Establishing the content validity of the King's Health Questionnaire in men and women with overactive bladder in the US.

BACKGROUND: Overactive bladder (OAB) consists of the symptoms of urinary urgency (with or without urgency incontinence) and increased urinary frequency and nocturia. As OAB is defined by symptoms, the patient is the best source of information for assessing the impact of the condition on health-related quality of life (HR-QOL). This assessment can be conducted through the use of valid patient-reported questionnaires, meaning the questionnaire has demonstrated content validity, among other acceptable psychometric properties. The aim of this study was to evaluate the content validity of the King's Health Questionnaire (KHQ) in patients with OAB in the US. METHODS: Men and women with continent or incontinent OAB were recruited from a clinical research site in the US. Participants completed the KHQ and were then asked about the instructions, items, and response options. Data were analyzed descriptively and qualitatively. RESULTS: A total of 24 participants (18 women, 6 men; mean [± SD] age 59.0 ± 11.1 years) with OAB were interviewed and provided feedback on the KHQ. Participants reported that overall, the KHQ covers the key aspects in which OAB impacts patients' daily lives. Most KHQ items and response options were acceptable and understandable to the participants; however, a few minor issues were noted. In item 3, shopping was not considered by some participants to be a household task, while shopping and cleaning were not relevant to some of the men. Two sets of items ('limit social life' and 'limit ability to see/visit friends' and 'bladder problem affect sleep' and 'feel worn out or tired') were perceived as redundant, while 'depressed' (item 12) and 'anxious or nervous' (item 13) were perceived by some participants as too intense. Some participants were unsure if the intended meaning of 'change your underclothes when they get wet' was about changing wet underwear or frequency of incontinence episodes. CONCLUSION: The KHQ demonstrated content validity and can be considered a relevant and appropriate tool to assess the impact of OAB on HR-QOL in men and women in the US.

National community prevalence of overactive bladder in the United States stratified by sex and age.

OBJECTIVE: To estimate the prevalence of and bother associated with overactive bladder (OAB) in adults aged ≥40 years in the United States, using current International Continence Society definitions. METHODS: Internet-based panel members were selected randomly to participate in EpiLUTS, a cross-sectional, population-representative survey. Participants used Likert scales to rate how often they experienced individual lower urinary tract symptoms during the previous 4 weeks and how much bother they experienced. Based on responses to questions regarding urgency and urgency urinary incontinence, OAB symptoms were categorized as occurring at least "sometimes" or at least "often." Symptom bother was categorized as at least "somewhat" or at least "quite a bit." RESULTS: The response rate was 59.6%, with a final sample of 9416 men and 10,584 women. Prevalence of OAB symptoms at least "sometimes" was 27.2% and 43.1% for men and women, respectively; prevalence of OAB at least "often" was 15.8% and 32.6%, respectively. Among men with OAB symptoms at least "sometimes," 60.0% were bothered at least "somewhat" and 27.8% were bothered at least "quite a bit." Among women, bother rates were 67.6% and 38.9%, respectively. Among respondents with OAB at least "often," 67.8% and 38.2% of men and 73.0% and 47.1% of women reported being bothered at least "somewhat" and at least "quite a bit," respectively. We estimate that 29.8 million adults aged ≥40 years in the United States have bothersome OAB symptoms. CONCLUSIONS: Bothersome OAB symptoms are highly prevalent among men and women aged ≥40 years in the United States.

Validation of the urinary sensation scale (USS).

AIM: The purpose of this study was to assess the validity of the Urinary Sensation Scale (USS) in men with overactive bladder and voiding symptoms (OAB-LUTS) and women with overactive bladder (OAB). METHODS: Data from two OAB clinical trials of tolterodine were used. The USS, a 5-point scale, assesses the amount of urinary urgency associated with each urination. Three methods to calculate the USS are: mean urgency (Mean USS); mode urgency (Mode USS); and sum urgency (sum USS). The validity and responsiveness of the scoring methods was assessed using Spearman's correlations, general linear models, and effect sizes. RESULTS: Data from 650 men (Study 1) and 413 women (Study 2) were analyzed. Mean age was 65.2 (men) and 47.8 (women); 70% were Caucasian in both studies. Correlations of USS scores with bladder diary variables were small to moderate and higher among Sum USS than Mean USS (r=0.02-0.64). Correlations among the USS and patient-reported outcomes (PROs) were again small to moderate and higher with Sum USS (r=0.05-0.41). Both the Mean USS and Sum USS significantly discriminated (all P<0.001) among all bladder diary variables (except nocturia and UUI in men) when grouped as improved/not improved as well as by the PROs. Effect sizes for men and women, respectively, were -0.52 and -1.09 for Mean USS and -0.72 and -1.36 for Sum USS. CONCLUSION: The USS is a valid and highly responsive measure of urinary urgency in men with OAB-LUTS and women with OAB.

The prevalence of chronic constipation and faecal incontinence among men and women with symptoms of overactive bladder.

