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

Authors


Karin Coyne, Senior Research Leader, United BioSource Corporation, 7101 Wisconsin Ave, Suite 600, Bethesda, MD 20814, USA.
e-mail: Karin.Coyne@unitedbiosource.com

Abstract

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.

Abbreviations
ancova

analysis of covariance

CATI

computer-assisted telephone interviews

CES-D

Center for Epidemiologic Studies Depression (scale)

ED

erectile dysfunction

EQ-5D (VAS)

EuroQol-5D (visual analogue scale)

(HR)QoL

(health-related) quality of life

MMAS

Massachusetts Male Aging Study

(S)(U)(M)UI

(stress) (urge) (mixed) urinary incontinence

OAB

overactive bladder

OAB-q SF

OAB Questionnaire Short-Form

PPBC

Patient Perception of Bladder Condition

WPAI

Work Productivity and Activity Impairment

SHP

Specific Health Problem

SG

subgroup.

INTRODUCTION

Overactive bladder (OAB) is a subset of storage LUTS characterized by urinary urgency but commonly occurring with other storage symptoms, including frequency, nocturia, and urgency urinary incontinence (UUI) [1]. Voiding symptoms, e.g. weak or slow stream, intermittency, hesitancy, straining and terminal dribble, and postmicturition symptoms, e.g. incomplete emptying and postmicturition dribble, can also co-occur with OAB [1]. Previous reports from the EPIC study estimated the overall prevalence of OAB in Europe and Canada to be 12.8% among women and 10.8% among men, while the overall prevalence of any LUTS was estimated to be 62.5% in men and 66.6% in women [2]. In the USA-based NOBLE study, Stewart et al.[3] estimated the prevalence of OAB as 16.0% among men and 16.9% among women, but did not collect data on the overall prevalence of LUTS. Litman and McKinlay [4] estimate that by 2025, there will be 52 million adults in the USA with LUTS, suggesting an increasing burden of LUTS on society.

Both OAB and LUTS have been shown to affect many aspects of patients’ lives, including social, physical, psychological, work productivity and sexual health [3,5–10], but the incremental impact of additional LUTS on OAB is not known. The purpose of the present study was to examine the impact of OAB alone and in conjunction with other LUTS on various patient outcomes, using population-based data from the EPIC study.

SUBJECTS AND METHODS

A secondary analysis of the case-control data from the EPIC study was conducted. EPIC, a population-based, cross-sectional telephone survey of adults aged ≥18, was conducted in five countries (Canada, Germany, Italy, Sweden and the UK). Details of the study design were published previously [2]. Computer-assisted telephone interviews (CATI) were conducted, and participants were asked about the presence of urinary symptoms, chronic health conditions and demographics. The 2003 ICS definitions of urinary symptoms were used to create the questions asked and to classify participants [1]. One deviation from the ICS definitions was the definition of nocturia; for this analysis, nocturia was defined as two or more night-time voids rather than one or more night-time voids.

All participants were asked about the presence of OAB symptoms, as determined by responses to the following questions: ‘Do you experience a sudden compelling desire to urinate which is difficult to put off? What I mean is a sudden intense feeling of urgency where you feel you must urinate immediately’ and ‘Do you leak urine with a sudden compelling desire to urinate? By that I mean in connection with a sudden intense feeling of urgency’. Participants who responded ‘yes’ to either of these questions were classified as OAB cases. For this case-control analysis, OAB cases were matched to a random sample of controls without OAB or stress UI (SUI) according to gender, age (5-year age bands) and country. Controls were not excluded if they reported other LUTS (e.g. straining, terminal dribble, weak stream, etc.)

Based on their responses to questions about these symptoms, OAB cases were divided into five subgroups (SG) based upon their symptom report, as follows. SG1, Continent OAB; (i) must have urgency but might also have additional storage symptoms, including frequency and/or nocturia, but no UI; (ii) no voiding symptoms; and (iii) no postmicturition symptoms. SG2, OAB with UI; (i) must have urgency or UUI but might also have additional storage symptoms, including frequency and nocturia, and any UI, including general UI, UUI, SUI, or mixed UI (MUI); (ii) no voiding symptoms; and (iii) no postmicturition symptoms. SG3, OAB +postmicturition; (i) must have urgency or UUI but might also have additional storage symptoms, including frequency, nocturia and/or UI; (ii) must have postmicturition symptom(s); and (iii) no voiding symptoms. SG4, OAB voiding; (i) must have urgency or UUI but might also have additional storage symptoms, including frequency, nocturia, and/or UI; (ii) must have voiding symptom(s); and (iii) no postmicturition symptoms. SG5, OAB postmicturition + voiding: (i) must have urgency or UUI but might also have additional storage symptoms, including frequency, nocturia, and/or UI; (ii) must have postmicturition symptom(s); and (iii) must have voiding symptom(s).

