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Surgical Management of Lower Urinary Tract Symptoms

Attributed to Benign Prostatic Hyperplasia: AUA Guideline


Amendment 2020
€ hler, Lori B. Lerner and Timothy J. Wilt
J. Kellogg Parsons,* Philipp Dahm, Tobias S. Ko
From the UCSD School of Medicine, La Jolla, California

Purpose: The AUA Guideline panel provides evidence-based recommendations


Abbreviations
for the surgical management of male lower urinary tract symptoms (LUTS)
and Acronyms
secondary to benign prostatic hyperplasia (BPH).
AUA [ American Urological
Materials and Methods: The Panel amended the Guideline in 2020 to reflect Association
additional literature published through September 2019. When sufficient
BPE [ Benign Prostatic
evidence existed, the Panel assigned the body of evidence a strength rating of
Enlargement
A (high), B (moderate), or C (low) for support of Strong, Moderate, or Con-
ditional Recommendations. In the absence of sufficient evidence, the Panel BPH [ Benign Prostatic
Hyperplasia
provided additional information as Clinical Principles and Expert Opinions
(See table 1). HoLEP [ Holmium Laser Enucle-
ation of the Prostate
Results: Amendments to these Guidelines include: 1) an amended statement
(Guideline 1) to include conducting a physical examination; 2) a new LUTS [ Lower Urinary Tract
Symptoms
statement (Guideline 6) discussing concepts of treatment failure and
retreatment; 3) an amended statement (Guideline 15) with updated sup- LUTS/BPH [ Lower Urinary Tract
porting text for prostatic urethral lift (PUL); 4) an amended statement Symptoms Attributed to Benign
Prostatic Hyperplasia
(Guideline 16) for PUL; 5) an amended statement (Guideline 17) with
updated supporting text for transurethral microwave therapy (TUMT); 6) an PAE [ Prostate Artery
amended statement (Guideline 18) with updated supporting text for water Embolization
vapor thermal therapy; 7) updated supporting text for water vapor thermal PUL [ Prostatic Urethral Lift
therapy (Guideline 19); 8) an amended statement (Guideline 21) with RCT [ Randomized Control Trial
updated supporting text for laser enucleation; 9) an amended statement ThuLEP [ Thulium Laser Enucle-
(Guideline 22) with updated supporting text for Aquablation; and 10) an ation of the Prostate
amended statement (Guideline 23) with updated supporting text for Pros- TURP [ Transurethral
tate Artery Embolization (PAE). Resection of the Prostate
Conclusions: These evidence-based updates to the AUA Guidelines further
inform the surgical management of LUTS/BPH. Accepted for publication July 6, 2020.
This document is being printed as submitted,
independent of standard editorial or peer review
Key Words: transurethral resection of the prostate, laser therapy, lower by the editors of The Journal of Urology.
urinary tract symptoms, prostate * Correspondence: UCSD School of Medicine,
La Jolla, California (e-mail: k0parsons@health.
ucsd.edu).
BPH is a histologic diagnosis that lead to an enlargement of the prostate
refers to the proliferation of glan- (benign prostatic enlargement [BPE]).
dular epithelial tissue, smooth mus- BPE may cause functional obstruction
cle, and connective tissue within the of the bladder outlet (benign prostatic
prostatic transition zone.1 BPH is obstruction), which may induce lower
common in the aging male. The urinary tract symptoms (LUTS), uri-
prevalence increases with age.2 nary infections, bladder stones, and
Asymptomatic BPH does not other conditions. Lower urinary tract
require treatment. However, BPH can obstruction may also be caused by

0022-5347/20/2044-0799/0 https://doi.org/10.1097/JU.0000000000001298
THE JOURNAL OF UROLOGY® Vol. 204, 799-804, October 2020
Ó 2020 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC. Printed in U.S.A.

www.auajournals.org/jurology j 799
Copyright © 2020 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.
800 SURGICAL MANAGEMENT OF LOWER URINARY TRACT SYMPTOMS: AUA GUIDELINE AMMENDMENT

