Extracorporeal Shock Wave Lithotripsy

Efficiency Comparison at Frequency of 60, 90

and 120 for Kidney Stone

Proposal for a Randomized Clinical Trial in dr. Soetomo

Hospital, Surabaya

Putu Ratih Dian Pardani

Sunaryo Hardjowijoto
Adi Santoso
Tarmono
Budiono
 Background
 Urinary tract stone prevalence:
Male Female
USA 10.6% 7.1%
German 9.7% 5.9%
Taiwan 9.01% 7.38%

 Indonesia (2002)
◦ 37.636 new cases
◦ 58,959 outpatient
◦ 19,018 admission

Statistik Rumah Sakit di Indonesia Seri 3: Morbiditas dan Mortalitas.

Dirjen Yanmed Depkes RI 2002
 Therapy modalities for urinary tract stone:
◦ Medication
◦ Chemolysis
◦ ESWL
◦ PCNL
◦ URS
◦ Laparoscopy
◦ Open surgery

Stoller ML. Smith’s General Urology 2008

ESWL
Prototype Dornier HM-1
(February 1980 in Germany)

Dornier HM-3 :
first commercial ESWL machine
(1983)

USA, 1984
Stone Free rate 72-90%

Lingeman et al. J Urol. 1986

+ -
 Ramping Coupling
up voltage techniques

Reducing the Facilitating

rate of SW fragment
delivery passage

Optimizing
Strategy Shock
Patient
wave
selection to improve delivery
outcome

McClain, Rev Urol 2013

Frequency Delivery in ESWL
 In vitro, in vivo and clinical evidence 
reducing the rate of shock wave delivery
enhances fragmentation & stone
clearance
 Vallencien et al (1989), in vitro
◦ Frequency of 75 and 150  better
fragmentation than frequency of 300 and 600
 Paterson et al (2002)
◦ In vivo, 30 vs 120
◦ Greater fragmentation occurred at frequency of
30
 Li et al (2013)
◦ Meta-analysis
◦ Decreasing the frequency from 120 to 60
increased overall success rates.
◦ Treatment duration of frequency 60 was
much greater  frequency 90 seemed to be
optimal,especially for large stones.
◦ Frequency of 120 might still be
recommended for small stones
ESWL at dr Soetomo Hospital (Ridha & Soebadi,2014)

241 patients (May 2011 – February 2012)

HK-ESWL V machine
130 single stone and 111 multiple stones
Number of ESWL
Stone location :
session :
41% lower pole Stone size:
59% 1x
69 % middle pole 53.9% <10 mm
32.2% 2x
11 % upper pole 42.3% 10-20 mm
6.6% 3x
16% proximal ureter 3.7% >20 mm
1.7% 4x
5% kidney pelvic
 ,,ESWL at dr Soetomo Hospital

Outcome

14.1

SFR
20.3 Residual stone <4mm
Residual stone >4mm
65.5
To date, there is no data regarding shock
wave frequency in relation with stone
free rate using HK ESWL V at dr
Soetomo hospital

Whether the implementation of strategy

by decreasing frequency as proposed by
various previous research may deliver
result as good as implementing the
strategy on HK ESWL-V
Problem Statements
• Is there any difference in the success rates on the second
week post ESWL between the groups receiving 60,90,and
120 shock per minute?
• Is there any difference in the number of ESWL session
required to achieve the success rate between the groups
receiving 60,90,and 120 shock per minute?
• Is there any difference in the number of total shock
wave required to achieve initial stone fragmentation in
ESWL between the groups given 60,90,and 120 shock per
minute?
• Is there any difference to the duration of ESWL session
between the groups given 60,90,and 120 shock per minute?
Objectives
 General Objective:
To find out the difference of ESWL
efficiency for kidney stone between
frequency of 60,90,and 120
 Specific Objectives:
 To compare the success rates on the second week
post ESWL between the groups receiving 60,90,and 120
shock per minute
 To compare the number of ESWL session needed to
achieve the success rate between the groups receiving
60,90,and 120 shock per minute
 To compare the number of total shock wave needed
to achieve initial stone fragmentation in ESWL between
the groups given 60,90,and 120 shock per minute
 To compare o the duration of ESWL session between
the groups given 60,90,and 120 shock per minute
Benefits
 Theoretical Benefit
◦ To give scientific information regarding the
difference of ESWL frequency towards
success rate for kidney stone patients
 Practical Benefit
◦ To give information about optimal shock wave
frequency to achieve success rate for kidney
stone patients
Literature Review
Anatomy of the Kidney
 Stone Formation
Sex Age Nutrition Climate Race Inheritance