The details about the CATI questionnaire development and translation are described elsewhere [2]. All participants were asked questions about the presence of LUTS, many of which were derived from previously validated measures such as the IPSS [11] and incontinence severity questions [12]. Both cases and controls were asked questions about generic quality of life (QoL, using the EuroQoL-5D) [13], work productivity (Work Productivity and Activity Impairment instrument, WPAI) [14], depressive symptoms (Center for Epidemiologic Studies Depression Scale, CES-D) [15], sexual satisfaction and erectile dysfunction (ED, men only, using the Massachusetts Male Aging Study, MMAS instrument) [16]. Cases answered additional condition-specific questions on health-related QoL (HRQoL, using the OAB-q Short-Form, SF) [17], the Patient Perception of Bladder Condition (PPBC) [18], and work productivity related to a specific health problem (WPAI-SHP). A brief description of each of the instruments used to assess patient outcomes is provided below.

The OAB-q was developed to assess the symptom bother and HRQoL impact of OAB on patients’ lives. A shortened version of the OAB-q was derived from the original questionnaire through item-response theory analyses. The 25-item HRQoL scale of the OAB-q was reduced to 13 items. The OAB-q SF has good internal consistency reliability, concurrent validity, discriminant validity and responsiveness [17].

The full eight-item Symptom Bother subscale was retained for EPIC rather than the OAB-q SF six-item version so as to assess a broader complement of Symptom Bother. Higher HRQoL scales indicate better HRQoL, and higher symptom bother scores indicate greater symptom bother. The recall period for the instrument is the previous 4 weeks, and each item is rated on a six-point Likert scale.

The EQ-5D is a six-item, preference-based instrument designed to measure generic health status [13]. The EQ-5D has two components: the EQ-5D descriptive system (five items; EQ-5D Index Score) and the EQ visual analogue scale (EQ-5D VAS). A unique EQ-5D health state is defined by combining one level from each of the five dimensions with the UK weight-based scores ranging from −0.0153 to 1.0, with higher scores indicating better overall health status.

The WPAI is a series of questions on the number of hours missed from work, the number of hours worked, and days during which work was difficult, followed by a rating of the extent to which the individual was limited at work during the past 7 days [14]. Outcomes are expressed as impairment percentages, with higher values indicating greater impairment and less productivity for the following: percentage of work time missed due to health problems, percentage impairment while working due to health problems, and percentage overall work impairment due to problems. All cases and controls were asked the generic WPAI. Cases were also asked productivity questions in relation to their urinary symptoms, using the WPAI-SHP. For this study, work productivity analyses were conducted among those participants aged <65 years who reported being employed.

The CES-D is a 20-item four-point Likert scale asking how often people felt or behaved in the manner described within the last week [15]. The possible score range is from 0 (not at all depressed) to 60 (very depressed) with a threshold score of 21 as an indicator of major depressive symptoms [19]. This scale has confirmed reliability and validity [15] and has been used in both continent and incontinent OAB populations [20].

The PPBC is a single item that assesses the patients’ subjective impression of their current urinary problems. Patients are asked to rate their perceived bladder condition on a six-point scale ranging from 1 (‘no problems at all’) to 6 (‘many severe problems’). The PPBC has good construct validity, responsiveness to change, and test-retest reliability among patients with OAB [18,21].

All cases and controls who reported being sexually active during the previous 12 months were asked to rate the degree to which their urinary symptoms caused a reduction in sexual enjoyment. Response options were: ‘not at all’, ‘somewhat’, ‘quite a bit’, and ‘a great deal.’ For both of these questions, responses of ‘somewhat’, ‘quite a bit’, and ‘a great deal’ were considered indicative of a negative effect of urinary symptoms and were dichotomized as such for the current analysis. The presence of ED was determined using the validated, single-question, self-report item from the MMAS [9].

