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Official reprint from UpToDate®

www.uptodate.com © 2023 UpToDate, Inc. and/or its affiliates. All Rights Reserved.

Medical treatment of benign prostatic hyperplasia

Author: Kevin T McVary, MD, FACS
Section Editor: Michael P O'Leary, MD, MPH
Deputy Editor: Jane Givens, MD, MSCE

All topics are updated as new evidence becomes available and our peer review process is complete.

Literature review current through: Feb 2023. | This topic last updated: Jan 23, 2023.

INTRODUCTION

Benign prostatic hyperplasia (BPH) increases in prevalence as men age. Urinary symptoms
include increased frequency of urination, nocturia, hesitancy, urgency, and weak urinary
stream. Treatment includes medical and surgical options.

The medical therapy of BPH will be reviewed here. The clinical manifestations and diagnosis,
epidemiology and pathogenesis, and surgical and other invasive therapies of BPH are all
discussed separately. (See "Clinical manifestations and diagnostic evaluation of benign prostatic
hyperplasia" and "Epidemiology and pathophysiology of benign prostatic hyperplasia" and
"Surgical treatment of benign prostatic hyperplasia (BPH)".)

Treatment of lower urinary tract symptoms (LUTS) in men due to etiologies other than BPH is
also discussed separately. (See "Lower urinary tract symptoms in males".)

GENERAL CONSIDERATIONS

Lifestyle modifications — Lifestyle modifications and behavioral interventions are first-line

treatments for all patients.

Lifestyle modifications include:

● Limiting fluid intake before bedtime or prior to travel

● Limiting intake of mild diuretics (eg, caffeine, alcohol)
● Limiting intake of bladder irritants (eg, highly seasoned or irritative foods)
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● Avoiding constipation
● Increasing activity, including regular strenuous exercise
● Weight control

Additional behavioral interventions include:

● Kegel exercises at time of urinary urgency. (See "Patient education: Pelvic muscle (Kegel)
exercises (The Basics)".)

● Timed voiding regimens – In patients who exhibit obstructive complaints (ie, decreased
force of stream) or who are noted to carry a high post-void residual, instructing them to
attempt to empty their bladder based on a time interval rather than by the usual
sensations can be effective in reducing lower urinary tract symptoms (LUTS). Requesting
that they urinate “by the clock” (every 90 to 120 minutes during the daytime) seems to be
effective.

● Double-voiding techniques – Similarly, men who complain of obstructive symptoms may

benefit by following one urination by a second attempt at emptying (the double void)
within a minute or two of the initial void.

Treatment considerations — Most commonly, treatment is indicated for symptom relief, if

lifestyle and behavioral modifications do not suffice. In a smaller subset of men, treatment is
need to reverse complications of LUTS/benign prostatic hyperplasia (BPH) such as a rising post-
void residual urine, bladder stone, associated hydronephrosis (with or without renal
compromise), or recurrent UTI. Symptoms include those of storage (frequency, urgency, and
nocturia) and voiding (slow or decreased force urinary stream, straining to void, intermittency,
hesitancy, and splitting of the voiding stream). (See "Lower urinary tract symptoms in males".)

We engage patients in a shared decision-making process to choose the preferred treatment

after initial evaluation [1]. Patients should be provided with the risk/benefit profile for all
treatment options. Symptomatic patients may benefit from medical or surgical treatment.
However, patients should generally be trialed on medical management before proceeding to
surgical intervention. If patients do not respond adequately to medical management, they
should be considered for surgical therapy to relieve obstruction and improve LUTS and overall
quality of life.

If medical treatment is considered, the patient should continue lifestyle modifications (see
'Lifestyle modifications' above). During medical treatment, it is recommended that the patient
be monitored to assess treatment success and possible adverse events. The time from the
initiation of therapy to treatment assessment varies according to the pharmacologic agent
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prescribed. If the treatment is successful and the patient is satisfied, yearly follow-ups should
be scheduled and include a repeat of the initial evaluation. The follow-up strategy will allow the
clinician to detect any changes that have occurred and, more specifically, if symptoms have
progressed or become more severe or if a complication has developed that requires surgery.
(See "Surgical treatment of benign prostatic hyperplasia (BPH)".)

Men with LUTS/BPH frequently suffer from multiple medical comorbidities. They may use
medications that can worsen LUTS (eg, diuretics, anticholinergics) or have drug-drug
interactions with medications used for the medical management of LUTS (eg, vasodilator drugs
used for the treatment of hypertension and alpha-adrenergic drugs used for LUTS). The
clinician should be aware of such iatrogenic causes for worsening LUTS before starting
treatment.

When to refer to a urologist — Although primary care clinicians can provide medical therapy
for LUTS/BPH, there are some clinical scenarios in which referral to a urologist is appropriate.
These include the complications of renal insufficiency, refractory urinary retention, recurrent
urinary tract infections, recurrent bladder stones or gross hematuria, rising post-void residual
urine volume, and bilateral hydronephrosis with renal functional impairment. In addition,
patients with persistent bothersome symptoms after basic management, or those who present
with severe symptoms, should be referred to a urologist for possible surgical therapy.

