Evaluation and Treatment of Lower Urinary Tract Symptoms in

Older Men
P. Abrams,*,† C. Chapple,‡ S. Khoury,§ C. Roehrborn储 and
J. de la Rosette¶ Abbreviations
and Acronyms
on behalf of the International Scientific Committee and members of the committees, 6th International Consultation AR ⫽ adrenergic receptor
on New Developments in Prostate Cancer and Prostate Diseases
BOO ⫽ bladder outlet obstruction
BPE ⫽ benign prostate enlargement
Purpose: The 6th International Consultation on New Developments in Prostate BPH ⫽ benign prostatic hyperplasia
Cancer and Prostate Diseases met from June 24 –28, 2005 in Paris, France to BPO ⫽ benign prostatic obstruction
review new developments in benign prostatic disease. DAN-PSS ⫽ Danish Prostate
Symptom Score
Materials and Methods: A series of committees were asked to produce recommen-
DRE ⫽ digital rectal examination
dations on the evaluation and treatment of lower urinary tract symptoms in older FVC ⫽ frequency volume chart
men. Each committee was asked to base recommendations on a thorough assessment ICIQ ⫽ International Consultation
of the available literature according to the International Consultation on Inconti- on Incontinence Questionnaire
nence level of evidence and grading system adapted from the Oxford system. I-PSS ⫽ International Prostate
Results: The Consultation endorsed the appropriate use of the current terminology Symptom Score
lower urinary tract symptoms/benign prostatic hyperplasia/benign prostate enlarge- LUTS ⫽ lower urinary tract
ment and benign prostatic obstruction, and recommended that terms such as “clin- symptoms
ical benign prostatic hyperplasia” or “the benign prostatic hyperplasia patient” be OAB ⫽ overactive bladder
abandoned, and asked the authorities to endorse the new nomenclature. The diag- PSA ⫽ prostate specific antigen
nostic evaluation describes recommended and optional tests, and in general places Qmax ⫽ maximum urinary flow rate
QoL ⫽ quality of life
the focus on the impact (bother) of lower urinary tract symptoms on the individual
RCT ⫽ randomized controlled trial
patient when determining investigation and treatment. The importance of symptom TURP ⫽ transurethral prostate
assessment, impact on quality of life, physical examination and urinalysis is empha- resection
sized. The frequency volume chart is recommended when nocturia is a bothersome
symptom to exclude nocturnal polyuria. The recommendations are summarized in 2
Submitted for publication September 24,
algorithms, 1 for basic management and 1 for specialized management of persistent 2007.
bothersome lower urinary tract symptoms. * Correspondence: Bristol Urological Institute,
Conclusions: The use of urodynamics and transrectal ultrasound should be Southmead Hospital, Bristol BS10 5NB United
Kingdom (e-mail: edu@bui.ac.uk).
limited to situations in which the results are likely to benefit the patient such as † Financial interest and/or other relationship
in selection for surgery. It is emphasized that imaging and endoscopy of the with Astellas, Bayer, Novartis, Pfizer, Plethora,
urinary tract have specific indications such as dipstick hematuria. Treatment AMS, Verathon, Ferring and Merck.
‡ Financial interest and/or other relationship
should be holistic, and may include conservative measures, lifestyle interventions with Pfizer, Astellas, Novartis, Allergan and Recordati.
and behavioral modifications as well as medication and surgery. Only treatments § Nothing to disclose.
with a strong evidence base for their clinical effectiveness should be used. 储 Financial interest and/or other relationship
with GlaxoSmithKline, VA Corporate Studies,
Southwest Oncology Group, Sanofi Aventis,
Key Words: urinary tract, urologic diseases, prostatic diseases CALGB Clinical Trial group, Lilly COS, NIDDK,
Spectrum Pharmaceuticals, Aeterna Zentaris,
Pfizer, Amgen, Abbot Laboratories, Bayer Health-
care and Watson Pharmaceuticals.
¶ Financial interest and/or other relationship
with Galil Medical, BSC and AMS.
THE 6th International Consultation collaboration with the American Uro-
on New Developments in Prostate logical Association, Confederacion Editor’s Note: This article is the
Cancer and Prostate Diseases met Americana de Urologia, European As- fourth of 5 published in this issue for
which category 1 CME credits can
from June 24 –28, 2005 in Paris, sociation of Urology, International So- be earned. Instructions for obtain-
France, under the cosponsorship of ciety of Urology and the Urological ing credits are given with the ques-
tions on pages 1970 and 1971.
the Union Internationale Contre le Association of Asia to review new de-
Cancer and the International Consul- velopments in prostate cancer, LUTS, For another article on a related
tation on Urological Diseases, and in benign prostatic disease, prostatitis topic see page 1926.

