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0022-5347/19/2023-0592/0 https://doi.org/10.1097/JU.0000000000000319
THE JOURNAL OF UROLOGY® Vol. 202, 592-598, September 2019
Ó 2019 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC. Printed in U.S.A.
592 j www.auajournals.org/jurology
Copyright © 2019 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.
LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA GUIDELINE AMENDEMENT 593
prostatic enlargement [BPE]). The prostate may to BPH” (LUTS/BPH) to indicate LUTS among men
cause obstruction at the level of the bladder neck for whom an alternative cause is not apparent.
(benign prostatic obstruction). Obstruction may also Since original publication3, a subset of the BPH
be caused by other conditions referred to as bladder Guideline panel worked on an amendment to the 2018
outlet obstruction (BOO). report given the interest in the newer technologies
Parallel to these anatomical and functional pro- and to avoid the longer intervals in similar BPH
cesses, LUTS increase in frequency and severity with Guideline efforts.4 The Guideline panel provided the
age. LUTS may be caused by a variety of conditions, Minnesota Evidence Review Team with identical key
including BPE and benign prostatic obstruction. In questions, interventions, comparators, and outcomes
this Guideline, the Panel refers to “LUTS attributed as was the case in the 2018 effort. The review team
Copyright © 2019 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.
594 LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA GUIDELINE AMENDEMENT
worked with the panel to refine the scope, key ques- 5. Clinicians should consider pressure flow studies prior to
tions, and inclusion/exclusion criteria. The panel surgical intervention for LUTS/BPH when diagnostic un-
noted several topics, interventions and technologies certainty exists. (Expert Opinion).
had meaningful peer reviewed publications qualifying
for additional statements, discussion and commen- Surgical Therapy
tary. When the reviewed materials did not impact the 6. Surgery is recommended for patients who have renal
2018 AUA BPH Clinical Guidelines the statements insufficiency secondary to BPH, refractory urinary reten-
were left unaltered without additional text. tion secondary to BPH, recurrent urinary tract infections,
recurrent bladder stones or gross hematuria due to BPH,
Lower Urinary Tract Symptoms (LUTS)
and/or with LUTS/BPH refractory to and/or unwilling to
In assessing the burden of disease, studies reveal a
progressive increase in the prevalence of moderate- use other therapies. (Clinical Principle).
to-severe LUTS, rising to nearly 50% by the eighth 7. Clinicians should not perform surgery solely for the
decade of life.5 Others estimate that 90% of men presence of an asymptomatic bladder diverticulum; how-
between 45 and 80 years suffer some type of LUTS.6 ever, evaluation for the presence of BOO should be
Although LUTS/BPH is not often life-threatening, considered. (Clinical Principle).
the impact of LUTS/BPH on QoL can be signifi-
cant and should not be underestimated. Transurethral Resection of the Prostate (TURP)
8. TURP should be offered as a treatment option for men
Index Patient with LUTS/BPH. (Moderate Recommendation; Evidence
The Index Patient is a male >45 who is consulting a Level: Grade B).
clinician for his LUTS. He does not have a history 9. Clinicians may use a monopolar or bipolar approach
suggesting non-BPH causes of LUTS, and his LUTS to TURP, depending on their expertise with these tech-
may or may not be associated with BPE, BOO, or BPH. niques. (Expert Opinion).
Sexual Dysfunction and Surgical Therapy
Simple Prostatectomy
Given the strong observed relationship between
10. Clinicians should consider open, laparoscopic or ro-
erectile dysfunction (ED) and LUTS/BPH, this
botic assisted prostatectomy, depending on their expertise
group of men is at high risk for sexual dysfunction.7
with these techniques, for patients with large prostates.
Patients should be counselled about the sexual side
(Moderate Recommendation; Evidence Level: Grade C).
effects of any surgical intervention and should be
The Panel recognizes that “large” is a relative term
made aware that surgical treatment can cause
as some providers have excellent results utilizing
ejaculatory dysfunction and may worsen ED.
transurethral approaches (e.g., bipolar TURP, Holmi-
Shared Decision Making um Laser Enucleation of the Prostate [HoLEP]) in
Patients should be provided with the risk/benefit prostates >60g. However, not all providers have access
profile for all treatment options in light of their to or are using bipolar TURP or HoLEP technology, and
circumstances to allow them to make informed de- may not wish to approach large glands transurethrally.
cisions regarding their treatments. Alternatively, larger prostates have been
treated with open simple prostatectomy. In recent
GUIDELINE STATEMENTS years, alternative techniques have been developed
that include laparoscopic and robot-assisted
Evaluation and Preoperative Testing laparoscopic approaches.
