Five year results of the prospective randomized
controlled prostatic urethral L.I.F.T. study
Claus G. Roehrborn, MD,1 Jack Barkin, MD,2 Steven N. Gange, MD,3
Neal D. Shore, MD,4 Jonathan L. Giddens, MD,5 Damien M. Bolton, MD,6
Barrett E. Cowan, MD,7 Anthony L. Cantwell, MD,8 Kevin T. McVary, MD,9Alexis E. Te, MD,10 Shahram S. Gholami, MD,11 William G. Moseley, MD,12Peter T. Chin, MD,13 William T. Dowling, MD,14 Sheldon J. Freedman, MD,15
Peter F. Incze, MD,16 K. Scott Coffield, MD,17 Sean Herron, MD,18
Prem Rashid, MD,19 Daniel B. Rukstalis, MD20
University of Texas Southwestern Medical Center, Dallas, Texas, USA / 2Toronto Urology Clinical Study Group, Toronto, Ontario, Canada
Summit Urology Group, Salt Lake City, Utah, USA / 4Carolina Urologic Research Center, Myrtle Beach, South Carolina, USA
5
Jonathan Giddens Medicine Professional Corporation, Brampton, Ontario, Canada / 6Austin Health, Heidelberg, Victoria, Australia
7
Urology Associates of Denver, Englewood, Colorado, USA / 8Advanced Urology Institute, Daytona Beach, Florida, USA
9Southern Illinois University School of Medicine, Springfield, Illinois, USA / 10Weill Cornell Medical College, New York, New York, USA
11
Urology Associates of Silicon Valley, San Jose, California, USA / 12Premier Urology Associates, San Diego, California, USA
13
Illawarra Urology, Figtree, New South Wales, Australia / 14Chesapeake Urology Research Associates, Baltimore, Maryland, USA
15
Sheldon J. Freedman, M.D., Ltd., Las Vegas, Nevada, USA / 16The Fe/Male Health Centres, Oakville, Ontario, Canada
17
Scott and White Healthcare, Temple, Texas, USA / 18Pinellas Urology Inc., St Petersburg, Florida, USA
19
Urology Centre, Port Macquarie, Australia / 20Wake Forest Baptist Health, Winston Salem, North Carolina, USA
1
3

ROEHRBORN CG, BARKIN J, GANGE SN, SHORE
ND, GIDDENS JL, BOLTON DM, COWAN BE,
CANTWELL AL, MCVARY KT, TE AE, GHOLAMI
SS, MOSELEY WG, CHIN PT, DOWLING WT,FREEDMAN SJ, INCZE PF, COFFIELD KS,
HERRON S, RASHID P, RUKSTALIS DB. Five year
results of the prospective randomized controlled
prostatic urethral L.I.F.T. study. Can J Urol 2017;24(3):8802-8813.
Introduction: To report the five year results of a prospective,
multi-center, randomized, blinded sham control trial of theProstatic Urethral Lift (PUL) in men with bothersome lower
urinary tract symptoms (LUTS) due to benign prostatic
hyperplasia (BPH).
Materials and methods: At 19 centers in North Americaand Australia, 206 subjects ≥ 50 years old with International
Prostate Symptom Score (IPSS ) > 12, peak flow rate (Qmax)≤ 12 mL/s, and prostate volume 30 cc-80 cc were randomized
2:1 to the PUL procedure or blinded sham control. In PUL
permanent UroLift implants are placed to hold open the

Accepted for publication May 2017
Address correspondence to Dr. Claus Roehrborn, Department
of Urology, UT Southwestern Medical Center, 5323 Harry
Hines Blvd., Dallas, TX 75390 USA© The Canadian Journal of Urology™; 24(3); June 2017

lateral lobes of the prostate to reduce urinary obstruction.
After randomized comparison at 3 months and the only
opportunity to add more PUL implants, PUL patients were
followed to 5 years. LUTS severity (IPSS), quality of life
(QOL), BPH Impact Index (BPHII), Qmax, sexual function,
and adverse events were assessed throughout follow up.
Results: IPSS improvement after PUL was 88% greaterthan that of sham at 3 months. LUTS and QOL weresignificantly improved by 2 weeks with return to preoperative
physical activity within 8.6 days. Improvement in IPSS,
QOL, BPHII, and Qmax were durable through 5 years withimprovements of 36%, 50%, 52%, and 44% respectively. No
difference was seen between Intent to Treat and Per Protocol
populations. Surgical retreatment was 13.6% over 5 years.
Adverse events were mild to moderate and transient. Sexualfunction was stable over 5 years with no de novo, sustained
erectile or ejaculatory dysfunction.
Conclusions: PUL offers rapid improvement in symptoms,
QOL and flow rate that is durable to 5 years. These
improvements were achieved with minimal use of a
postoperative urinary catheter, rapid return to normal,
and preservation of both erectile and ejaculatory function.
Symptom improvement was commensurate with patientsatisfaction. PUL offers a minimally invasive option in thetreatment of LUTS due to BPH.
Key Words: BPH, minimally invasive, surgery,
surgical therapy, sexual function