0022-5347/09/1814-1779/0 Vol. 181, 1779-1787, April 2009

THE JOURNAL OF UROLOGY® Printed in U.S.A.
www.jurology.com 1779
Copyright © 2009 by AMERICAN UROLOGICAL ASSOCIATION DOI:10.1016/j.juro.2008.11.127
1780 LOWER URINARY TRACT SYMPTOMS IN OLDER MEN
and chronic pelvic pain syndrome, and other related
fields. A full account of the Consultation’s work on
male lower urinary tract dysfunction has been pub-
lished in book form.1
A series of committees collaborated to produce
these recommendations on the evaluation and treat-
ment of LUTS in older men. Appendix 1 gives a list
of committees, chairs and members, page numbers
and number of references (references total in excess
of 1,000).
Each committee was asked to base their recom-
mendations on a thorough review of the available
literature and the global subjective opinion of recog-
nized experts serving on focused committees. The
recommendations are graded whenever possible ac-
cording to the International Consultation on Incon-
tinence level of evidence and grading system
adapted from the Oxford system. Full details of this
methodology are available.2 Each committee
searched the English language literature to be able
to give a level of evidence for the literature for each
topic. Four levels of evidence were used (1, 2, 3 and
4) without the subdivisions of the original Oxford
system (eg 1a and 1b). Level 1 evidence is when
there is a meta-analysis of RCTs or more than 1 good
quality randomized trial giving clear and consistent
evidence. Level 2 evidence refers to less good quality
RCTs, for example when there is less than 80%
followup. The level of evidence extends down to 4
when the only evidence is expert opinion without a
Delphi process or poor quality trials. Full details of
the reviewed literature and references are provided
in the book which was published as a full report of
the work of the committee, modified by the consul-
tation process that occurred in Paris.1
The 4 grades of evidence inform the grades of
recommendation A, B, C and D. Each can be a pos-
itive or a negative recommendation. Grade A recom-
mendations usually depend on level 1 evidence and
grade B recommendations on level 2 evidence. Some
flexibility in the grading system is needed when
there is a large consistent body of evidence, for ex-
ample, for the efficacy of TURP or extracorporeal
shock wave lithotripsy before there were RCTs.
The individual committee reports were developed
and peer reviewed by open presentation and com-
ment. Final recommendations were then refined by
the Scientific Committee which consisted of the
chairmen of all the committees. The recommenda-
tions apply only to the standard patient as defined.
Those outside the definition of a standard patient
may require diagnostic evaluation and treatment
beyond the scope of these recommendations. These
recommendations were agreed on in 2005, and will
be periodically reevaluated in light of clinical expe-
rience and technological progress.
TERMINOLOGY AND DEFINITIONS
Lower urinary tract symptoms include storage and/or
voiding disturbances which are common in aging men.
LUTS may be due to structural or functional abnor-
malities in 1 or more parts of the lower urinary tract
which comprises the bladder, bladder neck, prostate,
distal sphincter mechanism and urethra. It must also
be remembered that LUTS may result from abnormal-
ities of the peripheral and/or central nervous systems
which provide neural control to the lower urinary
tract. LUTS may also be secondary to cardiovascular,
respiratory or renal dysfunction or disease. This Con-
sultation endorses the previously recommended no-
menclature from the 5th International Prostate Con-
sultation detailed in the International Continence
Society Terminology Report published in 2002.3
LUTS is divided into 1) storage symptoms which
are experienced during the storage phase of the blad-
der and include daytime frequency and nocturia, and
2) voiding symptoms which are experienced during the
voiding phase. The overactive bladder syndrome is
defined as urgency with or without urgency inconti-
nence, usually with frequency and nocturia. Detrusor
overactivity is a urodynamic observation characterized
by involuntary detrusor contractions during the filling
phase that may be spontaneous or provoked. The term
benign prostatic hyperplasia is reserved for the histo-
logical pattern it describes. Benign prostatic enlarge-
ment is used when there is gland enlargement and is
usually a presumptive diagnosis based on the size of
the prostate. Benign prostatic obstruction is used
when obstruction has been proven by pressure flow
studies, or is highly suspected from flow rates and if
the gland is enlarged. Bladder outlet obstruction is the
generic term for all forms of obstruction to the bladder
outlet (eg urethral stricture) including BPO. There-
fore, terms such as “BPH patient,” “symptomatic
BPH,” “clinical BPH,” “drugs for BPH” and “BPH
treatment” are imprecise, cause confusion and are not
recommended.
