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- scopes and lithotripsy devices, so that the majority of cases
scopic stone fragmentation is considered the standard of care may be treated without ureteral dilation, making the proce-
at most institutions today. The main advantage of stenting is dure relatively atraumatic. As a result, we questioned
the prevention of ureteral obstruction and renal colic that whether routine stent placement is required after uncompli-
may develop as a result of ureteral edema from balloon dila- cated ureteroscopic lithotripsy. We determined whether
tion or stone manipulation during ureteroscopy. Ureteral stents may be eliminated after uncomplicated ureteroscopy
stents may also aid in the passage of stone fragments sec- for ureteral stones, which would eliminate stent related
ondary to the passive ureteral dilation that occurs with in- symptoms and morbidity, and improve patient satisfaction
dwelling ureteral stenting. Furthermore, it has also been with ureteroscopic lithotripsy.
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 METHODS
in the literature of a 10% to 85% incidence of stent related This study was designed as a prospective randomized con-
symptoms and/or morbidity.1–5 Moreover, ureteral stents add trolled trial and performed at our institutions after approval
some expense to the overall procedure of ureteroscopy and by the ethics review boards at each institution. To detect a
unless a pull string is routinely used at the distal end of the 30% difference in the proportion of stent related complica-
stent secondary cystoscopy is required for stent removal. tions in the treatment groups at a significance level of 0.05
Ureteroscopy is now performed with small caliber endo- and a power of 80% a sample size of 29 patients per group
Accepted for publication December 15, 2000.
was calculated. Randomization was done in a block random-
Supported by a grant from the Innovations for Patient Care Re- ization schedule according to the protocol devised by Peto et
search Fund, St. Joseph’s Health Care, London, Ontario, Canada al.6
and the R. Samuel McLaughlin Foundation of Canada. Adults 18 years or older were considered eligible for study
* Financial and/or other relationship with Boston Scientific and if they were scheduled for ureteroscopy for ureteral calculus
Cook Urological.
† Financial and/or other relationship with Boston Scientific. at any ureteral level. Patients were excluded from study
‡ Financial and/or other relationship with Cook Urological. when stone size was greater than 2 cm., previous ureteros-
1419
1420 PROSPECTIVE TRIAL OF NONSTENTED VERSUS STENTED URETEROSCOPIC LITHOTRIPSY
copy had been performed and had failed for treatment of the ysis and urine culture at each postoperative visit as well as
same stone or there was a history of urinary tract infection, by renal ultrasound 3 months postoperatively. Treatment
sepsis, renal failure, solitary kidney or pregnancy. Patients groups were analyzed using intent-to-treat analysis. Contin-
were also not considered eligible if a ureteral stent was in uous data (visual analog scales and analgesic requirements)
place at the time of treatment or if one had been indwelling were compared using the 2-tailed Student t test with com-
up to 30 days before definitive ureteroscopy for the same mercially available computer software.
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. RESULTS
Surgery for the ureteral stone was performed in standard
fashion using general anesthesia and a 6.9Fr semirigid or A total of 71 patients were enrolled in the study and un-
7.5Fr flexible, actively deflectable ureteroscope with a safety derwent a ureteroscopic procedure for stone treatment. Of
guide wire within the ureter. Generally, rigid ureteroscopy these patients 58 were randomized at the end of the uretero-
was done for distal ureteral stones and most mid ureteral scopic procedure, including 29 to the stented and 29 to the
stones, while the flexible ureteroscope was used for most nonstented group. The remaining 13 patients were not ran-
calculi in the upper ureter. Stones were fragmented with the domized because they did not meet the secondary intraoper-
holmium laser in all patients except 1 in the stented group, ative eligibility criteria of the study. As a result, stents were
who was treated with electrohydraulic lithotripsy. A hol- placed in the ureters of these patients at the conclusion of the
mium laser pulse energy of 0.6 to 1.2 J. and pulse frequency ureteroscopic procedure and they were excluded from study.
of 5 to 10 Hz. was used for laser lithotripsy. Patients were The reason for ineligibility was balloon dilation of the ureter
randomized to treatment groups after the stone had been to 18Fr in 6 cases and the clinical decision that a stent was
completely fragmented to particles less than 3 mm. for un- necessary because of significant ureteral edema at the site of
complicated procedures (no ureteral perforation) and when stone impaction in 7. Since these patients were not random-
the operating urologist thought that no circumstances were ized, they were not included in the analysis of the 2 treat-
present in which a stent should normally be placed (signifi- ment groups.
