Vol. 161,1180-1184,April 1999 Printed in U.S.A.
TH€JOURNAL OF UROLOGY Copyright 8 1999 by AMERICANU R O ~ I C A ASSOCIATION. L
HEALTH RELATED QUALITY OF LIFE IN OLDER MEN WITHOUT PROSTATE CANCER MARK S . LITWIN From the Departments of Uro1og.v and Health Services, University of California, Los Angeles, Los Angeles, California
Purpose: We measured health related quality of life in a population of m ~ n older d men for use a s controls in studies of older men treated for prostate cancer. Materials and Methods: A statistically valid, population based sample of older men without prostate cancer completed a validated quality of life questionnaire that addressed impairment in the physical, mental, urinary, bowel and sexual domains. General and disease targeted health related quality of life was measured by the RAND 36-Item Health Survey and University of California, Los Angeles Prostate Cancer Index, respectively. Results: Overall approximately a third of normal older men reported some degree of urinary leakage, while a third claimed some degree of rectal dysfunction and almost two-thirds acknowledged significant difficulty with erection. Conclusions: Older men in a randomly selected, population based sample do not have perfectly normal urinary continence, bowel function or sexual potency. By collecting data before treatment and following subjects longitudinally investigators may ensure that health related quality of life changes are analyzed in the context of any impairment that may have been present a t baseline. If a longitudinal study is not feasible, a control group of men who are similar in age and other demographic variables must be used. KEY WORDS:prostatic neoplasms, quality of life, outcomes research. prostate
Quality of life is a central concern for men newly diagnosed with prostate cancer. As they consider various treatment options, patients wish to maximize the chance of long-term survival while simultaneously maintaining physical and mental health, and avoiding urinary, bowel and sexual impairment. Quality of life outcomes have generated interest not only from patients, but also from third party payers, managed care organizations and government agencies who now seek to assess health related quality of life as a measure of quality of care. Because the quality of life literature on prostate cancer is still in its adolescence, groups often use methodologies in which health related quality of life is assessed crosssectionally rather than longitudinally. In cross-sectional surveys patients cannot serve as their own temporal controls, and so studies must rely on appropriate comparison groups. Selecting the best normal comparison group is critical for performing a meaningful analysis of health related quality of life OutcOmes. If r~Ormalis defined as the absence of any dysfunction, Prostate cancer treatment grOUPS may be held to too high a standard. If normal is determined bY assessing older men without prostate cancer, health related quality of life outcomes after prostate cancer treatment may be interPreted in a more valid context. In this study we document urinary, bowel and sexual habits as well as general health related quality of life in older men without known Prostate cancer. We particUlar'y wondered whether older men may already have age related decreases in these 3 intimate pelvic functions. METHODS
Subjects. A population based sample of 598 men was randomly selected from the computer records ofa large managed care plan in southern California. Subjects were selected to serve as a comparison group during the development phase of Accepted for publication October 26, 1998.
the University of California, LOSh g e l e s (UCLA) Prostate Cancer Index, a validated disease specific quality of life instrument used to measure quality of life in men treated for early stage prostate cancer.' They were intended as a comparison group to 321 men with prostate cancer identified in the plan tumor registry. Subjects were matched by age (by exact year) and zip code plan members with known correct addresses who were not known to have prostate or other noncutaneous cancer. After receiving a letter of introduction each patient was mailed a self-administered questionnaire, prestamped return envelope and $5 as a cash incentive. Telephone reminders were used for all patients who did not respond within 4 weeks of either survey. Of the 598 surveys mailed to comparison subjects 273 (46%) were returned, of which 268 (98%) were evaluable and form the basis of this report. No systematic differences in available demographic factors, such as age, were noted between survey respondents and nonrespondents. Age of the respondents was normally distributed. Measures. Health related quality of life was measured at general and disease targeted levels." Disease targeted quality of life was assessed by the UCLA Prostate Cancer Index. This self-administered 20-item questionnaire quantifies prostate cancer specific health related quality of life in 6 domains (urinary function and bother, bowel function and bother, and sexual function and bother) that focus on incontinence, proctitis and sexual difficulties, respectively, as well as on how much the patient is troubled by each dysfunction, Formal psychometric analyses were performed to estimate test-retest reliability, internal consistency reliability and validity. The index has been shown to be reliable and valid (test-retest reliability coefficient 0.77 or greater and internal consistency Cronbachs a coefficients3 0.65 to 0.93) in populations of older men with and without prostate c a n ~ e r . ~ , ~ General health related quality of life was evaluated by the RAND 36-Item Health Survey 1.0 (SF-36). This selfadministered 36-item questionnaire quantifies general