The Physicians’ Desk Reference lists as the indica-
tion for alfuzosin and tamsulosin the “treatment of the
signs and symptoms of benign prostatic hyperplasia
(BPH),” and for finasteride and dutasteride the “treat-
ment of symptomatic benign prostatic hyperplasia in
men with an enlarged prostate.” It is clear from this
discussion that these indications are less than clear. A
more appropriate listing of indications would be, “Al-
pha blockers are effective in treating LUTS, while
5␣-reductase inhibitors are effective in treating LUTS
in men with probable benign prostate obstruction with
gland enlargement.”
The standard patient is a man older than 50 years
consulting a qualified health care provider for LUTS.
These symptoms may or may not be associated with an
enlarged prostate gland, BOO or histological BPH. A
 LOWER URINARY TRACT SYMPTOMS IN OLDER MEN
Figure 1. Basic management of LUTS in men
qualified health care provider is a person (physician,
physician assistant, nurse practitioner or other mid
level provider) knowledgeable in diseases affecting the
urinary tract, in particular the prostate gland, who
has the expertise to perform the tests required as an
initial evaluation, and who has been trained and has
demonstrated competence in performing DRE.
LUTS consensus recommendations do not apply
when other disease pathologies are known to be re-
sponsible for the LUTS such as prostate cancer or
other genitourinary tract malignancies, or due to sig-
nificant comorbidities (eg severe diabetes mellitus) or
significant concomitant medications, prior pelvic sur-
gery or trauma. In addition to being responsible for the
symptoms, these diseases/conditions are likely to af-
fect the proposed treatment in a manner not consis-
tent with the consensus recommendations.
DIAGNOSTIC EVALUATION
In the classification of diagnostic tests and studies a
recommended test should be performed on every
1781
patient during the initial evaluation whereas an
optional test is a test of proven value in the evalua-
tion of select patients. In general, optional tests are
done during a specialized evaluation and usually
performed by a urologist.
Basic Evaluation and Recommended Tests
The basic evaluation should be done on every pa-
tient presenting to a health care provider with lower
urinary tract symptoms (fig. 1).
History. A relevant medical history should be ob-
tained focusing on the nature and duration of reported
genitourinary tract symptoms, previous surgical pro-
cedures (in particular as they affect the genitourinary
tract), general health issues, sexual function history,
medications currently taken and patient fitness for
possible surgical procedures or other treatments.
Assessment of symptoms and bother. At least a
semiquantitative assessment of symptoms and bother
is strongly recommended to grade the severity of lower
urinary tract symptoms and to understand the degree
1782 LOWER URINARY TRACT SYMPTOMS IN OLDER MEN
of bother caused by those symptoms. Excellent quan-
titative assessment tools have been developed and val-
idated such as the I-PSS with bother score. Other
questionnaires include the DAN-PSS, the ICIQ-
MLUTS and the BPH Impact Index.
Physical examination and DRE. A focused physical
examination should be performed to assess the supra-
pubic area to rule out bladder distention, and overall
motor and sensory function focused on the perineum
and lower limbs. DRE should be performed to evaluate
anal sphincter tone and the prostate gland with regard
to approximate size, consistency, shape and abnormal-
ities suggestive of prostate cancer.
Urinalysis. Urine should be analyzed using any of the
widely available dipstick tests. These tests are done to
determine if the patient has hematuria, proteinuria,
pyuria or other pathological findings (eg glucosuria,
ketonuria, positive nitrite test etc). Examination of the
urinary sediment and culture is indicated if the result
of the dipstick is abnormal. The results of urinalysis
may guide further and additional testing independent
of the evaluation for LUTS.
Serum PSA. The benefits and risks of PSA testing
should be discussed with the patient including the
possibility of false-positive and false-negative results,
the possible complications of subsequent transrectal
ultrasound guided biopsy, and the possibility of a false-
negative biopsy. In general the PSA test would only be
performed if life expectancy is greater than 10 years
and if a diagnosis of prostate cancer would modify the
management approach. Given the uncertainties sur-
rounding prostate cancer detection physicians must
use clinical judgment in determining which patients
should or should not undergo transrectal ultrasonog-
raphy and prostate biopsy in response to a particular
PSA. Serum PSA is a reasonable predictor of prostate
volume in men with LUTS and can be used in this
capacity in clinical decision making.
Frequency volume charts. Frequency volume
charts (voiding diary or time and amount voiding
charts) are particularly useful when nocturia is the
dominant symptom. The time and voided volume are
recorded for each micturition during several 24-hour
periods (usually 3), and help to identify patients
with nocturnal polyuria or excessive fluid intake
which are common in the aging male.
Specialized Evaluation
and Recommended Tests
Detailed quantification of symptoms by standard-
ized questionnaires. When patients present with
LUTS the use of a short, self-administered question-
naire in the appropriate language for the objective
documentation of symptom frequency from the pa-
tient’s perspective is highly recommended (fig. 2).
The 3 recommended short, patient completed ques-
tionnaires are the I-PSS and the ICIQ-MLUTS, both
of which include a single quality of life question, and
the DAN-PSS-1.
