Minimally invasive surgical therapies for BPH(MIST)

+
Minimally invasive
surgical therapies for
BPH(MIST)
Dr.Mariam Malallah
+
Benign prostatic hyperplasia (BPH)

A chronic and often progressive condition

Affecting the majority of men by the seventh decade of life.

The historical gold standard has been transurethral resection of prostate
(TURP)

TURP - an effective procedure still associated with risk of bleeding, TUR
syndrome, and need for general anesthetic and hospitalization.

Last decade several new treatment modalities for minimal invasive
therapy of benign prostatic hyperplasia have been developed, both
ablative and non-ablative.

Minimally Invasive Surgical Techniques aim to address these limitations
by offering lower morbidity, reducing hospitalization, and increasing
convenience.
+
(From Kaplan SA. Update on the American Urological Association guidelines for the treatment of benign prostatic hyperplasia.
Rev Urol 2006;8[Suppl. 4]:S10–7.)
+
TURP

It was developed in the United States in the 1920s and 1930s.

TURP, as a treatment modality for obstructing BPH

TURP is less invasive than open prostatectomy.

Is now considered the gold standard for the surgical management of
BPH.

Indications:
acute urinary retention, recurrent infection, recurrent hematuria, and
azotemia.

general or spinal anesthetic

Perioperative Antibiotics : first-generation cephalosporin in
combination with gentamicin

Monopolar versus Bipolar Techniques
- Monopolar with 1.5% glycine or mannitol as nonhemolytic fluids
- concerns about TUR syndrome: introduction of bipolar TURP.
+
TUR syndrome

Occurred in 2% of the patients.

Characterized by: mental confusion, nausea, vomiting,
hypertension, bradycardia, and visual disturbance.

Symptomatic - serum sodium concentration reaches 125
mEq/dL.

The risk is increased if the gland is >45 g and the resection
time >90 minutes.

Related to dilutional hyponatremia.

Can be reduced by the administration of 3% saline solution.

Other factors: Ammonium intoxication from glycine
metabolisim or direct toxic effect of the glycine
Harrison and colleagues (1956)
+
The Gyrus bipolar system

Generator 200-W capability/RF range of 320 to 450 kHz/Voltage
range of 254 to 350 V

A plasmakinetic resectoscope with a TUR loop of 80/20
platinum/iridium alloy electrode with the active and return
electrode on the same axis (axipolar) separated by a ceramic
insulator

In a systematic review of the literature and meta-analysis of
randomized controlled trials, compared the two techniques.
Unfortunately, the overall trial quality was poor. Long-term
efficacy evaluation of bipolar TURP was not possible.
Mamoulakis and colleagues (2009)

Awaiting well-designed multicenter RCT with a longer follow-up
and a cost analysis.
+
MIST

MISTs began to emerge in the last decade as a result of
research and development

Simpler and less morbid alternatives to TURP
+
Criteria for Utilization of Alternative
Minimally Invasive Therapies

Less adverse side-effects

Approaches or = surgical outcomes

No Anesthesia

Shorter Hospital stay

Less expensive

Safety profile = /> surgical therapy
+
Minimally Invasive Therapies(MIST)
Advantages

Disadvantages
Less Invasive




No anesthesia
No hospital stay


Cheaper



Resume their regular daily
activities within a few days.
Avoids of risks and complications
of surgery
Less favorable outcome
Retreatment
Cost $ & suffering of
retreatment
Complications- hematuria,
dysuria, retention
+ BPH Minimally Invasive Rx
Options


Heat or Thermal energy:LASER

Prostatic Urethral Lift (PUL)

Injection

MICROWAVE HYPERTHERMIA

ALCOHOL OR ETHANOL GEL

HIFU

OXYTETRACYCLINE

HYDROTHERMOTHERAPY
(WATER INDUCED HYPERTHERMIA)

PRX 302 (ACTIVATED PSA PROTEIN TOXIN)

Balloon Dilatation

Stent(Prostatic stents)

Embolizatiopn (PROSTATIC ARTERY)

TEMPORARY

BLADDER NECK INCISION (BNI)

PERMENANT

CATEHETRIZATION
+ Usually, heat is used to destroy excess prostate tissue.
Techniques differ in heat source, heat delivery method , side effects, and
number of treatments.
Delivery methods include:

Laser (e.g., non-contact, contact, interstitial)




Microwave





Indigo®
PVP
HoLAP
CoreTherm®
Cooled ThermoTherapy™/TUMT™
TherMatrx®
Prolieve™
Other treatment methods




AquaTherm™ System
Prostiva™ RF Therapy, previously known as TUNA
TUVP
HIFU
+
Urethral Stents

Initially conceived to relieve BOO 2º to BPH *, later to
urethral stricture

Types1. Temporary
2. Permanent

Endoscopic insertion

Major role in patients unfit for surgery
+
Urethral Stent- Temporary

Non-absorbable
Removed or changed q6-36 months.
Topical with sedation
Success 50-90%
No catheter or cysto with stent in situ
Complications - encrustation, migration, breakage,
stress incont. UTI, hematuria
+
Urethral Stent- Temporary

Biodegradable
Polyglycolic acid reinforced
Placed after laser prostatectomy, TUMT
Voiding difficulty at 3-4 wks, transient
Cost-effectiveness questioned, added to
TULP or TUMT
Await long term, multi-center RCT
+
Urethral Stent-Permanent

Attempt to permanently, definitively
treat BOO 2º BPH

Present use –
detrusor- sphincter dyssynergia, post- brachytherapy BOO,
anastomotic strictures and urinary incontinence after radical
prostatectomy
+
Urethral Stent- Urolume

Manufactured by AMS (American Medical Systems,
Minnetonka, MN) for BPH patients

Modified both stent and delivery device

Lengths vary from 1.5 –4.0 cm

Flow rates improve 4-6cc/sec(peak)

Used in nonsurgical candidates

Interest has waned with Tuna and TUMT
+
Urethral Stent- Urolume

Complications
Epithelial hyperplasia
Migration of stent
Irritative voiding
Painful ejaculation
+
Urethral Stent- Others

Memotherm- variable results

ASI (Advanced Surgical Instruments) –withdrawn from
production

Ultraflex-43 fr, 2-6cm, nickel-titanium alloy,
used in BPH, D-S dyssynergia
Epithelial hyperplasia and migration low
Conclusion- temporary stents are attractive after TUNA
and TUMT
+
+
Prostatic stents

Guideline:
- Are associated with significant complications, such as:
encrustation, infection and chronic pain.
- Their placement should be considered only in high-risk
patients, especially those with urinary retention.
+ Transurethral Needle Ablation of the
Prostate(TUNA).

Heat delivery system to induce necrosis of the prostate tissue
to relieve BOO
2º BPH

Aim to

Uses low-level radio frequency energy
needles into prostate

Use of topical anesthesia adequate
prostate temp >60º C
delivered by
+

The best candidates for TUNA are :
- Patients with a prostate volume <60 ml,
- Patients with predominant lateral lobe enlargement,
- Chronic urinary retention
- High-risk patients who can only be treated under local
anesthesia.
+
TUNA-Indications

BPH/BOO

Lateral lobe enlargement

Prostate volume <60gms

Median lobe not ideal, but can be Rx

Bladder neck hypertrophy not ideal candidate
+
TUNA- Experimental Data

TUNA creates 1cm necrotic lesion with no damage to rectum,
bladder base, or distal prostatic urethra
Goldwasser et al, 1993; Ramon et al, 1993

Necrosis maximal @ 7 days, fibrosis by 15 days

Sequential injury to different types of nerve endings may
occur

Central core Temp- 90-100ºC, edge of zone 50ºC

Treatment times of 5-7 min. needed to produce coagulation
necrosis in Rx Site
+
Transurethral needle ablation

Transuretheral needle ablation uses radio frequency energy
to heat the prostate adenoma, which causes necrotic lesions
and thermal damage to intraprostatic nerve fibers and results
in smooth muscle relaxation and clinical improvement.

The procedure can be performed in the office with local
anesthesia and anxiolytics and takes an average of 30–45
min.

