Endourology and Stones

A Prospective Randomized Study

Comparing Shock Wave Lithotripsy
and Semirigid Ureteroscopy for the
Management of Proximal Ureteral Calculi
Hosni K. Salem
OBJECTIVES To conduct a prospective randomized study comparing both techniques for the management of
solitary radio-opaque upper ureteral stones ⬍ 2 cm in diameter. The ideal treatment for upper
ureteral stones ⬎ 1 cm size remains to be determined with shock wave lithotripsy (SWL) and
ureteroscopy (URS) being acceptable options.
METHODS A total of 200 patients were included in the study. They were randomized into 2 equal groups.
Group A underwent in situ SWL as a primary therapy. Group B underwent URS, using semirigid
URS with intracorporeal lithotripsy. Efficiency quotient (EQ), cost analysis, and predictors of
failure were estimated for both techniques.
RESULTS For stones of size ⱖ 1 cm, the initial stone-free rate for URS and SWL was 88% and 60%,
respectively. The estimated EQ was 0.79 and 0.43 for both techniques respectively. For stones ⬍
1 cm, the initial stone-free rate for URS and SWL was 100% and 80%, respectively. The
estimated EQ was 0.88 and 0.70 for both techniques, respectively. The mean cumulative costs
were significantly more in SWL group (P ⬍.05). Predictors of URS failure included; male gender,
failure to pass guidewire beyond the stone, and extravasation. Predictors of SWL failure included
large stone size ⬎ 1 cm, calcium oxalate monohydrate stone, and higher degrees of hydrone-
phrosis.
CONCLUSIONS URS with intracorporeal lithotripsy is an acceptable treatment modality for all proximal ureteral
calculi, particularly stones ⬎ 1 cm. SWL should remain the first-line therapy for proximal
ureteral calculi ⱕ 1 cm because of the less invasive nature and lower anesthesia (i.v.
sedation). UROLOGY 74: 1216 –1222, 2009. © 2009 Elsevier Inc.

T
he treatment options for proximal ureteral calculi niques to establish the best treatment modality for the
include medical expulsive therapy, shock wave management of solitary radio-opaque upper ureteral
lithotripsy (SWL), ureteroscopy (URS), percuta- stones ⬍ 2 cm in diameter.
neous antegrade URS, laparoscopy, and open surgical
ureterolithotomy.1 Both SWL and URS are acceptable MATERIAL AND METHODS
first-line treatment for the management of symptomatic
ureteral calculi of size ⱕ 1 cm in the proximal ureter, After Institutional Review Board approval, 200 patients were
whereas the ideal treatment for stones ⬎ 1 cm remains to included in the study and were randomized into 2 equal groups.
Every odd number patient was given in A for SWL and even
be determined with SWL and URS being an acceptable
number in B for URS. The indications for interference included
options.2 Changes in SWL technology, endoscopic de- calculi that failed to pass spontaneously, recurrent renal colic,
sign, and intracorporeal lithotripsy improved dramati- and obstructive uropathy.
cally over the past 5 years.3 However, prospective ran- The inclusion criteria included solitary unilateral radio-
domized trials comparing the 2 modalities of treatment opaque calculi 5-20 mm in size and a functioning kidney. The
are generally lacking. other kidney should be functioning and nonobstructive.
We conduct a prospective randomized study compar- The exclusion criteria included pregnancy, pediatric group,
ing the outcome, safety, and efficacy of both the tech- multiple, bilateral, and radiolucent stones, nonfunctioning kid-
ney, associated renal stones requiring therapy or lower ureteric
stones in the ipsilateral side, stones ⬎ 20 mm in size, uremia,
sepsis, ureteral abnormalities, coagulative disorders, and body
From the Department of Urosurgery, Kasr El-Einy Hospital, Cairo, Egypt
Reprint requests: Hosni Khairy Salem, M.D., Department of Urosurgery, Kasr
habitus precluding either technique. The upper ureter was de-
El-Einy Hospital, PO Box 247 Giza, 12515 Egypt. E-mail: dr_hosni@yahoo.com fined as the part of the ureter between the pelviureteric junc-
Submitted: September 16, 2008, accepted (with revisions): June 10, 2009 tion and the upper border of the sacroiliac joint.

