validation of the urinary sensation scale (uss)

Neurourology and Urodynamics 30:360–365 (2011)

Validation of the Urinary Sensation Scale (USS)

Karin S. Coyne, PhD, MPH,1* Mary Kay Margolis,1 Ray Hsieh,1 Vasudha Vats,2 and Christopher R. Chapple,31United BioSource Corporation, Center for Health Outcomes Research, Bethesda, Maryland

2Pfizer, Inc., New York, New York3Royal Hallamshire Hospital, Sheffield, UK

Aim: The purpose of this study was to assess the validity of the Urinary Sensation Scale (USS) in men with overactivebladder and voiding symptoms (OAB-LUTS) and women with overactive bladder (OAB). Methods: Data from two OABclinical trials of tolterodinewere used. TheUSS, a 5-point scale, assesses the amount of urinary urgency associatedwith eachurination. Threemethods to calculate the USS are: mean urgency (Mean USS); mode urgency (Mode USS); and sum urgency(sumUSS).ThevalidityandresponsivenessofthescoringmethodswasassessedusingSpearman’scorrelations,general linearmodels, and effect sizes.Results: Data from650men (Study1) and413women (Study2)were analyzed.Meanagewas65.2(men) and 47.8 (women); 70%were Caucasian in both studies. Correlations of USS scores with bladder diary variables weresmall to moderate and higher among Sum USS than Mean USS (r ¼ 0.02–0.64). Correlations among the USS and patient-reportedoutcomes(PROs)wereagainsmalltomoderateandhigherwithSumUSS(r ¼ 0.05–0.41).BoththeMeanUSSandSumUSS significantly discriminated (all P < 0.001) among all bladder diary variables (except nocturia and UUI in men) whengrouped as improved/not improved as well as by the PROs. Effect sizes for men and women, respectively, wereS0.52 andS1.09 for Mean USS andS0.72 andS1.36 for Sum USS.Conclusion: The USS is a valid and highly responsive measure ofurinary urgency in men with OAB-LUTS and women with OAB. Neurourol. Urodynam. 30:360–365, 2011.� 2011 Wiley-Liss, Inc.

Key words: bladder diary; outcome measure; overactive bladder; urinary urgency

INTRODUCTION

Overactive bladder (OAB) affects up to 12–16% of the popu-lation.1,2 OAB is characterized by urinary urgency with orwithout urgency urinary incontinence (UUI) and often involvesincreased urinary frequency and nocturia.3 As the hallmarksymptom of OAB is urgency, a clear and objective means ofassessing urgency should be present. As the InternationalContinence Society (ICS) has provided a standard definition ofurinary urgency as ‘‘a sudden, compelling desire to pass urinethat is difficult to defer,’’ a purist approach to assessing urinaryurgency would reflect an all-or-none phenomenon. However,can it be so simple? In De Wachter and Hanno’s4 thoughtfulreview of urinary urgency, they conclude that more needs tobeknownastowhatconstitutesurgency.Animportantfirststepin this process is to see if patients can rate or grade urinaryurgency.4 There have been several varying attempts tomeasurethe concept of urinary urgency ranging from bladder diaryrecordings5–7 to single-item questionnaires,8 to multi-itemquestionnaires or visual analog scales.9,10

While each of these approaches to urinary urgency assess-ment has benefits and limitations, the European Agency for theEvaluation ofMedicinal Products (EMEA) guidance for the treat-ment of urinary incontinence suggests including a rating ofurinary urgency with each void.11 Specifically, the guidelinessuggest theuseofascalerangingfrom‘‘Nourgency, I feltnoneedto empty my bladder, but did so for other reasons’’ to ‘‘Urgeincontinence, I leaked before arriving to the toilet.’’11 As such,the Urinary Sensation Scale (USS) was further refined from theEMEA’s recommendationandisa5-pointscale incorporated intomicturition daily diaries designed to assess urinary urgencyassociated with each micturition. The USS can be scored usingdifferent algorithms for Mean USS score, Mode USS score, andSum USS score; however, the validity and responsiveness ofthesethreemethodshasnotyetbeendemonstrated.Thepurposeof this analysis was to assess the validity of three scoringmethods for the USS in men with OAB and voiding symptoms(OAB-LUTS) and women with OAB.

