Professional Documents
Culture Documents
BPH Surgical-Mgmt
BPH Surgical-Mgmt
Purpose
Methodology
The evidence team searched Ovid MEDLINE, the Cochrane Library, and the Agency
for Healthcare Research and Quality (AHRQ) database to identify studies indexed
between January 2007 and September 2017. Following initial publication in 2018,
this Guideline underwent an amendment in 2019 that included literature published
through January 2019. An additional literature search was conducted through
September 2019 and serves as the basis for the 2020 amendment. When
sufficient evidence existed, the body of evidence was assigned a strength rating of
A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional
Recommendations. In the absence of sufficient evidence, additional information is
provided as Clinical Principles and Expert Opinions.
GUIDELINE STATEMENTS
sectional imaging (i.e. magnetic resonance imaging [MRI]/ computed tomography [CT]) prior to surgical
intervention for LUTS attributed to BPH. (Clinical Principle)
3. Clinicians should perform a PVR assessment prior to surgical intervention for LUTS attributed to BPH. (Clinical
Principle)
4. Clinicians should consider uroflowmetry prior to surgical intervention for LUTS attributed to BPH. (Clinical
Principle)
5. Clinicians should consider pressure flow studies prior to surgical intervention for LUTS attributed to BPH when
diagnostic uncertainty exists. (Expert Opinion)
6. Clinicians should inform patients of the possibility of treatment failure and the need for additional or secondary
treatments when considering surgical and minimally-invasive treatments for LUTS secondary to BPH. (Clinical
Principle)
SURGICAL THERAPY
7. Surgery is recommended for patients who have renal insufficiency secondary to BPH, refractory urinary retention
secondary to BPH, recurrent urinary tract infections (UTIs), recurrent bladder stones or gross hematuria due to
BPH, and/or with LUTS attributed to BPH refractory to and/or unwilling to use other therapies. (Clinical Principle)
8. Clinicians should not perform surgery solely for the presence of an asymptomatic bladder diverticulum; however,
evaluation for the presence of BOO should be considered. (Clinical Principle)
9. TURP should be offered as a treatment option for men with LUTS attributed to BPH. (Moderate Recommendation;
Evidence Level: Grade B)
10. Clinicians may use a monopolar or bipolar approach to TURP, depending on their expertise with these techniques.
(Expert Opinion)
SIMPLE PROSTATECTOMY
11. Clinicians should consider open, laparoscopic or robotic assisted prostatectomy, depending on their expertise
with these techniques, for patients with large prostates. (Moderate Recommendation; Evidence Level: Grade C)
12. TUIP should be offered as an option for patients with prostates ≤30g for the surgical treatment of LUTS
attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)
13. Bipolar TUVP may be offered to patients for the treatment of LUTS attributed to BPH. (Conditional
Recommendation; Evidence Level: Grade B)
14. Clinicians should consider PVP as an option using 120W or 180W platforms for patients for the treatment of LUTS
attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)
15. PUL may be offered as an option for patients with LUTS attributed to BPH provided prostate volume <80g and
verified absence of an obstructive middle lobe. (Moderate Recommendation; Evidence Level: Grade C)
16. PUL may be offered to eligible patients who desire preservation of erectile and ejaculatory function. (Conditional
Recommendation; Evidence Level: Grade C)
17. TUMT may be offered to patients with LUTS attributed to BPH. (Conditional Recommendation; Evidence Level:
Grade C)
18. Water vapor thermal therapy may be offered to patients with LUTS attributed to BPH provided prostate volume
<80g; however. (Moderate Recommendation; Evidence Level: Grade C)
19. Water vapor thermal therapy may be offered to eligible patients who desire preservation of erectile and
ejaculatory function. (Conditional Recommendation; Evidence Level: Grade C)
20. TUNA is not recommended for the treatment of LUTS attributed to BPH. (Expert Opinion)
LASER ENUCLEATION
21. Clinicians should consider holmium laser enucleation of the prostate (HoLEP) or thulium laser enucleation of the
prostate (ThuLEP), depending on their expertise with either technique, as prostate size-independent options for
the treatment of LUTS attributed to BPH. (Moderate Recommendation; Evidence Level: Grade B)
AQUABLATION
22. Aquablation may be offered to patients with LUTS attributed to BPH provided prostate volume >30/<80g.
(Conditional Recommendation; Evidence Level: Grade C)
23. PAE for the treatment of LUTS secondary to BPH is not supported by current data and trial designs, and benefit
over risk remains unclear; therefore, PAE is not recommended outside the context of clinical trials. (Expert Opinion)
24. HoLEP, PVP, and ThuLEP should be considered in patients who are at higher risk of bleeding, such as those on
anti-coagulation drugs. (Expert Opinion)
outcomes: change in International Prostate Symptom strength refers to the body of evidence available for a
Score (I-PSS), percent responders based on I-PSS particular question and includes not only individual
(e.g., percentage achieving a minimally detectable study quality but consideration of study design,
difference [MDD] such as a 30-50% reduction in score consistency of findings across studies, adequacy of
from baseline or achieving an I-PSS score of ≤7 points sample sizes, and generalizability of samples, settings,
following treatment), change from baseline in quality of and treatments for the purposes of the guideline. The
life (I-PSS-QoL), perioperative adverse events, and AUA categorizes body of evidence strength as Grade A
other adverse events (e.g., symptom recurrence, need (well-conducted and highly-generalizable RCTs or
for reoperation). For blinding of outcome assessment exceptionally strong observational studies with
and incomplete outcome data the review team assessed consistent findings), Grade B (RCTs with some
ROB for short-, intermediate-, and long-term follow-up. weaknesses of procedure or generalizability or
The overall ROB judgement for each outcome across moderately strong observational studies with consistent
domains was determined using an approach suggested findings), or Grade C (RCTs with serious deficiencies of
in the Cochrane Handbook version 5.1.3 ROB was procedure or generalizability or extremely small sample
assessed by a single reviewer and quality checked by a sizes or observational studies that are inconsistent,
subject expert. Discrepancies were resolved by have small sample sizes, or have other problems that
consensus. potentially confound interpretation of data). By
definition, Grade A evidence is evidence about which
Data Synthesis and Analysis. Review ers assessed
the Panel has a high level of certainty, Grade B
clinical and methodological heterogeneity to determine
evidence is evidence about which the Panel has a
appropriateness of pooling data. Data were analyzed in
moderate level of certainty, and Grade C evidence is
RevMan4 using DerSimonian-Laird random effects to
evidence about which the Panel has a low level of
calculate risk ratios (RR) with corresponding 95 percent
certainty.
confidence intervals (CI) for binary outcomes and
weighted mean differences (WMD) with the AUA Nomenclature: Linking Statement Type to
corresponding 95 percent CIs for continuous outcomes. Evidence Strength. The AUA nomenclature system
Statistical heterogeneity was assessed with the I2 explicitly links statement type to body of evidence
statistic. If substantial heterogeneity was present (i.e., strength, level of certainty, magnitude of benefit or
I2 ≥70%), reviewers stratified the results to assess risk/burdens, and the Panel’s judgment regarding the
treatment effects based on patient or study balance between benefits and risks/burdens (Table 1).
characteristics and/or explored sensitivity analyses. For Strong Recommendations are directive
I-PSS and I-PSS- QoL, reviewers determined the statements that an action should (benefits outweigh
statistical significance of the effect of interventions risks/burdens) or should not (risks/burdens outweigh
versus control but defined clinical efficacy based on benefits) be undertaken because net benefit or net
whether the mean or median effect between harm is substantial. Moderate Recommendations are
intervention and control exceeded thresholds for clinical directive statements that an action should (benefits
significance (i.e., the MDD). For I- PSS this is a outweigh risks/burdens) or should not (risks/burdens
difference of > 3 points. For QoL reviewers defined this outweigh benefits) be undertaken because net benefit
as greater than 1 point. or net harm is moderate. Conditional Recommendations
are non-directive statements used when the evidence
Overall quality of evidence for the primary outcomes
indicates that there is no apparent net benefit or harm
within each comparison was evaluated using
or when the balance between benefits and risks/burden
GRADEpro5 based on give assessed domains.6,7 The
is unclear. All three statement types may be supported
quality of evidence levels range from high to very low.
by any body of evidence strength grade. Body of
The five domains include 1. Study limitations (ROB), 2.
evidence strength Grade A in support of a Strong or
Directness (single, direct link between intervention and
Moderate Recommendation indicates that the statement
outcome), 3. Consistency (similarity of effect direction
can be applied to most patients in most circumstances
and size among studies), 4. Precision (degree of
and that future research is unlikely to change
certainty around an estimate assessed in relationship to
confidence. Body of evidence strength Grade B in
MDD), and 5. Reporting bias.