About half of patients undergoing this procedure will need a
Foley catheter for 1–2 days.
+
TUNA-Instruments
+
TUNA-Treatment

Position- dorsolithotomy

Anesthesia-local, sedation, SAB, Gen

Instrument/needle placed with 0º fibrooptic telescope

Needle deployed/activated-20x10mm lesion

RF power delivered @2-15 W for 5min.,

catheter is optional
+
TUNA-World Experience
+
TUNA- Adverse Effects

Urinary retention-13-42%

Irritative voiding-40% (1-7days)

UTI-3%

Urethral stricture-1.5%

Hematuria-33%, mild, short-lived

Reoperation-12-14% in 2 yrs
+
TUMT-Transurethral Microwave Therapy

Evaluated for past decade

Widely used, variable urologist attitude

Evolution from low-energy to high-energy

Presently most commonly used devices are Prostatron and
Targis

Current methods use either urethral cooling catheter or noncooling catheter
What is Microwave
Thermotherapy?

A minimally invasive in-office procedure that delivers heat
created by a microwave generator to the prostate through a
catheter placed in the urethra

Technology approved by the FDA

Thousands of patients have been successfully treated with
microwave thermotherapy

6 weeks to 3 months to attain full recovery

Expectations during recovery:
- Slight risk of change in ejaculatory volume
- No expected incontinence
- No expected change in potency
+
TUMT- Method of Action

Heat induced hemorrhagic necrosis, sympathetic nerve injury,
apoptosis

Tissue exposed to 45ºC for 60 min
necrosis

Suggests thermal injury to adrenergic fibers likely accounts for
reduction in symptoms

1-adrenoreceptor density reduced after TUMT

Targis antenna(902-1928MHz) exceeds Prostatron (1296MHz) in
efficiency of delivery of thermal energy
suffered hemorrhagic
Larson and coworkers (1998a)
+
Treatment OptionMicrowave Thermotherapy
Advantages



Non-Surgical interbention
Minimal, short-term side effects
Potential for long resolution of
symptoms
Disadvantages

Post treatment side effects (
some systems much more so
than others)
Two Microwave Thermotherapy
Approaches
High energy, cooled thermotherapy

Premise:
- ‘Must cause deep tissue necrosis for long-term durability”
- ‘Must cool the catheter in order to achieve patient
tolerance”

Options:
- Prostatron
- Targis
TherMatrx Vs. High energy, cooled
microwave thermotherapy

*FDA IDE approved studies available on FDA Website
Thermotherapy Target Zones
Cooled Catheter
Approach
TherMatrx
U
R
E
T
H
R
A

In cooled-catheter thermotherapy,
treated tissue is displaced away from
urethral surface

TherMatrx TMX-200 treats
the obstructing periurethral
tissue
Thermotherapy Target Zones

TherMatrx TMX-200 treats the obstructing periurethral tissue
U
R
E
T
H
R
A
+
TUMT- Clinical Results
D’Ancona et al 1999,
+
Symptom Score Changes Over 12
Months

The reduction in all indices is statically significant at 12 months when
compared with baseline (p=0.00). To date, 6 patients have dropped out.
+
Sexual Function Changes Over 12
Months
+
Peak Flow Changes Over 12
Months

The increase in PFR is statically significant at 12 months when
compared with baseline (p-0.00).
+
TMx 2000 Microwave unit
+
TMx 200 Applicator

3 sizes – 2.5, 3.5, 4.5cm
+
What’s Involved in the procedure?

Non-surgical application of heat to specific tissue areas of prostate

Procedure done in the office approx. 90 mins

Oral anesthesia only

Patient takes oral pain meds morning of the treatment, before office
arrival.

Other basic checks- blood pressure, pulse rate

Treatment catheter placed

Treatment rubs automatically

Post treatment care at home
+
Treatment Eligibility
Exclusion Criteria
Inclusion Criteria



50 + years of age
AUA symptom score >12
Have experienced symptoms for
>6 months




Prior prostate surgery
Prostate cancer
Patients in Urinary retention
Pelvic implant
+

http://www.fda.gov/cdrh/safety/bph.html
+
‘To Cool Or Not To Cool’
Myth: ‘More Hotter, More Better’

‘ The higher temperature the patient can take, the better
outcome will be’

‘cooled systems deliver a known, measurable temperature’

‘TherMatrx offers a low temperature treatment’
+
‘To Cool Or Not To Cool’
Fact: ‘More Hotter, More Pain’

Side effect data for cooled devices indicates treatment too
aggressive
- Pain, ejaculatory dysfunction, fistulae, urethral stricture

Actual tissue treatment temperature are unknown
- Treatment temperature is a blend between circulating cold
water and actual tissue temperature
+
Microwave therapy-Conclusion

Transurethral microwave therapy is the most extensively
studied MIST and is considered by some to be the gold
standard for MISTs.

can be performed in a single 1-h session without anesthesia.