HEALTH RELATED QUALITY OF LIFE IN OLDER MEN WITHOUT PROSTATE CANCER
health related quality of life on 8 multi-item scales (physical function, role limitations due to physical health problems, bodily pain, general health perceptions, emotional wellbeing, role limitations due t o emotional problems, social function and energy-fatigue). The former 4 scales are considered physical health domains and the latter 4 are considered mental health domains. The SF-36 has been extensively tested, and shown to be reliable and valid (test-retest reliability coefficient 0.78 or greater and internal consistency Cronbachs cy coefficients 0.78 to 0.93) in various populations."-s Sociodemographic and co-morbidity data were collected by a questionnaire previously shown to perform well in older men with and without prostate cancer. Statistical analysis. Sociodemographic and co-morbidity data are presented as proportions and means plus or minus standard deviation as indicated. Individual item responses are reported as cross-tabulations for the urinary, bowel and sexual domains of the UCLA Prostate Cancer Index. In addition, composite scores are reported for the scales of the index and SF-36. Each composite scale score ranges from 0 to 100 with higher scores representing better outcomes. For age group comparison younger men below the median age were compared with older men above the median age using 2-tailed Student's t tests. RESULTS
Average subject age was 72.5 years (range 47 to 86, median 73), and they were predominantly white (64%'0),married (71%) and retired (82%). More than 42% of the subjects had at least a college education, while more than 34% had a household income greater than $30,000. The most prevalent co-morbid diseases were cardiovascular (42%),gastrointestinal (19%) and respiratory (14%) conditions, and diabetes (14%).Table 1 shows the demographic characteristics of the sample. Table 2 lists the urinary incontinence symptoms. Only 69 to 70% of the men claimed complete urinary control with no leakage. While subjects rarely reported using incontinence pads or adult diapers, a sizeable minority (13%) acknowledged that incontinence was at least a slight problem, while 1 7 4 reported at least a small degree of bother from urinary leakage problems. Table 3 shows the bowel habits of the
TABLE1. Description of the sample
No. subjects Mean age f SD (range1 Race %: White Black Hispanic Other Marital status % : Married (living with spouse or partner) In sihmificant relationship but not living together Not in significant relationship Education ' X : Less than high school High school, trade school or some college College degree or higher Working full or part-time 3 Annual household income: Less than $20,000 $20,000-$30.000 Greater than $30,000 Medical history 5:: Diabetes Cardiovascular disease Respiratory disease Gastrointestinal disease Renal disease Major depression Alcohol or drug problems Cigarette smoker - -~
268 72.5 t 7 . 5 147-861 63.7 15.7 11.1 9.5 70.6 10.6 18.8 23.8 42.1 34.1 18.3 34.3 23.3 42.4 14.1 42.1 14.4 19.3 2.5 5.7 7.7 12.7
TABLE2 . Urinary incontinence in a random control population older men specifically directed to consider the last 4 weeks
No. Subjects 1%) How often leaked urine: Not a t all 183 (70) Less than l/wk. 31 (12) About llwk. 22 (8) Every day 26 (10) Best description of urinary control: Total control 181 (69) Occasional dribbling 66 (25) Frequent dribbling 12 15) No control whatsoever 3 (1) Pads or adult diapers used daily to control leakage: 252 (98) None 1-2 4 (2) 3 or More 0 How big a problem is dripping urine or wetting pants: 172 (671 No problem 50 (19) Very small problem Small problem 28(11) Moderate problem 6 (2) Big problem 1 10) How big a problem is urine leakage interfering with sexual activity: 235 (94) No problem 7 13) Very small problem Small problem 2 (1) Moderate problem 4 (2) 1 (01 Big problem Bother from urinary incontinence153 (601 No problem 631251 Very small problem 22 191 Small problem 15 161 Moderate problem Big problem _ _ _ _ 4~(21_ Percentage of each item may not total 100% due to rounding
TABLE3. Bowel symptoms in a random control sample of older men specifically dtrected to consider the last 4 weeks No. Subjffts 1% __ Rectal urgency: Rarely or never About Ihvk. More than Ihvk. About Uday More than Uday Stools (bowel movements) that were loose or liquid (no form, watery, mushy): Never Rarely About half usually Always Distress caused by bowel movements: No distress Little distress Moderate distress Severe distress Crampy pain in abdomen or pelvis: Rarely or never About Umo. About Ihuk. Several times a wk. About Uday Several times a day Bother fmm bowel d.ysfundion: No problem Ve? small problem Small pmblem Moderate problem Big problem
29111) 17 17) 25 110) 8 13) 99 139) 131 (51) 21 ( 8 ) 4 121 0 178 (70) 621241 13 (5) 2 11) 201 (781 '28111) 17 17) 2 Ill 6 121 3 11) 168 1%) 48 I191 24 191 13 151 3 (1)
sample. Rectal urgency occurred a t least once weekly in almost a third of the subjects and bowel movements caused at least mild distress in a similar number. Diarrhea and crampy abdominal or pelvic pain were uncommon but present in approximately a tenth of the individuals. Overall only two-thirds of the subjects stated that the bowels caused no problems at all.