MEDICAL THERAPY FOR SYMPTOM RELIEF

Alpha-adrenergic receptor blockers for most patients — We use alpha-adrenergic receptor

blockers as initial pharmacologic agents in most patients with LUTS/BPH. Treatment effects are
seen within days.

Bladder outlet obstruction (BOO) is primarily mediated by alpha-1 adrenergic receptors located
on prostatic smooth muscle [2], which are upregulated in the stromal glandular hyperplasia
seen in BPH. Blocking signaling through the alpha-adrenergic receptors leads to relaxation of
the smooth muscle of the bladder neck and the prostatic urethra.

Selective alpha-1 adrenergic receptor antagonists are efficacious in relieving symptoms of BPH
but have fewer adverse effects than nonselective blockers [3]. The initially developed selective
alpha-1 adrenergic receptor antagonists required twice-daily dosing (prazosin, alfuzosin);
however, the extended duration of action of second-generation alpha-1 adrenergic receptor
antagonists enables single daily dosing (terazosin, doxazosin, tamsulosin, extended-release
alfuzosin, silodosin). The most common treatment regimens for the five alpha-adrenergic

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receptor blockers approved in the United States are shown in the table ( table 1). A
controlled-release tamsulosin tablet is also available in some markets but has not been well
studied for treatment of BPH.

Side effects and interactions — The most commonly reported adverse effects of alpha-
adrenergic receptor blockers include dizziness (5 to 15 percent) and rhinitis (12 percent) [4]. The
agents with greater prostate selectivity (eg, tamsulosin, silodosin) have fewer systemic adverse
effects but are associated with a higher frequency of retrograde or anejaculation (8 to 28
percent). Patients prescribed alpha-1 adrenergic blockers should be counseled about the
possibility of intraoperative floppy iris syndrome (IFIS). (See 'Intraoperative floppy iris syndrome'
below.)

Hypotension is an important potential side effect. Certain agents have a lower risk of
hypotension (eg, tamsulosin, alfuzosin, silodosin) than others (eg, terazosin and doxazosin) [5-
7]. Because of this, terazosin and doxazosin generally need to be initiated at bedtime (to reduce
postural lightheadedness soon after starting the medication), and the dose then titrated up
over several weeks. Blood pressures should be monitored in patients who are started on alpha-
adrenergic receptor blockers.

The hypotensive effects of terazosin and doxazosin can theoretically be worsened by

concomitant use of the phosphodiesterase type 5 (PDE5) inhibitors, particularly sildenafil or
vardenafil. Tamsulosin at a dose of 0.4 mg/day does not appear to significantly potentiate the
hypotensive effects of sildenafil [8].

Intraoperative floppy iris syndrome — Alpha-1 antagonists, particularly tamsulosin,

have been associated with IFIS. IFIS is a surgical condition associated with cataract operations,
characterized by a triad of findings: intraoperative miosis despite preoperative dilation, iris
prolapse, and a billowing flaccid iris [9]. Although a causal relation between the use of alpha-1
adrenergic blockers and IFIS remains controversial, IFIS is associated with increased rates of iris
trauma and posterior capsular rupture during cataract surgery [10].

The American Urological Association guidelines recommend that men with LUTS/BPH for whom
alpha blocker therapy is offered should be asked about planned cataract surgery. Men with
planned cataract surgery should avoid the initiation of alpha blockers until their cataract
surgery is completed. In men with no planned cataract surgery, there are insufficient data to
recommend withholding or discontinuing alpha blockers for bothersome LUTS/BPH.
Ophthalmologists must make themselves aware, via a medication history, of preoperative alpha
blocker use as they can take intraoperative precautions to reduce IFIS complications. (See
"Cataract in adults", section on 'Limiting risk of intraoperative floppy iris syndrome'.)

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Efficacy — In a meta-analysis of trials with alfuzosin, terazosin, doxazosin, or tamsulosin

versus placebo, all agents were found to be more effective than placebo [11].

Terazosin, doxazosin, tamsulosin, alfuzosin, and silodosin appear to have similar efficacy,
although there have been few direct comparisons [11-15]. Newer drugs such as silodosin may
have greater risk for sexual (altered ejaculation) adverse events (risk ratio [RR] 1.96, 95% CI
1.04-3.71, silodosin versus tamsulosin) compared with older drugs in this class (terazosin,
doxazosin, tamsulosin, alfuzosin) [12,15].

In a 2010 meta-analysis, alpha-1 adrenergic antagonists were more effective than 5-alpha-
reductase inhibitors for short- and long-term treatment of BPH [16]. (See '5-alpha reductase
inhibitors' below.)

Patients with erectile dysfunction — We use PDE5 inhibitors as initial therapy in men with
BPH-related symptoms and erectile dysfunction.

