JOURNAL OF ENDOUROLOGY

Volume 32, Number 10, October 2018

ª Mary Ann Liebert, Inc.
Pp. 923–927
DOI: 10.1089/end.2018.0222

Comparison of Safety and Efficacy in Preventing

Postoperative Infectious Complications of a 14/16F
Ureteral Access Sheath with a 12/14F Ureteral Access
Sheath in Flexible Ureteroscopic Lithotripsy

Yuntian Chen, MD,1,* Banghua Liao, MD,1,* Shijian Feng, MD,1 Donghui Ye, MD,1
Guohua Zeng, PhD,2 Kunjie Wang, PhD,1 and Ming Shi, PhD1
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Abstract
Purpose: There are a variety of ureteral access sheath (UAS) lengths (13–55 cm) and diameters (9.5/11.5F–16/
18F) available in the market. However, urologists are faced with a dilemma when choosing the ideal UAS
diameter. Thus, we evaluated a case–control study of the efficacy and safety of 12/14F and 14/16F UASs in
flexible ureteroscopic lithotripsy.
Materials and Methods: A retrospective case–control study was evaluated with patients who were treated with
flexible ureteroscopic lithotripsy for urinary calculi in a West China hospital from 2008 to 2017. Patients
deployed a 12/14F UAS were divided into group A, and the others were divided into group B. The primary
outcome was the postoperative infectious complication rate after the operation, including fever and sepsis. The
second outcome included safety, lithotripsy time, and the stone-free rate.
Results: There were 1139 patients in total included in our study, with 593 patients divided into group A and 546
divided into group B. There was no significant difference between the baselines of the two groups’ patients. The
patients in group A had a significantly lower postoperative rate compared to the patients in group B (6.4% vs
1.6%). The 14/16F UAS also worked better in high-risk patients, such as patients with stones >2 cm or patients
with infectious stones (7.6% vs 1.6%, 15.0% vs 3.1%, respectively).
Conclusions: Our study found that the 14/16F UAS showed an obvious advantage in preventing postoperative
infectious complications in flexible ureteroscopic lithotripsy compared to the 12/14F UAS.

Keywords: flexible ureteroscopic lithotripsy, ureteral access sheath, infectious complications

Introduction complish better complex surgical tasks, such as biopsy and

retrograde pyelogram, because it enables the ureteroscope to
enter and exit the ureter smoothly.3 In endoscopic surgery for
T he ureteral access sheath (UAS) is regarded as one
of the most important advances in endoscopic manage-
ment. In 1974, the first UAS, also called a ‘‘guide tube,’’ was
urolithiasis, the advantages of UAS placement have also been
proven. A larger series of studies has indicated that UAS
put into use to make a passage for the flexible ureteroscope.1 placement could improve the effectiveness of surgery, facili-
Over the past 35 years, urologists have made numerous im- tate ureteroscopic access, and decrease intrarenal pressure and
provements to the design of the UAS, such as adding a hy- postoperative complications in ureteroscopic lithotripsy.4–9
drophilic coating to enlarge the passage of the sheath, using a To fit the different sizes of ureters and equipment, a variety
hub-locking mechanism to fit the dilator and sheath together of lengths (13–55 cm) and diameters (9.5/11.5F–16/18F) of
and applying a kink-resistant design.2 UAS are available on the market. The length and diameter of
UAS placement has a documented benefit in urologic a UAS are chosen based on the sex, age, and ureter conditions
surgery. Deploying a UAS allows the ureteroscope to ac- of the patient. As for the length, a 36-cm UAS is appropriate
1
Department of Urology, Institute of Urology (Laboratory of Reconstructive Urology), West China Hospital, Sichuan University,
Chengdu, P.R. China.
2
Department of Urology, Guangdong Key Laboratory of Urology, The First Affiliated Hospital of Guangzhou Medical University,
Department of Urology, Guangzhou, P.R. China.
*Both authors contributed equally to this work.
Part of this article has been selected and accepted for presentation at the 36th World Congress of Endourology, Paris, France on
September 20–23, 2018.

