Reevaluating the Health-Related Quality of Life Impact and the Economic Burden of Urgency Urinary Incontinence

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1 EUROPEAN UROLOGY SUPPLEMENTS 10 (2011) 3 7 available at journal homepage: Reevaluating the Health-Related Quality of Life Impact and the Economic Burden of Urgency Urinary Incontinence Anastasios Athanasopoulos a, *, Salvador Arlandis Guzmán b a Urodynamic Urology Unit, Department of Urology, Medical School, University of Patras, Patras, Greece b Servicio de Urología, Hospital La Fe, Valencia, Spain Article info Keywords: Health-related quality of life Incontinence Overactive bladder Urgency urinary incontinence Abstract Context: Overactive bladder (OAB) is a prevalent condition that has a significant negative impact on almost all aspects of health-related quality of life (HRQoL). Urgency is the core symptom experienced by all patients who have OAB, either with or without urgency urinary incontinence (UUI). Objective: To describe the assessment and impact of UUI on patients HRQoL. Evidence acquisition: A nonsystematic review of the literature including PubMed and congress abstracts was performed in Evidence synthesis: Urodynamic measures are not necessarily predictive of the impact of OAB symptoms on the individual patient. Thus the use of validated, disease-specific instruments to assess patient-reported outcomes such as symptom bother, HRQoL, treatment satisfaction, and symptom frequency and severity has become standard in the diagnosis and treatment of OAB. Use of these measures in clinical research has shown that OAB with UUI has a greater impact on HRQoL than OAB without UUI, and reduction of UUI episodes is an important goal for patients with OAB with UUI. The impact of UUI on HRQoL is also greater than that of stress urinary incontinence or other types of urinary incontinence. Furthermore, UUI episodes contribute substantially to the personal and societal cost burden of OAB. Conclusions: Effective treatment of OAB symptoms, focussing on UUI, is essential to improve patient HRQoL and to minimise the costs associated with this condition. # 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Urodynamic Urology Unit, Department of Urology, Medical School, University of Patras, University Campus, Rio Patras, Patras, Greece. Tel.: ; Fax: addresses: tassos_athan@hotmail.com, anathan@upatras.gr (A. Athanasopoulos). 1. Impact of overactive bladder symptoms, particularly urgency urinary incontinence, on quality of life Overactive bladder (OAB) is a highly prevalent symptom syndrome with a significant negative impact on several aspects of health-related quality of life (HRQoL). As such, it is associated with substantial personal and societal costs [1]. The core symptom of OAB is urinary urgency, defined as a sudden, compelling desire to pass urine that is difficult to defer [2,3]. However, patients experience a range of symptoms. Urgency urinary incontinence (UUI) is involuntary leakage accompanied or preceded by urgency. Frequency indicates an increased number of voids during the day; traditionally, seven is considered the upper limit of normal, although this could vary between populations [3]. Nocturia is waking at night one time or more to void [2]. In the 2006 report of the EPIC study of > individuals /$ see front matter # 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi: /j.eursup

2 4 EUROPEAN UROLOGY SUPPLEMENTS 10 (2011) 3 7 A. Men Prevalence (%*) in the general population B. Women Prevalence (%*) in the general population SUI (1.2%) 0.3% *Weighted OAB (10.8%) UUI (1.8%) 0.9% MUI (2.3%) OAB (12.8%) 1.6% 6.9% 6.8% SUI (8.4%) UUI (3.8%) 0.6% Other UI (2.7%) MUI Other UI (0.6%) 1.5% (2.9%) 1.3% 0.4% 4.4% 2.0% 2.1% Fig. 1 Prevalence (percentage) of urinary incontinence subtypes among participants with overactive bladder. Reprinted from Eur Urol 2006;50, 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, p Copyright 2010, with permission from Elsevier [4]. OAB = overactive bladder; MUI = mixed urinary incontinence; SUI = stress urinary incontinence; UI = urinary incontinence; UUI = urgency urinary incontinence. from Canada and Europe, OAB was reported by 12.8% of women and 10.8% of men aged 18 yr (Fig. 1) [4]. For women reporting OAB symptoms, approximately 50% also reported urinary incontinence (UI), with 23.8% of this subpopulation indicating that their UI was due to UUI only. Among men reporting OAB symptoms, 28.7% also reported UI, with 41.6% of this subpopulation experiencing UUI only [4]. OAB is not