Validation of the bladder control self-assessment questionnaire (B-SAQ) in men

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1 Functional Urology Validation of the bladder control self-assessment questionnaire (B-SAQ) in men Arun Sahai*, Christopher Dowson*, Eduardo Cortes, Jai Seth*, Jane Watkins*, Muhammed Shamim Khan*, Prokar Dasgupta*, Linda Cardozo, Christopher Chapple, Dirk De Ridder, Adrian Wagg** and Cornelius Kelleher *Department of Urology, Guy's Hospital, MRC Centre for Transplantation, King's College London, King's Health Partners, Department of Gynaecology, Guy's and St Thomas NHS Trust, Department of Urogynaecology, King's College Hospital, London, Department of Urology, Royal Hallamshire Hospital, Sheffield, UK, Department of Urology, University Hospitals Leuven, Leuven, Belgium, and **Division of Geriatric Medicine, Department of Medicine, University of Alberta, Edmonton, AB, Canada Objective To validate the Bladder Control Self-Assessment Questionnaire (B-SAQ), a short screener to assess lower urinary tract symptoms (LUTS) and overactive bladder (OAB) in men. Patients and Methods This was a prospective, single-centre study including 211 patients in a urology outpatient setting. All patients completed the B-SAQ and Kings Health Questionnaire (KHQ) before consultation, and the consulting urologist made an independent assessment of LUTS and the need for treatment. The psychometric properties of the B-SAQ were analysed. Results A total of 98% of respondents completed all items correctly in <5min. The mean B-SAQ scores were 12 and 3.3, respectively for cases (n = 101) and controls (n = 108) (P < 0.001). Good correlation was evident between the B-SAQ and the KHQ. The agreement percentages between the individual B-SAQ items and the KHQ symptom severity scale were 86, 85, 84 and 79% for frequency, urgency, nocturia and urinary incontinence, respectively. Using a B-SAQ symptom score threshold of 4 alone had sensitivity, specificity and positive predictive values for detecting LUTS of 75, 86 and 84%, respectively, with an area under the curve of 0.88; however, in combination with a bother score threshold of 1 these values changed to 92, 46 and 86%, respectively. Conclusions The B-SAQ is an easy and quick valid case-finding tool for LUTS/OAB in men, but appears to be less specific in men than in women. The B-SAQ has the potential to raise awareness of LUTS. Further validation in a community setting is required. Keywords bladder control self-assessment questionnaire, B-SAQ, lower urinary tract symptoms, overactive bladder, King s Health Questionnaire Introduction An active case-finding approach to LUTS and overactive bladder (OAB) is recommended by national [1] and international guidelines [2]. The extent to which such an approach might have an impact on the eventual severity or possible complications of LUTS/OAB, associated comorbidities or costs is, as yet, unknown; however, LUTS and OAB are highly prevalent conditions, and there are strategies to treat them. It is therefore likely that active case-finding and treating of such patients has the potential to reduce healthcare costs. Data from the European Prospective Investigation into Cancer and Nutrition (EPIC) study, a large population-based cross-sectional survey, suggest that 64.3% of participants had at least one LUTS [3]. The prevalence of storage LUTS was greater than that for voiding and postmicturition symptoms combined. The overall prevalence of OAB was 11.8%, was similar in both sexes and increased in association with age. OAB comprises a subset of storage LUTS currently defined by the ICS as urgency, with or without urgency urinary incontinence (UI), usually with frequency and nocturia, with no proven infection or other obvious pathology [4]. In the EPIC study, OAB was more prevalent than all types of UI BJU International 2013 BJU International doi: /bju BJU Int 2014; 113: Published by John Wiley & Sons Ltd. wileyonlinelibrary.com