Demographic variables, medical comorbidities and individual LUTS were evaluated by descriptive analyses. Continuous case-control data were compared using t-tests, as age, gender and country were controlled by the initial matching for this analysis. OAB SGs were compared using analysis of covariance (ancova) controlling for age, with gender and country as factors. Post hoc pair-wise comparisons were adjusted using Scheffe’s adjustment for multiple comparisons. All categorical data were compared using chi-square tests. For all analyses, P < 0.05 was considered to indicate statistical significance.

RESULTS

Of the EPIC participants, 1434 identified cases of OAB 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 were female (65% in both groups; Table 1). Each country accounted for ≈20% of the case-control sample, and the mean age was 53.8 and 53.7 years, respectively. There were marginally statistically significant differences in marital status and education. Comorbid conditions differed significantly by case/control status, with cases reporting significantly greater rates of chronic cough, chronic constipation, asthma, diabetes, high blood pressure, bladder or prostate cancer, neurological conditions, and depression (Table 1). There were significant differences (all P < 0.001) between the cases and controls in all reported LUTS; 4.5% of controls reported some UI, and this represents the proportion of participants who stated that they leak urine but did not attribute their UI to a cause such as stress or urge.

Table 1.  Demographics and medical comorbidities of the cases and controls
CharacteristicCasesControlsP
  • *

    E.g. multiple sclerosis, stroke, or Parkinson’s disease.

No. of participants14341434 
Mean (sd) age, years  53.8 (16.4)  53.7 (16.5)0.90
n (%):
Male 502 (35.0) 502 (35.0)1.0
Race
 Caucasian1379 (96.2)1387 (96.7)0.34
 Black   9 (0.6)  12 (0.8) 
 Asian  27 (1.9)  20 (1.4) 
 Hispanic   2 (0.1)   0 
 Other  15 (1.1)  10 (0.7) 
 Missing   2 (0.1)   5 (0.4) 
Marital status
 Single 413 (28.8) 340 (23.7)0.02
 Married 780 (54.4) 838 (58.4) 
 Living as married/partner  92 (6.4)  90 (6.3) 
 Widow/widower 144 (10.0) 161 (11.2) 
 Missing   5 (0.4)   5 (0.4) 
Education
 <High school 349 (24.3) 331 (23.1)0.03
 High school graduate 651 (45.4) 650 (45.4) 
 College degree 302 (21.1) 346 (24.1) 
 Graduate degree  54 (3.8)  59 (4.1) 
 Other  66 (4.6)  39 (2.7) 
 Missing  12 (0.8)   9 (0.6) 
Country
 Sweden 272 (19.0) 272 (18.9)1.0
 Italy 295 (20.6) 295 (20.6) 
 Canada 293 (20.4) 293 (20.4) 
 Germany 297 (20.7) 297 (20.7) 
 UK 277 (19.3) 277 (19.3) 
Medical comorbidities (n sample)
 Chronic constipation (2863)  88 (6.2)  34 (2.4)<0.001
 Asthma (2866) 167 (11.7) 106 (7.4)0.001
 Diabetes (2865) 128 (8.9)  87 (6.1)0.004
 High blood pressure (2862) 418 (29.3) 325 (22.7)<0.001
 Bladder or prostate cancer (2828)  37 (2.6)  14 (1.0)0.001
 Neurological conditions*  58 (4.0)  16 (1.1)<0.001
 Depression (2866) 221 (15.4) 100 (7.0)<0.001
LUTS
 Mean (sd) voids/day (2605)   7.5 (4.1)   6.0 (2.4)<0.001
 Urinate too often (2838) 381 (27.0)  68 (4.8)<0.001
 Nocturia ≥ 2 (2853) 597 (41.8) 387 (27.2)<0.001
 Urgency (2864)1293 (90.4)   0<0.001
 UI (2855) 662 (46.5)  65 (4.5)<0.001
 UUI (2861) 452 (31.7)   0<0.001
 SUI (2867) 391 (27.3)   0<0.001
 Weak stream (2810) 178 (12.8)  34 (2.4)<0.001
 Strain to begin urination (2864)  82 (5.7)  18 (1.3)<0.001
 Incomplete emptying (2824) 273 (19.4)  47 (3.3)<0.001
 Terminal dribble 2812) 420 (30.0) 106 (7.5)<0.001
 Postmicturition UI (2856) 240 (16.8)  38 (2.7)<0.001