MATERIALS AND METHODS

Study Design

This secondary data analysis used data from two 12-weekclinical trials of tolterodineERversusplacebo in the treatmentofOAB. Study 1 was a double-blind, placebo-controlled, multi-national, multi-center, parallel group study of the addition oftolterodine ER versus placebo to ongoing alpha-blocker therapy.Menwith persistent OAB symptomswho rated their symptomsasat least ‘‘somemoderateproblems’’onthePatient’sPerceptionof Bladder Condition (PPBC) questionnaire were randomized atbaseline. Men were randomized to either tolterodine ER orplacebo, in addition to continuing on their currently prescribedalpha-blocker medication, for 12 weeks. Study 2 was a placebo-controlled, multi-center randomized 12-week double-blindfollowed by 12-week open-label phase to evaluate the effectof tolterodine ER versus placebo in women with OAB withUUI. Only data from the 12-week double-blind phase wereincluded in these analyses. In both studies, patients completedmicturition diaries prior to the Baseline, Week 4, and week 12

Conflictsof interest:KarinCoyne,MaryKayMargolisandRayHsiehareemployedbyUnited BioSource Corporation (UBC), which provides consulting and other researchservicestopharmaceutical,device,governmentandnon-governmentorganizations.In thesesalariedpositions, theyworkwithavarietyofcompaniesandorganizations.They receive no payment or honoraria directly from these organizations for servicesrendered. Vasudha Vats is an employee of Pfizer, Inc. Christopher Chapple is aconsultant for Pfizer, Astellas, Novartis, Tanabe and Recordati, Ono and Xentionand Allergan. As a consultant, Dr. Chapple receives speaker honorariums, researchgrants and participates in company-funded trials.Dirk De Ridder led the review process.Grant sponsor: Pfizer, Inc..*Correspondenceto:KarinS.Coyne,PhD,MPH, UnitedBioSourceCorporation,Centerfor Health Outcomes Research, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD20814. E-mail: [email protected] 11 December 2009; Accepted 18 August 2010Published online 20 January 2011 in Wiley Online Library

(wileyonlinelibrary.com).

DOI 10.1002/nau.21005

� 2011 Wiley-Liss, Inc.

visits. They also completed the OAB-q, PPBC, and Perception ofTreatment Benefit (PTB) at the Baseline, Week 4, and week 12visits (PTB only at weeks 4 and 12).

Measures

The Urinary Sensation Scale (USS). The USS is a 5-point scaledevelopedtoassess feelingsofurinaryurgency (i.e., intenseand/or sudden need to urinate) associated with each urination. Foreachurination,dayornight,patientswere instructedto ‘‘ratethebladder sensation thatwasassociatedwithurination’’ using thefollowing scale:

1 ¼ Nourgency:Nofeelingofurgency.Cancontinueactivitiesuntil it is convenient to use bathroom;2 ¼ Mildurgency: Feel urgency. Caneasily tolerate. Canfinishusual activity and task quickly, and then go right to thebathroom;3 ¼ Moderate urgency: Enough urgency discomfort. Need tostop usual activity and task, and go right to the bathroom;4 ¼ Severe urgency: Strong urgency discomfort. Almostcannot hold urine. Need to stop usual activity and taskimmediately, and run to bathroom to avoid a wettingaccident;5 ¼ Urge incontinence: Extreme urgency discomfort. Cannothold urine and have a wetting accident before arriving at thebathroom.

ThreemethodsofscoringtheUSSwereused:mean,mode,andsum. To calculate Mean USS, the urgency ratings across a giventime period were summed and divided by the total number ofmicturitions in that time period. Mode USS was the most fre-quenturgencyratinginagiventimeperiod,andSumUSSwasthesum of all urgency ratings in a given time period. The Sum USSreflectsbothurgencyandfrequencytocapturedefensivevoidsaswell as urgent voids sincemanypatientswill increase defensivevoiding so as to avoid urgency voids.