support of a Strong or Moderate Recommendation
Determination of Evidence Strength. The indicates that the statement can be applied to most
categorization of evidence strength is conceptually patients in most circumstances but that better evidence
distinct from the quality of individual studies. Evidence could change confidence. Body of evidence strength
TABLE 1: AUA Nomenclature Linking Statement Type to Level of Certainty, Magnitude of Benefit or
Risk/Burden, and Body of Evidence Strength
Strong Benefits > Risks/Burdens Benefits > Risks/Burdens Benefits > Risks/Burdens (or
(or vice versa) (or vice versa) vice versa)
Recommendation
Net benefit (or net harm) Net benefit (or net harm) Net benefit (or net harm)
(Net benefit or harm sub-
is substantial is substantial appears substantial
stantial)
Moderate Benefits > Risks/Burdens Benefits > Risks/Burdens Benefits > Risks/Burdens (or
(or vice versa) (or vice versa) vice versa)
Recommendation
Net benefit (or net harm) Net benefit (or net harm) Net benefit (or net harm)
(Net benefit or harm
is moderate is moderate appears moderate
moderate)
A statement about a component of clinical care that is widely agreed upon by urolo-
Clinical Principle gists or other clinicians for which there may or may not be evidence in the medical
literature
A statement, achieved by consensus of the Panel, that is based on members' clinical
Expert Opinion training, experience, knowledge, and judgment for which there is no evidence
Grade C in support of a Strong or Moderate an enlargement of the prostate called benign prostatic
Recommendation indicates that the statement can be enlargement (BPE). The onset of the enlargement is
applied to most patients in most circumstances but that highly variable as is the growth rate, though a 5%
better evidence is likely to change confidence. Body of increase in volume has been shown in longitudinal
evidence strength Grade C is only rarely used in studies of placebo treated patients.11 Clearly not all
support of a Strong Recommendation. Conditional men with BPH will develop any evidence of BPE. The
Recommendations can also be supported by any prostate gland may cause eventually obstruction at the
evidence strength. When body of evidence strength is level of the bladder neck, which in turned is termed
Grade A, the statement indicates that benefits and benign prostatic obstruction (BPO), assuming a non-
risks/burdens appear balanced, the best action depends cancerous anatomy. It is important to realize that not
on patient circumstances, and future research is all men with BPE will develop obstruction or BPO, just
unlikely to change confidence. When body of evidence as not all men with BPH will have BPE. To complicate
strength Grade B is used, benefits and risks/burdens matters further, obstruction may also be caused by
appear balanced, the best action also depends on other conditions referred to as BOO. Thus, BPO is a
individual patient circumstances and better evidence subset of BOO.
could change confidence. When body of evidence
Parallel to these anatomical and functional processes,
strength Grade C is used, there is uncertainty regarding
LUTS increase in frequency and severity with age and
the balance between benefits and risks/burdens,
are divided into those associated with storage of urine
alternative strategies may be equally reasonable, and
and with voiding or emptying. In addition, there are
better evidence is likely to change confidence.
other symptoms following urination (e.g. post void
Where gaps in the evidence existed, the Panel provides dribbling).
guidance in the form of Clinical Principles or Expert
Male LUTS may be caused by a variety of conditions,
Opinion with consensus achieved using a modified
which include BPE and BPO. The enlarged gland has
Delphi technique if differences of opinion emerged.4 A
been proposed to contribute to the male LUTS complex
Clinical Principle is a statement about a component of
via at least two routes: 1. Direct BOO/BPO from
clinical care that is widely agreed upon by urologists or
enlarged tissue (static component), and 2. From
other clinicians for which there may or may not be
increased smooth muscle tone and resistance within the
evidence in the medical literature. Expert Opinion refers
enlarged gland (dynamic component). This complex of
to a statement, achieved by consensus of the Panel,
storage symptoms is often referred to as overactive
that is based on members' clinical training, experience,
bladder (OAB). In men, OAB may be the result of
knowledge, and judgment for which there is no
primary detrusor overactivity/underactivity or develop
evidence.
secondary to the obstruction induced by BPE and BPO.12
BACKGROUND
It is important to recognize that LUTS are non-specific,
BPH is a histologic diagnosis that refers to the occur in men and women with similar frequency, and
proliferation of glandular epithelial tissue, smooth may be caused by many conditions, including BPE and
muscle, and connection tissue within the prostatic BPO. Histological BPH is common and may lead to BPE.
transition zone, hence the term “stromo-glandular BPE may cause BPO, but not all men with BPH will
hyperplasia.”8,9 While several hypotheses exist, BPH is develop BPE, and not all BPE will cause BPO. Because
likely the result of a multifactorial process, the exact BPH is nearly ubiquitous and because LUTS in men is
etiology of which is unknown. It is clear that male commonly associated with and/or caused by BPE/BPO,
androgenic steroid hormones testosterone and a compromise terminology is often used referring to
dihydrotestosterone (DHT) play at least a permissive “LUTS most likely associated with BPE/BPO and BPH” or
role as the absence of these hormones prior to puberty “LUTS secondary to BPH.” In this guideline, the Panel
prevents the development of BPH. BPH is nearly refers to “LUTS attributed to BPH” to indicate LUTS
ubiquitous in the aging male with worldwide autopsy among older men for whom an alternative cause is not
proven histological prevalence increases starting at age apparent after a basic evaluation. The Panel
40-45 years to reach 60% at age 60 and 80% at age acknowledges that with a more extensive evaluation,
80.10 some of these men will be found to have other
conditions causing or contributing to their symptoms.
BPH or histological hyperplasia in itself does not require
As treatments being considered specifically for BPO
treatment and is not the target of therapeutic
become more invasive and risky, the importance of a
intervention. BPH does, however, in many men lead to
more definitive diagnosis increases. to treat LUTS attributed to BPH, including alpha-
adrenergic antagonists (alpha-blockers), beta
Lower Urinary Tract Symptoms (LUTS)
adrenergic agonists, 5-alpha- reductase inhibitors (5-
The prevalence and the severity of LUTS increases as ARIs), anticholinergics, vasopressin analogs, PDE-5
men age and is an important diagnosis in the inhibitors, and phytotherapeutics, which can be utilized
healthcare of patients and the welfare of society. In alone or in combination to take advantage of their
assessing the burden of disease, the Urologic Diseases different mechanisms of action. Conversely, there exist
in America BPH Project examined the prevalence of clinical scenarios when either conservative
moderate-to-severe LUTS reported in U.S. population- management , including life style changes (e.g., fluid
based studies that used the definition of an AUA-SI restriction, avoidance of substances with diuretic
score of ≥7.13 Results from the Olmsted County Study properties) or pharmacological management are either
showed a progressive increase in the prevalence of inadequate or inappropriate, warranting consideration
moderate-to-severe LUTS, rising to nearly 50% by the of one of the many invasive procedures available for
eighth decade of life. The presence of moderate-to- the treatment of LUTS attributed to BPH. Indications for
severe LUTS was also associated with the development the use of one of these modalities may include a desire
of acute urinary retention as a symptom of BPH by the patient to avoid taking a daily medication, failure
progression, increasing from a prevalence of 6.8 of medical therapy to sufficiently ameliorate
episodes per 1,000 patient years of follow-up in the bothersome LUTS, and certain conditions that require
overall population to a high of 34.7 episodes in men more aggressive intervention where medical therapy is
aged 70 and older with moderate-to-severe LUTS. inappropriate. This latter category includes patients
Another study has estimated that 90% of men between with acute and/or chronic renal insufficiency, refractory
45 and 80 years of age suffer some type of LUTS.14 urinary retention, recurrent UTIs, and bladder stones or
Although LUTS/BPH is not often a life-threatening gross hematuria thought secondary to BPH.
condition, the impact of LUTS/BPH on QoL can be
Surgical treatment of symptomatic BPH has classically
significant and should not be underestimated.13 When
involved removal of the obstructing adenomatous tissue
the effect of BPH-associated LUTS on QoL was studied
typically via the transurethral route (TURP) using
in a number of community-based populations, for
monopolar electroconductivity. In instances where the
many, the most important motivations for seeking
physical size of the prostate precludes the ability to
treatment were the severity and the degree of bother
achieve this task safely utilizing TURP (i.e. risk of
associated with the symptoms. These were also
transurethral resection [TUR] syndrome resulting in
important considerations when assessing BPH and
dilutional hyponatremia/hypervolemia), open simple
deciding when treatment is indicated.15
prostatectomy (OSP) (i.e. retropubic or suprapubic) has
Treatment of LUTS attributed to BPH been the treatment of choice. These procedures
generally require regional (spinal, epidural) or general
The main focus of this guideline is on the treatment of
anesthesia in addition to varying durations of hospital
LUTS attributed to BPH utilizing common surgical
convalescence. Furthermore, as many patients who
techniques and minimally invasive surgical therapies
require surgery for BPH have concomitant medical
(MIST), although some additional statements are made
conditions (e.g., history of coronary artery disease,
regarding specific pre-operative tests and their utility in
cerebrovascular disease, deep vein thrombosis) that
identifying appropriate surgical candidates. To provide
necessitate anticoagulation or antiplatelet therapy, use
some reference to the clinical efficacy and side effect
of TURP or OSP can present significant clinical
profile of the procedures discussed in this guideline,
challenges or in some cases may be contraindicated. In
clinical statements are made in comparison to what is
addition, known complications associated with TURP
generally accepted as the gold standard, that being a
and open prostatectomy, such as intraoperative and
TURP (monopolar and/or bipolar).
