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Original Article
Abbreviations & Acronyms Objectives: To compare the performance and surgical outcomes of two different
$A = Australian dollars single-use digital flexible ureteroscopes with a reusable video flexible ureteroscope.
CI = confidence interval Methods: Patients undergoing retrograde flexible ureteroscopy at Nepean Hospital,
ECIRS = endoscopic Sydney, Australia, were included in this study. Three different flexible ureteroscopes
combined intrarenal surgery were used in this study: (i) single-use digital LithoVue (Boston Scientific, Marlborough,
fURS = flexible MA, USA); (ii) single-use digital PU3022A (Pusen, Zhuhai, China); and (iii) reusable digital
ureteroscopes URF-V2 (Olympus, Tokyo, Japan). Visibility and maneuverability was rated on a 5-point
NS = non significant Likert scale by the operating surgeon. Operative outcomes and complications were
NSW = New South Wales collected and analyzed.
PCNL = percutaneous Results: A total of 150 patients were included in the present study. Of these, 141
nephrolithotomy patients had ureteroscopy for stone treatment, four for endoscopic combined intrarenal
surgery and five for diagnostic/tumor treatment. There were 55 patients in the LithoVue
Correspondence: Jonathan group, 31 in the PU3022A group and 64 patients in the Olympus URF-V2 group. The
Kam B.Med., B.Sci. (Med) URF-V2 group had higher visibility scores than both the single-use scopes and higher
(Hons), M.D., Department of maneuverability scores when compared with the PU3022A. The LithoVue had higher
Urology, Gosford Hospital, visibility and maneuverability scores when compared with the PU3022A. There were no
Holden Street, Gosford, NSW differences in operative time, rates of relook flexible ureteroscopes, scope failure or
2250, Australia. Email: complication rates observed.
jonathan.s.kam@gmail.com Conclusions: Single-use digital flexible ureteroscopes have visibility and
maneuverability profiles approaching that of a reusable digital flexible ureteroscope.
Received 15 January 2019;
Single-use flexible ureteroscopes achieve similar clinical outcomes to the more expensive
accepted 16 July 2019.
reusable versions.
Key words: endoscopes, kidney calculi, laser lithotripsy, renoscopy, ureteroscopy.
Introduction
First described in 1987, single-use digital fURS have only recently gained increasing use.1
Decreasing costs and improved performance have resulted in a higher uptake of the single-
use fURS in some major tertiary referral stone centers.2,3 Concerns over the sterilizing process
for reusable fURS and their link to the transmission of infection between patients, and an
increasing consciousness about the environmental impact of fURS4 have also elevated the
profile of single-use fURS.5 Several studies have shown that single-use fURS are becoming
more economically viable, especially in lower-volume centers and for cases with a higher risk
of damage to reusable fURS.6–8 Several studies have shown that reusable fURS suffer damage
requiring repair after 10–25 cases.9,10 Once a ureteroscope has been repaired, it is more likely
to be damaged again, requiring further repair.9 The fragility of reusable fURS can result in
significant repair costs over time, which has also driven the increased uptake of single-use
fURS in some centers.
There are many single-use digital fURS already on the market, including LithoVue (Boston
Scientific, Marlborough, MA, USA), PU3022A (Pusen, Zhuhai, China), Polyscope (Lumenis,
Yokneam, Israel, Polydiagnost, Hallbergmoos, Germany), Semi-Flex Scope (Maxiflex, Los
Angeles, CA, USA), FlexoVue (Cook Medical, Bloomington, IN, USA) and Yc-FR-A
(YouCare Tech, Wuhan, China).11 In vitro testing has shown the second group (Disposable 2) used the single-use
that single-use scopes have equivalent optics, deflection abil- PU3022A (Pusen). The third group (Reusable) utilized the
ity and working channel flow rates to more expensive reusa- reuseable digital URF-V2 (Olympus). It is not feasible to
ble scopes.12–17 blind surgeons to the fURS used given the nature of this
In vivo testing has been limited. A European multicenter study. Selection of the fURS was based on the availability of
evaluation of the single-use LithoVue in 40 procedures found each type of fURS and individual operator preference on the
that operators rated the image quality as “good” or “very day of surgery.