Abnormal Disturbed Metabolic

UTI Genetic factors
renal anatomy urine flow abnormalities

Increased of :
Decreased of:
•stone forming constituents
•Crystallization inhibitors
•Crystallization promoters
•Urinary volume
•pH
•pH

Supersaturation

Crystal growth Abnormal crystalluria Crystal aggregation

 Pearle, 2012
 Matlaga, 2009 Urinary stone
 Chung,2007
Extracorporeal Shock Wave
Lithotripsy
Shock waves are generated by a source
external to the patient’s body and
propagated into the body and focused on
the kidney stone
 4 basic components:
◦ Generator (electrohydraullic, electromagnetic,
piezoelectric)
◦ Focusing system
◦ Imaging/localization system
◦ Coupling system
Dornier HM-1 Wolf Piezolith 3000
Stone fragmentation
 Theory:
1. Tear and shear force
2. Spallation
3. Quasi-static squeezing
4. Cavitation
5. Dynamic squeezing

Rassweiler,Eur Urol,2011
ESWL for Kidney Stone
 Dependent on the stone size
 Non-staghorn stones <10 mm
 Stone between 10-20 mm  ESWL can
be a first line treatment with
consideration of kidney anatomy, stone
location, stone composition
 Stone >20 mm  DJ stent

Lingeman, 2nd International Consultation on Stone Disease,2008

Contra-indication
 Relatives :
◦ Obesity, spine deformity, malformation of
kidney, uncontrolled hypertension
 Absolute :
◦ Pregnancy, uncorrected bleeding disorder,
active sepsis or untreated UTI

Lingeman, 2nd International Consultation on Stone Disease,2008

Complication
 Related to stone fragments:
◦ Steinstrasse, regrowth of residual fragments,
renal colic, obstruction, infection
 Tissue effect :
◦ Renal : haematoma
◦ Cardiovascular
◦ Gastrointestinal

EAU Guideline 2013

 Clinical Parameters that May Affect
Outcome of ESWL

Stone Stone
Stone size
location composition

Anatomy of
Obesity
the kidney

Lingeman et al,2nd International Consultation on Stone Disease,2008

Stone Size
 EAU guideline 2008:
◦ upper limit for ESWL  20 mm (300 mm2)
 Obek et al (2001)
◦ SFR : <1 cm2 72%,1-2 cm2 61%, >2cm2 49%
 Lingeman et al (1987)
◦ SFR ESWL vs PCNL
ESWL PCNL
<20 mm 76% 90%
>20 mm 41% 82%
Stone location
 Turna et al (2007)
◦ SFR : upper calyx 82.8%, middle calyx 83.4%,
lower calyx 67.5%
◦ ESWL  first choice for treatment of stones
<200mm2 in the upper & middle calyx
◦ Lower calyx stone <200mm2 one of the
option with high retreatment & auxiliary
procedure
Stone Composition
 Zhong & Perminger (1994)
◦ Stone fragility
◦ Fracture toughness :
cystine – COM – brushite – uric acid – COD –
struvite

 Matlaga & Lingeman (2012)

◦ Unfavorable to ESWL : cystin, brushit, COM
◦ Hardly fragmented or fragmented with result
of larger size
Kidney Anatomy
 Renal diverticula  poor stone clearance
 Duplex kidney, horseshoe kidney, ectopic
kidney, malrotated kidney  difficult
localization , incomplete clearance
 PUJO  hamper stone clearance

El-Husseiny, Urinary Tract Stone Disease,2011

Obesity
 Ackermann (1994), El Nahas (2007)
◦ Obesity  negative predictor for SFR post
ESWL

 Pareek et al (2005)
◦ BMI of patients with failed vs success ESWL:
30.8 vs 26.9
 Kanao (2009)
◦ Mathematical model to predict ESWL outcome
Evaluation
 No widely accepted guidelines regarding
post-ESWL imaging
 KUB, NCCT, US
 2 weeks post ESWL, 3 months post
ESWL

