LUTS patient reported outcomes tool: linguistic validation in 10 European languages.

AIM: To linguistically validate the translation of the Lower Urinary Tract Symptoms (LUTS) Tool from English to 10 European languages and assess whether the translations adequately reflected the concepts in the original version and if urological terms and the individual items were readily understood. METHODS: Residents of the target countries who spoke the native language and had LUTS were asked to evaluate a harmonized translation of the LUTS Tool, which was developed in 10 languages: Danish (Denmark), Dutch (Belgium, Netherlands), Finnish (Finland), French (Belgium, France, Luxembourg, and Switzerland), German (Germany, Switzerland), Greek (Greece), Icelandic (Iceland), Italian (Italy), Norwegian (Norway), and Spanish (Spain). After reviewing the language-appropriate version, participants were asked to explain why any words were difficult to understand and to paraphrase each sentence during a standardized cognitive debriefing interview. Linguistic validation teams (original translators, back translator, project manager, interviewer, and survey research expert) conducted a qualitative analysis of the cognitive debriefing findings. RESULTS: The terminology and concepts in the English-language version of the LUTS Tool were adequately captured in all language translations. The overall item comprehension rate, across languages, was 98.5%. Terms related to storage, voiding, and post-micturition LUTS were comprehensible. Minor difficulties with comprehension were identified in 9 of 10 translations, and those changes were made to improve clarity. CONCLUSIONS: Individuals with LUTS from 10 countries understood the individual items captured in translated versions of the LUTS Tool. The overall comprehension rate was high. Most changes were made to improve conceptual clarity based on country-specific linguistic and cultural nuances.

Sustained improvement in patient-reported outcomes during long-term fesoterodine treatment for overactive bladder symptoms: pooled analysis of two open-label extension studies.

OBJECTIVES: • To evaluate the effects of long-term fesoterodine treatment on health-related quality of life (HRQL) and treatment satisfaction in subjects with overactive bladder (OAB) symptoms. • To determine the impact of gender and age on these effects. PATIENTS AND METHODS: • This is a post hoc analysis of data pooled from identically designed open-label extensions of two randomized, double-blind, 12-week fesoterodine studies. • Initial treatment was once-daily fesoterodine 8 mg; subjects had the opportunity to receive open-label fesoterodine for ≥24 months. • After 1 month, subjects could elect dose reduction to 4 mg and subsequent re-escalation to 8 mg; dose reduction and re-escalation were each allowed once annually. • Changes in scores on the King's Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and a Likert scale evaluating severity of bladder-related problems were assessed at open-label baseline and months 12 and 24; treatment satisfaction was assessed at open-label baseline and at months 4, 12 and 24. RESULTS: • A total of 864 enrolled subjects were included (men, n= 182; women, n= 682; aged <45 years, n= 134; 45-64 years, n= 432; 65-74 years, n= 204; ≥75 years, n= 94); most subjects (77%) who continued treatment maintained the 8-mg dose. • Among subjects in the overall population, there were significant improvements in all KHQ domains, ICIQ-SF scores, and bladder-related problems at open-label baseline vs double-blind baseline (P < 0.05); additional significant improvements were observed at months 12 and 24 vs open-label baseline in all outcomes (P < 0.05) except for the KHQ General Health Perception domain. • When data were stratified by gender or age, significant improvements at open-label baseline vs double-blind baseline were further significantly enhanced or sustained at months 12 and 24 for most KHQ domains, and for ICIQ-SF scores and bladder-related problems for all groups. Women had significantly greater improvements than men in the KHQ Emotion (P= 0.0173) and Severity/Coping (P= 0.0112) domains and ICIQ-SF scores (P= 0.0276) during open-label treatment. Subjects aged <45 years had significantly greater improvement in the Personal Relationships domain compared with those aged 45-64 years (P= 0.0357) and in the Sleep/Energy domain compared with all other groups (all P < 0.02). • Treatment satisfaction was high (≥92%) throughout open-label treatment regardless of gender or age. CONCLUSIONS: • Long-term fesoterodine treatment was associated with sustained improvement in measures of health-related quality of life and bladder-related problems and with high treatment satisfaction in subjects with overactive bladder symptoms. • Effects of gender and age were minimal.

Moving towards a comprehensive assessment of lower urinary tract symptoms (LUTS).

