels as optional, in patients with

severe symptoms it is prudent to obtain these to rule

out chronic retention or associated azotemia. Urologists invariably will perform urinary flow rates as an

objective guide to therapeutic response, but for the

primary care doctor, improvement in the AUASS is

an adequate surrogate for other objective parameters.

The physician managing symptomatic benign prostatic hyperplasia must have a firm understanding of

those diseases that can mimic or worsen the symptoms

of this disease. For instance, diabetes mellitus with glycosuria will cause urinary frequency and urgency. It is

also important for the primary care physician to know

when to refer the patient to a urologist for further evaluation. The patient should be referred if hematuria is

found on routine urinalysis, if they are refractory to

medical therapy, if bladder calculi or urethral strictures

are suspected, if they have an elevated PSA or abnormal digital rectal examination, and for severe symptoms in young men in their 40s or 50s.

Primary care physicians should be comfortable

treating this disease with a complete and full understanding of its pathophysiology and a recognition of

those factors that should lead to the referral to urologic surgeons.

Brian J. Miles, M.D.

Associate Professor

Baylor College of Medicine

Scott Department of Urology

The Under Secretary for Health recently

appointed a committee to develop practice

guidelines for BPH in VA. Guidelines will be

available September, 1998.

REFERENCES:

Wasson JH, Reda DJ, Bruskewitz RC, Elinson J, Keller AM,

and Henderson WG. A comparison of transurethral surgery

with watchful waiting for moderate symptoms of benign

prostatic hyperplasia. N Engl J Med 1995;332:75-9.

Lepor H, Williford WO, Barry MJ, Brawer MK, Dixon CM,

Gormley G, et al. The efficacy of terazosin, finasteride, or both

in benign prostatic hyperplasia. N Engl J Med 1996; 335:533-9.

McConnell JD, Bruskewitz R, Walsh P, Andriole G, Lieber M,

Holtgrewe HL, et al. The effect of finasteride on the risk of

acute urinary retention and the need for surgical treatment

among men with benign prostatic hyperplasia. N Engl J Med

1998;338:557-63.

Schutz MJ editor. Management of Benign Prostatic Hyperplasia for Primary Care. Federal Practitioner 1996;13(10S):1-28.

Wilt TJ. Prostate cancer screening. Practice what the evidence

preaches. Am J Med 1998; 104:602-604.

Wilt TJ, Ishani A, MacDonald R, Stark G, Mulrow C, Lau J.

Serenoa repens for treatment of Benign Prostatic Hyperplasia:

a meta-analysis. VA HSR&D Annual Meeting 1998;16:67-68.

VA Practice Matters is a publication for VA decision makers and practitioners that summarizes the results of important research to help

inform policy and to promote the application

of research for improved health care delivery

and decision making within VA. It is produced

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field. For more information or to provide us

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