1216 © 2009 Elsevier Inc. 0090-4295/09/$34.00

All Rights Reserved doi:10.1016/j.urology.2009.06.076
Table 1. Mean patient age, gender, stone size, and operative time
Mean Age (Range) (y) Male-to-Female Ratio Mean Stone Size (Range) (mm) Mean Operation Time (min)
ⱖ 1 cm
URS 36.7 (20-48) 30:18 12.2 (12-20) 38.1 (25-66)
SWL 35.4 (37-55) ns 27:15 ns 12.5 (11-20) ns 65.7 (50-75) ns
⬍ 1 cm
URS 41.2 (36-50) 35:17 6.8 (6-9) 30.5 (22-54)
SWL 42.8 (37-60) ns 43:15 ns 6.2 (5-9) ns 55.4 (40-70) ns
ns indicates nonsignificant, P ⬎.05.

Table 2. Procedure count (primary ⫹ secondary, and adjunctive), stone-free rate, and EQ
No. Primary Stone-Free Secondary ⫹ Adjunctive Total No. of
Procedure Rate Procedures Procedures EQ
ⱖ 1 cm
URS 48 (30m, 18f) 44 (88%) 2 PCNL, 2 OPEN ⫹ 6 DJ ⫽ 10 58 0.79
SWL 42 (27m, 15f) ns 25 (60%) ns 12 reSWL ⫹ 5URS ⫽ 17 ns 59 ns 0.43*
⬍ 1 cm
URS 52 (35m, 17f) 52 7 DJ 59 0.88
SWL 58 (43m, 15f) ns 46 (80%) ns 10 reSWL ⫹ 2URS ⫽ 12 ns 70 ns 0.70 ns
EQ indicates efficiency quotient, PCNL, antegrade URS, DJ, DJ catheter; ns, nonsignificant, P ⬎.05.
* Statistically significant, P ⬍.05.

Preoperative urine analysis and culture were done; appropri- (primary ⫹ retreatment ⫹ auxiliary) or the percent of stone-free
ate antibiotics were given before intervention. Preoperative rate divided by 100 ⫹ (retreatment ⫹ auxiliary procedures).
image protocol for every patient included ultrasound (US), and All preoperative and postoperative data for both groups were
excretory radiography (intravenous pyelography) to comment recorded. Predictors of failure in either technique were esti-
on the stone size, site, and obstructive uropathy. mated by univariate and multivariate analysis.
In situ SWL (without stenting) was done as a primary ther- Statistical methods:
apy (Dornier HM3 Medical System, Inc., Wessling, Germany) Mean was used as the best estimate.
under i.v. sedation, with shock wave voltage ranging between Statistical significance at P ⬍.05 level (two-tailed) was used.
13 and 18 kV and maximum number limited to 3000 shock
waves. Univariate and multivariate analysis was used to compare
group’s variables.
URS was done as a primary therapy under spinal or general
anesthesia using 8.5-11 F semirigid URS, with diameter gradu-
ated from its tip till its base (Karl Storz Endoscopy-Germany). RESULTS
We started by cystoscopy with retrograde pyelography, place-
ment of 0.038-inch floppy-tip guidewire past the stone (glide
URS was performed as a primary procedure in 100 patients,
guidewire when necessary) to maintain access. Dilatation was including 48 patients with stones of size ⱖ 1 cm, whereas
limited to the intramural part in 30% of cases. Intracorporeal SWL was performed as a primary procedure in 100 patient
lithotripsy (Swiss LithoClast EMS, Nyon, Switzerland) was including 42 patients with stones of size ⱖ 1 cm.
used to fragment the stones, which were then extracted by Mean patient age, stone size, and operative time are
forceps. At the end, ureteric catheter or double J (DJ) was left summarized in Table 1.
in patients with large stone burden and/or extravasations. For stones 1 cm or greater the results are summarized in
The postoperative image protocol for every patient included Table 2.
biweekly KUB and US, with intravenous pyelography after 3 The initial stone-free rate for URS was 88% (44/48).
months to monitor the recovery of hydronephrosis and stone DJ stent was fixed in 6 cases (ancillary procedure) to
passage. We defined successful outcome when the patient is facilitate postoperative passage of the stones (5 cases) and
stone-free without any residual fragments (by KUB and US) 2 due to mild extravasations in 1 case. There were 4 failures
weeks after the primary procedure. (all were males) due to dislodgment of the stone in the
Cost analysis was assessed on the basis of cumulative fees of
kidney in 2 cases that were managed by ante grade URS
preoperative evaluation, operative costs, office visits including
through the smallest amplatz sheath in a tubeless man-
emergency room visits, and secondary and auxiliary procedures.
ner. The remaining 2 cases were converted to open
We also assessed the procedure count per patient (to render him
stone-free), including primary, secondary, and auxiliary proce- surgery because of failure to reach the stones to pass
dures. Efficiency quotient (EQ) determines the stone-free rate guidewire.
in relation to repeat lithotripsy as well the number of auxiliary By contrast, the initial stone-free rate for SWL was
procedures performed to render the patient stone-free.4 EQ was 60% (25/42). The estimated EQ was 0.43, which was
calculated to specifically address the efficiency for both the significantly lower than that of URS (0.79) (P ⬍.05).
techniques. It is calculated by the following formula: number of There were 17 failures; 12 cases were managed by suc-
stone-free patients divided by the total number of procedures cessful second session SWL (retreatment procedure),

