The impact on health-related quality of life of stress, urge and mixed urinary incontinence

Transcription

1 Original Article STRESS VS URGE INCONTINENCE K.S. COYNE et al. The impact on health-related quality of life of stress, urge and mixed urinary incontinence K.S. COYNE, Z. ZHOU*, C. THOMPSON and E. VERSI* MEDTAP International, Bethesda, MD and *Pfizer Corporation, New York, NJ, USA Accepted for publication 17 July 2003 OBJECTIVE To examine the impact of each type of urinary incontinence (stress, urge, and mixed) on health-related quality of life (HRQL). SUBJECTS AND METHODS The USA National Overactive Bladder Evaluation (NOBLE) programme of prevalence was used to identify respondents with incontinence based upon telephone survey responses. A nested case-control study was then conducted on respondents with symptoms of an overactive bladder (OAB), and on age and gender-matched controls; this consisted of the respondents completing a series of questionnaires, including the OAB-q (an HRQL scale for OAB), the Medical Outcomes Study (MOS) Short-Form-36 (SF- 36), the MOS Sleep Scale, and the Center for Epidemiological Studies - Depression (CES-D) scale. Respondents were categorized into subgroups according to the primary cause of urine loss, i.e. sudden/uncomfortable urge to urinate (urge, UI), physical pressure (stress, SI), or both (mixed, MI). Descriptive analyses, t-tests and analysis of variance with post hoc comparisons were used. RESULTS Of the 919 participants in the nested casecontrol study, 171 reported incontinence, i.e. UI (69), SI (62) and MI (40). Among this cohort, 82.5% were female, 85.4% were Caucasian and the population had a mean age of 55.9 years. All OAB-q subscale scores were significantly (P < 0.01) worse among those with MI than with SI. Respondents with UI reported significantly higher levels of symptom bother and lower sleep scores (both P < 0.001) than those with SI. There were no differences in HRQL between the MI and UI groups. Voiding frequency and nocturia episodes did not differ among the groups but compared with the SI group, both UI and MI groups reported significantly higher ratings of urinary urge intensity (P < 0.001) and rated their need for medical care significantly higher (P < 0.01). The MI group reported more incontinence episodes (P = 0.02) than the SI group. CONCLUSION Compared with SI, respondents with UI and MI reported not only significantly greater ratings of urinary urge intensity and more incontinence episodes, but also significantly worse HRQL. These results are consistent with previous findings which indicated a greater impact on HRQL for the urge component of MI than for the stress component. KEYWORDS urge, stress incontinence, mixed, quality of life, epidemiology INTRODUCTION Urinary incontinence is defined by the ICS as the complaint of any involuntary leakage of urine [1]. It is a very common condition, affecting an estimated 13 million Americans, that is at least as prevalent as other chronic diseases such as asthma, coronary artery disease and peptic ulcers [2]. Although urinary incontinence is not life-threatening it is a disease that affects all strata of society and has many medical and social ramifications. The condition not only causes considerable personal distress but is also of economic importance; the direct medical costs of urinary incontinence in the USA have been estimated at billion dollars each year [3,4]. Incontinence may be classified as urge incontinence (UI, involuntary leakage accompanied by or immediately preceded by urgency), stress incontinence (SI, involuntary leakage on effort or exertion, or on sneezing or coughing), or mixed incontinence (MI, involuntary leakage associated with urgency and with exertion, effort, sneezing or coughing) [1]. Regardless of type, incontinence has been shown to have a detrimental impact on patient health-related quality of life (HRQL) [5 9], with UI and MI noted to be more distressing than SI in many respects [6,9,10,11]. The pathophysiology underlying UI and SI differs; the former results from detrusor overactivity and SI is attributable to urethral hypermobility or sphincter weakness. As such, the symptomatic presentation of SI and UI differs and this may affect HRQL differently. While patients with SI and UI have been compared [11] only two studies have compared the impact of SI, UI and MI on HRQL [5,12]. However, both studies used