HEALTH RELATED QUALITY OF LIFE IN OLDER MEN WITHOUT PROSTATE CANCER
TABLE5. Age-related differences in urinary, bowel and sexual Table 4 shows subject sexual function. Almost two-thirds of quality of life domains in a random control population of older the men reported that levels of sexual desire, ability to have men, below and above the median age erection and ability to reach orgasm were fair, poor or very poor. Half of the respondents had erections firm enough for Older Men pValue intercourse but fewer than a third had erections whenever they wanted. Two-thirds of the men had not achieved inter- No. subjeas 134 134 268 66.4 2 5.1 78.6 Z 3.5 <0.001 course in the last month. Nocturnal or morning erections MeanageZSD soore 2 SD. were uncommon. Two-thirds of the subjects considered over- Mean Urinary function 92 2 13 89 2 16 0.023 90.02 14.8 all sexual function to be fair, poor or very poor and 58% Urinary bother 86 2 23 82 2 26 0.027 83.82 24.2 claimed significant bother from this dysfunction. Table 5 Bowel function 88% 13 84 2 16 0.01 86.0 2 14.8 Bowel bother 89 2 19 83 2 27 0.03 85.02 23.5 presents an age group comparison between the values of the sexual function 5 4 ~ 2 9 40230 <0.001 47.0 f 30.0 younger and older sample. Older men had more impairment Sexual bother 53 2 40 42 2 40 0.03 47.8 2 40.2 in the sexual and bowel domains but they were similar to the Physical function 73.1 5 26.3 younger men in the urinary domains. Role, physical 64.3 2 41.2 M Y Pain 72.0 2 23.8 The figure shows composite health related quality of life 68.9 2 24.3 General health perceptions scores for the general and prostate targeted domains. PerforEmotional well-being 76.9 2 18.6 mance on the SF-36 exceeded 60 of 100 points in all 8 doRole, emotional 74.0 2 38.0 mains. With the exception of energy-fatigue, mental health S o d function 79.4 2 25.2 EnergyHatigue 64.2 2 22.0 scores showed a trend higher than physical health scores. Overall subjects performed well in the urinary and bowel Each domain is scored from 0 to 100 with higher scores representing better domains. Sexual function and bother composite scores were quality of life. poorer with respondents reaching only 47 and 48, respectively, of 100 points.
TABLE 4. Sexual function in a random control population of older men specifically directed to consider the last 4 weeks No. Subjects (%I Level of sexual desire: Very good
Fair Pwr V e v poor Ability to have an erection: Very good
Good Fair Pwr
very Poor Ability to reach orgasm (climax): Very good Good Fair Poor Very poor Usual quality of erections: Firm enough for intercourse Firm enough for masturbation and foreplay Not firm enough for MY sexual activity None a t all Usual fmquency of erections: Whenever I wanted one More than half the time I wanted one About half the time I wanted one Less than half the time I wanted one Never How o h n awakened in morning or night with erection: Very often (more than 75%of time) ORen (more than half time) Not often (less than half time) Seldom (less than 25%of time) Never Frequency of intercourse: More than once Once No Overall ability to function sexually: Very good
Fair Poor V e v poor Bother from sexual dysfunction: No problem Very small problem Small problem Moderate problem Big problem Perrentage of each item may not total 100% due to rounding.
39 (15) 64 (251 76 (29) 44 (17) 35 (14) 26 (10) 66 (261 52 (21) 47 (19) 61 (241 55 (22) 61 (251 43 (18) 38 (16) 48 (20) 127 (50) 46 (18) 44 (17) 39 (15) 81 (32) 37 (15) 47 (18) 88 (35) 69 (27) 19 (7) 37 (15) 47 (18) 88 (35) 63 (25) 65 (26) 21 (9) 159 (65) 31 (12) 47 (19) 55 ( 2 2 ) 36 (14) 81 (32)
64 (26) 39 (16) 32 (13) 35 (14) 77 (31)
Composite scores for general and prostate targeted health related quality of life (HRQOL) in random control population of older men using SF-36and UCLA Prostate Cancer Index. Each domain was scored from 0 to 100 with higher score representing better quality of life. Phys, physical. Emot, emotional.
