development and validation of the overactive bladder satisfaction (oab-s) questionnaire

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Neurourology and Urodynamics 27:179–190 (2008) Development and Validation of the Overactive Bladder Satisfaction (OAB-S) Questionnaire Elisabeth Piault, 1 * Christopher J. Evans, 1 Derek Espindle, 1 Zoe Kopp, 2 Linda Brubaker, 3 and Paul Abrams 4 1 Mapi Values, Boston, Massachusetts 2 Pfizer Global Pharmaceuticals, New York, New York 3 Loyola University Medical Center, Maywood, Illinois 4 Southmead Hospital, Bristol Urological Institute, Bristol, United Kingdom Aims: To develop and validate a measure of patient satisfaction with treatment in overactive bladder: the Overactive Bladder Satisfaction Questionnaire (OAB-S). Methods: Development of the questionnaire included a comprehensive literature review, development of a conceptual model, item elicitation and cognitive debriefing interviews with US-English and US-Spanish patients, and assessment of the questionnaire’s translatability in other languages. Psychometric validation of the questionnaire was run on a longitudinal, non-randomized study involving 201 OAB patients. Analyses included construct validity, concurrent validity, tests of reliability, known-group validity, and responsiveness (exploratory). Results: The OAB-S is a patient-completed questionnaire including five scales: OAB Control Expectations (ten items); Impact on Daily Living with OAB (ten items); OAB Control (ten items); OAB Medication Tolerability (six items); and Satisfaction with Control (ten items) and five single-item overall assessments of patient’s fulfillment of OAB medication expectations, interruption of day-to-day life due to OAB, overall satisfaction with OAB medication; willingness to continue OAB medication and improvement in day-to-day life due to OAB medication. The hypothesized structure of the questionnaire was supported by statistical analyses. Internal consistency reliability coefficients (ranging from 0.76 to 0.94) and test-retest reliability coefficients (ranging from 0.72 to 0.87) were good for all dimensions. All dimensions except tolerability discriminated well according to self-reported OAB severity level and incontinence status. Conclusion: The OAB-S is a valid, comprehensive instrument to assess satisfaction with treatment of OAB based on independent scales that have demonstrated satisfactory psychometric performance. Neurourol. Urodynam. 27:179–190, 2008. ß 2008 Wiley-Liss, Inc. Key words: health outcomes; psychometrics; questionnaire; satisfaction INTRODUCTION Overactive Bladder (OAB) is a common condition character- ized by the symptoms of urinary urgency with or without urgency urinary incontinence (UUI), often with frequency and nocturia. 1,2 Data from the National Overactive Bladder Evaluation (NOBLE) Program indicate that approximately 33 million people in the United States (US) older than 18 experienced symptoms of OAB. 3 The condition may affect as many as 100 million individuals worldwide. Overactive bladder is a common condition which affects men and women alike with similar prevalence rates among women (16.9%) and men (16.0%) and becoming more prevalent as age increases. 4 Over- active bladder without urge incontinence is more common in men than in women, across all age groups. 5 In addition, relationships between different aspects of lifestyle (i.e., obesity, smoking, carbonated drinks and diet) and symptoms of urinary incontinence have been suggested. 6 The condition affects all dimensions of health-related quality of life (HRQL). 7–11 Studies report that HRQL scores for individuals with OAB are significantly lower (P > 0.001) than the general population in all dimensions of the SF-36. 12 Additionally, significant sleep impact is seen in patients with OAB. Patient satisfaction is the subjective, personal evaluation of treatment effectiveness and the service provided by the health care system. From the patient’s perspective, satisfaction includes accessibility/convenience, availability of resources, continuity of care, efficacy, finances, humaneness, informa- tion gathering, information giving, pleasantness of surround- ings and quality/competence. 13 At its most basic level, satisfaction is a comprehensive evaluation of several dimensions of health care based on patient expectations and provider and treatment performance. As an outcomes mea- sure, patient satisfaction allows health care providers to assess the appropriateness of treatment according to patient expectations. In chronic diseases, where patients must live with treatment, patient satisfaction may be the distinguish- ing outcome among treatments with comparable efficacy. 14 Evidence suggests that patient satisfaction may be more sensitive to change than quality of life in clinical trials in chronic diseases. 15 Satisfaction with treatment provides information on treat- ment effectiveness and is believed to affect clinical outcomes. High levels of patient satisfaction with medication correlate with treatment compliance, maintenance of a relationship with a specific provider and disclosure of important medical informa- tion. In the area of pain treatment, high levels of satisfaction have also been positively associated with good health status, fewer medical encounters and shorter hospital stays. 16 The Overactive Bladder Satisfaction Questionnaire (OAB-S) was developed to assess patients’ satisfaction with overactive bladder treatment including medications or non-pharmaceu- tical options such as physical therapy or biofeedback (use of a urination chart). To establish the value of the questionnaire, a Rodney Appell led the review process. No conflict of interest reported by the author(s). *Correspondence to: Elisabeth Piault, Mapi Values, 15 Court Square, Suite 620, Boston, MA 02108. E-mail: [email protected] Received 17 November 2006; Accepted 13 March 2007 Published online in Wiley InterScience (www.interscience.wiley.com) DOI 10.1002/nau.20455 ß 2008 Wiley-Liss, Inc.

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Neurourology and Urodynamics 27:179–190 (2008)

Development and Validation of the Overactive BladderSatisfaction (OAB-S) Questionnaire

Elisabeth Piault,1* Christopher J. Evans,1 Derek Espindle,1 Zoe Kopp,2 Linda Brubaker,3 and Paul Abrams41Mapi Values, Boston, Massachusetts

2Pfizer Global Pharmaceuticals, New York, New York3Loyola University Medical Center, Maywood, Illinois

4Southmead Hospital, Bristol Urological Institute, Bristol, United Kingdom

Aims: To develop and validate a measure of patient satisfaction with treatment in overactive bladder: theOveractive Bladder Satisfaction Questionnaire (OAB-S). Methods: Development of the questionnaire included acomprehensive literature review, development of a conceptual model, item elicitation and cognitive debriefinginterviews with US-English and US-Spanish patients, and assessment of the questionnaire’s translatability in otherlanguages. Psychometric validation of the questionnaire was run on a longitudinal, non-randomized study involving201 OAB patients. Analyses included construct validity, concurrent validity, tests of reliability, known-group validity,and responsiveness (exploratory). Results: The OAB-S is a patient-completed questionnaire including five scales:OAB Control Expectations (ten items); Impact on Daily Living with OAB (ten items); OAB Control (ten items); OABMedication Tolerability (six items); and Satisfaction with Control (ten items) and five single-item overallassessments of patient’s fulfillment of OAB medication expectations, interruption of day-to-day life due to OAB,overall satisfaction with OAB medication; willingness to continue OAB medication and improvement in day-to-daylife due to OAB medication. The hypothesized structure of the questionnaire was supported by statistical analyses.Internal consistency reliability coefficients (ranging from 0.76 to 0.94) and test-retest reliability coefficients (rangingfrom 0.72 to 0.87) were good for all dimensions. All dimensions except tolerability discriminated well according toself-reported OAB severity level and incontinence status. Conclusion: The OAB-S is a valid, comprehensiveinstrument to assess satisfaction with treatment of OAB based on independent scales that have demonstratedsatisfactory psychometric performance. Neurourol. Urodynam. 27:179–190, 2008. � 2008 Wiley-Liss, Inc.