2 Sahai et al. combined (9.4%). LUTS, including UI and OAB, have detrimental effects on health-related quality of life, cause significant bother to the individual and are responsible for considerable health and economic cost [5,6]. According to a health-economic model, the annual direct costs ofoabmanagementrangedfrom 269 to 706 per patient per year [7]. The largest cost was the use of incontinence pads, accounting for an average of 63% of the annual per patient cost of OAB management. The total cost to healthcare systems across all five countries in that health-economic study was estimated at 4.2 bn in 2000, and the expected total cost was estimated to reach 5.2 bn by In a nested case controlled analysis from the EPIC study, 54% of men were bothered by their symptoms, and those with co-existent UI were more bothered than women [8]. Furthermore, women were more likely than men to use a coping strategy, e.g. fluid alteration, physical exercise, physiotherapy and pads. Amongst those using such strategies, women were more likely to seek help from healthcare services [8]. A further subanalysis of the EPIC data suggested that only storage LUTS increased with age among men with OAB symptoms [5]. Men with LUTS commonly experience coexisting storage, voiding and post-micturition symptoms [5]. In the UK, the prevalence of OAB symptoms at least somewhat in men was 12% [9]. Men with bothersome OAB relative to OAB with no bother or no OAB at all were less likely to be in part-time or full-time work, more likely to work less productively and to report lower health-related quality of life, with higher levels of anxiety and depression [9]. The 5th International Consultation on Incontinence gave five screening/case-finding questionnaires a grade A recommendation for detecting OAB and/or UI [10]. One of those recommended was the Bladder Control Self-Assessment Questionnaire (B-SAQ), a short, concise questionnaire for LUTS/OAB which has been validated in women [11]. The purpose of the present study was to validate the B-SAQ in men. Patients and Methods Male patients attending a busy urology or dedicated stone outpatient clinic in a single centre were recruited to the present study at random. Each patient was approached by a trained research nurse who provided the patient with an information pack which included information about the study, the B-SAQ and the King s Health Questionnaire (KHQ). Patients who consented to participate completed both questionnaires before being seen by a clinician. The questionnaires were collected by a research nurse. A urologist made an independent decision about the presence and type of LUTS (e.g. storage, obstructive or mixed) as part of a normal consultation. The urologist had no access to the completed questionnaires. The consultation notes were recorded and all data were entered into a password-protected database by the research team. No member of the research team analysing the data was involved in assessing the patient in the outpatient clinic. Patients were excluded if they were unable to read Englishorwere<18 years old. The study had full ethics committee approval from the Nottingham Research Ethics Committee (11/EM/0043). The B-SAQ (Appendix S1) is an eight-item questionnaire developed by an expert European panel using a standardized multistep method: expert panel discussion, questionnaire piloting, focussed group interviews and direct patient involvement [11]. The questions were chosen and modified during piloting so as to be easily understood by patients. The short form evaluates symptoms of urinary frequency, urgency, nocturia and UI and their associated bother on a four-point Likert scale. The patient adds up symptom and bother scores and a scoring table indicates whether the patient should seek medical attention depending on that score. The questionnaire recommends seeking medical attention if the symptom score is 4 and states that the patient may benefit from help if the bother score is 1. A separate statement in bold at the bottom of the questionnaire specifically warns that those patients with haematuria, voiding difficulty or pain on passing urine should consult their doctor immediately. The KHQ was first developed and validated for assessing health-related quality of life in women with UI [12]. It has since been validated for OAB in men [13 17] and translated into more than 45 languages for use around the world. The KHQ is split into three sections: (i) general health and overall health related to urinary symptoms (general health perception and incontinence impact); (ii) specific domains of quality of life (role, physical and social limitations, personal relationships, emotions, sleep/energy and severity measures; and (iii) bother and impact of urinary symptoms (symptom severity). It has been given a grade A recommendation by the