923
 924
in most female patients and a 36- or 46-cm sheath in most
male patients. However, when considering the diameter of
the UAS, urologists are faced with a dilemma.
Urologists have been searching for an ideal sheath that
could decrease the intrarenal pressure as much as possible
and be easy enough to deploy to avoid ureteral injury, be-
cause persistent intrarenal pressure can result in postopera-
tive infection, even infective shock, in flexible ureteroscopic
surgery for urolithiasis. The American Urological Associa-
tion (AUA) guideline also indicated that controlling the in-
trarenal pressure to a proper level is particularly important to
prevent postoperative infection.10 Theoretically, a sheath
with a larger diameter will decrease the intrarenal pressure to
a lower level. Thus, it seems that the diameter of the sheath
should be chosen to be as large as possible. However, some
vivo studies did not support the assertion that a larger UAS
could provide lower intrarenal pressure.11 Besides, a larger
UAS was thought to cause a ureteral wall injury more easily.
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Furthermore, there have been no large clinical studies on that
problem. As a result, there was still no recommendation on
whether a large or small UAS was better for calculus patients.
The 12/14F and 14/16F sheaths are mostly used in flexible
ureteroscopy for urolithiasis for most patients without ure-
teral strictures. Thus, we evaluated a case–control study on
the efficacy and safety of the 12/14 F and 14/16F UASs in
flexible ureteroscopic lithotripsy.
Materials and Methods
Study design and participants
We evaluated a retrospective case–control single center
study on the efficacy and safety of UASs. We included all
patients who were treated with flexible ureteroscopic litho-
tripsy for urinary calculi in a West China hospital from 2008 to
2017. The patients with a ureteral stricture, abnormality, or
other metabolic disease, such as renal tubule acidosis or hy-
perparathyroidism, were excluded from the study. All eligible
patients were divided into two groups: group A included pa-
tients who were administered the 12/14F (Cook Medical) UAS
in the operation, while patients who were administered the 14/
16F (Cook Medical) UAS were divided into group B. All op-
erations were performed by the same skilled surgeon (K.W.).
Preoperative procedures
Patients received a ureteral stent placement 2 weeks before
the operation. A plain film of kidney, ureter, and bladder ra-
diograph (KUB) and a noncontrast CT were also taken after
admission. Blood-routine, urine-routine, and urine cultures
were done to identify whether there was anemia, urinary in-
fection, thrombocytopenia, or any other situation that needed
managing before the operation. All patients who did not have
infectious symptoms and negative urine culture received sin-
gle dose oral antibiotics prophylaxis 1 day before operation
(usually ceftriaxone sodium). If patients have positive urine
culture, antibiotic treatment according to sensitivity pattern is
used until the urine culture changes to negative. Intraoperative
antibiotics were used routinely in the operation.
Surgical technique
The ureteral stent was taken out using ureteroscopy at the
beginning of the operation. Then, a working wire and safety
CHEN ET AL.
wire were placed into the ureter cystoscopically. Before the
placement, the UAS was soaked on its inner and outer sur-
faces on the back table and then advanced over a stiff wire.
Dexamethasone and furosemide were used at the same time
by the anesthetist. The obturator and working wire were re-
moved after the sheath was in the desired location, a standard
ureteroscope (Olympus-P5 5.3F) was placed through the
sheath, and the lithotripsy was performed. Irrigation (90 mL/
minute) was done to keep the surgical vision clear. After the
lithotripsy, the ureteroscope was removed from the ureter
with the sheath, and the ureteral wall was checked for injury.
A Double-J stent was placed in patients after the procedure
for about 2 weeks.
Outcome measures and statistical analyses
The patients’ age, sex, and body mass index were recorded
in the medical record. The size(s), location(s), and number of
stones were also collected. In addition, a composition anal-
ysis of the calculi was conducted for all patients. The size(s)
of the stones was calculated using the superimposition of the
max diameters. Struvite calculi and carbonate-apatite calculi
were treated as infectious calculi.
The primary outcome was the postoperative infectious
complication rate after the operation, including fever and sep-
sis. Fever was defined as a patient temperature of ‡38.5C.
Patients were treated as having sepsis when they had more than
two of the following symptoms: (1) obnubilation, (2) systolic
pressure of £100 mm Hg, or (3) respiratory rate of ‡22 ac-
cording to the sepsis-3 guideline.12
The second outcome included safety, lithotripsy time, and
the stone-free rate. Safety was assessed by detecting the
condition of the ureteral wall at the end of the operation,
which was evaluated according to the ureteral injury grad-
ing.13 Lithotripsy time was defined as the full time that the
laser worked. The stone-free rate was defined as no more than
a 2-mm residual stone presented in a postoperative KUB.
Continuation data were analyzed using a t-test or analysis
of variance if they followed a normal distribution. Otherwise,
a nonparametric test would be conducted. Dichotomous data
were analyzed by chi-square analysis if their simple size
was ‡40 and theoretical frequency ‡5. Otherwise, Fisher’s
test was conducted. All statistical analyses were conducted
using R 3.0.
Results
Patient characteristics
There were 1139 patients in total included in our study,
with 593 patients divided into group A and 546 divided into
group B. There was no significant difference between the
baselines of the two groups’ patients (Table 1). Among all
enrolled patients, 128 patients had infectious calculi, in-
cluding 60 patients in group A and 68 patients in group B.
The primary outcome
Overall postoperative infectious complication rate. Only
three patients presented with sepsis in group A and one in
group B. As for the postoperative fever rate, patients in group
B had a significantly lower postoperative fever rate compared
with patients in group A (1.6%, 9/545 vs 6.4%, 38/593,
p < 0.001) (Fig. 1).
 INFECTIOUS COMPLICATIONS AND URETERAL ACCESS SHEATH 925