perioperative bleeding requiring transfusion, urethral
Traditionally, the primary goal of treatment has been to stricture, bladder neck contracture, stress urinary
alleviate bothersome LUTS that result from BPO. More incontinence, erectile dysfunction (ED), and retrograde
recently, treatment has also been focused on the ejaculation (RE), can negatively impact QoL. For
alteration of disease progression and prevention of reasons including obviating the need for regional or
complications that can be associated with general anesthesia, hospital stay, discontinuation of
BPH/LUTS, such as acute urinary retention.16 A variety anticoagulation therapy, and open surgery, a variety of
of pharmacologic classes of medications are employed alternatives to the standard monopolar TURP have
been developed and utilized to varying degrees in an as other studies show a worsening of EF.18 Most
attempt to achieve similar clinical efficacy and a importantly, sexual side effects from surgical
reduction in short- and long-term complications. These treatments are more likely to be permanent than those
alternative surgical treatments and MISTs either use from medical treatments, which can often be reversed
modifications to existing technology used in TURP or by stopping medical treatment or switching to an
utilize altogether new technologies and concepts. In alternative treatment.
this guideline, a decision was made to evaluate the
Shared Decision Making
commonly used surgical procedures and MISTs to treat
LUTS attributed to BPH when indicated based on It is the hope that this clinical guideline will provide a
evaluation by an appropriately trained clinician. These useful reference on the effective evidence-based
procedures include monopolar and bipolar TURP, robotic management of male LUTS attributed to BPH utilizing
simple prostatectomy (retropubic, suprapubic, and standard surgical techniques, MISTs using newer
laparoscopic), TUIP, bipolar TUVP, PVP, PUL, thermal technologies, and treatments the Panel feels are
ablation using TUMT, water vapor thermal therapy, investigative. This guideline also reviews a number of
TUNA of the prostate, enucleation using HoLEP or important aspects of the evaluation of LUTS, including
ThuLEP, and PAE. Data utilized to generate these available diagnostic tests to identify the underlying
statements are based on the results from what the pathophysiology and to better assist in identifying
Panel felt were acceptably performed RCTs and CCTs appropriate candidates for invasive treatments. Certain
comparing each technique to TURP . treatment modalities recommended in the guideline
may be unavailable to some clinicians, for example due
Index Patient
to lack of access to the necessary equipment/
For this guideline, the Index Patient is a male aged 45 technology or a lack of expertise in the use of such
or older who is consulting a qualified clinician for his modalities. In such instances, clinicians should discuss
LUTS. He does not have a history suggesting non-BPH the key treatment classes with patients and engage in a
causes of LUTS, and his LUTS may or may not be shared decision making approach to reach a treatment
associated with an enlarged prostate gland, BOO, or choice, which may necessitate a referral to another
histological BPH. clinician for the chosen treatment. In all instances,
patients should be provided with the risk/benefit profile
Sexual Dysfunction and Surgical Therapy
for all treatment options in light of their circumstances
Data on the sexual side effects of BPH surgery can be to allow them to make informed decisions regarding
difficult to ascertain as many studies are not primarily their treatment plans.
designed to answer this question. As such, many
studies evaluate sexual side effects by looking at
reported adverse events only, rather than specifically GUIDELINE STATEMENTS
assessing sexual function. In addition, in some studies,
especially those evaluating surgical treatments,
patients may not only be undergoing a surgical EVALUATION AND PEROPERATIVE TESTING
procedure but are also stopping the previous medical
therapy, which can confound interpretation of
postoperative sexual function. 1. In the initial evaluation of patients presenting
with bothersome LUTS possibly attributed to
Given the strong observed relationship between ED and
BPH, clinicians should take a medical history,
LUTS/BPH, this group of men is at high risk for sexual
conduct a physical examination, utilize the
dysfunction.17 Patients should be counselled about the
AUA Symptom Index (AUA-SI), and perform a
sexual side effects of any surgical intervention and
urinalysis. (Clinical Principle)
should be made aware that surgical treatment can
cause ejaculatory dysfunction (EjD) and may worsen A complete medical history should be taken to assess
ED. Interventions for LUTS/BPH have clear sexual side patient symptoms, prior procedures that could explain
effects. These treatments have a significant rate of EjD. presence of symptoms, sexual history, use of
Libido does not appear to be affected significantly by medications, and overall fitness and health. The AUA-
surgical therapy, and some studies have shown an SI, a validated self-administered questionnaire, can
improvement in erectile function (EF) after surgical provide clinicians with information regarding the
treatment, although this improvement is controversial symptom burden patients are experiencing.
Additionally, while a urinalysis cannot diagnose BPH, it protrusion (e.g., intravesical lobe, ball-valving middle
can help clinicians to rule out other causes of LUTS not lobe) has been recognized to predict poor outcomes
associated with BPH through the detection of bacteria, from watchful waiting and most medical therapies as
blood, white cells, or protein in the urine. When well as the presence of urodynamic obstruction.20
interpreting the results of the urinalysis, clinicians Currently available MISTs, such as water vapor thermal
should focus on the presence or absence of glucosuria, therapy and PUL are only indicated for prostates
proteinuria, hematuria, and infection. between 30g and 80g, and some very large prostates
should be treated with open, laparoscopic, or robotically
Optional studies that may be used to confirm the
assisted laparoscopic enucleation. The weight of the
diagnosis or evaluate the severity of BPH include PVR,
prostate gland in grams, without the seminal vesicles,
uroflowmetry, and pressure flow studies. A PVR can be
can be used as an alternative for prostate volume. 21
useful in determining a baseline ability of the bladder to
empty, detecting severe urinary retention that may not Since digital rectal examination is unreliable in
be amenable to medical therapy, and/or indicating estimating prostate size and serum prostate specific
detrusor dysfunction. There is no universally accepted antigen (PSA) is only a rough indicator of prostate size,
definition of a clinically significant residual urine it appears reasonable to recommend prostate imaging,
volume, and likely following a trend over time is the particularly prior to surgical interventions given that
best way to use this tool. prostate size may direct the clinician as to which
intervention to consider.22
Uroflowmetry is a simple and risk-free office-based
procedure that can be an important adjunct in the Assessment of prostate size and morphology can be
evaluation of LUTS. Flow rates of <10 mL/s have shown achieved by abdominal or transrectal ultrasonography
a specificity of 70%, a positive predictive value of 70%, or cystoscopy, or by cross-sectional imaging using CT
and a sensitivity of 47% for BOO.19 If the patient's or MRI. Many patients may have had such imaging as
condition is not sufficiently suggestive of obstruction part of the workup for PSA elevation and/or prostate
(e.g., peak urinary flow [Qmax] >10 mL/sec), pressure biopsy; therefore, any such imaging obtained in the 12
flow studies are optional as treatment failure rates are months preceding the planned surgical intervention
somewhat higher in the absence of obstruction. If may be utilized for size and shape assessment to verify
interventional therapy is planned without clear evidence suitability for the therapeutic alternatives under
of the presence of obstruction, the patient needs to be consideration since prostate growth rates are 1.6% per
informed of possible higher failure rates of the year on average.23 Imaging should provide cross-
procedure. sectional and sagittal imaging of sufficient resolution to
calculate prostate volume and assess presence or
Following initial evaluation, clinicians and patients
absence of an intravesical lobe.24
should utilize a shared decision making approach to
determine the need for and type of therapy. This
decision will guide the need for further evaluation
3. Clinicians should perform a PVR assessment
should the patient desire treatment.
prior to surgical intervention for LUTS
attributed to BPH. (Clinical Principle)
2. Clinicians should consider assessment of While the evidence base is limited, multiple
prostate size and shape via abdominal or organizations and their guidelines generally include PVR
transrectal ultrasound, or cystoscopy, or by measurement as part of the basic evaluation of LUTS. A
preexisting cross- sectional imaging (i.e. rising PVR can indicate medication failure and the need
magnetic resonance imaging [MRI]/ for surgical intervention, or further workup may be
computed tomography [CT]) prior to surgical warranted. A “large” PVR (>300 mL) is worth
intervention for LUTS attributed to BPH. monitoring, at the very least. Patients with symptoms
(Clinical Principle) from an elevated PVR (i.e. overflow incontinence,
bladder stones, UTI, upper tract deterioration), may
Since the publication of previous iterations of this
need to proceed on to surgery or for further
guideline, the approach to the differential diagnosis
urodynamics testing. To fully determine the etiology of
and the differentiated treatment of male LUTS/BPH has
an elevated PVR, formal urodynamics testing with a
become substantially more sophisticated with prostate
pressure flow study would need to be performed. While
size and morphology playing an important role in the
a clinically useful test that may drive management
decision making process. For example, the intravesical
employed for surgery compared to TURP(RR: 2.0; CI: The Albala trial (n=190) compared 40-minute TUMT
1.01, 3.8). In the GOLIATH study,97,98,99 an international with Sham. Mean I-PSS at baseline was 22 in both
multicenter RCT comparing the 180W PVP to TURP, the groups. Mean changes in I-PSS from baseline through 3
recently published 24-month data reported similar months was greater with TUMT compared with Sham (-
adverse events related to urinary incontinence (RR: 10 and -5.8 points, respectively). In the Albala trial,
1.0; CI: 0.3, 3.28), and overall need for reoperation need for re-catheterization for transitory urinary
(RR: 1.4; CI: 0.6, 3.0) between the two modalities. retention and gross hematuria were reported for 17%
Outcomes at study termination were also similar with and 9% of the TUMT participants compared to none for
regards to PSA, transurethral ultrasound (TRUS)-based the Sham group.
