0022-5347/01/1655-1419/0

THE JOURNAL OF UROLOGY® Vol. 165, 1419 –1422, May 2001

Copyright © 2001 by AMERICAN UROLOGICAL ASSOCIATION, INC.® Printed in U.S.A.

A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING

NONSTENTED VERSUS STENTED URETEROSCOPIC LITHOTRIPSY
JOHN D. DENSTEDT,* TIM A. WOLLIN,† MARIO SOFER, LINDA NOTT, MICHAEL WEIR AND
R. JOHN D’A. HONEY‡
From the Division of Urology, University of Western Ontario, London, St. Michael’s Kidney Stone Center, University of Toronto, Toronto,
Ontario, and Division of Urology, University of Alberta, Edmonton, Alberta, Canada

ABSTRACT

Purpose: A prospective randomized controlled trial was performed to determine whether stents
may be eliminated after uncomplicated ureteroscopic lithotripsy for ureteral stones.
Materials and Methods: A total of 58 patients underwent uncomplicated ureteroscopic intra-
corporeal lithotripsy. After stone fragmentation patients were randomized to a nonstented (29) or
a stented (29) treatment group. Intracorporeal lithotripsy was performed with the holmium laser
in 57 cases and by electrohydraulic lithotripsy in 1 without balloon dilation or the extraction of
stone fragments. Patients were followed 1, 6 and 12 weeks postoperatively. In stented cases the
stent was removed at 1 week. Outcome measures included postoperative symptoms assessed with
a visual analog scale, postoperative analgesic requirements, complications and the stone-free
rate.
Results: At 1 week the symptoms of flank pain, abdominal pain, dysuria and frequency were
significantly greater in the stented group (p ⬍0.005). There were no differences in symptoms in
the groups at subsequent followup visits. There was no difference in treatment groups in terms
of the amount of analgesic required in the recovery room or during 1 week after ureteroscopy.
Similarly there was no difference in the number of patients requiring antiemetics. One patient
in the stented group required hospitalization for genitourinary sepsis and 1 patient in the
nonstented group visited the emergency room for postoperative vomiting. The stone-free rate was
100% in each group.
Conclusions: These results demonstrate that after ureteroscopic intracorporeal lithotripsy with
the holmium laser patients with a stent have significantly greater irritative and painful symp-
toms than those without a stent in the early postoperative period. There was no difference in
nonstented and stented ureteroscopy with respect to complications or stone-free status. There-
fore, we believe that routine stenting after ureteroscopic intracorporeal lithotripsy with the
holmium laser is not required as long as the procedure is uncomplicated and performed without
balloon dilation of the ureteral orifice.
KEY WORDS: ureter; ureteral calculi; lithotripsy, laser; stents

The routine placement of ureteral stents after uretero-
scopic stone fragmentation is considered the standard of care
at most institutions today. The main advantage of stenting is
the prevention of ureteral obstruction and renal colic that
may develop as a result of ureteral edema from balloon dila-
tion or stone manipulation during ureteroscopy. Ureteral
stents may also aid in the passage of stone fragments sec-
ondary to the passive ureteral dilation that occurs with in-
dwelling ureteral stenting. Furthermore, it has also been
thought that stenting may promote ureteral healing and
prevent ureteral stricture. However, recognized complica-
tions have been associated with the use of stents with reports
in the literature of a 10% to 85% incidence of stent related
symptoms and/or morbidity.1–5 Moreover, ureteral stents add
some expense to the overall procedure of ureteroscopy and
unless a pull string is routinely used at the distal end of the
stent secondary cystoscopy is required for stent removal.
Ureteroscopy is now performed with small caliber endo-
Accepted for publication December 15, 2000.
Supported by a grant from the Innovations for Patient Care Re-
search Fund, St. Joseph’s Health Care, London, Ontario, Canada
and the R. Samuel McLaughlin Foundation of Canada.
* Financial and/or other relationship with Boston Scientific and
Cook Urological.
† Financial and/or other relationship with Boston Scientific.
‡ Financial and/or other relationship with Cook Urological.
1419
scopes and lithotripsy devices, so that the majority of cases
may be treated without ureteral dilation, making the proce-
dure relatively atraumatic. As a result, we questioned
whether routine stent placement is required after uncompli-
cated ureteroscopic lithotripsy. We determined whether
stents may be eliminated after uncomplicated ureteroscopy
for ureteral stones, which would eliminate stent related
symptoms and morbidity, and improve patient satisfaction
with ureteroscopic lithotripsy.