Key words: health outcomes; psychometrics; questionnaire; satisfaction

INTRODUCTION

Overactive Bladder (OAB) is a common condition character-ized by the symptoms of urinary urgency with or withouturgency urinary incontinence (UUI), often with frequency andnocturia.1,2

Data from the National Overactive Bladder Evaluation(NOBLE) Program indicate that approximately 33 millionpeople in the United States (US) older than 18 experiencedsymptoms of OAB.3 The condition may affect as many as100 million individuals worldwide. Overactive bladder is acommon condition which affects men and women alike withsimilar prevalence rates among women (16.9%) and men(16.0%) and becoming more prevalent as age increases.4 Over-active bladder without urge incontinence is more commonin men than in women, across all age groups.5 In addition,relationships between different aspects of lifestyle (i.e.,obesity, smoking, carbonated drinks and diet) and symptomsof urinary incontinence have been suggested.6 The conditionaffects all dimensions of health-related quality of life(HRQL).7–11 Studies report that HRQL scores for individualswith OAB are significantly lower (P> 0.001) than the generalpopulation in all dimensions of the SF-36.12 Additionally,significant sleep impact is seen in patients with OAB.

Patient satisfaction is the subjective, personal evaluation oftreatment effectiveness and the service provided by the healthcare system. From the patient’s perspective, satisfactionincludes accessibility/convenience, availability of resources,continuity of care, efficacy, finances, humaneness, informa-tion gathering, information giving, pleasantness of surround-ings and quality/competence.13 At its most basic level,satisfaction is a comprehensive evaluation of several

dimensions of health care based on patient expectations andprovider and treatment performance. As an outcomes mea-sure, patient satisfaction allows health care providers toassess the appropriateness of treatment according to patientexpectations. In chronic diseases, where patients must livewith treatment, patient satisfaction may be the distinguish-ing outcome among treatments with comparable efficacy.14

Evidence suggests that patient satisfaction may be moresensitive to change than quality of life in clinical trials inchronic diseases.15

Satisfaction with treatment provides information on treat-ment effectiveness and is believed to affect clinical outcomes.High levels of patient satisfaction with medication correlatewith treatment compliance, maintenance of a relationship with aspecific provider and disclosure of important medical informa-tion. In the area of pain treatment, high levels of satisfactionhave also been positively associated with good health status,fewer medical encounters and shorter hospital stays.16

The Overactive Bladder Satisfaction Questionnaire (OAB-S)was developed to assess patients’ satisfaction with overactivebladder treatment including medications or non-pharmaceu-tical options such as physical therapy or biofeedback (use of aurination chart). To establish the value of the questionnaire, a

Rodney Appell led the review process.No conflict of interest reported by the author(s).*Correspondence to: Elisabeth Piault, Mapi Values, 15 Court Square, Suite 620,Boston, MA 02108. E-mail: [email protected] 17 November 2006; Accepted 13 March 2007Published online in Wiley InterScience(www.interscience.wiley.com)DOI 10.1002/nau.20455

� 2008 Wiley-Liss, Inc.

psychometric validation was performed, the results of whichare the focus of this article.

MATERIALS AND METHODS

Instrument Development

As a precursor to framing the research scope and develop-ing any materials for this study, a conceptual framework oftreatment satisfaction in OAB was developed based on thereview of the literature regarding OAB and satisfaction, andfeedback from a clinician advisor. The framework hypothe-sizes that the level of patients’ satisfaction (i.e., the extent towhich expectations of OAB treatment are met given perceivedtreatment outcomes) is sensitive to both the levels ofexpectations and the treatment’s effectiveness.17 Satisfactionwith treatment effectiveness was measured in terms of control ofOAB symptoms, reduced need for coping behaviors (i.e.,bathroom mapping, wearing pads and/or dark clothes) anddecreased impact of OAB on sleep, productivity, physical andsocial activities. Level of patients’ bothersomeness withmedication’s side effects was also deemed of relevance.Although it was acknowledged that patients’ satisfactionwould depend on factors such as the amount of time a patienthas been on treatment, information received from the medicalprovider, and past experience with the condition, it wasconsidered that these factors were not directly related to thetreatment and therefore, were not included in the conceptualframework. Perceived convenience, an important factor innon-pharmacological interventions such as biofeedback andphysical therapy, was excluded as its applicability to pharma-cologic treatments is limited, and if researchers were inter-ested in measuring this factor, it could be done through theaddition of a single item question in that particular situation.

Patients’ feedback was then gathered during item elicita-tion interviews conducted face-to-face, and by phone, with19 US-English and 18 US-Spanish patients. Patients with OABwere recruited through advertising or in physicians’ practicesby Mapi Values and by a recruiting agency to assess theireligibility. Patients who were interested in participating inthis study received information letters containing studydetails. Health Insurance Portability and Accountability Act(HIPAA) compliant release of information/consent forms weresigned by patients allowing Mapi Values to obtain theirmedical information. Physicians completed case report forms(CRFs) to screen patients and determine their eligibility toparticipate in the study. Patients were included if they were18 years of age or older, had a confirmed diagnosis of OAB,were being treated for their OAB symptoms with antimuscarinics utilized for OAB treatment in the US includingDetrol1 LA (Tolterodine tartrate Extended-release), Ditropan1

XL 5, 10, 15 mg (Oxybutynin Extended-release), OxytrolTM

(Oxybutynin Transdermal System) or SancturaTM (Trospiumchloride 20 mg), and were capable of understanding theresearch nature of the study, and signed the informed consentform. Patients were excluded if they had a limitation, disa-bility or any life threatening health condition that would pre-

vent them from completing the study. A semi-structuredinterview guide was developed by two of the authors (EP andCE) and translated into US-Spanish by a native speaker. Afterall interviews were completed and transcripts created,summaries of the interviews were developed. A project team,consisting of PRO specialists and a clinician, performedcontent analysis based on a review of summary informationof the interviews grouped into preliminary domains,described in the conceptual framework, and by reference backto individual patient transcripts. This qualitative work aimedto confirm the relevance of the conceptual framework, and toassist in developing item wording by using patients’ quotes.The items were generated simultaneously in US-English andin US-Spanish (Table I).

Instrument Face and Content Validation

Following the item generation phase, the face validity of thedraft OAB-S was tested in face-to-face and phone interviewswith five US-English and four US-Spanish patients diagnosedwith OAB. The purpose of these interviews was to ensure therelevance of all of the concepts covered by the draft question-naire, the comprehensiveness and understandability of thequestionnaire, and the applicability and acceptability of the items.