Three-day (consecutive) bladder paper diary. Patients com-pleted a3-day (consecutive) paper diaryprior to each studyvisit.Patients recorded the daytime frequency, nighttime frequency,UUIepisodes,urgencyepisodes, incontinencepadsused (Study2only), and USS rating.

The following three patient-reported outcomes (PROs) wereassessed.

Overactive Bladder Questionnaire (OAB-q). TheOAB-q is a dis-ease-specific symptom bother and health-related quality of life(HRQL) questionnaire thatwasdeveloped andvalidated forOABpatients.12 The 33-item OAB-q consists of a Symptom Botherscale and four HRQL subscales (Coping, Concern, Sleep, andSocial interaction). Each subscale score is transformed to a 0-to 100-point scale; higher Symptom Bother scores indicategreater reports of symptom bother while higher HRQL scoresindicate better HRQL. The OAB-q has demonstrated validity andreliability among patients with OAB.8,12,13

Patient Perception of Bladder Condition (PPBC). The PPBC is avalidated, self-administered question that asks the patient todescribe the perception of his/her bladder condition.14 Patientsare asked to choose the statement which best describes his/hercurrent bladder condition, with responses ranging from 1(‘‘. . . does not cause me any problems at all’’) to 6 (‘‘. . . causesme many severe problems’’).

Perception of Treatment Benefit (PTB). The PTBQuestionnaireis an interviewer-administered questionnaire to assess thepatient’sperceivedbenefitandsatisfactionwiththestudymedi-cation.15 The PTB is a valid outcome that is considered a globalmeasure of the patient’s feelings on all aspects of a drug

treatment which are likely to include the amount of symptomrelief, life impact, side effects, drug costs, and convenience.15

Statistical Analysis

SAS statistical software Version 9.1.3 was used for allanalyses. All statistical tests used a two-sided significance levelof 0.05 unless otherwise noted. Descriptive statistics (e.g., fre-quencies, means) were used to evaluate sample characteristics.Comparisons of categorical data were performed usingchi-square tests.

Spearman correlations were used to examine the relation-ships between USS scores and the bladder diary variables, theOAB-q, and the PPBC. General linear models controlling for age,race,durationofOABsymptoms,andbaselinevaluewereusedtoassess the ability of USS scores to discriminate among groupsof patients according to clinical severity as measured bybladder diaries. Scheffe’s post hoc comparisons were used toevaluate mean differences among patient subgroups atBaseline, Week 12, and change scores in both study popu-lations.16 The responsiveness of the USS was examined by cal-culating change scores for the USS by taking week 12 scoresminus Baseline scores. Effect sizes (ESs) were calculated by sub-tracting eachBaseline score fromtheweek12score anddividingby the baseline standard deviation of each USS score. Thesamples for the discriminant validity and responsivenessanalyses which examined changes in patients’ conditions overtime only included participants who had completed the OABmeasures at Baseline and Week 12.

RESULTS

Descriptive Statistics

In Study 1, the mean age was 65.2 � 9.1 years and themajority of the men were White (70.0%; Table I). In Study 2,themean agewas 47.8 � 11.9 years andmajority of thewomenwere White (67.1%). The mean USS scores at Baseline were2.6 � 0.5 (Mean USS), 2.5 � 0.7 (Mode USS), and 136.9 � 36.3(SumUSS) for Study1and3.4 � 0.6 (MeanUSS), 3.2 � 0.9 (ModeUSS),and181.2 � 36.5 (SumUSS) forStudy2(Table I). ThemeninStudy 1 were significantly older but had a shorter duration ofsymptoms of OAB as well as fewer incontinence episodes, lessfrequency,andlowerratingsofurinaryurgencythanthewomenin Study 2 (all P < 0.001).