prostate volume, PVR, and EF. While the I-PSS at 24
months was 5.9 for TURP (compared to 6.9 for PVP),
this difference did not meet the non-inferiority criteria The Brehmer trial (n=44) compared 30- or 60-minute
in the study (defined as a 3-point difference in the I- TUMT to a Sham procedure.32 Although not statistically
PSS). A single center study comparing M-TURP, B- significant, the International Continence Society (ICS)
TURP and 120W PVP through 36 months supports the score, AUA Bother Score, and Qmax improved from
above insofar as there is similar change in IPSS and baseline in all treatment groups when reassessed at 4
IPSS-QOL between PVP and the TURP cohorts.95,96 month follow-up (P>0.05, all). Over the 12-month
study period, treatment failed and required retreatment
PUL:
in 7 participants in the Sham group (50%), compared
Based on the L.I.F.T. study, reoperation due to to 5 in the TUMT group (17%) (low quality of evidence
symptom recurrence at 5 years was reported for 19 of for retreatment of TUMT compared to Sham). The
140 participants with 6 receiving additional PUL Sham participants were treated with TURP or TUMT and
implants and 13 undergoing TURP or laser procedures. the TUMT participants were treated with alpha-blocker
Removal of encrusted implants was required in 10 or TURP.
participants while 3 non-encrusted implants exposed to
the bladder were removed prophylactically.
Additionally, 15 participants were taking an alpha Water Vapor Thermal Therapy:
blocker or 5-alpha reductase inhibitor at five years.
One double-blind trial from McVary et al. (n=197)
The prospective, multicentre, randomized, non-blinded compared water vapor thermal therapy with Sham.
BPH6 study was recently published in 2016 which From this trial, one participant in the thermal therapy
provided data comparing 2-year results of PUL group required a reoperation due to LUTS within the
compared to TURP.30 A total of 80 patients with LUTS/ double-blind period of three months.113,114,115,116 Serious
BPH were assessed for symptom relief, quality of treatment-related harms were reported for two
recovery, EF preservation, ejaculatory function participants in the thermal therapy group, including an
preservation, continence preservation and safety after incidence of de novo urinary retention that did not
receiving PUL or TURP treatments. Based on BPH6 resolve, compared with no incidence in the sham group
Study, the need for reoperation due to symptom (RR 2.3 [95%CI 0.1 to 46.4]) (very low quality of
recurrence did not significantly differ between groups evidence for related serious adverse events of Water
over the 2-year study period (RR: 2.4; CI: 0.5, 11.1).30 Vapor Thermal Therapy compared to Sham). There
Rates of serious (Clavien-Dindo grade 3b) and non- were significantly more non-serious treatment-related
serious harms (Clavien-Dindo grade 1 including harms (RR 3.9 [95% CI 1.8 to 8.6]) (high quality of
bleeding, irritative symptoms, urinary incontinence, and evidence for related non-serious adverse events of
urinary retention) related to treatment and need for Water Vapor Thermal Therapy compared to Sham)
reoperation were similar between groups. Six patients (e.g., dysuria, hematuria, frequency and urgency, and
(13.6%) in the PUL arm and two in the TURP arm urinary tract infections) in the thermal therapy group
(5.7%) of the BPH6 Study underwent retreatment for compared with sham.
LUTS/BPH during the 2-year follow up period. These
treatments included additional PUL, intradetrusor botox,
laser treatment or TURP. Laser Enucleation:
with the 4 remaining studies resulted in no differences evidence was rated as very low for need for reoperation
(RR: 0.42; CI: 0.07, 2.48].121, 122,123,124,125 Other for Aquablation compared to TURP at this time.
adverse events, including urethral stricture and bladder
neck contracture, were similar for the HoLEP and TURP
groups. SURGICAL THERAPY
Similarly, few patients required reoperation following 7. Surgery is recommended for patients who
ThuLEP and TURP. Pooled analysis from 3 studies found have renal insufficiency secondary to BPH,
that the groups were similar (RR: 1.3; CI: 0.2, refractory urinary retention secondary to BPH,
11.3).127,137,138 One trial reported that 7% of recurrent urinary tract infections (UTIs),
participants in the ThuLEP group and 9% in the TURP recurrent bladder stones or gross hematuria
group required recatheterization.140 TUR syndrome was due to BPH, and/or with LUTS attributed to
infrequent, with one case in the three studies reporting BPH refractory to and/or unwilling to use
that outcome.127,138,142 Other post-surgical complications other therapies. (Clinical Principle)
were similar for the ThuLEP and TURP groups (e.g.,
The overwhelming majority of patients with LUTS
stress incontinence urethral stricture, urge
attributed to BPH who desire treatment will choose
incontinence, urinary retention, urinary tract infection).
some form of medical therapy either with a single agent
The Zhang diode laser study reported urethral stricture or a combination of agents with different mechanisms
occurred in 1 participant (1%) in the diode laser group of action. Since the advent of medical therapy for BPH,
and 2 participants (3%) in the TURP group. There were this has resulted in a steady reduction in surgical
no reported cases of bladder neck contracture. therapies for this condition. In fact, between 1999 and
Incontinence was reported in 6% of the diode laser 2005, there was a 5% per year decrease in TURP.35
group and 5% of the TURP group; however, the Panel When this study was updated, there was a further
noted that this was rated very low quality of evidence 19.8% decrease from 2005 to 2008.36 As a result,
for urinary incontinence of Diode ELEP compared to patients who now undergo surgery for BPH are
TURP. In the Lusuardi trial, there was one case of generally older37 and have more medical
urinary tract infection (Clavien-Dindo grade 2) in the comorbidities.38 In addition, “failure of medical therapy”
diode laser group and none in the TURP group. The as an indication for surgery rose from essentially 0% in
Zhang trial reported that re-catheterization was 1988 to 87% in 2008.39
required in 3 (4%) and 2 (3%) of the diode laser group
Despite the more prevalent (and often first line) use of
TURP participants, respectively.33,34
medical therapy for men suffering from LUTS
associated with BPH, there still remain clinical scenarios
where surgery is indicated as the initial intervention for
Aquablation:
LUTS/BPH and should be recommended, providing
other medical comorbidities do not preclude this
approach. Classically, these conditions include renal
At 3 months, Aquablation resulted in fewer harms
insufficiency secondary to BPH, refractory urinary
classified as Clavien-Dindo grade ≥2 compared to
retention secondary to BPH, recurrent UTIs, recurrent
TURP, 26% versus 42%, P=.015. Additionally, other
bladder stones or gross hematuria due to BPH, and/or
harms occurring at similar rates in both groups, and
with LUTS attributed to BPH refractory to and/or
classified as Clavien-Dindo grades 1-4, included bladder
unwilling to use other therapies. Such patients are at
spasms, bleeding, dysuria, pain, and urethral damage.
much higher risk of renal deterioration if inadequately
treated on medication.