cant edema or tissue reaction causing ureteral obstruction). The 2 patient groups were comparable with respect to the
No attempt was made to remove stone fragments with bas- baseline variables of patient age, stone location and mean
kets or graspers. Instead stone fragments were left in situ, stone size (table 2). Mean operative time plus or minus stan-
allowing spontaneous passage. dard deviation in the nonstented group was 34 ⫾ 14 minutes
In patients randomized to the stented group a double pig- (range 15 to 72) compared to 36 ⫾ 20 (range 15 to 85) in the
tail ureteral stent was placed in the treated ureter under stented group. Mean recovery room time was 62 ⫾ 35 min-
fluoroscopic monitoring. In the nonstented treatment group utes (range 30 to 211) in the nonstented group compared to
the safety wire was removed from the ureter and the proce- 60 ⫾ 19 (range 25 to 95) in the stented group. There was no
dure was terminated. All patients were then followed 1, 6 and significant difference in the treatment groups. All patients
12 weeks postoperatively. In patients randomized to the were treated on an outpatient basis.
stented group the ureteral stents were removed at the first Table 3 shows the mean visual analog scores at 1, 6 and 12
visit using flexible cystoscopy at the urology clinic. weeks. At 1 week the mean visual analog score in the stented
The 4 outcomes measured were postoperative patient group was much higher than in the nonstented group. This
symptoms, postoperative analgesic requirements, stone-free result was highly statistically significant (p ⬍0.005). At 6
status, and early and late postoperative complications. At and 12 weeks patients had few symptoms and the mean
each followup visit postoperative symptoms were measured visual analog scores were not statistically different in the
using a patient questionnaire and a 10 cm. visual analog groups. There was no difference in the 2 treatment groups for
scale, on which 0 represented no symptoms and 10 repre- the amount of analgesic required in the recovery room or
sented severe symptoms. The visual analog scores measured during week 1 after ureteroscopy. Similarly there was no
the symptoms of flank pain, abdominal pain, dysuria, and difference in the number of patients requiring antiemetics
problems of urinary frequency and urgency. Postoperative (table 4).
analgesic and antiemetic requirements were evaluated in the Concerning postoperative complications, 1 patient in the
recovery room and also for week 1 after surgery. The recovery stented group required hospitalization for intravenous anti-
room value was based on the number of doses of narcotics biotics as a result of genitourinary sepsis and 1 in the non-
and/or oral codeine administered while in the post- stented group had postoperative vomiting that resulted in a
anesthesia recovery area. The outpatient value was deter- visit to the emergency room for antiemetics. This patient did
mined by asking patients to record the number of doses of not require hospital admission for treatment overnight. None
oral analgesic and antiemetic medications required during of the patients in the nonstented group were returned to the
week 1 after the ureteroscopic procedure. Table 1 shows the operating room for stenting because of pain and/or obstruc-
coding and scoring scheme used for this measure. Stone-free tion. Furthermore, no hydronephrosis or ureteral stric-
status was determined by plain x-ray of the kidneys, ureters tures were detected by 3-month postoperative followup
and bladder at each postoperative visit until clear. Compli- ultrasound. The stone-free rate has been 100% in each
cations were measured by the patient questionnaire, urinal- treatment group.
these data were not available when we designed our clinical for stones treated at any ureteral level. Ureteral stenting
trial and the standard of care at our centers at that time was after ureteroscopy and intracorporeal lithotripsy do not ap-
to place a stent after balloon dilation because of concern pear to be necessary if ureteral dilation is not performed,
about postoperative edema and obstruction. It is clear from there is no ureteral injury or pronounced ureteral edema and
their data that the majority of these patients do well when a an atraumatic lithotripsy device such as the holmium laser is
stent is not placed. Despite these findings until now we have used for intracorporeal lithotripsy. Implementing this prac-
continued to advocate stent placement after ureteral dilation, tice would improve the quality of patient care as it relates to
simply because it appears to be difficult to predict which ureteroscopy.
patients may have problems with postoperative pain due to
edema.
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