1. Clinicians should take a medical history and utilize the
AUA-Symptom Index and urinalysis in the initial evalu- Transurethral Incision of the Prostate (TUIP)
ation of patients presenting with bothersome LUTS 11. TUIP should be offered as an option for patients with
possibly attributed to BPH; select patients may also prostates £30g for the treatment of LUTS/BPH. (Mod-
require post-void residual, uroflowmetry, or pressure erate Recommendation; Evidence Level: Grade B).
flow studies. (Clinical Principle).
2. Clinicians should consider assessment of prostate size Transurethral Vaporization of the Prostate (TUVP)
and shape via abdominal or transrectal ultrasound, or 12. Bipolar TUVP may be offered to patients for the
cystoscopy, or by preexisting cross-sectional imaging (i.e. treatment of LUTS/BPH. (Conditional Recommendation;
magnetic resonance imaging/computed tomography) prior Evidence Level: Grade B).
to surgical intervention for LUTS/BPH. (Clinical Principle).
3. Clinicians should perform a post-void residual assess- Photoselective Vaporization of the Prostate (PVP)
ment prior to surgical intervention for LUTS/BPH. (Clinical 13. Clinicians should consider PVP as an option using
Principle). 120W or 180W platforms for patients for the treatment
4. Clinicians should consider uroflowmetry prior to surgical of LUTS/BPH. (Moderate Recommendation; Evidence
intervention for LUTS/BPH. (Clinical Principle). Level: Grade B).
Copyright © 2019 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.
LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA GUIDELINE AMENDEMENT 595
In a single center study comparing M-TURP, 18. Water vapor thermal therapy may be offered to
B-TURP and 120W PVP through 36 months sup- eligible patients who desire preservation of erectile and
ports the above insofar as there is similar change in ejaculatory function. (Conditional Recommendation;
International Prostate Symptom Score (IPSS) and Evidence Level: Grade C).
IPSS-QOL between PVP and the TURP cohorts.8,9 In the RCT comparing water vapor thermal
therapy to sham, the original 136 patients random-
Prostatic Urethral Lift (PUL)
ized to water vapor thermal therapy are expected to
14. Clinicians should consider PUL as an option for pa-
be followed for five years.12 At 36 months, no de novo
tients with LUTS/BPH provided prostate volume <80g
ED was reported but dysuria was reported by 1% of
and verified absence of an obstructive middle lobe; how-
participants.12e14 No significant changes in IIEF-EF
ever, patients should be informed that symptom reduction
scores were observed compared to baseline. Bother
and flow rate improvement is less significant compared to
and function scores associated with ejaculation,
TURP. Patients should be informed that evidence of effi-
assessed by the MSHQ-EjD, were significantly
cacy and retreatment rates are poorly defined. (Moderate
improved at 12 and 36 months following treatment,
Recommendation; Evidence Level: Grade C).
P[.006 and P[.003 respectively.
There was a study of PUL that purposely treated
men with obstruction including a middle lobe (a cysto- Transurethral Needle Ablation (TUNA)
scopic exclusion from previous randomized control trial 19. TUNA is not recommended for the treatment of
[RCT]). We reviewed and excluded this study by Ruk- LUTS/BPH. (Expert Opinion).
stalis et al. because it is not a randomized trial.10 The The lack of peer-reviewed publication in the
study is a “nonrandomized cohort” that used criteria literature review timeframe meeting the inclusion
identical to the LIFT trial except for some defined criteria and the decreasing clinical relevance
variables. It is essentially a case series with pre-post resulted in a lack of enthusiasm by the Panel to
outcomes. For this reason the statement above in recommend TUNA for the treatment of LUTS
which PUL must “verify absence of an obstructive attributed to BPH.
middle lobe” remains unchanged in this update.
Laser Enucleation
15. PUL may be offered to eligible patients concerned 20. Clinicians should consider HoLEP or thulium laser
with erectile and ejaculatory function for the treatment enucleation of the prostate (ThuLEP), depending on their
of with LUTS/BPH. (Conditional Recommendation; Evi- expertise with either technique, as prostate size-indepen-
dence Level: Grade C). dent suitable options for the treatment of LUTS/BPH.