The I-PSS is used to assess the frequency of 3
storage symptoms (frequency, nocturia, urgency)
and 4 voiding symptoms (feeling of incomplete emp-
tying, intermittency, straining, weak stream). The
bother score assesses the degree of bother associated
with the 7 symptoms in the aforementioned I-PSS
symptom severity score. The BPH Impact Index can
be used with the I-PSS, and has 4 questions asking
how the symptoms affect the patient’s everyday life
and interfere with daily activities, thus capturing
the impact of the condition. The results provide use-
ful additional information to the single QoL ques-
tion, “If you were to spend the rest of your life with
your urinary condition just the way it is now, how
would you feel about that?”
The ICIQ-MLUTS assesses the frequency and
bother of 8 storage symptoms (frequency, nocturia
and urgency, plus 5 questions on types of inconti-
nence, that is urgency, stress, unconscious enuresis
and post-micturition dribble) and 5 voiding symptoms
(feeling of incomplete emptying, intermittency, strain-
ing, weak stream, hesitancy). Bother is evaluated us-
ing a 0 to 10 linear analog scale. Additional ICIQ
modules on QoL (ICIQ-MLUTSqol) and sexual func-
tion (ICIQ-Msex) can be used with the ICIQ-MLUTS.
The advantage of the ICIQ-MLUTS is that it recog-
nizes and assesses symptoms due to causes other than
BPO in the pathogenesis of LUTS such as OAB.
Flow rate recording. Urinary flow rate measure-
ment is useful in the initial diagnostic assessment
and during or after treatment to determine re-
sponse. Because of the noninvasive nature of the
test and its clinical value, it is recommended as part
of the specialized evaluation to be performed before
embarking on any active therapy. Qmax is the best
single measure but a low Qmax does not distinguish
between obstruction and decreased detrusor con-
tractility. Because of the intra-individual variability
and the volume dependency of the Qmax, at least 2
flow rates should be obtained, ideally both with a
volume greater than 150 ml voided urine. If such a
voided volume cannot be obtained by the patient
despite repeated recordings the Qmax results at the
available voided volumes should be considered.
Residual urine. The determination of post-void re-
sidual urine is useful in the initial diagnostic assess-
ment of the patient and during subsequent monitor-
ing as a safety parameter. The determination is best
performed by noninvasive transabdominal ultra-
sonography. Because of the marked intra-individual
variability of residual urine volume, the test should
be repeated to improve precision, particularly if the
 LOWER URINARY TRACT SYMPTOMS IN OLDER MEN
Figure 2. Specialized management of persistent, bothersome LUTS after basic management. Rx, treatment
first residual urine volume is significant and sug-
gests a change in the treatment plan.
Pressure flow studies. These studies are recom-
mended before invasive therapy in men with a
Qmax greater than 10 ml per second. If Qmax is less
than 10 ml per second obstruction is likely and pres-
sure flow studies are not necessarily needed. Pres-
sure flow studies are of proven value in the evalua-
tion of patients before invasive therapies, or when a
precise diagnosis of BOO is important. Pressure flow
urodynamic studies are the only method to our
knowledge with the potential to distinguish men
with a low urinary flow rate due to detrusor under-
activity from those with bladder outlet obstruction.
This distinction is made by relating detrusor pres-
sure at maximum urinary flow rate to the maximum
flow rate.
1783
If patients are found not to have BOO yet have
severe LUTS they are less likely to benefit from
invasive treatments such as surgery designed to
relieve outlet obstruction. Consequently it is recom-
mended that these patients have symptoms treated
in an appropriate fashion. Such treatment can be
aimed at other underlying disease processes includ-
ing anticholinergics, bladder behavioral training,
biofeedback, etc. The most important parameter of
the pressure flow study is detrusor pressure at max-
imum urinary flow rate.
Prostate imaging with transabdominal or transrec-
tal ultrasound. When residual urine is determined
by transabdominal ultrasonography with a machine
generating real-time B-mode images, prostate
shape, size, configuration and protrusion into the
bladder may be simultaneously evaluated. Outside
1784 LOWER URINARY TRACT SYMPTOMS IN OLDER MEN
of this context imaging of the prostate by transab-
dominal or transrectal ultrasound is optional in se-
lected patients. The success of certain treatments
may depend on anatomical characteristics of the
prostate gland (eg hormonal therapy, thermother-
apy, stents, transurethral incision of the prostate).
When such treatments are planned transabdominal
or transrectal ultrasonography may be used to as-
sess prostatic size and shape. In men with serum
PSA increased above the locally accepted reference
range, transrectal ultrasonography is the method of
choice to evaluate the prostate and to guide a needle
biopsy of suspicious areas, or to perform biopsies to
rule out prostate cancer.