a life-threatening condition, and as such, its importance is often underestimated by both patients and health care providers. However, the impact of OAB on wellbeing, activities of daily living, and HRQoL can be substantial [5]. In particular, OAB is associated with a reduction in HRQoL that is similar to that observed with diseases such as type 2 diabetes [5]. This is likely applicable to UUI, as studies have shown that UUI has a greater negative impact on HRQoL than other types of UI (functional, stress, or mixed UI) [6 10]. The greater impact of UUI on patients HRQoL compared with OAB without incontinence episodes has been demonstrated by studies investigating these two subpopulations. In the National Overactive Bladder Evaluation (NOBLE) program in the United States, women with OAB and UUI reported significantly poorer HRQoL (ie, lower Short Form- 36 [SF-36] scores on the physical summary scale) than women without UUI [10]. Men with OAB and UUI had significantly more depression-related symptoms, as indicated by a higher Center for Epidemiologic Studies Depression Scale (CES-D) score, and worse quality of sleep, shown by a higher Medical Outcomes Sleep Scale score, than men with OAB without UUI [10]. Overall, patients with OAB and UUI had the poorest HRQoL scores on all domains of the SF-36 (Fig. 2) [10]. A nested, case-control study of NOBLE program respondents with OAB compared the impact of different types of UI (ie, UUI, stress UI [SUI], and mixed UI) on HRQoL [9]. Respondents with UUI had significantly greater symptom bother (ie, higher OAB questionnaire [OAB-q] domain score), worse quality of sleep, greater urinary urge intensity, and greater need for medical care for their bladder problems than respondents with SUI [11]. Recent findings from a study that classified OAB according to the OAB Symptom Score found that 79% of patients in the severe category had UUI compared with fewer than half of patients in the very mild (43%) or mild (36%) categories [12]. Findings from a nested, case-control analysis of EPIC data showed that although 54% of patients with OAB were bothered by their symptoms, according to assessment using the OAB-q, >70% of patients with UUI suffered symptom bother. Patients who reported symptom bother were more likely to seek help from a health care provider [11]. Overall, the results of these studies show that UUI has the most serious Mean SF-36 Score Physical function Role function Bodily pain General health perceptions Vitality Controls OAB without urge incontinence OAB with urge incontinence Social function Role emotional Mental health Fig. 2 Mean Short Form-36 scores for individuals with overactive bladder with or without urgency incontinence, and age- and sex-matched controls. With kind permission from Springer Science + Business Media: World J Urol, Prevalence and burden of overactive bladder in the United States, 20:2003, , Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ, Fig. 3 [13].

3 EUROPEAN UROLOGY SUPPLEMENTS 10 (2011) Table 1 Disease-specific questionnaires used in overactive bladder (adapted from Matza et al. [14]) Name of instrument Target condition/ population No. of items Recall period Subscales Key development/ validation citations Questionnaire (IIQ) Questionnaire Revised (IIQ-R) Questionnaire Short Form Incontinence Quality of Life Questionnaire (I-QOL) King s Health Questionnaire (KHQ) Male Urinary Symptom Impact Questionnaire Overactive Bladder Questionnaire (OAB-q) Quality-of-life Questionnaire for Urinary Urge Incontinence Women, UI 30 Current Physical activity, travel, social, emotional Women, UI 30 Current Physical activity, travel, social, emotional, embarrassment Shumaker et al, 1994 [22] van der Vaart et al, 2002 [23] Women, UI 7 Current NA Uebersax et al, 1995 [24] UI 22 Today Avoidance and limiting behaviours, Wagner et al, 1996 [25] psychological, social embarrassment UI 21 Current Role limitations, physical limitations, Kelleher et al, 1997 [7] social limitations, personal limitations, emotional problems, sleep/energy disturbance, severity (coping) measures, symptom severity, incontinence impact (single item), general health perception (single item) Men, UI 32 Not specified Activity, social contact, emotional health, self confidence, stability of support, sleep Continent and incontinent OAB 33 Past 4 wk Symptom bother, coping, concern, social interaction, sleep Women UUI 24 Not specific Activities, emotional impact, self image, sleep, wellbeing Urge Impact Scale Older patients, UI 24 Past month Psychological