generic health questionnaires, the Nottingham Health Profile [5] and a visual analogue HRQL scale, with mixed results [12]. Generic questionnaires are often insensitive to the specific condition measured and therefore fail to address many issues relevant to the disease [13]. The purpose of the present study was to examine the impact of incontinence type on HRQL in an adult USA community sample using both diseasespecific and generic HRQL questionnaires. SUBJECTS AND METHODS A national USA telephone survey using quota sampling methods was conducted to assess the prevalence of overactive bladder (OAB). The clinically validated computer-assisted telephone interview approach that was used in the survey was describe previously [14]. Questions were asked about urinary frequency, urgency and incontinence within 2003 BJU INTERNATIONAL 92, doi: /j x x 731

2 K.S. COYNE ET AL. the previous 4 weeks, and demographics, childbearing history, fluid intake, prostate problems, current medication use and other physician-diagnosed comorbid conditions. During the interview respondents answering yes to experiencing urinary urgency were asked to rate their urge intensity on a scale of 1 10, with 1 being Feel some urge, but do not have to go right away and 10 being Have to stop what you are doing and urinate immediately. For respondents answering yes to incontinence, a series of additional questions were asked to differentiate the type of incontinence (described below). As a follow-up to the national telephone survey, a nested case-control study was conducted to evaluate the HRQL of respondents who met the OAB case criteria, and of age- and gender-matched controls. OAB case criteria were derived for both continent and incontinent OAB. Continent OAB case criteria included at least four episodes of urgency over the past 4 weeks plus more than eight voids/day or at least one bladder-control coping behaviour (e.g. restricting fluid intake). Incontinent OAB criteria included the continent OAB criteria, plus at least three episodes of urinary incontinence over the previous 4 weeks that were not completely explained by SI symptoms. Controls did not meet the above criteria. A battery of self-administered questionnaires related to HRQL, sleep and depression were sent to OAB cases and controls. Institutional Review Board approval was obtained before starting the study and all participants provided informed verbal consent before data were collected. DEFINING INCONTINENCE Urinary incontinence was identified from four questions: In the past 4 weeks, did you wear any pad or other material to absorb urine that you may have lost? Have you lost or leaked urine for any reason? Some people lose urine on the way to the bathroom. Has this happened to you in the past 4 weeks? In the past 4 weeks, when you had an urge to urinate, did you ever lose urine before you could reach the bathroom? To be classified as incontinent and proceed to further questions about incontinence the respondents had to respond Yes to at least one of these questions. After meeting this criterion respondents were asked questions about the number and frequency of incontinence episodes over the last 4 weeks, and the duration of symptoms and quantity of urine loss. Two additional questions were asked to differentiate SI and UI symptoms: In the past 4 weeks, when you had urine loss, how often was it because of a physical pressure on your bladder? By physical pressure, I mean from coughing, sneezing, or laughing or activities like lifting, straining, or bending over? In the past 4 weeks, when you had urine loss, how often was it because of a sudden or uncomfortable urge to urinate? Response options to these questions were: Never, Rarely, Less than half the time, Half the time or more, and Always. Respondents were grouped into type of incontinence by their responses to the above questions: SI; must have responded Half the time or more or Always to the question 1 and Never, Rarely or Less than half the time on question 2. UI; must have responded Half the time or more or Always to the question 2 and Never, Rarely or Less than half the time on question 1. MI; must have responded Half the time or more or Always to both questions. Should respondents with incontinence not have met the above criteria, they were excluded from further analysis. For the nested case-control study, a series of questionnaires pertaining to disease-specific