Flexible Ureteroscopic Laser Lithotripsy versus

Extracorporeal Shock Wave Lithotripsy in management

of large proximal ureteral stone
THESIS

Submitted for Partial Fulfillment of Master Degree in Urology

By
Kyrillos Medhat Maher Iskandar
M.B., B. CH

Resident of Urology

Supervisors
.Prof. Dr

Ayman Ahmed Hassan

Professor of Urology

Faculty of Medicine – Tanta University

.Prof. Dr

Mohamed Abo-Elenen Ghalwash

Professor of Urology

Faculty of Medicine, Tanta University

Dr. Tarek Ahmed Gammel

Lecturer of Urology

Faculty of Medicine, Tanta University

Faculty of Medicine

Tanta University

2017
 Introduction

Ureteric stones are presenting usually with episodes of acute colicky loin pain
with nausea and vomiting, occur in at least 50% of patients. Large proximal ureteral
stones are commonly associated with obstruction, infection and may lead to
deterioration of renal function.(1,2) Patient symptoms and stone size are not good
predictors of renal function loss, and there is no clear time threshold for irreversible
damage. Therefore intervention should be strongly considered in any patient with
ureteral obstruction unless close monitoring of renal function is available. (3)

There are many options in the management of upper ureteral calculi which
includes extracorporeal shock wave lithotripsy (ESWL), ureteroscopy (URS) with
semirigid or flexible instruments, percutaneous nephrolithotomy (PCNL), laparoscopy
(LAP), and open surgery. The choice of therapy depends on stone factors like
localization, size, density and radiolucency, anatomical factors, obstruction, technical
capacity of the department, patient’s preference and surgeon’s skills. (3,4)

Nowadays, ESWL and URS are the most commonly performed treatment
options. Although guidelines showed that both URS and ESWL should be considered
as a first-line therapy for upper ureteral calculi but the optimal treatment of these
stones still remains debatable. (4)

Extracorporeal Shock Wave Lithotripsy (ESWL) was introduced in 1981. Rapid

modifications have been done in the first generation lithotripters and second
generation machines made it possible to treat the majority of ureteral stones. (5) It
considered as the first line treatment alternative for patients having proximal ureteral
stones less than 10 mm due to noninvasiveness and lower complication rates. The
major disadvantages of ESWL are long duration of treatment and requirement for
multiple sessions. (6)

Marshall first reported the application of flexible ureteroscopy for clinical

diagnosis in 1964.(7) With the advancements in the designs of ureterorenoscopes,
stone disintegration systems and endourologic techniques, ureteroscopic lithotripsy
especially flexible ureteroscopy has been widely used.(8) Usage of laser during URS
makes the stone clearance better in a single session even for the proximal ureteral
stones more than 10 mm and greatly decreased the complication rates. (9)

Meanwhile, percutaneous nephrolithotomy, laparoscopic ureterolithotomy and

open surgery can be used as alternative methods for removal of upper ureteral stones
more than 20 mm. (10,11)
 Aim of the work

The aim of this study is to compare the success and complication rates of flexible
ureteroscopic laser lithotripsy and extracorporeal shock wave lithotripsy for
management of patients with large upper ureteral calculi up to 2 cm.
 Review of Literature

(Anatomy of the upper third ureter)

The ureters are muscular tubes with narrow lumen that drain urine from the kidneys to
the bladder; the ureter is usually 25-30 cm long in adults and ~3–4 mm in diameter.
(12)

Embryology of the upper third ureter:

(12)
The kidney, ureter, bladder, and urethra have a mesodermal origin. By the 4th
gestational week, the growth of the mesonephric duct started medially to enter the
ventral cloaca forming the ureteric bud. During the fifth week, it starts with extension

and canalization to form a small duct with two ends. (13) The caudal end of the bud
forms the ureter, while the cranial end differentiates to form the pelvi-calyceal system.

Abnormalities of bud formation lead to number and shape anomalies. (13,14)

Gross Anatomy of the upper third ureter:

The ureter started at renal pelvis with a down course through the retroperitoneum;
ends distally in the bladder. The ureteropelvic junction usually at level of 2 nd lumbar
vertebra at the left, with a lower level at the right, it started posterior to the renal
artery and vein. This ureteropelvic junction causes a physiologic narrow at the start of

the ureter. (12)

The ureter runs at its upper third anterior to the psoas muscle, then down crossing
behind the gonadal vessels. The ureter crosses in front of the bifurcation of the iliac
(13)
vessels; causes a middle ureteral physiologic narrowing. The peritoneum with its
contents is related anterior to the ureters. The cecum, appendix, and ascending colon
lie anteriorly to the right ureter, and the descending and sigmoid colon lie anteriorly to

the left ureter. (12)

 Figure (1): The physiological sites of ureteral narrowing. (12)

Divisions of the ureter:

Anatomically, the abdominal part extends from renal pelvis till the crossing of the
iliac vessels. The pelvic part extends from the crossing of the iliac vessels till the
bladder entry. The intramural part of the ureter that runs with oblique anterior

direction through the bladder wall about 2 cm. (13)

It can be divided radiologically into upper, middle and lower thirds. The upper third
starts from the ureteropelvic junction till the upper border of sacroiliac joint. Then the
middle third part extends from the upper border till the lower border of the sacroiliac
joint. The lower third part of the ureter starts from the lower border of the sacroiliac

joint till the end. (12)

Figure (2): IVU shows right ureter radiological division. (12)

Microscopic Anatomy of the upper third ureter:
The ureter is roughly 3-4 mm in diameter. The wall of the ureter is formed of five
layers from inside outwards: mucosa, lamina propria, muscular coat, adventitia and
retroperitoneal connective tissue sheath (ureteric sheath), Histologically, the mucosal
layer of the ureter is formed by transitional cell epithelium, which consists short basal
layer then 3-4 layers of columnar cells, next is the lamina propria which is an elastic
connective tissue matrix. Then the smooth muscles muscularis layer which in the
upper third ureter, consists of a thin, poorly defined inner circular and an outer
longitudinal layer. The deficiency in muscularis layer of the upper ureter makes it
susceptible to serious injury during endoscopic instrumentation. The outer layer is the

adventitia, a fibrous layer that caries the vascular and lymphatic supply. (15)

Figure (3): Histological structure

of the ureter.(15)
LP = lamina propria

.TC = transitional cell epithelium

Arterial blood supply of the upper third ureter:

Multiple arterial branches supply the ureter segments along its course, in general the
arterial branches to the proximal part of the ureter located on the medial aspect.
The upper part of the ureter close to the kidney is supplied by branches from the renal
arteries, direct branches from the abdominal aorta and common iliac artery. One
special feature is that the arterial supply travels longitudinally in the periureteral
adventitia in a massive anastomosing plexus, thus permitting surgical mobilization
without altering the blood supply. Awareness of the ureteral vascular supply is of a
great importance in ureteral surgery, because a devascularized ureter may lead to
multiple complications varied from ureteral stricture to postoperative necrosis &

leakage (12, 13)

 Figure (4): Arterial blood
supply to the ureter. (12)

Ureteral Venous and lymphatic drainage of the upper third

ureter:

The venous drainage of the ureter is paired parallel with the arteries. Lymphatic
drainage of the upper ureter joins the renal lymphatic to the lumbar nodes. Then the
left ureter drains to the left paraaortic lymph nodes, and the right one is drains mainly

to right interaortocaval and paracaval lymph nodes. (12, 13)

Ureteral innervation and Pain Perception:

The ureter characterized by presence of an intrinsic pacemaker that leads to its

peristaltic movement. It also possesses autonomic inputs, thoracolumbar
preganglionic inputs synapse with superior and inferior hypogastric sympathetic
ganglions. Parasympathetic inputs derive from the S2-S4 segments. Mucosal irritation
and lumen distention lead to stimulation of the nociceptors whose afferents travel with
sympathetic nerves and result in the visceral type referred pain that give the picture of

ureteral colic. (12)

In general, the distribution of the subcostal, iliohypogastric, ilioinguinal, and
genitofemoral nerves responsible for the pain and smooth muscle spasm, resulting in
hyperalgesia and loin, groin, or scrotal/labial pain, depending on the location of the

stimulus. (12)

Figure (5) Referred somatic

pain from the upper urinary
tract. (13)
 Endoscopic anatomy of the ureter

Bladder neck trigone is identified as a raised, vascular, deeply colored and smooth
triangular zone with its apex directed toward the bladder neck and its base formed by
the two ureteral orifices and the interureteric ridge. Anatomically, the trigone is
formed by detrusor muscle and extension of the longitudinal muscle fibers of the
ureters. The elevated interureteric ridge between the ureteral orifices is also known as
Mercier’s bar. It seems to be more prominent in males; however, it can be easily

detected in almost all bladders. (16)

There are a size and shape variety in the endoscopic finding of the ureteric orifices.
They are usually symmetrically detected along the interureteric ridge, where the
distance between both ureteric orifices is 5 cm apart within the full bladder, decreases
for 2.5 cm only in an empty bladder. The physiological non refluxing orifice can have
different shapes, for example: a volcano, a horseshoe, or others. Mostly, it can be
easily detected; sometime it might be an inconspicuous slit that need close endoscopic
observation to detect its characteristic mucosal vascular pattern, where evident
mucosal vessels are usually seen coursing in an arc medial, lateral and inferior to the
orifice. Note that as the bladder fills, the intra vesical part of the ureter is compressed,

pushing the orifices lateral, making it more difficult to detect. (16)

Marshall, Lyon and Tanagho classified the ureteral orifice with two criteria:

1- Ureteric orifice position, where position A it was detected at the normal medial
aspect of the trigone. Position C if it was at the junction of the trigone and lateral
bladder wall. Position B if it was between A and C.
2- Ureteric orifice shape, where grade 0 the normal cone or volcano orifice; grade 1,
the stadium orifice; grade 2, the horseshoe orifice; and grade 3, the golf-hole orifice.
There are increasing possibility for reflux and laterality as long as the grade

progressed. (17)

The ureter starts with the intravesical part extends for about 1.5 cm. It is divided to the
submucosal part courses posterior and laterally in the bladder for about 0.5 cm, then
the intramural part runs obliquely through the bladder muscle for about 1 cm, and this

considered as the narrowest part at the ureter course. (16)

The normal ureter is easily to be distended; but there are the three physiological
narrow sites at the ureter. The narrowest part is the uretrovesical junction. The other
two narrowing sites (pelvic prim – the pelviureteric junction) is relatively wider, and

easily distended by fluid pressure of the endoscopy. (16)

The middle part of the ureter that lies on psoas muscle is partially straight lumen with
the typical stellate appearance. The ureteropelvic junction detected endoscopically as
a narrowing in the ureter lumen and presence of a posterolateral lip of mucosa
followed by the wide renal pelvis. Also the iliac vessels pulsation can be detected at

its crossing level behind the ureter. (18)

(b)

Figure (6): a- right ureteric orifice identification by endoscope

b- Ureter lumen seen with ureteroscope

 Upper ureteral stones
Urolithiasis is the third most common problem of the urinary tract, affects 5% of the
population. It is very common among men and women with estimated prevalence
among the population of 2-3% with an estimated life-time risk of 12% for males and 5-
6% for females, while ureteral stones account for 33-54% of urinary stones.
Mechanism of stone formation is so variable and multiple risk factors such as age, sex,

anatomic factors, seasonality, and metabolic diseases have been recorded. (19)

Types and classification of stones:

Calcium is the most common component element of urinary stones in nearly 75% of
stones. Calcium oxalate stones are about 70% of all stones; mixed calcium oxalate

and calcium phosphate 5-10%; both are radio opaque stone. (20)

Uric acid stones are about 5- 10%, it known by its complete radiolucency. Struvite
(magnesium ammonium phosphate) stones occur approximately 10-15%, whereas

cystine stones are rare 1-2%. They both characterized by relatively radiolucency. (21)

Xanthine Stones and stones associated with medications such as triamterene,

adenosine, silica, indinavir and ephedrine are extremely rare, and they are usually

radiolucent. (21)

Recent study about prevalence of urolithiasis among patients at our locality (Tanta
University Hospitals) revealed that calcium oxalate was the main component, found in
44.3% of the patients as pure stones and in 25.2% as a mixed form, followed by uric
acid stones which were found in 27.5% of patients as pure stones and in 24.4% of
patients as mixed stones with CaOx. Calcium phosphate and struvite stones; each

were found in 1.5% of patients. (22)

Mechanisms of stone formation

The mechanism of stone formation includes supersaturation of stone crystals, then

further aggregation to form the clinical stone. The crystals formation either in renal
tubular fluid or the renal interstitial fluid is encouraged by any urine stasis along the

urinary tract. (23)

A- Urine supersaturation

Solubility product (Ksp) is the point at which the dissolved and crystalline
components are in equilibrium state, but supersaturation state is defined as the ratio of
crystals concentration to its solubility which is the stone formation driving force, the

type of stone that is formed correlates with the crystal supersaturation state. (23) Process
of nucleation and crystal formation started when the urine becomes supersaturated

with one of the crystal forming stone substances.(24)

Two types of nucleation could be detected either:

-heterogenous nucleation where crystals need a solid surface to aggregate on.
-homogenous nucleation where crystals need a liquid medium with no surface.
Heterogeneous nucleation proceeds more rapidly than homogeneous nucleation,

because it requires less energy to form an organized mass. (25)

B- Crystal and matrix component

In general, stones consist of both crystalline and non-crystalline component. Healthy

person urine samples mostly contain small crystals amount formed in the papillary
collecting ducts, usually calcium oxalate dehydrate. Only 5% of the population may
develop stone formation pathology. Anatomic abnormalities or epithelium adherence
may prevent these crystals to flush out with the urine and retention permits the
crystals to grow larger, further they form a stone that will not pass spontaneously.
(25,26)

The matrix is the non-crystalline component of the stone; it varies from 2.5% of the
weight of the stone to 65% in some cases of chronic urinary tract infection. The
definite matrix composition is not certain, however chemical analysis shows a
heterogeneous mixture consisting of 65% protein, 9% non-amino sugars, 5%
glucosamine, 10% bound water, and 12% organic ash. Multiple proteins are found in
stone matrix, specifically, osteopontin/uropontin, Tamm-Horsfall protein, urinary

prothrombin fragment 1, and some subunits of the serum inter-α-inhibitor. (27)

C- Promoters of stone formation

Promoters lead to increase stone constituents crystallization by a number of

mechanisms.

