Assessment of treatment-seeking behavior and healthcare utilization in an international cohort of subjects with overactive bladder

Abstract

Objective:

To assess the association between incontinence severity, treatment-seeking behavior, and healthcare resource utilization (HRU) among participants with overactive bladder (OAB) in eight countries.

Research design and methods:

A cross-sectional online survey of subjects ≥18 years old in Australia, Europe, and North America, who had a past OAB diagnosis and/or experienced ≥1 urinary incontinence (UI) episode in the preceding 12 months, were eligible to participate. Subjects contacted for the survey were primarily from a voluntary medication monitoring registry, MediGuard. Predominantly stress incontinence subjects were excluded. Incontinence severity was assessed by the number of UI episodes over 3 days and grouped as 0 (‘dry’), 1–2, 3–4, and ≥5 UI episodes/day. Subject demographics, employment status, comorbidities, treatment-seeking behavior (past OAB diagnosis; spoken to healthcare provider [HCP]), and HRU (diagnostic tests; HCP visits in 6 months before screening) were analyzed by incontinence severity.

Results:

Overall, 1341 subjects with OAB (mean age 54.5 years; 70.7% female) were surveyed; 20.2%, 47.7%, 18.8%, and 13.3% of subjects reported 0, 1–2, 3–4, and ≥5 UI episodes/day, respectively. Employment status and comorbidities were significantly (p < 0.05) associated with incontinence severity. The two measures of treatment-seeking behavior were significantly (p < 0.05) associated with incontinence severity groups; the proportion of subjects with a past diagnosis of OAB were 35.8%, 44.8%, 52.4%, and 64.0% in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively; and 59.0%, 63.6%, 65.9%, and 78.1% of subjects in the respective UI severity groups talked to a HCP about their OAB symptoms. Multivariate linear regression analyses showed a positive and consistent association between incontinence severity and HRU; subjects reported a mean of 2.7, 4.1, 4.4, and 7.7 diagnostic tests overall (p < 0.001), and a mean of 1.4, 2.2, 2.7, and 4.0 HCP visits in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively (p < 0.001). A potential limitation of the study is the cross-sectional survey methodology which limits the ability to draw causal inferences from the results. Additionally, since this is a web-based survey it is possible respondents who have access to/are familiar with technology were more likely to be enrolled.

Conclusions:

Incontinence severity was positively associated with both treatment-seeking behavior and HRU among subjects with OAB.

Keywords::

• Burden of incontinence
• Healthcare resource utilization
• Incontinence severity
• Overactive bladder
• Treatment-seeking behavior
• Urinary incontinence
• Urinary symptoms

Introduction

Overactive bladder (OAB) is a common disorder that affects 12–17% of the general population1–3 and is characterized by symptoms of urgency with or without urinary incontinence (UI), usually with frequency and nocturia4. Patients with OAB and UI report a substantial decrease in their health-related quality of life including increased depression, poor sleep quality, and decreased work productivity5,6.

OAB is also associated with a considerable economic burden that is well documented6–8, with direct annual cost estimates of $51.4 billion in the United States8, and a range of €0.3 to 1.2 billion across five European countries7. Many studies of OAB cost estimates are based on the prevalence of incontinence in the general population9, and fail to consider healthcare resource utilization (HRU) rates specifically in the OAB population. Moreover, the disease-related and patient-specific factors that drive the costs associated with OAB are not clearly understood. For example, it has been hypothesized that the presence of incontinence may increase HRU10; however, there is a paucity of information on the relationship between the degree of incontinence and healthcare utilization rates among patients with OAB.

Although previous studies have cited incontinence as a reason for patients with OAB seeking treatment from their healthcare provider (HCP)11,12, there are few reports on the association of severity of incontinence with treatment-seeking behavior, which may be important in determining the unmet need for treatment and quality of care in OAB patients with UI.