AIMS: To evaluate the utility of the International Prostate Symptom Score (IPSS) and the LUTS Tool when assessing lower urinary tract symptoms (LUTS). Secondary objectives were to examine associations of LUTS and treatment seeking. METHODS: Analyses were performed using EpiLUTS data, a population-based, cross-sectional, Internet survey of men and women (aged ≥40) in Sweden, UK, and US with a sample of 30,000 participants. Participants completed the IPSS and the LUTS Tool. Prevalence rates of symptoms captured by the LUTS Tool were compared using IPSS summary scores: 0, 1-7, 8-19, and ≥20. LUTS Tool subscale scores were calculated. Pearson correlations between the LUTS Tool symptoms and subscales and IPSS symptoms were performed. Logistic regressions evaluated the associations of IPSS scores and LUTS Tool subscales with treatment seeking for LUTS. RESULTS: The IPSS did not assess some symptoms (i.e., incontinence) for which there was a high prevalence among participants. Correlations between the 7 symptoms assessed by the IPSS and LUTS Tool were moderate to high ranging between 0.37 (nocturia women) and 0.77 (weak stream men), indicating concordance. While the LUTS Tool subscales and the total IPSS score were all significantly associated with treatment seeking, the LUTS Tool OAB subscale in men and Voiding subscale in women most strongly predicted treatment seeking. CONCLUSION: LUTS that are excluded from the IPSS, most notably incontinence, were prevalent even among mildly symptomatic participants. Since storage symptoms appear to drive treatment seeking, identifying, and treating these symptoms is essential when caring for patients with LUTS.

Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction.

OBJECTIVE: • To estimate and predict worldwide and regional prevalence of lower urinary tract symptoms (LUTS), overactive bladder (OAB), urinary incontinence (UI) and LUTS suggestive of bladder outlet obstruction (LUTS/BOO) in 2008, 2013 and 2018 based on current International Continence Society symptom definitions in adults aged ≥20 years. PATIENTS AND METHODS: • Numbers and prevalence of individuals affected by each condition were calculated with an estimation model using gender- and age-stratified prevalence data from the EPIC study along with gender- and age-stratified worldwide and regional population estimates from the US Census Bureau International Data Base. RESULTS: • An estimated 45.2%, 10.7%, 8.2% and 21.5% of the 2008 worldwide population (4.3 billion) was affected by at least one LUTS, OAB, UI and LUTS/BOO, respectively. By 2018, an estimated 2.3 billion individuals will be affected by at least one LUTS (18.4% increase), 546 million by OAB (20.1%), 423 million by UI (21.6%) and 1.1 billion by LUTS/BOO (18.5%). • The regional burden of these conditions is estimated to be greatest in Asia, with numbers of affected individuals expected to increase most in the developing regions of Africa (30.1-31.1% increase across conditions, 2008-2018), South America (20.5-24.7%) and Asia (19.7-24.4%). CONCLUSIONS: • This model suggests that LUTS, OAB, UI and LUTS/BOO are highly prevalent conditions worldwide. Numbers of affected individuals are projected to increase with time, with the greatest increase in burden anticipated in developing regions. • There are important worldwide public-health and clinical management implications to be considered over the next decade to effectively prevent and manage these conditions.

The impact of overactive bladder on mental health, work productivity and health-related quality of life in the UK and Sweden: results from EpiLUTS.

OBJECTIVE: • To examine the prevalence and burden of overactive bladder (OAB) with bother in the UK and Sweden compared to OAB without bother and no/minimal OAB/lower urinary tract (LUTS) symptoms, respectively. PATIENTS AND METHODS: • A cross-sectional population-representative survey was conducted via the Internet in the UK, Sweden and USA. • Participants rated the frequency and bother of OAB and LUTS. Patient outcomes included the Overactive Bladder Questionnaire Short Form, Patient Perception of Bladder Condition, Short Form-12, Hospital Anxiety and Depression Scale-Anxiety and Hospital Anxiety and Depression Scale-Depression, as well as questions about treatment seeking and work productivity. • OAB was defined as urgency at least sometimes or the presence of urinary urgency incontinence. Three subgroups were compared: no/minimal symptoms, OAB without bother and OAB with bother. • Analyses were conducted by gender and country using general linear and logistic regression models to examine bothersome OAB and treatment seeking. RESULTS: • Survey response was 59.2%; 10,000 people (4724 men and 5276 women) participated. • The prevalence of OAB with bother at least 'somewhat' was 10.9% and 14.6% for men in the UK and Sweden, and 22.5% and 33.7% for women in the UK and Sweden, respectively. • Men and women with bothersome OAB were significantly more likely to seek treatment, report the lowest levels of health-related quality of life and work productivity and the highest levels of anxiety and depression compared to those with no/minimal symptoms and OAB without bother. • Greater symptom severity of urgency, urgency urinary incontinence, frequency, nocturia, and increasing levels of anxiety were strongly predictive of OAB bother in both men and women. • Predictors of treatment seeking included frequency, bother as a result of urgency, and lower levels of depressive symptoms in men, and frequency, nocturia and urgency in women. CONCLUSIONS: • OAB is common in the UK and Sweden, and women are more likely to be affected then men. • The impact of OAB is evident across generic and condition-specific domains of health-related quality of life.