Upper urinary tract imaging with ultrasonography
or excretory urography. Although imaging of the
upper urinary tract is not recommended as a routine
procedure, it is indicated in patients presenting with
1 or more of the signs or symptoms, or history of
upper urinary tract infection, hematuria (micro-
scopic or macroscopic), history of urolithiasis, renal
insufficiency (in this case ultrasonography is the
preferred imaging study) and recent onset nocturnal
enuresis.
Endoscopy of lower urinary tract. Endoscopic eval-
uation of the lower urinary tract is not recom-
mended in an otherwise healthy patient with an
initial evaluation consistent with BOO, although it
has certain indications as previously described for
imaging. There are treatment alternatives in which
success or failure depends on the anatomical config-
uration of the prostate (eg transurethral incision of
the prostate, thermotherapy etc). Endoscopy is rec-
ommended if considered helpful when such treat-
ment alternatives are contemplated.
TREATMENT RECOMMENDATIONS
Basic Management
If initial evaluation demonstrates the presence of
LUTS associated with 1 or more of the findings of
DRE suspicious of prostate cancer, hematuria, ab-
normal PSA, pain, recurrent infection (infection
should be assessed and treatment started by the
practitioner before referral), palpable bladder or
neurological disease, the patient should be referred
to a specialist (urologist) for appropriate evaluation
before advising treatment (fig. 1).
When initial evaluation demonstrates the pres-
ence of LUTS only, with or without some degree of
nonsuspicious prostate enlargement, if the symp-
toms are not significantly bothersome or if the pa-
tient does not want treatment, no further evaluation
is recommended. The patient is reassured and can
be seen again if necessary. This recommendation is
based on the opinion that this category of patients
with nonbothersome LUTS is unlikely to experience
significant health problems in the future due to their
condition.
In patients with bothersome symptoms it is now
recognized that LUTS has a number of causes that
may occur singly or in combination. Among the most
important are BPO, OAB and nocturnal polyuria.
The physician can discuss treatment options with
the patient based on the results of initial evaluation
with no further tests being needed.
In primary care there should be a discussion of
the benefits and risks involved with each of the
recommended treatment alternatives (watchful
waiting, medical treatment, interventional therapy,
surgical or nonsurgical treatment). The choice of
treatment is reached in a shared decision making
process between physician and patient.
If the patient has predominant significant noctu-
ria and gets out of bed to void 2 or more times per
night then he should be asked to complete a FVC for
3 days. The FVC will show 24-hour polyuria or noc-
turnal polyuria when present, the first of which has
been defined as greater than 3 l output. In practice
patients with symptoms are advised to aim for a
urine output of 1 l/24 hours. Nocturnal polyuria is
diagnosed when more than 33% of the 24-hour urine
output occurs at night. The patient should be
treated according to the nocturia algorithm (fig. 1).
If symptoms do not improve sufficiently he should be
treated along the same lines as men without pre-
dominant nocturia.
If the patient has no polyuria and medical treat-
ment is considered the physician can proceed with
therapy based mainly on first altering modifiable
factors such as concomitant drugs, regulation of
fluid intake especially in the evening, lifestyle
changes (avoiding a sedentary lifestyle) and dietary
advice (avoiding dietary indiscretions such as exces-
sive intake of alcohol and highly seasoned or irrita-
tive foods).
If treated pharmacologically the patient should be
followed to assess treatment success or failure and
possible adverse events. The time after initiation of
therapy for the assessment of treatment success var-
ies according to the pharmacological treatment pre-
scribed. It is usually 2 to 4 weeks for ␣-blocker
therapy and 3 months for a 5␣-reductase inhibitor.
If treatment is successful and the patient is sat-
isfied followup should be repeated approximately
once a year by repeating the initial evaluation as
previously outlined. The followup strategy will allow
the physician to detect any changes that have oc-
curred in the last year, more specifically, if symp-
toms have progressed or become more bothersome,
or if a complication has developed creating an indi-
cation imperative for surgery. If treatment fails and
the patient is not satisfied, he should be referred to
 LOWER URINARY TRACT SYMPTOMS IN OLDER MEN 1785

a urologist for further evaluation and possibly inter- perative indication for surgery. If treatment fails
ventional treatment. If interventional therapy is and the patient is not satisfied, he should be reas-
chosen the patient should be referred to the special- sessed and other therapies should be considered.
ist.
