Document

Neurological and Urodinamic Urology
Arch. Esp. Urol. 2013; 66 (6): 584-591
UROLIFT®, A NEW MINIMALLY INVASIVE TREATMENT FOR PATIENTS WITH
LOW URINARY TRACT SYMPTOMS SECONDARY TO BPH. PRELIMINARY
RESULTS
Pablo Garrido Abad, Almudena Coloma del Peso, Bryan Sinues Ojas and Manuel
Fernandez Arjona.
Urology Department. Hospital del Henares. Coslada. Madrid. Spain.
Summary.- OBJECTIVES: To report the preliminary
results of one of the first series of patients treated with a
new simple surgical technique for the treatment of lower
urinary tract symptoms (LUTS) due to benign prostatic
hyperplasia (BPH) and to evaluate its safety and feasibility.
METHODS: We have performed a novel surgical treatment of BPH, the UroLift® System (Neotract, Inc). It opens
the urethra directly by retracting the obstructing prostatic
lobes without applying incisions, surgical resection or
thermal injury to the prostate.
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RESULTS: The procedure was carried out in 20 patients
with a mean age of 74.3 (43-90) years, with mean
prostate volume of 42.6 mL (19-109) using the same
operative protocol in all case subjects. Mean operative
time was 19.1 min (range: 12-45). International Prostate Symptom Score (IPSS) at 4 weeks reduced from 26.7
to 16.7 and peak urinary flow rate (Qmax) increased
from 8.6 mL/s to 13.2 mL/s. No major complications
were encountered, neither sexual dysfunction. Mean follow-up: 12.3 (2-22) months.
CONCLUSIONS: The UroLift® System procedure appears to be safe and efficient at short term. This technique minimizes the bleeding of the urethra and, therefore, makes bladder catheter not always necessary, and
can preserve sexual function with low morbidity. Further
studies are warranted to determine long-term outcome.
Keywords: UroLift®. Benign prostatic hyperplasia. Minimally invasive surgical therapy. LUTS.
CORRESPONDENCE
Pablo Garrido Abad.
Servicio de Urología
Hospital del Henares.
Avda. Marie Curie s/n
28820. Coslada. Madrid (Spain)
[email protected]
Accepted for publication: February 18th, 2013
Resumen.- OBJETIVO: Presentar una de las primeras
series de pacientes tratados con una nueva y sencilla
técnica quirúrgica para los síntomas del tracto urinario
inferior secundaria a HBP, evaluando su seguridad y
eficacia con resultados preliminares.
MÉTODOS: Se ha empleado una nueva técnica para
el tratamiento quirúrgico de la HBP, el UroLift® System
(Neotract, Inc.), que aumenta el calibre de la uretra
prostática de forma directa, retrayendo los lóbulos prostáticos obstructivos sin realizar incisiones, resección quirúrgica o daño térmico sobre el tejido prostático.
RESULTADOS: El procedimiento ha sido realizado sobre
20 pacientes (media edad: 74.3 años) con un volumen
585
P. Garrido Abad, A. Coloma del Peso, B. Sinue Ojas, et al.
medio prostático de 42.6 cc. (19-109) y empleando el
mismo protocolo en todos los casos. El tiempo medio
de la intervención fue 19.1 min (7-45). La puntuación
del International Prostate Symptom Score (IPSS) a las 4
semanas se redujo de 26.7 a 16.7 y el Flujo máximo
(Qmax) se incrementó desde 8.6 mL/s hasta 13.2 mL/
s. No se presentaron complicaciones mayores, ni afectación de la función sexual. Seguimiento medio: 12.3
(2-22) meses.
Primary objectives of this study were the
assessment of the procedure effectiveness, and also
evaluate the number and severity of serious adverse
events (AE) related to the placement of the implants.
Before treatment all patients underwent
TRUS and cystoscopy to determine the dimensions
and structure of the prostate and exclude those with
middle lobe or urethral stenosis.