The primary objective of the International Burden of Incontinence Study was to assess the association between incontinence severity, treatment-seeking behavior, and patient-reported HRU among subjects with OAB in Australia, Europe, and North America. In addition, the overall association of incontinence severity with subjects’ demographics (age), employment status, and comorbidities was investigated.

Patients and methods

A cross-sectional online survey was administered via a web-based platform to eligible participants who selected OAB diagnosis in response to a screening question ‘Have you ever been diagnosed with any of the following conditions? Please select all that apply’ and/or had experienced ≥1 UI episode in the 12 months prior to screening (to ensure that all subjects did actually experience OAB symptoms). Individuals with a predominance of stress UI were excluded. Other exclusion criteria were: pregnancy, a history of neurological disorders, history of bladder disorders, including bladder stones and bladder outlet obstruction, a history of bladder or prostate cancer, and bladder reconstructive surgery. Participants were recruited in Australia, Canada, France, Germany, Italy, Spain, United Kingdom, and the United States and were ≥18 years old at the time of the survey.

Participants were recruited through MediGuard.org, a patient registry owned by Quintiles Inc. The MediGuard registry is a voluntary medication monitoring service that is provided to individuals and has the ability to re-contact interested individuals for study participation and educational purposes. In countries that did not have or only had a limited MediGuard registry, respondents were recruited through affiliate vendor databases, online search engines, social media, and health-related websites. Pretesting quality measures ensured that only eligible participants were able to access the survey. These included a screening questionnaire which was administered to all individuals who responded to the survey request to ensure that only subjects with previously diagnosed OAB, or those who had symptoms of OAB, were allowed to participate in the survey. Validated translations of questionnaires were included when available. All other items were translated and then translated back to English to ensure accuracy. Translations of the survey were evaluated for validity by physicians from each of the participating countries to ensure accurate comprehension and adherence to local/cultural norms. The study was approved by the Ethical and Independent Review Services, an independent centralized institutional review board.

Following informed consent online, subjects were granted access to the survey and compensated with a US$20 gift card upon completion. The survey was fielded over 3 months from December 2012 to March 2013, until the desired sample size of approximately N = 1300 was reached. Male, younger (18–39 years old), and older (≥65 years old) participants were oversampled to ensure representation in the sample. The survey included questions on subject demographics, employment status, OAB disease history, current, and past use of OAB medications, and treatment satisfaction. The comorbidities considered include benign prostatic hyperplasia, depression, diabetes, heart disease, high blood pressure, obesity, osteoporosis, and urogenital prolapse. Severity of incontinence, treatment-seeking behavior, employment status, and healthcare utilization rates were assessed using additional questionnaires.

Measures

In our study, incontinence severity was assessed by subjects’ response to a question on urinary urgency incontinence episodes in the past 3 days. The term ‘incontinence severity’ is used throughout the manuscript as a surrogate for ‘incontinence frequency’ and does not take into account the volume of urine loss per incontinence episode. Subjects were asked, ‘Thinking back over the past 3 days, how many times per day, in a typical day, would you say you experienced urinary leakage?’ The 2012 NICE guidelines on urinary incontinence in neurological disease13 categorized patients with UI as continent or ‘dry’ (0.14 UI episodes/day), mildly incontinent (2 UI episodes/day), and completely incontinent (at least 5 UI episodes/day). These guidelines were incorporated in greater granularity in the present study to categorize the subjects’ incontinence severity as ‘0’, ‘1–2’, ‘3–4’, and ‘≥5’ UI episodes per day.

The treatment-seeking behavior of subjects was assessed by recording their history of discussion of urinary symptoms with a HCP and a past clinical diagnosis of OAB. Subjects were asked: a) ‘Have you ever talked to a HCP about your urinary symptoms?’ and b) ‘Have you ever been diagnosed with any of the following conditions? Please select all that apply.’ OAB was in the list of selections, among other comorbid conditions. Current employment status was assessed as a component of the validated Work Productivity and Activity Impairment questionnaire14. The present analysis is restricted to the question, ‘Are you currently employed (working for money)? Yes/No.’