Interventional Therapy
If the patient elects to have interventional therapy
Specialized Management
and there is sufficient evidence of obstruction, eg
Patients with persistent bothersome LUTS after ba-
Qmax less than 10 ml per second, patient and phy-
sic management should receive specialist treatment.
sician should discuss the benefits and risks of the
The specialist will use additional testing beyond
various interventions. TURP is still the gold stan-
those tests recommended for basic evaluation such
dard for interventional treatment but, when avail-
as FVC, detailed LUTS questionnaire, urine flow
able, new interventional therapies could be dis-
studies and ultrasound estimate of residual urine.
cussed. The techniques accepted for clinical use are
If storage symptoms predominate (OAB) and
summarized in Appendix 2.
there is no indication of BOO, overactive bladder
If the patient’s condition is not sufficiently sug-
due to idiopathic detrusor overactivity is the most
gestive of obstruction, eg Qmax greater than 10 ml
likely cause if there is no indication of BOO from
per second, pressure flow studies are indicated as
flow study and ultrasound estimates of post-void
treatment failure rates are somewhat higher in the
residual urine. The treatment options of lifestyle
absence of obstruction. If interventional therapy is
intervention, behavioral modification (bladder train-
planned without clear evidence of the presence of
ing and pelvic floor muscle exercises) and pharma-
obstruction, the patient needs to be informed of pos-
cotherapy (antimuscarinic drugs) should be dis-
sible higher failure rates of the procedure.
cussed with the patient. The best results are
obtained by combined therapy using all 3 modalities.
Should improvement be insufficient and symptoms TREATMENT OPTIONS
severe, then newer modalities of treatment such as
Criteria for Acceptable Treatment Options
botulinum toxin and sacral neuromodulation can be
For a treatment to be considered an acceptable op-
considered.
tion it must meet several criteria. Effectiveness and
If there is evidence of BOO treatment options
safety of the treatment must have been shown in
should be discussed in the categories of drug therapy
trials according to the guidelines established by the
or interventional procedures. If drug therapy is con-
International Consultation on Prostate Diseases.
sidered decisions will be influenced by coexisting
Any treatment of the disease should improve symp-
OAB symptoms and prostate size or serum PSA. If
toms and/or prevent long-term complications by
there are coexisting BOO and OAB symptoms then
shrinking the enlarged prostate, and/or reducing ob-
the patient is sometimes treated with ␣-blocker and
struction or by other modes of action. The risks of
antimuscarinic combination therapy with increas-
morbidity and mortality associated with treatment
ing evidence of safety and efficacy. When BOO
must be considered in the context of the treatment.
symptoms predominate ␣1-adrenergic blocking
New interventional treatments should be compared
agents are the treatment of choice for LUTS due to
to sham, similar treatments of proven efficacy, or
BOO. However, combination therapy with a 5␣-re-
TURP. Pharmacological treatments should be com-
ductase inhibitor has shown the highest efficacy
pared to placebo, have minimal morbidity, be accept-
when the prostate is enlarged and/or if serum PSA is
able to the patient, should not interfere with patient
greater than 1.5 ng/ml.
sense of well-being or quality of life, and must not be
The patient should be followed to assess treat-
unacceptably hazardous to his health.
ment success or failure and possible adverse events.
After a new treatment is considered an acceptable
The interval after initiation of therapy for the as-
treatment option, long-term studies should be con-
sessment of treatment success varies according to
ducted to demonstrate durability and continued ef-
the pharmacological treatment prescribed, usually 2
fectiveness and safety, continued effectiveness rela-
to 4 weeks for ␣-blocker therapy and at least 3
tive to existing treatment options, and cost-
months for 5␣-reductase inhibitors.
effectiveness related to existing and emerging
If treatment is successful and the patient is sat-
therapeutic options. The results of such long-term
isfied, followup should be repeated approximately
studies could lead to a treatment being firmly estab-
once a year by repeating the initial evaluation as
lished in routine practice or to it being rejected as an
outlined previously. The followup strategy will allow
unacceptable option.
the physician to detect any changes that have oc-
curred in the last year, more specifically, if symp- Acceptable Treatment Options
toms have progressed or become more bothersome, The patient must be informed of all available and
or if a complication has developed creating an im- acceptable treatment options applicable to his clin-
1786 LOWER URINARY TRACT SYMPTOMS IN OLDER MEN
ical condition, and the related benefits, risks and
costs of each modality. LUTS associated with benign
prostatic obstruction can significantly affect the
quality of life in aging men but are rarely life threat-
ening. Moreover, a significant number of men with
histological BPH or even gland enlargement do not
have disease progression. Thus, it is reasonable to
discuss the benefits, risks and costs of the available
treatment strategies with the patient, and have him
actively participate in the choice of therapy (shared
decision making). Some patients with bothersome
symptoms might opt for surgery while others might
opt for watchful waiting or medical therapy depend-
ing on individual views of benefits, risks and costs.