good” in 95% of cases. Maneuverability was also rated simi- Preoperative data on all patients were collected in a
larly in 90% of these cases.2 A case–control study comparing prospectively maintained database. The number, location and
LithoVue with the reusable fiber-optic URF-P6 (Olympus, size of calculi were evaluated by computed tomography scan-
Tokyo, Japan), found comparable procedural outcomes and ning. Total stone burden was defined as the sum of the lar-
complication rates.3 That study also found that the overall, gest diameter of each calculi present. At the end of each
mean procedure time was 10 min shorter in cases using the case, the surgeon was asked to rate on a 5-point Likert scale
LithoVue.3 A recent systematic review found no difference in (1, bad; 2, poor; 3, fair; 4, good; 5, very good) the visibility
operative time, stone clearance or complications between dis- and maneuverability of the fURS for each case. This subjec-
posable and reusable fURS.18 tive 5-point Likert scale was based on the original in vivo
There are currently no in vivo studies comparing the per- assessment of the LithoVue ureteroscope by Doizi et al.2
formance of the different types of single-use fURS. To date, Scope failure was defined as the fURS’s condition being
just two studies have compared single-use scopes with mod- unsuitable to complete the procedure and a different fURS
ern reusable video fURS. One study of 34 patients compared being required to complete the case. Readmission and com-
the LithoVue with the fiber-optic URF-P5/P6 (Olympus) and plications within 30 days were classified according to the
the digital Flex Xc (Storz, Tuttlingen, Germany), and showed Clavien–Dindo system.21,22 Subanalysis for patients undergo-
that the LithoVue scored lower on most user comfort and ing fURS (without concurrent PCNL) for renal calculi were
maneuverability scores.19 Another study of 136 patients carried out to reduce heterogeneity in the sample population.
showed similar operative outcomes and complications A theoretical cost analysis comparing the costs of repair of
between the Flex Xc/X2S and LithoVue.20 reusable fURS with the costs of the disposable fURS was
The present study aimed to compare the operative perfor- carried out. All costings are reported in $A ($A1 is approxi-
mance of two single-use digital fURS with a reusable video mately $US0.75). As our institution has a no-fault institution-
fURS. We hypothesized that single-use fURS would have a wide contract for all endoscopes, it was not possible to calcu-
similar performance to reusable fURS with a lower scope late the exact cost incurred for each reusable fURS repair. A
failure rate. cost of $26 000 for each reusable fURS purchase and
$10 000 per major repair was selected for our theoretical
analysis, which is in line with the costs reported in other
Methods
fURS cost analysis articles.20
A prospective, single-center, cross-sectional study was carried Data were analyzed using IBM SPSS Statistics for Win-
out by the Nepean Urology Research Group at Nepean dows, version 24.0 (IBM Corporation, Armonk, NY, USA).
Hospital, Sydney, NSW, Australia, from January 2016 to Normality tests were carried out on continuous variables.
November 2017. Nepean Hospital is a high-volume, tertiary Comparisons between multiple groups were carried out with
referral center for complex stone disease situated in Sydney, analysis of variance tests followed by post-hoc Tukey hon-
Australia. The inclusion criteria were: (i) patients undergoing estly significant difference tests. Non-parametric Kruskal–
retrograde fURS for the management of renal calculi, tumors Wallis tests followed by Mann–Whitney U-tests were carried
and ureteric strictures or ECIRS; (ii) aged >18 years; and (iii) out on variables that were not normally distributed. Categori-
able to consent in English. Institutional review board cal variables were analyzed using Fisher’s exact test.
approval for this project was authorized (project-LNR/16/
NEPEAN/36) by the NSW Health Nepean and Blue Moun-
tains Local Health District Research Committee. All proce-
Results
dures performed in studies involving human participants were A total of 150 patients were included in the present study. Of
in accordance with the ethical standards of the institutional these, 55 patients underwent retrograde fURS using Dispos-
and/or national research committee, and with the 1964 Hel- able 1, 31 patients with Disposable 2 and 64 patients with
sinki declaration and its later amendments or comparable eth- the Reusable fURS. There were no differences in the patient
ical standards. Informed written consent was obtained from demographics, stone number, location or stone burden
all participants in this study. All patients had a preoperative between the three groups (Table 1). A total of 141 patients
urine culture with preoperative antibiotics if required. Intraop- had flexible ureteroscopy for stone treatment, four for ECIRS
erative antibiotics were given according to the Australian and five for diagnostic/tumor treatment.
Therapeutic Guidelines for all patients. The procedure was
performed by one of five urological residents or urologists.
Patients underwent retrograde fURS using one of the three
Visibility and maneuverability
digital fURS. The first group (Disposable 1) underwent sur- A representative image from all three ureteroscopes is shown
gery using the single-use LithoVue (Boston Scientific) and in Figure 1. There was a significant difference in the
Mean (95% CI) Disposable 1 (n = 55) Disposable 2 (n = 31) Reusable (n = 64) P-value
Fig. 1 Comparative images from (a) LithoVue and (b) Pusen PU3022A in the same patient. Images were recorded from the LithoVue and Pusen monitor, respec-
tively. Note that both images have a bright central image with shadowing of the peripheral image. (c) A comparative image from a separate patient recorded from
the Olympus Endoscopy Tower Monitor from the Olympus URF-V2 is shown for comparison.
visibility scores (H[2] = 25.480, P < 0.001) and maneuver- a difficult to reach stone was successfully reached when
ability scores (H[2] = 25.974, P < 0.001) between the three changing to a different type of scope (i.e. from disposable to
digital fURS groups. For visibility scores (out of a maximum reusable and vice versa). The most common scope failure
of 5 points) the Reusable fURS (4.8, 95% CI 4.7–5.0) out- was no image shown when the scope was plugged in (three
performed both the Disposable 1 (4.2, 95% CI 4.0–4.5, cases) and damage to the deflection mechanisms of the fURS
U = 1286, P = 0.002) and the Disposable 2 (3.9, 95% CI (three cases).