Table 1: AUA Nomenclature Linking Statement Type to Level of Certainty, Magnitude of Benefit or Risk/Burden, and Body of Evidence
Strength
Evidence Strength A (High Certainty) Evidence Strength B (Moderate Certainty) Evidence Strength C (Low Certainty)
Strong Benefits > Risks/Burdens (or vice versa) Benefits > Risks/Burdens (or vice versa) Benefits > Risks/Burdens (or vice versa)
Recommendation Net benefit (or net harm) is substantial Net benefit (or net harm) is substantial Net benefit (or net harm) appears
(Net benefit or Applies to most patients in most Applies to most patients in most substantial
harm substantial) circumstances and future research is circumstances but better evidence could Applies to most patients in most
unlikely to change confidence change confidence circumstances but better evidence is
likely to change confidence (rarely used to
support a Strong Recommendation)
Moderate Benefits > Risks/Burdens (or vice versa) Benefits > Risks/Burdens (or vice versa) Benefits > Risks/Burdens (or vice versa)
Recommendation Net benefit (or net harm) is moderate Net benefit (or net harm) is moderate Net benefit (or net harm) appears
(Net benefit or Applies to most patients in most Applies to most patients in most moderate
harm moderate) circumstances and future research is circumstances but better evidence could Applies to most patients in most
unlikely to change confidence change confidence circumstances but better evidence is
likely to change confidence
Conditional Benefits [ Risks/Burdens Benefits [ Risks/Burdens Balance between Benefits & Risks/
Recommendation Best action depends on individual patient Best action appears to depend on Burdens unclear
(No apparent net circumstances individual patient circumstances Alternative strategies may be equally
benefit or harm) Future research unlikely to change Better evidence could change confidence reasonable
confidence Better evidence likely to change
confidence
Clinical Principle A statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be
evidence in the medical literature
Expert Opinion A statement, achieved by consensus of the Panel, that is based on members clinical training, experience, knowledge, and judgment for which
there is no evidence

other etiologies. This condition is referred to as GUIDELINE STATEMENTS WITH UPDATES


bladder outlet obstruction.
Evaluation and Preoperative Testing
LUTS increase in frequency and severity with
1. In the initial evaluation of patients presenting
age, and may be caused by a variety of conditions
with bothersome LUTS possibly attributed to
other than BPE-induced obstruction: for example,
BPH, clinicians should take a medical history,
overactive bladder.2 In this Guideline, the Panel
conduct a physical examination, utilize the
refers to “LUTS attributed to BPH” (LUTS/BPH)
AUA Symptom Index (AUA-SI), and perform a
to indicate LUTS among men for whom an alter-
urinalysis. (Clinical Principle)
native cause is not apparent.
Language was added to this statement on con-
Since its publication, a working group of the BPH
ducting a physical examination for the initial eval-
Guideline panel has regularly amended the 2018
uation of patients presenting with bothersome
report with emerging clinical data on novel tech-
LUTS possibly due to BPH.
nologies.3 In contrast to prior BPH Guidelines, be-
Additionally, supporting text was added for
tween which several years would elapse between
interpreting the results of urinalysis.
updates, this new process provides timely and
important information to the urological community
on an annual basis. General Principles of Retreatment
The Guideline panel provided the Minnesota 6. Clinicians should inform patients of the possibil-
Evidence Review Team with key questions, in- ity of treatment failure and the need for additional
terventions, comparators, and outcomes identical or secondary treatments when considering surgical
to the 2018 process. The review team worked with and minimally-invasive treatments for LUTS sec-
the panel to refine the scope, key questions, and ondary to BPH. (Clinical Principle).
inclusion/exclusion criteria. The panel noted Guideline 6 is a new guideline recommending
several topics, interventions and technologies that patients be counseled as to the potential risks
with meaningful peer reviewed publications of treatment failure and need for additional thera-
qualifying for additional statements, discussion pies. The Panel identified several core concepts of
and commentary. When the reviewed materials treatment failure and retreatment. In addition to
did not impact the 2018 AUA BPH Clinical patient counseling, the Panel recommends consid-
Guidelines, the statements were left unaltered eration of these five issues when interpreting out-
without additional text. comes of clinical trials comparing different
Additionally, treatment information can be found therapeutic modalities, or of clinical trials of a sin-
in the Surgical Management of Lower Urinary gle modality with different lengths of follow-up.
Tract Symptoms Attributed to Benign Prostatic First, rates of treatment failure and retreatment
Hyperplasia Algorithm (figure 1). are influenced by both the duration and the