Lingeman, Stone Disease:2nd International Consultation on Stone Disease

 Yilmaz (2005) : 10 days

 Davenport (2006) : 3 months

 Ng (2012) : days 2 & 7, weeks 4 & 12

 Pace (2004): 2 weeks, 3 months

 Honey (2009) : 2 weeks, 3 months

ESWL Outcome
Success
rate

Stone
CIRF
free rate
 Stone Free Rate:
no evidence of any stone left after ESWL treatment, that are
proven by radiologic examination
 CIRF:
Asymptomatic, non-obstructive, non-infectious residual
fragments post ESWL less than 5 mm
 Clayman (1989)
◦ Described the use of Effectiveness Quotient

% SFR
EQ = ----------------------------------------
100% + % retreated + % aux.procedure
ESWL & Frequency Effect
 Pace et al (2004)
◦ 60 vs 120
◦ Success rate at 2 week: 87% vs 73%
◦ Success rate at 3 months : 82% vs 66%
◦ For stones 100mm2 or greater
 Davenport et al (2006)
◦ 60 vs 120
◦ No significant difference in outcome
◦ Mean stone size : 60 mm2
 Mazzuchi et al (2010)
◦ Frequency 60, 3000 shocks vs Frequency 90,
4000 shocks
◦ Reducing the frequency & total number of
shocks while maintaining the same results
without significantly increasing the duration
◦ No difference in stone free rate &
complication
 Yilmaz et al (2005)
◦ 120 vs 90 vs 60
◦ Success rate :
 Better in 90 vs 120 and 60 vs 120
 No difference in 90 vs 60 (single ESWL session)
◦ ESWL duration :
 Shorter in 120 vs 60 and 90 vs 60
 No difference in 120 vs 90
◦ Additional therapy :
 More in 120 vs 60 and 120 vs 90
 No difference in 90 vs 60
 Yilmaz et al.
 duration  an important problem in
ESWL performed at a low frequency
 As the duration increases  the number
of patients treated may decrease.
 optimal frequency should be
determined in terms of time and
success rate
 Yilmaz et al

Lower frequency

tissue damage, repeat

ESWL rate,
requirement for longer duration.
analgesics or
sedatives will decrease

performing ESWL at 90 shock waves per minute appears to be the

optimal frequency
 9 RCTs ,1,572 patients
 Primary outcomes :
◦ Overall success
◦ Success by size
 Secondary outcomes :
◦ Complications and total shock waves
◦ Treatment time
Fragmentation is better with slow
rate (theory)
Decreased shock wave

Reduced water & gas surrounding the stone

Decreased acoustic impedance mismatch
Optimize the production of cavitation bubbles

Improved bubble dynamics

  Shock wave  development of cavitation
bubble on the stone surface

More cavitation Attenuate the impact

Increased frequency bubbles accumulate in of subsequent shock
the stone surface wave
 HK ESWL V
 Electromagnetic
 Fluoroscopy and
ultrasound
 Focal distance 135
mm, focal area 18x60
mm, maximum
pressure 50MPa,
capacitance 0,4 µF
 Dornier Compact S HK ESWL V

Overall SFR (3 months) 95.9 % 85%

Retreatment rate 13.4 % 29.6%

Ancillary procedure 2.2% 10.2%

EQ 83% 60.8%
Pain score 6-10 1-5
Conceptual Framework & Hypothesis
Conceptual Framework
Hypothesis
• There is a better success rates on the second week post
ESWL for the group received 90 frequency compared to 60
and 120 group
• There is fewer ESWL session required to achieve the
success rate for the group received 90 frequency compared
to 60 and 120 group
• There is fewer number of total shock wave required to
achieve initial stone fragmentation in ESWL for group
received 90 frequency compared to 60 and 120 group
• There is longer duration of ESWL session for group received
60 frequency compared to 90 and 120 group
Research Methods
Material & Methods
Research Type