METHODS
This study was designed as a prospective randomized con-
trolled trial and performed at our institutions after approval
by the ethics review boards at each institution. To detect a
30% difference in the proportion of stent related complica-
tions in the treatment groups at a significance level of 0.05
and a power of 80% a sample size of 29 patients per group
was calculated. Randomization was done in a block random-
ization schedule according to the protocol devised by Peto et
al.6
Adults 18 years or older were considered eligible for study
if they were scheduled for ureteroscopy for ureteral calculus
at any ureteral level. Patients were excluded from study
when stone size was greater than 2 cm., previous ureteros-
1420 PROSPECTIVE TRIAL OF NONSTENTED VERSUS STENTED URETEROSCOPIC LITHOTRIPSY
copy had been performed and had failed for treatment of the
same stone or there was a history of urinary tract infection,
sepsis, renal failure, solitary kidney or pregnancy. Patients
were also not considered eligible if a ureteral stent was in
place at the time of treatment or if one had been indwelling
up to 30 days before definitive ureteroscopy for the same
stone. It was believed that this period was sufficiently long to
allow the ureter to return to its normal anatomical caliber
following passive stent dilation. Patients were enrolled in the
study after informed consent was obtained.
Surgery for the ureteral stone was performed in standard
fashion using general anesthesia and a 6.9Fr semirigid or
7.5Fr flexible, actively deflectable ureteroscope with a safety
guide wire within the ureter. Generally, rigid ureteroscopy
was done for distal ureteral stones and most mid ureteral
stones, while the flexible ureteroscope was used for most
calculi in the upper ureter. Stones were fragmented with the
holmium laser in all patients except 1 in the stented group,
who was treated with electrohydraulic lithotripsy. A hol-
mium laser pulse energy of 0.6 to 1.2 J. and pulse frequency
of 5 to 10 Hz. was used for laser lithotripsy. Patients were
randomized to treatment groups after the stone had been
completely fragmented to particles less than 3 mm. for un-
complicated procedures (no ureteral perforation) and when
the operating urologist thought that no circumstances were
present in which a stent should normally be placed (signifi-
cant edema or tissue reaction causing ureteral obstruction).
No attempt was made to remove stone fragments with bas-
kets or graspers. Instead stone fragments were left in situ,
allowing spontaneous passage.
In patients randomized to the stented group a double pig-
tail ureteral stent was placed in the treated ureter under
fluoroscopic monitoring. In the nonstented treatment group
the safety wire was removed from the ureter and the proce-
dure was terminated. All patients were then followed 1, 6 and
12 weeks postoperatively. In patients randomized to the
stented group the ureteral stents were removed at the first
visit using flexible cystoscopy at the urology clinic.
The 4 outcomes measured were postoperative patient
symptoms, postoperative analgesic requirements, stone-free
status, and early and late postoperative complications. At
each followup visit postoperative symptoms were measured
using a patient questionnaire and a 10 cm. visual analog
scale, on which 0 represented no symptoms and 10 repre-
sented severe symptoms. The visual analog scores measured
the symptoms of flank pain, abdominal pain, dysuria, and
problems of urinary frequency and urgency. Postoperative
analgesic and antiemetic requirements were evaluated in the
recovery room and also for week 1 after surgery. The recovery
room value was based on the number of doses of narcotics
and/or oral codeine administered while in the post-
anesthesia recovery area. The outpatient value was deter-
mined by asking patients to record the number of doses of
oral analgesic and antiemetic medications required during
week 1 after the ureteroscopic procedure. Table 1 shows the
coding and scoring scheme used for this measure. Stone-free
status was determined by plain x-ray of the kidneys, ureters
and bladder at each postoperative visit until clear. Compli-
cations were measured by the patient questionnaire, urinal-
TABLE 1. Postoperative analgesic requirement scoring system
Score Recovery Room Postop. Wk. 1
5 Greater than 3 morphine Any ketoralac tromethamine dose
doses
4 1–3 Morphine doses Greater than 10 acetaminophen
with codeine doses
3 Greater than 3 acetaminophen 6–9 Acetaminophen with codeine
with codeine doses doses
2 1–3 Acetaminophen with co- 1–5 Acetaminophen with codeine
deine doses doses
1 No pain medication No pain medication
ysis and urine culture at each postoperative visit as well as
by renal ultrasound 3 months postoperatively. Treatment
groups were analyzed using intent-to-treat analysis. Contin-
uous data (visual analog scales and analgesic requirements)
were compared using the 2-tailed Student t test with com-
mercially available computer software.