Copyright © 2020 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.
SURGICAL MANAGEMENT OF LOWER URINARY TRACT SYMPTOMS: AUA GUIDELINE AMMENDMENT 801

Figure 1.

completeness of follow-up. For the methodological Third, retreatment may take the form of medical
analyses of this guideline, the Panel focused pri- therapy, a minimally-invasive intervention, or a
marily on follow-up duration, a more objective and surgical procedure.
readily captured metric; and defined durations of Fourth, thresholds fordand types ofdretreat-
post-treatment follow-up as short- (<6 months), in- ment may vary substantially by provider, patient,
termediate- (6 to 12 months), or longer-term (>12 category of failure (i.e. objective, subjective, or
months). These time intervals were chosen by the both), and initial treatment modality.
Panel at the prior to the literature search based on Finally, in contrast to retreatment with
the available literature at that time. minimally-invasive and newer surgical therapies,
Second, the risks of objective (e.g., urinary including but not limited to Water Vapor Thermal
retention, reduction of flowrate, increasing residual Therapy and PUL, most older clinical trials do not
urine, infection) and subjective failure (e.g., wors- routinely report retreatment with medical therapy
ening of IPSS and/or quality of life) increase with as an outcome. The difficulty of accurately recording
longer duration of follow-up. initiation and duration of medical therapy precludes

Copyright © 2020 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.
802 SURGICAL MANAGEMENT OF LOWER URINARY TRACT SYMPTOMS: AUA GUIDELINE AMMENDMENT