CONCLUSIONES: El dispositivo UroLift® parece eficaz
y seguro a corto plazo. Está nueva técnica minimiza el
sangrado de la uretra prostática y, por tanto, no hace
siempre necesario el empleo de sondaje vesical posterior. Además presenta una baja morbilidad, preservando la función sexual. Sin embargo debemos esperar los
resultados de un número mayor número de pacientes
tratados mediante esta nueva técnica y con seguimientos más prolongados para extraer conclusiones más firmes.
All patients were ≥ 50 years, with moderateto-severe symptomatic BPH, with IPSS >20, Qmax.
under 15mL/s, and serum PSA level of < 10 ng/ml.
Following the same inclusion/exclusion criteria for
UroLift ® used by all authors until now, patients were
excluded if they had an obstructive median lobe in
cystoscopy and/or current infection in urine culture
previous to procedure. Also were excluded patients
with previous prostate surgery.
Palabras clave: UroLift®. Hiperplasia benigna
prostática. Tratamiento mínimamente invasivo. STUI.
All procedures were performed by a single
surgeon, under the same surgical protocol, and with the
same antibiotic prophylaxis: i.v 400mg Ciprofloxacin
and 5 days of oral 500mg Ciprofloxacin.
INTRODUCTION
BPH is the most common condition in aging
men, associated with LUTS and is associated with
bladder outlet obstruction (BOO). Despite the goldstandard surgical treatment of BOO, transurethral
resection of the prostate (TURP) has some limitations
and is associated with significant complications
and morbidity. Therefore, a demand for technologic
alternatives that can minimize the risks of TURP exists
(1).
The UroLift® System (Neotract, Inc., Pleasanton,
CA, USA.) is a minimally invasive procedure to treat
symptomatic BPH, using next-generation device that
facilitates the surgery under local anesthesia. It opens
the urethra directly by retracting the obstructing
prostatic lobes without applying incisions, surgical
resection or thermal injury to the prostate.
Patients were not excluded if they had history
of a-adrenergic receptor blocker medication or 5-a
reductase inhibitor medication.
Effectiveness parameters included the
International Prostate Symptom Score (IPSS), BPH
Impact Index (BPH II) and Qmax rate, Safety was
assessed through adverse event recording (AE).
Follow-up assessments were conducted at 4
weeks, 3, 6 and 12 months. The assessments included
AE reporting, uroflowmetry, IPSS and BII.
PATIENTS AND METHODS
The implantation procedure goal is to create
a channel through the anterior prostatic urethra
from bladder neck to veru montanum. Implants are
delivered to both right and left lateral lobes (usually at
the 2:30 and 9:30 position on the clock) advancing
from approximately 1.5 cms distal to the bladder
neck, after pivoting laterally to approximately 2030 degrees from center. To avoid mucosal abrasion
with the movements of the cystoscopy sheath is very
important to turn the device 90 degrees to either side
inside the bladder and not to rotate it while within
the prostatic fossa. The number of UroLift®‚ implants
required is typically four, but depends on prostate
size and configuration.
Retrospective study of our first 20 male
patients treated with the new device (UroLift® System,
Neotract, Inc.) between October 2010 and June
2012.
The procedure was performed with the patient
in lithotomy position and using a standard cystoscopy
to access the bladder transurethrally. After that, a 20F
Storz cystoscopy sheath and a 2.9 mm 0° telescope
We report our preliminary results of this novel
surgical technique for the treatment of LUTS due to
BPH. This is one of the first reports of patients treated
with UroLift® system in Europe.
UROLIFT®, A NEW MINIMALLY INVASIVE TREATMENT...
586
prostatic capsule. A stainless steel urethral end-piece
(8 mm x 1 mm x 0.5mm) was secured onto the suture
monofilament (size 0 polyethylene terephthalate
(PET) non absorbable) apposed to the urethral wall,
and the excess suture was cut.