The relationships of the USS scores with the OAB-q and PPBCwereexaminedforbothstudiesatBaselineandWeek12.TheUSSdemonstrated concurrent validity with moderate correlationswith the ancillary measures. At Baseline, in Study 1, the OAB-qSymptom Bother subscale correlated highest with all three USSscores (Mean USS, r ¼ 0.41; Mode USS, r ¼ 0.34; Sum USS,r ¼ 0.41; all P < 0.0001). The remaining OAB-q subscales corre-lated negatively and moderately (range r ¼ �0.20 to �0.36, allP < 0.05) with all three USS scores. In Study 2, the results weresimilar, though the correlationswere attenuated,with thehigh-est correlations between the OAB-q Symptom Bother subscaleand the Mean USS, Mode USS, and Sum USS; r ¼ 0.30, 0.26, and0.34, respectively (all P < 0.0001; Table II). The PPBCwas signifi-cantly correlatedwithMeanUSS (r ¼ 0.26),ModeUSS (r ¼ 0.20),and SumUSS (r ¼ 0.30; all P < 0.0001) in Study 1 and in Study 2(r ¼ 0.15, 0.14, and 0.23, respectively (all P < 0.01); Table II).Correlations among the bladder diary variables and the threeUSS scores were as expected given the statistical properties ofeach scoring method. Sum USS, a measure that incorporatesaspects of both frequency and urgency into the scoringalgorithm, was significantly correlated with each bladder diary

Validation of the USS 361

Neurourology and Urodynamics DOI 10.1002/nau

variable at both visits (range, r ¼ 0.16–0.89, all P < 0.01). MeanUSS and Mode USS were both highly correlated with urgencyepisodes (r ¼ 0.88 and 0.81 in Study 1 and r ¼ 0.30 and 0.23 inStudy 2; all P < 0.0001); however, Mean USS andMode USS hadweak to no relationships with urinary frequency (range,r ¼ �0.01 to 0.17), which is likely a reflection of the all-or-nonephenomenon or defensive voiding (Table II).

In Study1, all three scoringmethodsdiscriminatedby changein micturition frequency (Table III) and urgency episodes. Only

Mean USS and Sum USS discriminated for change in daytimemicturition frequency (both P < 0.001), and only the Sum USSdiscriminated for change in nighttime micturition frequency(P < 0.0001).Noneof the scoringmethodsdiscriminatedamongchanges inurgency incontinence episodes in Study1. In Study2,all three scoring methods significantly discriminated amongpatientswho improved in eachof the six bladder diary variables(micturition frequency, daytime micturition frequency, night-time micturition frequency, urgency episodes, urgency

TABLE II. Correlations of USS Scores and Other PRO Measures at Baseline (Visit 2)a

PRO measure

USS scoring method

Study 1 (N ¼ 650), r (n) Study 2 (N ¼ 413), r (n)

Mean USS Mode USS Sum USS Mean USS Mode USS Sum USS

OAB-q

Symptom bother 0.41�� (n ¼ 649) 0.34�� (n ¼ 649) 0.41�� (n ¼ 649) 0.30�� 0.26�� 0.34��Coping �0.28�� 0.20�� 0.34�� 0.22�� 0.14�� 0.30��Concern �0.31�� 0.25�� 0.34�� 0.23�� 0.19�� 0.29��Sleep �0.24�� 0.23�� 0.24�� 0.08 �0.05 �0.19��Social �0.27�� 0.20�� 0.28�� 0.21�� 0.13�� 0.24��HRQL total �0.32�� 0.26�� 0.36�� 0.23�� 0.16�� 0.31��

PPBC 0.26�� (n ¼ 649) 0.20�� (n ¼ 649) 0.30�� (n ¼ 649) 0.15�� 0.14�� 0.23��

Bladder diary variables

Study 1 (N ¼ 649), r (n) Study 2 (N ¼ 410), r (n)

Mean USS Mode USS Sum USS Mean USS Mode USS Sum USS

Frequencyb 0.15�� 0.17�� 0.60�� 0.02 �0.02 0.53��Daytime frequencyc 0.10�� 0.10�� 0.47�� 0.00 (n ¼ 409) 0.01 (n ¼ 409) 0.50�� (n ¼ 409)

Nighttime frequencyd 0.07 0.08� 0.17�� 0.01 (n ¼ 409) �0.02 (n ¼ 409) 0.16�� (n ¼ 409)