Based on the one-year outcome data from the Gilling Long standing BOO from BPH can progress to
study, at 12 months, one participant in the TURP group incomplete bladder emptying, bilateral
(2%) and 3 in the Aquablation group (3%) required hydroureteronephrosis, and ultimately acute and/or
surgical retreatment for BPH consisting of TURP (RR chronic renal insufficiency. Although transient urethral
1.68 [95% CI 0.17 to 15.83]).144 catheterization with concomitant medical therapy using
an alpha adrenergic antagonist can be considered, it is
unlikely that the latter will adequately ameliorate the
Need for reoperation was similar for Aquablation and obstructive process to sufficiently prevent further upper
TURP; however, the Panel notes that the quality of urinary tract deterioration. In men with refractory
urinary retention thought secondary to BPH, as opposed subsequent surgical approaches to treatment of BPH
to that related to other etiologies (e.g., urethral are compared and serves as the reference group for all
stricture, neurogenic bladder), surgery should be the other techniques in this guideline. Shared medical
mainstay of therapy. Recurrent UTIs not due to other decision making determines at which time point surgical
causes (e.g., bacterial prostatitis, renal calculi) and the intervention is performed along the spectrum of LUTS
presence of recurrent bladder calculi are generally severity secondary to BPH. Thus, in some patients, a
thought to result from incomplete bladder emptying trial of medical management of LUTS attributed to BPH
and a persistently elevated PVR. Surgical elimination of is not necessary prior to surgery. TURP helps to reduce
the obstruction when combined with the presence of urinary symptoms associated with BPH, including
adequate detrusor contractility should allow almost frequent/urgent need to urinate, difficulty initiating
complete bladder emptying, thereby decreasing the risk urination, prolonged urination, nocturia, non-continuous
of future infections. urination, a feeling of incomplete bladder emptying,
and UTIs. Successful TURP can relieve symptoms
Cystolithalopaxy can be performed concomitantly with
quickly with most men experiencing significantly
the surgical procedure used to remove the obstructing
stronger urine flow within days of the procedure. TURP
prostate tissue, and depending on the size and number
remains the single best gold standard against which to
of stones present, can influence the choice of surgical
measure the efficacy, effectiveness, and safety of any
approach (e.g., transurethral, open, or laparoscopic). It
other invasive treatments for male LUTS/BPH.
has been well demonstrated that the use of a 5-alpha
reductase inhibitor (i.e. finasteride, dutasteride) can be
an effective treatment for gross hematuria secondary to
10. Clinicians may use a monopolar or bipolar
BPH.40 If, however, gross hematuria persists, surgical
approach to TURP, depending on their
removal/ablation of the offending adenomatous tissue
expertise with these techniques. (Expert
should be the next step unless precluded by other
Opinion)
reasons. Finally, in patients with medically refractory
LUTS associated with BPH or who choose not to pursue A large body of literature has been published in recent
other minimally invasive therapies, surgery should be years regarding certain modifications of the standard
offered. TURP using monopolar energy, most notably the use of
bipolar energy transmission.
differences in the effect estimate were highly variable Recommendation; Evidence Level: Grade C)
as was the degree of heterogeneity. Length of stay and
Previous guidelines have emphasized the fact that
dilution hyponatremia both favored bipolar TURP;
complications increase with increasing resection time
however, there was close to 98% heterogeneity in each
and increasing resected tissue volume following
of the meta-analyses that evaluated these outcomes.
monopolar TURP. While no clear guidelines have been
Pooled data from Mamoulakis (2009), Burke (2010),
established, prolonged resection times should generally
Tang (2014), and Omar (2014) all supported that TUR
be avoided with monopolar approaches. Bipolar TURP
syndrome occurred less frequently in the group that
was subsequently introduced and extended the safe
received bipolar TURP.42-45
duration of TURP and thus the indication for larger
Risk reduction for clot retention favored bipolar TURP in glands. The Panel recognizes that large is a relative
general. Bleeding and drops in hemoglobin seem to term as some providers have excellent results utilizing
favor bipolar TURP but with a relatively high degree of transurethral approaches (e.g., bipolar TURP, HoLEP) in
heterogeneity in both meta-analyses. Need for blood prostates > 60g. However, not all providers have
transfusion post-operatively seems to favor bipolar access to or are using bipolar TURP or HoLEP
TURP, although two out of six meta-analyses revealed technology, and may not wish to approach large glands
no statistical significance. transurethrally.
The findings of the meta-analyses and systematic Alternatively, larger prostates have been treated with
reviews allow the following conclusions: OSP, either by suprapubic or retropubic approach. In
recent years, alternative techniques have been
Since there are no differences in efficacy, it is
developed that include laparoscopic (mostly
reasonable to compare surgical interventions in this
transabdominal and transvesical) and robot-assisted
guideline document with either monopolar or
laparoscopic approach.
bipolar TURP series regarding efficacy measures.
Four RCTs (n=433) were identified that compared OSP
Since the main difference between monopolar and techniques to TURP.46-49 Three trials used an open
bipolar TURP is regarding TUR syndrome, which is standard transvesical approach. Two trials47,48 reported
unique to TURP and no other treatment, safety significant differences in maximum urine flow at 12
parameters other than TUR syndrome can also be months favoring OSP, while one trial found no
compared between surgical interventions and difference between the groups.46 Need for blood
monopolar and bipolar TURP. transfusions were similar between groups (RR: 1.2; CI:
The reduced risk of hyponatremia and TUR 0.4, 3.4).46-48 Need for reoperation as reported in 2
syndrome allows for longer resection times; trials was lower in the OSP group compared to TURP
therefore, bipolar TURP may be used in larger (RR: 0.1; CI: 0.01, 0.8).47, 48 Long-term results for
glands compared to monopolar TURP. mean change in I-PSS were not reported. The
remaining study showed mean change in I-PSS through
Since not all hospitals have bipolar TURP equipment 36 months, blood transfusions, need for reoperation,
available, it is left to the surgeon’s discretion and and urinary incontinence was similar for laparoscopic
level of experience as to which type of TURP energy simple prostatectomy compared with TURP.49
she/he may use.
results were reported in terms of I-PSS and Qmax definitions using the International Prostate Symptom
changes. A meta-analysis comparing TUIP with TURP Score (IPSS); mean change in IPSS through 7 years;
after a minimum follow-up of 6 months identified a need for reoperation; and urinary incontinence.
lower rate of RE (18.2% versus 65.4%) and need for However, need for blood transfusion was lower for
blood transfusion (0.4% versus 8.6%) as the key TUVP compared with TURP (<1% versus 4% (RR 0.20
advantages of TUIP versus TURP.50 [95% CI 0.08 to 0.52).
For the search period of this guideline, 1 RCT (n=86, Six RCTs (n=601) compared effectiveness of TUVP and
data reported for 80 completers) conducted in Egypt bipolar TURP.71-76 Mean age was 66 years (range 60 to
that compared TUIP to TURP in men with small 69), baseline I-PSS was 21 (range 18 to 24), and mean
prostates (≤30g) was identified.51 Mean age of the prostate volume was 56mL (range 32 to 64). Data were
participants was 65 years, and baseline I-PSS was 19. insufficient to compare I-PSS changes. However, TUVP
Baseline prostate size was 28g. Follow-up was 48 showed similar need for reoperation (RR: 1.5; CI: 0.6,
months. In men with small prostates, long-term mean 3.9) and incontinence rates (RR: 0.9; CI: 0.4, 2.1) as
change from baseline in I-PSS was similar between the well as need for blood transfusion (RR: 0.6; CI: 0.3,
TUIP and TURP groups (WMD: 0.5; CI: -0.2, 1.2). Need 1.4).
for reoperation and blood transfusion was similar
between the TUIP and TURP groups. In terms of sexual
side effects, ED was reported for 8% of TUIP PHOTOSELECTIVE VAPORIZATION OF THE
participants compared to 20% for TURP participations, PROSTATE (PVP)
though this difference was not significant (RR: 0.4; CI:
14. Clinicians should consider PVP as an option
0.1, 1.3). There was, however, a significant difference
using 120W or 180W platforms for patients
in reports of RE with a total of 30 participants
for the treatment of LUTS attributed to BPH.
experiencing RE (9 in the TUIP arm and 21 in the TURP
(Moderate Recommendation; Evidence Level:
arm).
Grade B)
TRANSURETHRAL VAPORIZATION OF THE
PVP is a transurethral form of treatment that utilizes a
PROSTATE (TUVP)
600-micron side firing laser fiber in a noncontact mode.
13. Bipolar TUVP may be offered to patients for The laser wavelength is 532nm, which is preferentially
the treatment of LUTS attributed to BPH. absorbed by hemoglobin resulting primarily in tissue
(Conditional Recommendation; Evidence ablation/vaporization with a thin layer of underlying
Level: Grade B) coagulation that provides hemostasis. The procedure is
generally performed with saline irrigation, eliminating
Transurethral electrovaporization (TUVP) of the
the possibility of TUR syndrome that can occur with non
prostate is a technical electrosurgical modification of
-ionic irrigation. The goal of the procedure is to
the standard transurethral resection of the prostate.
vaporize the prostate adenoma sequentially outwards
TUVP can utilize a variety of energy delivery surfaces
until the surgical capsule is exposed and a defect is
including amongst others: a spherical rolling electrode
created within the prostate parenchyma through which
(rollerball), grooved roller electrode (vaportrode), or
the patient may now void.
hemi-spherical mushroom electrode (button). TUVP
typically uses saline and is powered with a bipolar A substantial collection of data has been published on
energy source. Compared to traditional resection loops, PVP since the last publication of this guideline. As part
the various TUVP designs hope to improve upon tissue of this review, RCTs of PVP versus TURP were identified
visualization, blood loss, resection speed and patient and examined for the 80W,77,86 120W,87-94 and 180W
morbidity. platforms.97-99 However, given the lack of availability of
the 80W platform and the superior outcomes as
Fourteen RCTs evaluating 1,828 participants compared
compared to the higher powered lasers, clinicians
bipolar TUVP with TURP.46, 52-70 Mean age among
utilizing PVP should utilize either the 120W or 180W
participants was 67 years (range 56 to 70). Mean
options.
baseline IPSS was 23 (range 18 to 27) and mean
prostate volume was 51 mL (range 36 to 65 mL). The Panel noted that PVP may be more efficacious for
Length of follow-up ranged from 3 months to 10.1 smaller volume prostates and that patient expectations
years. Overall, outcomes were similar in both groups should be aligned accordingly. The GOLIATH trial
for long-term response to treatment based on varying excluded men with prostate volumes > 80 cc,79 and at
least two cohort studies noted an increased probability Histopathologic analysis of tissue obtained after PUL
of intraoperative conversion to TURP for prostate demonstrates a benign response to the implant, and no
volumes > 60 cc to 80 cc.100,101 significant changes have been noted in PSA.