The healthcare resources used were reported, including diagnostic tests (urinalysis, blood tests, post-void residual volume, urodynamic testing, bladder ultrasound, and cystoscopy), and HCP visits (primary care/general practitioner, urologists, and urogynecologists). Subjects were asked to report the number of different types of diagnostic tests performed in the past 6 months because of their urinary symptoms. A positive response to any of the diagnostic tests was coded as a ‘Yes’. Subjects also reported the number of HCP visits in the past 6 months, where a reason for the visit was related to their urinary symptoms, including falls, broken bones, urinary tract infections, skin infections, urinary retention, and dehydration. A positive response to any type of HCP visit was coded as a ‘Yes’.

Statistical analysis

A target sample size of N = 1300 (United States = 350; United Kingdom = 150; Canada = 150; Australia = 250; France = 100; Germany = 100; Italy = 100; Spain = 100) was selected to provide a reliable assessment of the study participants globally, taking into account the number of accessible (based on MediGuard platform) subjects with OAB in each of the participating countries.

Descriptive analyses of the age, gender, employment status, number of comorbidities, treatment-seeking behavior, and HRU (mean, standard deviation, percentages) were conducted. Mantel–Haenszel chi-square test was used to evaluate the association of incontinence severity groups and categorical variables (gender, employment status, and treatment-seeking behavior). A chi-square test was conducted to assess whether the proportions of subjects in the categorical variables (gender, employment status, and treatment-seeking behavior) were statistically different across the incontinence severity groups. Analysis of variance (ANOVA) was used to test whether the mean estimate of each continuous measure (age and number of comorbid conditions) was the same across the incontinence severity groups. In addition, a post hoc Tukey test was conducted by comparing the 0 UI episode/day group (‘dry’) with each of the other groups with incontinence severity (i.e. 1–2, 3–4, and ≥5 UI episodes/day). Univariate regression analyses were performed to assess healthcare utilization rates between groups of subjects with 0, 1–2, 3–4, and ≥5 UI episodes/day. In multivariate linear regression analyses, using generalized linear modeling, the association between incontinence severity groups (0, 1–2, 3–4, and ≥5 UI episodes/day) and healthcare utilization rates were assessed after adjusting for age, gender, and the number of comorbidities. All statistical analyses were conducted using SAS v9.2 (Cary, NC, USA) with type 1 error level of α = 0.05 for all statistical tests.

Results

A total of 1341 subjects (United States = 356; United Kingdom = 184; Canada = 150; Australia = 254; France = 100; Germany = 98; Italy = 99; Spain = 100) completed the survey between December 2012 and March 2013. The demographic and baseline characteristics of the study population are presented in Table 1. The overall mean UI episodes/day were 2.3, with 271 (20.2%) subjects reporting 0 UI episodes/day (‘dry’), 640 (47.7%) subjects with 1–2 UI episodes/day, 252 (18.8%) subjects with 3–4 UI episodes/day, and 178 (13.3%) subjects with ≥5 UI episodes/day (Table 1). The mean age of the survey population was 54.5 years. At the UI severity subgroup level, the mean age of subjects with 0, 1–2, 3–4, and ≥5 UI episodes/day was 52.1, 54.8, 55.4, and 55.7, respectively (p < 0.05) (Table 1). Overall 70.7% (948/1341) of the subjects were female, including 70.1%, 69.5%, 71.8%, and 74.2% in the groups with 0, 1–2, 3–4, and ≥5 UI episodes/day respectively (Table 1).

Table 1. Baseline demographics by severity of daily UI episodes over a period of 3 days.