8802

Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study

Introduction
Chronic lower urinary tract symptoms (LUTS)
associated with benign prostatic hyperplasia (BPH)
can significantly impact quality of life by causing lossof sleep, reduced productivity, impaired sex life, social
isolation, and clinical depression.1 The prevalenceof histopathologic BPH increases from 40% among
men in their 50s to over 80% among men in their70s.2 While many men are managed medically, 25%
to 70% are non-compliant or discontinue medicines
altogether due to insufficient relief or bothersome side
effects that include erectile dysfunction, ejaculatory
dysfunction, weakness, fatigue and dizziness.3,4 Today,
the vast majority of these men who are underserved bypharmacologic therapy do not undergo interventional
treatment so as to avoid hospital stay, lengthy recovery,
sexual dysfunction, stress urinary incontinence,stricture, or bladder neck contracture, all potential
side effects associated with BPH surgery whether
conducted with unipolar or bipolar electrodes orlasers.5,6 Symptomatic obstructive BPH may lead toirreversible detrusor damage that may reduce theefficacy of surgery even if eventually performed.7,8 The
question whether long term pharmacological treatment
has altered the outcomes of BPH interventions is notclear at this point. The needs of this large population
underserved by traditional treatment options havebeen the focus of developments in less invasive
interventions. However, while over one quarter ofmen on medical therapy discontinue use each year,
no more than 3% elect the available surgical or lessinvasive treatment options.3,4Nearly all less invasive procedures have involved
a mechanism of action utilizing thermal energy toeffect tissue necrosis and resorption to achieve reduced
urinary obstruction. Treatment has been demonstrated
to result in reduction in LUTS. However, consistency
and durability have been less than anticipated.5 Thesethermal ablation therapies have succeeded in creatinga category of intervention that can be offered with lessanesthesia in the office or outpatient setting. Because atissue ablation injury model relies on biologic healing,
recovery is often not achieved for several weeks, andpatient urinary conditions often worsen before they
improve. Postoperative edema requires days to weeks
of urinary catheter, and patients are often plagued withbothersome irritative symptoms for several weeks.5
Regardless of the specific heat source, studies haveshown that the more energy applied to the prostate,
the greater and longer lasting LUTS improvement.
However, this can be at the cost of more significant
and lasting adverse events due to the longer recovery

8803

process from larger amounts of tissue ablated andresorbed. The very strongest microwaves, for instance,
showed efficacy that was non-inferior to transurethralresection of the prostate (TURP), but involved weeks
of retention, catheterization, and tissue sloughing toattain this.9 Those administering less energy wereassociated with fewer adverse effects but also showed
no improvement in flow rate over sham control.10 Not
surprisingly, thermal ablation has also been shown to
be associated with post therapy incidence of sexual
dysfunction such as erectile dysfunction (0%-3%) andejaculatory dysfunction (5%-15%).5 While thermal
ablation treatments offer a less invasive procedurethan surgery, one could argue they do not consistently
provide a patient expected minimally invasive andtolerable experience.
The Prostatic Urethral Lift (PUL) procedure wasdeveloped to address the shortcomings of surgery,medical therapy, and thermal ablation by creating
a more minimally invasive solution that the large
population of underserved men discontinuing medical
therapy might more readily choose to treat their
symptoms. By mechanically opening the prostatic
fossa and not requiring a response to injury, relief
has been shown to be rapid with mild to moderate
perioperative adverse effects (postoperative dysuria,
hematuria, pelvic discomfort, and urgency) thattypically resolve within 2 to 3 weeks.11,12 Because
implants hold the prostate open during the periodof expected immediate normal postoperative edema,urinary catheterization rates have been shown to be
as low as 20% for an overall mean duration under
1 day, somewhat lower than the 32% seen in thisstudy.12 Another important distinction of PUL is thatno new onset sustained sexual dysfunction has beenreported.11-17 It appears that PUL has succeeded inproviding a truly minimally invasive, out-patientpatient experience, and what remains to be answeredis the extent to which improvements are durable. In
this study we present the 5 year durability data of
the largest randomized, controlled study of the PUL
procedure.

Materials and methods
ProtocolA prospective, randomized, sham controlled, blindedstudy of the safety and effectiveness of the PUL procedure
was performed across 19 centers in the United States,
Canada and Australia. Enrollment criteria included age≥ 50 years, International Prostate Symptom Score (IPSS)≥ 13, peak flow rate (Qmax) ≤ 12 mL/s with a 125 mL
voided volume and a 30 cc-80 cc volume prostate as© The Canadian Journal of Urology™; 24(3); June 2017

Roehrborn ET AL.
measured by transrectal ultrasound. Exclusion criteria
included obstructive median lobe and active urinary
tract infection. Two hundred and six (206) subjects wererandomized 2:1 to active treatment with the PUL device(n = 140) or a sham procedure with rigid cystoscopy(n = 66). Subjects were required to undergo a washoutof 2 weeks for alpha-blocker, 3 months for 5 alphareductase inhibitor and 3 days for anticoagulants prior totreatment. The study was performed with approval frominstitutional review boards, Health Canada, Therapeutic
Goods Administration of Australia and the United States
FDA (Clinicaltrials.gov: NCT01294150).

Procedures

The PUL procedure is conducted by installing small
permanent implants transurethrally under endoscopic
guidance to lift apart the obstructing lateral lobes andreduce urethral obstruction. The procedural objective
is to create a channel through the anterior aspect ofthe prostatic fossa. The implant is comprised of amonofilament with a metallic capsular tab on one end
and a metallic urethral end-piece on the other.
After rigid cystoscopy, the implant delivery device(UroLift System, NeoTract, Pleasanton, CA, USA),
which houses a 2.9 mm telescope, is inserted into a 20F
sheath and angled laterally (20-30 degrees) usually at the
10 and 2 o’clock position to compress the anterior thirdof the obstructive lobe. The delivery device laterally
deploys a 19 gauge needle through the lobe. As theneedle is withdrawn, the capsular tab of the implantengages the prostatic capsule. The monofilament is thentensioned, cut to the specific width of the compressed
lobe, and secured in place by the urethral end-piece.
Thus, each implant is customized in length and locationin situ based on an individual’s prostate anatomy.
Because the fibromuscular capsule is less compliant
than the periurethral tissue, the capsular tab holds
firmly in place while the urethral end-piece holds thelobe apart to expand the urethral lumen. The narrow
urethral end-piece invaginates into the urethral wall
where epithelialization occurs.
The sham control procedure was conducted inas similar a manner as possible. For all active andcontrol procedures, a surgical barrier was placed so
the subject could not see below his waist. The shamprocedure consisted of rigid cystoscopy with sounds
that mimicked those of PUL, including the surgeon
calling for devices and deploying but not inserting adisposable biopsy device.