◦ Experimental research

◦ A Randomized Clinical Trial

◦ Prospective design

Research Population

◦ Patients with kidney stone requiring ESWL in dr Soetomo

general hospital Surabaya
Inclusion Criteria
 Patients with calyx stone or pelvic stone,
size >5mm - < 20mm
 Age > 18 years old
 Radio-opaque stone
 Single stone
 Creatinine serum levels <1,5 mg/dL
 Patients are willing to be involved in the
research
Exclusion Criteria
 Multiple calyx stone
 Non-opaque stone
 Blood pressure >140 mmHg (systole) &
>100 mmHg (diastole)
 Kidney anatomical anomalies (horseshoe
kidney, PUJO)
 Pregnancy
 Obesity (BMI >27)
 Estimated Sample Size
QD2/d2 = 1

n = (zα + zβ)2
Minimal sample size is
calculated using the = (1,96 + 0.842)2
formula for experimental
= 7.85 ~ 8 
study, with unknown
number of population considering the
possibility of drop out
n = (zα + zβ)2 QD2  10
d2
Total sample size for
3 groups : 30
Research Variables
Independent variable

◦ Shock wave frequency

Dependent variables

◦ Stone free status

◦ Residual stone fragment

◦ Total shock wave

◦ Duration of operation

Confounding variables

◦ Kidney anatomy

◦ Stone composition
Operational Definitions
 ESWL
◦ Stone fragmentation using external corporeal shock wave,
in which the produced shock wave will fragment the
stone.

 Frequency
◦ The amount of given shock wave in a minute.

 Calyx stone
◦ Urinary tract stone which is located in upper , middle or
lower calyx of kidney.

 Pelvic stone
◦ Urinary tract stone which is located in pelvic of kidney.
 Plain abdominal x-ray
◦ Radiologic imaging , using x-ray over abdominal area
to describe structure of organs in abdomen and the
presence of radioopaque kidney stone.
 Ultrasound
◦ Radiology diagnostic equipment , using ultrasonic
wave to visualized internal organs. The presence of
stone in kidney will show echoic shadow at
examination.
 Intravenous Pyelography
◦ Radiologic imaging using intra-venous contras
material which will describe the anatomy and function
of kidney, ureters and bladder.
 Success Rate
achievement of stone free status or clinically
insignificant residual fragment following ESWL
treatment
 Stone free status
no evidence of any stone left after ESWL
treatment, that are proven by plain abdominal x-
ray
 Clinically insignificant residual fragment
residual fragment <5mm in size without symptom,
that are proven by plain abdominal x-ray
 Initial stone fragmentation
first stone fragmentation during ESWL

 ESWL duration
The total time required to complete the ESWL
sesion, described in minutes. The time is
calculated from the first shock wave delivered
until the completion of stone fragmentation or
total of 3000 shock waves
Operational Framework (1)
,,operational framework (2)
ESWL procedure details
 Patients with kidney stone (plain
abdominal x-ray, IVU) & meet the
inclusion criteria
 Randomization  60,90 or 120 group
 Stone localization : fluoroscopy, will be repeated
at least every 200 shocks  to ensure
appropriate targeting and to evaluate the initial
stone fragmentation
 Treatment begin at an energy setting of 9 kV 
increase 1 kV every 100 shocks to a maximum
14.5 kV
 Termination of ESWL procedure:
◦ Stone appears to be completely fragmented, or
◦ Reach 3000 shocks

EAU Guideline 2008 & 2013

Pace et al (2004)
 2 weeks post-ESWL : plain abdominal x-
ray  evaluate the SFR or fragmentation
 If there is residual fragment(s) more than
5 mm, or symptomatic fragments at any
size  repeat the ESWL at least 2 weeks
after the first session
Statistical Analysis
◦ Descriptive statistics will be used to describe
the basic and demographic data of the samples
◦ Parametric or non parametric test depends on
normality of data distribution and homogenity
of data.
◦ Data distribution and homogeneity will be
tested using the appropriate test (Kolmogorov-
Smirnov test)
 Research Budget
 Plain abdominal x-ray @ Rp 80.000 x 90 Rp 7.200.000,00
 USG @ Rp 500.000,00 x 30 Rp 15.000.000,00
 IVU @ Rp 700.000,00 x 30 Rp 21.000.000,00
 ESWL @ Rp 3.000.000,- x 30 Rp 90.000.000,00
 Research operational Rp 2.000.000,00
 Total Rp 135.200.000,00
Research Organization
Researcher:

• dr Putu Ratih Dian Pardani

Mentors :

• Prof. DR. dr. Sunaryo Hardjowijoto, SpB.,SpU(K)

• dr Adi Santoso, SpB,SpU(K)

• Dr. dr.Tarmono, SpU (K)

• dr Budiono, MKes
Thank You