Variable	Average daily UI episodes over a period of 3 days
	0	1–2	3–4	≥5	Overall
	(n = 271)	(n = 640)^a	(n = 252)	(n = 178)	(N = 1341)
Age, mean ± SD	52.1 ± 14.4	54.8 ± 14.4	55.4 ± 14.1	55.7 ± 13.5	54.5 ± 14.3
Tukey’s test p value^b	Reference	<0.05	<0.05	<0.05	NA
Female^c, n (%)	190 (70.1)	445 (69.5)	181 (71.8)	132 (74.2)	948 (70.7)
Employed^d, n (%)	126 (46.5)	258 (40.3)	103 (40.9)	59 (33.1)	546 (40.7)
Number of comorbidities, mean ± SD	3.2 ± 2.6	3.1 ± 2.5	3.6 ± 2.6	4.3 ± 3.0	3.4 ± 2.6
Tukey’s test p value^b	Reference	>0.05	>0.05	<0.05	NA
Treatment seeking behavior, n (%)
Had been diagnosed with OAB^e	97 (35.8)	287 (44.8)	132 (52.4)	114 (64.0)	630 (47.0)
Talked to healthcare provider about OAB symptoms^e	160 (59.0)	407 (63.6)	166 (65.9)	139 (78.1)	872 (65.0)

^aThe ‘n’ for age is 639 because one subject has a missing value.

^bAnalysis of variance (ANOVA) with a post hoc Tukey test (p value) comparing the mean value of each incontinence severity category (1–2, 3–4, and >5 UI episodes/day, respectively) with the mean value of the 0 UI episode/day group (i.e. ‘dry’ group). The test is not applicable to the overall sample.

^cChi-square test p value is 0.648 for differences in the proportions among all the four incontinence severity groups. The test is not applicable to the overall sample.

^dChi-square test p value is 0.046 for differences in the proportions among all four incontinence severity groups. The test is not applicable to the overall sample.

^eChi-square test p value is <0.001 for differences in the proportions among all four incontinence severity groups. The test is not applicable to the overall sample.

NA, not applicable; OAB, overactive bladder; SD, standard deviation; UI, urinary incontinence.

The association between employment status and incontinence severity groups was statistically significant (p < 0.05) (Table 1). The proportion of employed subjects decreased with increasing severity of UI episodes: 46.5%, 40.3%, 40.9%, and 33.1% of subjects were employed in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively, and the differences in proportions are statistically significant (p < 0.05) based on a chi-square test (Table 1). Mean number of comorbidities were significantly different among the incontinence severity groups (p < 0.05), with the highest number of comorbidities observed in the most severely incontinent group (3.2, 3.1, 3.6, and 4.3 in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively) (Table 1).

The two measures of treatment-seeking behavior among subjects were significantly associated with incontinence severity groups (p < 0.05) (Table 1). Although all subjects reported at least 1 UI episode within the past 12 months, less than half (47.0%) indicated a past diagnosis of OAB including 35.8%, 44.8%, 52.4%, and 64.0% of the subjects in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively. A chi-square test shows that these proportions are statistically different (p < 0.001) from each other (Table 1). In addition, only 65.0% of subjects overall reported that they had talked to their HCPs about their OAB symptoms in the 6 months prior to screening. The proportion of subjects who had talked to their HCPs increased with increasing levels of incontinence severity (59.0%, 63.6%, 65.9%, and 78.1% in 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively), and are statistically different (p < 0.001) from each other (Table 1).

Univariate analyses assessed whether healthcare utilization rates differ between incontinence severity groups. The results of the univariate analyses are described as follows: the mean HRU rates increased with increasing levels of incontinence severity, and the mean values of diagnostic tests, including the various subtypes, and HCP visits are not statistically equal across the incontinence severity groups. The overall mean number of diagnostic tests conducted over 6 months prior to screening was 2.3, 3.5, 3.7, and 6.9 in subjects with 0, 1–2, 3–4, and ≥5 UI episodes/day, respectively (p < 0.001). The proportion of subjects receiving specific diagnostic procedures over the past 6 months was the highest in the most severely incontinent group (67.4% in the ≥5 UI episodes/day group), compared with 54.6%, 61.9%, and 60.3% in the 0, 1–2, and 3–4 UI episodes/day groups, respectively. Across the respective levels of incontinence severity of 0, 1–2, 3–4, and ≥5 UI episodes/day, there was an increasing trend in the mean number of different subtypes of diagnostic testing procedures, including urinalysis (0.8, 1.0, 1.1, and 1.6), blood tests (0.8, 1.0, 1.1, and 1.6), residual urine volume (0.2, 0.3, 0.3, and 0.8), bladder ultrasound (0.2, 0.5, 0.5, and 1.1), cystoscopy (0.1, 0.3, 0.4, and 0.9), and urodynamic testing (0.1, 0.3, 0.3, and 0.8); (p < 0.001). The proportion of subjects using each subtype of diagnostic test was consistently the highest in the most severely incontinent group (i.e. ≥5 UI episodes/day), and ranged from 15.7% to 58.8%.