RESULTS
A total of 71 patients were enrolled in the study and un-
derwent a ureteroscopic procedure for stone treatment. Of
these patients 58 were randomized at the end of the uretero-
scopic procedure, including 29 to the stented and 29 to the
nonstented group. The remaining 13 patients were not ran-
domized because they did not meet the secondary intraoper-
ative eligibility criteria of the study. As a result, stents were
placed in the ureters of these patients at the conclusion of the
ureteroscopic procedure and they were excluded from study.
The reason for ineligibility was balloon dilation of the ureter
to 18Fr in 6 cases and the clinical decision that a stent was
necessary because of significant ureteral edema at the site of
stone impaction in 7. Since these patients were not random-
ized, they were not included in the analysis of the 2 treat-
ment groups.
The 2 patient groups were comparable with respect to the
baseline variables of patient age, stone location and mean
stone size (table 2). Mean operative time plus or minus stan-
dard deviation in the nonstented group was 34 ⫾ 14 minutes
(range 15 to 72) compared to 36 ⫾ 20 (range 15 to 85) in the
stented group. Mean recovery room time was 62 ⫾ 35 min-
utes (range 30 to 211) in the nonstented group compared to
60 ⫾ 19 (range 25 to 95) in the stented group. There was no
significant difference in the treatment groups. All patients
were treated on an outpatient basis.
Table 3 shows the mean visual analog scores at 1, 6 and 12
weeks. At 1 week the mean visual analog score in the stented
group was much higher than in the nonstented group. This
result was highly statistically significant (p ⬍0.005). At 6
and 12 weeks patients had few symptoms and the mean
visual analog scores were not statistically different in the
groups. There was no difference in the 2 treatment groups for
the amount of analgesic required in the recovery room or
during week 1 after ureteroscopy. Similarly there was no
difference in the number of patients requiring antiemetics
(table 4).
Concerning postoperative complications, 1 patient in the
stented group required hospitalization for intravenous anti-
biotics as a result of genitourinary sepsis and 1 in the non-
stented group had postoperative vomiting that resulted in a
visit to the emergency room for antiemetics. This patient did
not require hospital admission for treatment overnight. None
of the patients in the nonstented group were returned to the
operating room for stenting because of pain and/or obstruc-
tion. Furthermore, no hydronephrosis or ureteral stric-
tures were detected by 3-month postoperative followup
ultrasound. The stone-free rate has been 100% in each
treatment group.
TABLE 2. Study population baseline variables
No Stent Stent
Mean age ⫾ SD (range) 54 ⫾ 15 (30–81) 49 ⫾ 15 (21–76)
No. males 19 17
No. females 10 12
Stone ureteral location:
Distal 23 20
Mid 3 5
Upper 3 4
Mean stone size 9 ⫾ 4 mm. (range 4 to 19).
 PROSPECTIVE TRIAL OF NONSTENTED VERSUS STENTED URETEROSCOPIC LITHOTRIPSY 1421
TABLE 3. Mean visual analog scores 1, 6 and 12 weeks ureter before ureteroscopy.10 The majority of patients (82%)
postoperatively had no pain postoperatively or discomfort for less than 1 day
Mean No Stent Mean Stent Score that was controlled with oral analgesia. Six patients (6.4%)
p Value
Score ⫾ SD (range) ⫾ SD (range) required hospitalization after ureteroscopy because of ongo-
1 Wk.: ing pain. However, 5 of these 6 patients had already been
Flank pain 1.7 ⫾ 2.5 (0–9.2) 4.1 ⫾ 2.9 (0–10) 0.001 hospitalized for renal colic preoperatively and postoperative
Abdominal pain 0.9 ⫾ 1.5 (0–5) 3.5 ⫾ 2.9 (0–9) 0.001 pain was such that immediate hospital discharge was not
Dysuria 1.0 ⫾ 1.5 (0–5) 5.1 ⫾ 3.3 (0–10) 0.001
Frequency 1.6 ⫾ 1.9 (0–6.5) 5.5 ⫾ 3.1 (0–9.9) 0.001
possible.