The impact of OAB on sexual health in men and women: results from EpiLUTS.

INTRODUCTION: Prior research suggests that overactive bladder (OAB) is common and adversely affects sexuality in both men and women. However, more data are needed from population-based studies to evaluate the impact OAB on sexual health. AIM: To describe sexual health outcomes in men and women with continent and incontinent OAB (C-OAB, I-OAB) compared to those with no/minimal urinary symptoms (NMS) and to evaluate correlates of decreased sexual activity and enjoyment in men and women, and correlates of erectile dysfunction (ED), ejaculatory dysfunction (EjD), and premature ejaculation (PE) in men. METHODS: A cross-sectional, population-representative survey was conducted via the Internet in the United Kingdom, Sweden, and United States. OAB was assessed via a questionnaire based on current International Continence Society definitions. Descriptive statistics were used to compare outcomes for those with I-OAB, C-OAB and NMS, and logistic regressions were used to evaluate predictors of sexual functioning. MAIN OUTCOME MEASURES: Participants responding to the sexual health portion of the survey were asked questions about sexual activity and satisfaction. Other outcomes included two domains from the Abbreviated Sexual Function Questionnaire, the erectile function domain of the International Index of Erectile Function, and questions assessing EjD and PE. RESULTS: Survey response was 59.2%; 6,326 men and 8,085 women participated in the sexual health portion of the survey. Across outcomes, I-OAB and C-OAB were associated with worse sexual health as compared to those with NMS. Logistic regressions showed that those with I-OAB and C-OAB were significantly (P<0.0001) more likely to report diminished sexual activity and enjoyment of sex. I-OAB and C-OAB were also significant predictors of ED and EjD in men, but not PE. CONCLUSIONS: The impact of OAB is evident across domains of sexual health in both men and women. Sexual health should be assessed in men and women presenting with OAB.

The psychometric validation of a 1-week recall period for the OAB-q.

INTRODUCTION AND HYPOTHESIS: As shorter recall periods are sometimes preferable to longer recall periods, the objective of this study was to evaluate the psychometric characteristics and measurement properties of the 1-week recall version of the Overactive Bladder Questionnaire (OAB-q). METHODS: Secondary analyses were performed on data for three 12-week clinical trials of fesoterodine. Patients completed the Patient Perception of Bladder Condition (PPBC), the Patient Perception of Urgency Scale (PPUS), and 3-day bladder diaries in addition to the OAB-q at baseline, 4 and 12 weeks. Analyses were conducted to evaluate the reliability, concurrent and discriminant validity and responsiveness of the OAB-q 1-week recall version. RESULTS: The patients in the three studies (Study 1: N=516, Study 2: N=441; Study 3: N=882) had a mean age of 59.6, 59.4, and 59.9 years, respectively; and most of the patients were female (77.1%, 88.9%, and 82.9%) and White (76.6%, 90.0%, and 88.0%). Patients had been diagnosed with OAB for a mean of 5.2, 8.3, and 9.1 years, respectively. Cronbach's alpha values were greater than 0.85 across all samples and subscales. Correlations between the 1-week recall version of the OAB-q and the PPBC, PPUS, and most of the bladder diary variables were moderate to strong. Discriminant validity of the OAB-q was good, with significant differences in mean OAB-q scores across all response categories of the PPUS. The OAB-q was highly responsive to changes in patients' conditions as indicated by moderate to large effect sizes. The OAB-q 1-week recall version has a similar factor structure to the 4-week recall version with each subscale model demonstrating acceptable fit. CONCLUSION: The 1-week recall version of the OAB-q appears to be reliable, valid, and responsive and is psychometrically equivalent to the 4-week recall version. The validation of the 1-week recall version offers researchers and clinicians an additional option for using the OAB-q.

Goal attainment scaling in patients with lower urinary tract symptoms: development and pilot testing of the Self-Assessment Goal Achievement (SAGA) questionnaire.