A translatability assessment of the OAB-S was also under-taken to ease the translation of the questionnaire into variouslanguages through early identification of possible conceptualdifficulties. This process aims at improving the formulation ofthe original instrument, increasing the cross-cultural equiva-lence between the original and its translations, and enhancingpooling of data and comparability of results across countries(Table II).

The initial OAB-S (pre-medication and medication modules)consisted of five hypothesized scales, OAB Control Expecta-tions (14 items); Impact on Daily Living with OAB (11 items);OAB Control (15 items); OAB Medication Tolerability (6 items);

Neurourology and Urodynamics DOI 10.1002/nau

TABLE I. Patient Characteristics (Development Phase)

Item elicitation interviews Cognitive debriefing interviews

No. of participants 37 9

Age Mean (Range) 48.0 (26–83) 56.0 (33–83)

Gender N (%)

Male 14 (38%) 3 (33%)

Female 23 (62%) 6 (67%)

Years since diagnosis mean (range) 3.75 years (3 months to 5 years) 7.6 years (1 months to 14 years)

TABLE II. Patient Characteristics (Validation Phase)

Age mean (SD) 52.87 (14.06)

Gendera N (%)

Male 92 (46.00)

Female 108 (54.00)

Years since diagnosis mean (SD)

OAB Diagnosis (year) (Clinician-reported) 2.46 (3.48)

OAB Diagnosis (year) (Patient-reported) 3.01 (4.71)

Patient-reported overall OAB severity rating N (%)

Very mild 19 (9.45)

Mild 64 (31.84)

Moderate 96 (47.76)

Severe 22 (10.95)

Medicationsa N (%)

Detrol LA1 (tolterodine tartrate extended-

release)

115 (57.50)

Ditropan XL1 (oxybutynin extended-release) 46 (23.00)

Oxytrol transdermal PatchTM (oxybutynin) 16 (8.00)

Oxytrol genericTM (oxybutynin) 6 (3.00)

SancturaTM (trospium chloride) 10 (5.00)

Other 7 (3.50)

aOne missing data.

180 Piault et al.

Satisfaction with Control (18 items), organized in two modules:pre-medication (25 items) and Medication assessment (50items). In addition, a version assessing patients’ satisfactionwith OAB treatment was also derived from the OAB-S;however, items regarding OAB Medication Tolerability werenot considered for inclusion in this modified version of theOAB-S. The pre-medication/pre-treatment module collectedinformation on expectations for medication efficacy regardingOAB control and the impact of OAB on day-to-day life. Themedication/treatment module contained information on theimpact of OAB on day-to-day life, medication/treatmentefficacy regarding OAB control and satisfaction with medica-tion/treatment. Medication tolerability was also assessed inthe medication module. The draft questionnaire and itsmodified version were created to enable differentiation insatisfaction levels between patients taking different medica-tions/treatments (Table III).

Instrument Psychometric Validation

Study design. The validation study was a 5-week, non-randomized, stand-alone study with patients treated for theirOAB. Patient recruitment followed the same process asdescribed previously. The objectives of this study were todetermine a consistent structure for the OAB-S, develop ascoring algorithm, determine the appropriate number of itemsby domain and test its validity, reliability and responsiveness(exploratory). On the first day, patients were requested toprovide demographic and medical characteristics and tocomplete the Pre-medication module of the OAB-S. Two andfour weeks later patients completed a 3-day diary recordingtheir OAB symptoms, and then the OAB-S Medication moduleand other questionnaires including the 33-item OveractiveBladder symptom severity and health-related quality oflife questionnaire (OAB-q), one question on OAB TreatmentControl, the Medical Outcomes Study short-form health survey(SF-12), the 13-item Treatment Satisfaction Questionnairefor Medication (TSQM), the one-item Patient’s Perception ofBladder Condition (PPBC) and the three-item Overall TreatmentEffect Scale of Overactive Bladder Control. A summary of themeasures used in this study are reported below:

. Each patient completed a bladder diary for 3 days and nightsto record details of their bladder behavior (frequency ofurinations, urgency occurrences, and incontinence). Inaddition, patients completed a daily checklist indicatingwhether or not they had consumed specific foods/beveragesthat are recognized as bladder irritants.

. The OABq18 is a 33-item validated, HRQL, self-administeredquestionnaire assessing how much patients have beenbothered by selected bladder symptoms during the previous4 weeks. For the purpose of this study, the recall period wasmodified to 2 weeks. The OABq consists of two distinctcomponents. The first questions comprise the SymptomSeverity Score (eight items) and remaining questions com-prise the HRQL component which includes the domains ofcoping, concern, sleep, and social function.

. The Treatment for Overactive Bladder Control consists of oneitem developed to document if the patient’s treatmentchanged between 2- and 4-week follow-up visits.

. Version 2 of the SF-1219 is a generic measure of health status.The SF-12 was developed to be a shorter alternative to theSF-36. The SF-12 measures eight concepts including physicalfunctioning, role limitations due to physical health problems,bodily pain, general health, vitality, social functioning, rolelimitation due to emotional problems and mental health(psychological distress and psychological well-being).

. The TSQM20 is a 14-item generic instrument that wasdeveloped to measure the major dimensions of patients’satisfaction with medication. The domains of TSQMincludes assessments for the patient’s satisfaction with themedication’s effectiveness, lack of side effects, convenience,and the patient’s global satisfaction in patients with chronicconditions (e.g., arthritis, asthma, major depression, type Idiabetes, high cholesterol, hypertension, migraine, andpsoriasis).

. The PPBC is a single-item validated, self-administeredmeasure that asks patients to describe their perception ofthe severity of their condition.

. The Overall Treatment Effects of Overactive Bladder Controlis three-item questionnaire developed as an exploratoryassessment tool in OAB to assess the overall effect of thetreatment interventions.

Neurourology and Urodynamics DOI 10.1002/nau

TABLE III. Summary of the Content of the OAB-S

Scale/Item scores

Nb of

item

21-item pre-medication

module item numbers

41-item medication

module item numbers Initial response values

OAB control expectations 10 R1, R2a, R2b, R2c, R2d,

R3a, R3b, 4a, 4b, R4c

Not included A lot (1) to Not at all (5)

All of the time (1) to none of the time (5)

Impact on daily living with OAB 10 R5a, R5b, R5c, R5d, R5e,

R5f, R5g, R5h, R5i, R5j

R6a, R6b,R6c, R6d, R6e,

R6f, R6g, R6h, R6i, R6j

Very satisfied (1) to very dissatisfied (5)

OAB control 10 Not included R1, R2a, R2b, R2c, R2d,

R3a, R3b, 4a, 4b, R4c

A lot (1) to not at all (5)

All of the time (1) to none of the time (5)

OAB medication tolerability 6 Not included 8a, 8b, 8c, 8d, 8e, 8f I did not have this side effect (0)/ it

bothered me a lot (1) to it did not

bother me at all (5)

Satisfaction with OAB control 10 Not included R9, R10a, R10b, R10c, R10d,

R11a, R11b, 12a, 12b, R12c

Very satisfied (1) to very dissatisfied (5)

Fulfilment of OAB medication expectations 1 Not included R5 Greatly exceeds expectation (1) to does

not meet my expectations at all (5)

Interruption of day-to-day life due to OAB 1 6 7 A lot (1) to not at all (5)

Overall satisfaction with OAB medication 1 Not included R13 Very satisfied (1) to very dissatisfied (5)

Willingness to continue OAB medication 1 Not included R14 Definitely yes (1) to definitely not (5)

Improved life with OAB medication 1 Not included R15 A lot (1) to not at all (5)

Key: R ¼ items that were reversed in the scoring algorithm so that the higher score indicate a better outcome (i.e., less symptoms, higher satisfaction).