As detailed in Statement 24, the need for a blood The Panel identified a single RCT—the BPH6 Study—
transfusion was lower for PVP 120W compared to TURP. comparing PUL to TURP. In this study, a lower
proportion of individuals in the PUL group responded to
While other laser technologies can be utilized for laser
treatment at 12 months follow up compared to TURP as
ablation/vaporization of the prostate, the Panel
measured by the I-PSS reduction goal of ≥30% (73%
concluded that these were either still investigational or
versus 91%; P=.05).30 At 24 months follow up, the
had results that were not considered sufficient or safe
mean difference between PUL and TURP was 6.1 points
to recommend them for routine use. This includes
(CI: 2.2, 10.0) favoring TURP; however, changes in I-
Nd:YAG, which is preferentially absorbed by
PSS-QoL were similar between groups at all follow up
hemoglobin and has a depth of penetration of
intervals. Additionally, Qmax was significantly lower in
approximately 1 cm. This laser was used in the 1990’s,
participants allocated to PUL at all follow up intervals,
but fell out of favor secondary to side effects and high
while changes in prostate volume were not reported.
reoperation rates. It has recently had a resurgence, but
data are lacking to support its routine use. Other lasers, The Panel identified a single RCT—the L.I.F.T study—
such as various diode wavelengths, are also available comparing PUL to sham.29 The mean change from
on the market. Diode lasers are absorbed by baseline I-PSS (MD: -5.2; CI: -7.45, -2.95) and
hemoglobin and water. Like Nd:YAG, the depth of improvements in I-PSS-QoL (MD: 1.2; CI: 1.7, -0.7)
penetration is deeper than PVP. Clinicians should be favored PUL. The mean change in Qmax at 3 months
aware that use of lasers for prostate surgery can lead was higher for those who underwent PUL (4.3mL/s)
to significant delivery of energy to the irrigating fluid, compared to sham (2.0mL/s), P=.005. Of the
thereby increasing the temperature of the irrigant. High participants randomized to PUL, five year follow up data
-powered and/or continuous lasers are at higher risk for demonstrated slight decreases in mean I-PSS and QoL
temperature increases. Surgeons are advised to use scores; however, both remained significantly improved
continuous irrigation, occasionally test the temperature from baseline.
of the efflux, and consider whether a fluid warmer
Only one treatment-related serious adverse event was
should be avoided. Thermal injuries to the bladder from
reported during the double-blind phase of the study. In
hot irrigant have been reported after laser prostate
the short-term, there were significantly more treatment
surgery.
-related events, serious and non-serious, for PUL
compared to sham (RR: 2.7; CI: 1.8, 3.9) including
dysuria, hematuria, pelvic pain/discomfort, urgency,
PROSTATIC URETHRAL LIFT (PUL)
bladder spasm, UTI, and urinary retention.
15. PUL may be offered as an option for patients
Clinicians should verify prostate morphology and
with LUTS attributed to BPH provided prostate
volume as previously detailed in the Evaluation and
volume <80g and verified absence of an
Preoperative Testing section. The BPH6 and LIFT
obstructive middle lobe. (Moderate
studies excluded patients with a prostate ³ 80g or
Recommendation; Evidence Level: Grade C)
obstructive middle lobe. Accordingly, the Panel limited
Developed in 2004, PUL alters prostate anatomy this Guideline Statement to include only those patients
without ablating tissue. PUL utilizes transprostatic with a prostate < 80g lacking an obstructive middle
suture implants delivered by a hand-held device lobe. The Panel identified a single PUL study that
through a cystoscope. The implants are composed of included men with an obstructive middle lobe but
two, T-shaped bars with one on each side of a length of excluded it from efficacy analysis because it was a
suture. They are spring loaded and deployed with one nonrandomized cohort study rather than an RCT.102
bar located outside the prostate capsule and the other
within the prostatic urethral lumen. The tension
between the two bars pulls the lumen of the prostatic 16. PUL may be offered to eligible patients
urethra towards the capsule, compresses the prostate concerned with erectile and ejaculatory
parenchyma, widens the prostatic urethral lumen, and function. (Conditional Recommendation;
improves symptoms. If properly placed, the urethral Evidence Level: Grade C)
side of the implant epithelializes within 12 months.
One of the purported advantages of PUL includes the 18. Water vapor thermal therapy may be offered
higher likelihood of preservation of sexual function.103 to patients with LUTS attributed to BPH
demonstrated that the sexual function of men with provided prostate volume <80g. (Moderatel
normal or moderate ED at baseline was unaffected, and Recommendation; Evidence Level: Grade C)
those with severe ED reported modest improvement.
One double-blind trial 113-115(n=197) compared water
There was no evidence of de novo EjD or ED over the
vapor thermal therapy (also referred to as transurethral
course of the study. Ejaculatory bother improved by
destruction of prostate tissue by radiofrequency
40% at 1 year (p<0.001), while intensity of ejaculation
generated water thermotherapy). Mean age of study
and amount of ejaculate improved by 23% and 22%,
participants was 63 years. Patients had a mean
respectively (p<0.001). This larger study verified the
baseline I-PSS of 22 and a mean prostate volume of 45
findings previously published in initial testing.104
cm3. Given the study inclusion criteria of prostate
In the BPH6 Study, no participants in the PUL group volume <80g, applicability of this therapy to larger
experienced adverse events related to sexual function. glands is unknown. Unlike other MISTs, this technology
In comparison, ED and RE occurred in 9% and 20%, did not exclude those men with obstructing middle
respectively, of the participants in the TURP group. lobes or median bars.
While measures of EF using the Sexual Health
Response to treatment through 3 months, based on an
Inventory for Men (SHIM) was similar between groups
improvement in I-PSS of ≥30% or ≥8 points, was
at all time points, ejaculatory function based on Male
significantly greater in the water vapor thermal therapy
Sexual Health Questionnaire for Ejaculatory Dysfunction
group (74%) compared to the sham group (31%) (RR:
(MSHQ-EjD) scores was better in the PUL group with
2.4; CI: 1.6, 3.5). Mean changes from baseline in I-PSS
TURP participants experiencing declines from month
and I-PSS-QoL at 3 months were greater in the water
one onward. MSHQ-EjD bother scores were similar
vapor thermal therapy group compared to the sham
throughout the 24-month follow up. The L.I.F.T. Study
group with a MDD of >3 points (MD: -6.9; CI: -9.1, -
showed non-significant differences in sexual function
4.8).
between PUL and sham groups as measured via SHIM,
IIEF-5, MSHQ-EjD function, and MSHQ-EjD bother. In Three-year results showed sustained improvements for
men so concerned about new onset of ED and/or EjD, the IPSS IPSS-QoL, and Qmax, with scores remaining
PUL likely does not pose additional risk. significantly improved from baseline;119 Qmax
improvement was > 50% from 3 to 24 months and
39% at 36 months.13 At 36 months in the intent-to-
TRANSURETHRAL MICROWAVE THERAPY (TUMT) treat population of the original 136 participants, mean
change from baseline in IPSS was -11.0 points and the
17. TUMT may be offered to patients with LUTS
mean score was 10.4 points, representing a 50%
attributed to BPH. (Conditional
improvement from baseline. Mean IPSS-QoL was
Recommendation; Evidence Level: Grade C)
improved from baseline by 49% at 3 years.
Evidence regarding efficacy, symptom improvement,
Rates of serious adverse events were low and similar
adverse events and urinary flow rates are inconsistent.
between groups. The incidence of non-serious transient
Four trials (n=499) compared TUMT to TURP or control.
105-112 adverse events, including dysuria, hematuria,
Mean baseline I-PSS was 21 (range 20 to 21),
frequency and urgency, and UTI, was significantly
and mean prostate volume was 56mL (range 50 to 69).
higher in the water vapor thermal therapy group.
Follow-up periods ranged from six months to five years.