International Consultation on Incontinence based on its standard psychometric testing [18]. The power calculation was based on the previous B-SAQ study and as the B-SAQ component focuses on predominantly storage symptoms was felt to be translational to males [11]. Provided that a 1:1 ratio of patients with LUTS (cases) to controls was achieved, a minimum of 100 patients and 100 controls was required to be able to detect an area under the curve (AUC) between the 95% confidence interval of Reliability was not statistically assessed as this has been documented in the previous study [11]. Relevant receiver operator characteristic and AUC calculations were made to identify the appropriate sensitivity, specificity and positive predictive value (PPV) of the B-SAQ in men and to 784 BJU International 2013 BJU International

3 Validation of the B-SAQ in men Table 1 Reasons for attendance at a urology clinic, and LUTS diagnosis by B-SAQ vs a clinician. Reason for attendance Number Median (range) age, years LUTS: positive according to clinician LUTS: positive according to B-SAQ LUTS (19 101) Raised PSA (32 81) Haematuria (27 76) 8 12 Urolithiasis (26 93) 3 14 Benign scrotal conditions (25 82) 1 8 Benign penile conditions (26 72) 2 3 Pain: testicular (23 74) 2 13 Testicular mass (25 82) 2 7 UTI 9 48 (27 86) 5 6 Erectile dysfunction 7 49 (27 61) 1 4 Haematospermia 7 34 (25 69) 2 3 Pain: other 6 52 (44 66) 3 6 Miscellaneous 5 48 (28 65) 2 2 Infertility 4 37 (33 62) 0 1 Renal mass 3 56 (48 71) 0 2 examine its validity to detect LUTS/OAB. Pearson s test was used to assess the correlation of the B-SAQ with the KHQ. Study results were analysed using SPSS 18 (SPSS Inc., Chicago, IL, USA). Results A total of 209 subjects were recruited to the study (101 cases, 108 controls). One subject in the control group did not fill out the B-SAQ correctly and two subjects (one in each arm) did not fill out the KHQ correctly. All of the B-SAQs were completed in <5 min. The reasons for attendance at the urology clinic and age stratification are outlined in Table 1. Cases were significantly older than controls (62 vs 41 years; P < 0.001). The mean (SD) B-SAQ scores were 12 (7) for cases and 3.3 (3.9) for controls (P < 0.001). The B-SAQ generally overestimated the number of patients with LUTS when compared with a clinician by a median of 2.5 patients per group (Table 1). There were two conditions (urolithiasis and testicular pain) in which the B-SAQ suggested 22 extra patients had LUTS when compared with the urologist s assessment. The B-SAQ symptom and bother scores correlated well for the entire cohort (Pearson s r =of 0.94; P < 0.01). A symptom score threshold of 4 showed that the B-SAQ had a sensitivity of 75%, a specificity of 87% and a PPV of 84% for the detection of LUTS. The AUC (Fig. 1) was In all, 95 patients with LUTS (94%) had some element of bother. For a bother score threshold of 1, the sensitivity, specificity and PPV were 91, 45 and 61%, respectively with an AUC of The overall sensitivity, specificity and PPV for B-SAQ threshold values combined were 92, 46 and 86%. There was significant correlation between the B-SAQ and the KHQ (Table 2). The reliability of the KHQ (individual symptoms in the symptom score domain) compared with Fig. 1 Receiver operator characteristic curve for B-SAQ symptom scores. AUC = Sensitivity Specificity B-SAQ individual symptom scores was assessed in 61 patients. The rates of agreement were 86% (frequency), 85% (urgency), 84% (nocturia) and 79% (UI). Discussion The B-SAQ is a simple, easy-to-complete case-finding tool with the vast majority of patients completing it correctly in <5 min. If a threshold is set using a symptom score of 4 it has good sensitivity (75%) specificity and positive predictive value in detecting LUTS. Combining the symptom score with a bother score threshold of 1, improves the sensitivity to 92% but lowers the specificity to 46%. AUCs of 0.88 for a symptom score 4 and of 0.85 for a bother score 1, suggest it is a good/excellent test for detecting LUTS in men. When each BJU International 2013 BJU International 785