First 2 patients were performed under spinal
anaesthesia, and next 18 patients were given only
minimal intravenous sedation.
Figure 1. The UroLift® System (Images copyright NeoTract, Inc.)
was inserted for using an implant delivery device.
(Figures 1,2,3) This device, contains a 19G needle,
and once the delivery device was deployed in an
anterolateral direction through the gland to access the
extracapsular space, a non-absorbable monofilament
suture with a nitinol capsular tab (0.6 mm diameter
x 8 mm long) was then advanced through the hollow
needle. The needle was retracted and tension was
applied to the suture to seat the capsular tab on the
Five patients (25%) also presented diabetes,
12 (60%) hypertension (TAS > 160; TAD > 90),
10 (50%) cardiac insufficiency (NYHA III-IV) and 3
(1.5%) nephropathy (defined as Cr > 2.0 mg/dL).
Seven patients (35%) were under oral
antiagregant drugs, and in 2 cardiovascular high risk
patients (10%), this medication was not discontinued
before surgery.
To test the changes from baseline a general
estimating equation model was fit to each output
parameter (IPSS, BPHII, and Qmax). This model was
used to calculate the P values for each follow-up
interval compared with the baseline value, using a
paired non parametric Wilcoxon´s t test. Statistical
significance was defined as P < 0.05.
Figure 2. Delivery sequence of UroLift® device (Images copyright NeoTract, Inc.)
Figure 3. Intraoperative view of the procedure. After treatment the urethral piece of the suture is deeply invaginated
(arrow) into the urethra.
587
P. Garrido Abad, A. Coloma del Peso, B. Sinue Ojas, et al.
RESULTS
Mean (range) preoperative IPSS was 26.7
(20-35), and mean (range) preoperative Qmax was
6.9 mL/s (0-13) including all patients. If we exclude
4 patients (20%) that were using a bladder catheter
before surgery, because chronic retention, Qmax was
8.6 mL/s. (3-13).
The mean (range) age was 74.3 (43-90)
years; Transrectal ultrasound (TRUS) prostate volume
was 42.6 (19-109) mL; Mean operating time was
19.1 (7-45) mins, and the mean (range) UroLift®
number of sutures implanted per patient was: 3.8 (26), 1.69 in right lobe and 2.15 in left lobe. Mean
(range) follow-up was 12.3 (2-22) months, and mean
(range) hospital stay was 20.6 hours (3-72).
All patients have been assessed at 4 weeks
follow-up visit, with mean (range) IPSS of 16.7 (1027), with 10.0-point mean improvement (37.5%).
Mean Qmax was 13.2 mL/s, increase: (+4.5) mL/s
if we exclude 4 patients with bladder catheter before
surgery. 17 patients (85%) achieved 3 months of
follow-up, with mean (range) IPSS of 16.6 (10-27),
with 9.9-point mean improvement (36.3%). Mean
Qmax. was 13.5 mL/s for 17 patients, with an
overall increase of (+4.8) mL/s excluding 4 patients
with bladder catheter before surgery. Until now, 14
patients (80%) have done the assessment at the 6
month follow-up visit with mean (range) IPSS: 17.3(1121) and improvement of 9.1-point (34.5%). 6 month
follow-up Qmax rate: 13.1 mL/s, increase: (+4.5)
mL/s, excluding patients with previous catheter. 10
patients 50% have done the 12 months follow-up
Table I. IPSS, BPHII and Qmax values, by visit. All values are mean.
