ureteral stent sympton questionnaire (spanish)

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General Research

The Spanish Linguistic Validation of the UreteralStent Symptom Questionnaire

Francesco Sanguedolce, MD, PhD, FEBU,1,* Felix Millán-Rodriguez, MD, PhD,1

Josep M. Santillana-Altimira, MD,1 Alberto Fantova-Alonso, MD,2 Francisco M. Sánchez-Martı́n, 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-Mávrich, MD1

Abstract

Background and Purpose: Ureteral Stent Symptoms Questionnaire (USSQ) is an intervention-specific health-related 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 andfemale lower urinary tract symptoms questionnaires at weeks 1 and 4 after stent insertions, and at week 4 aftertheir removal. In addition, 40 healthy people acted as a control group and completed the same questionnairestwice at 3-week intervals. Statistical analyses were performed to evaluate reliability, validity, and sensitivity tochange of the Spanish USSQ.Results: After revision of the initial two drafts after translation, back translation, and pilot testing, a final draftwas developed that underwent field testing. Psychometric analyses revealed satisfactory internal consistencies(Cronbach alpha coefficients: 0.73–0. 85) and test-retest reliability (Spearman correlation coefficient: > 0.6) for thedomains 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 andexisting validated questionnaires), and test–retest reliability ( p< 0.001). Analysis of the domains of the sexualmatter (21.4%) and work performance (35.7%) were limited because of the small proportion of the studypopulation for whom it was applicable.Conclusions: Results of our development and validation study demonstrate that the new Spanish version of theUSSQ is a psychometrically valid intervention-specific measurer for use in the second most common language inthe world. It is a reliable outcome measure that could be used for both clinical and research purposes.

Introduction

Ureteral stent placement is among the most commonprocedures performed in the urologist’s daily practice;

decompression of the upper urinary tract for obstruction orrenal colic, prevention of ureteral blockage after shock-

wave lithotripsy for large stones, and drainage of theupper urinary tract after surgical procedures are frequentindications.1

On the other hand, ureteral stents are associated with adecrease 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 toreduce the stent-related morbidity by introducing new de-

signs and materials for stents or testing different pharmaco-logic agents (alpha-blocker and anticholinergic) to control thesymptoms.3–5

Joshi and associates6 developed the Ureteral Stent Symp-tom Questionnaire (USSQ), a psychometrically valid measureto evaluate symptoms and impact on QoL of ureteral stents. It

consists of six domains, exploring stent-specific matters inthree (urinary symptoms, pain, and additional problems) andgeneral matters in the other three (general health, work per-formance, and sexual matters).

The USSQ has been adopted as a reliable outcome measurein several trials, allowing better understanding of the resultsand its application for meta-analysis.4,7–9 No validated

1Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.2Urology Department, Miguel Servét Hospital, University of Zaragoza, Zaragoza, Spain.3Bristol Urological Institute, Southmead Hospital, University of Bristol, Bristol, United Kingdom.4Urology Department, Cardiff and Vale University Health Board, University Hospital of Wales, Cardiff, Wales.

JOURNAL OF ENDOUROLOGYVolume 28, Number 2, February 2014ª Mary Ann Liebert, Inc.Pp. 237–242DOI: 10.1089/end.2013.0325

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versions of non-English USSQ have been used in some stud-ies, however, thus limiting the strength of their results.10–12

Accordingly, linguistic validation in different languages andacross cultures is needed for USSQ global validation andwider use.

Currently, validated versions of the USSQ have beenpublished in Italian and Korean, while validations in severalother 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 theworld and the second most common language in the UnitedStates.

Materials and Methods

Translation process and pilot testing

Linguistic translations in Spanish of the USSQ in situ andpoststent were developed in parallel by two independentSpanish native-speaking professional translators, with En-glish as their first foreign language. A first draft of the ques-tionnaire was issued after revision of the translations in aconsensus meeting attended by the two translators togetherwith the consultants of the Urolithiasis unit at FundacióPuigvert-Barcelona. The text was further refined using a plainlanguage easily understandable by patients from differentsociocultural backgrounds and by all Spanish-speaking peo-ple in the world.