4 Sahai et al. Table 2 Correlation of the B-SAQ domain scores with the KHQ domain scores. General health perceptions Incontinence impact Role limitations Physical limitations Social limitations Personal relationships Emotions Sleep/Energy Severity measures UU-S UU-B UF-S UF-B N-S N-B UI-S UI-B T-S T-B UU, urinary urgency; UF, urinary frequency; N, nocturia; UI, urinary incontinence; T, total; -S, symptom score; -B, bother score. Values are Pearson s r. P < for all values. individual KHQ domain was compared with each individual and total B-SAQ score, a high degree of correlation (r scores) was observed for all but General Health Perception (although this was still statistically significant (Table 2)). The specificity of the B-SAQ in men was, however, rather poor. The majority of men with LUTS tested positive by having a bother score of 1 on the B-SAQ; however, using this low threshold also picked up many men who were not consideredtohavelutsaccordingtotheclinician.this might suggest that clinicians are not good at asking how bothered the patients are if they didn t think they had specific LUTS or that a bother score of 1 may not be sufficiently discriminatory. In the present cohort, we identified a large group of patients (those with urolithiasis or testicular pain) with bother scores of 1 but who were not considered by the urologist to have LUTS. These conditions may have been disproportionately represented in our sample; removing them from the analysis resulted in an increase in B-SAQ specificity (to 70%), reducing the over-diagnosis of LUTS. This should not detract from the fact that these men did have genuine urological problems which required review by a specialist. In the previous report, the B-SAQ was quick and easy to complete, with 89% of respondents completing all items correctly in <5 min [11]. The internal consistency, criterion validity and test retest reliability of the questionnaire were good, suggesting the questionnaire was psychometrically robust. The sensitivity and specificity of the questionnaire in identifying patients with bothersome LUTS were 98 and 79%, respectively. The reliability of the B-SAQ was not formally retested in the present study; however, when comparing the individual symptom score questions from the KHQ with the B-SAQ, in a smaller sample of 61 patients, agreement for the frequency, urgency, nocturia and UI ranged between 79 and 86%, indicating the B-SAQ was reliable in this setting. A comparison of the B-SAQ and the OAB awareness tool, the OAB-V8, in women in both primary and secondary care, showed that both tools were good at detecting OAB and mixed urinary symptoms, but it appeared that the B-SAQ was better for detecting stress UI (AUC 0.85 vs 0.68) [19]. In a cross-sectional, multicentre study from Spain recruiting women attending urodynamic investigations, the B-SAQ correlated well with a3daybladder diary when assessing frequency and urgency; both these measures were the only instruments able to fully assess all the symptoms of OAB [20,21]. Recently the B-SAQ has been used as a case-finding tool in a primary care setting in >7000 Belgian women aged >40 years [22]. Approximately 34% of the women scored positive on the B-SAQ (symptom score 4 and bother score 1) and 10% had clinically significant symptoms with symptom and bother scores 7 and 4, respectively. Urgency and nocturia were considered the most bothersome and their prevalence and degree of bother increased with age. Although the B-SAQ is an assessment of storage LUTS, a statement at the end suggests seeking medical help for haematuria, difficulty or painful voiding. This is important for screening for the red flag symptoms which always need investigation. The main limitation of the present study is that we have shown the B-SAQ to be a valid tool in men in a secondary care setting only; a future study should evaluate it in primary care. Furthermore, the B-SAQ does not ask specific questions regarding voiding/obstructive LUTS, although there is a statement at the end of the questionnaire stating that if there is difficulty passing urine the patient should consult their doctor. In conclusion, the B-SAQ questionnaire is an easy and quick valid screening/case-finding tool for LUTS in men. The B-SAQ has the potential to raise awareness of LUTS and promote earlier treatment and thus potentially improve quality of life in patients. Although sensitive, it is less specific in men than in women, suggesting it may overdiagnose LUTS in men in this setting. Further validation in a community is 786 BJU International 2013 BJU International