IPSS
BPHII
Qmax mL/s
Baseline
4 weeks
3 months *
6 months *
12 months *
(N=20)
(N=20)
(N=17)
(N=13)
(N=9)
Baseline
26.7± 6.0
26.7 ± 6.0
26.5 ± 5.9
26.4 ± 5.9
26.3 ± 6.0
Follow-up
-
16.7
16.6
17.3
15.3
Change
-
- 10.0
- 9.9
- 9.1
-11.0
% Change (95% CI)
-
37.5%
37.3%
34.5%
41.8%
P
-
.001
< .001
.001
.008
Baseline
8.4 ± 2.3
8.4 ± 2.3
8.4 ± 2.2
8.4 ± 2.2
8.4 ± 2.2
Follow-up
-
5.1
5.3
4.9
5
Change
-
- 3.3
- 3.1
- 3.5
- 3.4
% Change (95% CI)
-
38.3%
36.5%
41.6%
40.5%
P
-
.001
.001
.001
.006
Baseline
8.6 ± 2.9
8.6 ± 2.9
8.7 ± 2.8
8.6 ± 2.8
8.6± 2.8
Follow-up
-
13.2
13.5
13.1
12.8
Change
-
+ 4.5
+ 4.8
+ 4.5
+ 4.2
% Change (95% CI)
-
51.7%
55.2%
52.3%
48.3%
P
-
.002
. 003
.008
.042
* Sample size reduced because not all patients had reached this follow-up visit
588
UROLIFT®, A NEW MINIMALLY INVASIVE TREATMENT...
visit, with mean IPSS: 15.3, 11-point improvement
(41.8%) and Qmax: 12.8 mL/s, increase: (+4.2) mL/
s excluding patients with previous catheter (Table I).
Mean (range) BPH II basement value was
8.4 (5-12). Mean (range) BPH II was 5.1 (2-8), with
a 3.3-point improvement (38.3%) at 4 weeks visit.
Mean (range) BPH II was 5.3 (2-8), with a 3.1-point
improvement (36.5%) at 3 months of follow-up; Mean
(range) was 4.9 (2-7), with an improvement of 3.5point (41.6%) at 6 months. Finally mean (range) BPH
II was 5.0 (3-7), with 3.4-point improvement (40.5%)
at 1 year of follow-up (Table I).
Some random patients were also evaluated
with cystoscopic examination after procedure. No
one showed calcification, migration or malfunction of
the implants.
Most commonly reported adverse effects
were mild dysuria (14 patients: 70%), and urgency
(8: 40%), and typically resolved within 2 weeks.
Mild haematuria presented in 6 patients (30%) and
stopped in all cases before 15 days (Table II).
Related serious adverse events were 2 urinary
retentions (10%) and 1 acute epididymo-orchitis
(5%). No patients reported urinary incontinence,
subjective changes in erectile function or ejaculation
after procedure, but no validated IIEF or MSHQ-EjD
questionnaires were filled (Table II).
Postoperative catheterization was necessary
in 2 patients (10%). This patient undergone TURP
6 months after UroLift® because continuing with
micturition severe difficulties. In this case, during TURP
the resecting loop cut the suture and does not require
alteration to standard procedure. This patient was
excluded from the analysis of treatment effectiveness
after the completion of their TURP but included in the
complete safety analysis.
DISCUSSION
BPH is the main reason for lower urinary tract
symptoms LUTS due to urethral blockade. Moderateto-severe LUTS is estimated to affect 30% of men aged
> 50 years or ª 26 million men in Europe (2).
There are 3 kinds of treatments for patients
with BPH: watchful waiting, medical and surgical
treatment. Whereas medical treatment using alphablockers or 5-α reductase inhibitors is the first-line
treatment of BPH (3). Surgical therapy is an option for
patients that are unable to tolerate medical therapy
or for whom medical therapy is not efficacious.
Traditional surgical therapy consists of TURP, which
is still considered the gold standard, the hallmark of
the urologist, the one against which other therapeutic
measures are compared (4).
Approximately 10% of patients with BPH
require surgical treatment (5). In some cases, surgery
could be the first choice for treatment rather than
medical therapy. Approximately 8% of subjects
receiving medical therapy require subsequent surgical
therapy (6).