• Urine pH

High acidic urine enhances the precipitation of uric acid crystals, that not only lead to
uric acid stone but may also promotes calcium oxalate heterogeneous crystallization,
in which one type of crystal acts as a solid surface, promoting crystallization of a

second type of crystal. (28) High alkaline urine may enhance secondary nucleation of
(29)
calcium oxalate by precipitation of calcium phosphate. Cystine solubility is
minimal at most known pH values with stone risk at minimal when urine pH is around

5.5–7.0. (30)

• Low urine volume

Low urine volume is usually present with all types of stone. Studies showed that stone
former patients have a lower 24 hour urine volume than healthy population in the
(31)
same age and sex. Urine volume less than 2 liters per day promotes the
supersaturation state of urine in cases of calcium oxalate and uric acid stones. Stone

recurrence rate could be significantly reduced by increasing fluid intake. (32)

• Hypercalciuria

Hypercalciuria could be detected in 25–60% of stone forming population. It enhances

the supersaturation of calcium oxalate or phosphate. It is often familial or diet
influenced. However many stone formers may have idiopathic hypercalciuria. Also
metabolic disorders that increase urinary calcium excretion could be the reason
behind hypercalcuric state, that include primary hyperparathyroidism and Vitamin D

intoxication. (33)

•Hyperuricosuria
Hyperuricosuria can be considered as a main factor in formation of stones composed
of uric acid salts as sodium and ammonium urate stones also play role in calcium
oxalate or calcium phosphate stones formation by reducing its solubility. Where
stones that are formed mainly of uric acid salts frequently have elements of the
(34)
calcium salts. High dietary intake of purines and low urine volume that occur in
chronic diarrhea due to intestinal inflammatory disease are the main factors of the

hyperuricosuria. (35,36)

• Hyperoxaluria
Hyperoxaluria may be due to genetic abnormal production or increased food intake

due to intestinal disorders or after bowel resection surgery.(37) Hyperoxaluria enhances

stone formation, either by its effect on calcium oxalate supersaturation or due to its

harmful effects on the renal epithelium.(38)

Hyperoxaluria is noted with calcium stones patient more often than those. The high

protein intake may increase oxalate formation. (39)

• Phosphaturia

There has been several studies about role of phosphaturia in nephrolithiasis. (40,41) An
abnormal mutation in the NHERF1 gene leads to diminishing reapsorpation of renal
phosphate. It also causes increased 1, 25- di-hydroxy vitamin D formation, which

enhance the formation of calcium phosphate stones. (42)

•Hypocitraturia
Hypocitraturia as an isolated disorder that is not common but usually accompanied by
(43)
other crystaluria defects such as hypercalciuria and hyperoxaluria. Studies show
different values for hypocitraturia detection between the affected population with
(44,45)
average 30–40% of stone formers. Mostly it is a diet related disorder,
specifically fruit but may be also accompanied by renal tubular acidosis and chronic
diarrhea. If no underlying error can be detected so the patient is diagnosed to have
idiopathic hypocitraturia. (43)

D- Inhibitors of stone formation

There are at least four main inhibitors of stone formation in urine:

1- organic anions such as citrate.
2- inorganic anions such as pyrophosphates.
3- metallic cations such as magnesium
4- macromolecules such as osteopontin and Tamm-Horsfall protein. (46)

• Citrate

Citrate can be considered as a stone formation inhibitor. It has several mechanisms; it

inhibits crystals aggregation and its attachment to urinary epithelium. It lowers the
calcium oxalate saturation by binding with calcium to form complexes. (47)

• Pyrophosphate

It is naturally present in urine with average sufficient amount that can inhibit crystal
formation. Mainly it inhibits crystals aggregation as calcium oxalate and calcium
phosphate crystal to the epithelium. (48)

• Magnesium

Magnesium has a role in inhibiting stone formation by inhibition crystal aggregation

(49)
and nucleation. Even though magnesium as a preventive diet supplement has a

negative results in stone formers patients. (50)

• Tamm-Horsfall protein

Tamm-Horsfall protein is present normally as a urinary protein where it produced by

average rate 100 mg per day by the ascending limb of the loop of Henle. (51) It has an
inhibitory effect on crystals aggregation, with no detectable effect on nucleation or
further crystals growth. Studies showed that it coats Ca oxalate crystals and inhabit its
adherence to the epithelium. Detection of Tamm-Horsfall protein defect in stone
former patient is not clear yet. (52)

Diagnosis of upper ureteral stones

I. Complete history taking & Clinical manifestations analysis.

A full itemed medical history should be taken. The symptoms usually develop during
the movement of the stones downward in the ureter. Patients may occasionally be
diagnosed with asymptomatic urolithiasis. (53) The main symptoms are:

1. Pain:

Upper ureteric stones usually present with sudden onset coilky pain radiates from the
costovertebral angle down along the course of the ureter toward the lower anterior
abdominal compartment. It may radiate into the suprapubic region, scrotum,
ipsilateral testicle or into the vulva, it may be more aggressive when the stone is

progressing down the ureter and causing intermittent obstruction. (53,54)

2. Hematuria:

Most patients showed a microscopic hematuria, and they rarely complain of

macroscopic gross hematuria. Also it may be absent in up to 15% of patients, usually

due to a completely obstruction. (55)

3. Associated symptoms:

Upper tract obstruction is frequently associated with nausea and vomiting and
sometimes fever; it considered a relative medical emergency due to severe urosepsis
which requires a proper drainage either by double-J stent or by insertion of

percutaneous nephrostomy tube. (53)

II. Physical examination

A full detailed physical examination is important in ureteric stone patient evaluation.
A proper abdominal examination is very important as an abdominal mass may be
palpable in patients with long standing obstructive urinary calculi with severe
hydronephrosis. The patient mostly presented with acute severe colicky pain where
patient is attempting to find relief in multiple bizarre positions, this can easily
differentiated from peritonitis patient who are afraid to move and are calm in the bed.
(53)

:III. Investigations

A. Laboratory

1. Complete Urine analysis

It may shows haematuria, crystalluria, bacteruria, and urinary casts and also
very important in identifying urine pH as it plays important role in enhancing

stone formation. (56)

2. Urine culture and sensitivity

If there is urinary tract infection, urine culture should be done. A proper

antibiotic should be given before any intervention to reduce risk of

bacteremia or sepsis. (57)

3. Renal function tests: blood urea and serum creatinine.

4. Routine investigations: including complete blood count (CBC), coagulation

profile as prothrompin time and activity and liver function tests. (58)

B. Radiological

1. Non contrast helical CT scan abdomen and pelvis

It is considered the investigation of choice, in a comparing study between Non
contrast helical CT scan CT and IVU, CT was shown to have a sensitivity of 94%–
100% and a specificity of 92%–100%, while IVU was shown to have a sensitivity of

64%–97% and a specificity of 92%–94%.(59)

CT scan without contrast study can be performed for patients with severely impaired
renal function or of allergy to IV contrast material. No intravenous administration of
contrast material therefore can be performed rapidly, without the need for the delayed
imaging required for IVU. Obstructing ureteral calculi can be identified, size and
hounsfield unit measured, but it is not recommended for patients with high risk for

radiation exposure, such as pregnant and pediatric patients. (60)

Figure (7): longitudinal nonenhanced CT

.showing upper third right ureteral calculus

2. Abdominal plain x-ray film (KUB)

Radio-opaque stones only could be visualized on well prepared X-ray film, where the
sensitivity of stones detection based on location was 67% for the proximal ureter.
Also, it has a limited value in accurate diagnosis because smaller stones are often
obscured by overlying ribs, transverse processes and bowel gases. It is not
recommended in patients with high risk for radiation exposure, such as pregnant and
(61)
pediatric patients.
R

Figure (8): KUB plain X-ray showing

.stone upper third left ureter
3. Abdomino-pelvic ultrasonography

It is universally available, non-invasive, inexpensive and radiation free investigation.

It can detect radiolucent stones. It is considered to be of limited value in identifying
stones in the ureter as an operator-dependent technology; due to obscuration by
overlying bowel gas and the deep location of ureters within the retroperitoneum. It is
very effective in demonstrating the degree of hydronephrosis in case of calculus
ureteral obstruction. US has a sensitivity of only 37% for direct visualization of
ureteral stone, when hydronephrosis was included as a positive sign for ureteral
calculi the sensitivity increased to 74%. It is recommended in patients with high risk

for radiation exposure, such as pregnant and pediatric patients. (62)

Figure (9): Left hydrouretronephrosis and stone in the left upper third ureter.

4. Intravenous Urography (IVU)

It was previously the investigation of choice; it may be used when indicated to

provides data about ureteric anatomy, level and degree of obstruction with a higher
sensitivity and specificity than an abdominal plain film. Because It cannot be used
when patients have poor renal function and IV contrast hypersensitivity, it has been

replaced by non-contrast helical CT as the investigation of choice. (63)

Figure (10): I.V.U films showing dilated left

pelvicalyceal system and the left ureter
till the level of obstructing ureteric stone.
 Lines of Treatment for upper third ureteral stones

There are various lines of treatment for upper third ureteral stones with different
efficacy rates; such as extracorporeal shock wave lithotripsy (ESWL), ureteroscopic
lithotripsy (URSL), laparoscopic ureterolithotomy and percutaneous antegrade
ureteroscopy, open ureterolithotomy, also conservative and medical treatment has a
rule in specific conditions. (64)

I. Non-surgical therapy; Spontaneous passage and medical

expulsive therapy

It has been found that it occurred in 95.1% of stones up to up to 4 mm in diameter. So

possibility of spontaneous stone passage always present beside the progressive

development of the less invasive high technical lines of treatment. (65)

However, it is less accepted in patients with prolonged partial obstruction (i.e. over 6
weeks) or persisting symptoms (pain, vomiting or urinary infection), which will lower
the possibility for spontaneous passage. (65)

The development of medical expulsive therapy facilitates passage of ureteral stones

that previously have required intervention. Pharmacologic treatment such as alpha
blockers or calcium channel blockers can facilitate passage of ureteral stones and

reduce more analgesics requirements and prevent needless intervention. (66)

II. Extracorporeal Shock Wave Lithotripsy (ESWL)

Methods and principles of ESWL

Before introduction of extracorporeal shockwave lithotripsy (ESWL) in 1980, the
only line treatment for stones that didn't pass spontaneously was open surgery. When
it compared with open and endoscopic procedures, ESWL is minimally invasive,

exposes patients to less anesthesia. (67)

The idea in general, external source generates the shock waves via various mechanism
to the patient's body and focuses it on the stone site, where it can pulverize the stone
in vivo into smaller fragments ideally less than 1 mm that the body can then pass
spontaneously. All lithotripsy machines have four basic components: shockwave

generator, focusing system, coupling mechanism and localization system. (67)

History and evolution of shockwave lithotripter

The beginning of lithotripsy was by Dornier’s research on the pitting of the fighter
aircraft surface as they fly at high speeds approaching the sound barrier. It was due to
shock waves that created in front of droplets of moisture on aircrafts surface at these
high speeds.

At first it designed to test supersonic aircraft parts then it used in humans for the first
time in 1980. The first commercial lithotripter of the first generation lithotripter, the
Dornier HM3, became available in the United States by 1983. It based on an
electrohydraulic shockwave generator with an ellipsoid lens as a focusing system and
biplane fluoroscopy for localization, where patient should be placed in a water bath.
Despite the continuous development of the lithotripters, it is remain the standard to

which other generations are compared due to its high effect and success rate. (68)

The second and third generation lithotripters based on electromagnetic or

piezoelectric generators as shock wave generator with a silicone cushions filled with
water. Their focusing units can deliver shockwaves that are similar in power to those
of the first generation lithotripters, but usually to a smaller focal zone to minimize
damage of surrounding soft tissue. However, because of their small focal zone,
respiration movement can cause the stone to move in and out of the target zone; this
may affect stone fragmentation. Thus it can be associated with failure rates,

incomplete treatment, and the need for retreatment sessions. (69,70)

The newest versions lithotripters provide more portability and adjustability. They
often offer imaging modularity to alternate with both fluoroscopy and
ultrasonography.

• Shockwave generators

A. Electrohydraulic:

It is the original method of shockwave generation that used in the Dornier HM3 was
production of the shock wave via spark-gap technology. Where a high-voltage electric
current passes through the spark-gap electrode that located in a water container,
producing a vaporization bubble, which expands and immediately collapses rapidly to
generate a high energy shock wave which is focused by a metal reflector shaped as a

hemi-ellipsoid. (68)

The electrohydraulic generator is so effective in breaking urinary tract stones.

However, the disadvantages are the short life span of the spark-gap electrode and the

considerable pressure fluctuations from shock to shock. (71)

B. Electromagnetic:

A high electrical voltage is applied to an electromagnetic coil; two cylindrical

electrically conducting plates separated by a thin membrane of insulating material.
Passage of an electrical current through the plates generates a strong magnetic field
between them, lead to vibration movement which generates a shock wave. An

acoustic lens is used to focus the shock wave. (72,73)

Electromagnetic shock wave generators are more practical than electrohydraulic

generators because their simple design and long life span, also the procedure is less
painful because it introduces the energy into the patient's body through a large skin
surface area, but it showed an increased rate of subcapsular hematoma formation (3.1

to 3.7%) due to the small focal region of high energy. (72,73)

C. Piezoelectric:

The piezoelectric effect generates electricity via application of mechanical stress.

Piezoelectric ceramics or crystals, placed in a container filled of water, then
stimulated via high voltage electrical currents. The alternating stress changes in the
crystals create ultrasonic vibration, generate a shockwave. It characterized by its long
service life and its high focusing accuracy, in spite of its insufficient power that it may

deliver, which is not effective enough to break the stone. (71)

D. Other Generators

Clinical application of micro explosions generators, laser beam or a multistage light

gas gun have also been tried but have not widely spread.