UROLOGY 74 (6), 2009 1217

Table 3. The morbidity (complications) and anesthesia for Table 4. Clavien grading system to evaluate the compli-
both modalities cations of both modalities
URS SWL Grade URS SWL
Extravasation 4 (Double J) — 0 No complications 73 46
Fever 2 (antibiotics) 0 1 Deviation from normal postoperative 10 23
Hematuria 2 (Anti-bleeding) 3 (Anti-bleeding) course without the need for
ER visits for renal 5 (Analgesics) 20 (Analgesics) intervention
colic (2 cases required 2 Minor complications requiring 0 2
hospitalization) intervention
Postoperative 1.2 3.5 3a Complications requiring intervention 13 22
office visits without general anesthesia
(average) 3b Complications requiring intervention 4 7
Anesthesia Spinal (82) and i.v. sedation with general anesthesia
general (18) 4a Life-threatening complications requiring 0 0
intensive care management (single
ER indicates emergency room.
organ dysfunction)
4b Life-threatening complications requiring 0 0
intensive care management (multiple
whereas the remaining 5 cases underwent successful URS organ dysfunction)
(ancillary procedure). 5 Death 0 0
For stones ⬍ 1 cm the results are summarized in Table 2.
The initial stone-free rate for URS was 100% (52 of 52).
DJ stent was fixed in 7 cases (ancillary procedure) to
between stone composition and success rate in each
facilitate postoperative passage of the stones (4 cases) and
modality is shown in Table 5.
due to mild extravasations in 3 cases.
The anesthetic technique did not have an effect on the
The initial stone-free rate for SWL was 80% (46/58)
outcome of URS.
after the primary procedure. There were 12 failures. They
Univariate and multivariate analysis were used to as-
were managed by successful second session SWL in 10
sess the predictors of failure in each modality (Table 6).
cases (re-treatment procedure), whereas the remaining 2
Predictors of URS failure included male gender, failure to
cases underwent successful URS (ancillary procedure).
pass guide wire beyond the stone, and extravasations,
No significant difference as regard the EQ was found
whereas the predictors of SWL failure included large
between both the techniques (0.88 and 0.70, respec-
stones of size ⬎ 1 cm, calcium oxalate monohydrate
tively) (P ⬍.05).
stone, and higher degrees of hydronephrosis.
As regard complications in the URS group, 4 cases had
Although the average costs after the initial treatment
mild extravasation and were managed by DJ fixation.
were more in URS group, the mean cumulative costs
Two diabetic cases had mild fever that was managed by
were significantly more in SWL group (P ⬍.05).
antibiotics and 2 cases had mild hematuria that was
Table 7 shows the details of cost analysis of both
managed by anti-bleeding measures in the form of
modalities.
konakion i.m. tds and dicynone i.v. tds till the bleeding
stopped. None required hospitalization for further man-
agement. COMMENT
By contrast, in the SWL group, 20 patients required This study showed that over all, for stones in the proxi-
visits to the emergency room for treatment of renal colic mal ureter (n ⫽ 200), URS had higher stone-free rate
induced by stone migration; 2 of them required hospital- than SWL. The difference in the stone-free rate, and the
ization till the renal colic relieved. Three cases had mild EQ was statistically significant for stones ⬎ 10 mm in
hematuria for a few days that was controlled by anti- diameter (n ⫽ 90). For stones ⬍ 10 mm in diameter
bleeding measures. Postoperative office visits were more (n ⫽ 110), URS had a higher stone-free rate than SWL
for SWL group (average 3.5 for SWL group vs 1.2 for but the difference was not statistically significant.
URS group). URS was associated with higher stone-free rate, and
Tables 3 and 4 show the morbidity of both modalities the number of procedures necessary were less. URS was
and the Clavien grading system for the complications. associated with better chance of becoming stone-free
Concerning the variables affecting the outcome, stone with a single procedure, but had a slightly higher com-
size did not influence the efficiency of URS but it did plication rate.
influence the efficiency of SWL because significant dif- Stone-free rate after URS did not vary significantly
ference in the EQ was noted between large (0.43) and with size (100% vs 88%), whereas the stone-free rate
small stones (0.70) P ⬍.05. after SWL negatively correlated with stone size (80% vs
Stone composition included calcium oxalate monohy- 60%). The success rate in our study correlated with the
drate 25% (50), mixed 24% (48), dihydrate 5% (10), findings in previous studies.5-8
calcium carbonate 20% (40), calcium phosphate 10% Changes in SWL technology, endoscopic design, and
(20), and not determined in 16% (32). The relationship intracorporeal lithotripsy improved dramatically over the