Table II. Device-related AEs ocurring in the first 30 days after the Urolift® procedure.
Number of patients (%)
Mean duration
(N=20)
(days)
Dysuria
14 (70%)
6.8
Irritative symptoms
8 (40%)
16.4
Haematuria
6 (30%)
4.1
Urinary retention
2 (10%)
7
Epididymo-orchitis
1 (5%)
21
Erectile dysfunction
0 (0%)
-
Ejaculation disorders
0 (0%)
-
AE
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P. Garrido Abad, A. Coloma del Peso, B. Sinue Ojas, et al.
TURP is assotiated with a 14.9-point mean
IPSS improvement at 1 year but has a 20% rate of
perioperative morbidity and longterm complications
that include urinary incontinence (3%), urethral
stricture (7%), erectile disfunction (10%) and
ejaculatory dysfunction (65%) (7-10).
Less invasive alternatives to TURP include:
Transurethral microwave thermotherapy (TUMT),
Transurethral needle ablation (TUNA), Laser ablation:
Neodimium YAG laser (Nd: YAG), holmium YAG
laser (Ho:YAG), potassium titanyl phosphate (KTP),
and diode laser, High-intensity focused ultrasound
(HIFU), Transurethral ethanol ablation of the prostate,
Water-induced thermotherapy and Plasma kinetic
tissue management system (Gyrus) (11).
Open surgery for LUTS secondary to BPH
is reserved for patients with very large symptomatic
prostate glands or those with concomitant pathology
such as large bladder stones or symptomatic bladder
diverticula (4).
Most procedural approaches remove or
destroy prostate tissue and can result in significant
morbidity. Exists then an unmet clinical need for an
alternative treatment that caters men who desire a
greater symptomatic improvement than is offered
by medical therapy and are not willing to risk the
complications of a surgical treatment (12).
The UroLift® delivery device mechanically
separates the obstructing prostatic lobes without tissue
removal or thermal injury. The lateral lobes of the
prostate are displaced towards the capsule to expand
the urethral lumen. Small suture-based implants are
then positioned to secure the lobes and maintain the
expanded urethra (12).
The UroLift® system treatment present several
advantages:
a) Endoscopic results can be immediately confirmed
post-procedure,
b) The procedure may be performed under local
anesthesia,
c) Some patients can avoid any catheterization,
d) Patients may experience symptom relief as early as
2 weeks post-procedure,
e) There have been no reports of new onset of sexual
dysfunction, retrograde ejaculation or permanent
erectile dysfunction,
f) UroLift®‚ system treatment does not preclude the
option for future TURP should one be indicated.
According to Barkin et al, we recommend
starting with prostates 50cc or below to learn the
technique. These glands will require fewer implants
as the urologist learns the most efficient locations at
which to retract the lateral lobes (13).
In the literature review, Woo et al reported
a prospective, non-randomized, multi-center clinical
study in Australia to establish the safety and feasibility
of the UroLift® device in 19 male patients ≥55 years
of age with a diagnosis of symptomatic BPH: the mean
(SD; range) age was 66 (55–77) years, and TRUS
prostate volume was 49 (21–97) mL. Patients with
obstructive prostatic middle lobe, current infection,
history of urinary retention, α-adrenergic receptor
blocker medication within 1 week of treatment, or
5α-reductase inhibitor medication within 6 months of
treatment were excluded. Before treatment, the patients
underwent TRUS and cystoscopic examination to
determine the dimensions and structure of the prostate
and to confirm study eligibility. All patients were
given general anaesthesia before undergoing the
PUL in the lithotomy position. Two to five sutures were
positioned in each patient (mean: 3.5). Postoperative
catheter was not required in 6 patients (31.5%), 11
patients (58%) were catheterised overnight and 2
patients (10.5%) needed catheter for 6 and 11 days.
