General Research

JOURNAL OF ENDOUROLOGY
Volume 28, Number 2, February 2014
Mary Ann Liebert, Inc.
Pp. 237242
DOI: 10.1089/end.2013.0325

The Spanish Linguistic Validation of the Ureteral

Stent Symptom Questionnaire
Francesco Sanguedolce, MD, PhD, FEBU,1,* Felix Millan-Rodriguez, MD, PhD,1
Josep M. Santillana-Altimira, MD,1 Alberto Fantova-Alonso, MD,2 Francisco M. Sanchez-Martn, MD,1
Oriol Angerri-Feu, MD,1 Juan M. Lopez Martinez, MD,1 Francis X. Keeley, MD, FRCS,3
Hrishi B. Joshi, MD, PhD, FRCS, FEBU,4 and Humberto Villavicencio-Mavrich, MD1

Abstract

Background and Purpose: Ureteral Stent Symptoms Questionnaire (USSQ) is an intervention-specific healthrelated quality-of-life (HrQoL) measure. We describe development and validation of the Spanish version.
Materials and Methods: We followed established methods to develop the Spanish version of the original USSQ.
After pilot testing, we conducted a formal validation study; 70 patients, undergoing placement of ureteral stents,
successfully completed the Spanish USSQ as well as the EuroQoL-5D (male and female), the ICIQ male and
female lower urinary tract symptoms questionnaires at weeks 1 and 4 after stent insertions, and at week 4 after
their removal. In addition, 40 healthy people acted as a control group and completed the same questionnaires
twice at 3-week intervals. Statistical analyses were performed to evaluate reliability, validity, and sensitivity to
change of the Spanish USSQ.
Results: After revision of the initial two drafts after translation, back translation, and pilot testing, a final draft
was developed that underwent field testing. Psychometric analyses revealed satisfactory internal consistencies
(Cronbach alpha coefficients: 0.730. 85) and test-retest reliability (Spearman correlation coefficient: > 0.6) for the
domains of urinary symptom, body pain, and general health. It demonstrated satisfactory discriminant validity
(sensitivity to change, p < 0.01), convergent validity (good correlations between the domains of the USSQ and
existing validated questionnaires), and testretest reliability (p < 0.001). Analysis of the domains of the sexual
matter (21.4%) and work performance (35.7%) were limited because of the small proportion of the study
population for whom it was applicable.
Conclusions: Results of our development and validation study demonstrate that the new Spanish version of the
USSQ is a psychometrically valid intervention-specific measurer for use in the second most common language in
the world. It is a reliable outcome measure that could be used for both clinical and research purposes.
Introduction

reteral stent placement is among the most common

procedures performed in the urologists daily practice;
decompression of the upper urinary tract for obstruction or
renal colic, prevention of ureteral blockage after shockwave lithotripsy for large stones, and drainage of the
upper urinary tract after surgical procedures are frequent
indications.1
On the other hand, ureteral stents are associated with a
decrease in quality of life (QoL) in up to 80% of the patients.2
In the last few years, a lot of research has been conducted to
reduce the stent-related morbidity by introducing new de-

signs and materials for stents or testing different pharmacologic agents (alpha-blocker and anticholinergic) to control the
symptoms.35
Joshi and associates6 developed the Ureteral Stent Symptom Questionnaire (USSQ), a psychometrically valid measure
to evaluate symptoms and impact on QoL of ureteral stents. It
consists of six domains, exploring stent-specific matters in
three (urinary symptoms, pain, and additional problems) and
general matters in the other three (general health, work performance, and sexual matters).
The USSQ has been adopted as a reliable outcome measure
in several trials, allowing better understanding of the results
and its application for meta-analysis.4,79 No validated

Fundacio Puigvert, Autonomous University of Barcelona, Barcelona, Spain.

Urology Department, Miguel Servet Hospital, University of Zaragoza, Zaragoza, Spain.
3
Bristol Urological Institute, Southmead Hospital, University of Bristol, Bristol, United Kingdom.
4
Urology Department, Cardiff and Vale University Health Board, University Hospital of Wales, Cardiff, Wales.
2

237

238
versions of non-English USSQ have been used in some studies, however, thus limiting the strength of their results.1012
Accordingly, linguistic validation in different languages and
across cultures is needed for USSQ global validation and
wider use.
Currently, validated versions of the USSQ have been
published in Italian and Korean, while validations in several
other languages are ongoing.13,14
This study was conducted to provide a validated version of
the USSQ in Spanish, the language most widely spread in the
world and the second most common language in the United
States.
Materials and Methods