Phosphodiesterase type 5 inhibitors — PDE5 inhibitors have been shown in several

randomized trials to be beneficial in improving symptom scores in patients with LUTS/BPH,
although no significant changes in urine flow rates have been demonstrated [17-19].

Reported adverse effects with PDE5 inhibitors are relatively rare, with the more commonly
reported effects consisting of headache, flushing, dyspepsia, nasal congestion, back pain,
myalgias, and sinusitis. There is an increased risk of hypotension in patients also using certain
alpha-adrenergic blockers. (See 'Alpha-adrenergic receptor blockers for most patients' above.)

A 2018 Cochrane review of 16 randomized trials comparing PDE5 inhibitors with either placebo
or alpha blockers in men with LUTS/BPH found that PDE5 inhibitors reduced symptom scores
slightly compared with placebo, with a possible increase in adverse events [20]. PDE5 inhibitors
were not superior to alpha blockers, and there was no benefit of adding PDE5 inhibitors to
therapy for LUTS/BPH with either alpha blockers or 5-alpha reductase inhibitors (5ARIs).

In a trial that compared tadalafil with tamsulosin, the two drugs were comparable in their
efficacy in LUTS improvement [21]. Tadalafil 5 mg/day has been approved for use in men with
LUTS/BPH in the United States.

These medications are discussed in more detail separately. (See "Lower urinary tract symptoms
in males", section on 'Phosphodiesterase 5 inhibitors'.)

Patients with overactive bladder symptoms — Beta-3 adrenergic agonists or anticholinergics

can be used for patients in whom OAB symptoms (frequency, urgency, and incontinence)
predominate. Lifestyle modifications remain an important component of treatment.
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Beta-3 adrenergic agonists — Beta-3 adrenergic agonists are effective in men with
concomitant OAB and its urodynamic manifestations: detrusor overactivity. The symptoms
attributed to this are urgency, urge incontinence, and frequency.

Beta-3 adrenergic agonists stimulate detrusor beta-3 adrenergic receptors to promote

relaxation. Though less abundant than beta-2 adrenergic receptors, beta-3 receptors are more
efficacious in promoting relaxation without compromising bladder contractility. Mirabegron
and vibegron are available treatments [22]. These medications may be preferred over
anticholinergic agents as they do not cause dryness of the mouth.

Meta-analyses of trials have found mirabegron treatment to be more efficacious in reducing

urgency and incontinence episodes than placebo and support the use of the medication in men
with concomitant BPH [23]. Mirabegron was not associated with an increased incidence of
urinary retention. However, blood pressure should be monitored in men receiving beta-3
adrenergic agonists because these drugs can raise blood pressure (see "Lower urinary tract
symptoms in males", section on 'Beta3-adrenoceptor agonists'). In a phase 3 trial, Vibegron has
shown reductions in micturitions, urgency episodes, and urge incontinence and increased the
volume per micturition without a risk of hypertension or need for titration [24].

Anticholinergics — Anticholinergic (antimuscarinic) agents are useful in treating

predominantly irritative symptoms due to OAB in men with BPH who do not have an increased
post-void residual.

There has been hesitation in utilizing anticholinergics in men with BPH due to the concern that
these drugs may increase the risk of acute urinary retention, especially in the setting of BPE
with obstruction. Therefore, a post-void residual should be measured prior to initiating
treatment with an anticholinergic agent; these drugs should be used cautiously in men with
elevated post-void residual (>300 mL).

Anticholinergic (antimuscarinic) agents are also used in combination with alpha-adrenergic

blockers in patients with BPH whose irritative symptoms persist after monotherapy with an
optimized dose of an alpha-adrenergic blocker. (See 'Combination therapy' below.)

Some of these agents are available in topical/transdermal formulations, although their use is
uncommon. Common oral therapeutic dosing is presented in the table ( table 2). Common
side effects include dry mouth, constipation, dyspepsia, blurred vision, urinary retention,
headache, somnolence, and nausea. These effects resulting from cross-reactivity with other
cholinergic receptors throughout the body.

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Anticholinergics are discussed in detail elsewhere. (See "Lower urinary tract symptoms in
males", section on 'Treatment options' and "Lower urinary tract symptoms in males", section on
'Treatment for urodynamically proven OAB'.)

THERAPY TO PREVENT PROGESSION

5-alpha reductase inhibitors — Steroid 5ARIs block the conversion of testosterone (T) to
dihydrotestosterone (DHT) and are efficacious in the treatment of LUTS due to prostate
enlargement as documented by digital rectal examination (DRE) or transrectal ultrasonography
(TRUS). As such, they are used to prevent BPH progression rather than acute symptom
treatment. Results from the Medical Therapy of Prostatic Symptoms (MTOPS) study support the
utility of 5ARIs in prostates larger than 35 g. The larger the prostate, the bigger the impact of
this class of agents [25]. PSA levels can be used as a proxy for prostate volume. Levels below 1.5
ng/mL indicate a prostate that is likely too small to benefit from this treatment. By decreasing
the prostatic volume, the static component of benign prostatic enlargement (BPE) is reduced,
thereby decreasing the effective BOO. Symptomatic individuals with smaller prostatic volumes
may not achieve similar treatment effects.

