Treatment of Benign Prostatic 

Hyperplasia: A Synthesis of the

Evidence

Benign prostatic hyperplasia (BPH) causes urinary hesitancy and 

intermittency, weak urine stream, nocturia (urinating at night), 

frequency, urgency, and the sensation of incomplete bladder emptying. 

These symptoms, collectively called “lower urinary tract symptoms,” or 

LUTS, can significantly reduce quality of life. Men with no symptoms or 

mild symptoms and those who tolerate moderate symptoms well, may 

be managed without pharmacotherapy (“watchful waiting”). For those 

who have moderate or severe symptoms, medical treatments include 

alpha-1-selective adrenergic receptor (a-1-AR) antagonists, 5-alphareductase inhibitors (5-aRIs), or a combination therapy with one drug 

from each of these classes. 

Investigators at the Portland VA Medical Center, and part of HSR&D’s 

Evidence Synthesis Pilot Program, conducted a comprehensive 

literature review of studies (conducted from 1966 through July 2006) 

on the treatment of BPH to assess the evidence regarding effective 

treatment. Following is a summary of their findings, submitted as part 

of a Final Report to HSR&D’s Central Office.

Report Results

Combination therapy versus an alpha blocker or 5-ARI alone

In the first year of treatment, alpha blockers are more effective than 

finasteride in improving symptoms. Combination therapy and an alpha 

blocker alone have similar effects on quality of life in the first year and 

a half of treatment.

For men who have BPH and a large prostate, or a high PSA at baseline, 

combination therapy can prevent about two episodes of clinical 

progression per 100 men, per year over 4 years of treatment. There is 

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no additional benefit within the first year of treatment. Most men who 

take combination therapy will have no additional benefit, and about 4 

additional patients per 100 will become impotent, who would not have 

taking an alpha blocker alone. Combination therapy also can be 

instituted after clinical progression occurs, but this strategy, while used 

widely, has not been studied.

There is considerable uncertainty about how best to monitor PSA in 

those who choose to take finasteride or combination therapy, and who 

are otherwise candidates for PSA screening. Candidates for combination 

therapy—patients who have large prostates and at least moderate 

symptoms—tend to have higher PSA levels than other patients who 

have BPH. Finasteride reduces prostate size and PSA levels, making 

detection of prostate cancer more difficult. Alpha-blockers do not affect 

PSA levels. Expanding access to combination therapy as an initial 

option would require higher utilization of ultrasound and PSA testing in 

BPH patients to assess the risk of progression. The consequences of 

such a program in a primary care setting have not been studied.

Choice of Alpha-Blocker

Previous, good-quality systematic reviews found that the alpha 

blockers, including alfuzosin prolonged-release and doxazosin GITS, 

have similar efficacy in improving symptoms related to urinary flow 

rate. Observational studies of doxazosin, terazosin, and tamsulosin in 

selected patients indicate that in most patients who respond to an 

alpha blocker and tolerate it well initially, the drug continues to work 

and to be well-tolerated for many years.

Head-to-head trials of alpha-blockers are few, small and have serious 

limitations. They do not adequately test commonly held beliefs about 

differences in the side-effect profiles of the alpha-blockers. Specifically, 

they do not prove that tamsulosin causes fewer cardiovascular adverse 

effects than other alpha-blockers because it does not reduce blood 

pressure. In placebo-controlled trials, tamsulosin caused higher rates of 

sexual ejaculation abnormalities than other alpha blockers. The placebocontrolled trials do not adequately test the hypothesis that use of 

tamsulosin as an initial therapy reduces the risk of symptomatic 

hypotension.

For combination therapy, doxazosin is the best-studied alpha blocker.

Treatment of BPH in subgroups of patients

Long-term observational studies establish that BPH can be treated 

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safely with alpha blockers in patients taking other medications for 

hypertension. Alpha-blockers should not be used as initial treatment for 

patients with hypertension, even those with BPH, because they are 

associated with poorer long-term outcomes than other choices. Data on 

the safety of alpha-blockers in patients taking erectile dysfunction 

drugs are sparse.

Recently, the FDA issued a notice that intra-operative Floppy Iris 

Syndrome (IFIS) has been observed during phacoemulsification 

cataract surgery in some patients currently or recently treated with 

tamsulosin.

Hefland M and Muzyk T. Comparative effectiveness review on benign prostatic hyperplasia (BPH) 

management in primary care – Screening and therapy. Final Report, September, 2006. 

Department of Veterans Affairs, Health Services Research & Development Service, Evidence 

Synthesis Pilot Program. 

NOTE: This Report does not represent a medication usage guideline, nor should it be read as an 

endorsement of, or recommendation for any particular drug, use or approach. Moreover, the 

Portland VA Medical Center does not recommend or endorse any guideline or recommendation 

developed by users of these reports.