• Focusing systems
It aims to direct the generated shockwaves at a certain focus. There are various
focusing systems depending on the shockwave generator type used. In
electrohydraulic generators; a metal reflector shaped as a hemi-ellipsoid directs the
shock wave created from the spark-gap electrode toward the focus center. In
electromagnetic systems, the generated waves are focused with either an acoustic lens
or a cylindrical reflector. In piezoelectric generators, the hemi-spherical arrangement

of the ceramic crystals directs the produced wave toward its focal point. (71,72)

• Coupling system:

In the transmission of the wave, portion of the produced energy is lost at passing
through different densities media. So it is needed to minimize energy loss of
shockwave as it passes till reach the skin. Water has a similar density to that of body
soft tissue, so the patient was immersed in a water bath in the 1st generation
lithotripters. However with development of other lithotripters, it uses a drums or

silicone cushions filled with water to provide air-free contact surface with the skin. (74)
The quality of coupling was markedly affected with air pockets covering 1.5–19% of
the coupling surface that lead to reduction in shock wave amplitude of 20%. Better
results can be obtained by delivering lithotripsy gel as a direct bolus to the coupling
head, and allowing it to spread upon contact with the skin, with minimizing the

handling of the coupling medium. (75)

• Localization systems

Stone Imaging is important to localize the stone site and focus the generated
shockwaves on it, also used to track the progress of treatment session. The two
methods commonly used to localize stones include fluoroscopy and ultrasonography.

A. Fluoroscopic localization

Fluoroscopy involves ionizing radiation to visualize stones; it is excellent for

detection radioopaque stones. However, it has no rule with detecting radiolucent
stones. To overcome this circumstance, intravenous contrast can be introduced
systemically or retrograde introduction of dye in the ureter can be performed.
Exposure of ionizing radiation to both the patient and medical staff should be taken in

consideration for high risk population. (71)

B. Ultrasonographic localization

Ultrasonographic localization allows for imaging of both radiopaque and radiolucent

stones and continuous monitoring of lithotripsy session. Although it offers the
advantage of preventing exposure to ionizing radiation. It has a limited rule in
detecting ureteral stone, especially middle and lower third stones due to interference

of intestinal loops and colonic gas destination with stone detection. (76)
C. Combined fluoroscopic and sonographic localization

Developing of Localization system with fluoroscopy for proper stone detection and
ultrasound for real time monitoring to reducing the risk of ionizing radiation

exposure. (71)

• Shock wave rate and power:

Studies on the effect of shock wave lithotripsy rate comparing slow rate (60 p/m) or
fast rate (120 p/m) on treatment outcome with renal and ureteral stones, showed that
the slow rate is associated with a significantly higher success rate at a lower number

of total shock waves compared to the fast rate. (77)

Also comparing three ESWL power strategies, were increasing output voltage from
18 to 20 and then to 22 kV every 500 shocks, decreasing output voltage from 22 to 20
and then to 18 kV every 500 shocks and maintaining a constant output voltage at 20
kV, as typically used in SWL procedures, showed that progressive increase in shock

wave output voltage can produce best results for stone fragmentation in vitro. (78)

Advances in lithotripter techniques

For the shock wave generators there are several advances under development and
evaluation. The Direx Duet (Direx Corp., Natick, MA, USA) is a dual-head
lithotripter where two shock-wave heads are installed at 72° and deliver shock waves

which meet at one focal point, either synchronous or asynchronous. (79)

Another generator system that delivers two shock waves is the tandem-pulse shock-
wave generator, where a second shock wave is formed along the same acoustic axis in

rapid succession, to drive the forceful collapse of bubbles against the stone. (80)

Also wide-focus low pressure lithotripters showed high efficiency reaching the
original Dornier HM3, they become commercially available: Lithospace (Jena,

Germany), Lithogold (Konostans, Germany), XX-ES (Xi Xin, China). (81)

Some modern lithotripters have their ability to switch between different focal sizes.
For example, in the Storz Modulith® SLX-F2 (Storz-Medical, Kreuzlingen,
Switzerland) and the PiezoLith 3000 (Richard Wolf, Knittlingen, Germany). This
allows an adjustment of the shock wave, with a wider focus for multiple, larger and

rather soft stones, and a smaller focus for smaller and harder stones. (82)

For stone location and imaging, new lithotripters are equipped with both fluoroscopy
(71)
and US to combine the advantages of both imaging methods. Plus adding of
optical or acoustic tracking systems, which facilitate stone targeting and reduce X-ray

exposure. (82)

Stone fragmentation mechanism during ESWL

A stone is fragmented when the shockwaves force exceeds the tensile strength of the
stone. Although stone fragmentation occurs through a combination of various
methods, including compressive and tensile forces, erosion, shearing, spalling, and
cavitation. Of these various forces, the generation of compressive and tensile forces

and cavitation are thought to be the most effective forces. (68,83)

When a shockwave is transmitted through water, it loses very little energy until it
reaches a different density medium. If the medium is denser, compressive forces are
generated in the new medium. But, if the new medium is less dense, tensile stress is
generated in the first medium. When the shock waves are hitting the anterior surface
of a stone, the change in density creates compressive forces, causing stone
fragmentation. As the wave proceeds through the stone to the posterior surface of the
stone, the change from high to low density reflects part of the shockwave’s energy,

producing tensile forces, which again disintegrate and fragment the stone. (83)

In cavitation, shockwave energy directed at a focal point leads to failure of the liquid
with generation of water vapor bubbles. These gaseous bubbles collapse rapidly,
creating a negative pressure that fracture and erode the calculus. This process can be
monitored with real-time ultrasonography during the treatment and appears as

swirling fragments and liquid in the focal zone. (83)

Indications of ESWL: (84)

The indications for intervention with ESWL for upper third ureteral stones includes :-

1. Failure of medical treatment in stone passage with increasing stone size.

2. Patients in whom the stones are associated with obstruction, refractory

attacks of pain, urinary tract infection, or significant hematuria.

3. Patients with hypertension, diabetes, or other medical conditions that

predispose to renal insufficiency.

4. Presence of stone in accessible site at localization system.

Contraindications of ESWL

A. Absolute contraindications: (85)

1- Active urinary tract infection or urosepsis must be treated before ESWL.

2- Uncorrected bleeding disorders or coagulopathies.

3- Pregnancy.

4- Uncorrected obstruction distal to the stone.

B. Relative contraindications: (85,86)

1- Morbid obesity and orthopedic or spinal deformities may prevent proper

positioning.

2- Ectopic kidney or malformations, such as: horseshoe kidneys and pelvic

kidneys.

3- Poorly controlled hypertension, due to increased bleeding risk.

4- Gastrointestinal disorders: In rare condition, these may be exacerbated

after ESWL treatment.

5- Renal insufficiency: Stone free rates in patients with renal impairment are
around 57%, were patients with better renal function show stone free rates
reaching 66%.
- Preexisting pulmonary and cardiac problems are not contraindications. In patients
with a history of cardiac arrhythmias, the shockwave can be linked to
electrocardiography (ECG) for early detection of any arrhythmias. Gated lithotripsy
can be done where firing wave only on the R wave in the cardiac cycle,

simultaneously with the refractory period of the cardiac. (87)

- Cardiac pacemakers are also not contraindicated, although consulting the

cardiologist for possible changes to pacemaker settings would be considered.

- Oral anticoagulants such as warfarin should be stopped. Platelet function is return to

the normal level by stopping aspirin containing products seven days before ESWL. (88)

- ESWL is not contraindicated in young children and elderly. (85)

Factors affecting the outcome of extracorporeal shockwave

lithotripsy (ESWL)

:I. Stone factors

a- Stone size

ESWL success rate significant decreases with stone size more than 2 cm
( stone free rate < 50%), and the need for retreatment sessions and adjunct
therapy increases. Also ESWL efficiency also decreases with very small
stones because it is more difficult radiologically to locate it. Pre-ESWL
stenting can be taken in consideration with large stone burden patients, it may

prevent obstructive urosepsis. (84)

b- Stone composition

Radiolucent stones like uric acid stones can't be located under fluoroscopy and
it can be imaged by either ultrasonography localization system or the addition
of retrograde or intravenous contrast induction.
 The stone density is a main factor to detect stone response either fragmented
or to resist ESWL. It mainly based on stone composition; stones composed of
calcium oxalate dehydrate and magnesium ammonium phosphate tend to be
softer and to respond well with ESWL session. On the other side, Stones
composed of calcium oxalate monohydrate or cystine stones are resist ESWL.
This can be predicted with measuring Hounsfield units on CT scan; ESWL is
more effective in stones with Hounsfield units [HU] less than 815 HU than

those with a higher values. (89)

c- Stone location:

Stone location is an important factor in assessing the likelihood of spontaneous

gravels passage after the session as well as in determining the success rate.
Accurate investigation is needed to line the course of ureter, showing any
anomalies or kinks. In general, fragmentation of upper third stones is more
effective than mid or distal stones. The stone-free rate for ESWL for proximal

ureteral stones overall was 83%. (84)

:II. Patient factors

a- Obesity

Several studies have showed that obesity, whether measured by body mass
index or skin to stone distance, negatively affects the effectiveness of ESWL.
The proximal ureter is farther from the skin of the flank than the kidney, so the
ability to get the stone within the focal zone of the lithotripter and deliver the
maximum energy is even more limited in ureteral compared with renal stone
patients.Skin to stone distance can be easily measured on CT scan; distance
more than 10cm has been showed to decrease ESWL success and efficiency.
(90)

b- Abnormal Anatomy
 Abnormal anatomy as ureteral ectopia, ureteroceles, megaureters and strictures
may affect the success rate of ESWL, in compare to those with normal ureteral
anatomy. The anatomic abnormality may need to be corrected before

fragmentation to permit successful drainage of ureteral stones. (84)

c- Medical condition and anesthesia type

— Most urologists prefer regional or local anesthesia. ESWL can often be

performed under intravenous sedation or general anathesia, although some
studies suggest that clinical outcomes are improved with general anathesia
compared with intravenous sedation as success rate of 87% vs 55%

respectively, due to decreased patient and kidney motion. (91)

:III. Technical Factors

The ESWL device type, Proper acoustic coupling, shock wave rate, number of
shock waves, energy setting, careful imaging control of localization and pain
control are affecting the ESWL outcome.

Complications after ESWL:

A. Renal complications

1. Bacteriuria

It occurs in 7.7-23.5% of patients post extracorporeal shockwave lithotripsy

and is more likely to develop in patients with infection rstones. Bacteremia
develops in up to 14% of patients, with less than 1% developing clinical
sepsis. IV antibiotics may be recommended as a pre-session medication in

patients with recurrent infection related stones and positive urine cultures. (92)

2. Hematuria and hematomas formation

Hematuria is usually mild and transient condition. In case of significant gross

hematuria with clots, urgent imaging of the kidneys should be done to exclude

a perinephric hematoma formation. (93)

 Perinephric, subcapsular, or intranephric hematomas can be presented with
severe attacks of pain, ileus, hypotension and shock. So any unexplained
severe pain or any unusual drop in blood pressure, you first should exclude
hematomas formation. Post ESWL hematoma mostly resolved with supportive
care, bed rest and blood transfusions. Multiple transfusions, arteriography and
selective embolization should be considered if it wasn't controlled by

supportive means. (93)

3. Pain or discomfort: occurs due to the passage of stone fragments. (92)

4. Steinstrasse or ''Stone Street''

The overall rate of steinstrasse occur post ESWL is 1-4%, with the rate
significantly increased for large stone burdens, it reaches 10% for stone
burdens >2 cm and approximately 40% for complete staghorn stone after

ESWL. (94)

Steinstrasse may be:- (94)

 1- Simple steinstrasse: column of stone fragments less than 5 cm in length, and

patient has no evidence of urosepsis; in this case it can be managed
conservatively. But if fragments fail to pass within 3-4 weeks or if patients
develop significant symptoms or definite obstruction, it must be effectively
managed by ureteroscopy and guide wire should pass beyond the obstruction.
If guide wire didn’t pass, uretroscopic procedure should be aborted because
the high risk of ureteral perforation. In this case ESWL insitu to the obstructed
region of the ureter and antegrade endoscopic techniques should be
considered.

 2- Complex steinstrasse: column of stone fragments more than 5 cm or there

are signs of urosepsis; so it is a more serious problem with a higher risk of
ureteral injury with ureteroscopy.
  3- Complicated steinstrasse: best managed with urgent percutaneous
nephrostomy drainage with appropriate antibiotic coverage, followed by
staged endoscopic removal of stone fragments.

5. Renal atrophy:

it is uncommon; it may occur in patients with renal vascular, parenchymal

disease or severe atherosclerotic disease. However, studies of ESWL in
patients with a single functioning kidney have shown no definite statistical

evidence of renal function deterioration secondary to ESWL therapy. (95)

B. General complications

1. Hypertension it is an uncommon complication, but may occur in patient

with paper like parenchyma kidney, also may occur with older patients with
abnormal renal function, they may develop hypertension within 26 months

after the ESWL session. (92)

2. Diabetes mellitus it is an uncommon complication, but may occur due to

injury to pancreatic islet cells by the shock waves on the right sided stones. (96)

3. Other rare complications as: Pulmonary contusion, Pancreatitis and Splenic

or hepatic hematoma, transient elevation of liver enzymes and biliary colic

with biliary stones fragmentation. (92)

III. Ureteroscopic management of stone upper third ureter

History and evolution of Ureteroscopes

The application of endoscopy for first time was to visualize the urinary bladder in
1912 when Hugh Hampton Young unintentionally introduced a 12F pediatric
cystoscope into a massively dilated right ureter of a child who had posterior urethral
valves and found himself gazing at the renal pelvis and became the first urologist to
view the calices endoscopically, and then the progression to visualize upper urinary
tract started. (97)

Management of distal ureteral stones was the first common use of rod-lens
endoscopy. The era of rigid ureteroscopes started by progression of the rod-lens
imaging to fiberoptic imaging with smaller diameter to cause less trauma. By 1989,
the fiberoptic based rigid endoscopes diameters reach 7F, that allowed it to reach the
distal ureter under direct vision without a vigorous balloon dilatation. Pneumatic and
laser lithotripter are added to facilitate distal ureteral stones management.

The first application of flexible ureteroscopy was by Marshall in 1964 manufactured

by Pelham Manor, NY. He started by a 9F flexible endoscope to visualize an
 impacted ureteral stone. These first flexible ureteroscopes used only as a diagnostic
tool, it didn't have a working channel with no method to control its direction. (98,99) 

The addition of first guide tube facilitated introduction of the flexible ureteroscopy
and irrigation fluid passage to displace the ureteral mucosa and debris away from the
endoscopic lens for better visualization. Flexible ureteroscopy was better alternative
(98,99)
to rigid ureteroscopy in case of proximal ureter and intrarenal stones.  