Steroid 5ARIs may be used alone or in combination with other medications. The reduction in
prostatic volume by 5ARIs may take many months, with the maximum effect in symptom relief
seen typically after 6 to 12 months of therapy [26]. They have the potential for long-term
reduction in prostate volume and a decrease in the need for prostate surgery.

Three isozymes of 5-alpha reductase have been identified: type 1, type 2, and type 3. Finasteride
is a selective competitive inhibitor of the type 2 isozyme, whereas dutasteride is a nonselective
inhibitor of both type 1 and type 2 isozymes. Both drugs are effective in reducing prostate
volume, improving symptoms and urinary flow rates, and reducing the need for surgical
intervention. The most common dosing of these medications is presented in the table
( table 2). Treatment should be continued indefinitely to prevent symptom relapse [25-30].

Side effects and concerns

Suppression of serum PSA levels — The use of 5ARIs suppresses serum PSA levels by
about 50 percent. For this reason, most investigators warn clinicians that a baseline serum PSA
should checked prior to using any 5ARIs. The baseline level can be used to determine whether
therapy is likely to be effective as described above, and the pretreatment level should be known
because 5ARIs lower PSA levels. Thus, clinicians may be lured into a false sense of security if a
suppressed PSA is measured after starting 5ARI without consideration as to the impact of drug.

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Most experts recommend multiplying PSA value by two in patients receiving long-term (>3
months of continuous treatment) 5ARI therapy. (See "Measurement of prostate-specific
antigen", section on 'Medications'.)

Concerns regarding prostate cancer — Two randomized trials, the Prostate Cancer
Prevention Trial (PCPT, using finasteride) and the REDUCE trials (using dutasteride), reported a
reduced risk of prostate cancer compared with placebo but raised concerns about a possible
increased risk of high-grade prostate cancer [31,32]. There was no survival benefit observed
with 5ARI treatment in either trial. The apparent increase in the incidence of high-grade cancer
may be due to detection bias. These findings led the US Food and Drug Administration (FDA) to
recommend evaluation for other urologic conditions, including prostate cancer in patients with
BPH being considered for treatment with a steroid 5ARI. This is discussed in detail elsewhere
(See "Chemoprevention strategies in prostate cancer", section on '5-Alpha reductase
inhibitors'.)

Sexual dysfunction — Sexual dysfunction concurrent with 5ARIs use has been well known
since the drug class development. The issue at hand is whether the persistence or emergence
of dysfunction following drug cessation even exists. This putative adverse event has been
coined “post finasteride syndrome” (PFS). Many have doubts about the mere existence of PFS
based primarily on the source and quality of the reports from those supporting this association
[33,34].

Most studies supporting PFS are plagued by systematic errors and biases arising from
shortcomings in study method and design. These include, for example, the absence of baseline
testing, an insufficient or nonexistent control population, no protection against the nocebo
effect [35], reporter bias based on awareness of PFS before onset of symptoms, a lack of the
use of validated questionnaires, and referral biases of study subjects. Attempting to assess
sexual function and depression in a retrospective fashion is a well-described error and prone to
severe recall bias [36,37]. These faults permeate nearly the entirety of the PFS literature. Only
now are better controlled epidemiological studies emerging which adhere to these
fundamental principles, and these fail to support the existence of PFS [38,39]. The results of
randomized controlled trials and well-designed, controlled epidemiological studies contain data
which do not support the existence of an association between finasteride and persistent sexual
dysfunction following drug discontinuation. These controlled studies used more rigorous
methods compared with the anecdotal reports of persistence. Additionally, the proposed
mechanisms for persistence have not been scientifically established and appear implausible in
many circumstances.

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Other side effects — 5ARIs may impact fetal development if ingested during pregnancy.
Thus, it is important that drug diversion for any reason be avoided. Pregnant females are also
advised to avoid contact with crushed or broken tablets.

Efficacy — In the North American finasteride trial, men with LUTS/BPH who were treated with
5 mg finasteride had a 23 percent reduction in obstructive and 18 percent reduction in
nonobstructive symptom scores, an increase in maximal urinary flow rate, and a 19 percent
reduction in mean prostatic volume compared with those who took placebo [26].

In the Proscar Long-term Efficacy and Safety Study (PLESS) trial, men taking 5 mg of finasteride
had improvements in symptoms and urinary flow rates, as well as a reduction in prostate
volume, that were durable over four years [25,27,28]. Finasteride treatment reduced the risk of
acute urinary retention and the need for surgical intervention when compared with placebo.