routine assessment. This pattern may lead to 19. Water vapor thermal therapy may be offered
underreporting of medical retreatment relative to to eligible patients who desire preservation of erec-
minimally invasive and surgical retreatments, for tile and ejaculatory function. (Conditional Recom-
which there are clearly definable timepoints at mendation; Evidence Level: Grade C).
which retreatment takes place. Changes were made to the supporting text to
In addition, the Panel defined and discussed reflect updated information from an RCT comparing
specific concepts of retreatment for photoselective water vapor thermal therapy to sham.7
vaporization of the prostate, prostatic urethral lift
(PUL), transurethral microwave therapy (TUMT), Laser Enucleation
water vapor thermal therapy, laser enucleation, and 21. Clinicians should consider HoLEP or ThuLEP,
Aquablation. These concepts are detailed in the depending on their expertise with either technique,
supporting statement of Guideline 6.4 as prostate size-independent options for the treat-
ment of LUTS attributed to BPH. (Moderate
Prostatic Urethral Lift (PUL) Recommendation; Evidence Level: Grade B).
15. PUL may be offered as an option for patients Changes were made to the supporting text to
with LUTS attributed to BPH provided prostate include data from recent publications.8
volume <80g and verified absence of an obstructive
middle lobe. (Moderate Recommendation; Evidence Aquablation
Level: Grade C). 22. Aquablation may be offered to patients with
The following phrases were removed from the LUTS attributed to BPH provided prostate volume
statement and supporting text “however, patients >30/<80g. (Conditional Recommendation; Evidence
should be informed that symptom reduction and Level: Grade C).
flow rate improvement is less significant compared The following phrase was removed from the
to TURP. Patients should be informed that evidence statement and supporting text: “however, patients
of efficacy and retreatement rates are poorly should be informed that long term evidence of effi-
defined.” cacy and retreatment rates, remains limited.” This
The supporting text was revised to clarify the information is now included in Statement 6.
results of two RCTs: the BPH6 Study and the
L.I.F.T study.5,6 Prostate Artery Embolization (PAE)
16. PUL may be offered to eligible patients who 23. PAE for the treatment of LUTS secondary to
desire preservation of erectile and ejaculatory BPH is not supported by current data and trial de-
function. (Conditional Recommendation; Evidence signs, and benefit over risk remains unclear;
Level: Grade C). therefore, PAE is not recommended outside the
Wording for this statement regarding preserva- context of clinical trials. (Expert Opinion).
tion of erectile and ejaculatory function was edited The statement was edited to include the following
for clarity. There were no changes to the supporting phrase: “PAE for the treatment of LUTS secondary
text of this statement. to BPH is not supported by current data and trial
designs, and benefit over risk remains unclear.”
Transurethral Microwave Therapy (TUMT) Additional changes were made to the supporting
17. TUMT may be offered to patients with LUTS text to reflect updated information.
attributed to BPH. (Conditional Recommendation;
Evidence Level: Grade C).
The following phrase was removed from the FUTURE DIRECTIONS
statement and supporting text: “however, patients There are enormous gaps in knowledge and, there-
should be informed that surgical retreatment rates fore, ensuing opportunities for discovery. These
are higher compared to TURP.” This information is include but are not limited to many unanswered
now included in Statement 6. questions related to the role of inflammation,
metabolic dysfunction, obesity, and environmental
Water Vapor Thermal Therapy factors in etiology, as well as the role of behavior
18. Water vapor thermal therapy may be offered to modification, self-management, and evolving ther-
patients with LUTS attributed to BPH provided apeutic algorithms in both the prevention and pro-
prostate volume <80g. (Moderate Recommendation; gression of disease. New technologies will continue
Evidence Level: Grade C). to emerge and require further investigation as to
The following phrase was removed from the efficacy and their unique positions in the surgical
statement and supporting text: “however, patients BPH armentarium. Evaluation of which modalities
should be counseled regarding efficacy and retreat- may be of greater benefit to which patients and
ment rates.” This information is now included in comparison of these against each other are areas of
Statement 6. great interest to surgeons and as such, offer an

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SURGICAL MANAGEMENT OF LOWER URINARY TRACT SYMPTOMS: AUA GUIDELINE AMMENDMENT 803