There were significant differences among the OAB case SGs in age, gender and country (Table 2), with SG1 being the youngest, and the fewest men (12.9%) being in the SG2. There were no significant differences in race, marital status or education. Several medical comorbidities differed significantly across groups, including chronic cough, constipation, asthma, bladder or prostate cancer, neurological conditions, and depression, with SG5 reporting the greatest prevalence of comorbid conditions except bladder or prostate cancer (Table 2). As expected, there were significant differences in all 12 LUTS (Table 2, all P < 0.001). SG5 had the highest mean number of voids (8.4/day), the greatest percentage of participants who reported that they urinate too often (43.8%), and the greatest proportion of participants with nocturia (two or more voids, 63.1%), incomplete emptying (65.6%) and postmicturition UI (55.7%).

Table 2.  The demographics and medical comorbidities of cases in the five SGs
VariableSG*P
12345
  1. P for overall comparisons are from chi-square analysis, and significant pair-wise comparisons between differences in least squares means estimated from the anova model presented for continuous outcomes using Scheffe’s test adjusting for multiple comparisons. *SG1, continent OAB; SG2, OAB with incontinence; SG3, OAB + postmicturition; SG4, OAB + voiding; and SG5, OAB + postmicturition + voiding. †SG1 vs SG2; ‡SG1 vs SG5.

No. of subjects440263162287281 
Mean (sd) age, years 50.7 (16.9) 56.6 (14.4) 54.1 (16.1) 54.5 (17.0) 55.2 (16.4)<0.001
n (%):
Male169 (38.4) 34 (12.9) 64 (39.5)110 (38.3)125 (44.5)<0.001
Race
 Caucasian422 (95.9)253 (96.2)154 (95.1)283 (98.6)266 (94.6)0.15
 Black  5 (1.1)  3 (1.1)  1 (0.6)  0  0 
 Asian  7 (1.6)  5 (1.9)  5 (3.1)  0 10 (3.6) 
 Hispanic  0  0  0  1 (0.4)  1 (0.4) 
 Other  6 (1.4)  2 (0.8)  2 (1.2)  3 (1.0)  2 (0.7) 
 Missing  0  0  0  0  2 (0.7) 
Marital status
 Single135 (30.7) 65 (24.7) 53 (32.7) 80 (27.9) 80 (28.5)0.23
 Married241 (54.8)147 (55.9) 88 (54.3)162 (56.5)141 (50.2) 
 Living as married/partner 31 (7.1) 15 (5.7)  8 (4.9) 19 (6.6) 19 (6.7) 
 Widow/widower 33 (7.5) 32 (12.2) 13 (8.0) 26 (9.1) 40 (14.2) 
 Missing  0  4 (1.5)  0  0  1 (0.4) 
Education
 <High school112 (25.4) 53 (20.2) 38 (23.5) 75 (26.1) 71 (25.3)0.16
 High school graduate212 (48.2)111 (42.2) 76 (46.9)125 (43.6)126 (44.8) 
 College degree 75 (17.1) 69 (26.2) 33 (20.4) 62 (21.6) 63 (22.4) 
 Graduate degree 19 (4.3) 10 (3.8)  5 (3.1) 11 (3.8)  9 (3.2) 
 Other 21 (4.8) 18 (6.8)  9 (5.5) 14 (4.9)  4 (1.4) 
 Missing  1 (0.2)  2 (0.8)  1 (0.6)  0  8 (2.90) 
Country
 Sweden 73 (16.6) 72 (27.4) 23 (14.2) 65 (22.7) 38 (13.5)<0.001
 Italy101 (23.0) 31 (11.8) 36 (22.2) 81 (28.2) 46 (16.4) 
 Canada 70 (15.9) 63 (24.0) 36 (22.2) 44 (15.3) 80 (28.5) 
 Germany110 (25.0) 52 (19.8) 41 (25.3) 46 (16.0) 48 (17.1) 
 UK 86 (19.6) 45 (17.1) 26 (16.1) 51 (17.8) 69 (24.6) 
Medical comorbidities (n sample)
 Chronic cough (1432) 48 (10.9) 30 (11.4) 21 (13.0) 32 (11.2) 53 (18.9)0.02
 Chronic constipation (1428) 22 (5.0)  7 (2.7) 12 (7.5) 19 (6.6) 27 (9.6)0.01
 Asthma (1432) 39 (8.9) 27 (10.3) 18 (11.1) 38 (13.2) 45 (16.1)0.04
 Diabetes (1430) 35 (8.0) 19 (7.2) 18 (11.1) 24 (8.4) 32 (11.4)0.34
 High blood pressure (1428)116 (26.5) 74 (28.1) 52 (32.1) 83 (28.9) 92 (33.1)0.35
 Bladder or prostate cancer (1416)  5 (1.1)  3 (1.2)  3 (1.9) 16 (5.7) 10 (3.6)<0.01
 Neurological conditions* (1433) 10 (2.3)  7 (2.7)  5 (3.1) 16 (5.6) 19 (6.8)0.01
 Depression (1432) 44 (10.0) 31 (11.8) 19 (11.7) 50 (17.5) 77 (27.4)<0.001
LUTS     <0.001
 Mean (sd) voids/day (1305)  6.9 (3.9)  7.3 (3.3)  7.8 (3.3)  7.6 (4.6)  8.4 (4.8)<0.001
 Urinate too often (1410) 75 (17.3) 54 (20.9) 53 (33.3) 77 (27.2)121 (43.8)<0.001
 Nocturia ≥ 2 (1429)131 (29.9) 89 (33.8) 75 (46.3)126 (43.9)176 (63.1)<0.001
 Urgency (1430)440 (100)203 (77.5)138 (85.7)260 (90.9)252 (89.7)<0.001
 UI (1422)0257 (100.0) 93 (57.8)138 (48.4)173 (62.0)<0.001
 UUI (1426)0176 (67.4) 63 (38.9) 94 (32.9)118 (42.6)<0.001
 SUI (1432)0151 (57.6) 48 (29.6) 77 (26.8)114 (40.6)<0.001
 Weak stream (1393)0  0  0 77 (27.4)101 (36.9)<0.001
 Strain to begin urination (1432)0  0  0 21 (7.3) 61 (21.7)<0.001
 Incomplete emptying (1404)0  0 90 (56.3)  0183 (65.6)<0.001
 Terminal dribble (1398)0  0  0214 (76.2)206 (73.8)<0.001
 Postmicturition UI (1427)0  0 84 (51.9)  0156 (55.7)<0.001