Higher-energy TUMT is the form of this treatment most often
used today

Higher-energy TUMT can be performed in a single 30-min
session
+
Cont...

Many types of microwave thermal therapy machines and
instruments available that differ in amount of energy,
duration and technique.

Higher energy is associated with better results but has a
greater risk of complications.

The degree of improvement is variable and depends on the
size of the prostate, degree of obstruction, type of machine
and treatment protocol used.
+
Cont…


best candidates for higher-energy TUMT are generally men
with larger prostates (>35 ml) and severe symptoms.
Likewise, with the use of low-energy protocols, the best
responders are generally those with mild disease and
smaller prostates.
Maximum effects of TUMT are evident by 3–6 months
+
TUMT-Conclusion

Symptomatic improvement after TUMT appears to be energy
related

Objective improvement after TUMT may be insignificant

Symptomatic improvement may be significant without
objective improvement
+
HIFU (High Intensity Focused Ultrasound)
 HIFU
ablation is a minimally invasive
procedure using a transrectal ultrasound
probe to image the prostate and deliver
timed bursts of heat to create coagulation
necrosis in a targeted area without harming
adjacent healthy tissue
(Leslie, 2006).
+
HIFU

An analogy can be drawn
between HIFU ablating the
prostate and sunrays entering
a magnifying glass to burn a
leaf.

Instead of light as the energy
source, HIFU utilises sound.
Instead of a magnifying glass
HIFU uses a transducer. Just as
the individual sunray is
harmless to the hand, and
individual sound wave is
harmless to the healthy tissue
it travels through.
+
+
+
HIFU
J UROL ROC Vol.13 No.1, March 2002
+
HIFU
J UROL ROC Vol.13 No.1, March 2002
+
J UROL ROC Vol.13 No.1, March 2002
+
J UROL ROC Vol.13 No.1, March 2002
+
COMPLICATIONS-HIFU
J UROL ROC Vol.13 No.1, March 2002
+
Laser Therapy

Types
- Neodynium:Yttrium-Aluminum-Garnet
wavelength-1064nn
- Potassium Titanyl Phosphate
wavelength-532nn
- Holmium: Yttrium-Aluminum-Garnet
wavelength-2100nn
- Diode- most energy efficient
- Thullium Laser
+
Laser Therapy

Methods of delivery
- End firing: Bare tip, Sculpted tip, Sapphire tip.
- Side firing: Metal or Glass reflector, Prismatic internal
reflector.
- Interstitial: Bare tip, Diffuser tip, Diffuser tip with
temperature transducer.

Energy levels can be varied, depending on the type of laser.
45-50ºC -tissue desiccation
50-100ºC - tissue coagulation,
irreversible effects
100ºC +- tissue boils, vaporizes,
carbonized
+
Interstitial laser thermal therapy
(ILC)

A neodymium:YAG laser was used in combination with
specially designed interstitial thermotherapy light-guides.
The tip of the light guide was inserted repeatedly into each
lobe of the prostate transurethrally, under direct vision. The
number of fibre placements depended on the size and
configuration of the gland. The prostatic urethra was
preserved during the procedure.
+
RESULTS:

Among the 31 patients followed for 6 months,

mean IPSS decreased significantly, from 18.9 at baseline to 7.7 (59%
improvement; P<0.001),

mean peak flow rate increased from 6.7 mL/s to 10.0 mL/s (49%
improvement; n=29; P<0.001),

mean
PVR
decreased
from
improvement; n=28, P<0.001)

mean prostate volume decreased significantly, from 37.1 mL to 31.6 mL (15
% reduction at 3 months; n=52, P<0.001).

There was a steady and progressive improvement in both the QOL
assessment and the BPH impact index scores at 3 and 6 months.