INTRODUCTION AND HYPOTHESIS: The Self-Assessment Goal Achievement (SAGA) questionnaire was developed to identify treatment goals and assess goal-achievement in patients with lower urinary tract symptoms (LUTS). METHODS: This study consisted of (1) gathering information on goal setting/attainment concepts, (2) goal elicitation (n = 41 patients with LUTS), (3) cognitive debriefing of draft questionnaire (n = 11), and (4) pilot testing (n = 104). RESULTS: SAGA consists of baseline (goal-assessment; ranking) and follow-up (goal-achievement) modules. In addition to goals most frequently mentioned, patients can list up to five open goals. Goals most commonly reported as "very important" in pilot testing included reducing urgency (72%), incontinence (65%), and nocturia (64%). Treatment goals spontaneously reported as "very important" were reducing incontinence (45%), nocturia (40%), and frequency (26%). CONCLUSIONS: SAGA may be used to identify treatment goals and assess goal-achievement in patients with LUTS in the clinic and for research (with additional validation). This information may promote patient-physician interaction and help patients establish realistic treatment goals, which may in turn improve treatment adherence and outcomes.

The burden of lower urinary tract symptoms: evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS.

OBJECTIVE: To evaluate the impact of lower urinary tract symptoms (LUTS) on urinary-specific health-related quality of life (HRQL), generic health indices, depression and anxiety in a population-representative sample of men and women, as research has linked LUTS with reduced HRQL and depression, but little is known about the effects of individual LUTS on HRQL, depression and anxiety. SUBJECTS AND METHODS: A cross-sectional population-representative survey was conducted via the Internet in the USA, the UK and Sweden. Participants rated the frequency and symptom-specific bother of individual LUTS and condition-specific HRQL, generic health status, anxiety and depression. Descriptive statistics were used to evaluate outcome differences by International Continence Society LUTS subgroups; logistic regressions were used to determine associations of LUTS and perception of bladder problems, anxiety and depression. RESULTS: The overall survey response rate was 59.2%; 30 000 subjects (14 139 men and 15 861 women) participated. Men and women with LUTS in the all LUTS subgroup (storage, voiding and postmicturition) reported the lowest levels of HRQL and highest levels of anxiety and depression, with 35.9% of men and 53.3% of women meeting self-reported screening criteria for clinical anxiety (Hospital Anxiety and Depression Scale, HADS, Anxiety > or =8), and 29.8% of men and 37.6% of women meeting self-reported criteria for clinical depression (HADS Depression > or =8). In both men and women, storage symptoms were significantly associated with greater perceived bladder impact, whereas voiding symptoms were not. Significant predictors of anxiety included nocturia, urgency, stress urinary incontinence, leaking during sexual activity, weak stream and split stream in women; and nocturia, urgency, incomplete emptying and bladder pain in men. For depression, weak stream, urgency and stress urinary incontinence were significant for women, and perceived frequency and incomplete emptying were significant for men. CONCLUSION: The negative effect of LUTS is apparent across several domains of HRQL and on overall perception of bladder problems, general health status and mental health. The high level of psychiatric morbidity in patients with multiple LUTS has important implications for treatment and highlights the need for further research to pinpoint specific mechanisms underlying this association.

The impact of lower urinary tract symptoms on male sexual health: EpiLUTS.

OBJECTIVE: To evaluate the association between International Continence Society categories of lower urinary tract symptoms (LUTS; storage, voiding, and postmicturition) and individual LUTS (associated with decreased sexual activity and sexual satisfaction in men) with erectile dysfunction (ED), ejaculatory dysfunction (EjD) and premature ejaculation (PE). SUBJECTS AND METHODS: The impact of LUTS on men's sexual health was captured as part of a cross-sectional epidemiological study to assess the prevalence LUTS among men and women aged > or =40 years in the USA, the UK and Sweden. RESULTS: The analysis included 11 834 men with a mean age of 56.1 years, 71% of whom reported being currently sexually active. The primary reason for not being sexually active was no partner (35%), followed by personal health (23%) and no desire (23%). Of the men, 26% had mild to severe ED, 7% had EjD, and 16% PE. Men with multiple LUTS had more severe ED and more frequent EjD and PE. Logistic regression analysis showed that greater age, hypertension, diabetes, depression, urgency with fear of leaking, and leaking during sexual activity were significantly associated with ED. The results were similar in the logistic regression analysis for EjD, whereas being younger and the absence of prostatitis were significantly associated with PE, as were the presence of terminal dribble, incomplete emptying, and split stream. CONCLUSION: LUTS are associated with common sexual dysfunctions in men. The results of this study highlight the importance of assessing the sexual health of men presenting with LUTS.

