Download Ureteral Stent Symptoms Questionnaire

Trauma/Reconstruction/Diversion
Assessing the Impact of Ureteral Stent Design on
Patient Comfort
James E. Lingeman,*,† Glenn M. Preminger, Evan R. Goldfischer‡
and Amy E. Krambeck (The Comfort Study Team)
From the Methodist Hospital Institute for Kidney Stone Disease (JEL, AEK), Indianapolis, Indiana, Division of Urology, Duke University
(GMP), Durham, North Carolina, and Hudson Valley Urology Center (ERG), Poughkeepsie, New York
Purpose: We assessed the near term comfort of newly designed ureteral study
stents or marketed control stents, including Polaris™ and Percuflex® stents.
Study stents had distal 6Fr pigtail ends with 3Fr or less loops. Decreased
material in situ was hypothesized to enhance comfort. Usefulness of the patient
self-administered Ureteral Stent Symptoms Questionnaire (Stone Management
Unit, Southmead Hospital, United Kingdom) was assessed.
Materials and Methods: This 4-arm multicenter study enrolled adults requiring
retrograde unilateral ureteral stent placement for 4 to 28 days. Ureteral Stent
Symptoms Questionnaire administration was done before placement (baseline),
on day 4 after placement and on day 30 after removal. A total of 236 patients were
randomized in a 1:1:1:1 ratio to the short loop tail stent (60), the long loop tail
stent (59), the Percuflex Plus stent (64) and the Polaris stent (53).
Results: Overall pain worsened from baseline to day 4 and improved from days
4 to 30. Mean pain medication use peaked for all stents on day 1 after placement.
Common device related symptoms were mild or moderate in severity, including
flank pain in 47 patients, hematuria in 39, dysuria in 34, frequent urination in 30
and urinary urgency in 27. Six patients experienced a total of 9 device related
adverse events requiring hospitalization. All adverse events resolved, including
most within 3 days of inpatient treatment.
Conclusions: Although it was not statistically significant, patients stented with
the short loop tail had lower questionnaire pain scores on day 4 after placement
and lower pain medication use on day 1 after placement when pain peaked in all
stent groups, suggesting that ureteral stent comfort, especially pain, may be
improved by less material in situ. The Ureteral Stent Symptoms Questionnaire
may be better suited for longer term comparisons in stented vs nonstented
patients, rather than in this short-term ureteral stent trial.
Abbreviations
and Acronyms
AE ⫽ adverse event
LLT ⫽ long loop tail
PC ⫽ Polaris stent
PPC ⫽ Percuflex Plus stent
SLT ⫽ short loop tail
USSQ ⫽ Ureteric Stent Symptoms
Questionnaire
VAS ⫽ visual analog scale
Submitted for publication October 9, 2008.
Study received approval from local institutional review boards.
* Correspondence: Methodist Hospital Institute for Kidney Stone Disease, 1801 Senate Blvd.,
Suite 220, Indianapolis, Indiana 46202 (telephone: 317-962-2485; FAX: 317-962-2893; e-mail:
[email protected]).
† Financial interest and/or other relationship
with Lumenis, Boston Scientific, Olympus, Karl
Storz Medical and Cook Urological.
‡ Financial interest and/or other relationship
with Boston Scientific.
Key Words: ureter, stents, pain, complications, questionnaires
THE precise etiology of pain during
ureteral stent indwell remains elusive. Previously groups have assessed
the impact of ureteral stent composition, caliber, length and configuration
on patient discomfort.1–5 With the introduction of USSQ in 2003 a standardized instrument became avail-
able for use in clinical trials to
evaluate patient comfort after stent
placement. 6,7 USSQ validation in
the United Kingdom was done in a
clinical trial setting, comparing symptoms in stented and nonstented patients who were evaluated 1 and 4
weeks after stent placement, and 4
0022-5347/09/1816-2581/0
THE JOURNAL OF UROLOGY®
Copyright © 2009 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 181, 2581-2587, June 2009
Printed in U.S.A.