HRQL, generic health status, sleep and depression were mailed to the respondents. The questionnaires, the OAB questionnaire (OAB-q), the Medical Outcomes Study (MOS) Short-Form 36 (SF-36), the MOS Sleep Scale (MOS Sleep) and the Center for Epidemiological Studies - Depression (CES-D), were previously described in detail elsewhere [15]. Respondents were also asked to rate on a scale of 0 10 their need to seek medical care for their bladder control problems with 0 being no need and 10 being an urgent need. All data were analysed statistically, with continuous data compared using t-tests or ANOVA and categorical data using chi-square tests. ANOVAs were used with post hoc pairwise comparisons controlling for age, gender and clinical conditions (i.e. diabetes, congestive heart failure, prostate problems, previous bladder surgeries, cancer, number of births, and use of diuretics). P values were not adjusted for multiple comparisons, as this examination of the data was considered exploratory. For all analyses P < 0.05 was considered to indicate statistical significance. RESULTS Of the 1769 questionnaires sent to telephone respondents, 919 participants returned their questionnaires (52% response rate). Of these, 171 met the criteria for SI, UI or MI and were included in the analysis. The demographics of the incontinence groups are presented in Table 1. Overall, this cohort was primarily Caucasian (85.4%) with most being women (82.5%), and a mean age of 55.9 years. There were no differences in age among the incontinence groups, but there were significantly more men (P < 0.001) in the UI than the other groups. There were significantly fewer Caucasians in the UI than in the other groups; there were no other differences among the demographic characteristics. The clinical characteristics of the incontinence groups are also shown in Table 1. Diabetes was significantly more prevalent in the UI and MI than the SI group and the MI group had the most respondents with a history of bladder surgery (Table 1). There were no other differences in clinical characteristics among the incontinence groups. There were no differences among the incontinence groups in the frequency of voids/day or nocturia episodes/night (Table 1). The UI and MI groups reported significantly higher ratings of urinary urge intensity than the SI group. The MI group reported significantly more incontinence episodes than the SI group. When estimating the quantity of urine lost per incontinent episode, 33% of the MI and 21% of the UI group reported that they lost more than a few drops more than half the time, compared with 12% of the SI respondents (P = 0.04). The impact of incontinence type on HRQL as assessed by the OAB-q is shown in Fig. 1. Among all OAB-q subscales, the MI group reported significantly lower HRQL (P < 0.02) and greater symptom bother (P < 0.001) than the SI group. The UI group reported BJU INTERNATIONAL

3 STRESS VS URGE INCONTINENCE TABLE 1 Demographics, clinical characteristics, voiding variables and questionnaire scores for the incontinence groups Group Characteristic SI UI MI P N Mean (SD) age, years 54.3 (15.4) 56.5 (15.1) 57.4 (15.0) 0.56 Gender, n (% male) 3 (4.8) 24 (34.8) 3 (7.5) < Race, n (%) Caucasian 56 (90.3) 54 (78.3) 36 (90.0) 0.02 Black 2 (3.2) 10 (14.5) 0 Other 2 (3.2) 5 (7.2) 4 (10.0) Missing 2 (3.2) 0 0 Marital status, n (%) Married/living as married 33 (53.2) 36 (52.2) 26 (65.0) 0.35 Widowed 12 (19.4) 8 (11.6) 8 (20.0) Divorced/Separated 12 (19.4) 17 (24.6) 5 (12.5) Never married 4 (6.5) 8 (11.6) 1 (2.5) Missing 1 (1.5) 0 0 Education, n (%) < high school 5 (8.0) 8 (11.6) 6 (15.0) 0.40 High school graduate 23 (37.1) 14 (20.3) 15 (37.5) Some college 16 (25.8) 22 (31.9) 12 (30.0) College degree 12 (19.4) 17 (24.6) 4 (10.0) Graduate degree 6 (9.7) 8 (11.6) 3 (7.5) Clinical Diabetes 2 (3.2) 14 (20.9) 9 (22.5) Congestive heart failure 2 (3.2) 5 (7.3) 5 (12.5) 0.20 CNS disorder 1 (1.6) 7 (10.1) 3 (7.5) 0.13 Interstitial cystitis 1 (1.6) 1 (1.5) 2 (5.0) 0.45 History of bladder surgery 10 (16.1) 12 (17.4) 14 (35.0) 0.05 Prostate problems (29 men) 0 11 (45.8) 1 (33.3) 0.43 History of cancer 5 (8.1) 11 (16.2) 5 (12.5) 0.37 Use of bladder medications 3 (4.9) 10 (14.5) 7 (17.5) 0.10 Use of diuretics 13 (21.3) 18 (26.5) 10 (25.0) 0.77 Mean (SD) duration, months 69.4 (94.3) 68.2 (99.3) 79.3 (87.9) 0.19 Voiding variables (controlling for age, gender, and clinical condition) Urge