Dutasteride has also been shown in randomized trials and a 2013 meta-analysis to improve
symptom scores and maximal urinary flow rates, decrease prostate volume, and reduce the risk
of acute urinary retention and need for surgical BPH intervention [29,40]. In a head-to-head
comparison of finasteride and dutasteride, no significant difference in prostate volume
reduction and improvements in urine flow rates was found between the two drugs [30]. The
most commonly reported adverse effects of finasteride and dutasteride include erectile
dysfunction, decreased libido, ejaculatory dysfunction, gynecomastia, and breast tenderness.

COMBINATION THERAPY

For certain patients, combination therapy may be appropriate.

Combination of alpha-adrenergic blockers and steroid 5-alpha reductase inhibitors — We

use combination therapy with an alpha-adrenergic blocker and a steroid 5ARI in men who have
demonstrated prostate enlargement and moderate to severe symptoms of BPH (International
Prostate Symptom Score [IPSS] >12). (See "Lower urinary tract symptoms in males", section on
'International Prostate Symptom Score'.)

The VA Cooperative Study, the Prospective European Doxazosin and Combination Therapy
(PREDICT) trial, and the Medical Therapy of Prostatic Symptoms (MTOPS) study [41-43]
compared finasteride plus doxazosin combination therapy, finasteride monotherapy, doxazosin
monotherapy, and placebo, respectively. Combination therapy was associated with a greater
reduction in symptomatic clinical progression, episodes of acute urinary retention, incidence of
renal insufficiency, recurrent urinary tract infections, and urinary incontinence compared with
monotherapy with either agent. Furthermore, when men were stratified for prostate size and
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PSA, those with larger prostates (>40 mL) and higher baseline PSA (>4.0 ng/mL) showed a more
significant reduction in disease progression. The Combination of Avodart and Tamsulosin
(CombAT) trial randomized men with BPH to combination of dutasteride plus tamsulosin,
dutasteride alone, or tamsulosin alone. The combination of dutasteride and tamsulosin was
superior to monotherapy with either drug in improving BPH symptoms and clinical progression;
combination therapy was superior to tamsulosin, but not dutasteride, in reducing the risk of
acute urinary retention and surgical intervention, especially for men with prostate volumes ≥30
mL [44].

Combination antimuscarinics or beta-3 adrenergic agonist and alpha blockers — OAB is a

chronic symptom syndrome that can affect up to a third of the adult population [45].
Diagnosing OAB in men can be complicated by the presence of the voiding symptoms
experienced by men with LUTS/BPH [46]. Recommended pharmacologic treatments for
LUTS/BPH include alpha-1 adrenoreceptor antagonists (alpha-1 blockers), although these
therapeutics may fail to alleviate urine storage symptoms when they are administered as single
agents.

Numerous clinical studies have demonstrated that antimuscarinics are effective and generally
well-tolerated treatments for patients with OAB and that they successfully reduce the storage
symptoms of frequency, nocturia, and urgency [47-49]. Studies in men have shown that
antimuscarinics in combination with alpha-1 blockers can improve OAB-related symptoms [50-
52]. However, there are concerns about the tolerability of antimuscarinics due to the risk or
occurrence of specific side effects such as dry mouth, urinary retention, and possible dementia
[53-55].

Limited data are available on the use of mirabegron in combination in men with underlying
LUTS/BPH. In a pilot study, the combination of mirabegron and tamsulosin (TAM+MIRA) was
effective and well tolerated in 94 patients with OAB symptoms induced by LUTS/BPH [56]. An
investigation (PLUS study) was conducted in North America and Europe to assess the efficacy
and safety of mirabegron versus placebo as add-on therapy to alpha-1 blocker treatment for
men with ongoing OAB symptoms [57]. TAM+MIRA was statistically superior to tamsulosin plus
placebo in reducing the mean number of micturitions/day. Statistically superior results were
noted for TAM+MIRA in mean voided volume per micturition and urgency episodes/day but not
on symptom severity as measured by the IPSS.

Combination tadalafil and finasteride — Clinicians are occasionally asked about the use of
low-dose daily tadalafil with finasteride. In our opinion, this combination offers little or no
advantages in symptom improvement over finasteride alone.

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A combination pill of finasteride-tadalafil (5 mg-5 mg) was compared with finasteride

monotherapy in a short-duration (26-week) trial [58]. At six months, there was little to no
difference in response to treatment, as defined as a change from baseline of ≥3 points in IPSS
or mean change in IPSS. Additionally, there was no difference between groups in frequency of
nocturia. Of note, the trial duration was not long enough to expect any meaningful impact from
the finasteride arm due to the expected time to effect of 5 alpha-reductase inhibitors. Not
surprisingly, the combination of low-dose daily tadalafil with finasteride greatly increased
erectile response over finasteride alone.