Average HCP visits also increased with increasing levels of incontinence severity, with mean values of 1.2, 1.8, 2.3, and 3.6 in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively. There was a corresponding increase in the proportion of subjects reporting HCP visits, with 45.0%, 53.1%, 53.6%, and 59.0% of subjects in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively, visiting a HCP during the 6 months prior to screening. There was an increasing trend across the 0, 1–2, 3–4, and ≥5 UI episodes/day groups in the average number of patient visits, respectively, with primary care providers (0.7, 0.9, 1.2, and 1.6), urologists (0.4, 0.5, 0.6, and 1.1), and urogynecologists/gynecologists (0.1, 0.4, 0.4, and 0.9); (p < 0.001). The proportion of subjects who reported visiting primary care providers, urologists, and urogynecologists/gynecologists was the highest in the most severely incontinent group (i.e. ≥5 UI episodes/day) ranging from 24.2% to 50.0%.

The results of the multivariate analyses were similar to the univariate analyses and are shown in Table 2. After controlling for age, gender, and comorbidities, a multivariate analysis of HRU by severity of daily UI episodes showed that the mean HRU rates increased with increasing levels of incontinence severity (Table 2); the adjusted mean values of diagnostic tests, including the various subtypes, and HCP visits were not statistically equal across the incontinence severity groups. The adjusted mean number of diagnostic tests conducted over 6 months before screening was 2.7, 4.1, 4.4, and 7.7 in subjects with 0, 1–2, 3–4, and ≥5 UI episodes/day, respectively (p < 0.001). Across the respective levels of incontinence severity of 0, 1–2, 3–4, and ≥5 UI episodes/day, there was an increasing trend in the mean number of different subtypes of diagnostic testing procedures, including urinalysis (0.8, 1.1, 1.2, and 1.6), blood tests (1.0, 1.2, 1.3, and 1.8), residual urine volume (0.2, 0.4, 0.4, and 1.0), bladder ultrasound (0.3, 0.6, 0.6, and 1.2), cystoscopy (0.2, 0.4, 0.5, and 1.0), and urodynamic testing (0.1, 0.3, 0.4, and 0.9) (p < 0.001) (Table 2).

Table 2. Multivariate analysis of healthcare resource utilization over the past 6 months by severity of daily UI episodes.