In 1980, major improvements were applied to improve the flexible fiberoptic

ureteroscope. Addition of a working channel to allow irrigation fluid to pass through
the endoscope. Also, active tip deflection was added to direct the endoscopy to areas
of need with improvement altering the stiffness of the ureteroscopy shaft. In 1990, a
10F outer diameter, a standard 3.6F working channel, and unidirectional active tip
deflection flexible ureteroscopy with direct guidewire used in inspection of the
intrarenal collecting system and the ureter. (100)

In 2001 the application of small diameter flexible ureteroscope 8F in diameter, a

standard 3.6F working channel for irrigation and accessory instruments allow better
therapeutic and diagnostic efficacy of ureteroscopy into the upper urinary tract
without intramural dilation.

Replacement of fiberoptics with the digital imaging endoscopes provides better

visualization with high clarity equivalent to ten times the pixel resolution of standard
fiberoptic endoscopes. These endoscopes have an integrated light source and distal
digital chip-based camera, no need for a separate camera head or light cord, they may
potentially be more durable. (101)

Flexible ureteroscopy: mechanics and instrumentation

The flexible endoscope divided anatomically into 3 portions: the control body,
insertion tube and actively deflecting tip.

- The control body of the endoscope is the wide upper portion that houses the
objective lens or video system, deflection lever, entry access to the working irrigation
port and light cable or cable attachment post.
- The insertion tube runs from the control body to the deflecting tip and houses the
illumination system, optical bundle, working irrigation channel and deflecting
mechanism.

- The deflecting tip, usually the distal 3 cm of the insertion tube, allows for active
curvature of the tip. The tip of the endoscope contains the very fragile lenses covering
the illumination bundle and optical bundle. Active movement of the tip of the
endoscope is controlled via the deflecting mechanism. (102)

Figure (11): Three anatomical divisions of modern flexible endoscope. A-actively deflecting
(102)
tip. B-insertion tube. C-control body

The optical system formed by fiberoptic light fibers, fibers are form molten glass that
covered with a second layer of a different refractive index glass to improve the
internal reflection and light transmission. Splitting of the distal light bundle provide a
better light distribution with a more centered working channel. Also small lenses are
placed proximally and distally to provide wide field of view and proper image

magnification. (103)

The deflection mechanism of the flexible ureteroscope allows a wide look within the
collecting system of the kidney. This mechanism is operated manually, where
manipulating the lever will deflect the tip through several wires running down the
length of the endoscope and attached to a lever. The current endoscopes have
increased defelection degree upward and downward up to 270 degrees with a

continuous controlled dual to allow maximum movement. (104)

All current endoscopes have a working channel of at least 3.6 Fr. It allows the
performer to place under direct vision of a various accessories, such as: graspers,
baskets, wires and laser fibers through the endoscope beside the irrigation fluid. All
these equipment composed of polymer material to allow high grade deflection and
durability. (105)

Normal saline is the standard irrigation fluid solution in ureteroscopic lithotripsy.

Irrigation fluids are needed to clear the visual field and cool the tip of energy
delivering devices. Fluid passes through the same working channel, controlled by a
side arm. Ideally, the intrarenal pressure should be less than 30 cm H2O. Over
distention of the intrarenal collecting system may be the cause of significant
postoperative pain experienced by some patients. (106)

Incorrect use of holmium laser leads to damage of the working channel, when the
fiber firing end is located too close to the ureterscopy tip. The new generation
endoscopes add bead-like ceramic rings at the tip of the working channel for 1.5 cm to
protect it from the thermal damage.

Flexible ureteroscopy durability is a matter of discussion, is affected by the number of

surgical procedures, the difficulty of the procedure, the experience of the surgeon and
the method of sterilization. Majority of flexible ureteroscopes need major repair after
12 -15 endoscope usages or 13 hour of usage. Newer generations show a less
frequently repair rate, especially when it used by an experienced endourologist. (107)

Figure (12): DUR8-Elite flexible

ureterorenoscope, first instrument that
incorporates secondary active deflection.
(113)

Equipments
Most endoscopic instruments are covered with a polymer sheath. Over time, these
sheath diameters have become small enough to permit passage through the typical
3.6F working channels of flexible ureteroscopy.

1- Guidewires:
Most are around 150 cm in length, shorter wires are not recommended because

of the longer length of flexible ureteroscopy. (108)

a- Standard 0.035 and/or 0.038 inch polytetrafluoroethylene (PTFE) wires

with floppy tips “double-floppy”.
b- The Terumo Glide wire: Purely hydrophilic wires with curved or
straight tips are particularly useful in cases of difficult ureteral access. It
is employed as an access guide wire and not a working guide wire.
c- “Hybrid” Sensor guide wires with smooth hydrophilic nitinol based
distal tip that are curved or straight with stiffer, non-hydrophilic kink-
resistant shafts made of nitinol alloy core (and thus easier to handle) and
PTFE-coated stainless steel jacket which adds stiffness and helps
prevent endoscope buckling during endoscope placement into the ureter.
d- “Extra-stiff” PTFE wires: PTFE guide wire and the Zebra wire (PTFE
coated with nitinol core) are useful to help facilitate endoscope tip access

to the ureter in routine cases. (108)

2- Ureteral stents:

Polyurethane ureteral stent is preferred to allow a greater inner to outer

diameter ratio, increasing luminal urine flow and the greater strength material

permit passage over larger guidewires. (109)

3- Ureteral access sheath: (110,111,112)

Many urologists feel that ureteral access sheaths 12-14 F, particularly with
kink-free, hydrophilic designs, greatly facilitate flexible ureteroscopy.
Advantages:
1. Allow better drainage and lower renal pelvis pressure.
 2. Easier to insert and remove the flexible ureteroscopy.
3. it may increase lifespan and durability of the flexible ureteroscopy.
4. May shorten time of URS procedure.
5. Newer sheaths have second channels for wires or irrigation.
Disadvantages:
1. Costly to buy.
2. May cause injury of the ureter.
3. May be difficult to insert, particularly in smaller caliber ureters.
4. The inner diameter of the sheath (generally 10F or 12F) limits the
size of stones that can be extracted to 2 or 3mm in size.

The access sheath consists of two components: an inner obturator and an outer
cannula (sheath), both of which are advanced into the upper tract over a
preplaced ureteral guidewire. The outer sheath is 2F larger in diameter than the
inner obturator and is packaged as a unit according to the diameter of the
obturator/sheath and length of the outer sheath. The outer sheath has a locking
mechanism that attaches to the lock hub of the inner obturator, allowing the

sheath and obturator to move as a single unit. (113)

The 12/14-F access sheath is typically used for most ureteroscopic
procedures, as it provides excellent irrigant flow and is generally easy to

advance through the ureter in an a traumatic manner. (113)

Figure (13): Ureteral access sheath showing the lock hub mechanism.
4- Lithotripsy devices:

Several types of intracorporeal lithotripters can be used for the management of

ureteric stone, including pneumatic lithotripsy, electrohydraulic lithotripsy,

ultrasonic lithotripsy and laser lithotripsy.(108)

Laser lithotripsy

Many laser types can be used in various urological procedures. Holmium: yittrium-
aluminum-garnet (Ho:YAG) laser, neodymium: yittrium -aluminum-
garnet(Nd:YAG)laser, KTP (KTP)laser, indigo laser and carbon dioxide(CO2)laser.
(99)

The Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) Laser

It is the most commonly used laser in the treatment of urinary calculi as it is effective
for all stone compositions. It also produces small fragments compared to other
devices which can pass more easily in the ureter. Its wave length of 2,120 nm is very
near the absorption peak of water (1,910 nm). So it can be used for stone
fragmentation with a tissue-based applications, since both contain significant amounts
of water If fired directly onto mucosa, the holmium laser has a minor penetration
depth of 0.5 mm, thus limiting mucosal injury. The holmium laser generator is highly
cost device, but there are less expensive, low-power versions, which yield up to 20 W

of power, sufficient for most laser applications, except prostate inoculation. (114)

Laser fibers are used to transfer the laser energy from the generator to the target
lesion, mainly from silica to provide flexibility, durability and are bio-compatibility.
The fibers are relatively inexpensive and, despite being used as disposable fibers in
many centers, can be reused after appropriate re-sterilization.

The fibers may be:

- End-firing where the laser energy emerges from the tip of the fiber parallel to the
length of the fiber.
- Side-firing where the laser energy emerges at an angle to the length of the laser
fiber.
- Radially diffusing where the laser energy emerges at multiple angles from the fiber
radially.

The diameters of the fibers range from 200 to 1,000 µm, and allow for reasonably
precise aiming of the laser energy, in which the smallest diameter laser fiber (200
micron) helps to preform complete tip deflection. The vaporization bubble produced
when this laser energy is delivered in a water-based irrigant increases significantly
with larger fiber diameters. The 365 micron fiber more efficiently clears stone, with a

high durability, but the stiffer nature of this fiber limits its deflection. (112)

The holmium laser has two mode of actions either pulsated in which the laser energy
is released intermittently in a series of pulses, or continuously in which emit laser

energy continuously. It used primarily as a pulsed option. (112)

Holmium lasers achieve their effects on urinary calculi via photo-mechanical and
photo-thermal effects, which result in more controlled lithotripsy with less stone
movement during laser energy application. This, however, results in a drilling action
on large stones, which causes the stone to be whittled down rather than broken into
multiple pieces. This can sometimes be time-consuming, especially with larger stones.
(115)

Figure (14):
Holmium:YAG LASER
lithotripsy device and
fibers.

• The advantages of holmium laser lithotripsy

1. It can transmit its energy through a flexible fiber, which provides a high mobility.
2. Its ability to fragment all types of stones regardless of composition.
3. One of the safest, most effective, and most versatile intracorporeal lithotripters.
4. It provides us with a significant small stones fragments compared with other
lithotripters.
5. It produces a reasonable shockwave, which reduces possibility of stone retropulsion

in compared with pneumatic lithotrities. (116)

• The disadvantages of holmium laser lithotripsy

1. High cost of the device and laser fibers.

2. Cyanide is produced by a photo-thermal mechanism during holmium laser

lithotripsy of uric acid calculi, Cyanide lead to inhibition of the mitochondrial enzyme
that get the cells through histotoxic hypoxic  state, but the amount of cyanide

produced is clinically insignificant. (117)

5- Stone Extraction Devices: (102,108)

a- Endoscopic graspers: two and three-pronged grasping forceps (3Fr.) - rat
tooth or alligator forceps.
b- Ureteroscopic baskets: it varieties include helical, double-helical, tipless,
and parachute designs. Also it differs in the number of wires as 3, 4, 5 or 6
wires.
c- The Dretler stone cone and the Cook N-Trap.

6- Balloons:
Small dilating balloons with a 3F shaft and an inflated diameter of 4mm can
be passed up the ureteroscopy under direct vision for dilatation of tight areas.
These utilize a very fine 0.018 inch guidewire.

a b
 c d

Figure (15): a- Three-pronged rat tooth forceps b- Tipless 4 wires ureteroscopic balloon

c- The Dretler stone cone d- The Cook N-Trap

Indications of flexible ureteroscopic laser lithotripsy: (118,119)

Recent studies have demonstrated that ureterscopy and holmium laser lithotripsy is
highly efficient even for upper third ureter stones.

There are specific indications favoring the ureteroscopic approach:

1- ESWL failure.
2- Morbid obesity.
3- Musculoskeletal deformities.
4- Bleeding diathesis.
Contraindications of flexible ureteroscopic laser lithotripsy: (118,119)

1- Active urinary tract infections should have been treated preoperatively.

2- Coagulopathy should have been treated if possible. If intervention is

urgent, necessary and blood coagulation cannot be improved, complication
rate of ureterscopy is lower than of ESWL.
3- Pregnancy is a relative contraindication. It has been demonstrated as safe
even during pregnancy.

Complications of flexible ureteroscopic laser lithotripsy:

1. Minor intraoperative complications:

A- Bleeding:

When bleeding occurs, it can alter vision clarity making the procedure much
more difficult. It can be improved by proper irrigation, which can be
achieved by pressurized irrigation, the use of access sheath and the smallest

caliber instruments. (120)

By laser or a 2.4F ball tip electrocautery electrode a small bleeding vessels

can be controlled. If it continues, a stent ( double j stent) should be placed
and postpone the procedure. Embolization of the feeding artery or open

exploration can be a choice, if a significant uncontrolled bleeding occurs. (120)

B- Proximal stone migration: (121)

Retrograde stone migration during ureteroscopic lithotripsy occurs in 5%-

40% of cases and occurs mainly with small stones in the presence of
proximal dilatation. There are several techniques can be used to minimize it

1) Reverse trendelenberg position of the operating table.

 2) Decreasing the irrigation pres.sure force during stone fragmentation.

3) Hold the stone against the posterior ureteric wall during the lithotripsy.

5) the use one of the ureteric occlusion devices.

6) If retrograde migration occurs, the stone can be pulled distally in the ureter
using graspers, then continue lithotripsy afterwards.

C-Thermal injury:

It can cause thermal injury and perforation to the ureter that cause delayed
fibrosis and stricture formation. Adequate irrigation is critical to allow

cooling and prevent thermal injury. (118)

D- Irrigation back flow:

Fluid absorption and the pyelovenous backflow should be taken with

consideration, however fluid absorption during ureteroscopy has been shown
to be 1ml per minute. Increase renal pelvis pressure by any form of high
pressure irrigation and prolonged exposure of the kidney to high pressures
(200mmHg or more) can lead to forniceal rupture, fluid extravasation,
subcapsular hematoma, and renal scarring. To minimize renal pelvic pressure
adequate bladder drainage should be maintained, and use of ureteral access

sheaths can help. (122)

2. Major intraoperative complications:

A- Ureteral perforation:

It can be either interruption of the mucosal continuity or by the appearance of

periureteral fat, that occurs by forceful manipulation of impacted large stones
in case of ureteric stricture after previous surgery or radiation therapy, or
improper introduction of the ureteroscopy that is more common with the

semi rigid more than the flexible ureteroscopy. (123)

periureteral urinoma formation or other fluid collections must be considered

in the patient with persistent postoperative fever and colic, ultrasonography

or CT studies can measure and localize the collection. (123)

Perforation with stone migration into the defect may occur in 0.5–1% of
ureteroscopic cases and leads to formation of a stone granuloma and ureteral
wall stricture. No attempt should be made to grab the stone through the
perforation because these will worse and enlarge the perforation.