SANGUEDOLCE ET AL.
with alpha-blockers, anticholinergics, analgesics, and other
drugs, possibly interfering with lower urinary tract function
or pain assessment, in men and women. We also excluded
cases of complicated ureteroscopy, defined as (1) mucosal
injury edema, or perforation, (2) multiple, large (more than
2 cm) or impacted stones.
In both institutions, the same type of 6F Double-J ureteral
stent was inserted in all cases by experienced urologists, using
three different lengths (26, 28, and 30 cm, respectively) according to ureteral length.
All subjects were fully informed about the purpose of the
study, which was approved by the Institutional Review
Board, and all provided written informed consent.
During the same period, 40 healthy people were recruited
at Fundacio Puigvert in Barcelona as a control group.

Translation process and pilot testing

Linguistic translations in Spanish of the USSQ in situ and
poststent were developed in parallel by two independent
Spanish native-speaking professional translators, with English as their first foreign language. A first draft of the questionnaire was issued after revision of the translations in a
consensus meeting attended by the two translators together
with the consultants of the Urolithiasis unit at Fundacio
Puigvert-Barcelona. The text was further refined using a plain
language easily understandable by patients from different
sociocultural backgrounds and by all Spanish-speaking people in the world.
This first draft of the Spanish USSQ version was sent for
back-translation to two additional bilingual professional
translators, with English as their native language, and blinded
to the original English version.
The two back-translation versions were then reviewed by a
professional English linguistic reviewer for scientific publications and compared with the original English version to
highlight discordances. Accordingly, a second draft of the
Spanish USSQ version was developed in a new consensus
meeting; this draft was eventually sent to a member of the
Royal Academy of the Spanish Language (Real Academia de
la Lengua Espanola) for a linguistic revision.
Finally, five patients with stents were asked to review the
texts and to give their opinions regarding the ease in reading
and comprehending the questions. No additional remarks
were generated by the second draft of the USSQ, so it was
considered ready for use.
Patient selection
Between January 2012 and August 2012, 78 patients who
underwent placement of a ureteral stent were recruited at two
tertiary academic urological institutions in Spain (Barcelona
and Zaragoza). Inclusion criteria were unilateral temporary
stent insertion for acute benign ureteral obstruction or placement after diagnostic/therapeutic upper urinary tract procedures. Exclusion criteria were (1) a history of or current
treatment for lower urinary tract symptoms, chronic bacterial
prostatitis, chronic pelvic pain syndrome, and prostate cancer
in men, (2) stress/urge/mixed urinary incontinence, lower
urinary tract dysfunction, and pregnancy in women, and (3)
chronic ureteral obstruction, obstruction from malignancy,
bleeding diathesis, history of bladder cancer, recurrent urinary tract infections, overactive bladder syndrome, neurologic and psychiatric diseases, and concomitant medication

Data collection
The Spanish version of the USSQ-in situ was self-administered by all patients at weeks 1 and 4 after stent placement.
The USSQ-poststent version was self-administered at week 4
after stent removal, considering this interval of time adequate
for the patients to come back to the prestent condition. This
was the time frame used during validation of the original
questionnaire.
Scores for urinary symptoms, body pain, general health,
work performance, and sexual matters domains were computed according to the original author (HBJ) instructions. No
score was recorded for the additional problems domain,
because this is a descriptive/qualitative domain, and the
global QoL domain was scored on the basis of a single
question.
In addition, all the patients were asked to complete the
EuroQoL-5D, ICIQ-MLUTS (male) and ICIQ-FLUTS (female)
questionnaires at the same time; all these questionnaires
were validated in Spanish and provided by the corresponding
authors.15,16

Table 1. Patient and Control Demographics

Cases
Number of subjects
Mean age (SD)
Male/female ratio
Nationality (%)
Spanish
Mexican
Colombian
Ecuadorian
Venezuelan
Argentinean
Cuban
N.A.
Employment status (%)
Student
Employed
Unemployed
Retired
N.A.

70
56.8 (15)
32:38
58
2
1
2
1
3

(82)
(2.8)
(1.4)
(2.8)
(1.4)
(4.3)

3 (4.3)
3
25
13
15
14

(4.3)
(35.7)
(18.5)
(21.5)
(20)

SD = standard deviation; N.A. = not applicable.