1218 UROLOGY 74 (6), 2009

Table 5. The relationship between stone composition and success rate in each modality
Stone Composition n (%) URS Success SWL Success
Calcium oxalate monohydrate 50 (25) 35 35/35 15 1/15
Mixed 48 (24) 20 19/20 28 24/28
Dihydrate 10 (5) 8 7/8 2 2/2
Calcium carbonate 40 (20) 20 19/20 20 16/20
Calcium phosphate 20 (10) 12 11/12 8 8/8
Not determined 32 (16) 5 5/5 27 20/27
Total 200 (100) 100 96/100 100 71/100

Table 6. Predictors of failure in each modality

URS Univariate Multivariate SWL Univariate Multivariate
Failures 4/100 (4%) 29/100 (29%)
Stone composition of failure cases
Calcium oxalate monohydrate 0/35 14/15
Mixed 1/20 4/28
Dihydrate 1/8 ns ns 0/2 * *
Calcium carbonate 1/20 4/20
Calcium phosphate 1/12 0/8
Not determined 0/5 7/27
Hydronephrosis of failure cases
Present 1/4 ns ns 25/29 * *
Absent 3/4 4/29
EQ according to stone size
⬎ 1 cm 0.79 0.43 * *
⬍ 1 cm 0.88 ns ns 0.70
Gender of failure cases
Male 4/4 16/29 ns ns
Female 0/4 ns * 13/29
EQ indicates efficiency quotient, ns, nonsignificant; P ⬎.05.
* Statistically significant, P ⬍.05.