In general, with large perforations of the ureter, the procedure should be

aborted and ureteric stent should be inserted using the safety guidewire. The
stent remains 3-6 weeks with proper antibiotics and an abdominal ultrasound
and IVU should be done one month after removal of the stent for follow up

to detect stricture formation and hydronephrosis. (124)

Double J stent is routinely recommended in case of unusual difficulty or false

passages and mucosal tears up to full thickness mucosal injuries. Stenting for

3 weeks will significantly facilitate the next ureteroscopy session. (124)

B- Ureteral avulsion:

Ureteral avulsion is a rare complication and it is probably the most

catastrophic injury. It was more common in the early ureteroscopy era and
blind basketing. It may occur due to forceful extraction of large stone in one
piece without access sheath or using stone basket in the upper third of the
ureter because the proximal ureter has less muscle support and contains a
thinner lining of mucosal cells than the distal ureter. Stones must be
fragmented in to small particles enough to pass spontaneously or be extracted
smoothly by a basket inserted through the ureteroscope on a safety guide
wire.
 Ureteroureterostomy or ureteroneocystotomy repair with a psoas hitch or a
Boari bladder wall flap can be performed either at time of the injury or in a
staged repair operation after proximal percutaneous drainage. Alternative
therapy is based on either ileal ureter or renal auto transplantation to a pelvic

position. (125,126)

Figure (16): Ureteral avulsion during

basket extraction of ureteric stone. (129)

C- Complications related to ureteroscopic techniques and equipments: (107)

- Damage of the ureteroscope itself:

Flexible ureteroscopes are delicate, expensive and extremely fragile
devices. Periodic repair should be done every 15 cases or 13 hours of
usage to extend its durability with maximum benefit. Gentle care and
handling should be used at all times, particularly at the end of the
procedure.
- Mucosal injury due to forced introduction of the access sheath.
- Entrapped stone baskets or disruption of one of the basket wires.

3. Postoperative complications:

Early postoperative complications:

A- Renal colic:

It is one of the common complications occurs in 3.5 to 9 % of postoperative

cases and may be the result of transient obstruction from ureteric edema,
 clots, or stone fragments. It usually managed by good hydration and
analgesic as a conservative treatment. If the colic persists for more than 48

hours, proper imaging should be done with possibility of ureteric stent. (125)

B- Infection:

Low grade fever occurs in 6.9% of postoperative cases, but significant

infection, bacteremia and sepsis is rare and occurs in 0.3 to 1.3% of patients.
This can be significantly reduced by administration of perioperative
antibiotics and proper intravenous postoperative antibiotic. If it persists with

no improvement on medical treatment, proper drainage should be done. (125)

C- Bleeding:

It is very rare postoperative complication( less than 0.5%) and may occur
from mucosal tears or due to penetration of the ureteric catheter to one calyx.
Usually it is self-limiting and rarely requires haemostatics or blood
transfusion. Open surgery may be necessary if bleeding become life

threatening. (125)

Late postoperative complications:

A- Ureteral stricture:

It occurs in 2 to 4% of patients, more common in high risk patients who have

history of previous retroperitoneal surgery or pelvic radiation; the main
reasons for these strictures include previous stone impaction, mechanical
trauma, urinary extravasation, ureteral ischemia, and thermal injury. It can be

detected by routine postoperative imaging for high risk. (127, 128)

Factors affecting the outcome of endourologic management of a ureteral
stricture include the length of the stricture and the amount of passed time.
Strictures which are present for less than three months have been associated
with up to a 91 % successful repair rate while those which have been present
for greater than three months do not respond as well, mostly due to a

compromised vascular supply from the progressive fibrosis. (127, 128)

 Balloon dilatation has been reported to be successful in management of an
82% of ureteral strictures located beneath the ureteropelvic junction,
providing that the length of stricture was less than 1 cm. long standing
strictures were not successfully managed with this technique. A combination
of ureteral dilatation and cold knife endoscopic incision has also been

successful. (127)
Strictures which are long or those which do not respond to endourologic
techniques can be treated with open reconstructions associated with a psoas

hitch, Boari flap, ileal interposition or autotransplantation. (128)

B- Ureteral meatal stenosis:

Ureteral meatal stenosis is another late complication that can be managed by

either balloon dilatation or ureteral meatotomy. If these techniques failed in
opening the orifice, a percutaneous nephrostomy can be performed with the
passage of a guidewire, then ureteral balloon dilatation can be performed in a
retrograde fashion. If these modalities fail, ureteroneocystotomy is the

treatment of choice. (130)

C- Vesico - ureteric reflux (VUR):

The development of late reflux following flexible ureteroscopy does not

appear to be significant. Reflux has been shown to develop in only few
patients, and when it does occur, it is only low grade and complete resolution

of reflux occurs within 2 weeks postoperatively. (131)

IV. Laparoscopic uretrolithotomy

Both transperitoneal and retroperitoneal approaches have been used for laparoscopic
ureterolithotomy. A transperitoneal route provides a wider working space, a better
view and clearer anatomical landmarks as compared with a retroperitoneal approach.
However, the retroperitoneal approach has several advantages over the transperitoneal
 approach, such as no need to mobilize the colon, and a low risk of visceral organ

injury, beside it is also associated with a shorter period of convalescence. (132)

Laparoscopy should be considered with large stones ( more than 2 cm) which cannot
be accessed ureteroscopically or cannot be fragmented and patient refuses the open

surgical removal of a ureteral calculus. (133)

V. Percutaneous Antegrade Ureteroscopy

Percutaneous antegrade ureteroscopic access is a viable treatment alternative for

upper ureteral stones, in cases where ureteroscopic management is not possible. This
approach using flexible ureteroscopy combined with laser lithotripsy usually comes
with a high stone free rate, but may be accompanied by significant complications and

increased fluoroscopy exposure. (134)

VI. Open Uretrolithotomy

It is seldom performed since the advent of endourology and the introduction of shock
wave lithotripsy. (135)

Open ureterolithotomy may be associated with a greater morbidity, longer

hospitalization, blood loss and wound complications. So, endourologic solution for
ureteral stones is greatly favored. (135)

Patients and Methods

I. Type of the study:
This is a prospective randomized comparative study between extracorporeal
shock wave lithotripsy and flexible ureteroscopic laser lithotripsy in the treatment

of proximal ureteral stones that can be defined as stones up to 2 cm located in the

lumbar ureter between the ureteropelvic junction to the upper border of sacroiliac
joint.
 The study included thirty patients admitted to Tanta Urology Department
suffer from proximal ureteral stones during the period from February 2016 to
October 2016.

II. Patients:
Grouping of patients

Thirty patients included in this study and they randomly divided into two
groups (Even–odd randomization):

Group A (Flexible ureteroscopy group - 15 patients)

Fifteen patients underwent holmium laser lithotripsy using flexible

ureteroscopy (KARL STORZ 8 Fr., Germany).

Group B (ESWL group - 15 patients)

Fifteen patients underwent extracorporeal shock wave lithotripsy (Dornier Compact

Delta II lithotripter, Germany).

Patient selection

Inclusion criteria:

 Adult patient.
 Solitary proximal ureteric stone.
 Radioopaque stones.
 Stone size up to 2 cm.
Exclusion criteria:
 Upper ureteral stones larger than 2 cm or smaller than 0.5 cm.
 Radiolucent stones.
 Multiple upper ureteral stones.
 Children.
 Active Urinary tract infection.
 Bleeding diathesis.
 Distal ureteric obstruction.
  Renal insufficiency.
 Pregnancy.
 Morbid obesity.

 Written informed consent obtained from all patients after full explanation of
the benefits and risks of each procedure.

 There was a code number for each patient's file that includes all data and
investigations so they was confidential and private.

 The participation was voluntary and the patient can discontinue participation at
any time without penalty or loss of benefits.

 Any unexpected risks appeared during the course of the research cleared to the
participants and the ethical committee on time.

 Data tabulated and statistically analyzed.

Patient evaluation:

All patients were preoperatively evaluated by:

Complete history taking including:
 Full personal history (name, age, sex ... etc.)
 Complaint.
 History of present illness (pain, hematuria … etc.)
 Past history (diabetes mellitus, hypertension, stone passage,
bilharziasis, previous intervention (surgery or endoscopic ...etc.)
 Family history (stone disease and malignancy...etc.)

Examination including:
 General examination (temperature, pulse, blood pressure,
respiratory rate ...etc.)
 Examination of chest, heart, abdomen and lower limbs.
  Local urological examination including abdominal, digital rectal
and external genitalia examination.

Laboratory investigations including:

 Routine urine analysis.
 Culture and sensitivity when indicated.
 Renal function tests (urea and creatinine).
 Coagulation profile.
 Complete blood count (CBC).
 Fasting and postprandial blood sugar.

Radiological evaluation including:

 Spiral non contrast CT abdomen and pelvis.
 Plain urinary tract to assess stone site, size and radiopacity.
 Intravenous urography (IVU) when indicated.

III. Methods:

(Flexible ureteroscopic laser lithotripsy group)

The patients are treated by flexible ureteroscopic laser lithotripsy, after discussing the
benefits of the procedure, the associated risks and complications. Also patients signed
an informed consent before starting the procedure.

The Steps:
Preoperative Preparation including

 Preoperative intravenous antibiotics administration for a single dose of

broad spectrum parental antibiotics (third generation cephalosporin) for
all patients one hour prior to the procedure.

The procedure:

1. Anesthesia: spinal or general anesthesia can be used. In our study general

anesthesia is preferred in all cases because it prevents patient movement, provides
a stable controlled environment, and allows the surgeon to take as much time as
required to perform the procedure in a safe manner.

2. Positioning of the Patient: the patient is typically positioned in the lithotomy

position, C-arm fluoroscopy was available.

3. Sterilization of the genitalia and toweling was done before the procedure.

4. Visualizing urethro-Cystoscopy and guide wire insertion.

Visualizing cystoscopy with the semi-rigid cystosope (KARL STORZ 22F.,

Germany) is performed to identify the ureteric orifice. If identification was
difficult, methylene blue injected intravenous. The next step was insertion of a
guidewire under fluoroscopic assistance into the renal pelvis. Also, if the initial
wire used is hydrophilic coated, it changed it to a PTFE (Teflon) 0.036 inch
coated or nonhydrophilic wire, as the hydrophilic wires have a tendency to
migrate rapidly out of the upper urinary tract and are often not practical for stent
placement. Changing a wire accomplished by passing an open ended catheter over
the hydrophilic wire, allowing it to be removed without losing access to the renal
pelvis. Then in most cases a retrograde ureteropyelography was done to determine
the upper tract anatomy and to reduce the chance of complications or failure to
detect the stone. Two wires placed into the renal pelvis; one wire is the working
wire, used for the passage of the ureteroscopy into the renal pelvis. The other wire
is a safety wire, which provides continuous access to the kidney if difficulties
arise.
 Figure (17): a- Urethra visualization by cystoscopy b- Ureteric orifice detection
c- Guide wire insertion through silicone open tip

5. Ureteral dilatation:

Ureteral dilation performed by dilating balloons in one case with a tight ureteric
orifice and sequential hydrophilic ureteral dilators, which are passed over the
guidewire or passage of the semi-rigid ureteroscopy.

6. Ureteral access sheath insertion:

A ureteral access sheath was inserted over the wire to facilitate multiple
withdrawals and reinsertions of the flexible ureteroscopy. The safety lock that is
found on the distal end of the sheath tightly locked. The surgeon must be mindful
of the length of the inner obturator that extends several centimeters beyond the
outer sheath. The access sheath is removed under direct vision to allow the
surgeon to inspect the mucosa for perforations or bleeding.

Figure (18): Insertion of ureteric access sheath under fluoroscopic assistance

7. Irrigation mechanism:
It is important for proper visualizing field and to cool the tip of energy delivering
devices. Normal saline at body temperature was the irrigation fluid of choice that
we used in flexible ureteroscopic laser lithotripsy. Using the control-pump syringe
technique has the advantage of allowing increased direct pressure at critical times
of the operation inspite of the need for an assistant to operate the devices.

8. Flexible ureteroscopy insertion:

Insertion of flexible ureteroscopy (Karl Storz 8 Fr.) up to the ureter after

adjustment of the focus done with two persons (the urologist and an assistant)
under fluoroscopic guidance. Stabilizing the end of the guidewire and fix it in a
straight position with tension without actually pulling the wire down is important
in facilitating smooth passage of the ureteroscope. Hold the ureteroscope with the
dominant hand, with the thumb on the active deflector lever. The other hand
stabilizes the shaft of the ureteroscope.

Figure (19): Insertion of Flexible URS through the Ureteral access sheath
9. Disintegration of the stone by Holmium:YAG laser:

A 200-µm holmium laser fiber was used; it is most effective if the fiber tip is in
contact with the stone surface, where the energy is transmitted directly to the stone
surface. The settings (VersaPulse PowerSuite 100W, Lumenis) adjusted on 0.6 J
pulse energy at a rate of 6 to 8 Hz. The pulse energy can be raised up to 0.8 J or
1.0 J for tough stones, and the frequency can be increased up to 20 Hz if
necessary. The fiber tip should be visualized few millimeters away from the tip of
the ureteroscope before firing the laser. Firing while the fiber tip within or close to
the ureteroscope will destroy it.
 Figure (20): . Disintegration of the stone by Holmium:YAG laser

If slightly larger stone gravels will not pass into the access sheath, the stone basket
(Zero Tip Nitinol Stone Basket 3 F., Boston Scientific, USA) can be used in a
retrograde manner. The stone basket is controlled via a plastic handle at the
proximal end which may be fixed to the basket, or detachable that enables the
surgeon to remove the handle, withdraw the URS, and leave the stone basket in
place. This may be of benefit in the situation of a lodged impacted stone basket.
Small ureteric stones or fragments can be removed fast and safely with forceps
which can be better controlled than a basket.

Figure (20): Stone extraction by stone basket

6. After the procedure:

Indwelling double J stent (5-6 fr) was inserted after ureteroscopy especially if
there were stone migration, stone impaction, large number of stone fragments,
large stone burden, long time procedure or in suspected ureteral injury.

In other patients, a 5or 6 Fr. open ended ureteric catheter attached externally to a
16fr Foley's urethral catheter, was placed also as a routine step following
ureteroscopy if there were small stones or in short time procedures. The urethral
and ureteric catheters were removed 48 hours later.
Operative data:

The operative data that were recorded include:

1. Operative time (starting from beginning of the maneuver).

2. Intraoperative complications.

3. Auxiliary procedures that can be defined as procedures that required

readmission of the patient for another intervention after the primary treatment as
JJ insertion, nephrostomy tube or ureteroscopy.

Postoperative data:

1. Postoperative medications including antibiotics, coagulants and analgesics

were given when indicated.