DOI:10.1016/j.juro.2009.02.019
www.jurology.com
2581
2582
URETERAL STENT DESIGN AND COMFORT
weeks after stent removal. This timing was consistent with standard practice in the United Kingdom.
Near term (less than 1 week) comfort was not assessed in the USSQ validation study. Until recently
near term comfort had not been assessed in a large
clinical population involving a comparison of multiple stent types.
We examined the hypothesis that substituting
the distal pigtail end of a ureteral stent with an SLT
or LLT design would enhance patient comfort by
decreasing mass and material in situ. USSQ was
used in this study and we secondarily evaluated it as
a tool for assessing stent discomfort.
MATERIALS AND METHODS
This was a prospective, 4-arm multicenter study comparing stent related comfort in patients 18 years old or older
who had undergone uncomplicated ureteroscopy requiring
retrograde unilateral placement of a ureteral stent for 4 to
28 days inclusive. Study exclusion criteria were active
urinary tract infection, urinary malignancy, nonstone related pain or stricture, spinal cord injury, bilateral stent
placement or chronic anti-inflammatory medication. Patients provided signed informed consent before study entry at study centers and the study was approved by local
institutional review boards.
The study was designed to compare differences in
patient ureteral stent related comfort, as assessed by
the patient self-administered USSQ. USSQ is the only
standardized instrument available to assess patient
comfort (pain and quality of life) after ureteral stent
placement.6 – 8 Appropriate to anatomical differences,
male and female versions of USSQ were administered.
The timing of instrument administration involved certain time points, including baseline (immediately before
stent placement), 4 days after stent placement and 30 ⫾
5 days after stent removal. The Appendix lists USSQ
components. Changes in the pain score were assessed
between day 4, when peak pain was expected, and day
30, when patient comfort levels were expected to return
to an almost normal level.9
Patients were randomized in a 1:1:1:1 ratio to receive 1
of 4 stents. All patients were blinded to the stent received.
The 2 study stents were the SLT and LLT stents, and the
2 control stents were the PC and PPC stents. The proximal portions of all stents were configured in identical 6Fr
pigtail designs of the same basic composition but they
differed in the distal third portion. Control PC and PPC
were standard double-pigtail designs, while SLT and LLT
study stents had substitution of the distal pigtail ends
with 2, 5 cm 3Fr or less loops (SLT) or 2, 8 cm 3Fr or less
loops (LLT) (see figure). The distal ends of SLT and LLT
stents each had 70% less mass by volume than a standard
pigtail end. The length of stent placed was determined by
patient height.
During the postoperative period patients had unrestricted access to pain medications such as oxycodone or
hydrocodone under principal investigator guidance. At
discharge home the pain management regimen included 1
Study stents were substituted for control stent distal pigtail ends
with 2, 5 cm 3Fr or less loops (SLT design) or 2, 8 cm 3Fr or less
loops (LLT design).
or 2 tablets of 325 mg/5 mg oxycodone or 500 mg/5 mg
hydrocodone every 4 to 6 hours as needed for pain.
To compare patient comfort during stent placement
pairwise comparisons were made among stent groups.
Comparisons were performed using multiple comparison
tests at an overall 5% significance level. The 2-sided F-test
was used to determine significant differences in USSQ
scores or pain medication use among the 4 stent groups,
followed by the Tukey HSD pairwise test when F-test
p ⬍0.05. Additionally, a comparison was made of the
pooled pair of study stents with the pooled pair of control
stents. Statistical analysis was performed using SAS®
software.
RESULTS
From April 2003 to February 2004, 236 patients
were eligible for ureteral stent placement and were
assigned randomly to 1 of the 4 stent groups, including 60 to the SLT group, 59 to the LLT group, 64 to
the PPC group and 53 to the PC group. Since the
study was stopped after interim analysis, an unequal number of patients were in each group. The 4
treatment groups were comparable demographically
(table 1). A 17.7-year-old patient was enrolled in the
study as an inadvertent protocol deviation. Table 2
lists surgical procedure details. Operative time and
anesthesia type were not collected as part of the
protocol.