HERBAL REMEDIES

Nonconventional approaches to the management of lower urinary tract symptoms

(LUTS)/benign prostatic hyperplasia (BPH) are of interest to many patients, and the use of
plant/herb-based remedies for LUTS/BPH is common. Of particular appeal are the dietary
supplements, which include extracts of the saw palmetto plant (Serenoa repens) and stinging
nettle (Urtica dioica). A 2008 survey found that phytotherapy was the second most commonly
utilized remedy behind only the alpha-adrenergic blocker monotherapy across Europe; these
agents were typically used by patients with the lowest International Prostate Symptom Score
(IPSS) [59]. As the production and sale of these agents are not subject to the stringent
requirements of the US Food and Drug Administration (FDA)'s drug approval process, the
manufacturing of these agents is not standardized, and the efficacy and safety of most herbal
products that are sold over the counter have not been rigorously tested. Although 5-alpha
reductase inhibition, antiinflammatory effects, and growth factor alteration have been
postulated as potential mechanisms, proof of mechanism studies have been generally lacking.

Saw palmetto — Saw palmetto, derived from berries of the S. repens (dwarf palm plant), has
commonly been utilized as a phytotherapeutic for BPH. This is discussed in detail elsewhere.
(See "Clinical use of saw palmetto", section on 'Benign prostatic hypertrophy'.)

Hypoxis rooperi — South African star grass (Hypoxis rooperi) contains a beta-sitosterol which is
believed to be its active ingredient. A meta-analysis noted that while studies of beta-sitosterol
have reported improvements in urine flow rates and symptom scores, the problems of study
design in these studies precluded strong inferences. Therefore, the long-term efficacy and
safety of this product remain unclear [60]. Similar to case with saw palmetto, the American
Urological Association guidelines in 2011 recommended against these agents.

Pygeum africanum — African plum (Pygeum africanum) is believed by some to exert an

antiinflammatory effect by an inhibitory effect on neutrophils as well as on basic fibroblastic

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growth factor- and epidermal growth factor-induced prostatic fibroblast proliferation. Proof of
this postulated potential mechanism is lacking. There has been a paucity of randomized
placebo-controlled trials and the efficacy of P. africanum remains uncertain.

REFERRAL FOR SURGICAL MANAGEMENT

In general, patients should be trialed on medical management before proceeding to surgical

intervention. If patients have not responded to medical management, they should be
considered for surgical therapy to relieve obstruction and improve symptoms and overall
quality of life. However, many men with lower urinary tract symptoms (LUTS)/benign prostatic
hyperplasia (BPH) will not experience a significant degree of bother from their symptoms, and
these individuals may elect a period of active surveillance. The clinician should reassure the
patient that a period of active surveillance is unlikely to result in any serious or irreversible
damage to the urinary tract. (See "Surgical treatment of benign prostatic hyperplasia (BPH)".)

SOCIETY GUIDELINE LINKS

Links to society and government-sponsored guidelines from selected countries and regions
around the world are provided separately. (See "Society guideline links: Benign prostatic
hyperplasia".)

INFORMATION FOR PATIENTS

UpToDate offers two types of patient education materials, "The Basics" and "Beyond the
Basics." The Basics patient education pieces are written in plain language, at the 5th to 6th grade
reading level, and they answer the four or five key questions a patient might have about a given
condition. These articles are best for patients who want a general overview and who prefer
short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more
sophisticated, and more detailed. These articles are written at the 10th to 12th grade reading
level and are best for patients who want in-depth information and are comfortable with some
medical jargon.

Here are the patient education articles that are relevant to this topic. We encourage you to print
or e-mail these topics to your patients. (You can also locate patient education articles on a
variety of subjects by searching on "patient info" and the keyword(s) of interest.)

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● Basics topics (see "Patient education: Benign prostatic hyperplasia (enlarged prostate)
(The Basics)")

● Beyond the Basics topics (see "Patient education: Benign prostatic hyperplasia (BPH)
(Beyond the Basics)")

SUMMARY AND RECOMMENDATIONS

● Lifestyle modifications for all patients – It is suggested that all men with lower urinary
tract symptoms (LUTS)/BPH be instructed in lifestyle interventions. These should be
tailored to symptoms but may include avoiding fluids prior to bedtime or before going
out, reducing consumption of mild diuretics such as caffeine and alcohol, and double
voiding to empty the bladder more completely. (See 'Lifestyle modifications' above.)

● Medical management for symptom relief – Men with LUTS/BPH can be treated with one
or more classes of medications and, in general, should try medical treatment prior to
considering surgical interventions. For most patients, we initiate monotherapy with an
alpha-1 adrenergic antagonist for initial treatment ( table 1) (see 'Alpha-adrenergic
receptor blockers for most patients' above). Alternative monotherapy agents may be used
in certain settings ( table 2). These include:

• In men who have concomitant erectile dysfunction, phosphodiesterase type 5 (PDE5)

inhibitors are a reasonable alternative to alpha-1 adrenergic antagonists for initial
medical therapy. (See 'Phosphodiesterase type 5 inhibitors' above and "Treatment of
male sexual dysfunction", section on 'Erectile dysfunction'.)

• In men with low post-void residual urine volumes and irritative symptoms,
anticholinergics or beta-3 agonists are a reasonable alternative to alpha-1 adrenergic
antagonists for initial medical therapy. (See 'Patients with overactive bladder
symptoms' above.)