This first draft of the Spanish USSQ version was sent for back-translation to two additional bilingual professionaltranslators,with English as their native language, and blindedto the original English version.

The two back-translation versions were then reviewed by aprofessional English linguistic reviewer for scientific publi-cations and compared with the original English version tohighlight discordances. Accordingly, a second draft of theSpanish USSQ version was developed in a new consensusmeeting; this draft was eventually sent to a member of theRoyal Academy of the Spanish Language (Real Academia dela Lengua Españ ola) for a linguistic revision.

Finally, five patients with stents were asked to review thetexts and to give their opinions regarding the ease in readingand comprehending the questions. No additional remarkswere generated by the second draft of the USSQ, so it wasconsidered ready for use.

Patient selection

Between January 2012 and August 2012, 78 patients whounderwent placement of a ureteral stent were recruited at twotertiary academic urological institutions in Spain (Barcelona

and Zaragoza). Inclusion criteria were unilateral temporarystent insertion for acute benign ureteral obstruction or place-ment after diagnostic/therapeutic upper urinary tract proce-dures. Exclusion criteria were (1) a history of or currenttreatment for lower urinary tract symptoms, chronic bacterialprostatitis, chronic pelvic pain syndrome, and prostate cancerin men, (2) stress/urge/mixed urinary incontinence, lowerurinary tract dysfunction, and pregnancy in women, and (3)chronic ureteral obstruction, obstruction from malignancy, bleeding diathesis, history of bladder cancer, recurrent uri-nary tract infections, overactive bladder syndrome, neuro-logic and psychiatric diseases, and concomitant medication

with alpha-blockers, anticholinergics, analgesics, and otherdrugs, possibly interfering with lower urinary tract functionor pain assessment, in men and women. We also excludedcases of complicated ureteroscopy, defined as (1) mucosalinjury edema, or perforation, (2) multiple, large (more than2 cm) or impacted stones.

In both institutions, the same type of 6F Double-J ureteralstent was inserted in all cases by experienced urologists, using

three different lengths (26, 28, and 30 cm, respectively) ac-cording to ureteral length.

All subjects were fully informed about the purpose of thestudy, which was approved by the Institutional ReviewBoard, and all provided written informed consent.

During the same period, 40 healthy people were recruitedat Fundació Puigvert in Barcelona as a control group.

Data collection

The Spanish version of the USSQ-in situ was self-adminis-tered by all patients at weeks 1 and 4 after stent placement.The USSQ-poststent version was self-administered at week 4after stent removal, considering this interval of time adequatefor the patients to come back to the prestent condition. Thiswas the time frame used during validation of the originalquestionnaire.

Scores for urinary symptoms, body pain, general health,work performance, and sexual matters domains were com-puted accordingto the original author(HBJ) instructions. Noscore was recorded for the additional problems domain, because this is a descriptive/qualitative domain, and theglobal QoL domain was scored on the basis of a singlequestion.

In addition, all the patients were asked to complete theEuroQoL-5D, ICIQ-MLUTS (male) and ICIQ-FLUTS (female)questionnaires at the same time; all these questionnaireswere validated in Spanishand provided by the correspondingauthors.15,16

Table 1. Patient and Control Demographics

Cases Control

Number of subjects 70 40Mean age (SD) 56.8 (15) 42 (12)Male/female ratio 32:38 20:20

Nationality (%)Spanish 58 (82) 36 (90)Mexican 2 (2.8)Colombian 1 (1.4)

Ecuadorian 2 (2.8)Venezuelan 1 (1.4)Argentinean 3 (4.3) 1 (2.5)Cuban 1 (2.5)N.A. 3 (4.3) 2 (5)

Employment status (%)Student 3 (4.3)Employed 25 (35.7) 40 (100)Unemployed 13 (18.5)Retired 15 (21.5)N.A. 14 (20)

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

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Controls were evaluated with the USSQ-poststent twotimes,the first time with the additional questionnaires and thesecond 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 in-cluded a correlation coefficient between the USSQ and in-dividual questions of other validated questionnaires of atleast 0.56 (the lowest found in the validation of the originalquestionnaire2), a = 0.05, b = 0.10, and a response rate of atleast 80%.