When examining the impact of OAB on patient-reported outcomes among cases and controls, there were significant differences across indices (Table 3). Among OAB cases, 11.4% reported CES-D scores of ≥21, compared to 3.6% of controls (P < 0.001). Among participants age <65 years, rates of unemployment were higher for cases than controls (42.0% vs 33.6%, P < 0.001). For work productivity, OAB cases had a greater impairment on two of the three scales of the WPAI, with significant differences in percentage impairment at work due to health and percentage overall work impairment due to health (both P < 0.001). Almost a quarter of cases aged <65 years reported some form of work impairment, vs 12.2% of controls (P < 0.001). Cases reported slightly lower mean EQ-5D scores (indicating lower overall health; P < 0.001). Finally, cases were less likely to report being sexually active in the past month (62.4% of cases vs 68.2% of controls; P = 0.002) and more likely to report decreased enjoyment of sexual activity (15.4% vs 2.8%, respectively, P < 0.001) and more ED (9.8% of cases reported being ‘moderately’ to ‘completely impotent’ vs 5.6% of controls, P = 0.01).

Table 3.  Patient reported outcomes comparing cases and controls
Characteristic (n sample)CasesControlsP
Mean (sd) EQ-5D Index score (2851)  0.85 (0.2)  0.90 (0.1)<0.001
n (%):
Employment status (age < 65) (2010)
 Full time406 (40.5)485 (48.2)<0.001
 Part time176 (17.5)184 (18.3) 
 Not employed421 (42.0)338 (33.6) 
Mean (sd) WPAI (age < 65)
 % work time missed due to health (1155)  5.2 (19.7)  3.4 (16.3) 0.103
 % Impairment at work due to health (1235)  8.8 (22.4)  3.6 (15.5)<0.001
 % Overall work impairment due to health (1145) 11.0 (25.3)  5.3 (19.0)<0.001
 Any work impairment (1245), n (%)143 (24.7) 81 (12.2)<0.001
n (%):
CES-D Scale ≥ 21 (2583)148 (11.4) 46 (3.6)<0.001
Sexually active in past 12 months (2501)790 (62.4)842 (68.2) 0.002
Decreased enjoyment of sexual activity (1618)
 ‘Somewhat’ to ‘A great deal’121 (15.4) 23 (2.8)<0.001
ED (607)
 ‘Moderately impotent’ to ‘completely impotent’ 28 (9.8) 18 (5.6)<0.02

There were significant differences among patient outcomes when examining the relative impact of storage, voiding, and postmicturition symptoms in conjunction with OAB (Table 4). In the pair-wise comparisons, SG5 reported significantly greater levels of Symptom Bother (P < 0.001) and worse HRQoL (P < 0.001) than the other SGs. SG1 had significantly lower levels of Symptom Bother (P < 0.001) than each of the other groups and significantly better HRQoL scores (P < 0.001) than each SG except SG2.

Table 4.  Patient reported outcomes comparing cases in the five SGs