Rationale for the study methods and design of the epidemiology of lower urinary tract symptoms (EpiLUTS) study.

Accurate prevalence data on illnesses are of paramount importance for medical decision-making, healthcare planning, and the appropriate allocation of healthcare resources. When assessing the prevalence of any illness or health condition, it is important to base prevalence data on an assessment of the general population at large and not on selected groups of the population. Previous estimates of the prevalence of lower urinary tract symptoms (LUTS) have used postal surveys, telephone and in-person interviews, and, more recently, the Internet. Determining the mode of data collection for a research study is dictated by several factors, including target population, topic sensitivity, timeliness, and available resources. The purpose of this report is to document the rationale for conducting a large prevalence study of LUTS and its impact on patient outcomes using Internet- or Web-based surveys. A brief overview of important survey considerations is provided, and previous survey methods used in assessing the prevalence of LUTS discussed. The research objectives and sampling approach used in the EpiLUTS study in the USA, the UK and Sweden are presented, with a discussion of the advantages and disadvantages of this Internet-based sampling approach in relation to other epidemiological methods.

The overlap of storage, voiding and postmicturition symptoms and implications for treatment seeking in the USA, UK and Sweden: EpiLUTS.

OBJECTIVE: To assess the (i) the overlap between voiding, storage, and postmicturition symptoms; and (ii) the relative effect of bother and implications for treatment seeking within these symptom groups, using data from the EpiLUTS study. SUBJECTS AND METHODS: This cross-sectional population-representative survey was conducted via the Internet in the USA, the UK and Sweden. Participants were asked to rate the frequency and symptom-specific bother of individual LUTS. Descriptive statistics were used to examine differences in International Continence Society LUTS subgroups. Logistc regressions were used with treatment seeking as the dependent variable and the bother of individual symptoms as predictors. RESULTS: The survey response rate was 59%. The sample included 30,000 participants (14,139 men and 15,861 women); 71% of men and 75% of women reported at least one LUTS, and about half reported LUTS from more than one symptom group. Rates of bother were greatest for those who reported multiple storage, voiding and postmicturition LUTS (men 83%, women 89%). Less than a third of participants with LUTS from all three groups reported seeking treatment. Consistent correlates of treatment seeking across genders included bother due to weak stream, incomplete emptying, perceived daytime frequency, nocturia and urgency. There were also significant associations for several types of incontinence, most commonly stress incontinence in women and leaking during sexual activity in men. Despite high rates of symptom overlap and symptom-specific bother, few participants sought treatment for LUTS. CONCLUSION: Common conditions such as BPH and OAB are treatable, and clinicians should proactively ask patients about urinary symptoms. Given the many types of LUTS that patients experience, it is imperative that clinicians assess all LUTS to ensure that appropriate treatments are prescribed.

Risk factors and comorbid conditions associated with lower urinary tract symptoms: EpiLUTS.

OBJECTIVE: To explore the risk factors and comorbid conditions associated with subgroups of lower urinary tract symptoms (LUTS) in men and women aged > or =40 years in three countries, using data from the EpiLUTS study, as LUTS are common amongst men and women and increase in prevalence with age. SUBJECTS AND METHODS: This cross-sectional, population-representative survey was conducted via the Internet in the USA, the UK and Sweden. Participants were asked to rate how often they experienced individual LUTS during the past 4 weeks on a 5-point Likert scale. Eight LUTS subgroups were created. Descriptive statistics and logistic regressions within each LUTS subgroup were used to assess the data. RESULTS: The survey response rate was 59%. The final sample was 30,000 (men and women). The voiding + storage + postmicturition (VSPM) group reported the highest rates of comorbid conditions for both men and women, and the fewest were reported in the no/minimal LUTS and the postmicturition-only groups. Increasing age was associated with increasing LUTS in men, but not in women. Comorbid conditions significantly associated with the VSPM group were arthritis, asthma, chronic anxiety, depression, diabetes (men only), heart disease, irritable bowel syndrome, neurological conditions, recurrent urinary tract infection, and sleep disorders. Risk factors, such as body mass index, exercise level and smoking, played less of a role, except for childhood nocturnal enuresis, which was significantly associated with most LUTS subgroups. CONCLUSION: In this large population study, many comorbid conditions and risk factors were significantly associated with LUTS among both men and women. Further longitudinal investigations of the associations noted here would help physicians to understand the pathophysiology of LUTS and comorbid conditions, and provide clinical guidelines for patient management of comorbid conditions sharing common pathophysiological pathways.