(Moderate Recommendation; Evidence Level: Grade B).
Transurethral Microwave Therapy (TUMT)
16. TUMT may be offered to patients with LUTS/BPH; Aquablation
however, patients should be informed that surgical 21. Aquablation may be offered to patients with LUTS
retreatment rates are higher compared to TURP. (Con- attributed to BPH provided prostate volume >30/<80g,
ditional Recommendation; Evidence Level: Grade C). however, patients should be informed that evidence
of efficacy, including longer-term retreatment rates, re-
Water Vapor Thermal Therapy mains limited. (Conditional Recommendation; Evidence
17. Water vapor thermal therapy may be offered to pa- Level: Grade C).
tients with LUTS/BPH provided prostate volume <80g; Aquablation surgery utilizes a robotic handpiece,
however, patients should be counseled regarding efficacy console and conformal planning unit (CPU). The
and retreatment rates. (Conditional Recommendation; Ev- technique is not in the MIST category as patients
idence Level: Grade C). must undergo general anesthesia. The resection of
Three-year results showed sustained improvements the prostate is performed using a water jet from a
for the IPSS IPSS-QoL, and Qmax, with scores transurethrally placed robotic handpiece. After
remaining significantly improved from baseline; Qmax completion of the resection, electro-cautery via a
improvement was > 50% from 3 to 24 months and 39% standard cystoscope/resectoscope or traction from a 3
at 36 months.11 At 36 months in the intent-to-treat way catheter balloon are used to obtain hemostasis.
population of the original 136 participants, mean One low risk of bias RCT (n [ 181) assessing
change from baseline in IPSS was -11.0 points and the Aquablation was evaluable by the panel.15e17 The
mean score was 10.4 points, representing a 50% trial utilized standard inclusion/exclusion criteria
improvement from baseline. Mean IPSS-QoL was limiting participants to prostate sizes between 30-80
improved from baseline by 49% at 3 years. Because grams. Treatment response through 12 months,
this additional paper demonstrating durable outcomes defined as at least a 5-point improvement in Inter-
out to three years was not a second cohort the Con- national Prostate Symptom Score (IPSS), was similar
ditional Recommendation and Evidence Level: Grade for Aquablation and TURP (Quality of Evidence:
C from the 2018 AUA Guideline remain unchanged. Moderate). Mean improvement in lower urinary tract
Copyright © 2019 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.
596 LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA GUIDELINE AMENDEMENT
symptoms (LUTS) based on the IPSS through 12 points and/or a QoL 3 points, was similar between
months was similar for Aquablation and TURP the PAE and TURP groups (RR 0.9 [95%CI 0.7 to
(Quality of Evidence: Moderate).15,17 Mean improve- 1.1]; low quality of evidence).18 Success through 12
ment in quality of life based on the IPSS-QoL through months was reported for 87% of the PAE partici-
12 months was similar for Aquablation and TURP pants compared with 100% in the TURP group.
(Quality of Evidence: Moderate). Need for blood Overall, results at intermediate term follow-up (>3
transfusion and reoperation was similar for Aqua- to 12 months) were similar between groups (WMD
blation and TURP (Quality of Evidence: Very low) 4.8 points [95% CI -2.9 to 12.5]; very low quality of
with blood transfusion reported for one Aquablation evidence).18,19 The smallest trial (n[30) reported
participant and none receiving TURP (RR 1.69 [95% substantially greater improvement in symptoms
CI 0.70 to 41.0]). At follow-up (12 months), maximum with TURP compared with PAE (MD 9 points [95%
flow rates increased similarly in the Aquablation CI 4.6 to 13.1])18 and the other (n[107) reported no
group compared to TURP, 10.3 vs 10.6 mL/s (P[.86), significant difference between the groups at 3 and
respectively. 12 months.19
At 3 months, Aquablation resulted in fewer The need for reoperation was reported for 7 par-
harms classified as Clavien-Dindo grade 2 ticipants in the PAE group compared with 2 in the
compared to TURP, 26% versus 42%, P[.015.15,16 TURP group (RR 2.9; CI: 0.7, 11.9; very low quality
Additionally, rates of retrograde ejaculation were of evidence). Two trials found incidences of sexual
higher (P[.002) with TURP (23%) compared to dysfunction to be higher with TURP compared with
Aquablation (6%). Other harms occurring at similar PAE.18,20 One trial reported all 15 TURP partici-
rates in both groups, and classified as Clavien- pants experienced retrograde ejaculation while no
Dindo grades 1-4, included bladder spasms, cases were reported among PAE participants.18 The
bleeding, dysuria, pain, and urethral damage. No short-term trial found incidence of ejaculatory
deaths were reported. Also at 3 months, reduction in dysfunction was lower with PAE (56%) compared
prostate volume was significantly less with Aqua- with TURP (84%) after 12 weeks (RR 0.67 [95%CI
blation (31%) compared to TURP (44%) (P[.007).15,16 0.45 to 0.98).20 One trial reported a higher incidence
Among a non-random subset of sexually active men, of acute urinary retention requiring re-catheteriza-
the proportion of subjects who reported worsening tion in the PAE group (26%) versus the TURP group
sexual function through 6 months on the IIEF-5 6%, P[.004).