burden, perception of personal control, self concept Urge Incontinence Impact Questionnaire Urinary Incontinence Handicap Inventory Urinary Incontinence Severity Score York Incontinence Perception Scale (YIPS) Robinson and Shea, 2002 [26] Coyne et al, 2002 [27] Marquis et al, 1996 [28] DuBeau et al, 1999 [29] MUI, UUI 32 Past 4 wk Travel, activities, physical activities, feelings, relationship, physical function, nighttime bladder control Lubeck et al, 1999 [30] Elderly women, 17 Past 4 wk NA Rai et al, 1994 [31] UI caused by detrusor activity Women, UI 10 Current NA Stach-Lempinen et al, 2001 [32] Women, UI 8 Current NA Lee et al, 1995 [33] UI = urinary incontinence; OAB = overactive bladder; UUI = urgency urinary incontinence; MUI = mixed urinary incontinence. negative impact on HRQoL parameters for patients with OAB, forcing them to modify their lifestyle and daily activities and to cope with poor sleep quality and depression symptoms. 2. Quality-of-life assessment Evaluation of the severity of OAB typically involves documentation of urinary symptoms, a bladder diary, and urodynamic data [5]. However, these clinical measures provide little information on the impact of OAB symptoms on a patient s life. Thus the importance of patient-reported outcomes in clinical practice has been increasingly acknowledged, with diagnosis and treatment assessment for OAB now often combining the measurement of symptom bother and HRQoL outcomes with bladder diary variables [13]. Importantly, care should be taken to ensure that the assessments are relevant to the patient [13]. In the assessment of HRQoL among patients with OAB, it is important to examine disease-specific aspects, such as sleep, emotional functioning (eg, self-esteem, anxiety about hygiene and having incontinent episodes, sadness, health preoccupation, and helplessness), sexual functioning, and social functioning (eg, work loss, social and activity avoidance) [5]. HRQoL can be measured objectively, and several HRQoL instruments have been developed and validated [5], including generic and disease-specific questionnaires [14]. Generic HRQoL instruments include the Medical Outcomes Study (MOS) SF-36, and the MOS Sleep Scale. Validated generic instruments are reliable, readily available, and useful in assessing HRQoL in different disease states across a variety of populations and ages [5]. However, generic questionnaires can be insensitive to aspects of the disease being evaluated and, therefore, may not capture all information relevant to a specific disease. Thus, diseasespecific instruments are more beneficial than generic questionnaires in evaluating the impact of OAB symptoms on patients HRQoL and more sensitive for assessment of treatment-related changes [5,14]. The major diseasespecific instruments that are available for OAB are summarised in Table 1 (see Matza et al. [14] for a comprehensive review of these instruments). A variety of disease-specific instruments are available to measure the impact of OAB on patients lives. Each instrument varies in the subscales or domains being evaluated. The OAB-q and the King s Health Questionnaire, for example, are both questionnaires commonly used in OAB to evaluate HRQoL. The OAB-q is also designed to evaluate the symptom bother

4 6 EUROPEAN UROLOGY SUPPLEMENTS 10 (2011) 3 7 associated with the condition. Other questionnaires focus on the impact of a specific symptom, such as urgency (eg, Urge Impact Scale), urge incontinence (eg, Urge Questionnaire), or incontinence (eg, Urinary Incontinence Severity Score). The number of items evaluated within these subscales and the period of time over which patients are requested to report on their symptoms are variable [14]. The International Consultation on Incontinence Modular Questionnaire has been developed to provide a standardised guide for the selection of questionnaires for use in clinical practice and research [15]. In addition to questionnaires that measure HRQoL, tools have been developed to assess patient satisfaction with treatment. These include the Treatment Satisfaction Questionnaire for Medication, a generic measure permitting comparison of treatment satisfaction across medications [16,17]; the Benefit, Satisfaction and Willingness questionnaire, designed to assess treatment benefit, patient satisfaction with treatment, and patient willingness to continue treatment [18]; and the Overactive Bladder Treatment Satisfaction Questionnaire, which evaluates expectations of OAB control, impact on daily living with OAB, OAB control, tolerability to medication, and satisfaction with OAB control [19,20]. 