OBJECTIVE: To estimate the prevalence and overlap of overactive bladder (OAB), chronic constipation (CC) and faecal incontinence (FI) among a general population sample of adults in the USA. PATIENTS AND METHODS: A cross-sectional internet-based survey of randomly selected panel members who were ≥ 40 years of age was conducted. Participants reported how often they experienced symptoms of OAB, CC and FI using Likert scales and modified Rome III criteria. Analyses were conducted to examine the overall prevalence of OAB, CC and FI in men and women separately and to characterize the extent of overlap between these conditions in participants with OAB vs those without OAB, and those participants with continent vs incontinent OAB. RESULTS: The response rate for the survey was 62.2% and the final sample (N= 2000) included 927 men and 1073 women. The overall prevalence of OAB [defined as a response of ≥ 'sometimes' to urinary urgency (i.e. 'sometimes' or more often) or 'yes' to urinary urgency incontinence (UUI)] was 26.1% in men and 41.2% in women. The overall prevalence of CC was significantly lower in men than in women (15.3 vs 26.3%), but both men and women with OAB were significantly more likely to report CC (22.3 and 35.9% vs 5.7 and 6.7%, respectively, P < 0.0001). The overall prevalence of FI reported 'rarely' or more was 16.7% of men and 21.9% of women. Men and women with OAB were significantly more likely to report FI than those without OAB. FI was also more common in participants with incontinent OAB than in those with continent OAB. Logistic regressions controlling for demographic factors and comorbid conditions suggest that OAB status is a very strong predictor of CC, FI and overlapping CC and FI (odds ratios, range 3.55-7.96). CONCLUSIONS: Chronic constipation, FI and overlapping CC and faecal incontinence occur more frequently in patients with OAB and should be considered when evaluating and treating patients with OAB. These findings suggest a shared pathophysiology among these conditions. Additional study is needed to determine if successful treatment of one or more of these conditions is accompanied by commensurate improvement in symptoms referable to the other organ system.

Contributors to satisfaction with combined drug and behavioral therapy for overactive bladder in subjects dissatisfied with prior drug treatment.

PURPOSE: To assess contributors to treatment satisfaction with a focused, self-administered behavioral intervention combined with tolterodine extended release (ER) in subjects from an open-label study who had reported dissatisfaction with antimuscarinic treatment for overactive bladder (OAB) before that study. METHODS: Cognitive debriefing interviews were conducted with a convenience sample of 15 participants 7 to 10 months after completing the open-label trial. Reasons that contributed to participants' satisfaction with tolterodine ER treatment combined with behavioral intervention were assessed in the context of their dissatisfaction with prior antimuscarinic treatment. Also assessed were participants' treatment expectations and experiences with specific aspects of study participation and the self-administered behavioral intervention. RESULTS: Among the 15 participants (median age, 57 years; 13 women, 2 men), 12 attributed dissatisfaction with prior antimuscarinics to lack of efficacy. Only 7 participants had positive expectations of tolterodine ER treatment, 5 did not expect it to work, and 3 did not know what to expect. Reasons given for satisfaction with combined treatment were improved OAB symptoms (n = 13), attention of clinic staff (n = 8), review of educational materials on OAB symptoms and treatment (n = 14), and keeping a bladder diary (n = 13). One-third of participants (n = 5) continued to take tolterodine ER for 7 to 10 months after completing the open-label study. CONCLUSION: In addition to antimuscarinic therapy, treatment satisfaction and OAB symptoms may be improved in many patients by using a focused educational pamphlet with verbal reinforcement that increases awareness of OAB causes, treatments, and strategies for improving bladder control, including behavioral interventions and keeping bladder diaries.

Pharmacotherapy adherence and costs versus nonpharmacologic management in overactive bladder.

OBJECTIVE: To evaluate adherence with overactive bladder (OAB) pharmacotherapy and compare costs between patients receiving pharmacotherapy versus nonpharmacologic management. STUDY DESIGN: Retrospective cohort study using anonymous, patient-level data from administrative claims from the PharMetrics database. METHODS: Patients 18 years of age or older who received an OAB diagnosis or OAB medication prescription from January 1, 2005, through December 31, 2006, were identified. Eligible patients had continuous health plan enrollment from 6 months before to 12 months after the index date (date of first OAB prescription or first OAB diagnosis); exclusion criteria included prior OAB therapy use. Study cohorts were stratified as OAB therapy or nonpharmacologically managed based on evidence of treatment and matched using propensity score methodology. Outcomes included adherence rates with OAB therapy (defined as proportion of days covered [PDC]) and comparative costs of OAB pharmacotherapy versus nonpharmacologic management from a healthcare payer perspective. RESULTS: Adherence among OAB therapy patients was low, with 14% of patients achieving PDC of 80% or higher and an average PDC of 32%. Unadjusted total costs were approximately 3% higher for OAB therapy versus nonpharmacologically managed patients due to higher pharmacy costs. Conversely, outpatient service and inpatient hospitalization costs were higher for nonpharmacologically managed patients. Results did not change after adjusting for patient characteristics. CONCLUSION: Results confirm low adherence to OAB pharmacotherapy, with few patients achieving PDC of 80% or higher. Total costs were higher among OAB therapy patients due to higher pharmacy costs, but outpatient and inpatient costs were higher among nonpharmacologically managed patients. Additional research into optimizing pharmacotherapeutic regimens may provide insight into improving treatment adherence.