Study assessments

A double blind was maintained and tested through the
3 month end point with the subject and assessor blinded© The Canadian Journal of Urology™; 24(3); June 2017

to randomization. After randomized comparison tosham control, all subjects were unblinded, and 80% (53of 66) of sham subjects enrolled in a crossover study.15,18
PUL subjects were followed for 5 years and assessed on
symptom response (IPSS), quality of life (IPSS QOL and
BPH Impact Index, BPHII), peak flow rate (Qmax), sexualfunction (International Index of Erectile Function, IIEF,
and Male Sexual Health Questionnaire for Ejaculatory
Dysfunction, MSHQ-EjD) and adverse events. Analyses
were conducted both on Per Protocol (PP) and Intent toTreat (ITT) bases. Subjects who underwent an additional
BPH procedure, were taking a BPH medication, or
represented a protocol deviation were censored in the
PP analysis; for the ITT analysis their last value prior tocensoring event was carried forward. An independent
clinical events committee adjudicated all adverse events.
An independent central reviewer over-read all uroflow
waveforms, calculating Qmax using the 2-second rule.19

Statistical methods

Randomization was conducted just prior to treatmentusing permuted blocks of various sizes chosen at
random and concealed through a password protected
central electronic data program. The study was powered
for the primary endpoint assuming a t-test comparisonof mean values with 0.05 two-sided type 1 error and
80% statistical power. To evaluate change from baseline
for multiple time points a general estimating equation
model (GEE) was fit to each output parameter. Change
from baseline was the dependent variable; visit andbaseline score were used as independent variables. An
exchangeable correlation structure and identity link
were used. This model was used to calculate p values
for each follow up interval compared to baseline. ITT
analysis utilized a last observation carried forward(LOCF) imputation method. Imputed ITT values werecompared to the non-imputed PP efficacy parametervalues using a t-test.

Results
A total of 430 subjects were assessed from which
206 were deemed eligible and enrolled between
February and December of 2011. Of those assessed
for randomization 23 (5.3%) were excluded for an
obstructive median lobe. Subjects were excluded
only if it was deemed cystoscopically that laterallobe distraction would not mitigate obstruction.
Randomization assigned 140 subjects to PUL and66 subjects to sham, Figure 1. In North America, allprocedures except one (99.4%) were conducted using
local anesthesia. An average of 4.9 implants (range
2 to 11) was delivered with four implants being the8804

Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study

Figure 1. CONSORT diagram of patient enrollment, allocations, treatment
and follow up.

8805

most common number (42%), and
85% subjects receiving 6 or lessimplants. A third of PUL subjects(32%) required catheterization
for failed voiding trial resulting
in mean catheter duration of
0.9 days averaged over the total
cohort. Subjects returned topreoperative activity level by 8.6± 7.5 days. Peri-operative adverse
events were typically mild tomoderate and transient, with themost frequent being hematuria,
dysuria, pelvic pain, urgency
and urge incontinence. Over the
5 year course of the study, few
related adverse events occurred
after the initial 3 months, Table 1.
There was no reported incidenceof new chronic ejaculatory or
erectile dysfunction after PUL.
All primary and secondary
endpoints were met. Randomized
comparison at 3 months showedthat PUL was associated with an
88% greater reduction in IPSS
compared to sham on an ITT basis(IPSS improvement: PUL -11.1 ±7.7, sham -5.9 ± 7.7, p = 0.003).9
Improvements in QOL and Qmax
were also significantly greaterfor PUL than for sham (Qmax
improvement: PUL 4.28 ± 5.16,
sham 1.98 ± 4.88, p = 0.005; QOL
improvement: PUL 2.2 ± 1.8,
sham 1.0 ± 1.5, p < 0.001). Mean
sexual function measures were notdifferent between groups. After 3
month randomized comparison,
ITT PUL results remained durable
to 5 years, Figure 2. While there
was a modest decrease in IPSS
improvement over the 5 years,
QOL improvement remained
stable. On both ITT and PP bases
PUL efficacy remained durable
through 5 years, with IPSS, QOL,
Qmax, and BPHII remaining
improved 35%, 44%, 50%, and 47%(ITT) and 36%, 50%, 44%, and 52%(PP), respectively, Tables 2 and 3.
There was no significant differencein any efficacy measure between© The Canadian Journal of Urology™; 24(3); June 2017

Roehrborn ET AL.