Variable (n sample)SG*P
12345
  1. SG groups are as given in Table 2. P values are for pair-wise comparisons between differences in least squares (LS) means estimated from the ancova model with gender, country and storage, voiding and symptom categories as factors, and age as a covariate, using Scheffe’s test adjusting for multiple comparisons. 1, SG1 vs SG2; 2, SG1 vs SG3; 3, SG1 vs SG4; 4, SG1 vs SG5; 6, SG2 vs SG4; 7, SG2 vs SG5; 9, SG3 vs SG5; 10, SG4 vs SG5, with * P < 0.05, P < 0.01 and P < 0.001.

No. of subjects440263162287281 
LS mean (sem)
OABq-SF (1430)
 Symptom Bother  9.9 (0.8) 17.1 (1.1) 19.8 (1.3) 19.1 (1.0) 29.8 (1.0)1, 2, 3, 4, 7, 9, 10
 HRQoL 94.8 (0.6) 92.0 (0.8) 89.6 (1.0) 87.1 (0.8) 79.6 (0.8)2, 3, 4, 6, 7, 9, 10
 EQ-5D Index (1426)  0.9 (0.0)  0.9 (0.0)  0.9 (0.0)  0.8 (0.0)  0.8 (0.0)3, 4, 6*, 7, 9, 10
Employment status (age < 65) (1003), n (%)
 Full time144 (43.1) 66 (37.9) 46 (40.7) 88 (44.9) 62 (33.3) 0.06
 Part time 63 (18.9) 38 (21.8) 20 (17.7) 29 (14.8) 26 (14.0) 
 Not employed127 (38.0) 70 (40.2) 47 (41.6) 79 (40.3) 98 (52.7) 
LS mean (sem) WPAI (age <65)
 % Work time missed due to health (526)  2.8 (1.4)  0.6 (2.2)  5.9 (2.7)  5.9 (1.9)  8.5 (2.1) 
 % Impairment at work due to health (572)  4.2 (1.5)  7.2 (2.2) 11.5 (2.7)  9.8 (2.0) 12.1 (2.3) 
 % Overall work impairment-health (519)  6.4 (1.8)  6.5 (2.7) 13.2 (3.3) 13.7 (2.4) 15.0 (2.7) 
 % Work time missed due to LUTS (511)  0.0 (0.7)  1.2 (1.0)  3.8 (1.3)  1.4 (0.9)  2.1 (1.0) 2*
 % Impairment at work due to LUTS (568)  1.4 (0.9)  5.2 (1.3)  4.8 (1.6)  3.7 (1.2)  4.0 (1.4) 
 % Overall work impairment LUTS (510)  1.4 (1.1)  5.4 (1.6)  5.8 (2.1)  5.0 (1.5)  6.1 (1.7) 
Any work impairment 39 (18.9) 26 (25.0) 24 (36.4) 35 (30.2) 36 (41.4)<0.001
CES-D scale (1300)
 Score < 21379 (94.5)215 (91.9)130 (87.8)229 (88.1)199 (77.4)<0.001
 Score ≥ 21 22 (5.5) 19 (8.1) 18 (12.2) 31 (11.9) 58 (22.6) 
PPBC (1428)
 Does not cause you any problems252 (57.4) 65 (24.9) 47 (29.2)105 (36.7) 42 (14.9)<0.001
 Causes minor problems170 (38.7)148 (56.7) 85 (52.8)121 (42.3)139 (49.5) 
 Causes moderate to very severe problems 17 (3.9) 48 (18.4) 29 (18.0) 60 (21.0)100 (35.6) 
Sexually active in past year (1266)261 (69.0)133 (57.1) 92 (62.2)164 (63.8)140 (56.0) 0.006
Decreased enjoyment of sexual activity (784)
 Not at all247 (95.7)113 (85.6) 70 (76.1)141 (86.5) 92 (66.2)<0.001
 ‘Somewhat’ to ‘A great deal’ 11 (4.3) 19 (14.4) 22 (23.9) 22 (13.5) 47 (33.8) 
ED (287)
 None 88 (84.6) 17 (85.0) 25 (67.6) 52 (74.3) 32 (57.1) 0.01
 Minimal 13 (12.5)  1 (5.0)  6 (16.2) 10 (14.3) 15 (26.8) 
 ‘Moderate’ to ‘Complete’  3 (2.9)  2 (10.0)  6 (16.2)  8 (11.4)  9 (16.1) 0.01