● Therapy to prevent progression – In men with demonstrated benign prostatic

enlargement (BPE), treatment with 5-alpha reductase inhibitors (5ARIs) to prevent disease
progression is a reasonable option. Treatment for 6 to 12 months is generally needed
before prostate size is sufficiently reduced to improve symptoms. Finasteride and
dutasteride appear to have similar efficacy and side effect profiles. (See '5-alpha reductase
inhibitors' above.)

● Combination therapy for some patients

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• For patients with low post-void residual urine volumes and irritative symptoms (eg,
frequency, urgency) that persist during monotherapy with an alpha-1 adrenergic
antagonist or anticholinergic agents, we use combination treatment with alpha-1
adrenergic antagonists and anticholinergic agents or beta-3 agonists. (See
'Combination therapy' above.)

• We use combination therapy with an alpha-adrenergic blocker and a steroid 5ARI in

men who have demonstrated prostate enlargement and moderate to severe symptoms
of BPH. (See 'Combination of alpha-adrenergic blockers and steroid 5-alpha reductase
inhibitors' above.)

● When to refer to urology – Referral to a urologist is appropriate for patients with the
complications of renal insufficiency, refractory urinary retention, recurrent urinary tract
infections, recurrent bladder stones or gross hematuria, rising post-void residual urine
volume, or bilateral hydronephrosis with renal function impairment. In addition, patients
with persistent bothersome symptoms after basic management, or those who present
with severe symptoms, should be referred to a urologist for possible surgical therapy. (See
'When to refer to a urologist' above and "Surgical treatment of benign prostatic
hyperplasia (BPH)".)

● No role for herbal remedies – Data concerning efficacy and safety of herbal therapies for
BPH are concerning. Until additional studies are available, we do not use these agents for
the treatment of BPH. (See 'Herbal remedies' above.)

● Surgical management – If patients have not responded to medical management, they

should be considered for surgical therapy to relieve obstruction and improve symptoms
and overall quality of life. (See 'Referral for surgical management' above.)

ACKNOWLEDGMENTS

The UpToDate editorial staff acknowledges Glenn Cunningham, MD, and Dov Kadmon, MD, who
contributed to an earlier version of this topic review.

Use of UpToDate is subject to the Terms of Use.

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Topic 6891 Version 72.0

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GRAPHICS

Alpha-1-receptor antagonists used to treat lower urinary tract symptoms

due to benign prostatic hyperplasia (BPH)

Medication Dose* Administration

Alfuzosin (Uroxatral, Initial and 10 mg Once daily immediately

Xatral) maintenance following a meal at the
same time each day

Silodosin (Rapaflo) Initial and 8 mg Once daily with a meal

maintenance at the same time each
day

Tamsulosin (Flomax) Initial and 0.4 mg Once daily

maintenance approximately 30
minutes after a meal at
the same time each
If inadequate response 0.8 mg day; 0.8 mg dose may
after 2 to 4 weeks be administered as 0.4
mg twice daily

Tamsulosin extended- Initial and 0.4 mg Once daily with a meal

release (Flomax CR) maintenance at the same time each
day; maximum dose
(NOTE: formulation
0.4 mg once daily
available in some
countries other than
the United States)

Conventional agents: Titration recommended to reduce orthostatic effects

Dose is advanced as shown if patient remains symptomatic and is tolerating current dose

Doxazosin Days 1 to 3 1 mg Once daily at bedtime

immediate-release
Days 4 to 14 2 mg
(Cardura)
Weeks 2 to 6 4 mg

Week 7 and thereafter 8 mg

Doxazosin Days 1 to 21 4 mg Once daily with

extended-release morning meal
(Cardura XL) Week 4 and thereafter 8 mg

Terazosin (Hytrin) Standard titration (appropriate for most patients)

Days 1 to 3 1 mg Once daily at bedtime

Days 4 to 14 2 mg

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Weeks 2 to 6 5 mg

Week 7 and 10 mg
thereafter

If inadequate 20 mg
response after 4 to
6 weeks of 10
mg/day

Rapid titration (for selected patients)

Days 1 to 3 1 mg Once daily at bedtime

Days 4 to 14 2 mg

Weeks 2 to 3 5 mg

Week 4 and 10 mg
thereafter

If inadequate 20 mg
response after 4 to
6 weeks of 10
mg/day

Dosing recommendations are for oral administration in adult patients with normal organ
function. Titration schedules are examples; other regimens may be appropriate. For
recommendations on clinical use and individualizing drug selection, refer to the clinical topic
review of BPH and individual drug information topics.
Alpha-1-receptor antagonists may have additive hypotensive effects with phosphodiesterase-5
inhibitors (eg, sildenafil) and other agents that lower blood pressure. For specific drug
interactions, refer to the Lexicomp drug interactions database included within UpToDate.
Dosing recommendations for other agents used to treat lower urinary tract symptoms due to
BPH is available in a separate table within UpToDate.