6 Wks.: In the other study Rane et al did not place a stent in 44
Flank pain 0.25 ⫾ 0.6 (0–2.4) 1.0 ⫾ 2.0 (0–9.6) Not significant patients treated with ureteroscopy for distal ureteral
Abdominal pain 0.3 ⫾ 0.6 (0–1.8) 0.6 ⫾ 2.0 (0–10) Not significant stones.11 A 9Fr semirigid ureteroscope was used in 31 cases
Dysuria 0.04 ⫾ 0.07 (0–0.2) 0.2 ⫾ 0.6 (0–2.3) Not significant
Frequency 1.0 ⫾ 1.7 (0–6) 1.1 ⫾ 2.0 (0–7.8) Not significant
and a 7.5Fr semirigid scope was used in the remainder. No
12 Wks.: balloon dilation was done. At followup 1 patient was rehos-
Flank pain 0.28 ⫾ 0.7 (0–2.4) 0.2 ⫾ 0.5 (0–2.1) Not significant pitalized with flank pain, while 2 complained of mild lower
Abdominal pain 0.1 ⫾ 0.2 (0–1.1) 0.1 ⫾ 0.3 (0–1) Not significant abdominal pain and urinary frequency during week 1 post-
Dysuria 0.02 ⫾ 0.06 (0–0.3) 0.03 ⫾ 0.1 (0–0.5) Not significant
Frequency 0.8 ⫾ 1.7 (0–5.9) 0.4 ⫾ 1.0 (0–4.6) Not significant
operatively.
The current standard of care as it relates to stenting after
ureteroscopy is still evolving. Nevertheless, based on our
randomized study, and the results of Hosking10 and Rane11 et
TABLE 4. Analgesic scores and patients requiring antiemetics
al routine stenting in all cases after uncomplicated uretero-
postoperatively
scopic lithotripsy no longer appears to be necessary. How-
No Stent Stent ever, it must be emphasized that until other prospective
Mean analgesic score ⫾ SD (range 1 to 5): trials verify our data these results apply only to the tech-
Recovery room 2.5 ⫾ 1.7 2.8 ⫾ 1.4 nique of ureteroscopy described in this study, namely uret-
Postop. wk. 1 2.0 ⫾ 1.2 2.2 ⫾ 1.1
No. pts. treated with antiemetics:
eroscopic stone fragmentation with the holmium laser with-
Recovery room 5 9 out basketing the stone fragments from the ureter. The
Postop. wk. 1 1 2 holmium laser creates smaller stone fragments than the
other common intracorporeal lithotriptors in use today.12
With electrohydraulic or pneumatic lithotripsy the larger
fragments produced may potentially cause more problems
DISCUSSION
with spontaneous passage. We believe that if fragments are
With the relatively recent development of small caliber manipulated, it is possible that these results would not be
ureteroscopes and more effective intracorporeal lithotripsy applicable. Stone fragments may be retrieved for stone anal-
devices it is now possible to perform ureteroscopy in most ysis by straining the urine immediately after the procedure,
patients without ureteral dilation.7 As a result, ureteroscopic thus, obviating the need for routine basketing.13 Further-
stone fragmentation has become a relatively atraumatic pro- more, in our experience with tertiary care referral practice
cedure.8, 9 It is our belief that because of these technological we routinely perform a large volume of ureteroscopies in
advances, postoperative stent symptoms have now become clinical practice. Thus, these results must be interpreted
the most morbid part of ureteroscopic stone removal in the within this clinical context.
majority of patients. Potential complications associated with In addition, the patient population in our study was a
stenting for short periods after ureteroscopy include stent select group. Patients were not enrolled in the study if they
dysuria, frequency and flank pain, hematuria, stent migra- had a stone greater than 2 cm., had undergone previous
tion, urosepsis and ureteral erosion.1–5 Moreover, stents add ureteroscopy for the same stone or there was a history of
to the cost of ureteroscopic stone treatment and cystoscopy is sepsis, solitary kidney or renal failure. Patients were only
required for stent removal unless a pull string is routinely randomized to a treatment group when ureteral dilation had
used on the distal end. Therefore, if a ureteral stent were not been performed, the ureteroscopic procedure was uncom-
eliminated in select patients, it would improve the quality of plicated (no evidence of ureteral perforation) and there was
patient care associated with ureteroscopic lithotripsy. no evidence of clinically significant ureteral edema that
This prospective controlled study objectively demonstrates would cause ureteral obstruction. We believe that in these
that ureteral stenting after uncomplicated ureteroscopic clinical situations a stent should still be routinely placed to
stone fragmentation is no longer absolutely necessary in all avoid postoperative complications.