Response to treatment, defined as an I-PSS ≤7 or
>50% improvement from baseline, through 12 months
18. Water vapor thermal therapy may be offered
was similar between the TUMT and TURP groups.
to eligible patients who desire preservation of
Reoperation was significantly higher with TUMT (9.9%)
erectile and ejaculatory function. (Conditional
compared to TURP (2.3%). Incontinence through long-
Recommendation; Evidence Level: Grade C)
term follow-up was significantly lower with TUMT
(0.7%) compared to TURP (3.9%). ED was similar for In the RCT comparing water vapor thermal therapy to
TUMT (6.3%) compared to TURP (11.5%). sham, the original 136 patients randomized to water
vapor thermal therapy are expected to be followed for
five years. 114 At 36 months, no de novo erectile
WATER VAPOR THERMAL THERAPY dysfunction was reported but dysuria was reported by
Function scores associated with ejaculation, assessed Due to the chromophore of water and minimal tissue
by the MSHQ-EjD, were significantly improved at, 36 depth penetration with both holmium and thulium
and 48 months following treatment (P=.005 and (0.4mm for holmium, 0.2 mm for thulium), these two
P=.003) but not at 12 and 24 months.116 Bother scores lasers achieve rapid vaporization and coagulation of
associated with ejaculation, assessed by the MSHQ-EjD, tissue without the disadvantage of deep tissue
were significantly improved at 12, 24, and 36 months penetration. They have better coagulative properties in
but not at 48 months following treatment.117 tissue than either monopolar or bipolar TURP, and
combined with their superficial penetration, both
thulium and holmium are reasonable for endoscopic
TRANSURETHRAL NEEDLE ABLATION (TUNA) enucleation. 119
20. TUNA is not recommended for the treatment HoLEP and ThuLEP have similar outcomes when
of LUTS attributed to BPH. (Expert Opinion) compared to TURP for the treatment of symptomatic
BPH as measured by I-PSS and I-PSS-QoL outcomes.
Initially after its release by the FDA, there was
Based on 4 studies reporting long-term follow-up
considerable literature generated evaluating the
comparing HoLEP to TURP, ranging from 12 to 92
prostate morphology before and after TUNA using
months, mean changes in I-PSS (approximately -19)
ultrasound, MRI, PSA, and endoscopy to evaluate this
between groups were statistically similar (WMD: -0.5;
volume reduction issue. The conclusion now is that the
CI: -1.2, 0.3). 120-126 Only 2 studies reported I-PSS-QoL
prostatic volume is reduced less than initially
outcomes (mean change approximately -3.5) at follow
anticipated. BPH histologic architecture is likely
up of greater than 12 months, and mean differences
replaced in part with scar, leaving modest at best
between groups were not statistically significant (0.10;
volume reduction. Absent a consensus on mechanism of
CI: -0.05, 0.25). 125,126
action, attempts to identify favorable candidates for
TUNA, both in terms of short-term response and in When comparing ThuLEP to TURP, 3 trials 127-130
terms of durability of improvement have been found to reported long-term results in I-PSS reduction (mean
be difficult and inconsistent. change approximately -15), ranging from 18 to 60
months (WMD: 0.4 points; CI: -0.9, 1.6). Similarly,
In 2010 the AUA BPH Clinical Guidelines Panel
there was no significant difference in mean reduction in
commented that since the development of the 2003
I-PSS-QoL outcomes (mean change approximately -
Guideline, little new information on effectiveness and
2.0). At long-term follow-up, the mean difference was -
safety had been published. 1,118 At that time, the Panel
0.3 (CI: -0.4, 0.9).
concluded that a degree of uncertainty remained
regarding TUNA because of a paucity of high-quality Qmax at last follow-up after HoLEP and ThuLEP
studies. In the development of the current guideline, compared to TURP is generally similar. Of the 11
the Panel again searched for studies meeting the studies reporting Qmax, 9 found the HoLEP and TURP
updated inclusion criteria, yet none were identified. The groups to be similar. 121-126,131-135 Two studies, however,
lack of peer-reviewed publication in the literature found significantly higher Qmax in the HoLEP groups.
120,136
review timeframe meeting the inclusion criteria and the The ThuLEP and TURP groups were similar at 3
decreasing clinical relevance resulted in a lack of months, 126,127,137-139 12 months, 1286,138,141,142 18
enthusiasm by the Panel to recommend TUNA for the months, 130 48 months, 141 and 5-year follow-up.129
any treatment of LUTS attributed to BPH.
In reviewing the need for blood transfusion, either peri-
or post-operatively, likelihood was significantly lower
compared to TURP for both HoLEP (RR 0.20; CI: 0.08,
LASER ENUCLEATION
0.47) and ThuLEP (RR: 0.4; CI: 0.1, 0.9).
21. Clinicians should consider holmium laser
Three studies reported International Index of Erectile
enucleation of the prostate (HoLEP) or
Function (IIEF) scores following treatment with
HoLEP.120,125,126 One study reported that IIEF-5 scores also used to monitor tissue resection in real time during
were similar at 3, 12, and 24 months120 and another the procedure. After completion of the resection,
reported similar scores at 6 months for the HoLEP and electro-cautery via a standard cystoscope/resctoscope
TURP groups.126 The other reported IIEF function and or traction from a 3 way catheter balloon are used to
overall satisfaction scores were similar at 92 months.125 obtain hemostasis.
An earlier article on this trial reported the HoLEP and
One low risk of bias RCT (n = 181) assessing
TURP groups experienced similar levels of new onset
Aquablation was evaluable by the panel.143-145 The trial
erectile dysfunction (9% and 8%, respectively) and
utilized standard inclusion/exclusion criteria limiting
retrograde ejaculation (75% and 61%) at 24 months.16
participants to prostate sizes between 30-80 grams.
Three studies reported retrograde ejaculation with one
Treatment response through 12 months, defined as at
also reporting erectile dysfunction; no differences were
least a 5-point improvement in International Prostate
noted between groups at follow-up to 24 months.
Symptom Score (IPSS), was similar for Aquablation and
Two studies reported IIEF scores following treatment TURP (Quality of Evidence was rated moderate for long-
with ThuLEP. IIEF were similar between the thulium term treatment response for Aquablation compared to
laser and TURP groups at 18 months and 12 TURP). Mean improvement in lower urinary tract
months.129,142 Retrograde ejaculation was reported in symptoms (LUTS) based on the IPSS through 12
four studies with all reporting similar outcomes for the months was similar for Aquablation and TURP (Quality
thulium laser and TURP groups.127,137,138,142 of Evidence was rated moderate for IPSS mean-change
from baseline for Aquablation compared to TURP).143,144
In addition to HoLEP and ThuLEP, other laser modalities
Mean improvement in quality of life based on the IPSS-
have been utilized for enucleation - namely Diode and
QoL through 12 months was similar for Aquablation and
Greenlight. Diode lasers used in urology have variable
TURP (Quality of Evidence was rated Moderate for long-
wavelenghs and several have been utilized for
term mean improvement in quality of life based on the
enucleation, but only by a handful of surgeons with few
IPSS-QoL for Aquablation compared to TURP).143,144 At
studies. GreenLEP has gained in popularity and more
follow-up (12 months), maximum flow rates increased
studies have been published since it was first described.
similarly in the Aquablation group compared to TURP,
Published studies show promise with these modalities
10.3 vs 10.6 mL/s (P=.86), respectively.
as yet another energy source for enucleation in the
hands of surgeons comfortable with the technique of At 3 months, Aquablation resulted in fewer harms
endoscopic enucleation. As of yet, the studies are too classified as Clavien-Dindo grade ≥2 compared to
few to make guidelines recommendations. However, TURP, 26% versus 42%, P=.015.143,144 Additionally,
endoscopic enucleation, particularly with laser energy, rates of retrograde ejaculation were higher (P=.002)
has clearly become an accepted modality and further with TURP (23%) compared to Aquablation (6%). Other
applications and support in guidelines are likely in the harms occurring at similar rates in both groups, and
future. classified as Clavien-Dindo grades 1-4, included bladder
spasms, bleeding, dysuria, pain, and urethral damage.