The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study.

OBJECTIVE: To estimate and compare the prevalence and associated bother of lower urinary tract symptoms (LUTS) in the general populations of the USA, UK and Sweden using current International Continence Society (ICS) definitions, as no previous population-based studies evaluating the prevalence of LUTS in the USA, using the 2002 ICS definitions, have been conducted. SUBJECTS AND METHODS: This cross-sectional, population-representative survey was conducted via the Internet in the USA, the UK and Sweden. Members of Internet-based panels were randomly selected to receive an e-mailed invitation to participate. If interested, respondents selected a link to an informed consent page, followed by the survey. Participants were asked to rate how often they experienced individual LUTS during the previous 4 weeks, on a five-point Likert scale, and, if experienced, how much the symptom bothered them. Descriptive statistics were used to summarize and present the data. RESULTS: Responses rates for the USA, the UK and Sweden were 59.6%, 60.6% and 52.3%, respectively, with a final sample of 30,000 (USA 20,000; UK 7500; Sweden 2500). The mean age (range) of the participants was 56.6 (40-99) years; the mean percentages for race were 82.9% white, 6.7% black, 6.0% Hispanic and 4.4% Asian/other. The prevalence of LUTS was defined by two symptom frequency thresholds, i.e. at least 'sometimes' and at least 'often' for all LUTS except incontinence, where frequency thresholds were at least 'a few times per month' and at least 'a few times per week'. The prevalence of at least one LUTS at least 'sometimes' was 72.3% for men and 76.3% for women, and 47.9% and 52.5% for at least 'often' for men and women, respectively. For most LUTS, at least half of the participants were bothered 'somewhat' or more using a frequency threshold of at least 'sometimes'. For a threshold of at least 'often', 'somewhat' or more bother was reported by > or =70% of participants except for terminal dribble in men and split stream in women. CONCLUSION: In this large population study of three countries, LUTS are highly prevalent among men and women aged >40 years. In general, LUTS experienced 'often' or more are bothersome to most people.

The impact of overactive bladder, incontinence and other lower urinary tract symptoms on quality of life, work productivity, sexuality and emotional well-being in men and women: results from the EPIC study.

OBJECTIVES: To examine the effect overactive bladder (OAB) and other lower urinary tract symptoms (LUTS) on health-related quality of life (HRQoL) in a population sample, as OAB often occurs in conjunction with many other LUTS. SUBJECTS AND METHODS: A nested case-control analysis was performed on men and women with (cases) and without (controls) OAB, from the EPIC study. OAB was assessed using 2002 International Continence Society definitions. Based on their responses to questions about LUTS, cases were classified into five groups; continent OAB, OAB with incontinence, OAB + postmicturition, OAB + voiding, and OAB + postmicturition + voiding. Both cases and controls were asked questions about symptom bother (OAB-q), generic QoL (EQ-5D), work productivity (Work Productivity and Activity Impairment, WPAI), depressive symptoms (Center for Epidemiologic Studies Depression Scale), sexual satisfaction, and erectile dysfunction (men only) using the Massachusetts Male Aging Study. Cases answered additional condition-specific questions HRQoL (OAB-q short form), Patient Perception of Bladder Condition and work productivity related to a specific health problem (WPAI-SHP). General linear models were used to evaluate group differences. RESULTS: Of the EPIC participants, 1434 identified OAB cases were matched by age, gender and country, with 1434 participants designated as controls. Cases and controls were primarily Caucasian (96.2% and 96.7%, respectively), and most (65%) were female; the mean age was 53.8 and 53.7 years, respectively. Comorbid conditions differed significantly by case/control status, with cases reporting significantly greater rates of chronic constipation, asthma, diabetes, high blood pressure, bladder or prostate cancer, neurological conditions and depression. There were significant differences between the cases and controls in all reported LUTS. The OAB + postmicturition + voiding group reported significantly greater symptom bother, worse HRQoL, higher rates of depression and decreased enjoyment of sexual activity, than the other subgroups. CONCLUSION: OAB has a substantial, multidimensional impact on patients; OAB with additional LUTS has a greater impact. The diagnosis and treatment of OAB should be considered in conjunction with other LUTS, to maximize treatment options and optimize patient outcomes.

Examining lower urinary tract symptom constellations using cluster analysis.