The total economic burden of overactive bladder in the United States: a disease-specific approach.

OBJECTIVE: To employ results from a recent US population-based survey to calculate disease-specific total costs of overactive bladder (OAB). STUDY DESIGN: Disease-specific total cost-of-illness method using population prevalence estimates. METHODS: Cases were identified as community-dwelling adults reporting the presence of urinary urgency or urgency urinary incontinence. Two OAB classifications were used based on Likert scale responses of OAB symptoms: "often" (base case) or "sometimes" (alternative). The study estimates disease-specific total costs of OAB from the societal perspective and using an average costing method. A population-based survey, a claims data analysis, and the published literature provided the prevalence and resource utilization data. RESULTS: The prevalence of OAB as defined in the base case (alternative) was 18.6% (28.7%) in the adult US population, accounting for 42.2 million (65.1 million) community-dwelling adults. The disease-specific total cost of OAB is estimated at $24.9 billion for the base case and $36.5 billion for the alternative case. Total direct costs were $22.3 billion in the base case and $33.5 billion in the alternative case. Costs were higher among adults younger than 65 years of age, compared with adults 65 years or older. This relative cost burden was lower for the base case compared with the alternative case in the full sample, with a larger gap among men. CONCLUSION: The total cost of OAB among community-dwelling adults is significant and varies with demographic groups. Future research is needed to determine whether the differential cost burden is robust to alternate cost-of-illness estimation methods.

Impact of overactive bladder on work productivity in the United States: results from EpiLUTS.

OBJECTIVE: Little research has focused on the impact of overactive bladder (OAB) on work productivity. Consequently, the impact of OAB and other lower urinary tract symptoms (LUTS) on work productivity was evaluated in employed men and women aged 40 to 65 in the United States. STUDY DESIGN: Data from a population-based, cross-sectional Internet survey were used to examine the impact of OAB symptoms on work productivity. US participants aged 40 to 65 working full- or part-time were included in the analysis. Participants were asked about the incidence of OAB and other LUTS and a series of questions about work productivity. METHODS: Descriptive statistics and linear and logistic regressions were used to evaluate outcome differences for men and women by the OAB groups of no/minimal symptoms, continent OAB, and incontinent OAB. RESULTS: The response rate was 60%, and a total of 2876 men and 2820 women were analyzed. Men and women with incontinent OAB reported the lowest levels of work productivity and highest rates of daily work interference. Storage symptoms associated with OAB were most consistently associated with work productivity outcomes; however, significant associations were also found for other storage, voiding, and postmicturition LUTS. CONCLUSION: In this large US population-based study, OAB was highly prevalent and was associated with lower levels of work productivity. These findings add to the literature documenting the burden of OAB and other LUTS, underscoring the need for increased screening and treatment.

Increased sexual dysfunction in men with storage and voiding lower urinary tract symptoms.

INTRODUCTION: Sexual dysfunction (SD) and lower urinary tract symptoms (LUTS) are highly prevalent in men and increase with age. Previous studies have shown that LUTS and SD are highly associated in men, but most have not distinguished between voiding and storage LUTS. Aims. Assess impact of voiding and storage LUTS on recorded diagnosis of SD in men in U.K. general practice. METHODS: Identified records of patients with SD and storage (e.g., overactive bladder) and voiding LUTS (e.g., benign prostatic hyperplasia) from a population-based study using The Health Improvement Network database with records from 333 general practices. Study period was 2000-2007; study population was men aged >or= 18 years. MAIN OUTCOME MEASURES: Prevalence rates of SD, and storage and voiding LUTS on January 1 of each year from 2000 to 2007. RESULTS: Overall prevalence of recorded SD rose from 1.7% in 2000 to 4.9% in 2007. The prevalence of storage and voiding LUTS also increased. Median age at diagnosis was 60 years for erectile dysfunction (ED), 62 years for other SD, 62 years for storage LUTS, and 61 years for voiding LUTS. Compared to men with no LUTS, odds ratios (95% CI) for ED were as follows: storage LUTS, 3.0 (2.6-3.4); voiding LUTS, 2.6 (2.4-2.7); and both voiding and storage LUTS, 4.0 (3.4-4.8). Among the 11,327 men with any recorded LUTS and ED at the beginning of 2007, LUTS diagnosis preceded SD in 63.1% of patients by a mean of 4.8 years. CONCLUSIONS: Prevalence of SD was significantly higher in the presence of either storage or voiding LUTS compared to men with no recorded LUTS. The diagnosis of LUTS preceded SD in the majority of cases. Further research into the interrelationships between functional problems of the genitourinary tract may have implications for current treatment approaches and future therapeutic developments.