Type of healthcare resource	Number of daily UI episodes over a period of 3 days								p Value^a
	0 (n = 271)		1–2 (n = 640)		3–4 (n = 252)		≥5 (n = 178)
	Mean (95% CI)	Usage %	Mean (95% CI)	Usage %	Mean (95% CI)	Usage %	Mean (95% CI)	Usage %
Diagnostic tests, overall	2.7 (1.9–3.6)	54.6	4.1 (3.6–4.7)	61.9	4.4 (3.5–5.3)	60.3	7.7 (6.6–8.7)	67.4	<0.001
Urinalysis	0.8 (0.6–1.0)	43.9	1.1 (1.0–1.3)	50.2	1.2 (1.0–1.4)	48.0	1.6 (1.4–1.9)	57.8	<0.001
Blood test	1.0 (0.8–1.2)	43.5	1.2 (1.1–1.4)	49.5	1.3 (1.1–1.5)	45.5	1.8 (1.5–2.1)	53.4	<0.001
Residual urine volume	0.2 (0.1–0.4)	7.4	0.4 (0.3–0.5)	13.7	0.4 (0.3–0.6)	14.7	1.0 (0.8–1.2)	21.3	<0.001
Bladder ultrasound	0.3 (0.2–0.5)	18.8	0.6 (0.5–0.7)	25.0	0.6 (0.4–0.8)	21.0	1.2 (1.1–1.4)	34.8	<0.001
Cystoscopy	0.2 (0.0–0.4)	7.7	0.4 (0.3–0.5)	13.6	0.5 (0.3–0.7)	13.9	1.0 (0.8–1.2)	23.0	<0.001
Urodynamic testing	0.1 (−0.01–0.3)	5.5	0.3 (0.2–0.4)	10.5	0.4 (0.2–0.5)	11.5	0.9 (0.7–1.1)	15.7	<0.001
Healthcare provider visits	1.4 (0.9–1.9)	45.0	2.2 (1.9–2.5)	53.1	2.7 (2.2–3.2)	53.6	4.0 (3.4–4.6)	59.0	<0.001
PCP	0.8 (0.5–1.0)	36.9	1.0 (0.9–1.2)	43.3	1.4 (1.2–1.6)	43.6	1.7 (1.5–2.0)	50.0	<0.001
Urologist	0.5 (0.3–0.7)	19.6	0.7 (0.6–0.8)	24.8	0.8 (0.6–1.0)	23.8	1.3 (1.0–1.5)	29.2	<0.001
Urogynecologists/gynecologists	0.1 (–0.03–0.3)	9.2	0.4 (0.3–0.5)	18.3	0.5 (0.3–0.6)	17.5	0.9 (0.7–1.1)	21.2	<0.001

^ap Values determine whether the mean estimates for the UI episode severity groups differ significantly from each other.

CI, confidence interval; PCP, primary care provider; UI, urinary incontinence.

Average HCP visits also increased with increasing levels of incontinence severity, with adjusted mean values of 1.4, 2.2, 2.7, and 4.0 in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively (p < 0.001) (Table 2). There was an increasing trend across the 0, 1–2, 3–4, and ≥5 UI episodes/day groups in the average number of patient visits, respectively, with primary care providers (0.8, 1.0, 1.4, and 1.7), urologists (0.5, 0.7, 0.8, and 1.3), and urogynecologists/gynecologists (0.1, 0.4, 0.5, and 0.9) (p < 0.001) (Table 2).

The proportion of subjects using diagnostic procedures overall, as well as those reporting HCP visits, increased with increasing levels of incontinence severity, and were similar to the results observed in the univariate analysis. Similarly, there were no differences in the proportion of subjects using different subtypes of diagnostic tests in the univariate and multivariate analyses (Table 2).

Discussion

This cross-sectional online survey of 1341 subjects with OAB across multiple countries demonstrates that an increased severity of incontinence is associated with decreased employment, and increased age, number of comorbidities, treatment-seeking behavior, and utilization of healthcare resources, including diagnostic testing and HCP visits. These findings are relevant to clinicians, policy makers, and researchers, particularly as they evaluate appropriate treatment pathways and allocation of healthcare resources in patients with OAB.

Our study found that the proportion of employed subjects decreased with increasing levels of incontinence severity, where only one-third of the most severely incontinent subjects were employed. Although employed subjects who are ‘dry’ (i.e. 0 UI episodes/day) are slightly younger than employed subjects who are severely incontinent (≥5 UI episodes/day), the differences are within the margin of error and not large enough to draw any statistically meaningful conclusions. Furthermore, the survey pre-specified that at least 20% of subjects be enrolled in the study from each of the following age groups: 18–39 years, 40–64 years, and ≥65 years. There were no significant differences in the proportions of subjects who were ≥65 years of age in each UI severity group (22.1%, 30.2%, 28.2%, and 28.6% in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively). Thus, the employment status is determined by UI severity rather than differences in the proportion of subjects who are ≥65 years of age across the UI categories. These results are in line with a recent retrospective cross-sectional study wherein 31.2% of incontinent OAB patients were employed15. A previous analysis of an age-matched group of patients with OAB showed higher rates of employment, with a total of 58.0% of patients with OAB (vs 66.5% without OAB) reporting full-time and part-time employment5. However, the OAB cases included patients with stress UI, and thus cannot be compared directly to the results in our study, which excluded subjects with stress incontinence. Findings in our study may have potential implications for burden of incontinence associated with OAB from a societal perspective as shown in a previous economic study, wherein lost work productivity accounted for 21% of the total aggregate costs of $65.9 billion based on 34 million persons with OAB8.