Urgency episodese 0.88�� 0.81�� 0.89�� 0.30�� (n ¼ 408) 0.23�� (n ¼ 408) 0.59�� (n ¼ 408)

UUI episodesf 0.31�� 0.17�� 0.31�� 0.64�� (n ¼ 408) 0.46�� (n ¼ 408) 0.64�� (n ¼ 408)

aSpearman correlations: �P < 0.05, ��P < 0.01, ��P < 0.001, ��P < 0.0001.bDefined as mean number of micturitions per 24 hr.cDefined as mean number of micturitions from the time the subject starts the day (time arose) until he/she goes to bed for the night.dDefined as mean number of micturitions for the remainder of the 24-hr period.

eDefined as mean number of micturitions with Urinary Sensation Scale rating of �3 per 24 hr.fDefined as mean number of micturitions with Urinary Sensation Scale rating of 5 per 24 hr.

TABLE I. Baseline Demographic and Clinical Characteristics

Characteristic Study 1 population (N ¼ 650) Study 2 population (N ¼ 413) P-value

Age (mean, SD) 65.2 (9.1) 47.8 (11.9) <0.001

Gender (n, %)

Male 650 (100.0%) n/a <0.001

Female n/a 411 (99.5%)

Missing 2 (0.5%)

Race (n, %)

White 455 (70.0%) 277 (67.1%) <0.001

Black 6 (0.9%) 82 (19.9%)

Asian 139 (21.4%) 7 (1.7%)

Other 50 (7.7%) 45 (10.9%)

Missing 0 (0.0%) 2 (0.5%)

Bladder diary variables (mean, SD)

Micturitions/24 hr 11.4 (2.9) 12.8 (4.1) <0.001

UUI episodes/24 hr 0.2 (0.8) 2.3 (1.9) <0.001

Nocturia episodes/night 1.7 (1.5) 1.8 (1.4) 0.599

Mean USS 2.6 (0.5) 3.4 (0.6) <0.001

Mode USS 2.5 (0.7) 3.2 (0.9) <0.001

Sum USS 136.9 (36.3) 181.2 (36.5) <0.001

Years since OAB diagnosis (mean, SD) 3.7 (4.6) 5.8 (7.3) <0.001

362 Coyne et al.


incontinence episodes, and number of pads used) from Baselineto week 12 and those who worsened or had no change (allP < 0.01).

Discriminant validity was also examined using patients’responses to the PTB. All three scoring methods of the USSsignificantly discriminated among patients who reported ‘‘Nobenefit,’’ ‘‘Littlebenefit,’’and‘‘Muchbenefit’’ (allP < 0.05)exceptfor Mode USS for ‘‘No benefit’’ versus ‘‘Little benefit’’ in Study 2(Table IV). The three USS scores significantly discriminatedamong patients who had rated themselves in differentcategories of the PPBC in Study 1 at both Baseline andweek 12 (all P < 0.0001). In Study 2, only Mean USS (P < 0.05)and Sum USS (P < 0.0001) significantly discriminated atBaseline, though all three scoring methods discriminated atweek 12 (all P < 0.0001). Discriminant validity was alsoexamined for the subscales of the OAB-q. All three USS scoringmethods significantly discriminatedbetweenpatientswhomet

the 10-point minimal important difference (MID) for each sub-scaleversus thosewhodidnotmeet the10-pointMID(Study1allP < 0.0001; Study 2 all P < 0.05).

The ES was largest for the SumUSS scoring (�0.72 in Study 1and�1.36 in Study 2).MeanUSS andModeUSS had ESs of�0.52and�0.36, respectively, in Study 1. In Study 2, ESs forMeanUSSand Mode USS were �1.09 and �0.69, respectively. For bothstudies, all three scoringmethodswere significantly responsiveto changes from Baseline to week 12 (all P < 0.0001; Table V).WhenexaminingchangeofModeUSS,52%ofmeninStudy1and41% of women in Study 2 did not change their Mode USS scorebetween Baseline and Week 12.