Control
40
42 (12)
20:20
36 (90)

1 (2.5)
1 (2.5)
2 (5)

40 (100)

SPANISH LINGUISTIC VALIDATION OF THE USSQ

Table 2. Internal Consistency
and TestRetest Reliability

Internal consistency
(Cronbach a)
Domain
Urinary symptoms
Body pain
General health
Work performance
Global QoL

Week 1

Week 4

0.82
0.73
0.77
0.70
N.A.

0.85
0.73
0.85
0.60
N.A.

Testretest
reliability
Spearman
correlation
coefficient p-Value
0.64
0.62
0.63
0.47
0.66

0.0001
0.0001
0.0001
0.014
0.0001

QoL = quality of life.

Controls were evaluated with the USSQ-poststent two

times, the first time with the additional questionnaires and the
second time after 3 weeks with the USSQ alone.
Statistics
Sample size calculation was based on convergent validity.
The minimum number of subjects with stent per sex, i.e. 35,
was estimated according to different variables, which included a correlation coefficient between the USSQ and individual questions of other validated questionnaires of at
least 0.56 (the lowest found in the validation of the original
questionnaire2), a = 0.05, b = 0.10, and a response rate of at
least 80%.
We used descriptive statistics to obtain participant characteristics. To evaluate if the questions could be understood
by, and acceptable to, the participants, we calculated response
rate for each item. Domain scores were calculated by simple
addition of the scores for each question in that domain, as per
the original scoring guide.
Individuals mean was used for the small number of
missing data, and unanswered whole domain was omitted in
the analysis.
Reliability was evaluated by internal consistency (tested by
Cronbach alpha coefficient) and test-retest reliability between
week 1 and 4 (tested by Spearman correlation coefficient) after
stent insertion.
Spearman correlation coefficients were used to assess
relations between different domains of the Spanish USSQ.
Convergent validity was assessed by correlating the scores
of urinary symptom domain with the MLUTS in men and
FLUTS in women, and by correlating the scores of general
health domain with the visual analogue scale (VAS) of the
EuroQoL questionnaire. Wilcoxon-rank sum tests were

239
used to compare scores with the stent in situ and after removal (sensitivity to change) and the results of patients
at week 4 with those of the healthy group (discriminant
validity).
Data were collected and analyzed under the supervision of
a statistician member of the Iberoamerican Cochrane Centre
at Barcelona; the software SPSS 20.0 for Windows (SPSS,
Chicago, IL) was used for the study purposes and results were
two-sided with p < 0.05.
Results
The demographic characteristics are shown in Table 1. A
total of 70 patients completed all the questionnaires; 8 patients
dropped out of the study because of consent form retrieved
(n = 4), detection of malignancy (n = 1), recurrent acute urinary
retention during the observation period (n = 1), displacement
of the stent (n = 1), and lost to follow-up before completion of
the study (n = 1).
In eight (11%) cases, a small number (1 to 4) of unanswered
questions were detected; the missing data were uniformly
distributed throughout the domains. No entire domains remained unanswered.
Only a small proportion of the study population were
sexually active [n = 15 (21.4%) at week 1 and n = 18 (25.75%) at
week 4 with the stent in situ] when compared with n = 37 after
stent removal.
Although this clearly indicates difficulty with sexual
function with the stent in situ, the results of the statistical
analysis might not be reliable because of small numbers and
hence were omitted from presentation in the final draft.
Reliability and validity
Internal consistency was high for the urinary symptoms and
body pain domains, and satisfactory for general health and
work performance domains (Table 2), both at weeks 1 and 4.
Test-retest reliability was always significant for all the domains compared at weeks 1 and 4, with weaker Spearman
correlation coefficients recorded for body pain and work
performance domains.
Similarly, test-retest reliability was significant for all the
domains in the control group, including also the sexual matter
domain, which was applicable because all the subjects were
sexually active (Spearman correlation coefficient 0.71, p 0.0001).
Domain structure and convergent validity
Most USSQ domains showed moderate correlations with
each other (Table 3).
For the convergent validity, when comparing the USSQ
urinary symptom domains with the ICIQ male and female

Table 3. Total Domain Correlations at Weeks 1 and 4

Urinary symptom
Body pain
General health
Work performance
Global QoL
QoL = qualify of life.