TABLE 1. Adverse events over 5 year course of study
Time period [months]

0-3

4-12

13-24

25-36

37-48

49-60

Total available subjects

140

139

130

118

108

96

Total subject-months (SM)413.6

1210.31463.81324.91186.61056.3

Related adverse events [total events]

162

15

6

4

2

1

Related adverse events [subjects]

100

12

6

2

2

1

% SM with adverse event per total SM:						Abdominal pain
0.3%					Bladder spasm
0.3%
0.09%				Chills (rigors)				
< 0.01%		
Diarrhea
0.2%					Dizziness
0.2%					Fever (pyrexia)
0.06%					Vomiting
0.02%					Hypotension
0.04%					Orchitis/epididymo-orchitis
0.3%					Painful erection
0.2%					Urinary retention
0.4%					Urethral stenosis (stricture)< 0.01%< 0.01%				
Prostatitis
0.4%< 0.01%
0.06%			Urinary tract infection
0.1%
0.03%
0.03%
0.03%		Pelvic pain
6%1%				
Hematuria
4%0.2%
0.3%		
0.07%
Dysuria
9%
1%
1%
1%		
Urinary urge incontinence
3%
3%
2%
1%
1%
Other
4%
3%
5%
4%
3%

a

c

b

d

0.07%
1%
3%

Figure 2. Intent to Treat outcomes for PUL and Sham control for a) International Prostate Symptom Score (IPSS);b) Quality of Life (QOL); c) BPH Impact Index (BPHII); d) peak urinary flow rate (Qmax).

© The Canadian Journal of Urology™; 24(3); June 20178806

Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study
PP and ITT analyses. When looking at IPSS QOL, 82%
of PUL subjects reported some level of satisfaction with
their urinary symptoms at 5 years. Of the 18% who weredissatisfied with their resulting urinary symptoms tosome extent (QOL > 3), 10 (77%) entered the study withsevere LUTS (IPSS ≥ 20).
At 5 years of follow up, data were available for 104
of 140 PUL subjects (74.3%). Of the 36 not available, 18(12.9%) subjects were lost to follow up; 9 (6.4%) died ofunrelated causes; 9 (6.4%) subjects exited the study forthe following reasons: 5 sought treatment for unrelated
cancer and 4 exited after undergoing TURP. Surgicalretreatment for failure to cure was 13.6% at 5 years
with 6 (4.3%) receiving additional PUL implants and13 (9.3%) undergoing TURP or laser ablation (including
the 4 exited subjects). All surgical retreatment was
conducted routinely with no adverse effect from thepresence of implants. Of the 19 retreated subjects, 18
had severe baseline LUTS (IPSS ≥ 20) and one subject’sbaseline IPSS was 19. At 5 years 15 (10.7%) subjects

were taking an alpha blocker or 5-alpha reductase
inhibitor and no patients were taking anticholinergic
medication. Analyzing the 12.9% lost to follow up,
average IPSS at last follow up was 13.5 ± 9.0 with amatched paired change from baseline of -10.4 ± 8.2 on amean duration prior to study exit of 28.7 ± 15.9 months.
These values were not different from the mean scoresof the available cohort.
Genitourinary interventions over 5 years wereas follows: one subject required stricture dilation,
one underwent transurethral lithotripsy of a ureterickidney stone, one required cystolitholapaxy forstones not related to implants (this subject later
underwent TURP and was counted as retreatment),
and 2 subjects underwent radical prostatectomy for
unrelated prostate cancer. Both radical prostatectomies
were conducted routinely with no interference from
implants, and dissection planes remained intact. Ten
subjects underwent removal of encrusted implantsthat had been deployed too proximally such that theyTABLE 2a. Paired outcome measures after PUL (intent to treat analysis) – 2 weeks to 12 months
Test		
2 weeks
1 monthN (paired) 140
140
IPSS
Baseline
22.32 ± 5.42
22.32 ± 5.42
Follow up 18.07 ± 7.76
12.43 ± 6.92
Change-4.25-9.89% change-17.3%-43.6%(95% CI)(-23.0%, -11.6%) (-48.3%, -39.0%)
p value< .0001< .0001
QOL
N (paired) 140
140
Baseline
4.62 ± 1.05
4.62 ± 1.05
Follow up 3.63 ± 1.63
2.62 ± 1.68
Change-0.99-2.00% change-18.0%-41.7%(95% CI)(-25.3%, -10.6%) (-48.0%, -35.5%)
p value< .0001< .0001
Qmax N (paired)			
Baseline			Follow up			
Change			% change			(95% CI)			
p value			
140
BPHII N (paired) 140
Baseline
6.92 ± 2.79
6.92 ± 2.79
Follow up 7.03 ± 3.43
4.13 ± 3.14
Change0.11-2.79% change
28.3%-32.3%(95% CI)(8.1%, 48.5%)(-45.0%, -19.5%)
p value
0.7360< .0001

3 months
6 months
140
140
22.32 ± 5.42
22.32 ± 5.42
11.26 ± 7.65
11.58 ± 7.45
-11.06-10.7449.4%-48.0%(-54.6%, -44.1%) (-53.2%, -42.7%)< .0001< .0001140
140
4.62 ± 1.05
4.62 ± 1.05
2.42 ± 1.72
2.22 ± 1.70
-2.20
-2.40
-46.2%-51.2%(-52.6%, -39.9%) (-57.1%, -45.2%)< .0001< .0001139		
7.88 ± 2.41		
11.74 ± 5.29		
3.86		
57.8%		
(44.6%, 71.0%)		
< .0001		
140
140
6.92 ± 2.79
6.92 ± 2.79
2.98 ± 3.08
2.76 ± 2.96
-3.94
-4.16
-55.3%-59.2%(-63.1%, -47.5%) (-65.9%, -52.5%)< .0001< .0001

12 months
140		
22.32 ± 5.42
12.36 ± 7.51
-9.96		
-44.2%(-49.5%,-38.8%)< .0001140
4.62 ± 1.05
2.43 ± 1.70
-2.19
-47.4%(-53.4%, -41.5%)< .0001139		
7.88 ± 2.41
11.50 ± 5.18
3.63		
54.5%
(41.4%, 67.5%)< .0001140		
6.92 ± 2.79
3.13 ± 3.12
-3.79		
-54.1%(-61.9%,-46.2%)< .0001

PUL = prostatic urethral lift; IPSS = International Prostate Symptom Score; QOL = quality of life; Qmax = peak flow rate;
BPHII = BPH Impact Index

8807© The Canadian Journal of Urology™; 24(3); June 2017

Roehrborn ET AL.