intensity 4.0 (0.4) 7.4 (0.4) 6.8 (0.5) < 0.001* Frequency per day 7.8 (0.8) 8.1 (0.8) 7.7 (1.0) NS Nocturia episodes 1.2 (0.2) 1.5 (0.2) 1.4 (0.2) NS Incontinence episodes/month 18.4 (6.1) 29.7 (6.0) 41.4 (7.4) 0.02 Mean (SE) SF-36, MOS Sleep and CES-D scores (controlling for age, gender and clinical condition) SF-36 Physical function 65.1 (3.9) 70.2 (3.8) 59.2 (4.7) NS Role physical 58.9 (5.6) 61.3 (5.3) 52.4 (6.6) NS Bodily pain 63.4 (3.5) 61.9 (3.4) 59.6 (4.1) NS General health 63.2 (2.9) 57.7 (2.9) 63.2 (3.5) NS Vitality 49.3 (2.7) 48.9 (2.7) 45.7 (3.2) NS Social function 71.1 (3.3) 74.2 (3.2) 75.0 (4.0) NS Role emotional 54.9 (5.4) 67.5 (5.3) 67.7 (6.6) NS Mental health 70.0 (2.4) 64.9 (2.4) 70.6 (2.9) NS MOS Sleep problems index 16.6 (0.7) 16.8 (0.7) 16.8 (0.9) NS CES-D 19.5 (1.1) 21.0 (1.0) 21.5 (1.2) NS Need for care 2.4 (0.4) 4.1 (0.4) 4.5 (0.5) < 0.01 *SI vs UI and MI; SI vs MI; SI vs UI and MI. significantly higher levels of symptom bother and lower HRQL in the sleep subscale (both P < 0.001) than the SI group. There were no significant differences in HRQL or symptom bother between the UI and MI groups. Table 1 also shows the SF-36, MOS Sleep Index score and CES-D; there were no significant differences among the groups on any of the subscales. The mean score for the CES-D was >16 (a threshold for depressive symptoms) in all incontinence groups, indicating that the respondents were having depressive symptoms. Respondents with UI or MI rated their need for care significantly higher than the SI group (P < 0.01). Correlations of the need-for-care variable with the OAB-q subscales were highly significant, ranging from (all P < 0.001). DISCUSSION Urinary incontinence is associated with significant morbidity, and is correlated with an increased risk of hospitalization and admission to a nursing home [16]. It is a significant clinical problem and may have a considerable impact on a patient s HRQL. [7 9,17]. Many aspects of a sufferer s life are impaired, including psychological well-being, social interactions and activities, and sexual and interpersonal relationships [18]. The impact of UI and SI on HRQL was reported previously [11]. In one study, women with UI had a significantly reduced quality of life, as measured with the Incontinence Impact Questionnaire, but SI was not significantly associated with reduced HRQL [11]. The differential impact of UI, SI and MI on HRQL has been compared in two previous studies [5,12]. The first assessed the impact of incontinence type of HRQL using the generic Nottingham Health Profile questionnaire, but did not report differences among the incontinence groups, only against controls. These findings may have been a result of small sample sizes per group or lack of sensitivity of the questionnaire. In contrast, the second study, using a visual analogue HRQL scale, concluded that women with UI or MI had a significantly lower quality of life than women with SI. As reported by Simeonova et al. [12], the results of the current study indicate that UI and MI affect HRQL and symptom bother to a similar extent, and both affect HRQL to a greater degree than SI. The symptom of 2003 BJU INTERNATIONAL 733

4 K.S. COYNE ET AL. urinary urgency appears to distinguish UI and MI from SI in terms of the impact on HRQL. The significantly higher ratings of urinary urgency, increases in symptom bother and reduced HRQL in the sleep subscale are all related to the urge component of incontinence. Grimby et al. [5] reported similar findings for sleep disturbances among patients with UI that were significantly worse than controls. The current results are also consistent with those reported by Coyne et al. [19] indicating that urinary urgency is the most significant LUTS to affect HRQL in continent and incontinent patients with OAB. In particular, among respondents with incontinent OAB, urinary urgency had the greatest impact of all urinary variables on HRQL, whereas the number of incontinent episodes was not a significant contributing factor. Those with SI can adapt their lifestyle by, e.g. avoiding heavy lifting or exercising, and thus prevent situations that lead to involuntary loss of urine [12]; Wyman et al. suggested that UI and MI are particularly distressing, as patients cannot predict incontinent episodes, and thus have less control over their bladder symptoms. The present findings support this hypothesis. The MI group had