3.44–4.4, U = 421, P < 0.001; Figs 2,3). The Disposable 1
had a higher visibility score than the Disposable 2 (U = 545,
Subanalysis for retrograde stone surgery
P = 0.009). The Disposable 2 (4.1, 95% CI 3.9–4.3) had a
lower maneuverability score than the Disposable 1 (4.7, 95% A subanalysis was carried out for the 137 patients undergoing
CI 4.5–5.0, U = 545.5, P = 0.009) and the Reusable (4.9, fURS for retrograde stone surgery to decrease heterogeneity
95% CI 4.8–5.0, U = 480.5, P < 0.001; Figs 2,3). in the patient population. The differences in maneuverability
and visibility scores between the fURS groups were similar
to the analysis of the entire patient sample. There was a sig-
Scope failure and complications
nificant difference in the visibility scores (H[2] = 24.939,
A total of 14 fURS (9%) failed during the operations, with P < 0.001) and maneuverability scores (H[2] = 29.889,
no difference in the failure rate between the three groups. P < 0.001) between the three digital fURS groups. The Reu-
There was no difference in the complication rate between the sable (4.8, 95% CI 4.6–4.9) outperformed both the Dispos-
three groups (Table 2). All three groups had one case where able 1 (4.5, 95% CI 4.3–4.6, U = 1157, P = 0.012) and the
Visibility score 6.25 per 100 cases. At an estimated $10 000 per major
repair, this results in an estimated repair cost of $625 per
*
case. At our institution, this is approaching the cost of the
**
Disposable 2, which is approximately 50–75% of the cost of
5 ** the Disposable 1.
When capital procurement costs for the purchase of reu-
sable fURS and endoscope video display towers are consid-
4
ered, the cost per case for reusable fURS is likely to be
similar to disposable fURS, although this depends on the
3 volume of cases. For example, most centers would have at
(/5)
Maneuverability
Discussion
*
The present study is the first in vivo comparison of two sin-
5 * gle-use video fURS with a reusable video fURS. The results
of our study show that single-use video fURS are approach-
4 ing the performance of reusable video fURS. This study
showed there was a difference in image quality and maneu-
verability between single-use and reusable digital fURS.
3 There was also a small difference between the Disposable 1
(/5)
Mean (95% CI) Disposable 1 (n = 55) Disposable 2 (n = 31) Reusable (n = 64) P-value
Visibility score 4.2 (4.0–4.5) 3.9 (3.44–4.4) 4.8 (4.7–5.0) P < 0.001
Disposable 1 < Reusable (P = 0.02)
Disposable 2 < Reusable (P < 0.001)
Disposable 2 < Disposable 1 (P = 0.009)
Maneuverability score 4.7 (4.5–5.0) 4.1 (3.9–4.3) 4.9 (4.8–5.0) P < 0.001
Disposable 2 < Disposable 1 (P = 0.001)
Disposable 2 < Reusable (P < 0.001)
Operative outcomes for patients undergoing retrograde stone surgery (n = 137)
No. patients 51 27 59
Visibility score (retrograde stone 4.5 (4.3–4.64) 3.9 (3.5–4.2) 4.8 (4.6–4.9) P < 0.001
surgery only) Disposable 1 < Reusable (P = 0.049)
Disposable 2 < Reusable (P < 0.001)
Disposable 2 < Disposable 1 (P < 0.001)
Maneuverability score (retrograde 4.7 (4.5–4.8) 4.2 (4.0–4.3) 4.8 (4.7–4.9) P < 0.001
stone surgery only) Disposable 2 < Disposable 1 (P = 0.002)
Disposable 2 < Reusable (P < 0.001)
Operative time (min) 86.1 (68.0–104.3) 87.0 (73.2–100.8) 72.3 (63.3–81.3) NS
Total time in operating theatre (min) 112.8 (91.4–134.2) 114 (98.2–129.8) 95.6 (85.7–105.4) NS
Total radiation screening time (s) 51.5 (35.4–67.5) 46.6 (31.4–61.8) 38.7 (10.6–66.8) NS
Radiation exposure – dose area 368.0 (193.0–545.0) 235.6 (173.2–298.0) 284.0 (150.2–417.7) NS
product (cGycm2)
Relook pyeloscopy required 7 (13%) 2 (7%) 6 (10%) NS
$2500
$2000
$1500
$1000
$500
Fig. 4 Cost analysis per case of reusable fURS
for different volume institutions over time. This is
calculated for an institution with four
1st year 2nd year 3rd year 4th year
ureteroscopes with a purchase cost of $26 000
High volume (200 cases/year) Intermediate volume (100 cases/year) per ureteroscope and a repair cost of $625 per
Low volume (50 cases/year) case.
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