There is limited information on treatment-seeking behavior among OAB patients with varying levels of incontinence, and the few studies that have evaluated these relationships have reported conflicting results. Kinchen et al.16 found that the 38% of the patients who sought treatment had severe UI symptoms, and were significantly more likely to seek help. In contrast, Yu et al.17 found no difference in treatment-seeking behaviors based on severity of symptoms and reported that 27% of OAB patients had sought treatment for their UI symptoms. Findings in our study suggest that, overall, 47% to 65% of subjects with OAB demonstrated treatment-seeking behavior, which increased with increasing severity of incontinence. The higher rates of treatment-seeking behavior in our study may be attributable to the study methodology wherein subjects were recruited from a medication monitoring service, and hence were more likely to have seen a HCP. Nevertheless, 22% of the most severely incontinent subjects (those with ≥5 UI episodes/day) in our study had never talked to their HCPs about their OAB symptoms, and 36% of the subjects did not report a past diagnosis of OAB. These results are in line with a previous study in which 22–45% of patients with incontinence never sought care for their condition11, and suggests an unmet need in OAB patients and a lack of awareness of potentially effective therapeutic options that are available for the treatment of OAB with incontinence.

Other studies also have reported a low incidence of treatment-seeking behavior among patients with OAB and lower urinary tract symptoms (LUTS). In one US study16, less than 50% of community-dwelling adult women with LUTS reported having talked with their physicians about UI. In a European multi-site study12, only 31% of all women consulted a physician about their UI symptoms. Furthermore, only one-quarter of women with any UI, and one-half of women with significant UI reported consulting a physician12. Further exploration of the reasons for not seeking treatment among subjects in our study is warranted, and may help improve treatments and allocate healthcare resources.

There is limited understanding of the factors that drive the economic burden of disease, and the costs are calculated on modeling data based on assumptions of disease prevalence. Our study uniquely evaluates patient-reported data on utilization of healthcare resources, and underscores disease severity as an important factor when calculating costs associated with OAB symptoms. Overall, approximately 60–70% of subjects with incontinence used diagnostic tests, compared with 55% of subjects with continent OAB. Urinalysis and blood tests were the most frequently used diagnostic procedures among subjects in this study. Of the 50–60% of subjects who reported HCP visits, nearly half saw a primary care physician, and 20–30% of subjects saw specialists.

Other economic studies have estimated the costs of OAB by combining data assumptions of prevalence, costs, and utilization rates. The major cost drivers in one study18 were nursing home care, complications, medical devices, and physician visits. However, the cost estimates did not consider the impact of patients’ incontinence status. Another study19 estimated that the major cost drivers were the number of physician visits, prevalence of depression within the OAB population, and costs associated with OAB medication. However, the costs were calculated by comparing the OAB population with a non-OAB population. The results in our study show patient-reported usage of healthcare resources that may allow for cost estimates that more closely mirror the direct costs incurred due to OAB and associated symptoms, and may have implications for future allocation of healthcare resources for OAB patients.