In 231 of 236 cases (97.9%) mean ⫾ SD device
indwelling time was 4.1 ⫾ 1.99 days, including 4.0 ⫾
0.13 days in 64 PPC, 4.0 ⫾ 0.44 days in 53 PC, 4.5 ⫾
3.98 days in 57 LLT and 4.0 ⫾ 0.26 days in 57 SLT
cases. In the remaining 5 of 236 patients (2.1%) a
protocol deviation occurred due to AEs and the
stents were removed before day 4, including in 1
URETERAL STENT DESIGN AND COMFORT
2583
Table 1. Patient characteristics in each treatment cohort
PPC
No. pts
Age:
No. pts
Mean (range)
No. sex (%):
M
F
Wt:
No. pts
Mean lbs (range)
Ht:
No. pts
Mean in (range)
PC
64
64
50.48
38
26
(21.6–81.6)
(59.4)
(40.6)
64
196.32 (127.9–353.0)
64
67.32
(59.0–82.0)
LLT Stent
53
59
53
50.33 (23.8–81.7)
59
46.57
34
19
34
25
(64.2)
(35.8)
53
183.50 (95.0–341.0)
52
67.34 (60.0–74.0)
patient each in the PC and SLT groups, and in 3 in
the LLT group.
Many device related AEs were expected side effects of ureteral stents. Tables 3 and 4 list procedure
and device related AEs. Of device related AEs 86.5%
were judged by the investigators to be mild or moderate in severity. Comparison of the overall AE rate
among the 4 stent types, including 43.8% for PPC,
64.2% for PC, 52.5% for LLT and 40.0% for SLT,
showed no statistical significance (p ⫽ 0.051). Comparison of the device related AE rate among the 4
stent types, including 37.5% for PPC, 49.1% for PC,
37.3% for LLT and 36.7% for SLT, was also not
significant (p ⫽ 0.495).
Six patients (2.5%), including 1, 4 and 1 with a
SLT stent, LLT stent and PC, respectively, experienced a total of 9 device related AEs that led to
hospitalization. These events were flank pain in 3
patients (3 events), stent migration in 1 (1 event),
urinary tract infection in 2 (2 events), urosepsis and
concurrent fever in 1 (2 events, respectively) and
suicidal thoughts in 1 (1 event). All events resolved
after hospitalization, including most within 3 days
of inpatient treatment.
In 10 patients, including 4, 4, 1 and 1 with LLT
stent, SLT stent, PC and PPC, respectively, stents
were removed due to AEs. Stents in 5 patients
were removed within 4 days of placement, while in
4 the stents remained in place for 9 to 28 days. The
duration of stenting in 1 patient was not recorded.
AEs leading to stent removal were typically flank
or suprapubic pain and urinary urgency or frequency.
The patterns of change in overall USSQ comfort
scores (combined body pain questions P3 to P9) were
similar in all stent cohorts (table 5). Comparison of
the individual USSQ components, body pain question P3 (VAS) and body pain questions P4 to P9
(kidney pain related to daily activity) again demonstrated no change from days 4 to 30 among the
different stent types (p ⫽ 0.667 and 0.898, respec-
SLT Stent
60
(17.7–85.0)
(57.6)
(42.4)
59
202.37 (101.0–389.0)
59
67.21
Totals
(59.0–79.0)
60
53.65
37
23
236
(18.0–78.9)
(61.7)
(38.3)
60
190.90 (117.0–328.5)
60
68.03
(61.0–74.0)
236
50.27 (17.7–85.0)
143
93
(60.6)
(39.4)
236
193.58 (95.0–389.0)
235
67.48 (59.0–82.0)
tively). Overall patients experienced worsening of
pain from baseline to day 4 (increasing USSQ score)
and then improvement in pain from days 4 to 30
(decreasing USSQ score). Patients with an SLT
stent had lower USSQ pain scores day 4 after placement. However, differences in pain scores among
stent types and between stent groups (study vs control) at each time point were not statistically significant. In all stent groups more patients reported
pain localized to the groin, bladder or flank areas,
although no statistically significant differences were
observed among the stents.