Table 7. Analysis of all costs for both modalities scope had improved the success rate of URS for proximal
URS* SWL* ureteral calculi, particularly if holmium:YAG laser was
Item (EP) (EP) used for intracorporeal lithotripsy.13,14 Many adjunctive
Preoperative investigations 500 350 measures have contributed to the enhanced success of
Operation 3000 2500 ureteroscopic management of ureteral calculi; the intro-
Secondary & adjunctive procedures 1000 1500 duction of devices to prevent stone migration during
Post operative investigations and 700 1000 lithotripsy (stone cone and N trap),15 small nitinol-made
office visits Basket devices,14 ureteral access sheaths,16 digital uret-
Postoperative ER visits for renal colic 150 1150
Auxiliary procedures 350 — eroscope,17 and wireless and sheathless ureteroscope.18
Total 5700 6500 All this advancement improved the efficacy and reduced
EP indicates Egyptian pound.
morbidity associated with ureteroscopic management of
* Mean cost. upper ureteral calculi. URS is now deemed appropriate
for stones of any size in the proximal ureter.19
past 10 years. However, these technological improve- However, these new technologies are very expensive
ments added much to URS technique than to SWL and not accessed by many institutions in the developing
technique. countries (as the case in our study) and need technical
As regard SWL, the introduction of the second- and skills and frequent repair.20 In the present study, we used
third-generation lithotripter with high peak pressure and semirigid ureteroscope because at the start of the study,
smaller focal zones had not been associated with improve- we had no access to flexible ureteroscope; however, we
ments in stone-free rates or reduction in the number of currently started study comparing semirigid ureteroscope
procedures needed. These newer generations have much and flexible ureteroscope in the management of upper
less anesthesia, minimal tissue injury, but this at the cost of ureteral stones.
efficacy. These newer generations did not replace the stone- Cost comparison in our study showed that the total
free rates of the original HM3 (the one used in our study) charges (initial procedures, additional procedures, radio-
and they have a higher retreatment rate.9,10 graphs, postoperative office visits) for SWL were more
As regard URS, smaller available ureteroscope (7.5F) than URS, although the initial charges were more for
allowed URS without dilatation.11,12 Flexible uretero- URS. If similar study using flexible ureteroscope instead