Overactive Bladder Satisfaction Questionnaire 181

Statistical methodology. ‘‘Gold standard’’ psychometrictests and criteria21,22 were used to analyze the OAB-S. Theyincluded:

. Structure of the questionnaire

* Principal components factor analysis (PCA) with Varimaxrotation, item discriminant validity (item correlates morewith its own scale than with any other scale), itemconvergent validity (item correlates at or above 0.40 withits own scale after removing the item from the scale scoreand scale-scale correlations). Analyses were conducted ondata collected on the 2-week visit.

. Reliability

* Internal consistency reliability (defined as a Cronbach’s acoefficient equal or higher than 0.70). Analysis wasconducted on data collected on the 2-week visit.

* Test-retest reliability using intraclass correlation coeffi-cient (ICC coefficient of �0.70 provides confidence in test-retest reliability) for scale score and weighted k for overallassessment item scores (weighted k coefficient of �0.40provides a moderate test-retest reliability and �0.61provides substantial test-retest reliability); Test-retestreliability was evaluated using the data from patientswho reported little or no change in their overactivebladder condition based on their response to the firstquestion of the Overall Treatment Effect Scale of Over-active Bladder Control form (1. Have there been anychanges in your bladder symptoms over the past 2 weeks?).

. Concurrent validity

* This was assessed through correlations with externalmeasures including a 3-day diary, the OAB-q, the TSQMand the SF-12. Scales with similar content were expectedto have high correlations (e.g., OAB-S Tolerability scale andTSQM Side effect).

. Known-group validity

* This was assessed by describing and comparing 2-weekfollow-up visit OAB-S scores for subgroups of patientsbased on self-reported OAB severity level and inconti-nence status.

. Responsiveness

* The responsiveness of the OAB-S scores was assessedfor exploratory purposes. Estimates of responsiveness ofthe OAB-S were assessed by examining subjects whoreported an improvement or no change in their conditionbased on their responses to the first question of theOverall Treatment Effect Scale of Overactive BladderControl (responses ‘‘Better’’ or ‘‘About the same’’). Sinceonly three subjects at the 4-week follow-up visit reportedthat their OAB had gotten worse during the last 2 weeks,the analysis assessing the responsiveness of the ques-tionnaire to worsening could not be performed. Standardeffect sizes (SES) were used to assess responsiveness of theOAB-S scores. The ‘‘Better’’ group was also contrasted withthe ‘‘No Change’’ group.

All analyses were conducted on data collected from the2-week visit, except test-retest reliability and respon-siveness analyses which were evaluated between the2- and 4-week follow-up visit (Table IV).

Descriptive statistics were calculated for continuous vari-ables. For nominal and ordinal variables, the number ofpatients and the percentage for each response category werecalculated. A PCA was performed using the MINEIGENcriterion and by fixing the number of factors to the numberof hypothesized dimensions. To compare groups of subjects forquantitative or ordinal data, Student t tests were used tocompare two groups, and one way ANOVA tests were used tocompare three or more groups. There was no adjustment ofthreshold P values, since these analyses were exploratory innature and P values were presented only as an indication oftrend (Table V).

Data processing and most analyses were performed withSAS software (Statistical Analysis System, Version 9.1.3).Multitrait analyses (construct validity) and calculation ofCronbach’s a was performed using MAP-R (Multitrait AnalysisProgram) for Windows, Version 1.0.

RESULTS

Subject Characteristics

Two hundred and thirty four (234) subjects were recruitedin the stand-alone validation study; however, 33 were excludedfrom the analyses because they were not taking any OABmedication at 2- or 4-week follow-up visits and therefore didnot complete the OAB-S and the TSQM. The analysis popula-tion consisted of 201 subjects. Males and females wererepresented equally (46.00% and 54.00%, respectively). Onaverage, patients had been diagnosed with OAB for approxi-mately 3 years prior to participation in the study (2.46 � 3.48patient-reported, 3.01 � 4.71 clinician-reported) and half ofthem were treated with tolterodine extended release (57.50%)or oxybutynin extended release (23.00%). Most of the patientsrated their condition as moderate (47.76%) (Table VI).

Structure of the Questionnaire

Factor analysis. The results of the factor analysis, using amaximum likelihood indicated, identified 18 factors (factorswith Eigenvalue > 1); a structure with six scales explained89.31% of the total variance and a structure with the fourscales explained 83.67% of the total variance. Although thefactor analysis revealed a six-factor solution, it was decidedthat this solution was logically inconsistent with the layout ofthe questionnaire and therefore a four-scale structure waschosen for the medication module (i.e., OAB Control, Impact ofDaily Living with OAB, OAB Medication Tolerability andSatisfaction with OAB Control). This decision was consistentwith the fact that a factor analysis on each of the hypothesizedscales revealed that a one-factor solution for each scale wasacceptable and that each of the scales passed the tests ofinternal consistency reliability, convergent and discriminantvalidity. Following construct validity analyses and also basedon items’ face-validity, several items were deleted due to itemoverlap (two items similar in content and a high correlationbetween the items), ceiling effects or poor content validity.It was further decided that the overall assessment items(i.e., Fulfillment of OAB Medication Expectations; Interruptionof Day-to-Day Life due to OAB; Overall Satisfaction with OABmedication; Willingness to Continue OAB Medication;Improvement in Day-to-Day Life due to OAB Medication)would be scored separately. The final OAB-S (pre-medicationand medication modules) consists of five scales, OAB ControlExpectations (10 items); Impact on Daily Living with OAB

Neurourology and Urodynamics DOI 10.1002/nau

182 Piault et al.

(10 items); OAB Control (10 items); OAB Medication Tolerability(6 items); Satisfaction with OAB Control (10 items) and fiveoverall assessment items mentioned previously. The scalescould be used independently or could be regrouped in a 20-item Pre-medication module (i.e., OAB Control Expectationsand Impact on Daily Living with OAB scales and Interruptionof Day-to-Day Life due to OAB overall assessment) designed tobe completed by the patient at the start of a study and in a 40-item Medication module (Impact on Daily Living with OAB,the three remaining scales and all five single-item globalassessments) and designed to be completed at follow-up visits(Table VII).