(6-point decrease) or the Male Sexual Health Given the heterogeneity in the literaturedand
Questionnaire (MSHQ-EjD) (2-point decrease) was concerns regarding radiation exposure, post-embo-
33% in the Aquablation group compared with 56% lization syndrome, vascular access, technical feasi-
in TURP group (P[.03).15,16 bility, and quality control at lower volume
centersdit is the opinion of the Panel that PAE
Prostate Artery Embolization (PAE) should only be performed in the context of a clinical
22. PAE is not recommended for the treatment of LUTS/ trial until sufficient evidence from rigorously per-
BPH outside the context of a clinical trial. (Expert Opinion). formed studies is available to indicate definitive
PAE is a newer, largely unproven MIST for BPH. clinical benefit. The Panel recommends trials
High level evidence remains sparse, and the overall involve multi-disciplinary teams of urologists and
quality of the studies is uniformly low. Some of the radiologists; and that, as with other MIST thera-
deficiencies of the included trials include 1. A lack pies, RCTs comparing PAE to sham be considered to
of randomization, 2. High levels of susceptibility to account for significant placebo effects.
selection, detection, attrition, and reporting biases,
Medically Complicated Patients
3. The common inclusion of a preoperative status of
23. HoLEP, PVP, and ThuLEP should be considered in
urinary retention, and 4. The absence of standard
patients who are at higher risk of bleeding, such as
inclusion/exclusion criteria for a LUTS/BPH RCT.
those on anti-coagulation drugs. (Expert Opinion).
Three RCTs (n[247) were identified comparing
In support of the concept of 120W PVP use in
PAE to TURP; however, there was substantial het-
anticoagulated patients, recent publications report
erogeneity between the two trials (I2[ 90%).18e20
that the need for a blood transfusion was lower for
One trial reported outcomes up to 2 years, one up to
photoselective vaporization prostatectomy 120W
12 months, and the other only through 12 weeks.
compared to TURP.8,9
There was substantial heterogeneity between trials
and pooled results must therefore be interpreted
with caution. Definitions of and outcomes for sub- FUTURE DIRECTIONS
jective symptom response varied substantially be- There are enormous gaps in knowledge and, there-
tween trials. One trial reported the proportion of fore, ensuing opportunities for discovery. These
responders, defined as achieving an IPSS score 8 include but are not limited to many unanswered
Copyright © 2019 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.
LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA GUIDELINE AMENDEMENT 597
questions related to the role of inflammation, warnings. These guidelines and best practice state-
metabolic dysfunction, obesity, and environmental ments are not intended to provide legal advice about
factors in etiology, as well as the role of behavior use and misuse of these substances.
modification, self-management, and evolving ther- Although guidelines are intended to encourage
apeutic algorithms in both the prevention and pro- best practices and potentially encompass available
gression of disease. technologies with sufficient data as of close of the
literature review, they are necessarily time-limited.
DISCLAIMER Guidelines cannot include evaluation of all data on
This document was written by the Benign Prostatic emerging technologies or management, including
Hyperplasia Guideline Panel of the American Uro- those that are FDA-approved, which may immedi-
logical Association Education and Research, Inc., ately come to represent accepted clinical practices.
which was created in 2016. This amended Benign For this reason, the AUA does not regard tech-
Prostatic Hyperplasia Guideline was drafted in 2019 nologies or management which are too new to be
by a subset of the original panel. This amendment addressed by this guideline as necessarily experi-
updates the original guideline document to reflect mental or investigational.
literature released following original publication.