Pain medication use was measured daily from
baseline to day 4 (table 6). Mean use peaked in all
stent groups on day 1 after placement and patients
who received a SLT stent had the lowest mean use
at this point. Mean pain tablet counts on days 2 and
3 were significantly higher in LLT cases than in
others (Tukey HSD test p ⬍0.05), although mean
use on day 4 was clinically and statistically the same
as that of the other stents. Patients in the SLT and
LLT groups experienced the largest percent decrease from peak use to day 4 (53% and 57%, respectively).
DISCUSSION
Multiple ureteral stent shapes, sizes, compositions
(durometers) and designs have been studied to decrease patient discomfort during ureteral stent placement and indwelling time. However, the precise
etiology of pain during ureteral stent indwelling remains elusive. Clinical evaluation of 2 investigational stents (SLT and LLT) and currently available
double pigtail PC and PPC showed similar comfort
and safety profiles. The absence of statistically significant differences between USSQ pain scores in
patients with different stents may have been the
result of several factors related to stent design,
study design and the choice of USSQ as the instrument with which to measure near term comfort.
2584
URETERAL STENT DESIGN AND COMFORT
Table 2. Surgical procedure in each patient cohort
No. PPC (%)
Overall
Antibiotic regimen before procedure:
120 mg Gentamicin ⫹ ampicillin
120 mg Gentamicin, no ampicillin
400 mg Ciprofloxacin
1 gm Cefazolin
Other
Missing data
Ureteroscopy purpose:
Stone
Diagnosis
Other
Ureteroscopy:
Flexible
Rigid
Flexible ⫹ rigid
Dilation:
None
Balloon
Rigid
Other
Dilator size (Fr):
12 or Less
Greater than 12–less than 18
18 or Greater
Procedure sheath:
Yes
No
Intracorporeal lithotripsy:*
Not applicable
Holmium laser
Other
Stone removal device:†
Not applicable
Stone basket
Stone cone
3-Prong graspers
Other
Residual fragments:
None visible
2 mm or Less
Greater than 2 mm
Foley catheter:
Yes
No
Stent side:
Lt
Rt
No. PC (%)
No. LLT Stent (%)
No. SLT Stent (%)
Total No. (%)
64
53
59
60
236
20 (31.3)
8 (12.5)
3 (4.7)
26 (40.6)
6 (9.4)
1 (1.6)
17 (32.1)
6 (11.3)
2 (3.8)
22 (41.5)
6 (11.3)
0
20 (33.9)
5 (8.5)
5 (8.5)
22 (37.3)
5 (8.5)
2 (3.4)
19 (31.7)
4 (6.7)
3 (5.0)
31 (51.7)
3 (5.0)
0
76 (32.2)