There are several inconsistencies in the existing literature with respect to categorization of OAB severity based on the number of incontinence episodes1,5,20,21. The 2012 NICE guidelines13 categorized patients with UI episodes as continent or ‘dry’ (0.14 UI episodes/day), mildly incontinent (2 UI episodes/day), and completely incontinent (at least 5 UI episodes/day). An important strength of the present study is the broad adaptation of the incontinence severity categories as elucidated in the NICE guidelines, thereby avoiding the arbitrary cut-offs reported in previous studies.

However, there are several limitations in this study. One potential limitation is the survey methodology; the cross-sectional nature of the study limits the ability to draw causal inferences from the results. Although the study includes participants from a diverse multinational population, the information collected is based on patient-reported responses, and hence is subjective. Since this is a web-based online survey, it is possible that respondents who have access to or are familiar with technology were more likely to be enrolled in the study. Recall bias may impact the interpretation of results as subjects were requested to report their urinary symptoms over a 3 day period, rather than document them in a daily diary. Additionally, subjects were asked to recall healthcare utilization over a 6 month period preceding the survey, and hence their responses may be influenced by recall bias, similar to a previous study22 that reported much lower rates of HRU among patients in monthly surveys compared with weekly surveys. Furthermore, the overall survey duration (6 months) may be a short time frame for a chronic condition such as OAB. Finally, potential gender differences in treatment-seeking behavior and healthcare utilization among individuals with OAB were not investigated due to the small sample size of males in our study population.

Conclusion

In this cross-sectional survey of subjects with OAB, increased severity of incontinence is associated with decreased employment, and increased age, comorbidities, treatment-seeking behavior, and utilization of healthcare resources, which was consistent across all types of diagnostic testing and HCP visits. Although treatment-seeking behavior among subjects increased with increasing severity of incontinence, many did not report a diagnosis of OAB and did not discuss their OAB symptoms with a HCP. The results of this study help demonstrate the importance of continuing to search for effective treatment options to satisfy any unmet treatment need of OAB patients. Further exploration of the reasons for not seeking treatment among subjects in our study is warranted, and may help with improving treatments, allocation of healthcare resources, heightening disease awareness among patients, and engagement with their healthcare providers.

Transparency

Declaration of funding

This study was funded by Allergan, Inc. Data were collected by Quintiles Inc. and were monitored and analyzed by Allergan, Inc.

All authors were involved in data analysis and interpretation, drafting of the manuscript, and critical revision of the manuscript for important intellectual content. All authors provided final approval to submit the manuscript.

Declaration of financial/other relationships

M.J.-C. has disclosed that he has received grant/research support from Astellas Pharma SA, has been a consultant to Allergan and Astellas Pharma, and has participated in a speaker’s bureau for Allergan, Astellas Pharma, and Medtronic. P.C. has disclosed that he has been a consultant to Allergan. A.S. has disclosed that he has received grant/research support from Allergan, AMS, and Astellas, and has participated in a speaker’s bureau for Astellas and Pfizer. C.P.S. has disclosed that he has been a consultant/advisor to Allergan and has participated in a speaker’s bureau for Allergan. S.H. has disclosed that he has received grant/research support from Allergan, Astellas, and Pfizer, and has been a consultant/advisor to Astellas, Pfizer, Allergan, Lilly, Promedon, and Merus. D.N.-M. and A.D. have disclosed that they are employees of Allergan, Inc. K.T. has disclosed that she is a student at the University of Arizona College of Pharmacy, Tucson, AZ, USA and is on a 1 year fellowship at Allergan, Inc.

CMRO peer reviewers on this manuscript have no relevant financial or other relations to disclose.

Acknowledgments

The authors acknowledge Denise Globe and Patrick Gillard from Allergan, Inc., for their contribution to the conceptualization of the study, development of the study methods, and initiation of the survey. The authors acknowledge Quintiles Inc. for conducting the study for Allergan, Inc. Assistance with writing and development of the manuscript was provided by Jaya Kolipaka of Evidence Scientific Solutions, Philadelphia, PA, and was funded by Allergan, Inc.

Previous presentation: Presented at the International Continence Society (ICS) 43rd Annual Meeting, 26–30 August 2013, Barcelona, Spain.