No deaths were reported. Also at 3 months, reduction
AQUABLATION in prostate volume was significantly less with
Aquablation (31%) compared to TURP (44%)
22. Aquablation may be offered to patients with
(P=.007).143,144
LUTS attributed to BPH provided prostate
volume >30/<80g. (Conditional Aquablation has a theoretical advantage in preservation
Recommendation; Evidence Level: Grade C) of EF or ejaculation as conductive heat (and its
potential damage of erectile nerves) is not used to
Aquablation surgery utilizes a robotic handpiece,
remove prostate tissue. This theoretical advantage may
console and conformal planning unit (CPU). The
be in part mitigated by use of electro-cautery to
technique is not in the minimally invasive surgical
achieve hemostasis. In addition, there are unknowns as
treatment (MIST) category as patients must undergo
to the MOA for the decreased rates of ejaculatory
general anesthesia. The resection of the prostate is
dysfunction. It may be secondary to decreased tissue
performed using a water jet from a transurethrally
removal at the verumontanum or possibly treatments
placed robotic handpiece. Pre-treatment transrectal
that avoid effecting the bladder neck. This requires
ultrasound is used to map out the specific region of the
further inquiry to address. Among a non-random
prostate to be resected with a particular focus on
subset of sexually active men, the proportion of
limiting resection in the area of the vermontanum. It is
subjects who reported worsening sexual function Results also differed between the trials regarding
through 6 months on the IIEF-5 (6-point decrease) or improvements in Qmax. Two trials reported lower flow
the Male Sexual Health Questionnaire (MSHQ-EjD) (2- rates with PAE compared with TURP1486,148and one trial
point decrease) was 33% in the Aquablation group reported similar flow rates between groups.147 Mean
compared with 56% in TURP group (P=.03).143,144 No 12 prostate volumes were significantly higher in the PAE
-month follow-up data have been reported to date. group compared with the TURP group at all follow-up
time points.144,147Two studies found mean prostate size
decreased among participants in the TURP group at
PROSTATE ARTERY EMBOLIZATION (PAE) short,148 intermediate, and long-term follow up.147
Additionally, the 12-week trial reported PAE was not as
23. PAE for the treatment of LUTS secondary to
effective in reducing bladder outlet obstruction,
BPH is not supported by current data and trial
indicated by change in detrusor pressure at maximum
designs, and benefit over risk remains
flow rate, compared with TURP, -17.2 vs. -41.1 cmH2O
unclear; therefore, PAE is not recommended
(P=.002).148 Postoperatively, 56% of PAE patients were
outside the context of clinical trials. (Expert
considered less obstructed compared with 93% of TURP
Opinion)
(P=.003).148
access, technical feasibility, and quality control at lower energy in a superficial layer thereby “sealing” vessels
volume centers—it is the opinion of the Panel that PAE and creating shallow coagulation zones. Holmium and
should only be performed in the context of a clinical thulium both have similar wavelengths (holmium
trial until sufficient evidence from rigorously performed 2,140nm, thulium 2,013nm) and are absorbed by
studies is available to indicate definitive clinical benefit water. The major difference is that holmium is a pulsed
and define specific indications. The Panel recommends laser while thulium is continuous, which impacts how
trials involve multi-disciplinary teams of urologists and quickly the temperature rises in the tissue. The
radiologists; and that, as with other MIST therapies, decreased penetration depth of holmium and thulium as
RCTs comparing PAE to sham be considered to account compared to monopolar energy leads to a more
for significant placebo effects.149 superficial area of ischemia and can reduce risk for
delayed bleeding as eschar sloughs approximately 7-14
days post procedure. During this timeframe, any
MEDICALLY COMPLICATED PATIENTS anticoagulant therapy that may have been discontinued
will have resumed and be in effect, thereby making the
24. HoLEP, PVP, and ThuLEP should be considered
reduction in eschar a significant benefit. 119,154-159
in patients who are at higher risk of bleeding,
such as those on anti-coagulation drugs. The safety of thulium in anticoagulated patients has
(Expert Opinion) been reported in several publications. In one study of
56 patients (32 on aspirin, 8 on clopidogrel or
Multiple studies have shown the need for a blood
clopidogrel plus aspirin, and 16 on phenprocoumon), 4
transfusion (either peri- or post-operatively) was
patients needed blood transfusions, and 4 patients
significantly less likely with HoLEP and ThuLEP as
required immediate reoperation. Given this high risk
compared to TURP (RR: 0.20; CI: 0.08, 0.47) and (RR
group and despite the reported issues, the patients did
0.4; CI: 0.1, 0.9), respectively.72,121,123,132-
134,136,138,141,142,150-152 well overall. 160 Two other studies have described the
In addition, studies of holmium
feasibility of thulium laser for prostate surgery in
laser prostate surgery in patients maintained on
anticoagulated patients and those bridged with low
anticoagulation therapy at time of surgery have
molecular weight heparin (LMWH). A 2013 study of 76
supported a relatively low transfusion rate. In a 2013
patients compared those on anticoagulant/antiplatelet
retrospective review on a series of 125 patients treated
therapy during surgery to those who were bridged with
with HoLEP (52 patients were on antithrombotic
LMWH. There were no statistically significant variations
therapy at the time of surgery and 73 patients were
in hemoglobin between the two groups. 158
not), only 4 men (7.7%) in the antithrombotic group
required a blood transfusion compared to none in the A similar more recent 2017 study of 103 patients
control group. 153 A similar 2016 study compared 116 revealed the drop in hemoglobin levels in the pre- and
patients who required anticoagulation/antiplatelet post-operative periods were significantly higher in the
therapy at the time of HoLEP to 1,558 patients who did LMWH bridged group than those who remained on
not. Other than a slightly increased duration of bladder anticoagulant/antiplatelet therapy during surgery.
irrigation and hospital stay, the use of anticoagulation/ Given that no cardiopulmonary adverse events occurred
antiplatelet therapy did not adversely affect outcomes. and bleeding was not problematic, the authors
154
Lastly, a 2017 meta-analysis of patients on recommend abandoning LMWH bridging and continuing
therapeutic anticoagulation/antiplatelet therapy when anticoagulant/antiplatelet therapy during thulmium
undergoing HoLEP supported that this approach can be laser surgery. 161
performed safely on these patients, but stressed that
PVP is performed using the LBO laser, which has a
there are limited data surrounding the class of direct
wavelength of 532 nm and a chromophore of
oral anticoagulants and safety. 157
hemoglobin. The depth of penetration with PVP is 0.8
While there are differences between wavelengths as mm. Multiple studies have found that PVP is safe and
well as the chromophore in which laser energy is effective for patients who continue their anticoagulant/
absorbed (i.e. water, hemoglobin, pigment), in general, antiplatelet therapy, with negligible transfusion rates.
lasers have favorable hemostatic properties that treat However, surgeons should be aware that longer
bleeding more effectively than monopolar energy. Most catheterization and irrigation with an increased rate of
lasers used in urology (532 nm, holmium, thulium) complications has been reported, and delayed bleeding
have superficial penetration and thermal diffusion is more pronounced in these patients. 162-165 A 2017
depths that lead to the concentration of high-density study confirmed these findings in 59 of 373 patients
undergoing PVP. Overall, Greenlight PVP with the 180W nighttime urination frequency/volumes and the role of
laser unit on patients therapeutic on heparin, warfarin, sleep apnea is an area of great importance given that
clopidogrel, dipyridamole, or new oral anticoagulant nocturia is also associated with increases in overall
drugs revealed good safety outcomes. 166 As expected, mortality. Due to the considerable burden of nocturia
anticoagulated patients were older, had a higher on QoL and a lack of effective management options,
American Society of Anesthesiologists (ASA) score than more funded research is needed. Nocturia is often
the control group and, although no patient required multifactorial in origin and symptomatic of other
blood transfusion, there was a higher incidence of high- medical problems, further complicating effective
grade Clavien–Dindo events. Similar to other studies, management. Nocturia, whether global, reduced
the therapeutically anticoagulated group had a bladder capacity, or mixed, is a unique symptom
significantly longer length of hospital stay and duration complex requiring special concern and judicious
of catheterization as compared to the controls. In evaluation.
support of the concept of 120W PVP use in
Urodynamic Evaluation and Imaging
anticoagulated patients, recent publications report that
the need for a blood transfusion was lower for The natural history and predictive ability of various
photoselective vaporization prostatectomy 120W urodynamic measures, such as flow rate and PVR, in
compared to TURP.95,96 regards to predicting patient reported outcomes (e.g.,
symptoms, QoL), and objective outcomes (e.g., peak
For additional information on the use of anticoagulation
flow, development of total retention, need for
and antiplatelet therapy in surgical patients, refer to
retreatment) is an area of great interest with
the ICUD/AUA review on Anticoagulation and
substantial clinical and health care economic
Antiplatelet Therapy in Urologic Practice. 167
consequences.
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John T. Stoffel, MD (PGC Rep) Leadership Position: Steven A. Kaplan, MD: M edi-
Univ of Michigan Med Ctr vizor, EcoFusion, AvantCourse
Ann Arbor, MI
Health Publishing: Deborah J. Lightner, MD: AUA,
Urology/Elsevier; Claus G. Roehrborn, MD: NIDDK
Manhar Gandhi, MD (Patient Advocate)
Memphis Health Center Other: Lori B. Lerner, MD: P rocept; Charles Welliv-
Memphis, TN er, MD: BMJ Best P ractice, Oakstone P ublishing,
Amgen
Consultants
2019 Amendment:
Timothy J. Wilt, MD
Philipp Dahm, MD Consultant/Advisor: Kevin T. McVary, MD: AM S/
Lauren McKenzie, MPH Boston Scientific, Merck, Olympus; Lori B. Lerner, MD:
Christina Rosebush, MPH Boston Scientific; Kellogg Parsons, MD: MDx Health,
Rod MacDonald, MPH Endocare
Michael Risk, MD Meeting Participant or Lecturer: Tobias S. Kohler,
Jae Jung, MD MD: Coloplast; Lori B. Lerner, MD: Lumenis, I nc.,
Nancy Greer PhD Neotract, Augmentix
For this reason, the AUA does not regard technologies or man-
agement which are too new to be addressed by this guideline
as necessarily experimental or investigational.