23 (9.7)
13 (5.5)
101 (42.8)
20 (8.5)
3 (1.3)
60 (93.8)
4 (6.3)
0
49 (92.5)
3 (5.7)
1 (1.9)
58 (98.3)
1 (1.7)
0
55 (91.7)
5 (8.3)
0
222 (94.1)
13 (5.5)
1 (0.4)
24 (37.5)
27 (42.2)
13 (20.3)
23 (43.4)
21 (39.6)
9 (17.0)
25 (42.4)
27 (45.8)
7 (11.9)
28 (46.7)
26 (43.3)
6 (10.0)
100 (42.4)
101 (42.8)
35 (14.8)
45 (70.3)
9 (14.1)
4 (6.3)
6 (9.4)
41 (77.4)
4 (7.5)
6 (11.3)
2 (3.8)
48 (81.4)
0
7 (11.9)
4 (6.8)
42 (70.0)
5 (8.3)
8 (13.3)
5 (8.3)
176 (74.6)
18 (7.6)
25 (10.6)
17 (7.2)
9 (14.1)
4 (6.3)
6 (9.4)
6 (11.3)
3 (5.7)
3 (5.7)
7 (11.9)
4 (6.8)
0
10 (16.7)
7 (11.7)
1 (1.7)
32 (13.6)
18 (7.6)
10 (4.2)
32 (50.0)
32 (50.0)
23 (43.4)
29 (54.7)
24 (40.7)
35 (59.3)
25 (41.7)
35 (58.3)
104 (44.1)
131 (55.5)
21 (32.8)
43 (67.2)
0
21 (39.6)
31 (58.5)
1 (1.9)
21 (35.6)
38 (64.4)
0
26 (43.3)
33 (55.0)
1 (1.7)
89 (37.7)
145 (61.4)
2 (0.8)
27 (42.2)
33 (51.6)
2 (3.1)
1 (1.6)
1 (1.6)
26 (49.1)
24 (45.3)
1 (1.9)
2 (3.8)
0
20 (33.9)
34 (57.6)
2 (3.4)
2 (3.4)
1 (1.7)
21 (35.0)
35 (58.3)
2 (3.3)
0
2 (3.3)
94 (39.8)
126 (53.4)
7 (3.0)
5 (2.1)
4 (1.7)
34 (53.1)
30 (46.9)
0
28 (52.8)
23 (43.4)
2 (3.8)
34 (57.6)
24 (40.7)
1 (1.7)
33 (55.0)
25 (41.7)
0
129 (54.7)
102 (43.2)
3 (1.3)
11 (17.2)
53 (82.8)
6 (11.3)
47 (88.7)
3 (5.1)
56 (94.9)
3 (5.0)
57 (95.0)
23 (9.7)
213 (90.3)
20 (31.3)
21 (32.8)
19 (35.8)
13 (24.5)
21 (35.6)
13 (22.0)
18 (30.0)
19 (31.7)
78 (33.1)
66 (28.0)
* Electrohydraulic, pneumatic and pulsed dye laser lithotripsy was not used.
† Alligator graspers were not used.
The ureteral stent designs may have been too
similar to generate statistically significant differences in USSQ pain scores and, thus, each stent was
equally comfortable. However, other data potentially support the hypothesis that less material in
the bladder was associated with enhanced comfort.
Patients who received an SLT stent had lower USSQ
pain scores on day 4 after placement and lower pain
medication use on day 1 after placement, when pain
peaked in all stent groups.
Compared to all other stent recipients, patients
who received an LLT stent appeared to experience
more pain, in that mean pain medication use was
higher on days 1 and 2, and 3 (each p ⬍0.05).
Furthermore, a greater proportion of patients who
received an LLT stent reported flank pain and
suprapubic pain compared to the other patients.