cases. Patients in whom a stent was not placed had no in- We recognize that the latter criterion is somewhat subjec-
creased rate of complications after ureteroscopy compared to tive and difficult to quantify objectively. The decision not to
those in the stented group. Instead these patients had an randomize was made according to operating surgeon discre-
improved early postoperative course with respect to the usual tion and represented a judgment decision based on the
irritable voiding symptoms and flank pain compared to the amount of edema and inflammation at the site of stone im-
stented group. This difference was statistically significant. paction. Generally patients were not randomized and a stent
Furthermore, the primary objective of ureteroscopic treat- was placed when there was edema that appeared to be sig-
ment (achieving a stone-free result) was also not compro- nificantly compromising the ureteral lumen. More re-
mised by eliminating a stent. In addition, although cost anal- cently, we have been performing retrograde ureterography
ysis was not performed for this clinical trial, a direct cost through the ureteroscope before removal or through an
savings to the health care system would be anticipated by the open ended ureteral catheter at the end of the procedure to
decreased use of stents, balloon dilators, baskets-graspers observe ureteral drainage on fluoroscopy. Visualizing a
and secondary procedures to remove the stent. Indirect cost free flow of contrast material into the bladder indicates
savings in the form of patient time lost from work because of that it is unlikely that there may be problems with post-
stent symptoms and return visits for stent removal would ureteroscopic edema and obstruction. This easy test adds
also be expected in the nonstented group. some objectivity to the intraoperative clinical decision of
Reported experience of nonstented ureteroscopic litho- whether to place a ureteral stent.
tripsy is small.10, 11 In the clinical series of Hosking et al 93 Based on the experiences of Hosking et al10 one may argue
consecutive patients were treated with nonstented ureteros- that patients who underwent ureteral balloon dilation poten-
copy, of whom 82 (88%) underwent balloon dilation of the tially did not need to be eliminated from the study. However,
1422 PROSPECTIVE TRIAL OF NONSTENTED VERSUS STENTED URETEROSCOPIC LITHOTRIPSY
these data were not available when we designed our clinical
trial and the standard of care at our centers at that time was
to place a stent after balloon dilation because of concern
about postoperative edema and obstruction. It is clear from
their data that the majority of these patients do well when a
stent is not placed. Despite these findings until now we have
continued to advocate stent placement after ureteral dilation,
simply because it appears to be difficult to predict which
patients may have problems with postoperative pain due to
edema.
Patients with a stent in place within 30 days of treatment
were not enrolled in our study. The 2 institutions participat-
ing in this study are tertiary referral sites for stone manage-
ment and the majority of ureteroscopy cases are referred
from other urologists. Thus, many of our patients invariably
have a stent in place, and so this exclusion criterion affected
accrual into the study. Nevertheless, we believed that it was
important to adhere to this exclusion criterion because if it
were shown that nonstented ureteroscopy was possible in
previously unstented ureters, the results may be extrapo-
lated to patients with a stent in place before ureteroscopy.
Passive dilation of the ureter should only help to prevent
obstructive symptoms after stone manipulation. In fact, dur-
ing the last 9 months of the trial we offered nonstented
ureteroscopic lithotripsy to our patients with a stent in place
who were, therefore, ineligible for study. An additional 98
patients were treated in this fashion. These cases have au-
tomatically been entered into our database and they have
been followed prospectively. As in our nonstented study
group, none of these patients had problems in the postoper-
ative period without a stent. Therefore, we believe that our
results may be extrapolated to this patient group as well.
Since this practice represents a considerable departure
from the philosophy of care related to the treatment of pa-
tients who undergo ureteroscopy, it is paramount to inform
patients that if they remain without a stent, there is a slight
possibility of flank pain or colic that may require stenting
within 48 hours after ureteroscopy. However, in our experi-
ence to date the majority of patients are willing to elect this
slight risk to avoid the potential irritating symptoms of a
stent postoperatively.
CONCLUSIONS
These results of stented versus nonstented ureteroscopic
stone fragmentation reveal that patients without a stent
have significantly fewer symptoms in the early postoperative
period. There were no differences in treatment groups in
terms of postoperative complications and stone-free status
for stones treated at any ureteral level. Ureteral stenting
after ureteroscopy and intracorporeal lithotripsy do not ap-
pear to be necessary if ureteral dilation is not performed,
there is no ureteral injury or pronounced ureteral edema and
an atraumatic lithotripsy device such as the holmium laser is
used for intracorporeal lithotripsy. Implementing this prac-
tice would improve the quality of patient care as it relates to
ureteroscopy.
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