DISCUSSION

Overall, theUSS isameasureofurinaryurgencythatdiscrimi-nates well and is responsive to patient-reported changes after

TABLE III. Discriminant Validity: USS Change Scores at week 12 by Change in Micturition Frequency From Baseline to Week 12�

USS score

Change in micturition frequency

LS mean difference (95% CI) P-valueWorse/no change, LS mean (SE) (N ¼ 369) Improved LS, mean (SE) (N ¼ 211)

Study 1

Mean USS �0.20 (0.07) �0.43 (0.07) 0.23 (0.14–0.32) <0.0001

Mode USS �0.15 (0.09) �0.35 (0.09) 0.20 (0.09–0.32) 0.0006

Sum USS �17.1 (4.16) �52.4 (4.32) 35.25 (29.54–40.97) <0.0001

USS score

Change in micturition frequency

LS mean difference (95% CI) P-value�

Worse/no change, LS mean (SE) (N ¼ 184) Improved, LS mean (SE) (N ¼ 131)

Study 2

Mean USS �0.33 (0.08) �0.83 (0.09) 0.50 (0.36–0.65) <0.0001

Mode USS �0.31 (0.11) �0.88 (0.11) 0.57 (0.37–0.76) <0.0001

Sum USS �25.8 (5.73) �74.3 (6.04) 48.54 (37.94–59.13) <0.0001

�General linear model (Proc GLM) controlling for age, race, duration of OAB symptoms, and baseline value.

TABLE IV. Discriminant Validity: USS Change Scores at week 12 by Perception of Treatment Benefit

USS score

Perception of treatment benefit

Overall testa P-valuebNo benefit,

LS mean (SE) (N ¼ 155)Little benefit,

LS mean (SE) (N ¼ 243)Much benefit,

LS mean (SE) (N ¼ 182)

Study 1

Mean USS �0.03 (0.07) �0.22 (0.06) �0.57 (0.07) <0.0001 1: 0.0013; 2: <0.0001; 3: <0.0001

Mode USS 0.04 (0.09) �0.14 (0.08) �0.53 (0.09) <0.0001 1: 0.0259; 2: <0.0001; 3: <0.0001

Sum USS �4.73 (4.49) �27.4 (4.12) �54.1 (4.25) <0.0001 1: <0.0001; 2: <0.0001; 3: <0.0001

USS score

Perception of treatment benefit

Overall testa P-valuebNo benefit,

LS mean (SE) (N ¼ 108)Little benefit,

LS mean (SE) (N ¼ 81)Much benefit,

LS mean (SE) (N ¼ 127)

Study 2

Mean USS �0.15 (0.08) �0.46 (0.09) �1.00 (0.08) <0.0001 1: 0.0014; 2: <0.0001; 3: <0.0001

Mode USS �0.16 (0.12) �0.44 (0.12) �1.03 (0.11) <0.0001 1: 0.0646; 2: <0.0001; 3: <0.0001

Sum USS �12.4 (5.55) �41.1 (5.96) �83.2 (5.42) <0.0001 1: <0.0001; 2: <0.0001; 3: <0.0001

aGeneral linear model (Proc GLM) controlling for age, race, duration of OAB symptoms, and baseline value.bPairwise comparisons betweenmeans were performed using Scheffe’s test adjusting for multiple comparisons: 1, no versus little; 2, no versus much; 3, little

versus much.



treatmentregardlessof thescoringalgorithmused,althoughtheSumUSSscoringappearedtobethemostsensitive tochangeanddiscriminativeamongpatientgroups, followedbytheMeanUSSscoring and thenMode USS scoring. This is likely due to the factthat theSumUSSscoring captures thevariabilityofbothurinaryurgencyandfrequencywhileMeanUSSandModeUSSscoringdonot. Certainly, SumUSS scoring captures the essence of Chappleetal.’s17modelofurinaryurgencyandreducedintervoid intervalwithout the need to calculate the intervoid interval. Patientswho make trade-offs between frequency and urgency (i.e., voidmore frequently to avoidurgency episodes)mayhaveMeanUSSand Mode USS scores that reflect the unresolved nature of theunderlying problem as void frequency may decrease whileurgency ratings do not.