2. Postoperative complications and hospital stay were also recorded.

3. Stone free rate was recorded after 1 month.

(ESWL GROUP)

The patients treated on an outpatient basis, using (Dornier Compact Delta II lithotripter)
after explanation of the procedure and potential complications. Also patients signed an
informed consent before starting the procedure.
 Figure (21): Dornier Compact Delta II lithotripter

The steps:

1. An IV line was inserted for fluids, diuretics mannitol 10% and analgesics
administration when needed.

2. The patient was placed in the supine position with his affected side facing the
machine drum.

3. You have to be sure that the table is placed in the zero position.

4. The stone was localized and focused by fluoroscopy in two axes in

anteroposterior and in oblique axe.

5. Local infiltration anesthesia with 10 cm 2% Lidocaine diluted in 10 cm normal

saline is given subcutaneously in the area of drum contact.

6. A thin layer of K-Y jelly is applied on the machine drum directly after filling
the drum with the fluid automatically.

7. Fine localization of the stone site in the focus was done fluoroscopically both in
the anteroposterior and in the oblique position.

8. The number of shock waves used ranging from (2000-4000), at a rate of (70-
90) shock per minute at first then the intensity gradually increased till
reaching the full power of machine.

9. Monitoring of the stone site in the focus will be tested every 5 minutes.

10. IV fluids and analgesic can be given during ESWL session.

11. The patients are allowed to be discharged at the same day of treatment.

12. Post ESWL Follow up:

 The patients were followed with urine analysis, urine culture and
sensitivity and plain X-Ray after four weeks.
  During this period the patient received medical expulsive therapy,
antiseptics, analgesics and spasmolytics.
 Patients with residual fragments more than 5 mm were exposed to second
session of treatment with three weeks interval.
 Those with residual fragments less than 5 mm were followed up with
medical treatment for spontaneous passage.

Figure (22): localization of the stone site in the focus

.under fluoroscopy

Operative data:

The operative data that was recorded include:

1. The number of ESWL sessions needed for stone fragmentation

2. The number of shock waves used in every ESWL session.

3. Intraoperative complications.

Postoperative data including:

1. Postoperative medications including antibiotics, coagulants and analgesics

were given when indicated.

2. Postoperative complications were also recorded.

3. Stone free rate was recorded after 1 month.

IV. Patients follow up for both groups:

 Post operatively the patients will be evaluated after four weeks by:

 Plain urinary tract.

 Spiral non contrast CT abdomen and pelvis when indicated.
 Intravenous urography when indicated.

V. The method of randomization:

The patients were randomized into two groups; every odd number patient was
given in group (A) for flexible ureteroscopic laser lithotripsy, and every even
number in group (B) for ESWL to avoid any kind of bias.

VI. Statistical analysis of the data: (136)

Data were fed to the computer and analyzed using IBM SPSS software package

version 20.0. (Armonk, NY: IBM Corp) (137) Qualitative data were described using
number and percent. The Kolmogorov-Smirnov test was used to verify the
normality of distribution Quantitative data were described using range (minimum
and maximum), mean, standard deviation and median. Significance of the
obtained results was judged at the 5% level.

The used tests were:

1 - Chi-square test : For categorical variables, to compare between different

groups.

2 - Fisher’s Exact or Monte Carlo correction

Correction for chi-square when more than 20% of the cells have expected count
less than 5

3 - Student t-test: For normally quantitative variables, to compare between two

studied groups
The results of both groups will be compared as regards the following:

1- Procedure time.
2- Retreatment rate.
3- Post-operative complication rate.
4- Stone free rate (SFR).
5- Secondary or auxiliary procedure rate.

- Retreatment was defined as the need for a second session of the same
modality.
- Complication rate via The Clavien-Dindo Classification of Surgical

Complications in to 4 grades : (138)

 

.Table (1): Clavien-Dindo Classification of Surgical Complications

- The stone free rate (SFR) defined as no stone residual fragments or

asymptomatic insignificant residual fragments less than or equal to 4 ml
during patients follow up four weeks after the first F-URS or ESWL
session.
- Secondary or auxiliary procedure rate was defined as using a method of
treatment other than the primary treatment to render the patient free of
stones.
 Results
This is a prospective randomized comparative study between extracorporeal shock
wave lithotripsy and flexible ureteroscopic laser lithotripsy in the treatment of

proximal ureteral stones that can be defined as stones up to 2 cm located in the

lumbar ureter between the ureteropelvic junction to the upper border of sacroiliac
joint.

The study includes thirty patients admitted to Tanta Urology Department

suffer from proximal ureteral stones during the period from February 2016 to
October 2016.
The patients were randomly divided into two groups:

Group A (Flexible ureteroscopy group - 15 patients)

Fifteen patients underwent holmium laser lithotripsy using flexible ureteroscopy

(KARL STORZ 8 Fr.).

Group B (ESWL group - 15 patients)

Fifteen patients underwent extracorporeal shock wave lithotripsy (Dornier Compact

Delta II lithotripter).

The results are summarized in the following data:

A. Demographic data:

Lithotripsy

Flexible Extracorporeal
Test of
ureteroscopic laser shock wave p
Sig.
(n = 15) (n = 15)

No. % No. %

Sex

Male 11 73.3 10 66.7 2= FE

p=
 Female 4 26.7 5 33.3  1.000

Age (years)

Min. – Max. 30.0 – 54.0 28.0 – 54.0

t=
Mean ± SD. 39.80 ± 8.65 41.07 ± 8.62 0.691
0.402
Median 38.0 45.0

BMI (Kg/m2)

Min. – Max. 23.0 – 30.0 23.0 – 30.0

t=
Mean ± SD. 26.60 ± 1.96 26.73 ± 2.34 0.867
0.169
Median 27.0 27.0

.Table (2): Comparison between the two studied groups according to demographic data

As regard sex of patients in our study, there were 21 males (70%) and 9 females
(30%). In FURS group; there were 11 males (73.3%) and 4 females (26.7%). In
ESWL group; there were 10 males (66.7%) and 5 females (33.3%).

The age of patients in FURS group ranged from 23 to 30 with a mean of 39.80 ± 8.65
years. The age of patients in ESWL group ranged from 28 to 54 years with a mean of
41.07 ± 8.62 years.

The BMI of patients in FURS group ranged from 23 to 30 with a mean 26.60 ± 1.96.
The age of patients in ESWL group ranged from 23 to 30 with a mean of 26.73 ± 2.34.

There was no significant difference between both groups as regard sex, age and BMI
of patients as P- value = 1.000, 0.691 and 0.867 respectively.

B. Radiological data:

Lithotripsy Test of p
Sig.
Stone Flexible Extracorporeal
ureteroscopic laser shock wave
(n = 15) (n = 15)
 No. % No. %

Site

Right 8 53.3 9 60.0 

0.713
Left 7 46.7 6 40.0 

Size

<1.5 10 66.7 9 60.0

0.144 0.705
≥1.5 5 33.3 6 40.0

Min. – Max. 0.60 – 1.80 0.50 – 2.0

t=
Mean ± SD. 1.31 ± 0.36 1.27 ± 0.48 0.830
0.217
Median 1.30 1.30

.Table (3): Comparison between the two studied groups according to stone data

In our study, there were 17 patients (56.6%) with the stone in the right ureter, and 13
patients (43.4%) with the stone in the left ureter. In FURS group, there were 8 patients
(53.3%) with the stone in the right ureter and 7 patients (46.7%) with the stone in the
left ureter. In ESWL group, there were 9 patients (60%) with the stone in the right
ureter and 6 patients (40%) with the stone in the left ureter.

As regard stone size, our study included 19 patients (63.3%) with stone <1.5 cm and 11
patients (36.7%) with stone ≥1.5 cm. The stone size in FURS group ranged between
(0.60-1.80 cm), the mean was 1.31 ± 0.36 cm and in ESWL group, the size ranged
between (0.50 – 2.0 cm), the mean was 1.27 ± 0.48 cm. There was no statistical
significant difference in both groups as regard the site and the size of the stone as P
value = 0.713 and 0.830 respectively.

C. Procedure time:

Procedure time (min.) Lithotripsy t p

 Flexible Extracorporeal
ureteroscopic laser shock wave
(n = 15) (n = 15)

Min. – Max. 60.0 – 90.0 35.0 – 55.0

Mean ± SD. 72.07 ± 9.20 43.53 ± 6.30 9.911* <0.001*

Median 70.0 40.0

*: Statistically significant at p ≤ 0.05

Table (4): Comparison between the two studied groups according to procedure time.

The procedure time in FURS group ranged between (60.0 – 90.0 mins), the mean was
72.07 ± 9.20 mins and in ESWL group, ranged between (35.0 – 55.0 mins), the mean
was 43.53 ± 6.30 mins. There was statistical significant difference as regard the
procedure time as P value = <0.001.

Lithotripsy (stone size ≥1.5)

Flexible Extracorporeal
Procedure time (min.) t p
ureteroscopic laser shock wave
(n = 5) (n = 6)

Min. – Max. 80.0 – 90.0 40.0 – 55.0

Mean ± SD. 83.40 ± 4.22 47.0 ± 5.76 11.709* <0.001*

Median 82.0 45.0

*: Statistically significant at p ≤ 0.05

Table (5): Comparison between the two studied groups stone size ≥1.5 cm according to
procedure time.

Also Comparison between the two studied groups (stone size ≥1.5cm) according to
procedure time showed in FURS group ranged between ( 80.0 – 90.0 mins), the mean
was 83.40 ± 4.22 mins and in ESWL group, ranged between (40.0 – 55.0 mins), the
mean was 47.0 ± 5.76 mins. There was statistical significant difference as regard the
procedure time with stone size ≥1.5 cm as P value = <0.001.
D. Retreatment rate:

Lithotripsy

Flexible Extracorporeal
ureteroscopic laser shock wave FE
p
(n = 15) (n = 15)

No. % No. %

Retreatment rate 0 0.0 6** 40 0.016 *

*: Statistically significant at p ≤ 0.05

**: for 2 sessions.
Table (6): Comparison between the two studied groups according to retreatment rate.

In our study 6 patients (40%) in ESWL group need for a second session of
extracorporeal shock wave lithotripsy, with no retreatment rate in FURS group (0%).
There was statistical significant difference as regard the Retreatment rate with as P
value = 0.016.

Lithotripsy (stone size ≥1.5)

Flexible Extracorporeal
ureteroscopic laser schock wave FE
p
)n = 5( )n = 6(

.No % .No %

Retreatment rate 0 0.0 5** 83.3 *

0.015

*: Statistically significant at p ≤ 0.05

**: for 2 sessions.
Table (7): Comparison between the two studied groups stone size ≥1.5 cm according to
retreatment rate.
Also Comparison between the two studied groups (stone size ≥1.5cm) according to
Retreatment rate showed 5 patients (83.3%) in ESWL group need for a second session
of extracorporeal shock wave lithotripsy, with no retreatment rate in FURS group
(0%). There was statistical significant difference as regard the Retreatment rate with
stone size ≥1.5 cm as P value = 0.005.
E. Complication rate:

Lithotripsy

Complication rate Flexible Extracorporeal

(The clavien–dindo ureteroscopic laser schock wave  MC
p
classification) (n = 15) (n = 15)

No. % No. %

GI 1 6.7 2 13.3

GII 3 20.0 1 6.7  0.836

GIII 1 6.7 1 6.7

Table (8): Comparison between the two studied groups according to complication rate
(the Clavien-Dindo classification).

Figure (23): Comparison between the two studied groups according to complication
rate (the Clavien-Dindo classification).
In our study regarding complication rate showed 5 patients (16.6%) in FURS group
had post-operative complication, but 4 patients (13.3%) in ESWL group had post-
operative complication.

According to the Clavien-Dindo classification, in FURS only one patient (6.7%) with
GI complication in form of colic relived by analgesics, 3 patients (20%) with GII
complictions in form of fever (2-3days) treated by IV antibiotics. And one patient
(6.7%) with GIII complication. A single function kidney patient suffered from anuria
and elevation of serum creatinine after 24 hour from open tip stent removal. Urgent Dj
stent was inserted. In ESWL group, 2 patients (13.3%) with GI complication in form
of colic treated by analgesics, one patient (6.7%) with GII complication in form of
fever treated by IV antibiotic, one patient (6.7%) with GIII complication, steinstrasse
after ESWL treated by semirigid URS and pneumatic lithotripsy. There was no
statistical significant difference in both groups as regard the complication rate as P
value = 0.836.

Lithotripsy (stone size ≥1.5)

Complication rate Flexible Extracorporeal

(The clavien–dindo ureteroscopic laser schock wave  MC
p
classification) )n = 5( )n = 6(

.No % .No %

GI 0 0.0 1 16.7

GII 1 20.0 1 16.7  1.000

GIII 0 0.0 1 16.7

Table (9): Comparison between the two studied groups stone size ≥1.5 cm according to
complication rate (the clavien-dindo classification).
 Figure (24): Comparison between the two studied groups stone size ≥1.5 cm according
to complication rate (the clavien-dindo classification).

Also Comparison between the two studied groups (stone size ≥1.5cm) according to
complication rate showed only one patient (20%) in FURS group had GII
complication in form of fever treated by IV antibiotic, but 3 patients (50%) in ESWL
group had post-operative complication. One patient (16.7%) with GI complication in
form of colic treated by analgesics, one patient (16.7%) with GII complication in
form of fever treated by IV antibiotic, one patient (16.7%) with GIII complication,
steinstrasse after ESWL treated by semirigid URS and pneumatic lithotripsy. There
was no statistical significant difference in both groups as regard the complication rate
as P value = 1.000.

F. Stone Free rate and secondare procedure:

Lithotripsy

Flexible Extracorporeal
ureteroscopic laser schock wave  p
(n = 15) (n = 15)

No. % No. %

Stone free rate 13 86.7 7 46.7 * 0.020*

Secondary procedure 2 13.3 2 13.3 0 FE

p=1.000

*: Statistically significant at p ≤ 0.05

Table (10): Comparison between the two studied groups according to stone free rate
and procedure time.

As regard Stone free rate, 13 patients (86.7%) in FURS group and 7 patients (46.7%)
in ESWL group, showed no stone residual fragments or asymptomatic insignificant
residual fragments less than or equal to 4 ml during one month follow up after 1st
session. There was statistical significant difference between the two groups as regard
the Stone free rate as P value = 0.02.
As regard usage of secondary procedure, 2 patients (13.3%) in FURS group need
secondary method of treatment other than the primary method to render the patient
free of stones. One patient underwent for ESWL session and one patient underwent
for semi-rigid URS. In ESWL group only 2 patients (13.3%) underwent for semi rigid
URS pneumatic lithotripsy. There was no statistical significant difference in both
groups as regard the secondary procedure as P value = 1.