Watchful waiting. Progression of LUTS, BPE
and/or BPO in terms of symptoms, future prostate
growth and long-term complications has been shown
to be more likely in men with larger glands and
higher serum PSA (ie 1.5 ng/ml or greater). Many
men with smaller glands and/or lower serum PSA
may have minimal progression of symptoms over
time. Moreover, the level of symptoms individual
men may tolerate before being bothered by them is
highly variable. Therefore, watchful waiting is an
accepted treatment option for patients with mild,
moderate or even severe symptoms as long as they
are not bothered by them and the imperative indi-
cations for surgery have not developed (mainly up-
per tract dilatation and/or increased creatinine).
After being adequately informed of the various
treatment options and their consequences, if the
patient chooses watchful waiting as the preferred
form of management, he should be followed approx-
imately yearly by repeating the initial evaluation as
previously outlined. This followup strategy will al-
low the physician to detect any changes that have
occurred in the last year, specifically if symptoms
have progressed or become more bothersome, or if a
complication has developed, creating an imperative
indication for surgery.
Medical therapy. Patients initiated on medical
therapy should be followed at appropriate intervals
by repeating the initial evaluation, assessing treat-
ment success or failure and possible adverse events,
and determining whether an alteration in treatment
plan is indicated. Once patients are stable on treat-
ment, followup intervals should be at least yearly.
Before deciding on a specific medical therapy the
physician should discuss the benefits and risks of
the available drugs with the patient.
␣-Adrenergic receptor antagonists (␣-blockade).
␣1-AR antagonists are effective, improve quality of
life and have acceptable safety as documented in
properly conducted randomized clinical trials. ␣1-AR
antagonists are an acceptable treatment option for
patients with LUTS with bothersome symptoms
thought to be due to BPO in whom serious compli-
cations have not developed. The long-term efficacy
and safety of ␣1-AR antagonists have been docu-
mented in open label extension investigations but
continued study for example of cost-effectiveness is
recommended. The clinical efficacy and safety of
␣1-AR antagonists cannot be reliably predicted from
preclinical data. However, the effects on flow may be
predicted. The most advantageous subtype selectiv-
ity profile for an ␣1-AR antagonist has not been
established. Clinical uroselectivity as defined by the
International Consultation on BPH (“desired effect
on obstruction and lower urinary tract symptoms
related to adverse effects”) is still a valid concept. All
clinically available ␣1-AR antagonists can be associ-
ated with dizziness, asthenia and orthostatic hypo-
tension, and have the potential to lower blood pres-
sure. The frequency of ␣1-AR antagonist side effects
may vary among individual agents, and the choice of
a particular ␣1-blocker might be influenced by the
cardiovascular and sexual status of the patient. Diz-
ziness and asthenia may be mediated by the central
nervous system. Adequate head-to-head compari-
sons among ␣1-AR antagonists are still scarce, mak-
ing fair comparisons among agents difficult. More
such studies are needed. The clinical action of ␣1-AR
antagonists is rapid and treatment success is usu-
ally assessed after 2 to 4 weeks of treatment. In
patients with BPO and hypertension ␣1-AR antago-
nists remain a first line treatment for BPO. Associ-
ated hypertension and cardiovascular diseases
should be treated independently according to estab-
lished guidelines.
5␣-Reductase inhibitor therapy. Of the available
forms of hormonal therapy (androgen ablation, anti-
androgens and 5␣-reductase inhibitors) only the 5␣-
reductase inhibitors have demonstrated efficacy and
acceptable safety in properly conducted randomized
clinical trials. The 5␣-reductase inhibitors are less ef-
fective in terms of symptom relief and flow rate in men
who do not have clinically enlarged prostates. It is
considered an acceptable first line treatment option in
patients with clinically enlarged prostates and bother-
some symptoms in whom serious complications have
not developed. The long-term efficacy and safety of
5␣-reductase inhibitors have been demonstrated in
open label extension investigations but continued
study of cost-effectiveness is recommended. Available
data show that 5␣-reductase inhibitors have a preven-
tive influence on the progression of BPE, and signifi-
cantly reduce clinically important end points such as
acute urinary retention and the need for surgery. 5␣-
Reductase inhibitors decrease serum PSA but this can
be corrected with sufficient clinical accuracy by multi-
plying the value by 2. To date there is no evidence that
 LOWER URINARY TRACT SYMPTOMS IN OLDER MEN
5␣-reductase inhibitors mask the detection of prostate
cancer. The most common side effects of 5␣-reductase
inhibitors are sexual adverse events (decreased ejacu-
lation, decreased libido and impotence). After initia-
tion of therapy the time for the assessment of treat-
ment success is at least 3 months.
Combination treatment. The combination of an
␣-adrenergic receptor antagonist and a 5␣-reductase
inhibitor (combination therapy) is an appropriate
and effective treatment for patients with LUTS as-
sociated with demonstrable prostatic enlargement.