We used descriptive statistics to obtain participant char-acteristics. To evaluate if the questions could be understood by, and acceptable to, the participants, we calculated responserate for each item. Domain scores were calculated by simpleaddition of the scores for each question in that domain, as perthe original scoring guide.

Individual’s mean was used for the small number of missing data, and unanswered whole domain was omitted inthe analysis.

Reliability was evaluated by internal consistency (tested byCronbach alpha coefficient) and test-retest reliability betweenweek 1 and 4 (tested by Spearman correlation coefficient) afterstent insertion.

Spearman correlation coefficients were used to assessrelations between different domains of the Spanish USSQ.Convergent validity was assessed by correlating the scoresof urinary symptom domain with the MLUTS in men andFLUTS in women, and by correlating the scores of generalhealth domain with the visual analogue scale (VAS) of theEuroQoL questionnaire. Wilcoxon-rank sum tests were

used to compare scores with the stent in situ and after re-moval (sensitivity to change) and the results of patientsat week 4 with those of the healthy group (discriminantvalidity).

Data were collected and analyzed under the supervision of a statistician member of the Iberoamerican Cochrane Centreat 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. Atotal of 70 patients completed all the questionnaires; 8 patientsdropped out of the study because of consent form retrieved(n = 4), detection of malignancy (n= 1), recurrent acute urinaryretention during the observation period (n = 1), displacementof 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 unansweredquestions were detected; the missing data were uniformlydistributed throughout the domains. No entire domains re-mained unanswered.

Only a small proportion of the study population weresexually active [n= 15(21.4%) atweek 1 and n = 18 (25.75%) atweek 4 with the stent in situ] when compared with n = 37 afterstent removal.

Although this clearly indicates difficulty with sexualfunction with the stent in situ, the results of the statisticalanalysis might not be reliable because of small numbers andhence 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 andwork performance domains (Table 2), both at weeks 1 and 4.

Test-retest reliability was always significant for all the do-mains compared at weeks 1 and 4, with weaker Spearmancorrelation coefficients recorded for body pain and workperformance domains.

Similarly, test-retest reliability was significant for all thedomains in the control group, including also the sexual matterdomain, which was applicable because all the subjects weresexually active (Spearman correlation coefficient 0.71, p 0.0001).

Domain structure and convergent validity

Most USSQ domains showed moderate correlations witheach other (Table 3).

For the convergent validity, when comparing the USSQurinary symptom domains with the ICIQ male and female

Table 2. Internal Consistencyand Test–Retest Reliability

Internal consistency(Cronbach a)

Test–retestreliability

Domain Week 1 Week 4

Spearmancorrelationcoefficient p-Value

Urinary symptoms 0.82 0.85 0.64 0.0001Body pain 0.73 0.73 0.62 0.0001General health 0.77 0.85 0.63 0.0001Work performance 0.70 0.60 0.47 0.014Global QoL N.A. N.A. 0.66 0.0001

QoL=quality of life.

Table 3. Total Domain Correlations at Weeks 1 and 4

Urinary symptom Body pain General health Work performance Global QoL

Urinary symptom 1.00/1.00Body pain 0.34/0.60 1.00/1.00General health 0.45/0.51 0.35/0.51 1.00/1.00Work performance 0.26/0.14 0.53/0.31 0.27/0.20 1.00/1.00Global QoL 0.50/0.49 0.26/0.32 0.29/0.41 0.27/0.20 1.00/1.00

QoL=qualify of life.

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LUTS questionnaires, all the correlation coefficients werestatistically significant, with just the exception of the com-parison between the urinary symptom domain and the totalincontinence score of the ICIQ FLUTS at week 1 (Spearmancorrelation coefficient 0.16, p = 0.36).

Similarly, statistically significant correlations have beenfound when comparing the USSQ global health domain andthe EuroQoL questionnaire (Table 4).

Sensitivity to change and discriminant validity

Significant changes were observed in all the domains whencomparing 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 thedomains scores of patients at week 4 after the stent placementand of healthy controls (Table 6): Each domain score wassignificantly different, indicating good discriminant validityof the Spanish USSQ.

Discussion

Placement of an indwelling ureteral stent is a commonurologic intervention. With a wide variety of stents available,with different designs from various manufacturers, the need

for a widely validated instrument to measure the stent-relateddiscomforts is important.