Lithotripsy (stone size ≥1.5)

Flexible Extracorporeal
ureteroscopic laser schock wave FE
p
(n = 5) (n = 6)

No. % No. %

Stone free rate 4 80.0 1 16.7 0.080

Secondary procedure 1 20.0 1 16.7 1.000

Table (11): Comparison between the two studied groups stone size ≥1.5 cm according
to stone free rate and procedure time.

Also Comparison between the two studied groups (stone size ≥1.5cm) according to
Stone free rate showed 4 patients (80.0%) in FURS group and 1 patient (16.7%) in
ESWL group. There was no statistical significant difference in both groups as regard
the Stone free rate as P value = 0.08.

Also Comparison between the two studied groups (stone size ≥1.5cm) according to
Secondary procedure, FURS group showed one patient (20%) underwent secondary
ESWL session. ESWL group showed one patient (16.7%) underwent for semi-rigid
URS lithotripsy. There was no statistical significant difference in both groups as
regard the Secondary procedure as P value = 1.000.

Discussion
Urinary stones are the third most common problem of the urinary tract, and ureteral
(19)
stones account for 33-54% of urinary stones. Ureteral stones are commonly
associated with obstruction that may lead to irreversible damage of renal parenchyma,
 (3)
so proper management should be strongly considered. Multiple lines of treatment,
from open ureterolithotomy to endourological procedures, have been used for
management of ureteral stones. However, the optimal treatment option for upper

ureteral stone still has a controversial topic. (4)

Open surgery for the treatment of ureteric calculi has gradually decreased in the last 30
years due to marked updates in minimally invasive techniques. The aim of lithotripsy
for upper ureteral stone is based on stone fragmentation into smaller pieces which pass
spontaneously or easily removed. So energy should be transferred to the stone either
percutaneously (extracorporeal shock wave lithotripsy) or through an endoscope

(intracorporeal lithotripsy). (139)

In 1980 was the first to report the clinical application of shock wave lithotripsy in the
(67)
management of urinary stones. It has been recommended as a first-line treatment
for upper ureteric calculi in several studies with a success rate of 80-90%. Also with
the several advances in the shock wave generators; from the Dual-head, the tandem-
pulse and wide-focus low pressure lithotripters, till the advances in stone location and

imaging, (79,80,81) ESWL supporters believe that it is preferred even for relatively large
ureteric stones, as a noninvasive and less morbid technique with a low complication
rate. Others have noted that the stone-free rates are much less than those achieved by
URS, as well as the need for frequent retreatment sessions in these situation. Multiple
sessions in case of relatively large ureteric stones increase cost burden beside

increasing complication rate. (5)

In the era of endourology, with the advent of small-caliber ureteroscopes, flexible

ureteroscopes and holmium: yttrium-aluminum-garnet (Ho: YAG) laser lithotripsy, the
treatment of upper ureteric stones has shifted towards ureteroscopy with success rates

approaching 95% but with documented complication rate. (6)

The choice of extracorporeal shock wave lithotripsy or flexible ureteroscopy and

holmium lithotripsy for ureteric stone management is one of the most commonly
debated controversies in urology. This is partly due to a parallel advancement in
technologies in both fields. This debate is higher regarding the treatment of large size
proximal ureteral stones using ESWL versus FURS. The optimal choice of treatment
depends on various factors, including stone size, composition and location, clinical

patient factors, equipment availability and surgeon capability. (6)

Our study was a prospective randomized comparative study between extracorporeal

shock wave lithotripsy and flexible ureteroscopic laser lithotripsy, to evaluate the
optimal treatment modality for patients with large proximal radio opaque ureteral
stones (0.5 to 2 cm) by comparing procedure time, the stone free rate, retreatment rate,
secondary procedure and post-operative complication rate after 4 weeks follow up. We
prospectively randomized 30 patients into 2 groups; Group (A) Fifteen patients
undergo holmium laser lithotripsy using flexible ureteroscopy (KARL STORZ 8 Fr.,
Germany) under general anesthesia, Group (B) Fifteen patients undergo extracorporeal
shock wave lithotripsy (Dornier Compact Delta II lithotripter, Germany) on outpatient
basis under local infiltration anesthesia.

In our study comparison between the demographic patients data including age, sex
and body mass index, showed no significant difference between both group FURS and
ESWL. Also comparison between radiologic finding of stones in both group
including size and site, showed no significant difference.

FURS group:

In our study, the procedure time was calculated from the start of our urological
intervention till the end of the urological procedure, not including anesthesia induction
and reverse consumed time. In our study as regard the procedure time, on 15 patients
with proximal ureteric stone measured between 0.5 cm – 2 cm treated by flexible laser
lithotripsy, it ranged between (60-90) minutes, and the mean was 72.07 ± 9.20 minutes
per procedure. And it was longer with the 5 patients group with stone size measured
≥1.5cm, the procedure time ranged between (80-90) minutes, and the mean was 83.40
± 4.22 minutes per procedure.

Zejun Y et al. (2015) on 382 consecutive patients with renal and proximal ureteral
calculi with mean stone size measured 11.5±4.1 mm (range 4–28 mm) who had
undergone PolyScope and laser lithotripsy by a single surgeon, the mean operative
(140)
time per procedure was 67.1±19.2 min (range, 35–116 min). A study by Karadag
et al. (2014) on 61 patients suffered from proximal ureteric stones with mean
diameter measured 11.01 ± 2.24mm, then underwent flexible laser lithotripsy showed
(141)
mean operative time 84.06 ± 16.7 minutes.   Khoder et al. (2014) divided
proximal ureteric stones exposed to ureteroscopic Ho:YAG laser lithotripsy in to 2
groups as small size (<10 mm) 34 patients and large size (>10 mm) 23 patients.
According to their result, mean procedure time in small size stone group (<10 mm)
was 80.7 ± 6.5 minutes, and in large size stone group (>10 mm) was 82.3 ± 5.9
(142)
minutes. Both Karadag et al. (2014) and Khoder et al. (2014) showed mean
procedure time near to our study result. Other studies showed mean procedure time
less than our result; Hyams et al. (2015) on 71 patients underwent flexible laser
lithotripsy for proximal ureteric stones with mean stone size measured mean 7.4 mm
(143)
(range 5 to 15mm), showed a mean operative time as 60.3 minutes. At the end it
may differ according to surgeon techniques and center facilities, with average more
than one hour in a smooth flexible laser lithotripsy session in a patient suffered from
proximal ureteric stone. Mean procedure time will increase respectively with
increasing stone size more than 1.5 cm.

The retreatment rate was defined as the need for a second session of the same
modality as long as there was a significant residual more than 4 mm during follow up.
Our study showed no retreatment sessions for our 15 proximal ureteric stone patients
in FURS group.

Khoder et al. (2014) showed also a low retreatment rate around 1.1 ± 0.1 as a mean
number of laser retreatment in 51 patients; as 1,1 ± 0,1 for small size stone group
(142)
(<10 mm) and 1,2 ± 0,1 for large size stone group (>10 mm). There was a higher
retreatment rate at Karadag et al. (2014) on 61 patients suffered from proximal
ureteric stones with mean diameter measured 11.01 ± 2.24mm, showed the retreatment
rate around 6%, where 4 patients of 61 patients suffered from proximal ureteric stone,

need for a second session of flexible laser lithotripsy to render them free of stone. (141)
Regarding the post-operative complication rate, it classified by The Clavien-Dindo
Classification of Surgical Complications for better evaluation. Our study showed over
all 9 patients suffered from post-operative complication, ranged between GI to GIII,
with no patients suffered from either G IV or G V in our study.

In our study as regard the post-operative complication rate, on 15 patients with

proximal ureteric stone measured between 0.5 cm – 2 cm treated by flexible laser
lithotripsy, showed 5 patients (16.6%) in FURS group had post-operative
complication. only one patient (6.7%) with GI complication in form of colic in the
first 24 hours relived by intravenous analgesics, 3 patients (20%) with GII
complications in form of fever 48 hours post-operative treated by IV antibiotics. one
patient (6.7%) with GIII complication where a single function kidney patient suffered
from anuria and elevation of serum creatinine after 24 hour from open tip stent
removal, Urgent Dj stent was inserted with marked improved after then. In the 5
patients group with stone size measured ≥1.5cm, it showed that only one patient
(20%) in FURS group had GII complication in form of fever treated by IV antibiotic.

Karadag et al. (2014) on 61 patients suffered from proximal ureteric stones with
mean diameter measured 11.01 ± 2.24mm, showed post-operative fever (Clavien-
Dindo grade GII) in 8 (13.1%) patients in FURS group and bleeding in 5 (9.8%)
(141)
patients in the same group. Also Khoder et al. (2014) stated that all early
postoperative complications were (Clavien-Dindo grade GII) febrile urinary tract
(142)
infections that responded successfully to parenteral antibiotics. Hyams et al.
(2015) on 71 patients underwent flexible laser lithotripsy for proximal ureteric stones
with mean stone size measured mean 7.4 mm (range 5 to 15mm), showed that
postoperative complications developed in 6 patients (8.7%), including urinary tract
infection in 3 patients (Clavien-Dindo grade GII), urinary retention in 2 patients
(Clavien-Dindo grade III) and flash pulmonary edema in 1 patients (Clavien-Dindo

grade GIV). (143) Cui Y et al. (2014) in their study on 80 patients who underwent
ureteroscopic holmium laser lithotripsy for a single radiopaque ureteral stone (the size
8-15 mm), showed 2 patients (2.5%) suffered from colic (Clavien-Dindo grade GII),
Gross hematuria (Clavien-Dindo grade GII) in 2 patients (2.5%) and Voiding
(144)
symptom in 27 patients (33.75%). all the reviewed studies showed complications
between Clavien-Dindo grade GI to GIII, with average less than 20% of patients, with
no documented G IV or G V or direct relation between complication rate and stone.

In our study, the stone free rate (SFR) defined as no stone residual fragments or
asymptomatic insignificant residual fragments less than or equal to 4 ml during patient
follow up four weeks after the first F-URS or ESWL session and secondary
procedure rate was defined as using a method of treatment other than the primary
treatment to render the patient free of stones.

In our study as regard the stone free rate, on 15 patients with proximal ureteric stone
measured between 0.5 cm – 2 cm treated by flexible laser lithotripsy, 13 patients
(86.7%) in FURS group, showed no stone residual fragments or asymptomatic
insignificant residual fragments less than or equal to 4 ml during one month follow up
after 1st session. As regard usage of secondary procedure, 2 patients (13.3%) in
FURS group need secondary method of treatment other than the primary method to
render the patient free of stones. One patient underwent for ESWL session and one
patient underwent for semi-rigid URS. In the 5 patients group with stone size
measured ≥1.5cm, it showed that 4 patients (80.0%) was stone free after the first
FURS session, and one patient (20%) underwent secondary ESWL session.

Studies showed that success rate of FURS in proximal ureteral stones larger than 10
mm varies between 57-96%. Zejun Y et al. (2015) on 382 patients with renal and
proximal ureteral calculi who had undergone FURS and laser lithotripsy, showed
stone free rates following the first and the second procedures were 74.3 and 86.9%,
respectively, where the overall stone-free rate was 86.9% and the stone free rate for
(140)
proximal ureteric stone was 100%. Success rate at Karadag et al. (2014) study
was 57/61 (93%) of the patients, Initial stone free status which was achieved after
disintegration of the stones < 4 mm or complete extraction of the fragments decided
by the surgeon at the end of the procedure was 86.8% (53/61) after 1 st session of
FURS, This rate increased to 90.1% (55/61) at 1st month radiologic controls. Third
(141)
month radiologic investigations revealed a stone free rate of 93.4% (57/61). Also
Khoder et al. (2014) showed overall Stone free rate 90.3% (28/31) in proximal 
ureteric stones ≤ 10 mm and 100% (20/20) in proximal ureteric stones > 10 mm.
Where Stone free rate after first treatment is 80.6% (25/31) in proximal ureteric stones
≤ 10 mm and 85% (17/20) in proximal ureteric stones > 10 mm after first treatment.
Also Stone free rate after second treatment is 90.3% (28/31) in proximal ureteric
stones ≤ 10 mm and 100% (20/20) in proximal ureteric stones > 10 mm after second
(142)
treatment. Hyams et al. (2015) showed that 61 patients (95%) were stone free.
All patients was suffering from stone size was greater than 10 mm while residual
stones were between 1 and 3 mm. One of these patients need secondary procedure in
(143)
form of semirigid URS to clear the residual stones. Cui Y et al. (2014) showed
97.5% stone free rate in 80 patients with proximal single radiopaque ranging from 8
(144)
mm to 15 mm treated by flexible holmium laser lithotripsy. All reviewed studies
showed the stone free rate with average between 80% - 93% after first session of
FURS for proximal ureteric stones, it may differ according to performer skills and
experience, with a lower stone free rate in stone size more than 1.5 cm.

ESWL group:

In our study as regard the procedure time, on 15 patients with proximal ureteric stone
measured between 0.5 cm – 2 cm treated by ESWL, it ranged between (35.0 – 55.0
minutes), the mean was 43.53 ± 6.30 minutes. Also in the 6 patients group with stone
size measured ≥1.5cm treated by ESWL, showed a longer procedure time ranged
between (40.0 – 55.0 minutes), the mean was 47.0 ± 5.76 minutes.

Cui Y et al. (2014) showed in his study on 80 patients with proximal ureteric stone
(144)
less than 1.5 cm treateted by ESWL a mean procedure time 40.0±10.0 minutes.
Seyed et al. (2012) in his study on 30 patients with proximal ureteral stones larger
than 12 mm (12–26 mm) with a mean size of 17.64 mm, showed mean procedure time
(145)
was 48.33 ± 9.228 minutes. Ehab R (2010) on 71 patients with large proximal
ureteric stones more than 1 cm showed a mean operative time was 68 minutes range
(146)
between 59 – 78 minutes. Where all the reviewed studies showed average
procedure time near to our study result, with increasing of procedure time in case of
ESWL for proximal ureteric stone ≥ 1 cm with excess 60 minutes in some studies.

In our study as regard the retreatment rate, on 15 patients with proximal ureteric stone
measured between 0.5 cm – 2 cm treated by ESWL, 6 patients (40%) need for a
second session of extracorporeal shock wave lithotripsy. While the group of 6 patients
with stone size ≥1.5cm treated by ESWL, showed 5 patients (83.3%) need for a
second session of extracorporeal shock wave lithotripsy.