Alternative treatments. Alternative medical treat-
ment for LUTS mainly includes phytotherapeutic
preparations and derivatives of polyene substances.
The use of alternative medical treatments for LUTS
varies greatly among countries due to the evolution
of treatment traditions and structures of the health
care systems. In some countries it is regarded as a
drug treatment and partly or totally reimbursable,
while in others it is not reimbursed but still consid-
ered a drug treatment, or merely considered a di-
etary supplement.
Most phytotherapeutic preparations are plant ex-
tracts with various components manufactured by var-
ious extraction procedures, which complicates their
comparison despite originating from the same plant.
Progress has been made toward isolation of compo-
nents of these preparations and their possible mecha-
nism(s) of action. Randomized clinical studies against
placebo have been conducted with 1 extract of Serenoa
repens (Permixon® extract) and suggest superior effi-
cacy against placebo. Comparative studies of this ex-
tract with other medical treatments are not conclusive
because they do not include a placebo arm. Other prod-
ucts (extracts from Pygeum africanum, preparations
containing high concentrations of ␤-sitosterol and me-
partricin) have not been evaluated in studies adequate
to draw significant conclusions.
Further studies according to the guidelines of the
International Consultation are needed. Long-term
followup is lacking. These studies are encouraged as
the Consultation considers this approach an inter-
esting direction for further pharmaceutical and clin-
ical research.
Interventional therapies. Standard surgical ap-
proaches produce the most significant, long-term
REFERENCES
1. Male lower urinary tract dysfunction: evaluation
and management. In: 6th International Consulta-
tion on New Developments in Prostate Cancer and
Prostate Diseases. Edited by J McConnell, P
Abrams, L Denis, S Khoury and C Roehrborn. Paris:
Health Publications 2006.
1787
symptom improvement with acceptable risks. How-
ever, there is increasing acceptance of minimally
invasive therapies that produce variable degrees of
symptom improvement with risks that (in some
cases) may be less than those of surgery. However,
evidence of durability is lacking and it remains un-
certain whether these new technologies are more
cost-effective in the long term than standard surgery
(eg TURP). The present status of the various avail-
able techniques is summarized in Appendix 2.
APPENDIX 1
Committees with page numbers
LUTS: Etiology and Patient Assessment
ABRAMS P. United Kingdom (Chair), D’ANCONA C. Brazil, FOO K. T. Republic of
Singapore, GRIFFITHS D. United States, NISHIZAWA O. Japan, NITTI V. United
States, TUBARO A. Italy, VAN KERREBROECK P. The Netherlands, WEIN A. United
States. Pages 69-142, 401 references.
New Medical Developments in the Management of LUTS in Adult Men
ARTIBANI W. Italy, BERGES R. Germany, CHAPPLE C. United Kingdom (Chair),
KAPLAN S. United States, MICHEL M. C. The Netherlands, PERRIN P. France,
PREZIOSO D. Italy, TAKEDA M. Japan, TAMMELA T. L. Finland, TEILLAC P. France.
Pages 143-194, 358 references.
New Minimally Invasive and Surgical Developments in the Management
of BPO
BABA S. Japan, BADLANI G. United States, DE LA ROSETTE J. The Netherlands
(Chair), ELHILALI M. Canada, GRAVAS S. Greece, JEVTICH H. M. United States,
MUSCHTER R. Germany, NAITO S. Japan, NETTO N. R. Brazil. Pages 195-234, 217
references.
Prevention of BPH Outcomes and Clinical Progression
EMBERTON M. United Kingdom, GIULIANO F. France, HIRAO Y. Japan, JARDIN A.
France, KEUPPENS F. Belgium, O’LEARY M. United States, ROEHRBORN C. United
States (Chair), ROSEN R. United States. Pages 235-298, 64 references.
APPENDIX 2
Clinically acceptable interventional techniques
Conventional and novel treatments for BPO, and
recommendations about their use in international guidelines
Interventional International Consultation
therapies Abbreviation on BPH 2005
Transurethral resection of the TURP Acceptable
prostate
Open prostatectomy OP Acceptable
Transurethral electrovaporization TUVP Acceptable
Laser vaporization LV Acceptable
Transurethral microwave therapy TUMT Acceptable
Transurethral needle ablation TUNA Acceptable
Interstitial laser coagulation ILC Acceptable
Urethral stents Acceptable with restriction
2. Abrams P, Khoury S and Grant A: Evidence-based of lower urinary tract function: report from the
medicine overview of the main steps for develop- Standardisation Sub-committee of the International
ing and grading guideline recommendations. Prog Continence Society. Neurourol Urodyn 2002; 21: 167.
Urol 2007; 17: 681.
3. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P,
Ulmsten U et al: The standardisation of terminology