Table 1. The Overview and Comparison patients suffered a ureteral wall injury during the operation,
of Baseline of Patients in Group A including 29.1% of patients who suffered a grade I injury and
and Patients in Group B 7.9% who suffered a grade II injury in group A. The situation
was not significantly worse in group B, in which 38.6% of
Group A Group B p
patients suffered a ureteral wall injury during the operation,
No. of patients 593 546 including 30.4% of patients who suffered a grade I injury and
Male, gender 274 234 n.s. 8.2% who suffered a grade II injury ( p = 0.679, 0.651, and
Age at surgery, years 47.53 – 12.254 46.57 – 11.887 n.s. 0.074 for totally injury, grade I injury, and grade II injury,
Body mass index 21.48 – 4.6 22.37 – 3.7 n.s. respectively) (Fig. 2).
Stone size, cm 1.86 – 1.1 1.91 – 1.2 n.s.
Stone location
Upper calix 46 51 n.s. Lithotripsy time and stone-free rate. In our study, pa-
Medium calix 184 172 n.s. tients in group B showed a significant advantage in average
Lower calix 99 82 n.s. lithotripsy time compared to patients in group A (19.5 – 14.9
Ureter 130 121 n.s. minutes vs 16.811 – 12.9 minutes, p < 0.001) (Fig. 2). This
Multiple 134 120 n.s. advantage did not alter in patients with calculi larger than
Stone component 2 cm or from the infectious calculus patient subgroup, in
Calcium oxalate 512 480 n.s. which patients in group B had average lithotripsy times of
Calcium phosphate 49 63 n.s. 23.74 – 13.85 and 18.5 – 11.42 minutes, respectively, while
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Struvite 11 12 n.s.
Others 26 21 n.s.
Postoperative complication rate in large calculi and infec-
tious calculi patients. When only considering patients whose
calculi were larger than 2 cm, the difference became larger.
Still, only 1.6% (4/241) of patients had a postoperative fever
in group B, while 7.6% (15/195) of patients suffered a post-
operative fever in group A ( p < 0.001) (Fig. 1).
As for patients with infectious calculi, patients in group B
(4/68, 5.1%) still had a lower postoperative rate than patients
in group A (9/60, 15%; p < 0.001) (Fig. 1).
The second outcome
The safety assessment. Only three patients failed to
deploy the 14/16F UAS after the preoperative ureteral stent
operation, and they were detected to have a ureteral stricture
that was not found by a preoperative CT scan. They effec-
tively finished the operation with a 12/14F UAS.
We did not record any grade III or grade IV ureteral wall
injuries in our study. As for slight ureteral wall injuries, 38%
the average lithotripsy times were 26.33 – 16.58 minutes and
22.53 – 12.59 minutes, respectively, in group A ( p = 0.042
and p < 0.001, respectively).
There was no significant difference in the stone-free rate
between group A and group B at the 4-week follow-up (90.1%
vs 89.6%, p = 0.861).
Discussion
Infectious complications, such as sepsis or infectious
shock, are the most common and dangerous complications of
flexible ureteroscopic lithotripsy.14 One of the core functions
of a UAS is to control intrarenal pressure to prevent infec-
tious complications. In our study, we found that compared
with the 12/14F UAS, the 14/16F UAS had a significant
advantage in preventing infectious postoperative complica-
tions, especially in some patients at a high risk for infection,
while it did not significantly increase the ureteral wall injury