Urinary symptom

Body pain

General health

Work performance

Global QoL

1.00/1.00
0.34/0.60
0.45/0.51
0.26/0.14
0.50/0.49

1.00/1.00
0.35/0.51
0.53/0.31
0.26/0.32

1.00/1.00
0.27/0.20
0.29/0.41

1.00/1.00
0.27/0.20

1.00/1.00

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SANGUEDOLCE ET AL.
Table 4. Convergent Validity

Table 6. Discriminant Validity

Spearman correlation coefficient

Week 1 p-Value Week 4 p-Value
Urinary symptom vs
FLUTS filling score
FLUTS voiding score
FLUTS incontinence
score
FLUTS total score
MLUTS voiding score
MLUTS incontinence
score
MLUTS total score
General health vs
EuroQoL total score
EuroQoL VAS

0.40
0.41
0.16

0.014
0.012
0.36

0.65
0.35
0.57

0.0001
0.047
0.0001

0.53
0.51
0.49

0.001
0.003
0.006

0.70
0.47
0.43

0.0001
0.007
0.013

0.54

0.001

0.44

0.013

0.52
- 0.41

0.0001
0.001

0.62
- 0.58

0.0001
0.0001

FLUTS = female lower urinary tract symptoms module; MLUTS =

male lower urinary tract symptoms module; EuroQoL = European
quality of life.

LUTS questionnaires, all the correlation coefficients were

statistically significant, with just the exception of the comparison between the urinary symptom domain and the total
incontinence score of the ICIQ FLUTS at week 1 (Spearman
correlation coefficient 0.16, p = 0.36).
Similarly, statistically significant correlations have been
found when comparing the USSQ global health domain and
the EuroQoL questionnaire (Table 4).
Sensitivity to change and discriminant validity
Significant changes were observed in all the domains when
comparing patients with (week 1 and 4) and without a stent
(Table 5). All the patients had no pain after stent removal.
Discriminant validity has been conducted comparing the
domains scores of patients at week 4 after the stent placement
and of healthy controls (Table 6): Each domain score was
significantly different, indicating good discriminant validity
of the Spanish USSQ.
Discussion
Placement of an indwelling ureteral stent is a common
urologic intervention. With a wide variety of stents available,
with different designs from various manufacturers, the need

Median domain index

Urinary symptom
Body pain
General health
Work performance

Cases (week 4
with stent)

Controls

p-Value

score (IQR)
27 (2334)
19 (1722)
14 (10.517.5)
7 (69)

16 (1317)
0
7 (69.5)
3 (33)

0.0001
0.0001
0.0001
0.004

IQR = interquartile range.

for a widely validated instrument to measure the stent-related

discomforts is important.
The original English USSQ first captured the impact of the
side effect associated with stent insertion by using a well developed questionnaire; they recorded a reduced QoL in up to
80% of patients.2
A similar result was shown in a Spanish-speaking cohort,
by assessing the urinary symptoms and QoL with nonspecific questionnaires for patients with indwelling ureteral
stents.17
We validated the Spanish translation of the USSQ, contributing to the diffusion of this useful tool, to objectively
evaluate the impact of stents for clinical use. The Spanish
language is currently estimated to be the second most widely
spoken native language in the World18; Spanish has also been
ranked as the second language learned by native speakers of
American English.19
Psychometric properties of our validation study demonstrate that the Spanish USSQ is a reliable and valid instrument
for measuring the ureteral stent-related symptoms in male
and female patients.
As pointed out by the original authors, patients with an
indwelling ureteral stent are affected mostly by urinary
symptoms and pain that eventually affect their general health
by impacting social life and limiting physical activities.2,6 This
is reflected by the fully satisfactory internal consistency coefficients found for these domains in our study (Table 1), in
line with those showed in the previous publications: (urinary
symptoms 0.770.96; body pain 0.730.88; general health:
0.770.93).6,13,14
Sexual life and work performance are more variable domains depending on several factors not necessarily related to
an indwelling ureteral stent, such as normal sexual activity,
cultural behaviors, and social situation, and working status,
respectively. Likewise in the Korean study, in our cohort,

Table 5. Sensitivity to Change

p-Value
Median with stent (IQR)
Week 1
Urinary symptom
Body pain
General health
Work performance
Global QoL

29
19.5
13
6
5

(2334)
(1523)
(1016.5)
(39)
(46)

IQR = interquartile range; QoL = quality of life.