Finally, all AEs of flank pain that led to hospitalization were experienced by patients who received
a LLT stent. These observations seem contradic-
URETERAL STENT DESIGN AND COMFORT
Table 3. Breakdown of 103 procedure related AEs
Condition
No. PPC (%)
No. PC (%)
No. LLT
Stent (%)
No. SLT
Stent (%)
Overall
Abdominal pain
Nausea
Vomiting
Rigors
Fever
Catheter migration
Fungal infection
Urosepsis
Urinary tract
infection
Bladder/suprapubic
pain/spasm
Back pain
Flank pain/colic
Groin/testicular
pain
Headache/dizziness
Suicidal ideation
Dysuria
Incontinence not
otherwise
specified
Urgency
Frequency
Urethral pain
Urinary retention
Vesicoureteral
reflux
Acute renal failure
Ureteral
perforation
Hematuria
Nocturia
Respiratory
problem
24
1 (4.2)
2 (8.3)
0
0
0
0
0
0
3 (12.5)
29
0
4 (13.8)
2 (6.9)
1 (3.4)
2 (6.9)
0
0
1 (3.4)
0
27
1 (3.7)
0
0
0
0
0
1 (3.7)
0
2 (7.4)
23
4 (17.3)
1 (4.3)
1 (4.3)
0
1 (4.3)
1 (4.3)
0
0
1 (4.3)
6 (25.0)
6 (20.6)
4 (14.8)
5 (21.7)
0
16 (66.7)
0
1 (3.4)
15 (51.7)
2 (6.9)
0
20 (74.1)
0
1 (4.3)
10 (43.5)
1 (4.3)
0
0
11 (45.8)
3 (12.5)
2 (6.9)
0
10 (34.5)
0
1 (3.7)
1 (3.7)
7 (25.9)
0
0
0
7 (30.4)
0
7 (29.2)
9 (37.5)
0
1 (4.2)
0
2 (6.9)
3 (10.3)
0
0
0
6 (22.2)
6 (22.2)
0
1 (3.7)
1 (3.7)
8 (34.8)
5 (21.7)
2 (8.7)
1 (4.3)
0
0
0
0
0
1 (3.7)
1 (3.7)
0
0
15 (62.5)
1 (4.2)
0
13 (44.8)
0
0
12 (44.4)
1 (3.7)
0
12 (52.2)
0
1 (4.3)
tory to the study central hypothesis of less stent
material in the bladder or intramural ureter resulting in less patient discomfort, especially since
the SLT and LLT stents maintain an identical
mass in the bladder. However, the additional loop
length of the LLT stent resides in the ureter.
Therefore, the etiology of pain caused by loop
tailed ureteral stents may involve a combination
of the stent distal end profile, length, mass and
movement within the bladder or ureter, or at the
ureteral orifice.
The study design validating the USSQ was based
on a comparison of USSQ scores in stented and
nonstented cases.6 In contrast to this all or none
study design, in the current study we assessed patient comfort among 4 stents with only subtle design
differences. Therefore, USSQ by design may not
have been sufficiently sensitive to detect differences
in comfort among patients receiving similarly designed stents. Furthermore, post hoc statistical modeling in the current investigation indicated that a
2585
study population of approximately 1,000 patients
was needed to show statistical separation among the
4 study and control ureteral stents. Therefore, only a
quarter of the necessary number of patients were
analyzed and no statistically or clinically significant
differences in patient comfort could have been observed among the stents at any time point. Recently
Lee et al reported no statistically significant differences in USSQ pain scores in 44 patients who completed the questionnaire 1, 3 and 5 days after ureteral stent placement.10
USSQ is a lengthy and complicated instrument.
Patient psychological and physical status in the
days immediately following ureteral stent placement can create a motivational challenge for completing USSQ. Some groups who have studied
comfort have acknowledged the issue of patient
discomfort in regard to USSQ complexity and they
have used ad hoc questionnaires, while others have
adapted existing instruments validated for other
symptoms, eg following prostate biopsy,11,12 although
the USSQ was available. Modifying USSQ by abridging it or validating its modules for discrete or improvisational use may enhance its usefulness in more
diverse clinical study settings.