FIG. 1. Comparison of postoperative fever rate in all pa-

tients, patients with stones >2 cm, and patients with infectious
stones between group A (12/14F UAS) and group B (14/16F FIG. 2. The comparison of ureteral wall condition after
UAS). *Means the comparison has statistical significance operation between the patients of group A and patients of
( p < 0.05). UAS = ureteral access sheath. group B.
 926
rate. As we know, it is the first large clinical study of the
efficacy and safety of UASs with different diameters.
The 14/16F UAS showed a high and stable efficacy in
preventing postoperative infectious complications. Larger
stones and infectious stones were recorded in many studies as
predicative factors for a postoperative fever.15,16 However,
among all the patients administered the 14/16F UAS in our
study—regardless of the size or component of their stones—
the postoperative fever rate was relatively low and stable. In
contrast, when the stone size became larger, the postoperative
fever rate significantly increased in the 12/14F group. In
patients with stones smaller than 2 cm, the fever rate was
only 5.7%, while the fever rate was 7.6% in those who had
stones larger than 2 cm. What is more, when we only took
those who had infectious stones into account, the fever rate
increased to 15.0%. Actually, due to the relatively high in-
fection rate of flexible ureteroscopic lithotripsy, many urolo-
gists recommended choosing percutaneous nephrolithotomy
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to deal with large or infectious calculi. Our results provided
new evidence that with a 14/16F UAS, flexible ureteroscopic
lithotripsy can deal with such complicated stones effectively
and safely.
The advantage of a 14/16F UAS is twofold. First, it can
decrease the intrarenal pressure to a lower level. Although a
study in vivo in 201011 indicated that when the working
channel of a flexible ureteroscope is occupied with a 2.4F
basket, a larger UAS did not improve the intrarenal irrigant
flow. However, this study also found that when the working
channel is empty, the 14/16F laser caused about six times
the irrigant flow with a hydrostatic column of about 1 m in
height. In other words, when urologists are searching for the
target calculi or working with a laser, the 14/16F UAS
works much better. This conclusion was also found in an-
other study conducted in 2016, which demonstrated that a
lower scope-to-sheath ratio, which was defined as the ratio
of the diameters of the scope and sheath, caused a greater
irrigant flow.17 A larger scope-to-sheath ratio can not only
maintain a lower intrarenal pressure but also rinse out the
residual stone faster when needed, resulting in a shorter
lithotripsy time. Our result also supported the finding that
the 14/16F UAS shortened the lithotripsy time compared to
the 12/14F UAS, making the operation safer, which is the
second advantage of the 14/16F UAS. The ‘‘dusting’’
technique has become a trend recently. In our experience
large sheath still has significant advantage when surgeons
use the ‘‘dusting’’ strategy, especially on the patients with
large stone burden. First, large sheath provides greater flow
rate, which means better surgical vision. Besides, large
sheath also enables surgeon to wash the residual stone out
more smoothly and quickly with the same water perfusion.
Both of the above advantages can significantly shorten the
operation time so as the postoperative infection rate.
One of the major concerns with using a large UAS is the