TABLE 2b. Paired outcome measures after PUL (intent to treat analysis) – 24 months to 60 months
Test		IPSS
N (paired)
Baseline
Follow up
Change% change(95% CI)p valueQOL
N (paired)
Baseline
Follow up
Change% change(95% CI)p valueQmax
N (paired)
Baseline
Follow up
Change% change(95% CI)p value
BPHII
N (paired)
Baseline
Follow up
Change% change(95% CI)p value

24 months
140
22.32 ± 5.42
13.27 ± 7.98
-9.05
-40.0%(-45.8%, -34.3%)< .0001140
4.62 ± 1.05
2.49 ± 1.74
-2.13
-45.8%(-51.9%, -39.7%)< .0001
139
7.88 ± 2.41
11.46 ± 5.17
3.58
54.8%
(40.9%, 68.7%)< .0001140
6.92 ± 2.79
3.15 ± 3.27
-3.77
-52.9%(-61.2%, -44.7%)< .0001

36 months
140
22.32 ± 5.42
13.69 ± 8.06
-8.63
-38.3%(-44.2%, -32.3%)< .0001140
4.62 ± 1.05
2.54 ± 1.76
-2.08
-44.2%(-50.5%, -37.8%)< .0001
139
7.88 ± 2.41
11.12 ± 4.71
3.24
51.6%
(38.5%, 64.8%)< .0001140
6.92 ± 2.79
3.28 ± 3.31
-3.64
-49.0%(-58.7%, -39.2%)< .0001

48 months
140
22.32 ± 5.42
14.04 ± 8.11
-8.28
-36.7%(-42.5%, -30.8%)< .0001140
4.62 ± 1.05
2.58 ± 1.72
-2.04
-43.5%(-49.7%, -37.3%)< .0001
139
7.88 ± 2.41
11.47 ± 5.08
3.60
56.7%
(42.9%, 70.4%)< .0001140
6.92 ± 2.79
3.45 ± 3.30
-3.47
-47.4%(-56.5%, -38.4%)< .0001

60 months
140
22.32 ± 5.42
14.47 ± 8.37
-7.85
-35.0%(-41.0%, -29.0%)< .0001140
4.62 ± 1.05
2.54 ± 1.76
-2.08
-44.4%(-50.5%, -38.4%)< .0001
139
7.88 ± 2.41
11.08 ± 4.72
3.21
49.9%
(37.4%, 62.3%)< .0001140
6.92 ± 2.79
3.51 ± 3.34
-3.41
-46.8%(-55.8%, -37.7%)< .0001

PUL = prostatic urethral lift; IPSS = International Prostate Symptom Score; QOL = quality of life; Qmax = peak flow rate;
BPHII = BPH Impact Index

protruded into the bladder vesicle. Additionally, threesubjects underwent prophylactic removal of implants
exposed to the bladder that had not encrusted. These
procedures typically only removed the misdeployedimplant, but if additional implants were placedor tissue resection was conducted, the procedure
was counted in the retreatment numbers reported
above. As prior described, independent review of
1 year video cystoscopy revealed that no implant
properly deployed within the prostate showed signsof encrustation, but 2.1% of implants were found to
be deployed too proximally such that the implant was
exposed to standing urine in the bladder.
Sexual function was preserved with no PUL subjects
reporting an adverse event of de novo sustained
ejaculatory or erectile dysfunction. This measure
was a secondary safety endpoint of the FDA study.
There was no significant degradation in mean erectile
function (IIEF-5) or ejaculatory function (MSHQ-EjD
Function) over the course of 5 years, Table 3. Bother© The Canadian Journal of Urology™; 24(3); June 2017

due to ejaculatory function improved rapidly andremained modestly improved at 5 years, p = 0.02.

Conclusions
The results of this largest randomized, controlled 5 year
study of PUL demonstrate both the clinical advantagesof this minimally invasive therapy and definitive 5 year
durability, with sustained improvement in symptoms(36% IPSS), quality of life (50% QOL; 52% BPHII) andurinary flow rate (44% Qmax) and an acceptably low
surgical retreatment rate of 2%-3% per year. With 82%
reporting some level of satisfaction with their urinary
symptoms at 5 years, it would appear that this result
is sufficient for the vast majority of PUL subjects. With
regard to clinical advantages, PUL was shown to be freefrom serious adverse effects of traditional BPH surgery,such as stress urinary incontinence and transfusion;
it is associated with the lowest postoperative catheter
requirement of any available BPH procedure; PUL