Table 4. Breakdown of 94 device related AEs
Condition
No. PPC (%)
No. PC (%)
No. LLT
Stent (%)
No. SLT
Stent (%)
Overall
Abdominal pain
Nausea
Vomiting
Rigors
Fever
Catheter migration
Urosepsis
Urinary tract
infection
Bladder/suprapubic
pain/spasm
Back pain
Flank pain/colic
Groin/testicular
pain
Headache/dizziness
Suicidal ideation
Dysuria
Incontinence not
otherwise
specified
Urgency
Frequency
Urethral pain
Urinary retention
Vesicoureteral
reflux
Hematuria
Nocturia
24
1 (4.2)
2 (8.3)
0
0
0
0
0
3 (12.5)
26
1 (3.8)
3 (11.5)
2
1 (3.8)
2 (7.7)
0
1 (3.8)
0
22
1 (4.5)
0
0
0
0
1 (4.5)
0
1 (4.5)
22
4 (18.1)
1 (4.5)
1 (4.5)
0
1 (4.5)
1 (4.5)
0
1 (4.5)
6 (25.0)
5 (19.2)
6 (27.2)
5 (22.7)
0
15 (62.5)
0
1 (3.8)
14 (53.8)
1 (3.8)
0
18 (81.8)
0
1 (4.5)
9 (40.9)
1 (4.5)
0
0
11 (45.8)
4 (16.7)
2 (6.9)
0
10 (38.5)
1 (3.8)
0
1 (4.5)
7 (25.9)
2 (9.1)
0
0
7 (31.8)
0
10 (41.7)
12 (50.0)
0
0
0
3 (11.5)
4 (15.4)
1 (3.8)
0
1 (3.8)
9 (40.9)
9 (40.9)
0
0
1 (4.5)
8 (36.4)
6 (27.3)
2 (9.1)
1 (4.5)
0
14 (58.3)
1 (4.2)
10 (38.5)
1 (3.8)
10 (45.5)
2 (9.1)
10 (45.5)
0
2586
URETERAL STENT DESIGN AND COMFORT
Table 5. USSQ P3 to P9 combined body pain scores for each stent from days 4 to 30
Mean Score (range)
No. pts
Day 4
Day 30
Day 4–30 change
PPC
PC
LLT Stent
SLT Stent
Totals
54
28.72
(0.0–64.1)
5.79
(0.0–34.9)
⫺22.93 (⫺64.1–14.0)
49
27.86
(0.0–76.0)
7.75
(0.0–41.0)
⫺20.11 (⫺76.0–25.4)
49
29.37
(0.0–63.5)
7.74
(0.0–39.4)
⫺21.63 (⫺55.0–17.9)
55
25.99
(0.0–73.5)
6.81
(0.0–49.3)
⫺19.19 (⫺73.5–21.2)
207
27.95
(0.0–76.0)
6.98
(0.0–49.3)
⫺20.96 (⫺76.0–25.4)
The timing of USSQ administration may have a
role in obtaining robust data. In its validation
study USSQ administration time points reflected
management regimens in the United Kingdom,6
where ureteral stents are typically placed for an
extended duration between physician visits. The
current study was performed primarily in the
United States, where stents are typically placed
for a shorter duration. In the current study pain
was assessed by USSQ on baseline, on day 4 after
placement and on day 30 after removal. However,
data on pain medication use indicated that patients experienced peak pain 1 day after stent placement. Therefore, USSQ was administered when patient pain was subsiding. Had maximum potential
pain scores been obtained, differences among the
stents on day 30 may have shown greater separation. In a study comparing comfort among multiple
similarly designed stents the optimal timing for
USSQ administration appears to be 1 to 2 days after
the stent is placed.
Certain study limitations must be recognized.
Each study arm included an unequal number of
patients because the study was terminated early
after interim statistical analysis demonstrated no
significant differences among the study arms. Stent-
p Value
0.344
0.715
ing duration was not fixed among the study arms to
allow variations in clinical practices and treatment
scenarios. Finally, 2 control stents were used, although PC and PPC have similar designs and materials. Using 2 different control groups we could
expand the study by further comparing different
standard double pigtail stents. Despite these limitations to our knowledge the current study is the first
to compare the near term comfort of indwelling ureteral stents using USSQ in a large clinical study
population involving a comparison of multiple stent
types.
In future investigations comparing stent comfort
study design considerations must include appropriate statistical powering and clinical assessments.