Week 4
27
19
14
7
4

(2334)
(1722)
(10.517.5)
(69)
(44)

Median without stent (IQR)

Week 4 poststent

Week 1 vs
4 poststent

Week 4 vs
4 poststent

19 (1622)
0
9 (712)
3 (34)
1.5 (12)

0.0001
0.0001
0.003
0.0004
0.0001

0.0001
0.0001
0.0001
0.001
0.0001

SPANISH LINGUISTIC VALIDATION OF THE USSQ

there were only 15 and 18 sexually active patients at weeks 1
and 4, respectively, which did not enable us to compute the
internal consistency for this domain.
Similarly, a weak internal consistency for the work performance domain (0.70 and 0.60 at 1 and 4 weeks) was detected as a consequence of the relatively low number of active
workers (35.7%).
Test-retest reliability was satisfactory for the urinary
symptoms, body pain, general health, and global QoL domains, and weak for the work performance section. As in the
original study and in the Italian validation, we chose a
3-week interval for this test, which can be biased by a maturation bias (change of conditions and higher symptom
tolerance) and by a recall bias for longer or shorter intervals,
respectively. Counterbalancing each other, we think that 2
(as used by the Korean group) and 3 weeks are both acceptable intervals to limit these biases for this kind of study.
Test-retest reliability of sexual matters was performed in the
control group as a surrogate of the study group where it was
not applicable, showing a good correlation coefficient (0.71;
p = 0.0001).
Moderate correlations were detected in the domain correlation analysis but, as previously stated in the original and
Korean articles, this is a peculiar aspect of the USSQ that reflects different components of the dynamic stent experience, at
least partly unrelated to each other. Similar to the previous
studies, stronger correlations were found at week 4 between
urinary symptoms, body pain, and general health domains,
indicating the impressions that patients with more severe
urinary symptoms experience higher levels of body pain and
vice versa; these clinical experiences might eventually affect
the general health perceptions.
The Spanish version of USSQ showed moderate correlation
with other validated symptom measures: moderate convergent validity with high statistical significance was detected
when comparing urinary symptoms domains with ICIQ
MLUTS in men and ICIQ FLUTS in women, with the exception of the incontinence score for female patients at week 1.
These are expected findings, taking into account that even
though similar, these questionnaires have been developed for
different patients and with different clinical conditions.
Moderate correlations were also found when comparing the
general health sections with the EuroQoL total scores and
VAS scores. Unlike the previous validation studies, we did
not compare the global QoL single question of the USSQ to the
VAS scale of the EuroQoL-5D questionnaire, preferring the
general health score for this purpose. Sensitivity to change
and discriminant validity were satisfactory when comparing
patients with stents with poststented patients and controls,
respectively.
A potential limitation of our study may be that formal
validation has not been conducted in the Central or South
American Spanish speaking countries. We have designed the
Spanish validation of USSQ, however, taking into account
the differences that can exist among the diverse accents of the
Spanish language in the world. For this reason, the final draft
of the questionnaires was reviewed by an official member of
the Spanish Royal Academythe official regulatory board of
the Spanish language in Spain and one of the 20 permanent members of the Association of Spanish Language
Academiesso that all the Spanish-speaking people around
the world can easily understand the texts.

241
Finally, the absence of any problem with reading or comprehension of the text by overseas patients recruited in our
study suggests the suitability of our Spanish USSQ for use in
any Spanish-speaking country of the world.
Conclusion
The Spanish version of the USSQ is a reliable and robust
instrument that can be self-administered by Spanishspeaking patients worldwide to investigate the impact of
ureteral stents in different clinical aspects. Validation in
other languages would be useful to increase the worldwide
population of patients undergoing the placement of a ureteral stent who could be evaluated for clinical and research
purposes.
Copies of the questionnaire are available from the authors
on request.
Acknowledgments
The authors wish to sincerely thank Dr. Gianluca Giannarini (University of Udine) for his advice on study design;
Mrs. Dorothy Mulvey for the bilingual translation and
linguistic support; Prof. Francisco Rico (Real Academia
Espanola) for the linguistic revision of the Spanish USSQ;
Dr. Ignasi Gich (Iberoamerican Cochrane Centre, Barcelona)
for statistical support.
Disclosure Statement
No competing financial interests exist.
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Address correspondence to:

Francesco Sanguedolce, MD, PhD FEBU
Fundacio Puigvert
c/ Cartagena 340-350
08025 Barcelona
Spain
E-mail: fsangue@hotmail.com

Abbreviations Used
EuroQoL European quality of life
ICIQ FLUTS International Consultation on Incontinence
Questionnaire Female Lower Urinary Tract
Symptoms Module
ICIQ MLUTS International Consultation on Incontinence
Questionnaire Male Lower Urinary Tract
Symptoms Module
QoL quality of life
USSQ Ureteral Stent Symptom Questionnaire
VAS visual analogue scale

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