opportunity for study. A BPH calculator that could indications, contraindications, precautions and
allow providers to enter patient characterizations warnings. These guidelines and best practice
and then receive recommended options would give a statements are not intended to provide legal advice
tool to urologists to help them navigate the ever- about use and misuse of these substances. Although
expanding procedural based treatment options. guidelines are intended to encourage best practices
For investigators interested in scientific discovery, and potentially encompass available technologies
be it cellular to surgical, BPH provides an area with with sufficient data as of close of the literature re-
much left to learn and understand. view, they are necessarily time-limited. Guidelines
cannot include evaluation of all data on emerging
technologies or management, including those that
DISCLAIMER are newly FDA-approved or amended, which may
This document was written by the Benign Prostatic immediately come to represent accepted clinical
Hyperplasia Guideline Panel of the American Uro- practices. For this reason, the AUA does not regard
logical Association Education and Research, Inc., technologies or management which are too new to
which was created in 2016. The Practice Guidelines be addressed by this guideline as necessarily
Committee (PGC) of the AUA selected the commit- experimental or investigational.
tee chair. Panel members were selected by the chair.
Membership of the Panel included specialists in
urology and primary care with specific expertise on CONFLICT OF INTEREST DISCLOSURES
this disorder. The mission of the panel was to All panel members completed COI disclosures.
develop recommendations that are analysis based or Disclosures listed include both topic- and non-topic-
consensus-based, depending on panel processes and related relationships. 2018 Panel: Consultant/
available data, for optimal clinical practices in the Advisor: Kevin T. McVary, MD: AMS/Boston Sci-
treatment of early stage testicular cancer. Funding entific, Merck, Olympus; Michael J. Barry, MD: US
of the panel was provided by the AUA. Panel Preventive Services Task Force; Steven A. Kaplan,
members received no remuneration for their work. MD: Astellas, proverum, ProArc, Zenflow, Serenity,
Each member of the panel provides an ongoing Allium, Avadel, Nymox; J. Kellogg Parsons, MD:
conflict of interest disclosure to the AUA, and the MDx Health, Endocare; Lori B. Lerner, MD: Boston
Panel Chair, with the support of AUA Guidelines Scientific; Claus G. Roehrborn, MD: Glaxo Smith
staff and the PGC, reviews all disclosures and ad- Kline, Protox, Neotract, NERI, Procept Bio-
dresses any potential conflicts per AUA’s Principles, robotics, Boston Scientific, nymox; Charles Well-
Policies and Procedures for Managing Conflicts of iver, MD: Coloplast. Meeting Participant or
Interest. While these guidelines do not necessarily Lecturer: Tobias S. Kohler, MD: Coloplast; Lori B.
establish the standard of care, AUA seeks to Lerner, MD: Lumenis, Inc. Scientific Study or Trial:
recommend and to encourage compliance by prac- Kevin T. McVary, MD: Astellas, NIDDK; Michael J.
titioners with current best practices related to the Barry, MD: Healthwise; Tobias S. Kohler, MD:
condition being treated. As medical knowledge ex- American Medical Systems; Claus G. Roehrborn, MD:
pands and technology advances, the guidelines will Southwest Oncology Group, CALGB Clinical Trial
change. Today these evidence-based guidelines Group, Nxthera, Astellas; Charles Welliver, MD:
statements represent not absolute mandates but Procept Biorobotics, Auxillium, Mereo. Leadership
provisional proposals for treatment under the spe- Position: Steven A. Kaplan, MD: Medivizor, EcoFu-
cific conditions described in each document. For all sion, AvantCourse. Health Publishing: Deborah J.
these reasons, the guidelines do not pre-empt Lightner, MD: AUA, Urology/Elsevier; Claus G.
physician judgment in individual cases. Treating Roehrborn, MD: NIDDK. Other: Lori B. Lerner,
physicians must take into account variations in re- MD: Procept; Charles Welliver, MD: BMJ Best
sources, and patient tolerances, needs, and prefer- Practice, Oakstone Publishing, Amgen. 2019
ences. Conformance with any clinical guideline does Amendment: Consultant/Advisor: Kevin
not guarantee a successful outcome. The guideline T. McVary, MD: AMS/Boston Scientific, Merck,
text may include information or recommendations Olympus; Lori B. Lerner, MD: Boston Scientific;
about certain drug uses (‘off label’) that are not Kellogg Parsons, MD: MDx Health, Endocare.
approved by the Food and Drug Administration Meeting Participant or Lecturer: Tobias S. Kohler,
(FDA), or about medications or substances not MD: Coloplast; Lori B. Lerner, MD: Lumenis, Inc.,
subject to the FDA approval process. AUA urges Neotract, Augmentix. Scientific Study or Trial:
strict compliance with all government regulations Kevin T. McVary, MD: Astellas, NIDDK, SRS
and protocols for prescription and use of these sub- Medical Systems; Tobias S. Kohler, MD: American
stances. The physician is encouraged to carefully Medical Systems. Leadership Position: Kevin
follow all available prescribing information about T. McVary, MD: Uronext. Other: Lori B. Lerner, MD:

Copyright © 2020 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.
804 SURGICAL MANAGEMENT OF LOWER URINARY TRACT SYMPTOMS: AUA GUIDELINE AMMENDMENT

Procept. 2020 Amendment: Consultant/Advisor: Health, Dendreon, Boston Scientific. Meeting


Tobias S. Kohler, MD: Abbvie, American Medical Participant or Lecturer: Lori B. Lerner, MD: Boston
Systems, Coloplast; Kellogg Parsons, MD: MDx Scientific, Augmenix

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Copyright © 2020 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.

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