More than 90% of the patients reported satisfaction with the treatment and
none reported the new onset of erectile dysfunction. There were no serious
side-effects, except for two cases of loss of ejaculation.
119
mL
to
29
mL
(76%
British Journal of Urology Volume 78, Issue 1, pages 93–98, July 1996
+
Conclusions

The early clinical results suggest that the ILC procedure is a
safe and effective less-invasive treatment for BPH that
appears to have favourable effects on the patients' quality
of life.
+
Photoselective
vaporization(GREEN LIGHT
LASER)
 Relatively new procedure for treating BPH.

Uses a high-powered laser, also known as ‘green light laser’,
to quickly vaporize and remove the obstructing prostate
tissue without harming other tissue.
+
JOURNAL OF ENDOUROLOGY
Volume 20, Number 8, August 2006
KTP Laser versus Transurethral Resection: Early Results of a
Randomized Trial
+
JOURNAL OF ENDOUROLOGY
Volume 20, Number 8, August 2006
+
JOURNAL OF ENDOUROLOGY
Volume 20, Number 8, August 2006
+
+
VLAP (VISUAL LASER ABLATION)

HoLAP (holmium laser ablation of the prostate) involves using a
laser to vaporize obstructive prostatic tissue.

The decision whether to use HoLAP or HoLEP (holmium
enucleation of the prostate) is based primarily on the size of the
prostate. Ablation usually is performed when the prostate is
smaller than 60 cc .

HoLAP offers many of the same advantages as HoLEP when
compared to traditional surgery (e.g., TURP).
These potential benefits include a shorter hospital stay, less
bleeding and shorter catheterization and recovery times.

Patients who undergo HoLAP usually do not require overnight
hospitalization and in most cases, the catheter is removed the
same day or the morning following the procedure.
+
Advantages

Less bleeding,

Less risk of TUR syndrome

Limited hospital stay

Surgery last 20–50 min

Local anesthesia on an outpatient basis.

Immediate postoperative symptom relief

Minimal need for catheter use (many patients require no
catheterization

Lower incidence of retrograde ejaculation compared to TURP
+
INTRA PROSTATIC BOTOX

An open-labeled study, 77 men with BPH received an
intraprostatic injection of 200 units of Botulinum toxin A (BT-A,
Botox) using an ultrasound-guided transperineal approach.

The American Urological Association (AUA) score, serum
prostate-specific antigen (PSA), prostatic volume, residual
volume, and peak urinary flow rates were evaluated before and
after treatment at 1, 2, 6, 12, 18, 24, and 30 months follow-up.

The primary endpoint was symptomatic improvement (AUA
score) and peak urinary flow rates.

The secondary endpoint was the evaluation of prostatic volume,
serum PSA, and residual urinary volume.
Indian J Urol. 2009 Jul-Sep; 25(3): 421–423
+

At the evaluation after 30 months, all 77 patients continued to
have good voiding without worsening of LUTS. Their AUA
symptoms score was 11.1 ± 2.7 (P = 0.02 vs. 2-month value)
and total PSA was 3.1 ± 0.7 ng/mL (P = 0.7 vs. 2-month value)

intraprostatic Botulinum toxin injection is a promising
approach that is safe and effective
Indian J Urol. 2009 Jul-Sep; 25(3): 421–423
+
+
Water-induced thermotherapy

Water-induced thermotherapy is a newer MIST with limited
data.

Uses water as a source to produce heat-induced coagulative
necrosis and secondary ablation of prostatic tissues.

performed as a 45-min outpatient procedure using only
topical anesthesia.

operator independent and has a relatively short learning
curve
+
WIT-CONT…..

Water-induced thermotherapy (WIT), administered by the
Thermoflex System.

The Thermoflex System consists of an extracorporeal heat
source and a proprietary closed-loop catheter system. Water,
heated to 60 degrees C, is continuously circulated through
the catheter to a treatment balloon, which conducts thermal
energy to targeted prostatic tissue.

The combination of heat and compression reduces the heat
sink effect of the circulating blood, thus enhancing the
thermal energy transfer to the compressed tissue.
+
Continued…

Short-term results appear inferior to TURP.