Internal consistency reliability. All scales satisfied theminimum recommended level for reliability of Cronbach’scoefficient a (0.70) (range for Cronbach’s a, 0.76–0.96).This implies that the individual items in each domain areconsistent with each other and are measuring a commonunderlying construct. The internal consistency reliability ofthe OAB Medication Tolerability scale meets the recommendedcriterion, but was lower than for the other scales. This isprobably related to the content of the Tolerability scale, whichis an index of side effects that are understandably lesshighly correlated with each other than are the items in theother OAB-S scales. The internal consistency reliability of theImpact on daily living with OAB scale was high (0.96), but thisis likely to be explained by the redundancy within the itemwording: we intended to include two range of duration (i.e.,short duration or less than 30 min and long duration or morethan 1 hr) when assessing the impact of OAB on the physicaland social activities of daily living (including commutingand working). The Satisfaction scale also displayed a highCronbach’s a coefficient (0.96) indicating probable redundancy.No items were considered for deletion though in order toconserve the parallel content with OAB Control expectationand OAB control scales (Table VIII).

Item convergent and discriminant validity. The itemconvergent validity criteria demonstrated that 94% of theitems had a correlation higher than 0.40 at 2-week follow-up.Of note, two items, ‘‘Wear pads’’ and ‘‘Wear dark clothes’’displayed a correlation with the OAB Control scale lower than0.40, corrected for overlap. This can be explained by threethings: the response options for these two items are differentthan for the other items in the OAB Control scale; the directionof item coding for these two items is in the opposite directioncompared to the other items in the scale; and these two itemsask about coping behaviors, whereas the other items in thescale ask about symptoms.

Internal correlations among OAB-S scales and overallassessment items. The internal correlations among theOAB-S scales and overall assessment items ranged from lowto moderately high. Moderately high correlations among theOAB Control, Impact of Daily Living with OAB and Satisfactionwith OAB control scales demonstrate that the scales arerelated but not redundant. The OAB Medication Tolerabilitydemonstrated low correlations (<0.20) with the other scalesor with the overall assessment items. The overall assessmentsthat are considered proxies for patients’ satisfaction withmedication (i.e., fulfillment of expectation, willingness tocontinue the medication, overall satisfaction) displayed

Neurourology and Urodynamics DOI 10.1002/nau

TABLE

IV.Key

Properties

ofth

eOAB-S

inPatien

tsDiagnosedandTreatedforTheirOAB(N

¼201)

Scale/Item

scores

Nbof

item

Intern

alconsisten

cyreliability(Cronbach

a)

Percentageofitem

-scale

correlations

higher

orsignificantlyhigher

with

ownscale

thanwithother

scales

Test-retest

Clinicalvalidityaccording

toOABconditionseverity

(Pvalues

one-way

ANOVA)

Clinicalvalidityaccordingto

OABconditionincontinen

ce( P

values

Studen

tt-test)

SESofch

angefor‘‘B

et-

tergroup’’(exploratory)

OA

Bco

ntr

ol

10

0.8

37

6.7

0.8

2*

<0

.00

01

<0

.00

01

0.2

6

Imp

act

on

da

ily

liv

ing

wit

hO

AB

10

0.9

69

6.7

0.8

3*

<0

.00

01

<0

.00

01

0.2

6

OA

Bm

edic

ati

on

tole

rab

ilit

y6

0.7

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Overactive Bladder Satisfaction Questionnaire 183

moderate to high correlation with each other and with theOAB scales except Tolerability.

Test-Retest Reliability

The OAB-S scale scores demonstrated good test-retestreliability (ICC > 0.70), while the test-retest reliability of theoverall assessment item scores was moderate to substantial(range for weighted k coefficient; 0.51–0.68).

Concurrent Validity

The concurrent validity of the OAB-S was confirmed bymoderate to large correlations between it and the overactivebladder questionnaire (OAB-q) and treatment satisfactionquestionnaire for medication (TSQM) scores for the scalesand overall assessment items with similar content. Forexample, OAB-S Medication Tolerability scale versus TSQMSide Effect scale (r ¼ 0.40; P< 0.0001); OAB-S Control scaleversus TSQM Effectiveness (r ¼ 0.63; P< 0.0001) and OAB-q

Neurourology and Urodynamics DOI 10.1002/nau

TABLE V. Scale–Scale and Overall Assessment Item-Scale Correlation (N¼ 201)

Scale/Item Nb of item

Scales Overall assessment items

IDL TOL SAT FULFIL INTERRUPT OVSAT CONTINUE IMPLIFE

OAB control 10 0.57 0.16 0.74 0.62 0.33 0.64 0.57 0.63

Impact on daily living with OAB (IDL) 10 0.20 0.78 0.55 0.39 0.58 0.49 0.54

OAB medication tolerability (TOL) 6 0.20 0.12 0.13 0.18 0.13 0.15

Satisfaction with OAB control (SAT) 10 0.67 0.43 0.80 0.71 0.76

Fulfillment of OAB medication expectations (FULFILL) 1 0.29 0.62 0.59 0.62

Interruption of day-to-day life due to OAB (INTERRUPT) 1 0.29 0.28 0.27

Overall satisfaction with OAB medication (OVSAT) 1 0.79 0.78

Willingness to continue OAB medication (CONTINUE) 1 0.82

Note: IMPLIFE: Improved Life with OAB Medication.

TABLE VI. OAB-S Clinical Validity According to OAB Incontinence Status (N¼ 201)

Scale/Item scores Nb of item Criteria n Mean SD F value P value

OAB Control 10 Very mild 19 79.47 18.44 12.7463 <0.0001

Mild 64 74.54 15.44

Moderate 96 65.03 15.26

Severe 22 53.98 22.10

Impact on daily living with OAB 10 Very mild 19 92.10 14.24 15.4035 <0.0001

Mild 64 80.85 15.71

Moderate 96 67.54 21.89

Severe 22 58.09 26.41

OAB medication tolerability 6 Very mild 19 87.54 13.41 3.1136 0.0274

Mild 64 78.26 16.07

Moderate 95 74.74 17.90

Severe 20 75.00 20.48

Satisfaction with OAB control 10 Very mild 19 87.72 17.19 15.7828 <0.0001

Mild 64 77.69 16.28

Moderate 96 65.00 21.46

Severe 22 51.35 28.04

Fulfillment of OAB medication expectations 1 Very mild 19 3.89 1.20 7.503 <0.0001

Mild 64 3.45 1.05

Moderate 96 3.05 0.97

Severe 22 2.59 1.01

Interruption of day-to-day life due to OAB 1 Very mild 19 3.89 1.20 13.6220 <0.0001

Mild 64 3.11 1.01

Moderate 96 2.58 0.91

Severe 22 2.18 1.22

Overall satisfaction with OAB medication 1 Very mild 19 4.42 0.77 5.3297 0.0015

Mild 64 4.17 1.03

Moderate 96 3.70 1.06

Severe 22 3.45 1.26

Willingness to continue OAB medication 1 Very mild 19 4.47 0.70 3.8255 0.0108

Mild 64 4.09 1.08

Moderate 96 3.86 1.02

Severe 22 3.45 1.30

Improved life with OAB medication 1 Very mild 19 4.47 1.12 3.0613 0.0293

Mild 64 4.06 1.17

Moderate 96 3.75 1.08

Severe 22 3.59 1.40

184 Piault et al.

Symptom Severity (r ¼�0.59; P< 0.0001) scales; OAB-S Satis-faction with OAB Control, Overall Satisfaction, Willingness toContinue OAB Medication and Improved Life with OAB scalesversus TSQM Satisfaction scale (range for r, 0.72–0.79;P< 0.0001).