The results of this study provide evidence that patients areable to rate their levelofurinaryurgencywitheachvoidandthatlevels of urinary urgency can change with treatment. The vali-dationoftheSumUSSalsodemonstrates thatpatientsdochangetheir voiding patterns to accommodate increased or decreasedperceptionsofurgency.ThesefindingsareconsistentwithEMEAguidelines and other researchers’ and clinicians’ opinions thatthe construct of urinary urgency can be subjectively rated.18

These findings support the view posited by Blaivas et al.19 andDeWachter andWyndaele20 that two types of urinary urgency,an all-or-none and an intensification of normal urge to void, doexist among patients complaining of urinary urgency with afocus on the latter urgency type. The USS provides evidence tosupport patients’ subjective assessment of urinary urgency on acontinuum. Doing so eliminates the semantic task of dis-tinguishing urgency from urge and enables patients to charac-terize their own perception of each void using a graded scale.While not within the scope of this manuscript, qualitative con-tent validationof theUSS scalewasperformed;21patients foundthe USS easy to understand and relevant and were able to dis-criminate among the response options.

The gender differences noted in this analysis with womenreportinggreater benefitsand responsiveness thanmensuggestthat a pure OAB patient population rather than an OAB-LUTSpatient population is more responsive when assessing urinaryurgency which would provide further evidence as to the con-struct validity of the USS. The differences in the magnitude ofcorrelations among men and women, particularly among thebladder diary variables of frequency andurgency andMeanUSSand Mode USS, are likely reflective of more defensive voidingamongwomen, or thatmen andwomenmay perceive and rateurinary urgency differently. Gender perceptions of urinaryurgencymerit further investigation togainabetterunderstand-ing of assessing urinary urgency.

Obtaining an objectivemeasure of a subjective phenomenonisadifficulttask.Thisisparticularlytruewiththeelusiveconcept

of urinary urgency, in that everyone experiences a need to voidbut there is theneed todifferentiateanormalurge tovoid fromapathologicurgencytovoid.WhiletheUSSisastepinthedirectionof quantifying urinary urgency, it has its limitations with someof the initialword choices (i.e., the inclusion of ‘‘discomfort’’ and‘‘urge incontinence’’ rather than ‘‘urgency incontinence’’) notreflecting the current ICS terminology. As with any secondarydataanalysis, thedataarewhattheyare.Thisscalewasvalidatedwith the term ‘‘urge incontinence’’; however, changing theterm to ‘‘urgency incontinence’’ would likely have minimalimpact of patient understanding of response, although thischange would need to be validated among patients to verifypatient understanding and interpretation. The importance ofthis research is the demonstration that urinary urgency can bequantifiedandanalyzedinameaningfulmannerthat is relevantto patients.

Urinary urgency is also one of the most bothersome symp-toms to patients and results in a significant negative impact onpatients’ HRQL.22,23 The need to accurately assess urinaryurgencywhen treating OAB is paramount to evaluating patientoutcomes. The USS provides a means to objectively capture asubjective phenomenon and when using the Sum USS scoringalgorithm reflects current clinical conceptualizations of urinaryurgency.

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TABLE V. Responsiveness: Mean Change in USS Scores From Baseline to week 12 and Effect Size

USS score N Baseline, mean (SD) Week 12, mean (SD) Mean changea P-value Effect sizeb

Study 1

Mean USS 580 2.64 (0.54) 2.36 (0.58) �0.28 <0.0001 �0.52

Mode USS 580 2.54 (0.74) 2.28 (0.72) �0.27 <0.0001 �0.36

Sum USS 580 137.30 (36.5) 111.12 (41.1) �26.18 <0.0001 �0.72

Study 2

Mean USS 331 3.41 (0.52) 2.84 (0.71) �0.57 <0.0001 �1.09

Mode USS 331 3.29 (0.92) 2.66 (0.93) �0.63 <0.0001 �0.69

Sum USS 331 182.36 (35.4) 134.03 (51.2) �48.33 <0.0001 �1.36

aCalculated as week 12 (Visit 4) score minus Baseline (Visit 2) score.bCalculated as score difference � SD of Baseline (Visit 2) score.

364 Coyne et al.


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