possibility of ureteral wall injury, which may lead to the
formation of ureteral strictures. Our results showed that
compared with the 12/14F UAS, deploying the 14/16F UAS
did not increase the risk of ureteral wall injury. Our result was
also better than those of some other clinical studies on the 12/
14F UAS, where the total rate of ureteral wall lesions was
46.5%, including 13.3% of patients who had a severe injury
involving the smooth muscle layer.18 The possible reason for
the relatively low injury rate was the preoperative stenting of
CHEN ET AL.
all patients before deploying the UAS. We placed the ureteral
stent at least 2 weeks before the operation, which can de-
crease the ureteral wall injury rate effectively in our experi-
ence. Although it may increase the medical cost, we still
recommend that all patients who will use the 14/16F UAS
during the operation receive a preoperative stent.
In this study, dexamethasone and furosemide were given at
time of sheath placement because our experience and some
study indicated that giving dexamethasone and furosemide
can decrease postoperative infectious rate.19,20 The possible
mechanism is that furosemide has diuretic action which can
help the irrigation and decrease the regurgitation of the toxin
and urine, as well as the dexamethasone which can decrease
the inflammatory response. Prestenting was done in all pa-
tients before operation in our study. It is a hot topic that if
prestenting could benefit patients. Many studies have indi-
cated that prestenting has better effect in patients with large
stones. For example, Jessen and colleagues21 have indicated
that prestenting is an excellent concept to lower complication
rate. Chu L’s cost effective analysis indicated that prestenting
could decrease cost of ureteroscopy especially with stones
>1 cm.22 In our study, the average stone size was 1.89 –
1.1 cm, while the minimum stone size was 1.04 cm. In such
situation, prestenting in all patients was necessary. Our study
is limited by its retrospective nature. However, it could still
provide guidance for choosing the ideal UAS. In addition, we
could not follow-up with the patients who suffered a ureteral
wall injury, because most of our patients were out of touch
after confirming that their stones were free. We should aim to
evaluate a prospective study to confirm whether deploying a
14/16F UAS increases the risk of ureteral stricture formation.
Conclusion
Our study found that the 14/16F UAS showed an obvious
advantage in preventing postoperative infectious complica-
tions in flexible ureteroscopic lithotripsy compared to the 12/
14F UAS. We highly recommended using the 14/16F UAS in
patients with stones larger than 2 cm or with infectious
stones. Furthermore, with a preoperative stent, the deploy-
ment of a 14/16F UAS does not increase the possibility of a
ureteral wall injury.
Acknowledgments
Supported by (1) 1.3.5 project for disciplines of excellence,
West China Hospital, Sichuan University (ZY2016104), (2)
Central financial fund, Guangzhou Medical University
(2010A060801016).
Author Disclosure Statement
No competing financial interests exist.
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Address correspondence to:
Kunjie Wang, PhD
Department of Urology
Institute of Urology (Laboratory of Reconstructive Urology)
West China Hospital
Sichuan University
No. 37 Guo Xue Xiang
Chengdu, Sichuan 610041
P.R. China
E-mail: wangkj@scu.edu.cn
Abbreviations Used
CT ¼ computed tomography
KUB ¼ kidney, ureter, and bladder radiograph
UAS ¼ ureteral access sheath