The Practice Guidelines Committee (PGC) of the
AUA selected the committee chair. Panel members CONFLICT OF INTEREST DISCLOSURES
were selected by the chair. Membership of the Panel All panel members completed COI disclosures.
included specialists in urology and primary care Disclosures listed include both topice and non-
with specific expertise on this disorder. The mission topic-related relationships. Consultant/Advisor:
of the panel was to develop recommendations that Kevin T. McVary, MD: AMS/Boston Scientific,
are analysis-based or consensus-based, depending Merck, Olympus; Michael J. Barry, MD: US Pre-
on panel processes and available data, for optimal ventive Services Task Force; Steven A. Kaplan, MD:
clinical practices in the surgical treatment of benign Astellas, proverum, ProArc, Zenflow, Serenity,
prostatic hyperplasia. Allium, Avadel, Nymox; J. Kellogg Parsons, MD:
Funding of the panel was provided by the AUA. MDx Health, Endocare; Lori B. Lerner, MD: Boston
Panel members received no remuneration for their Scientific; Claus G. Roehrborn, MD: Glaxo Smith
work. Each member of the panel provides an Kline, Protox, Neotract, NERI, Procept Biorobotics,
ongoing conflict of interest disclosure to the AUA. Boston Scientific, nymox; Charles Welliver, MD:
While these guidelines do not necessarily estab- Coloplast. Meeting Participant or Lecturer: Tobias
lish the standard of care, AUA seeks to recommend S. Kohler, MD: Coloplast; Lori B. Lerner, MD:
and to encourage compliance by practitioners with Lumenis, Inc. Scientific Study or Trial: Kevin T.
current best practices related to the condition being McVary, MD: Astellas, NIDDK; Michael J. Barry,
treated. As medical knowledge expands and tech- MD: Healthwise; Tobias S. Kohler, MD: American
nology advances, the guidelines will change. Today Medical Systems; Claus G. Roehrborn, MD: South-
these evidence-based guidelines statements repre- west Oncology Group, CALGB Clinical Trial Group,
sent not absolute mandates but provisional pro- Nxthera, Astellas; Charles Welliver, MD: Procept
posals for treatment under the specific conditions Biorobotics, Auxillium, Mereo. Leadership Position:
described in each document. For all these reasons, Steven A. Kaplan, MD: Medivizor, EcoFusion,
the guidelines do not pre-empt physician judgment AvantCourse. Health Publishing: Deborah J.
in individual cases. Lightner, MD: AUA, Urology/Elsevier; Claus G.
Treating physicians must take into account var- Roehrborn, MD: NIDDK. Other: Lori B. Lerner,
iations in resources, and patient tolerances, needs, MD: Procept; Charles Welliver, MD: BMJ Best
and preferences. Conformance with any clinical Practice, Oakstone Publishing, Amgen 2019
guideline does not guarantee a successful outcome. Amendment: Consultant/Advisor: Kevin T. McVary,
The guideline text may include information or rec- MD: AMS/Boston Scientific, Merck, Olympus; Lori
ommendations about certain drug uses (‘off label’) B. Lerner, MD: Boston Scientific; Kellogg Parsons,
that are not approved by the Food and Drug MD: MDx Health, Endocare. Meeting Participant or
Administration (FDA), or about medications or Lecturer: Tobias S. Kohler, MD: Coloplast; Lori B.
substances not subject to the FDA approval process. Lerner, MD: Lumenis, Inc., Neotract, Augmentix.
AUA urges strict compliance with all government Scientific Study or Trial: Kevin T. McVary, MD:
regulations and protocols for prescription and use of Astellas, NIDDK, SRS Medical Systems; Tobias S.
these substances. The physician is encouraged to Kohler, MD: American Medical Systems. Leader-
carefully follow all available prescribing information ship Position: Kevin T. McVary, MD: Uronext.
about indications, contraindications, precautions and Other: Lori B. Lerner, MD: Procept.
Copyright © 2019 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.
598 LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA GUIDELINE AMENDEMENT
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Copyright © 2019 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.