There were marginal differences (P = 0.06) in employment status among the OAB SGs; rates of unemployment were 52.7% in SG5 vs ≈40% in each of the other four SGs. There were significant overall group differences in all of the WPAI-SHP subscales, but only one pair-wise comparison difference when examining percentage impairment. However, when examining the proportion of participants reporting any work impairment, there were significant differences, with the highest in SG5 (41.4%) and lowest in SG1 (18.9%; P < 0.001).

Rates of clinically elevated CES-D scores differed significantly across groups (P < 0.001), with 22.6% of participants in SG5 having scores of ≥21, vs 11.9% in SG4, 12.2% in the SG3, 8.1% in SG2 and 5.5% in SG1.

There were also significant differences (P < 0.001) in the participants’ perceptions of their bladder condition, i.e. 35.6% of SG5 reported that their bladder condition caused them ‘moderate’ to ‘very severe problems’, vs 21.0% in SG4, 18.0% in SG3, 18.4% in SG2 and 3.9% in SG1.

There were similar patterns of significant group differences (P < 0.001) in sexual activity and satisfaction, with the proportion of participants who had been sexually active in the past year being lowest in SG5 (56.0%) and highest in SG1 (69.0%), although group differences were marginally statistically significant (P = 0.006). Of SG5, ≈40% reported that their enjoyment of sexual activity was decreased ‘somewhat’ to ‘a great deal’, vs 13.5% in SG4, 23.9% in SG3, 14.4% in SG2 and 4.3% in SG1. The proportion of participants reporting ‘moderate’ to ‘complete’ ED was highest in SG3 and SG5 (16.2% and 16.1%, respectively) followed by SG4 (11.4%), SG2 (10.0%) and SG1 (2.9%). In summary, SG5 reported the lowest levels of disease-specific and general HRQoL, the greatest levels of Symptom Bother, and the highest rates of depression, moderate to very severe bladder problems, and decreased enjoyment of sexual activity among all OAB SGs.

DISCUSSION

To date, this is the first study to report population-based findings of the impact of OAB and other LUTS, using the 2002 ICS definitions of LUTS, on work productivity, sexuality and overall health. When compared with demographically matched controls, participants with OAB reported significantly less work productivity and sexual satisfaction, higher rates of depressive symptoms and ED, and slightly lower levels of overall health, which is consistent with previous research on the impact of OAB on patient outcomes [2,3,7]. In a population-based prevalence survey, OAB was associated with clinically and statistically higher depression scores, poorer sleep quality and lower levels of overall HRQoL [3]. Irwin et al.[2] also found that OAB was related to greater feelings of depression and stress, as well as compromising patients’ working lives. While the present study confirms previous research on the impact of OAB on patient outcomes, perhaps of greater importance are the findings of the SG analyses of OAB cases with additional storage, voiding and postmicturition symptoms.