The required population size will create challenges
from the perspectives of multiple investigational
centers, patient enrollment, the effect on study duration and total cost. Survey instruments designed
to measure patient subjective assessments of comfort and pain must be appropriately timed and administered to coincide with expected maximum and
minimum periods of comfort. Objective study assessments should be measured, such as events of early
stent removal, new or increased pain medication use
or pill counts, or the need for unscheduled physician
Table 6. Analgesia with acetaminophen plus 325 mg/5 mg oxycodone or 500 mg/5 mg hydrocodone
PPC
No. pts
Day 0:
No. pts
Mean No.
Day 1:
No. pts
Mean No.
Day 2:
No. pts
Mean No.
Day 3:
No. pts
Mean No.
Day 4:
No. pts
Mean No.
Overall:
No. pts
Mean No.
PC
LLT Stent
SLT Stent
Totals
p Value
59
49
49
52
209
tablets (range)
46
2.07 (0.0–10.0)
36
1.78 (0.0–12.0)
40
2.61 (0.0–8.0)
40
1.98 (0.0–5.0)
162
2.11 (0.0–12.0)
0.379
tablets (range)
47
3.87 (0.0–15.0)
41
4.00 (0.0–12.0)
41
5.05 (0.0–10.0)
42
3.60 (0.0–12.0)
171
4.12 (0.0–15.0)
0.137
tablets (range)
47
3.70 (0.0–12.0)
40
3.40 (0.0–12.0)
41
4.93 (0.0–11.0)
42
3.15 (0.0–12.0)
170
3.79 (0.0–12.0)
0.045
tablets (range)
48
3.17 (0.0–10.0)
39
2.56 (0.0–12.0)
41
4.44 (0.0–16.0)
41
2.83 (0.0–12.0)
169
3.25 (0.0–16.0)
0.036
tablets (range)
47
2.28 (0.0–9.0)
36
2.06 (0.0–10.0)
40
2.18 (0.0–10.0)
41
1.68 (0.0–12.0)
164
2.05 (0.0–12.0)
0.688
tablets (range)
49
14.37 (1.0–54.0)
43
12.51 (0.0–58.0)
41
19.09 (4.0–46.0)
42
13.04 (0.0–47.0)
175
14.70 (0.0–58.0)
0.035
URETERAL STENT DESIGN AND COMFORT
visits. Clearly there are many considerations for
future clinical investigations of patient comfort after
ureteral stent placement.
APPENDIX
USSQ Components
USSQ Component
Extent of body pain
CONCLUSIONS
We examined the hypothesis that substituting the
distal pigtail end of a ureteral stent with an SLT
or LLT design would enhance patient comfort in
regard to less mass and material in situ. Patients
who received an SLT stent had lower USSQ pain
scores on day 4 after placement and lower pain
medication use on day 1 after placement, when
pain peaked in all stent groups. The absence of
statistically significant differences among USSQ
pain scores in patients with the different stents
suggests that USSQ may be better suited for
longer term comparisons among stented and nonstented cases, rather than in this short-term study
design. Future studies of ureteral stent comfort
will require balancing subjective and objective end
points. Opportunities exist for further studies and
survey instrument development.
2587
Location of body pain†
Urinary tract
symptoms
Other USSQ
information
Parameters
7 Questions:
P3, a VAS (0—no pain/discomfort to 10—
worst possible pain)*
P4 to P9, multiple choice questions
VAS rating (P3) at 4 locations (females) and 5
locations (males):
Kidney front/side area
Groin area
Bladder area
Kidney back (flank) area
Penis (males only)
11 Multiple choice questions (U1 to U11)
General health, work performance, sexual matters
and additional problems
* The VAS was read by 2 readers. When the 2 readings were not within 0.5 points,
the readings were adjudicated by a third reader.
† The pictorial question P3 (extent of body pain) asked the patient to rate pain
on the VAS at 4 locations (females) and 5 locations (males). Therefore, the
maximum score in females was 40 and in males it was 50. The scale in women
was normalized to 50 to have the same scale in all patients, including the 2
sexes.
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