In a trial of 125 patients, IPSS score improved by a median of
12.5 points from baseline, Qmax increased by 6.4 ml/s and
QOL score increased by 2.5 points. At the end of 1 year, a
total of 61.5% patients achieved >50% improvement in IPSS
score, 71.3% patients achieved >50% improvement in Qmax
and 71.6% patients had >50% improvement in QOL score.
+
Advantages



WIT is efficacious, simple, and
inexpensive,
Few side effects
Does not need special probes to
monitor prostate or rectum
temperature; thus, it can be used
in hospitals, outpatient clinics, and
doctors' offices
Disadvantages


Needed prolonged
catheterization (>1 week)
Long term follow up studies
are needed
+
Percutaneous ethanol injection

Transperineal route in to the prostate OR Transrectal OR
Transabdominal

6.0ml ethanol

LA

TRUS guidance

4 or more sites

Urge incontinence

Perineal pain

Median symptom score reduced from 21 to 10 in 3 months

Peak flow rate increased from 11ml/sec to 16ml/sec

PVR dropped from 130 to 27ml
+ Research
Trans-abdominal
Article
Intra-prostatic Injection of Ethanol and
Oxytetracycline HCl under Ultrasonographic Guidance as a New
Approach for Treatment of Benign Prostatic Hyperplasia

Oxytetracycline HCl is less painful than absolute ethanol as
intraprostatic injections, absolute ethanol is more potent
than oxytetracycline HCl for chemical destruction of
prostate in case of BPH.
(Azoz et al., 2001)

BOTH produce chemical destruction of the prostate glands
after one to two month of injection AND ALSO HAS
antibacterial action which controls the infection if it is
present.
+
+
CONCLUSION
Trans-abdominal intra-prostatic injection under ultrasound guidance is
an easy and accurate method
Trans-abdominal intra-prostatic injection of either oxytetracycline HCl or
ethanol is an easy applicable, safe, quick, cheap, less invasive and
effective approach .
+

Seventy patients with BPH who showed poor oral drug efficacy and were
medically fragile or unwilling to undergo operative therapy received
ultrasound-guided transrectal ethanol injection and were followed up at 1, 3, 6,
12, and 24 months post-treatment .

After 24 months of treatment, prostate volume, IPSS, QOLs and PVR of patients
were significantly reduced when compared with the pretreatment values (55.9
± 16.7 vs 46.8 ± 8.1 mL, 29.3 ± 6.7 vs 9.8 ± 2.4 points, 5.3 ± 1.7 vs 1.9 ± 0.7
points, and 130.8 ± 71.5 vs 25.9 ± 12.0 mL, respectively, P <.05).

Qmax significantly increased to 15.3 ± 3.2 mL/s than the pretreatment Qmax
of 4.7 ± 3.1 mL/s (P = .001).
+

Four of 36 patients who received a high dose of ethanol
developed liquefaction necrosis and urinary tract injury (2
patients each).

However, the subsequent 34 patients received a reduced
dose of ethanol and had no complications.
Conclusion:
The minimally invasive technique of ultrasound-guided
transrectal ethanol injections showed good efficacy with few
complications for the treatment of patients with BPH and
other high-risk comorbidities.
Li Y et al, 2014
+
Balloon Dilation

Endoscopic balloon dilation for treatment of BPH involves the
insertion of a balloon catheter tip through the urethra into the
prostatic channel where it is inflated to stretch the urethra
narrowed by the prostate.

"a fallout in enthusiasm" for this treatment

The 4th International Consultation on BPH has rated balloon
dilation as an unacceptable treatment option since 1995.
(Lukkarinen, 1999).
(Denis, 1998).
+
Intraprostatic injection of PRX302

Is a PSA activated pore forming protein toxin

Included :-

IPSS >12

Prostate 30-80 grams

Transperineal /TRUS guided in to right and left transition zone

IPSS/QoL/Q-Max/IIED/PSA level

60% had 30% improvement

Dose dependant ( >1.0ml showed better response)
EUR Urol.59:issue 5 ;747-754
+
THE JOURNAL OF UROLOGY® Vol. 189, 1421-1426, April 2013
+
THE JOURNAL OF UROLOGY® Vol. 189, 1421-1426, April 2013
© 2013 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
+
+
Prostatic Artery Embolization (PAE)

PAE has been proposed as a treatment for BPH to reduce the blood
supply of the prostate gland which results in some of the gland
undergoing necrosis with subsequent shrinkage.