* If therapy is interrupted for 3 or more days, reinitiate at lowest dose and re-titrate according to
schedule.

Data from:
1. Lee M. Management of benign prostatic hyperplasia. In: Pharmacotherapy, 7th ed, Dipiro JT, Talbert RL, Yee GC, et al
(Eds), McGraw-Hill Medical 2008.
2. Lexicomp Online. Copyright © 1978-2023 Lexicomp, Inc. All Rights Reserved.
3. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1:
Diagnosis and treatment recommendations. J Urol 2003; 170:530.

Graphic 129672 Version 6.0

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Medications other than alpha-1-receptor antagonists used to treat lower

urinary tract symptoms due to benign prostatic hyperplasia (BPH)

Pharmacologic Titration Maximum

Medication Initial dose
class interval dose

Phosphodiesterase- Tadalafil (Cialis) 5 mg daily None 5 mg daily

5 (PDE-5) inhibitor*

5-alpha-reductase Finasteride 5 mg daily None 5 mg daily

inhibitors (5-ARIs) ¶ (Proscar)

Dutasteride 0.5 mg daily None 0.5 mg daily

(Avodart)

Beta-3 adrenergic Mirabegron 25 mg daily May increase 50 mg daily

agonists (Myrbetriq) dose as needed
and tolerated
after ≥4 weeks

Vibegron 75 mg daily None 75 mg daily

(Gemtesa)

Anticholinergic Fesoterodine 4 mg daily May increase 8 mg daily

agents Δ (Toviaz) dose as needed
and tolerated
after ≥2 weeks

Tolterodine IR 1 to 2 mg twice None 2 mg twice daily

(Detrol) daily

Tolterodine ER 2 to 4 mg daily 4 mg twice daily

(Detrol LA)

Oxybutynin IR 5 mg 2 to 3 times May increase 5 mg 4 times

◊
(Ditropan ) daily dose as needed daily
and tolerated in 5
Oxybutynin ER 5 to 10 mg daily mg increments 30 mg daily
(Ditropan XL) every 1 to ≥2
weeks

Darifenacin 7.5 mg daily May increase 15 mg daily

(Enablex) dose as needed
and tolerated
Solifenacin 5 mg daily 10 mg daily
after ≥2 weeks
(Vesicare)

Trospium IR 20 mg twice daily None 20 mg twice daily

◊
(Sanctura ) (once daily if >75
years old)

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Trospium ER 60 mg daily 60 mg daily

◊
(Sanctura XR )

Dosing recommendations are for oral administration in adult patients with normal organ
function. For information on clinical use and individualizing drug selection according to
predominant symptoms, refer to the clinical topic review of BPH and individual drug information
topics included within UpToDate. For information on drug interactions, refer to the Lexicomp
drug interactions database.
Dosing recommendations for alpha-1-receptor antagonists used to treat lower urinary tract
symptoms due to BPH are available in a separate table within UpToDate.

IR: immediate-release; ER: extended-release.

* PDE-5 inhibitors are a useful choice in men with erectile dysfunction. Tadalafil is approved by the
US Food and Drug Administration (FDA) for treatment of signs and symptoms of BPH. Other PDE-5
inhibitors (eg, sildenafil, vardenafil) that are not FDA-approved for this use may also improve BPH
symptoms. Do not prescribe in men who take nitrate therapy. In patients taking alpha-1-receptor
antagonists or other drugs that lower blood pressure, additive hypotensive effects may be
observed.

¶ Generally used for prevention of BPH progression; treatment for 6 to 12 months is typically
needed for symptom improvement.

Δ A post-void residual (PVR) should be measured prior to initiating treatment; not recommended for
use with elevated PVR (eg, >300 mL).

◊ Branded product no longer available.

Data from: Lexicomp Online. Copyright © 1978-2023 Lexicomp, Inc. All Rights Reserved.

Graphic 129671 Version 7.0

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Contributor Disclosures
Kevin T McVary, MD, FACS Patent Holder: Thermal-Activated Penile Prosthesis [Erectile dysfunction].
Grant/Research/Clinical Trial Support: Boston Scientific [Benign prostatic hyperplasia];MedeonBio [Benign
prostatic hyperplasia];Urovant [Overactive bladder]. Consultant/Advisory Boards: Antares[Voiding
dysfunction];Boston Scientific [Benign prostatic hyperplasia]. All of the relevant financial relationships
listed have been mitigated. Michael P O'Leary, MD, MPH No relevant financial relationship(s) with
ineligible companies to disclose. Jane Givens, MD, MSCE No relevant financial relationship(s) with
ineligible companies to disclose.

Contributor disclosures are reviewed for conflicts of interest by the editorial group. When found, these are
addressed by vetting through a multi-level review process, and through requirements for references to be
provided to support the content. Appropriately referenced content is required of all authors and must
conform to UpToDate standards of evidence.

Conflict of interest policy

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