Known-Groups Validity

The validity of the questionnaire was supported by the factthat in a series of one-way ANOVAs, except for the OABMedication Tolerability scale, all scales and overall assessmentitems in the questionnaire were able to discriminate betweenself-reported OAB severity levels (very mild, mild, moderate,and severe patients). In addition, in a series of Student t tests,all the OAB-S scales and overall assessment items except theOAB Medication Tolerability score were able to discriminateaccording to the patient’s incontinence status. This testin particular is strong evidence of the clinical validity of theOAB-S.

Responsiveness

Standardized effect sizes for change for the ‘‘Better’’ groupwere slightly higher and positive (range 0.16–0.27 for thescales and 0.22–0.48 for overall assessment items, except

Improved Life with OAB Medication with an effect size of0.07), indicating that some improvement in that group’sscores had indeed occurred between 2- and 4-week follow-upvisits. Overall however, these SES indicated only smallimprovement for the ‘‘Better’’ group. The small SES are likelydue to the fact that in this observational study there was nosystematic attempt to induce change in the study sample, andthus no large changes could be expected.

DISCUSSION

Patient satisfaction assessments are valuable for a numberof reasons. First, satisfaction with treatment and care isrelated to adherence to clinician instructions, which is animportant determinant of health outcomes.23 Second, patientsatisfaction assessments add another dimension to theunderstanding of patient outcomes. Although they are notobjective and do not correspond directly to clinician assess-ments, the information captured goes beyond the rating ofhealth care or health status.1 Third, feedback from patientsmay be used to alter and improve the quality of health caredelivery.21

Well-developed and validated patient satisfaction ques-tionnaires that may be used in clinical trial and survey

Neurourology and Urodynamics DOI 10.1002/nau

TABLE VII. OAB-S Clinical Validity According to OAB Incontinence Status (N¼ 201)

Scale/Item scores Nb of item Criteria n Mean SD F value P value

OAB control 10 Continent 103 75.31 16.05 1.08 <0.0001

Incontinent 98 60.76 16.69

Impact on daily living with OAB 10 Continent 103 80.56 18.08 1.67 <0.0001

Incontinent 98 65.20 23.33

OAB medication tolerability 6 Continent 102 79.21 15.93 1.24 0.0857

Incontinent 96 74.93 18.87

Satisfaction with OAB control 10 Continent 103 78.45 19.60 1.25 <0.0001

Incontinent 98 60.49 21.94

Fulfillment of OAB medication expectations 1 Continent 103 3.55 1.09 140 <0.0001

Incontinent 98 2.84 0.92

Interruption of day-to-day life due to OAB 1 Continent 103 3.00 1.20 1.60 0.0251

Incontinent 98 2.65 0.95

Overall satisfaction with OAB medication 1 Continent 103 4.18 0.99 1.26 <0.0001

Incontinent 98 3.59 1.11

Willingness to continue OAB medication 1 Continent 103 4.18 1.00 1.21 0.0013

Incontinent 98 3.70 1.09

Improved life with OAB medication 1 Continent 103 4.19 1.08 1.19 0.0002

Incontinent 98 3.59 1.18

TABLE VIII. Responsiveness of the OAB-S Scales and Overall Assessment Items Between 2- and 4-week Follow-up Visits ‘‘About the Same’’ Group’’ Versus‘‘Better’’ Group

Scale/Item scores Nb of item

About the Same (n¼ 133) Better (n¼ 60)

n SES of change n SES of change

OAB control 10 133 0.05 60 0.26

Impact on daily Living with OAB 10 133 0.06 60 0.26

OAB medication tolerability 6 132 0.09 60 0.16

Satisfaction with OAB control 10 133 0.07 60 0.27

Fulfillment of OAB medication expectations 1 133 0.09 60 0.11

Interruption of day-to-day Life due to OAB 1 133 0.13 60 0.48

Overall satisfaction with OAB medication 1 133 �0.01 60 0.23

Willingness to continue OAB medication 1 133 0.01 60 0.22

Improved life with OAB medication 1 133 �0.04 60 0.07

Overactive Bladder Satisfaction Questionnaire 185

research are in short supply. With few exceptions, there is alack of rigor in the development of satisfaction questionnaires,and the measurement of treatment satisfaction has beencharacterized as poor.24 This study presents the results of amethodologically rigorous process to develop and validate aquestionnaire specifically for overactive bladder. The OAB-Sand its modified version (pre-treatment and treatmentmodules) consist of five scales that may be fielded as a singlequestionnaire or as independent modules. The OAB-S istherefore appropriate for use in clinical research (e.g., pre-medication module provided at baseline and medicationmodule at follow-up), or in routine clinical practice (e.g., useof the Satisfaction with OAB control or Impact on daily livingwith OAB scale). We are aware of two other satisfactionmeasures that may be used in trials of OAB patients: OAB-SAT-Q,15 and the generic TSQM.18 The OAB-SAT-Q was developedconcurrent to this OAB-S and there are several limitations tothis questionnaire. In terms of supporting promotional claimswe find the OAB-SAT-Q is deficient in two important aspects.First, the OAB-SAT-Q was not developed around a conceptualframework of satisfaction in OAB and the draft guidance onpatient-reported outcomes (PROs) measures released by USFood and Drug Administration (FDA) (FDA Guidance forIndustry: Patient-Reported Outcome Measures: Use in MedicalProduct Development to Support Labeling Claims, published indraft on 3 February 2006) require a conceptual frameworkfor the development of any new PRO questionnaire. Second,whereas we utilized 46 patient interviews in the developmentof the OAB-S, the developers of the OAB-SAT-Q did not useindividual patient interviews in the development of theirmeasure, instead they reviewed generic measures of patientsatisfaction and did a cognitive debriefing of their newmeasure on patients, thus missing an important step in thedevelopment of a new measure. In addition, in the OAB-SAT-Qonly one question has an expectation component, whereas inthe OAB-S several expectation questions are included to matchspecific satisfaction questions. Further, the OAB-SAT-Qincludes only three items on side effects in general, whereasthe OAB-S measures bother on specific side effects; therefore itis expected to show better sensitvity. Finally, the OAB-SAT-Qcontains only one multi-item scale and 11 stand alonequestions, whereas the OAB-S contains five multi-item scalesand five single-item overall assessments. In addition, the OAB-SAT-Q uses different response formats (four to six-point Likertscales), which might add in terms of patient-completion time,and complicate the scoring algorithm by adding rules to havean equal item weight. The presence of multi-item scales inquestionnaires has been demonstrated to improve the relia-bility of the questionnaire.