The original English USSQ first captured the impact of theside effect associated with stent insertion by using a well de-veloped questionnaire; they recorded a reduced QoL in up to80% of patients.2

A similar result was shown in a Spanish-speaking cohort, by assessing the urinary symptoms and QoL with nonspe-cific questionnaires for patients with indwelling ureteralstents.17

We validated the Spanish translation of the USSQ, con-tributing to the diffusion of this useful tool, to objectivelyevaluate the impact of stents for clinical use. The Spanishlanguage is currently estimated to be the second most widelyspoken native language in the World18; Spanish has also beenranked as the second language learned by native speakers of American English.19

Psychometric properties of our validation study demon-strate that the Spanish USSQis a reliable and valid instrumentfor measuring the ureteral stent-related symptoms in maleand female patients.

As pointed out by the original authors, patients with anindwelling ureteral stent are affected mostly by urinarysymptoms and pain that eventually affect their general health

by impacting social life and limiting physical activities.2,6 Thisis reflected by the fully satisfactory internal consistency co-efficients found for these domains in our study (Table 1), inline with those showed in the previous publications: (urinarysymptoms 0.77–0.96; body pain 0.73–0.88; general health:0.77–0.93).6,13,14

Sexual life and work performance are more variable do-mains depending on several factors not necessarily related toan 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 4. Convergent Validity

Spearman correlation coefficient

Week 1 p-Value Week 4 p-Value

Urinary symptom vsFLUTS filling score 0.40 0.014 0.65 0.0001FLUTS voiding score 0.41 0.012 0.35 0.047

FLUTS incontinencescore 0.16 0 .36 0.57 0.0001

FLUTS total score 0.53 0.001 0.70 0.0001MLUTS voiding score 0.51 0.003 0.47 0.007MLUTS incontinence

score0.49 0.006 0.43 0.013

MLUTS total score 0.54 0.001 0.44 0.013

General health vsEuroQoL total score 0.52 0.0001 0.62 0.0001EuroQoL VAS - 0.41 0.001 - 0.58 0.0001

FLUTS= female lower urinary tract symptoms module; MLUTS =male lower urinary tract symptoms module; EuroQoL =Europeanquality of life.

Table 5. Sensitivity to Change

Median with stent (IQR) Median without stent (IQR)p-Value

Week 1 Week 4 Week 4 poststentWeek 1 vs4 poststent

Week 4 vs4 poststent

Urinary symptom 29 (23–34) 27 (23–34) 19 (16–22) 0.0001 0.0001Body pain 19.5 (15–23) 19 (17–22) 0 0.0001 0.0001General health 13 (10–16.5) 14 (10.5–17.5) 9 (7–12) 0.003 0.0001Work performance 6 (3–9) 7 (6–9) 3 (3–4) 0.0004 0.001Global QoL 5 (4–6) 4 (4–4) 1.5 (1–2) 0.0001 0.0001

IQR= interquartile range; QoL =quality of life.

Table 6. Discriminant Validity

Cases (week 4with stent) Controls p-Value

Median domain index score (IQR)Urinary symptom 27 (23–34) 16 (13–17) 0.0001Body pain 19 (17–22) 0 0.0001General health 14 (10.5–17.5) 7 (6–9.5) 0.0001

Work performance 7 (6–9) 3 (3–3) 0.004

IQR= interquartile range.



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there were only 15 and 18 sexually active patients at weeks 1and 4, respectively, which did not enable us to compute theinternal consistency for this domain.

Similarly, a weak internal consistency for the work per-formance domain (0.70 and 0.60 at 1 and 4 weeks) was de-tected as a consequence of the relatively low number of activeworkers (35.7%).

Test-retest reliability was satisfactory for the urinary

symptoms, body pain, general health, and global QoL do-mains, and weak for the work performance section. As in theoriginal study and in the Italian validation, we chose a3-week interval for this test, which can be biased by a mat-uration bias (change of conditions and higher symptomtolerance) 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 ac-ceptable intervals to limit these biases for this kind of study.Test-retest reliability of sexual matters was performed in thecontrol group as a surrogate of the study group where it wasnot applicable, showing a good correlation coefficient (0.71; p = 0.0001).