8808

Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study

TABLE 3a. Paired outcome measures after PUL (per protocol analysis), including sexual function – 2 weeks to
12 months
Test		
2 weeks
1 month
3 months
6 months
12 months
IPSS
N (paired) 135
135
136
133
123		
Baseline
22.33 ± 5.51
22.27 ± 5.49
22.31 ± 5.49
22.21 ± 5.51
22.13 ± 5.56
Follow up 18.01 ± 7.88
12.28 ± 6.94
11.17 ± 7.68
11.24 ± 7.31
11.52 ± 7.27
Change-4.3-9.99-11.14-10.97-10.61% change -17.5%-44.1%-49.7%-49.0%-47.4%(95% CI)(-23.4%, -11.6%) (-48.9%, -39.3%) (-55.0%, -44.4%) (-54.3%, -43.7%) (-52.9%, -41.8%)
p value< .0001< .0001< .0001< .0001< .0001
QOL
N (paired) 136
135
136
133		
123
Baseline
4.62 ± 1.06
4.61 ± 1.06
4.62 ± 1.06
4.60 ± 1.06
4.56 ± 1.01
Follow up 3.62 ± 1.65
2.59 ± 1.68
2.40 ± 1.72
2.17 ± 1.65
2.25 ± 1.61
Change
-1.00
-2.02
-2.22
-2.44
-2.31
% change -18.0%-42.2%-46.7%-52.2%-50.6%(95% CI)(-25.6%, -10.5%) (-48.7%, -35.8%) (-53.2%, -40.2%) (-58.2%, -46.3%) (-56.8%,-44.4%)
p value< .0001< .0001< .0001< .0001< .0001
Qmax
N (paired)			122		102Baseline			
8.02 ± 2.40		
8.04 ± 2.35
Follow up			
12.31 ± 5.28		
12.07 ± 5.28
Change			4.29		4.03
% change			64.4%		58.5%(95% CI)			
(49.8%, 79.0%)		
(42.8%, 74.1%)
p value			< .0001		
< .0001
BPHII
N (paired) 136
135
136
133
123
Baseline
6.90 ± 2.82
6.88 ± 2.83
6.90 ± 2.83
6.92 ± 2.82
6.80 ± 2.79
Follow up 7.01 ± 3.47
4.03 ± 3.07
2.91 ± 3.00
2.66 ± 2.84
2.83 ± 2.91
Change
0.11
-2.85
-3.99
-4.26
-3.98
% change 29.2%-32.8%-56.0%-60.1%-57.3%(95% CI)(8.4%, 49.9%)(-46.0%, -19.6%) (-63.9%, -48.1%) (-66.9%, -53.3%) (-65.5%, -49.2%)
p value
0.7725< .0001< .0001< .0001< .0001
IIEF-5N (paired)		 88
91
94
87Baseline		
16.28 ± 7.12
16.16 ± 7.02
16.27 ± 7.01
15.99 ± 7.14
Follow up		
17.25 ± 7.63
17.44 ± 7.58
17.33 ± 7.63
16.69 ± 7.76
Change		
0.9
1.27
1.06
0.70
% change		
16.6%
14.4%
11.6%
18.5%
(95% CI)		
(3.5%, 29.8%)(5.7%, 23.2%)(2.7%, 20.5%)(-3.6%, 40.6%)
p value (GEE)0.05830.00370.01040.2916
MSHQ-EjD N (paired)		 88
91
94		
87
function
Baseline		
8.92 ± 3.08
8.67 ± 3.09
8.76 ± 3.23
8.69 ± 3.26
Follow up		
11.22 ± 3.30
10.98 ± 3.16
10.53 ± 3.29
10.25 ± 3.16
Change		2.30
2.31
1.78		
1.56
% change		
36.2%
35.9%
35.9%		27.5%(95% CI)		
(24.5%, 47.9%) (25.2%, 46.5%) (17.0%, 54.7%) (17.2%, 37.8%)
p value (GEE)< .0001< .0001< .0001		< .0001
MSHQ-EjD N (paired)		 87
91
94		
87
botherBaseline		
2.15 ± 1.65
2.20 ± 1.65
2.19 ± 1.63
2.18 ± 1.69
Follow up		
1.30 ± 1.40
1.13 ± 1.34
1.27 ± 1.30
1.43 ± 1.37
Change		
-0.85
-1.07
-0.93		
-0.76
% change		-33.3%-47.6%-40.2%		
-28.3%(95% CI)		
(-50.1%, -16.5%) (-61.8%, -33.4%) (-53.6%, -26.8%) (-45.4%, -11.3%)
p value (GEE)< .0001< .0001< .0001		< .0001
PUL = prostatic urethral lift; IPSS = International Prostate Symptom Score; QOL = quality of life; Qmax = peak flow rate;
BPHII = BPH Impact Index; IIEF-5 = International Index of Erectile Function; MSHQ-EjD = Male Sexual Health Questionnaire
for Ejaculatory Dysfunction

8809© The Canadian Journal of Urology™; 24(3); June 2017

Roehrborn ET AL.

TABLE 3b. Paired outcome measures after PUL (per protocol analysis), including sexual function – 24 months
to 60 months
Test		
24 months
IPSS
N (paired)
103
Baseline
21.82 ± 5.62
Follow up
12.69 ± 7.85
Change-9.13% change-41.4%(95% CI)(-48.1%, -34.6%)
p value< .0001
QOL
N (paired)
103
Baseline
4.52 ± 1.00
Follow up
2.33 ± 1.64
Change-2.19% change-47.4%(95% CI)(-54.6%, -40.1%)
p value< .0001
Qmax
N (paired)86
Baseline
8.33 ± 2.40
Follow up
12.53 ± 5.43
Change4.21% change
58.6%(95% CI)(40.5%, 76.7%)
p value< .0001
BPHII
N (paired)
103
Baseline
6.53 ± 2.88
Follow up
2.76 ± 2.96
Change-3.78% change-54.8%(95% CI)(-64.7%, -44.9%)
p value< .0001
IIEF-5N (paired)72
Baseline
15.63 ± 7.04
Follow up
16.68 ± 7.55
Change1.06% change
22.0%(95% CI)(-2.6%, 46.7%)
p value (GEE) 0.0391
MSHQ-EjD N (paired)72
function
Baseline
8.75 ± 3.39
Follow up
9.83 ± 3.28
Change1.08% change
30.2%(95% CI)(8.0%, 52.5%)
p value (GEE) < .0001
MSHQ-EjD N (paired)72
botherBaseline
2.25 ± 1.68
Follow up
1.63 ± 1.49
Change-0.63% change-20.5%(95% CI)(-40.7%, -0.3%)
p value (GEE) < .0001