OBJECTIVE: To gain a better understanding of how patients experience lower urinary tract symptoms (LUTS) and to determine whether particular symptoms cluster together, as LUTS seldom occur alone. SUBJECTS AND METHODS: A secondary analysis of a cross-sectional, population-based survey of adults in Sweden, Italy, Germany, UK and Canada was undertaken to examine the presence of LUTS groups. Of the 19,165 telephone surveys, 13,519 respondents reported at least one LUTS and were included in the analysis. All respondents were asked about the presence of 14 LUTS (International Prostate Symptom Score plus seven additional LUTS). K-means cluster analyses, a statistical method for sorting objects into groups so that similar objects are grouped together, was used to identify groups of people based on their symptoms. Men and women were analysed separately. A split-half random sample was selected from the dataset so that exploratory analyses could be conducted in one half and confirmed in the second. On model confirmation, the sample was analysed in its entirety. RESULTS: Included in this analysis were 5014 men (mean age 49.8 years; 95% white) and 8505 women (mean age 50.4 years; 96% white). Among both men and women, six distinct symptom cluster groups were identified and the symptom patterns of each cluster were examined. For both, the largest cluster consisted of respondents with minimal symptoms (i.e. reporting essentially one symptom), 56% of men and 57% of women. The remaining five clusters for men and women were labelled based on their predominant symptoms. For men, the clusters were nocturia of twice or more per night (12%); terminal dribble (11%); urgency (10%); multiple symptoms (9%); and postvoid incontinence (5%). For women, the clusters were nocturia of twice or more per night (12%); terminal dribble (10%); urgency (8%); stress incontinence (8%); and multiple symptoms (5%). The multiple-symptom groups had several and varied LUTS, were older, and had more comorbidities. Clusters of terminal dribble and male postvoid incontinence had a lower prevalence of all other LUTS, but were fairly common (11% and 5% of men). CONCLUSIONS: This analysis provides an empirical approach to examining the presentation of multiple LUTS and suggests it is possible to identify subgroups of patients with LUTS based on their symptom presentation. These analyses need to be replicated to evaluate the clinical relevance of these findings.

Cluster analysis and lower urinary tract symptoms in men: findings from the Boston Area Community Health Survey.

OBJECTIVES: To classify lower urinary tract symptoms (LUTS) in a large, representative sample of men in the USA by means of cluster analysis and to investigate risk factors and comorbidities associated with the resulting cluster patterns. SUBJECTS AND METHODS: A combination of hierarchical and non-hierarchical cluster methods was used to assign men with LUTS in the Boston Area Community Health (BACH) study to symptom-based categories or clusters. Of the 2301 men in the BACH study, those reporting one or more of 14 common LUTS (1592 men) were included in the analysis. The prevalence and frequency of symptoms in each cluster was assessed, in addition to the demographic, lifestyle risk factors, comorbidities, quality of life, and interference with activities of daily living associated with each cluster. We used anova methods for assessing cluster effects on continuous variables, and cross-classification and chi-square tests for categorical measures. Internal validity of the cluster solution was tested by means of a split-half replication, and external validity by comparison with previously published data. RESULTS: Five clusters were identified among symptomatic men. About half of the symptomatic men were assigned to Cluster 1, which included individuals with a low prevalence and frequency of urological symptoms and a correspondingly low level of interference with activities of daily living. There were intermediate levels of symptom frequency and prevalence in Clusters 2-4, which were characterized by mixed patterns of voiding, storage and postvoiding symptoms. Cluster 5 consisted of predominantly older men (mean age 58.9 years), with a high prevalence and frequency of urological symptoms with a mean (SD) number of symptoms of 9.9 (2.1), and with elevated levels of comorbid cardiovascular disease (P < 0.001). These men also had higher rates of kidney and bladder infections and previous urological surgery. Men with increased waist circumference and more sedentary lifestyles were over-represented in the more symptomatic clusters. CONCLUSION: Cluster analysis provides an empirically based method for categorizing men with LUTS. These findings provide a new framework for examining aetiological pathways and mechanisms, the potential impact of and consequences for comorbid conditions, and for assessing prognosis and outcomes associated with common urological disorders.

Do urological symptoms cluster among women? Results from the Boston Area Community Health Survey.