That participants with symptoms in three LUTS groups (i.e. SG5, OAB + postmicturition + voiding) reported the greatest impact on Symptom Bother and lowest levels of HRQoL and overall health is not surprising. Participants with this constellation of symptoms also had higher rates of moderate to very severe bladder condition problems and clinically elevated depression scores. By contrast, participants in SG1 tended to report higher outcomes in these areas. This pattern of increased risk notwithstanding, these SG differences do not elucidate the effects of individual symptoms. For example, the proportion of participants with UI varied by group, making it impossible to disentangle the impact of this symptom relative to other LUTS. Thus, it is possible that UI, or another symptom, might be disproportionately responsible for the observed differences more than the multiplicity of symptoms.

This study builds on previous work showing that the severity of LUTS is associated with worse disease-specific HRQoL [8,22] and that storage symptoms (particularly UI) tend to be associated with the greatest patient-reported bother [23–26] by illuminating SG differences in specific areas of HRQoL, including symptom bother and disease-specific HRQoL, overall health, work productivity, depression and sexual functioning. When comparing men and women with OAB with and without UI, Irwin et al.[2] found the greatest degree of work interference among those with UI. Similarly, Stewart et al.[3] found that men and women with OAB with UUI had significantly higher depression symptoms and lower levels of sleep quality and overall HRQoL than those with OAB without UUI.

LUTS severity has been associated with decreased sexual activity and sexual satisfaction [8,10], and ED [10,27,28]. Although some evidence suggests that sexual dysfunction is higher in men with voiding symptoms [28,29], findings from others studies suggest that ED might be more closely associated with OAB symptoms [9,27,30]. Our SG analysis supports higher rates of ED and decreased sexual satisfaction being associated with OAB plus voiding symptoms more so than OAB alone or OAB with UI alone.

There are several limitations to the present study. First, many of the questionnaires used to evaluate the impact of LUTS were OAB-specific, as an objective of this study was to explore the prevalence and impact of OAB. It is possible that the use of less OAB-specific measures would yield a different pattern of results. Future epidemiological research is needed to explore the possibility of other constellations of LUTS and their relative contribution to patient outcomes. Second, controls were not asked all questions, which limits the case-control comparisons. Last, the OAB and LUTS classifications used are based entirely on patient-reported symptoms; there was no urodynamic testing to confirm the type of LUTS, nor was there confirmation by a medical professional. This presents a limitation notwithstanding the use of clinically validated questions with high sensitivity and specificity, and the unfeasibility of measuring LUTS based on a rigorous physician examination in a large-scale, multinational epidemiological study (see [2] for further discussion of this issue).

OAB has a substantial impact on patients’ lives; OAB with additional LUTS has a greater impact on their lives. Multiple LUTS should be considered when treating OAB so that clinicians can maximize treatment options and patient outcomes with therapies for the LUTS if needed. The diagnosis and treatment of OAB should be considered in conjunction with other LUTS, to maximize treatment options and optimize patient outcomes.

ACKNOWLEDGEMENTS

The authors acknowledge Christer Eksvärd and Christine Thompson for statistical programming for the project. This study was sponsored by Pfizer Inc. The authors also acknowledge to contribution of the EPIC Study Group: Paul Abrams, Bristol Urological Institute, Southmead Hospital, Bristol, UK; Walter Artibani, Urology Unit, University of Padova, Padova, Italy; Christian Hampel, Urologische Klinik und Polyklinik, Johannes Gutenberg-Universität, Mainz, Germany; Sender Herschorn, Sunnybrook and Women’s College Health Science Centre, University of Toronto, Toronto, ON, Canada; Steinar Hunskaar, Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway.

CONFLICT OF INTEREST

Karin Coyne and Chris Sexton are employees of United BioSource Corporation, who were paid consultants to Pfizer in connection with the development of the manuscript. Deb Irwin is a consultant for Pfizer and a meeting participant for Pfizer. Zoe Kopp is an employee of Pfizer. Con Kelleher is a consultant, investigator, and lecturer for Astellas, GSK, Novartis, Pfizer, Tanabe, UCB, and Watson. Ian Milsom is a consultant for Pfizer and United BioSource; an investigator for Pfizer and Astellas; offers grant support for Pfizer and Astellas; is a lecturer for Pfizer, Astellas, and Novartis. This study was supported by Pfizer Inc.

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