Moderate correlations were detected in the domain corre-

lation analysis but, as previously stated in the original andKorean articles, this is a peculiar aspect of the USSQ that re-flects different components of the dynamic stent experience, atleast partly unrelated to each other. Similar to the previousstudies, stronger correlations were found at week 4 betweenurinary symptoms, body pain, and general health domains,indicating the impressions that patients with more severeurinary symptoms experience higher levels of body pain andvice versa; these clinical experiences might eventually affectthe general health perceptions.

The Spanish version of USSQ showed moderate correlationwith other validated symptom measures: moderate conver-gent validity with high statistical significance was detectedwhen comparing urinary symptoms domains with ICIQ

MLUTS in men and ICIQ FLUTS in women, with the excep-tion of the incontinence score for female patients at week 1.These are expected findings, taking into account that eventhough similar, these questionnaires have been developed fordifferent patients and with different clinical conditions.Moderate correlations were also found when comparing thegeneral health sections with the EuroQoL total scores andVAS scores. Unlike the previous validation studies, we didnot compare the global QoL single question of the USSQ to theVAS scale of the EuroQoL-5D questionnaire, preferring thegeneral health score for this purpose. Sensitivity to changeand discriminant validity were satisfactory when comparingpatients with stents with poststented patients and controls,respectively.

A potential limitation of our study may be that formalvalidation has not been conducted in the Central or SouthAmerican Spanish speaking countries. We have designed theSpanish validation of USSQ, however, taking into accountthe differences that can exist among the diverse accents of theSpanish language in the world. For this reason, the final draftof the questionnaires was reviewed by an official member of the Spanish Royal Academy—the official regulatory board of the Spanish language in Spain and one of the 20 perma-nent members of the Association of Spanish LanguageAcademies—so that all the Spanish-speaking people aroundthe world can easily understand the texts.

Finally, the absence of any problem with reading or com-prehension of the text by overseas patients recruited in ourstudy suggests the suitability of our Spanish USSQ for use inany Spanish-speaking country of the world.

Conclusion

The Spanish version of the USSQ is a reliable and robustinstrument that can be self-administered by Spanish-speaking patients worldwide to investigate the impact of ureteral stents in different clinical aspects. Validation inother languages would be useful to increase the worldwidepopulation of patients undergoing the placement of a ure-teral stent who could be evaluated for clinical and researchpurposes.

Copies of the questionnaire are available from the authorson request.

Acknowledgments

The authors wish to sincerely thank Dr. Gianluca Gian-narini (University of Udine) for his advice on study design;Mrs. Dorothy Mulvey for the bilingual translation and

linguistic support; Prof. Francisco Rico (Real AcademiaEspañ ola) 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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Urol Esp 2007;31:738–742.18. Lewis MP, Simons GF, Fennig CD, eds. Ethnologue: Lan-

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Address correspondence to:Francesco Sanguedolce, MD, PhD FEBU

Fundació Puigvertc/ Cartagena 340-350

08025 BarcelonaSpain

E-mail: [email protected]

Abbreviations UsedEuroQoL¼European quality of life

ICIQ FLUTS¼ International Consultation on IncontinenceQuestionnaire Female Lower Urinary TractSymptoms Module

ICIQ MLUTS¼ International Consultation on IncontinenceQuestionnaire Male Lower Urinary TractSymptoms Module

QoL¼ quality of life

USSQ¼Ureteral Stent Symptom QuestionnaireVAS¼visual analogue scale



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C o p y r i g h t o f J o u r n a l o f E n d o u r o l o g y i s t h e p r o p e r t y o f M a r y A n n L i e b e r t , I n c . a n d i t s c o n t e n t

m a y n o t b e c o p i e d o r e m a i l e d t o m u l t i p l e s i t e s o r p o s t e d t o a l i s t s e r v w i t h o u t t h e c o p y r i g h t

h o l d e r ' s e x p r e s s w r i t t e n p e r m i s s i o n . H o w e v e r , u s e r s m a y p r i n t , d o w n l o a d , o r e m a i l a r t i c l e s f o r

i n d i v i d u a l u s e .

ureteral stent sympton questionnaire (spanish)

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