OBJECTIVES: To conduct a cluster analysis of urological symptoms among women in the Boston Area Community Health (BACH) Survey, to describe the distribution of urological symptoms within each cluster, and to determine whether comorbidities, demographic characteristics, and lifestyle factors were associated with cluster membership. SUBJECTS AND METHODS: The BACH Survey is a racially and ethnically diverse random sample (3205 women) of community-dwelling residents of Boston, MA, USA, aged 30-79 years. Fourteen urological symptoms measured by participant self-report (using previously validated scales) were included in this analysis. Cluster analyses were conducted using hierarchical and non-hierarchical (k-means) methods. Within clusters, demographic characteristics, risk factors for urological symptoms and the interference of symptoms with daily activities were also assessed. RESULTS: Three-quarters of the sample reported at least one urological symptom; four symptom clusters were identified. Most symptomatic women (54%) were assigned to Cluster 1, which was characterized by storage symptoms (nocturia and urinary frequency) with an accompanying low prevalence of other urological symptoms; a second cluster was distinguished by frequency symptoms. Clusters 3 and 4 were characterized by a high prevalence of urinary incontinence and had increased interference scores and more symptoms overall (including voiding and post-voiding symptoms) than the other two clusters. Cluster 4 (8% of symptomatic women) was characterized by a high prevalence of nearly all urological symptoms and the highest interference score. In this most symptomatic cluster, body size and waist circumference were markedly higher, as was the prevalence of diabetes, hypertension and cardiovascular disease than in the other cluster groups or asymptomatic women. Women in Cluster 4 were more likely to be surgically menopausal, or to have had other forms of urogynaecological surgeries than women in the other clusters. CONCLUSION: Four distinct clusters of urological symptoms were identified among symptomatic women in the BACH Survey, two of which had a high prevalence of urinary incontinence. These cluster patterns provide a novel, empirically-based framework for investigating aetiological mechanisms and management outcomes for common urological symptoms in women.

Racial differences in the prevalence of overactive bladder in the United States from the epidemiology of LUTS (EpiLUTS) study.

OBJECTIVES: To estimate the prevalence of overactive bladder (OAB) in men and women in the United States (US) to determine whether there were racial differences. METHODS: This was a secondary analysis of data from the EpiLUTS (Epidemiology of Lower Urinary Tract Symptoms) survey, an Internet-based cross-sectional, population-representative epidemiologic survey conducted in the US, UK, and Sweden. These analyses were limited to the data of men and women aged 40 and older from the US. The presence of OAB was defined as experiencing urinary urgency or urinary urgency incontinence. Case definitions of OAB symptoms were categorized as occurring at least "sometimes." Prevalence rates of OAB were estimated by race. Logistic regression analyses were conducted for each gender to examine the role of race on OAB status, controlling for risk factors and comorbid conditions. RESULTS: The response rate in the US was 59.6%. A total of 9237 men and 10,407 women self-identified their race and were included in the analytic sample. The prevalence of OAB at least "sometimes" ranged from 26% in Asian men to 33% in African American men. Similarly, the prevalence of OAB at least "sometimes" was lowest in Asian women (27%) and highest in African American women (46%). Race was predictive of OAB in men but not for women. CONCLUSIONS: The prevalence of OAB ranged from 26-33% across races for men and from 27-46% across races for women. African American and Hispanic race is predictive of OAB for men but not for women.

Effect of bothersome overactive bladder symptoms on health-related quality of life, anxiety, depression, and treatment seeking in the United States: results from EpiLUTS.

OBJECTIVE: To determine the bother associated with overactive bladder (OAB) symptoms and its influence on health-related quality of life (HRQL), anxiety, depression, and treatment seeking in adults in the United States. METHODS: Data from U.S. respondents aged ≥ 40 years participating in the Epidemiology of Lower Urinary Tract Symptoms survey, a population-based, cross-sectional Internet survey, were analyzed to assess OAB prevalence, OAB-associated bother, and effect of OAB on HRQL, anxiety, depression, and healthcare use. Likert data were categorized as no/minimal OAB symptoms, OAB without bother, and OAB with bother at least "somewhat." RESULTS: Of 31 588 completed surveys, 20 000 participants (9416 men and 10 584 women) were randomly selected and matched to U.S. census demographics. Of the respondents with OAB at least "sometimes," the women were more likely than the men to be bothered by OAB, with 68% of the women and 60% of the men bothered at least "somewhat." Men and women with OAB with bother were more likely to report that their bladder condition caused at least some problems; had worse scores on HRQL, anxiety, and depression assessments; and had the greatest number of healthcare visits annually compared with those with OAB without bother and those with no/minimal symptoms. The strongest correlation between bother and symptom frequency was seen for urinary urgency, followed by urgency urinary incontinence and nocturia. CONCLUSION: OAB symptoms can be quite bothersome, especially for women, and can negatively affect HRQL, increase anxiety and depression, and increase healthcare usage. In the present study, the strongest predictor of OAB-associated bother was urinary urgency.