This study demonstrates that older men in a randomly selected, population based sample do not have perfectly normal urinary continence, bowel function or sexual potency. Overall approximately a third reported some degree of urinary leakage, while a third claimed some degree of rectal dysfunction and 60% acknowledged significant difficulty with erection. As expected, within the sample older men were more likely to have sexual and bowel dysfunction, and be bothered by these impairments. Also as expected, urinary incontinence was equivalent in the 2 age groups. Most urinary incontinence was manifest as occasional dribbling but it occurred with surprising frequency. Of the respondents 18%stated that they had urinary leakage daily or weekly, although they rarely required pads or adult diapers. Notably only 69% of the subjects described themselves a~
HEALTH RELATED QUALITY OF LIFE IN OLDER MEN WITHOUT PROSTATE CANCER having complete urinary control. They were not severely bothered by leakage, since 94% believed t h a t incontinence was a small, very small or no problem. No doubt some urinary dysfunction was associated with benign prostatic hyperplasia, a prevalent condition in men of this age. Nevertheless, t h e items were specifically constructed to focus on urine leakage and not on obstructive symptoms. In this group of normal older men bowel function was also far from perfect. Interestingly rectal tenesmus occurred at least weekly in 31% of the respondents, while crampy abdominal or pelvic pain bothered 11%a t least weekly and 10%had loose stools at least half of the time. That 6% of the men found overall bowel function to be moderately or severely bothersome a n d 30% reported at least some distress due to this dysfunction suggests t h a t many older men significantly worry about bowel movements. Hence, even normal men do not uniformly consider bowel function to be normal. Overall sexual function in most of these normal older men without prostate cancer was fair to poor. In addition to decreased libido, erection was decreased in frequency and quality. Half of t h e respondents stated that they did not sustain a n erection sufficient for intercourse and 65% had not achieved intercourse in t h e previous 4 weeks. Notably 55%of t h e men believed t h a t impotence was a small, very small or no problem. A review of t h e literature suggests that the impact of urinary, bowel and sexual impairment after prostate cancer treatment varies according to the treatment and setting, and i t may affect general and disease specific health related quality of life. Few studies have compared patients with control groups and fewer have reported outcomes longitudinally. Those who used controls found that men who underwent radical prostatectomy or pelvic irradiation had more urinary and sexual impairmentg.10 but no differences were noted in general health related quality of life.' The longitudinal study of Braslis et a1 following prostate cancer treatment indicates that, while erectile dysfunction after prostatectomy has a profound effect on disease specific domains of health related quality of life, effects on general quality of life a r e difficult to detect." This finding also appears t r u e i n men with advanced prostate cancer who a r e treated with androgen ablation therapy.12 That health related quality of life outcomes evolve with time underscores the importance of obtaining baseline and followup assessments.13-16 Urinary function is known to decrease with age in healthy older populations, although most research has focused on t h e obstructive voiding symptoms associated with benign prostatic hyperplasia.17-'9 Thorn reported that the prevalence of urinary incontinence i n healthy older men is at least 204 with approximately 10% reporting some degree of leakage daily.20 Erectile function may be impaired by a number of physical and psychological conditions as well as prostate cancer and its treatments. Sexual function also decreases with age. The Massachusetts Male Aging Study showed that rates of complete impotence triple from 5 to 15% between ages 40 and 70 years, although libido often persists2' Mulligan and Moss found that sexual function decreases but sexual interest remains in older veterans, although it is also diminished." Helgason et a1 confirmed t h a t sex is important to elderly men, such t h a t almost half of a sample of population based controls in t h e eighth decade of life achieved orgasm a t least once monthly.23 While the incidence of bowel symptoms in t h e older population is more difficult to determine, some groups have reported it to be as high as 1 to 36%24with a significant impact on quality of life.25 Our study h a s important limitations. Although a 46%'response rate is considered good in population based survey research. unseen a n d unaccounted factors mav have biased O W findings. Because our population was chought to be it may differ from other populations, such as Medi~~
care or Medicaid populations, in which co-morbidity may be greater or the case mix may be different. CONCLUSIONS
The most methodologically rigorous way of reporting quality of life outcomes in men with prostate cancer is to use patients as their own controls. By collecting d a t a before treatment and following subjects longitudinally health related quality of life changes can be analyzed in the context of any impairment that may have been present at baseline. If a longitudinal study is not feasible, a control group of men similar in age and other demographic variables must be used. This study presents general and disease targeted health related quality of life outcomes of a statistically valid population based control sample of older men without prostate cancer. It may be used for comparison in cross-sectional investigations. REFERENCES
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