36 months
93
21.56 ± 5.88
12.73 ± 7.95
-8.83
-41.1%(-48.2%, -34.0%)< .000193
4.47 ± 1.01
2.23 ± 1.57
-2.25
-48.8%(-56.5%, -41.1%)< .000169
8.32 ± 2.39
11.79 ± 4.81
3.47
53.1%
(32.7%, 73.5%)< .000193
6.43 ± 2.86
2.65 ± 2.82
-3.78
-53.2%(-65.9%, -40.5%)< .000166
16.48 ± 6.77
17.02 ± 7.86
0.53
4.0%
(-5.6%, 13.6%)
0.340766
9.17 ± 3.01
9.73 ± 3.47
0.56
8.9%
(-0.6%, 18.3%)
0.012266
2.15 ± 1.63
1.56 ± 1.45
-0.59
-27.4%(-44.3%, -10.5%)
0.000248 months
78
21.38 ± 5.92
12.58 ± 7.88
-8.81
-40.6%(-48.7%, -32.6%)< .000178
4.50 ± 0.98
2.08 ± 1.42
-2.42
-52.0%(-60.1%, -44.0%)< .000160
8.45 ± 2.38
12.72 ± 5.62
4.27
63.4%
(39.2%, 87.7%)< .000178
6.41 ± 2.69
2.63 ± 2.56
-3.78
-55.7%(-66.4%, -45.0%)< .000154
16.87 ± 6.44
17.17 ± 7.07
0.30
7.3%
(-7.4%, 22.1%)
0.472455
9.18 ± 3.01
9.98 ± 3.37
0.80
12.3%
(1.6%, 23.1%)
0.002155
2.20 ± 1.67
1.36 ± 1.31
-0.84
-31.3%(-49.9%, -12.7%)< .0001

60 months
72
21.47 ± 5.99
13.92 ± 8.44
-7.56
-35.9%(-44.4%, -27.3%)< .000172
4.51 ± 0.98
2.19 ± 1.54
-2.32
-50.3%(-58.4%, -42.2%)< .000152
8.52 ± 2.15
12.00 ± 4.86
3.48
44.3%
(29.4%, 59.1%)< .000171
6.42 ± 2.61
2.94 ± 2.87
-3.48
-51.8%(-63.2%, -40.5%)< .000149
16.82 ± 6.22
16.45 ± 7.12
-0.37
6.1%
(-12.9%, 25.2%)
0.602649
9.22 ± 2.89
9.53 ± 3.21
0.31
9.3%
(-3.8%, 22.5%)
0.096249
2.18 ± 1.67
1.90 ± 1.45
-0.29
-6.3%
(-31.5%, 18.8%)
0.0195

PUL = prostatic urethral lift; IPSS = International Prostate Symptom Score; QOL = quality of life; Qmax = peak flow rate;
BPHII = BPH Impact Index; IIEF-5 = International Index of Erectile Function; MSHQ-EjD = Male Sexual Health Questionnaire
for Ejaculatory Dysfunction© The Canadian Journal of Urology™; 24(3); June 2017

8810

Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study
offers significant improvement in LUTS by 2 weeks,with the typical mild to moderate adverse effects oftransurethral access mitigated in a similar timeframe;
and finally, PUL is the only BPH therapeutic option,other than tadalafil, shown to be free from iatrogenic
lasting sexual dysfunction, erectile or ejaculatory. As
it is rare that any prospective study in BPH extends
beyond 5 years, we believe this report demonstrates
that PUL has reached maturity as a standard of carefor BPH.
In any long term follow up analysis, the qualityof the study and the percentage of patients available
for follow up must be considered. The accuracyof outcomes such as retreatment rates and efficacy
is compromised when the percentage of patientsavailable for follow up is low. In the L.I.F.T. study,
74% of subjects were available at 5 years (over
80% of living subjects with a prostate at 5 years),a rate commensurate with high quality studies.
The percentage of patients available at 5 years inprospective studies ranges from 28%-73% for TURP,21-23
37.6%-77% for PVP laser,24-26 39%-83% for TUMT,21,27
28%-94% for TUNA,22,28 and 33%-69% in BPH drug
trials.29,30 Thus, comparisons made between PUL fromthis study and other BPH treatments must be madewith caution as low quality studies can be misleading.
A question to be asked in any clinical study is to what
extent loss to follow up affects the data. We answer
this in the LIFT study by reporting efficacy results
both in the traditional PP analysis and using an ITT
analysis where last available data is carried forward.
No statistical difference in results was seen at 5 years
between PP and ITT analyses. Also, analyzing the
12.9% subjects lost to follow up shows that their final
IPSS improvement prior to exiting the study was on
average substantial (10.4 point improvement over an
average of 28 months).
In addition to sustained efficacy, durability has
traditionally been assessed by the rate of surgical reintervention for recurrent BPH symptoms. We report acumulative rate of 10.7% after 3 years and 13.6% after 5
years for PUL, or about 2-3% per year. In comparison,
the rates are 6.1%-17.7% for PVP laser at 5 years24-26 and5.8%-7.0% (often quoted as 1% to 2% per year) for TURP
at 5 years.31,32 Surgical retreatment rates for thermal
ablation treatments have been reported to be 9%-21% for
TUMT at 5 years,21,27 14%-15% for TUNA at 5 years.22,28
However, it should be noted that the majority ofstudies of thermal ablation procedures show higher
retreatment rates over a shorter follow up duration,with TUMT retreatment at 31%-40% at 3 years,
TUNA at 20%-36% at 2-3 years.33,35 Among medical
therapies, the rates of progression to surgery have8811