The TSQM is a valid and psychometrically sound measure ofthe major dimensions of patients’ satisfaction with medica-tion with an intended use across disease states. We believethat a disease-specific satisfaction measure offers severaladvantages to a generic measure. In exploratory testing of theOAB-S and the TSQM25 in this validation study, we found thatalthough both questionnaires achieved the minimum recom-mended level of internal consistency reliability (Cronbach’sa> 0.70; weighted k> 0.50), the OAB-S outperformed theTSQM in other tests. For instance, the test re-test reliability ofthe all scales and individual items on the OAB-S showed goodreliability (ICC range for ICC; 0.72–0.87 and range for weightedk coefficient; 0.51–0.68); however, only the global satisfac-tion domain of the TSQM demonstrated good reliability(ICC ¼ 0.82). The ability of the questionnaires to discriminateamong known-groups of patients based on patient-reported OABsymptoms severity was tested and the relative validity (RV)

was calculated. The RV was higher for the OAB-S scorescompared to the TSQM scores of same content. In addition,except for the medication effectiveness domains of the OAB-Sand the TSQM, the SES for all the other domains were higherfor the OAB-S compared to the TSQM indicating betterresponsiveness for the OAB-S.

There were several limitations to the OAB-S stand valida-tion study. The validation study was conducted only in the US.Whether these results are generalizable to other countries willrequire additional testing. However, we feel that the additionof a translatability assessment step during the developmentphase improves the prospects that the OAB-S can be easilyadapted to other settings. A second limitation is that parti-cipants for both the development and validation populationsconsisted of a convenience sample of patients. Although wewere able to confirm diagnosis of OAB with physicians, thereis no guarantee that this sample is representative of thegeneral OAB population. A third limitation of our analysis ofthe OAB-S was that it was confined to previously treatedpatients, the performance of this questionnaire in treatmentnaı̈ve patients is currently unknown, although testing in thispopulation is currently underway. Further, although themeasure was developed to be relevant to different types ofOAB treatments, and has good face and content validity acrosstreatments (except for the tolerability scale) the OAB-S, todate, has only been tested in patients treated by pharmaco-logical interventions. For non-pharmacologic treatments, suchas physical therapy, the addition of a single item question onconvenience may be warranted to obtain a complete picture ofpatient satisfaction. Finally, the test-retest reliability wasgood for all scales and single items. The effect size forresponsiveness was only low to moderate. This is a potentialshortcoming of the OAB-S and may be due to the widedistribution in this relatively small sample, which will tend todecrease the effect size. The small SES are likely due to the factthat in this observational study there was no systematicattempt to induce change in the study sample, and thus nolarge changes could be expected. Because of the observationalstudy design, these results are likely to underestimate thetrue responsiveness the OAB-S. A clinical trial using a cross-over design with placebo versus an active OAB treatmentwould be the ideal study for evaluating the responsiveness ofthe OAB-S. Currently, the OAB-S is being used in clinicaltrials, and further analyses will be conducted to determinecut-off points and minimal important difference that willallow the OAB-S to be used and interpreted in routine clinicalpractice.

CONCLUSIONS

The results of this work indicate that the OAB-S is avalid instrument that will be useful for further assessmentof patient satisfaction in OAB therapy in a variety of settings.

APPENDIX A: OAB-S Pre-Medication Module

OAB Control Expectations

The following questions will help us understand what youexpect from your OAB medication. For each question, mark anin the one box that best describes your answer.

Neurourology and Urodynamics DOI 10.1002/nau

186 Piault et al.

(1) On your way to the bathroom, you expect your OABmedication to keep you from having urine loss:

Neurourology and Urodynamics DOI 10.1002/nau

All of the time you go to

the bathroom

Most of the time you go to the bathroom Some of the time

you go to the

bathroom

A little of the

time you go to

the bathroom

None of the time you

go to the bathroom

&1 &2 &3 &4 &5

(2) You expect your OAB medication to decrease the number of times: A lot Moderately Somewhat A little Not at all

2a You have a sudden urgency to urinate &1 &2 &3 &4 &5

2b You have urine loss due to an urgency to urinate &1 &2 &3 &4 &5

2c You wake up during the night to urinate &1 &2 &3 &4 &5

2d You have to urinate during the day &1 &2 &3 &4 &5

(3) You expect your OAB medication: A lot Moderately Somewhat A little Not at all

3a To improve your control of your urine loss &1 &2 &3 &4 &5

3b To improve your control of your need to urinate &1 &2 &3 &4 &5

(4) While on your OAB medication, you expect to:

All of the

time

Most of the

time

Some of the

time

A little of the

time

None of the

time

4a Wear pads &1 &2 &3 &4 &5

4b Wear dark and/or baggy clothes &1 &2 &3 &4 &5

4c Be comfortable being away from a bathroom &1 &2 &3 &4 &5

(5) Keeping in mind how your OAB symptoms may interruptyour activities, how satisfied are you with your ability: Very satisfied

Somewhatsatisfied

Neither dissatisfiednor satisfied

Somewhatdissatisfied Very dissatisfied

5a To perform physical activities lasting 30 min or less (e.g.,

going for a walk)

&1 &2 &3 &4 &5

5b To perform physical activities lasting more than 1 hr

(e.g., shopping or exercising)

&1 &2 &3 &4 &5

5c To participate in activities with others lasting 30 min or

less(e.g., talking on the telephone)

&1 &2 &3 &4 &5

5d To participate in activities with others lasting more than

1 hr (e.g., sitting in a movie theater or going out to

dinner)

&1 &2 &3 &4 &5

5e To travel for 30 min or less (e.g., commuting) &1 &2 &3 &4 &5

5f To travel for more than 1 hr (e.g., going on a car trip) &1 &2 &3 &4 &5

5g To complete work and/or household duties lasting

30 min or less

&1 &2 &3 &4 &5

5h To complete work and/or household duties lasting more

than 1 hr

&1 &2 &3 &4 &5

5i To focus on work and/or household duties &1 &2 &3 &4 &5

5j To sleep through the night without having to go to the

bathroom

&1 &2 &3 &4 &5

The following questions will help us understand what you expect your day to day life to be like while on your OABmedication. For each question, mark an in the one box that best describes your answer.

Impact on Daily Living With OAB

The following questions will help us understand how satisfied you are with your day to day life with your OAB. For eachquestion, mark an in the one box that best describes your answer.