The procedure is performed with the individual under local anesthetic
using a percutaneous trans- femoral approach.

Embolization is achieved using microparticles (such as gelatin sponge,
polyvinyl alcohol [PVA], and other synthetic biocompatible materials)
introduced by super-selective catheterization to block small prostatic
arteries.

Early results from a United States clinical trial evaluate the efficacy and
safety of PAE in 20 men with BPH (Bagla, 2014). Following embolization,
19 of 20 participants experienced average AUA symptom score
improvements of 10.8 points (p<.0001), 12.1 points (p=.0003) and 9.8
points (p=.007) at 1-, 3-, and 6 months, respectively
+
+
+
Prostatic Urethral Lift (PUL)

The PUL procedure is a minimally invasive treatment for
symptomatic LUTS secondary to BPH.

A PUL device is permanently implanted with the individual
under local anesthesia and is intended to hold the lateral
prostatic lobes apart and create a passage through an
obstructed prostatic urethra to improve the voiding channel.

The NeoTract UroLift®System (NeoTract Inc., Pleasanton, CA)
received FDA 510(k) designation (K130651) on September
13, 2013 as a de novo device indicated for the treatment of
men 50 years of age and older with LUTS secondary to BPH.
+
PUL

The PUL procedure was performed on 19 men in Australia.

Small suture-based implants were implanted transurethrally under
cystoscopic visualisation to separate encroaching lateral prostatic
lobes.

Patients were evaluated at 2 weeks and 3, 6, and 12 months after
PUL.

Results

All cases were successfully completed with no serious or
unexpected adverse events (AEs).

Between two and five sutures were delivered in each patient and
the prostatic urethral lumen was visually increased in all patients.
+
Cont…

The prostatic urethral lift mechanically opens the prostatic
urethra with UroLift implants that are placed transurethrally
under cystoscopic visualization, thereby separating the
encroaching prostatic lobes.

Reported postoperative AEs were typically mild and
transient and included dysuria and haematuria.

Follow-up cystoscopy at 6 months in a subset of patients
showed no calcification. Histological findings from two of
three patients who progressed to transurethral resection of
the prostate for return of symptoms showed no evidence of
inflammation related to the implanted materials.

The mean International Prostate Symptom Score was reduced
by 37% at 2 weeks and 39% at 1 year after PUL as compared
with baseline.
(BJU International volume 108, Issue 1, pages 82–
88, July 2011)
(The Journal of Sexual Medicine Volume 9, Issue
2, pages 568–575, February 2012)
+
+
+
CONCLUSION

Initial experience that the PUL procedure is safe and
feasible.

The safety profile of the PUL procedure appears favourable;
most patients reported sustained symptom relief to 12
months with minimal morbidity

PUL therefore warrants further study as a new option for the
many patients who seek an alternative to current therapies.
+

A meta-analysis on the efficacy and safety of minimally invasive
surgical therapies for BPH compared with TURP.
+
Conclusions:

The selection of an appropriate surgical modality for BPH should
be assessed by fully understanding each patient's clinical
conditions.
+

The different bipolar systems and photoselective vaporisation
might replace the ''gold standard'' monopolar TURP, in the near
future.

The holmium laser enucleation of the prostate is also a real
challenger of the ''gold standard'', but the technique is difficult to
learn.

The TUMT definitively found its place as alternative to TURP,
especially because it can be performed in an outpatient setting
without the need of anaesthesia. Therefore it is also suitable in
patients at high risk.

The long-term data on TUNA and HIFU is disappointing and
therefore these treatment modalities did not stand the test of
time.
Van Hest P, D'Ancona F. Minerva Urol Nefrol. 2009 Sep;61(3):257
+

WIT seemed to be a promising therapy, but durability is questionable.

Intraprostatic ethanol injections are safe and effective in small series,
but larger series are needed to confirm its efficacy.

Intraprostatic botulinum toxin A injections are the first treatment of
BPH to target both the increase in smooth muscle tone (dynamic
component) and the excessive growth (static component) of BPH.
Conclusion:

This approach of BPH is very promising but more studies with longterm follow up are needed.
Van Hest P, D'Ancona F. Minerva Urol Nefrol. 2009 Sep;61(3):257
+
Thank you..