been reported to be 4%-27.7% by 3-5 years withalpha blockers,29,35,36 2%-4% by 4-5 years with 5-alphareductase inhibitors29,37 and 1%-6% by 4-5 years withcombination therapy.29,38 It should be noted that thesesurgery rates may underestimate the true failure rates
for medical therapy. Often drug patients dissatisfied
with medication will change prescriptions, stop andstart treatment or discontinue altogether without
electing surgery.3,4,31 This “treatment interruption” rate
has been shown to be at least 16% per year,32 and thedrug discontinuation rate after 12 months of treatment
is as high as 62%-91%.3,4,39
Use of BPH medication after surgical treatment
has been poorly reported to date in most clinicalstudies. However, recent attention has been paid tothis in population studies, showing a very high rateof pharmacotherapy after surgery. The incidence of
BPH medical treatment after PUL was 3.6% at 1 year
and 10.7% at 5 years post-procedure. A comprehensive
population study of 2,620,269 BPH patients in France
found that among the patients who had BPH surgery(80% with TURP), the incidence of BPH medication
treatment was as high as 13.8% at 1 year and 40%
at 5 years post-surgery. 31 The authors noted that
their study elucidated the gap between scientificknowledge of BPH surgery based on clinical trial
reporting and the findings in real-world practice inwhich medication rates post-surgery are quite high.
Similarly, a retrospective study of 6,430 U.S. TURP
and laser patients found that the rate of new use of
BPH medication was 22% at 3 years post-surgery
for both types of patients (20%-25% TURP, 18%-25%
laser).40 Direct comparisons between prospective
controlled studies and population studies must be
made with caution, and perhaps if similarly rigorous
reporting of medication usage could be demanded ofprospective studies moving forward, this phenomenon
can be better understood. While the need for BPH
pharmacotherapy after surgical treatment could bea result of misdiagnosis or inadequate treatment, it
could also be interpreted as a result of patients seeking
surgical options too late in the disease progression.
Because of the morbidity associated with traditional
surgical treatments, men may tend to delay surgery
at the expense of decreasing bladder function, andmedication after surgery is continued in an attempt
to address unmitigated bladder issues. One goal of
PUL is to provide a less invasive option, such thatmen may be compelled to elect treatment prior toirreversible bladder dysfunction. Whether PUL elected
earlier in the disease process effectively addresses a
possible window of curability for imminent bladderdysfunction requires further study.
© The Canadian Journal of Urology™; 24(3); June 2017

Roehrborn ET AL.
With regard to technical learning from this study, as
discussed in prior work, there was no dependence of
PUL efficacy on prostate volume, number of implants
or number of implants per prostate volume. For all
investigators in North America, the data represent
their very first PUL procedures, as there was no runin to this study. The typical procedure involves four
implants and the average number was 4.9 for thisstudy. Encrustation did not occur on any implant
properly deployed within the prostate. From thisstudy we learned that implants should be placed 1.5 cm
from the bladder neck, as is standard training today
in the many institutions offering PUL. If an implantis inadvertently placed too proximally such that it is
exposed to the bladder vesicle, it should be removed
peri-operatively with endoscopic graspers. PUL waseffective independent of baseline flow rate or LUTS
within this study range, though, as one would predict,greater IPSS change occurs with greater baseline IPSS
score. A follow on study conducted at seven of theclinical sites gave evidence of continued learning
curve, and catheterization rate dropped to 20%, returnto preoperative activity was reduced to 5 days, andIPSS was reduced to a greater extent at 2 and 4 weeks.12
BPH is a quality of life disease, and treatment
options focus on improving quality of life. For manymen, improving LUTS while inadvertently damaging
sexual function, causing incontinence, or exposing
them to other safety concerns, may not result in a net
positive health outcome. PUL has been demonstrated
to be tolerable under local anesthesia in the officesetting, to offer rapid recovery and relief typicallywithout the need for post operative catheter, to provide
improvements in symptoms, flow and quality oflife through 5 years, and to uniquely preserve both
ejaculatory and erectile function. Because of thesecharacteristics for many men suffering from BPH, PUL
may be a preferred treatment choice.

Acknowledgements

The authors would like to thank the participants, clinicalresearch coordinators, and supporters of the L.I.F.T.
study. Special thanks to Drs. Rodney Anderson, Kyle
Anderson, and Rajesh Shinghal for their work on the
independent clinical events adjudication committee.

Disclosures

All authors are investigators for this study. Drs. Chin,
Gange and Barkin are clinical training consultants for
NeoTract. Drs. McVary, Gange, Shore, Cowan, andRoehrborn are investigators for NxThera sponsoredstudies, and Drs. Te and Roehrborn are investigators
for Procept studies.
© The Canadian Journal of Urology™; 24(3); June 2017

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© The Canadian Journal of Urology™; 24(3); June 2017