3 patients (15.7%) underwent TURP after one-year
follow up. Mean IPSS improved by 37% at 2 weeks
and 39% at 1year after Urethral Lift. No significant
change of maximum flow rate, postvoid residual and
prostate-specific antigen was measured.(12)
After that,Chin et al also reported another
10 cases performed with local anesthesia and
i.v sedation, using a next-generation device. The
procedure was well tolerated, and improvements
were seen at 2 weeks. Mean baseline IPSS value was
22.9. Improvement was 41% (- 9.4) at 2 week followup, 46.2% (- 10.6) at 1 year follow-up, and 41%
(-9.4) at 3 years follow-up. Mean baseline QOL was
4.9, with an improvement of 44% (-2.2) at 2 weeks
of follow-up, and of 51% (-2.5) at 1 year of follow-up.
Mean baseline BPH II was 7.3, with an improvement
of 39% (-2.9) at 2 weeks follow-up and 60% (-4-4) at
1year follow-up. (14)
More recently, Woo et al presented in AUA
2011 results of a multicenter study. 64 patients (mean
age: 67 years; mean prostate volume: 50mL). All
procedures were successfully completed; 33 under
local anesthesia with a mean catheter duration of 1.5
days. Reported adverse effects: dysuria, hematuria
and frequency resolved within 2 weeks. Normal
UROLIFT®, A NEW MINIMALLY INVASIVE TREATMENT...
sexual function was maintained with no incidence of
retrograde ejaculation (15).
Actually a Phase III RCT “The Safety and
Effectiveness of Urolift: LIFT Pivotal Study” is ongoing
in US. All subjects will be followed through 12
months, and through 5 years for those that receive
investigational device. Primary effectiveness will be
achieved by looking at the improvement of IPSS and
safety will be reviewed based on pertinent adverse
events.
There is no publication about patients treated
with UroLift‚ system and previous treatments with
prostate radiotherapy or brachytherapy.
In spite of a higher number of patients
and longer follow-up, our preliminary results are
in concordance with previous results reported in
literature.
Patients in our serie had a decrease in IPSS
of 37.5, 37.3. 34.5 and 41.8% at 4 weeks, 3, 6 and
12 months of follow-up respectively. After procedure,
BPH II had also a decrease in 38.3, 36.5, 41.6 and
40.5% at 4 weeks, 3, 6 and 12 months of followup respectively, without serious adverse events. Our
Qmax increase was impressive, with 51.7, 55.2,
52.3 and 48.3% at 4 weeks, 3, 6 and 12 months
visit. IPSS lower improvement in our serie could be
determined by the older (74.3 years vs 66-67 years
of other series) and lower number of patients included
in our publication. 1 patient (5%) with prostate
volume > 80cc, did not present any improvement and
underwent TURP without incidences.
In future patients we should try starting to
perform this procedure under local anaesthesia
(instilation of 20cc of cold lidocaine gel into the
urethra and the bladder 20 min before surgery), with
much more benefits for the patient, because a shorter
recovery and making possible to proceed with UroLift
system in Consultation room.
After our preliminary results we confirm
previous reported findings that the Prostatic Urethral
Lift is a safe and feasible treatment for symptomatic
BPH that can preserve sexual function with low
morbidity.
According to our experience, UroLift® is
not only suitable for high risk patients with previous
treatment failures, and also for patients with BPH and
LUTS as a first line surgical option after failure or
adverse effects of oral medication.
590
CONCLUSION
The Urolift® system is safe and feasible, and
represents an alternative solution for men with LUTS
due to benign prostatic hyperplasia (BPH) for whom
medical therapy is no longer desirable but the risk/
benefit profile of TURP is not attractive.
No major complications were reported,
and moreover normal sexual function is preserved.
Improvements are sustained through 1 year of follow
up.
We think that patients with prostate volume
(20-50cc) are the best candidates to UroLift®, and
larger prostates (> 75cc) develope poor results.
Nevertheless, further studies are indicated to continue
evaluating this promising technique.
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