A lot Moderately Somewhat A little Not at all

&1 &2 &3 &4 &5

6. How much do your OAB symptoms interrupt your day to day life?

Overactive Bladder Satisfaction Questionnaire 187

Neurourology and Urodynamics DOI 10.1002/nau

All of the time yougo to the bathroom Most of the time you go to the bathroom

Some of the time yougo to the bathroom

A little of the time yougo to the bathroom

None of the time yougo to the bathroom

&1 &2 &3 &4 &5

(2) Your OAB medication decreases the number of times: A lot Moderately Somewhat A little Not at all

2a You have a sudden urgency to urinate &1 &2 &3 &4 &5

2b You have urine loss due to an urgency to urinate &1 &2 &3 &4 &5

2c You wake up during the night to urinate &1 &2 &3 &4 &5

2d You have to urinate during the day &1 &2 &3 &4 &5

(3) Your OAB medication: A lot Moderately Somewhat A little Not at all

3a Improves your control of your urine loss &1 &2 &3 &4 &5

3b Improves your control of your need to urinate &1 &2 &3 &4 &5

APPENDIX B: OAB-S MEDICATION MODULE

OAB Control

The following questions will help us understand the effects your OAB medication has on your OAB symptoms. For eachquestion, mark an in the one box that best describes your answer.

(1) Your OAB medication enables you to reach the bathroom without urine loss:

(4) While on your OAB medication, you: All of the time Most of the time Some of the time A little of the time None of the time

4a Wear pads &1 &2 &3 &4 &5

4b Wear dark and/or baggy clothes &1 &2 &3 &4 &5

4c Are comfortable being away from a

bathroom

&1 &2 &3 &4 &5

The following questions will help us understand the effect your OAB medication has on your day to day life. For eachquestion, mark an in the one box that best describes your answer.

Greatly exceeds my expectationsSomewhat exceeds my

expectations Meets my expectationsDoes not quite meet my

expectationsDoes not meet myexpectations at all

&1 &2 &3 &4 &5

(5) To what degree does your OAB medication meet your expectations?

(6) Keeping in mind how your OAB symptoms may interrupt youractivities, how satisfied are you with your ability: Very satisfied

Somewhatsatisfied

Neither dissatis-fied nor satisfied

Somewhatdissatisfied

Verydissatisfied

6a To perform physical activities lasting 30 min or less

(e.g., going for a walk)

&1 &2 &3 &4 &5

6b To perform physical activities lasting more than 1 hr (e.g.,

shopping or exercising)

&1 &2 &3 &4 &5

6c To participate in activities with others lasting 30 min or less

(e.g., talking on the telephone)

&1 &2 &3 &4 &5

6d To participate in activities with others lasting more than

1 hr (e.g., sitting in a movie theater or going out to dinner)

&1 &2 &3 &4 &5

6e To travel for 30 min or less (e.g., commuting) &1 &2 &3 &4 &5

6f To travel for more than 1 hr (e.g., going on a car trip) &1 &2 &3 &4 &5

6g To complete work and/or household duties lasting 30 min or less &1 &2 &3 &4 &5

6h To complete work and/or household duties lasting more than 1 hr &1 &2 &3 &4 &5

6i To focus on work and/or household duties &1 &2 &3 &4 &5

6j To sleep through the night without having to go to the bathroom &1 &2 &3 &4 &5

Impact on Daily Living With OAB

The following questions will help us understand how satisfied you are with your day to day life with your OAB. For eachquestion, mark an in the one box that best describes your answer.

188 Piault et al.

Neurourology and Urodynamics DOI 10.1002/nau

A lot Moderately Somewhat A little Not at all

&1 &2 &3 &4 &5

Impact on Daily Living With OAB (con’t)

(7) How much do your OAB symptoms interrupt your day to day life?

I did not havethis side effect

I had this side effect and:

It botheredme a lot

It bothered memoderately

It botheredme somewhat

It botheredme a little

It did notbother me at all

8a Constipation &0 &1 &2 &3 &4 &5

8b Dry mouth &0 &1 &2 &3 &4 &5

8c Drowsiness &0 &1 &2 &3 &4 &5

8d Headache &0 &1 &2 &3 &4 &5

8e Nausea &0 &1 &2 &3 &4 &5

8f Blurred vision &0 &1 &2 &3 &4 &5

OAB Medication Tolerability

The following questions will help us understand how bothered you are by the side effects of your OAB medication. For eachquestion, mark an in the one box that best describes your answer.

Very satisfied Somewhat satisfiedNeither dissatisfied

nor satisfiedSomewhatdissatisfied Very dissatisfied

&1 &2 &3 &4 &5

(10) Overall, how satisfied are you with your OABmedication’s ability to decrease the number of times:

Very satisfied Somewhatsatisfied

Neither dissatisfiednor satisfied

Somewhatdissatisfied

Verydissatisfied

10a You have a sudden urgency to urinate &1 &2 &3 &4 &5

10b You have urine loss due to an urgency

to urinate

&1 &2 &3 &4 &5

10c You wake up during the night to urinate &1 &2 &3 &4 &5

10d You have to urinate during the day &1 &2 &3 &4 &5

(11) Overall, how satisfied are you with your OABmedication’s ability

Verysatisfied

Somewhatsatisfied

Neither dissatisfiednor satisfied

Somewhatdissatisfied

Verydissatisfied

11a To improve your control of your urine loss &1 &2 &3 &4 &5

11b To improve your control of your need to

urinate

&1 &2 &3 &4 &5

Satisfaction With OAB Control

The following questions will help us understand how satisfied you are with your OAB medication’s ability to treat your OABsymptoms. For each question, mark an in the one box that best describes your answer.

(9) Overall, how satisfied are you with your OAB medication’s ability to allow you to reach the bathroom without urine loss:

(12) Overall, how satisfied are you with your OABmedication’s ability: Very satisfied

Somewhatsatisfied

Neither dissatis-fied nor satisfied

Somewhatdissatisfied Very dissatisfied

12a To decrease the need to wear any pads at all &1 &2 &3 &4 &5

12b To decrease the need to wear dark and/or baggy

clothes

&1 &2 &3 &4 &5

12c To allow you to be away from a bathroom &1 &2 &3 &4 &5

The following questions will help us understand how satisfied you are with the effect your OAB medication has on your dayto day life. For each question, mark an in the one box that best describes your answer.

(8) Since you started your medication, how much have you been bothered by each of the following side effects?

Overactive Bladder Satisfaction Questionnaire 189

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Neurourology and Urodynamics DOI 10.1002/nau

Very satisfied Somewhat satisfied Neither dissatisfied nor satisfied Somewhat dissatisfied Very dissatisfied

&1 &2 &3 &4 &5

The following questions will help us understand your overall satisfaction with your OABmedication. For each question, mark anin the one box that best describes your answer.

(13) Overall, how satisfied are you with your OAB medication?

Definitely yes Probably yes Do not know Probably not Definitely not

&1 &2 &3 &4 &5

(14) Based on your experience with your current OAB medication, would you like to continue using this OAB medication?

A lot Moderately Somewhat A little Not at all

&1 &2 &3 &4 &5

(15) How much has your OAB medication improved your day to day life?

Thank you for your time.

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