5 Validation of the B-SAQ in men required and further formal study is needed to examine whether case-finding in the general population would help prevent disease severity, avoid complications and have the potential to save some of the considerable associated cost. Acknowledgements Urology Consultants, Department of Urology, Guy s Hospital. AS & PD would like to acknowledge the MRC Centre for Transplantation: Medical Research Council (MRC) Centre for Transplantation, King s College London, UK MRC grant no. MR/J006742/1. This research was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy s and St Thomas NHS Foundation Trust and King s College London. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Conflict of Interest The followings authors are members of the European Overactive Bladder Forum sponsored by Astellas: C.K., L.C., C.C., D.D.R. and A.W. C.K. has received honoraria from Allergan, Astellas and Pfizer. L.C. has the following conflicts: Astellas: advisory board, principle trial investigator, speaker at satellite symposia; Pfizer: advisory board, trial investigator; and Allergan, Astellas, Ethicon, Merck, Pfizer and Teva Research: consultancy and/or advisory work. D.D.R. is a consultant and speaker for AMS, Astellas, Medtronic and Pfizer, has been an investigator for AMS, Astellas and Pfizer, and has received grants from Astellas, BARD and Medtronic. A.W. has been a consultant for the following: Astellas Pharma, Pfizer Corp, SCA and Watson Pharma, has been involved in research activity for Astellas, Pfizer and SCA, and has received speaker fees from Astellas, Pfizer and SCA. C.C. is a speaker for Ranbaxy, a consultant for AMS, Lilly and ONO, and a consultant, researcher, speaker and trial investigator for Allergan, Astellas, Pfizer and Recordati. A.S. has received honorarium and spoken on behalf of Astellas and Pfizer. He is currently a trial investigator for Astellas and AMS. He has also received honoraria and an unrestricted educational grant and been a trial investigator for Allergan. C.D., J.S., J.W., M.K., P.D. and E.C. have no conflicts of interest. References 1 CG97: Lower Urinary Tract Symptoms: The Management of Lower Urinary Tract Symptoms in Men. London: National Institute for Health and Clinical Excellence, Abrams P, Andersson KE, Birder L et al. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn 2010; 29: Irwin DE, Milsom I, Hunskaar S et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 2006; 50: ; discussion Abrams P, Cardozo L, Fall M et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002; 21: Irwin DE, Milsom I, Kopp Z, Abrams P, Artibani W, Herschorn S. Prevalence, severity, and symptom bother of lower urinary tract symptoms among men in the EPIC study: impact of overactive bladder. Eur Urol 2009; 56: Stewart WF, Van Rooyen JB, Cundiff GW et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003; 20: Reeves P, Irwin D, Kelleher C et al. The current and future burden and cost of overactive bladder in five European countries. Eur Urol 2006; 50: Irwin DE, Milsom I, Kopp Z, Abrams P; EPIC Study Group. Symptom bother and health care-seeking behavior among individuals with overactive bladder. Eur Urol 2008; 53: Coyne KS, Sexton CC, Kopp ZS, Ebel-Bitoun C, Milsom I, Chapple C. 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6 Sahai et al. 20 Jimenez-Cidre MA, Lopez-Fando L, Esteban-Fuertes M et al. The 3-day bladder diary is a feasible, reliable and valid tool to evaluate the lower urinary tract symptoms in women. Neurourol Urodyn 2013; doi: /nau [Epub ahead of print] 21 Jiménez MA, López-Fando L, Esteban M et al. 632 OAB symptoms in women: Do all instruments measure the same? Eur Urol Suppl 2012; 11: e632 eb 22 de Ridder D, Roumeguere T, Kaufman L. Overactive bladder symptoms, stress urinary incontinence and associated bother in women aged 40 and above; a Belgian epidemiological survey. IntJClinPract2013; 67: Correspondence: Arun Sahai, Department of Urology, Guy s Hospital, London SE1 9RT, UK. arun.sahai@gstt.nhs.uk Abbreviations: B-SAQ, Bladder Control Self-Assessment Questionnaire; OAB, overactive bladder; KHQ, Kings Health Questionnaire; EPIC, European Prospective Investigation into Cancer and Nutrition; UI, urinary incontinence; AUC, area under the curve; PPV, positive predictive value. Supporting Information Additional Supporting Information may be found in the online version of this article at the publisher s web-site: Appendix S1 B-SAQ Questionnaire. 788 BJU International 2013 BJU International