significantly more incontinence episodes than did those with SI alone. Respondents with UI tended to have significantly more incontinence episodes than the SI group. Furthermore, the UI and MI groups did not significantly differ in this variable, and in both it had a substantial impact on HRQL. The MI group reported significantly greater impairment than the SI group in all HRQL domains. For respondents with UI there tended to be a significantly greater impact on HRQL than for the SI in the coping, concern and social interaction subscales. Healthcare seeking among those with urinary incontinence is generally low [11,12,20 22]. People with incontinence may not express the desire for treatment unless they are asked; most are unaware that a family practitioner can successfully treat incontinence [23]. Many people are also reluctant to consult a doctor about this condition because of embarrassment. However, in the present study, respondents with UI and MI rated their need for medical care as significantly higher than the SI group. This has been noted in previous research on care-seeking behaviour [17,22,24]; the first report also noted that FIG. 1. The OAB-q subscale for each incontinence group (SI, green; UI, red hatched; MI, open), controlling for age, gender and clinical condition. A higher score indicates a better HRQL, except for bother, where the higher scores indicate greater bother. *P < 0.01 SI vs MI; P < 0.05 SI vs UI; Higher score indicates better HRQL; higher symptom bother scores indicative of greater symptom bother OAB-q 60.0 Subscales 50.0 Score Symptom Bother those with incontinence, regardless of type, who had lower HRQL scores on the SF-36 were more likely to seek healthcare services. The highly significant correlations in the present study between the need for care and the OAB-q subscale scores support this previous finding. The disease-specific OAB-q was more sensitive in detecting differences among incontinence groups than the other measures used in this study. If relying upon a generic health measure to evaluate HRQL, no differences would have been detected among the incontinence groups, which is consistent with the results of the study by Grimby et al. [5] using the Nottingham Health Profile. To determine the true effect of urinary symptoms on HRQL with a generic health questionnaire, numerous factors not specifically related to the disease in question have to be corrected for, and this is often impossible [11]. The focus of the OAB-q on bladder symptoms and their impact increases the sensitivity of the questionnaire to detect subtle differences among incontinence groups. Such disease-specific instruments should be used in future research examining HRQL by incontinence type. This study has several limitations: the incontinence classifications used are based entirely on patients reports of symptoms; there was no urodynamic testing to confirm the type of incontinence. However, the questions used in this survey were clinically Coping Concern Sleep Social Interaction validated, with a resulting high sensitivity and specificity [14], and are consistent with the definitions of each incontinence type set forth by the ICS Standardization Sub-Committee [1]. Although many clinically relevant data were collected about urinary incontinence, this survey was initially designed to estimate the prevalence of OAB, not the prevalence of incontinence type. As such, the criteria used in defining OAB cases may have led to an oversampling of those with UI and MI over SI, which would limit the generality of these findings. HRQL Total Urinary incontinence is significantly underdiagnosed and many people suffer from the life-disrupting consequences of a condition that is largely treatable. It is necessary to improve patient awareness of the benefits of seeking treatment for incontinence. This can be achieved through simple measures, including specific enquiries about incontinence by caregivers and the availability of educational material in patient waiting rooms [21]. The prevalence of urinary incontinence increases with advancing age; as life-expectancy increases globally, the subsequent rise in the proportion of older people is likely to result in an increase in the prevalence of urinary incontinence. While SI predominates in younger populations, UI and MI become more prevalent with ageing [12,16]. In conclusion, the present findings indicate that the effects of UI on HRQL are similar to BJU INTERNATIONAL