Mohamed M et al. (2014) on 50 patients with solitary radiopaque proximal ureteral

(147)
stones measured ≤1 cm, showed average number of session was 2.6 session.
Manzoor S et al. (2013) on 100 hundred patients with 10 -15 mm proximal ureteric
(148)
stones, showed a retreatment rate 40% same to our study. Lopes N et al. (2012)
showed  2.9 ± 1.4 session as a average number of session needed in ESWL group for
(149)
treatment of large proximal ureteral stones greater than 1 cm. Youssef R et al.
(2009) on 427 patients were treated for upper ureteral stones less than 20 mm, showed
(150)
a higher retreatment rate than our study, it was 65% in the ESWL group. Murota
K et al. (2008) on 192 patients with proximal ureteric stones measured < 10 mm,
showed retreatment rate 9.9 % in ESWL group and on 187 patients with proximal
ureteric stones measured ≥ 10 mm, showed retreatment rate 22.5 % in ESWL group.
(151)
Murota K et al. (2008) showed a lower retreatment rate than our study and the
other reviewed studies. It may be explained due to the small focus and lower shock
wave energy in new generation lithotripter in comparison with the first generation
HM3. Thus treatment of a stone larger than 1 cm will need multiple sessions of
ESWL to render the patient free of stones.
In our study regarding complication rate in 15 patients with proximal ureteric stone
measured between 0.5 cm – 2 cm treated by ESWL, 4 patients (13.3%) had post-
operative complication. According to the Clavien-Dindo classification, 2 patients
(13.3%) with Clavien-Dindo GI complication in form of colic treated by analgesics, one
patient (6.7%) with Clavien-Dindo GII complication in form of fever treated by IV
antibiotic, one patient (6.7%) with Clavien-Dindo GIII complication, steinstrasse after
ESWL treated by semirigid URS and pneumatic lithotripsy. In the group of 6 patients with
proximal ureteric stone measured ≥1.5cm treated by ESWL, showed 3 patients (50%)
in ESWL group had post-operative complication. One patient (16.7%) with Clavien-
Dindo GI complication in form of colic treated by analgesics, one patient (16.7%) with
Clavien-Dindo GII complication in form of fever treated by IV antibiotic, one patient
(16.7%) with Clavien-Dindo GIII complication, steinstrasse after ESWL treated by
semirigid URS and pneumatic lithotripsy.

Cui Y et al. (2014) on 80 patients with proximal ureteric stone measured < 1.5 cm,
showed 9 patients with post ESWL renal colic (11.25%), 16 patients with post ESWL
(144)
gross hematuria (20%), 5 patients with post ESWL voiding symptoms (6.25%).

Mohamed M et al. (2014) on 50 patients had proximal ureteral stones and 47 patients
had middle ureteral stones, they were treated by ESWL using Dornier lithotripter S II
system. Almost, 90% of patients presented with renal colic, 14% with irritative lower
(147)
urinary symptoms and 3% with gross hematuria. Butt A et al (2005) on 432
patients treated by ESWL for upper urinary tract stone, reported pain incidence in
(152)
5.9% patients after ESWL treatment and steinstrasse in 2.9% of cases. Fong Y et
al (2004) on 50 cases of proximal ureteric stone ( mean stone size 10.7mm) treated by
ESWL, reported incidence of steinstrasse in 3 patients (6%) of cases which is higher
(153)
than that in our study. all the reviewed studies showed complications between
Clavien-Dindo grade GI to GII in form of colic, fever and hematuria, with less than
3% documented GIII in some cases, with no documented G IV or G V as a post-
operative complication.
In our study as regard stone free rate, in 15 patients with proximal ureteric stone
measured between 0.5 cm – 2 cm, 7 patients (46.7%) in ESWL group, showed no stone
residual fragments or asymptomatic insignificant residual fragments less than or
equal to 4 ml during one month follow up after 1st session. As regard usage of
secondary procedure, In ESWL group only 2 patients (13.3%) underwent for semi
rigid URS pneumatic lithotripsy.

In our study as regard stone free rate, in 6 patients with proximal ureteric stone
measured ≥1.5cm, showed 1 patient (16.7%) in ESWL group. According to
Secondary procedure in ESWL group, showed one patient (16.7%) underwent for
semi-rigid URS lithotripsy.

Cui Y et al. (2014) on 80 patients with proximal uretric stone measured < 1.5 cm,
showed Stone clearance rates 77.5% for ESWL after 1 st session, 87.5% after 2nd
(144)
session and 92.5% after 3rd session. Manzoor S et al. (2013) on 100 hundred
patients with 10 -15 mm proximal ureteric stones, showed Success rate similar to our
(148)
study result with a 49.2% success rate after the first session of ESWL. Seyed et
al. (2012) in his study on 30 patients with proximal ureteral stones larger than 12 mm
(range 12–26 mm) with a mean size of 17.64 mm, showed the initial stone-free rate
for ESWL similar also to our study, it was 46.66% (14 of 30 patients ), and in the
(145)
second session it was successful in 7 more patients (23.33%). Lopes N et al.
(2012) showed  Extracorporeal shock wave lithotripsy had a 35.7% success rate for
treatment of large proximal ureteral stones greater than 1 cm, which considered less
(149)
than our study result. Mohamed M et al. (2014) on 50 patients had proximal
ureteral stones and 47 patients had middle ureteral stones, showed a higher success
rate than our study, where the overall success rate was 94%. Stone clearance was
achieved in 87 patients (87%) after 3 months of follow-up and 7 patients (7%) showed
insignificant residual (<4 mm). Failure of stone clearance occurred in 6 patients (6%),
4 out of them (4%) showed no change at all in stone size after 3 sessions of ESWL
and the remaining 2 patients (2%) showed partial disintegrations. Hence, they
underwent ureteroscopy. Stone free rates after ESWL for upper (abdominal), middle
 (147)
(pelvic) ureteral stones were 94%, 95.7%. Ehab R (2010) on 71 patients with
large proximal ureteric stones more than 1 cm showed the initial stone free rate for in
ESWL was 58% (41 of 71) patients. In 13 patients with failed ESWL a second ESWL
session was performed which succeeded in 2 patients. Ureteroscopy was done for 14
patients with failed SWL of whom 12 (86%) became stone free. percutaneous stone
management was performed successfully for one patient. The remaining patients
(146)
preferred to do open surgery. Salem H (2009) on 100 patients with proximal
ureteric stone, showed for stones of size ≥ 1 cm, the initial stone-free rate for ESWL
(154)
was 60%. For stones < 1 cm, the initial stone-free rate for ESWL was 80%.
Youssef R et al. (2009) on 427 patients were treated for upper ureteral stones less
than 20 mm, the success rate was 83.7% for ESWL and the need for auxiliary

procedures was 16.3%.(150) Fong Y et al (2004) on 50 cases of proximal ureteric stone

( mean stone size 10.7mm) treated by ESWL,  the 1-month stone free rate 50% in
(153)
ESWL. The 3-month stone free rate was higher 78% in ESWL. Turna B et al.
(2008) on 44 patients with proximal ureteric stone, showed the stone free rate was
86.3% for ESWL. For the group with stones <100 mm, the SFR was 85.4% for
(155)
ESWL. Coz F et al (2000) on a series of 397 upper ureteral stones less than 1.5
cm treated with a Modulith® SL-20 lithotriptor showed the stone-free rate was 84.3%
(156)
at 3-month follow up. Park et al (1998) treated 301 upper ureteral stones;
achieving an 84.3% stone-free rate after a single session for stones less than 10 mm.
(157)
Recently the 3-month success rate for the Dornier® Compact Delta® for
proximal ureteral stones less than 10 and 10 to 20 mm was reported to be 96% and
90%, respectively. Nabi et al (2003) noted that patients with larger ureteric stones
treated by ESWL are likely to have a higher re-treatment rate, more auxiliary
procedures and more complications. However, the number of patients with proximal
stones in this series was only 74, which is a relatively small sample size compared to
(158)
that in most SWL series. Mobley T et al (1994) on a large series of 8,447
proximal ureteral stones, the stone-free rate for stones larger than 20 mm in diameter
(159)
was reported to be 64.8%. Pace et al (2000) confirmed a low success rate of
repeat SWL for upper ureteral stones after initial treatment failure. In their series they
treated 1,593 ureteral calculi with a Dornier MLF 5000 lithotriptor. The stone-free
rate after initial treatment was 68% (1,086 of 1,593 cases), which decreased to 46%
for the first re-treatment and 31% for the second re-treatment. Overall the success rate
increased to 77% after 3 treatments compared with 76% after 2 treatments thus,
suggesting that ureteroscopic management may be better than SWL after initial SWL

failure. (160)

All the reviewed studies showed average less than 50% stone free rate after the first
ESWL session for proximal ureteric stone less than 1.5 cm, some studies showed
more than 80% success rate after first session. That may explained because usage of
the different lithotripters in the reviewed studies with different factors affecting the
result from stone hounsfield unit and skin to stone distance. Almost all the studies
confirmed lower stone free rate, retreatment rate and higher secondary procedure
usage rate in case of treatment of proximal ureteric stones more than 1.5cm by ESWL.
In contrast, FURS had superiority over ESWL because laser energy can fragment all
stones types in all patients with no limitations, regardless stone composition or
patients' body mass index. Despite a lower SFR and higher retreatment rates, ESWL
remains a treatment modality because of its noninvasive nature. Also FURS beside its
invasive nature, the need for expensive fragile instruments such as laser fibers and
zero tip baskets with the low durability and life span of flexible ureteroscopy, this all
considered a high cost burden in comparing with ESWL modality.

One of the defect in our study was the short term follow up of patients after one
month, with no 3 months follow up, with could affect the result of the stone free rate.
Also the small number of patients in both groups and no data interpretation for the
factors affecting stone fragmentation in ESWl such as stone composition and density,
skin to stone distance and body mass index.
 Summary and conclusion
Proximal ureteric stones commonly associated with obstruction, infection and may
lead to deterioration of renal function. Different treatment options are available for the
management of upper ureteral calculi, including: ESWL, Ureteroscopic lithotripsy
either semi rigid or flexible URS, PCNL, and laparoscopic or open ureterolithotomy.
The aim of this study is to determine the appropriate treatment modality for
management of patients with large proximal ureteral calculi up to 2 cm by comparing
by comparing procedure time, the stone free rate, retreatment rate, secondary procedure
and post-operative complication rate.

This is a prospective randomized comparative study, includes thirty patients admitted

to Tanta Urology Department suffer from proximal ureteral stones during the period
from February 2016 to October 2016, with age ranging from 30 to 54 years, 21 male
patients and 9 female patients, with average body max index range between 23-30,
with stone size ranging between 0.6 to 2 cm, 17 patients with right side stone and 13
patients with left side stone.

All patients included in this study are randomly divided into two groups (Even–odd
randomization):

Group A (Flexible ureteroscopy group - 15 patients): Fifteen patients underwent

holmium laser lithotripsy using flexible ureteroscopy (KARL STORZ 8 Fr.,
Germany).

Group B (ESWL group - 15 patients): Fifteen patients underwent extracorporeal

shock wave lithotripsy (Dornier Compact Delta II lithotripter, Germany).

All patients were subjected to the following: detailed medical history, physical
examination, laboratory evaluation (complete blood picture, serum creatinine, liver
function tests, prothrombin time and concentration, complete urine analysis) and
radiological evaluation (KUB, spiral CT and IVU if indicated).

All patients showed no significant difference regarding the preoperative data as the
age, sex, body mass index, stone site and stone size.

The data collected including: procedure time, retreatment rate, stone free rate,
secondary procedure and post-operative complication rate.
The Results were summarized as the following:

Flexible laser lithotripsy was done in 15 cases with mean stone size 1.31±0.36 cm,
the overall mean operative time was 72.07±9.2 minutes and for stones ≥ 1.5 cm was
83.40 ± 4.22 minutes, the retreatment rate was 0%, the initial overall stone free
rate after one month for stones were 86.7% and for stones ≥ 1.5 cm was 80%, the
overall secondary procedure usage rate was 13.3% and for stones ≥ 1.5 cm was
20%.

Extracorporeal shock wave lithotripsy was done in 15 cases with mean stone size
1.27±0.48 cm, the overall mean procedure time was 43.53±6.3 minutes and for
stones ≥ 1.5 cm was 47 ± 5.76 minutes, the overall retreatment rate was 40% and
for stones ≥ 1.5 cm was 83.3%, the initial overall stone free rate after one month for
stones were 46.7% and for stones ≥ 1.5 cm was 16.7%, the overall secondary
procedure usage rate was 13.3% and for stones ≥ 1.5 cm was 16.7%.

No major intraoperative complications were recorded in both groups. The

postoperative complications were minor (Clavien-Dindo GI, GII and GIII), 5
patients (33.3%) in FURS group and 4 patients (26.7%) in ESWL group.

Where in FURS group only one patient (6.7%) with GI complication in form of colic,
3 patients (20%) with GII complictions in form of fever and one patient (6.7%) with
GIII complication in form of anuria in a single kidney patient treated by urgent Dj
insertion.

In ESWL group, 2 patients (13.3%) with GI complication in form of colic, one patient
(6.7%) with GII complication in form of fever, one patient (6.7%) with GIII
complication, steinstrasse after ESWL treated by elective Semi-rigid URS with
pneumatic lithotripsy.

Conclusion
Prediction of success or failure of both modalities can be affected by many factors as
stone size, Hounsfield unit, degree of hydronephrosis, stone impaction, equipment
availability and type of lithotripter. In our study we concluded that both FURS with
laser lithotripsy and ESWL have no statistically significant difference as regard
complication rate and secondary procedure usage rate in patients with stones from 0.5
to 2 cm, but FURS with laser lithotripsy has a significant result as a lower retreatment
rate and higher stone rate, but longer procedure time when it compared with ESWL
session which is considered as a less invasive and outpatient procedure. Data analysis
for stones equal or more than 1.5 cm showed almost the same with significant lower
retreatment rate and longer procedure time for flexible laser lithotripsy group.

So, flexible laser lithotripsy is recommended as a treatment modality for proximal

ureteric stones of 0.5-2 cm with higher stone free rate and lower retreatment rate.
Shock wave lithotripsy can be considered as a reasonable noninvasive modality in
patients with smaller stones less than 1 cm.