UROLOGY 74 (6), 2009 1219

of rigid ureteroscope, this cost comparison may not be the for all proximal ureteral calculi particularly stones ⱖ 1
same because flexible ureteroscope is less durable and cm in size. This can be applied in the developing
more expensive than semirigid ureteroscope. countries where new technology cannot accessed. Al-
Advocates of SWL stated that it can be done under i.v. though no significant difference was noticed in the EQ
sedation, of less invasive nature, high patient tolerance between the 2 modalities, SWL should remain the
even with repeat SWL, and rarity of adverse effects. Also, first-line therapy for proximal ureteral calculi of size ⬍ 1
it avoids the problem of stenting associated with URS cm because of less invasive nature and lower anesthe-
and the expense of stent fixation and later on removal by sia (i.v. sedation).
secondary cystoscopy.21,22 The final decision is made between the patient and the
Proponents for URS stated that it can be done with urologist weighing several factors, such as benefit risk
minimal anesthetic technique as an ambulatory surgi- ratio of the modality, success rate, costs, health care
cal procedure with high success rates and limited need facility, availability of various technology, predictors of
for secondary procedures.23,24 Also, many patients failure, and patient preference.
have the desire to be stone-free in 1 session because
the access to the health care might be too expensive
for ancillary or repeat procedures in many countries.25 References
Moreover, recent studies have proved that routine 1. Preminger GM, Assimos DG, Lingeman JE, et al. Report on the
stenting after uncomplicated URS may not be neces- management of staghorn calculi. Available at: http://www.auanet.
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Several points add strength to our study—a prospec- extracorporeal shock wave lithotripsy and ureteroscopy in the
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36:376-379.
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ary and auxiliary procedures. Many of these points were 10. Lam JS, Greene TD, Gupta M. Treatment of proximal ureteral
lacking in previous studies. calculi: holmium:YAG laser ureterolithotripsy versus extracorpo-
real shock wave lithotripsy. J Urol. 2002;167:1972-1976.
However, our study had certain limitations. Com- 11. Liong ML, Dayman RV, Gittes RF, et al. Treatment options for
position of the stone was undetermined in 16% of proximal ureteral uro-lithiasis: review and recommendations.
cases, pediatric age group and body mass index were J Urol. 1989;141:504-509.
not included, and we had no access to new technolo- 12. Tawfiek ER, Pagley DH. Management of upper urinary tract calculi
gies (flexible URS with laser fragmentation) at the with ureteroscopic techniques. Urology. 1999;53:25-31.
13. Bagley DH, Huffnan JL, Lyon ES. Combined rigid and flexible
start of the study; however, we are currently doing a
urteropyeloscopy. J Urol. 1983;130:243-244.
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dex and patient preference for the comparison between 15. Maislos SD, Volpe M, Albert PS, et al. Efficacy of the stone cone
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18. Johnson GB, Portela D, Grasso M. Advanced ureteroscopy: wireless detection after surgical removal, so the reported SFR in the
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19. Chow GK, Patterson DE, Blute ML, et al. Ureteroscopy: effect of Even though the authors discuss the use of flexible URS for
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99-102.
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20. Goel R, Aron M, Kesarwani PK, et al. Percutaneous antegrade
ible URS is a safe and efficient technique for stone fragmenta-
removal of impacted upper-ureteral calculi: still the treatment of
choice in developing countries. J Endourol. 2005;19:54-57. tion above the level of the iliac vessels with better access to the
21. Park H, Park M, Park T. Two year experience with ureteral stones: proximal ureter, thereby decreasing the chance of ureteral in-
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Chicago, IL: AMA Publishing; 2002:706. Overall, the current study supports the recent EAU-AUA
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REPLY
ureteral calculi. Arch Esp Urol. 1996;49:86-91. We read with great interest the comments given by Dr. Dorit
30. Watterson JD, Girvan AR, Cook AJ, et al. Safety and efficacy of and Dr. Glenn regarding our article, as they have raised 2
holmium: YAG laser lithotripsy in patients with bleeding diatheses. points.
J Urol. 2002;168:442-445.
The first comment was about imaging protocol after shock
wave lithotripsy and ureteroscopy.
We agree that noncontrasted spiral computed tomography is
the gold standard imaging modality for stone detection after
EDITORIAL COMMENT surgical removal, but in our hospital, only 1 unit of computed
In this prospective randomized study, the authors compare tomography is available for all specialties, including urology;
shock wave lithotripsy (SWL) and ureteroscopy (URS) for the hence, for this imaging modality there were strict indications
management of proximal ureteral calculi ⬎ 1 cm. Both groups and priorities (tumor staging, trauma, stroke, etc.), and at the
were comparable in terms of stone size, patient’s age, and sex. start of the study, it was not possible to prospectively perform
SWL was associated with more postoperative office and emer- this imaging modality for 200 patients. In our study, we in-
gency room (ER) visits for pain management, and had a higher cluded only radio-opaque stones and started follow-up 2 weeks
percentage of complications (using the Calvien grading sys- after intervention by using KUB and ultrasound; the definition
tem), as compared with URS. URS was associated with higher of successful outcome was the patient being stone free without
stone-free rates (SFR) and found to be superior in treating any residual fragments (by KUB and ultrasound) 2 weeks after
calcium oxalate monohydrate stones. Overall, URS scored the primary procedure. We did not overestimate the stone-free
higher in terms of the efficiency quotient (EQ) for stones ⱖ 1 rates in our study because if we depended on such a protocol
cm as compared with SWL. Finally, the mean total cost for after 3 months, the success rates (stone-free rates) would have
SWL was significantly higher as compared with URS when definitely increased.
taking into account additional office and ER visits as well as The second point regarding the use of flexible ureteroscopy
auxiliary procedures needed for the management of residual for upper ureteral stone treatment.
stones after SWL. Flexible ureteroscopy has been primarily indicated to treat
The authors should be commended for completing this large, extracorporeal shock wave lithotripsy–resistant renal stones,
well-organized, prospective trial that looks specifically at the but with changes in the technology of incorporating secondary
treatment of proximal ureteral stones ⱖ 1 cm. Yet, we would active deflection and availability of laser fibers, its horizon for
not recommend biweekly imaging, not only because of cost, indications to treat stones is being widened.
inadequacy, and radiation considerations but also as stones can When the cost of the treatment is a major constraint, we
pass up to 3 months after SWL. Most protocols use imaging should think sensibly to deliver healthcare with efficacy and the
performed at 3 months of follow-up as the standard time to safety on the basis of the available evidence.
determine the success of their treatment modality. Moreover, The advantages of the flexible ureteroscopes are their ability
most investigators would argue that noncontrasted spiral CT is to safely negotiate the angulations of the ureter; they can also
now considered the gold standard imaging modality for stone access the entire upper collecting system in ⬎ 90% of patients

UROLOGY 74 (6), 2009 1221