3. Overactive bladder is associated with significant costs Symptom burden and reduced HRQoL contribute to the cost of OAB through costs related to diagnosis and treatment, including pad use; comorbidities that might include falls and fractures; nursing home admissions; and costs associated with work absenteeism and impaired performance at work (presenteeism). The economic impact of OAB has been evaluated in European countries in two large studies [1,21], one of which also included Canada. Together they demonstrate the significant economic burden of OAB and suggest that UUI is associated with increased cost. In an analysis of data from the EPIC study [4], the costs of OAB including medical consultations, medications, incontinence pad use, diagnostics and treatment of clinical depression, nursing homes, and lost productivity were assessed for 2005 [1]. Across Canada, Germany, Italy, Spain, Sweden, and the United Kingdom, the estimated total cost burden of OAB per country, excluding nursing home and lost productivity costs, ranged from s333 million in Sweden to s1.2 billion in Germany. Nursing home costs were estimated at s4.7 billion per year, and costs of absenteeism related to OAB were estimated at s1.1 billion per year. The costs of OAB with UUI were higher than those for OAB without UUI when considered without the impact of nursing home admissions, and the additional nursing home costs were entirely related to OAB with UUI [1]. In another study reported by Reeves et al in which the burden and costs of OAB were assessed in Germany, Italy, Spain, Sweden, and the United Kingdom, the estimated total cost of OAB to the health care system in 2000 ranged from s255 million in Sweden Total direct cost (, billion) 1,600 1,400 1,200 1, Italy to s1.4 billion in Italy [21]. Total costs were predicted to increase by 20 33% across countries by 2020 in line with ageing populations [21]. ThelargestcostofOABwasthe use of incontinence pads, accounting for an average of 63% of the annual per patient cost of OAB management [21]. Medication use accounted for only 7% of the annual costs, ranging from 3% to 14% among the five countries (Fig. 3) [21]. These studies suggest that controlling OAB symptoms, with a focus on UUI, could have a significant positive financial impact, in addition to improving patients HRQoL. 4. Conclusions OAB has a significant negative impact on HRQoL and is associated with a substantial financial burden for both patients and health care systems. This burden is exacerbated in patients suffering OAB with UUI episodes. It is important to assess HRQoL and to evaluate the symptoms that are most burdensome to individual patients, so treatment goals for symptom relief can be prioritised. Effective treatment of OAB symptoms is essential to improve patients HRQoL and to decrease the economic burden of this prevalent condition. Funding support Germany Anastasios Athanasopoulos and Salvador Arlandis Guzmán were paid consultants to Pfizer Inc. in connection with the development of this manuscript. Writing/editorial assistance was funded by Pfizer Inc. Acknowledgement statement Spain Fall & fracture* Skin condition* UTI* MD consultation Pad use* Drug use Sweden Fig. 3 Total estimated costs of overactive bladder in five European countries in 2000 (euros, billions). Reprinted from Eur Urol 2006;50, Reeves P, Irwin D, Kelleher C, Milsom I, Kopp Z, Calvert N, Lloyd A. The current and future burden and cost of overactive bladder in five European countries, p Copyright 2010, with permission from Elsevier [21]. Editorial/medical writing assistance was provided by Susan Cheer, PhD, and Deborah Burrage, PhD, at Burson-Marsteller Healthcare and Patricia B. Leinen, PhD, at Complete Healthcare Communications Inc. UK

5 EUROPEAN UROLOGY SUPPLEMENTS 10 (2011) Conflicts of interest In the field of overactive bladder and antimuscarinics, Anastasios Athanasopoulos has received research support, lecturer and/or consultant honoraria from Pfizer, Astellas, Lilly, UCB, and Allergan. Salvador Arlandis Guzmán has received research support, lecturer and/or consultant honoraria from Allergan, Pfizer, Indas, and Astellas. References [1] Irwin DE, Mungapen L, Milsom I, Kopp Z, Reeves P, Kelleher C. The economic impact of overactive bladder syndrome in six Western countries. BJU Int 2009;103: [2] 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: [3] Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. 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