5 STRESS VS URGE INCONTINENCE those of MI; this suggests that the urge component of MI has a greater impact on HRQL than the stress component. Incontinence compromises HRQL regardless of type, however the effects of urinary urgency further diminish the HRQL and increase the symptom bother of incontinent patients. ACKNOWLEDGEMENTS This research was funded by the Pharmacia Corporation. REFERENCES 1 Abrams P, Cardozo L, Fall M et al. The standardization of terminology of lower urinary tract function: Report from the standardization sub-committee of the International Continence Society. Neurourol Urodyn 2002; 21: Payne CK. Epidemiology, pathophysiology, and evaluation of urinary incontinence and overactive bladder. Urology 1998; 51: Lenderking WR, Nackley JK, Anderson RB, Testa MA. A review of the quality-oflife aspects of urinary urge incontinence. Pharmacoeconomics 1996; 9: Thom D. Variation in estimates of urinary incontinence prevalence in the community: effects of difference in definition, population characteristics, and study type. J Am Geriatr Soc 1998; 46: Grimby A, Milsom I, Molander U et al. The influence of urinary incontinence on the quality of life of elderly women. Age Aging 1993; 22: Hunskaar S, Vinsnes A. The quality of life in women with urinary incontinence as measured by the sickness impact profile. J Am Geriatr Soc 1991; 39: Kobelt G, Kirchberger I, Malone-Lee J. Quality-of-life aspects of the overactive bladder and the effect of treatment with tolterodine. BJU Int 1998; 83: O Conor R, Johannesson M, Hass S, Kobelt-Nguyen G. Urge incontinence. Quality of life and patients valuation of symptom reduction. Pharmacoeconomics 1998; 14: Wyman J, Harkins S, Choi S, Taylor J, Fantl A. Psychosocial impact of urinary incontinence in women. Obstet Gynecol 1987; 70: Kelleher CJ, Cardozo LD. Sexual dysfunction and urinary incontinence. J Sex Health 1994; 3: Van der Vaart CH, De Leeuw JRJ, Roovers JPWR, Heintz APM. The effect of urinary incontinence and overactive bladder symptoms on quality of life in young women. BJU Int 2002; 90: Simeonova Z, Milsom I, Kullendorff AM, Molander U, Bengtsson C. The prevalence of urinary incontinence and its influence on the quality of life in women from an urban Swedish population. Acta Obstet Gynecol Scand 1999; 78: Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Managed Care 2000; 6 (Suppl.): S Stewart WF, Van Rooyen JB, Cundiff GW et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003; 20: Coyne KS, Revicki DA, Hunt T et al. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res 2002; 11: Thom DH, Hann MN, Van Den Eeden SK. Medically recognized urinary incontinence and risks of hospitalization, nursing home admission and mortality. Age Aging 1997; 26: Hagglund D, Walker-Engstrom M, Larsson G, Leppert J. Quality of life and seeking help in women with urinary incontinence. Acta Obstet Gynecol Scand 2001; 80: Kelleher CJ, Cardozo LD, Tooz-Hobson PM. Quality of life and urinary incontinence. Curr Opin Obstet Gynecol 1995; 7: Coyne KS, Payne C, Bhattacharyya SK et al. The impact of urinary urgency and frequency on health-related quality of life in overactive bladder: results from a national community survey. Value in Health 2003 (in press) 20 Dolan LM, Casson K, McDonald P, Ashe RG. Urinary incontinence in Northern Ireland: a prevalence study. BJU Int 1999; 83: Roberts RO, Jacobsen SJ, Rhodes T et al. Urinary incontinence in a communitybased cohort. prevalence and healthcareseeking. J Am Geriatr Soc 1998; 46: Ushiroyama T, Ikeda A, Ueki M. Prevalence, incidence, and awareness in the treatment of menopausal urinary incontinence. Maturitas 1999; 33: Viktrup L. Female stress and urge incontinence in family practice: insight into the lower urinary tract. Int J Clin Pract 2002; 56: Norton P, MacDonald L, Sedgwick P, Stanton S. Distress and delay associated with urinary incontinence, frequency, and urgency in women. BMJ 1988; 297: Correspondence: K. Coyne, PhD, MPH, Senior Research Scientist, MEDTAP International, 7101 Wisconsin Ave, Suite 600, Bethesda, MD 20814, USA. coyne@medtap.com Abbreviations: UI, SI, MI, urge, stress, mixed incontinence; HRQL, health-related quality of life; OAB(-q), overactive bladder (-questionnaire); MOS, Medical Outcomes Study; SF-36, Short-Form 36; CES-D, Center for Epidemiological Studies - Depression (scale) BJU INTERNATIONAL 735