~--SYMPOSIUM PROCEEDINGS
`
`Overactive Bladder Significantly Affects Quality of Life
`
`Paul Abrams, MD; C.]. Kelleher, MD, MRCOG; Lindsey A. Kerr, MD; and Rebecca G. Rogers, MD
`
`Presentation Summary
`()veractivc bladder (OAB), with
`symptoms of frequency, urgency,
`and urge incontinence, substan-
`tially affects the lives of millions of
`people. The symptoms associated
`with OAB can significantly affect
`the social, psychological, occupa-
`tional, domestic, physical, and
`sexual aspects of those who suffer
`from it. Unfortunately, many suf-
`ferers are reluctant
`to discuss
`their condition with their health-
`
`care provider or family members.
`As a result, OAB remains underre-
`ported, despite increased aware-
`
`ness and improved diagnosis and
`treatment.
`lIealth—relatcd quality
`of life can be measured objective-
`ly, and several instruments have
`been developed, validated, and
`used in research. Currently, there
`are 2 major types of quality-of-life
`questionnaires: generic and dis-
`ease specific. Although these ques-
`tionnaires have been helpful and
`are widely used,
`the goal
`is to
`establish a single questionnaire
`that is acceptable throughout the
`world for use by urologists, gyne-
`cologists, urogyneeologists, geria-
`tricians, and epidemiologists.
`
`veractive bladder (OAB) is a
`
`0 major cause of suffering in
`
`requiring
`patients,
`many
`long-term therapy to maintain symp-
`tom relief. Although OAB can affect
`anyone at any age,
`the prevalence
`tends to increase with advancing age.‘
`The symptoms are associated with
`significant social, psychological, occu-
`pational, domestic, and physical stig-
`mas. Patients who suffer from OAB
`
`focus on and may be preoccupied
`with such concerns as locating the
`closest bathroom,
`looking for aisle
`seating, and estimating the amount of
`time until
`their next work break.
`
`Furthermore, OAB affects daily activ-
`ities, such as travel, physical activity,
`
`function, and
`relationships, sexual
`nocturnal bladder control, which can
`affect sleep.
`
`Impact of OAB
`It is estimated that at least 17 mil-
`
`lion Americans are affected by OAB;
`however, the prevalence is difficult to
`estimate because few surveys have
`measured symptoms of urgency and
`frequency with or without urge incon-
`tinencef OAB is characterized by
`symptoms of urgency (a
`sudden,
`strong desire to urinate),
`frequency
`(urinating more than 8 times in 24
`hours), or urge incontinence (sudden
`and involuntary loss of urine), alone or
`in combination. Both urinary inconti-
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`QUALITY or LIFE
`
`nenee and urgency/frequency have
`been shown to affect a patients physi-
`cal, social, and emotional well-being.
`Unfortunately, many people do not
`seek medical help because they mis-
`takenly believe that bladder control
`problems are an inevitable part of
`aging and that there is no treatment
`available or they are too embarrassed
`to discuss their problem with their
`healthcare provider. Of those sufferers
`who seek medical attention, it is esti-
`mated that 30% receive no assessment
`
`of their symptoms and approximately
`80% are not treated?
`
`In a European survey conducted by
`SIFO Research and Consulting AB,‘ it
`was found that OAB adversely affect-
`ed the lives of the majority of respon-
`dents with symptoms of (JAB (65% to
`67%).
`In addition, 60% found the
`symptoms bothersome enough to
`consult
`a medical
`practitioner.
`
`Interestingly, frequency and urgency
`were almost as common as urge
`incontinence as a reason for seeking
`help. Most important, only half the
`respondents with OAB said they were
`likely to discuss the problem with
`their healthcare provider again, pro-
`viding
`additional
`evidence
`that
`although many people find the symp-
`toms troubling,
`the disease remains
`vastly underreported.
`
`Paticnt's Perception
`Studies have shown that patients
`with OAB have a significantly poorer
`quality of life than age-nlatched popu-
`lations. For instance, using the patient-
`administered Short Form 36 (SF-36)
`quality—of—life questionnaire, patients
`who suffer from (JAB were found to
`
`have a lower quality of life in the social
`and functional domains than patients
`with diabetes (Figure 1).“ Many people
`
`Figure 1. Comparison of Quality—of-Life Scores in Patients with OAB, Diabetes, and
`Normal Subjects
`
`90
`
`
`
`80
`
`70
`
`60
`
`50
`
`ShortForm-36Score
`
`
`
`IIuI|IlII contra] group
`— — - Diabetes
`
`
`
`ts
`‘:9
`4‘
`
`£\°°
`(‘G
`Q»
`3
`0&9
`9
`
`as
`<5: oi‘
`0- %
`z~’< ea
`Q9‘ @
`
`Q9
`\
`‘'3
`6°
`
`Source: Abrams P, Wein AJ. The Overactive Bladder: A Widespread But Trearable Cono’irr'on.
`Stockhom, Sweden: Erik Sparre Medical AB; 1998. Reprinted with permission.
`
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`SYMPOSIUM PROCEEDINGS
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`with OAB tend to stop pursuing many
`of
`the social and physical activities
`they have enjoyed for much of their
`lives, enduring OAB and its symptoms
`in silence because they are too embar-
`rassed to talk about it or are unaware
`that it can be treated.
`The most common reactions to
`
`urinary incontinence are embarrass-
`ment,
`frustration, anxiety, annoy-
`ance, depression, and fear of odor. To
`cope with symptoms of OAB, many
`sufferers develop elaborate behaviors
`(coping mechanisms) aimed at hiding
`and managing urine loss, such as:
`
`I Limiting daily travel to places and
`routes where they know the loca-
`tions of all restrooms
`
`0 Reducing fluid intake
`0 Avoiding sexual intimacy
`0 “fearing adult incontinence pads
`or diapers
`0 Preferring to drive themselves
`everywhere, so they can control
`bathroom stops
`- Carrying extra clothes and diapers
`everywhere they go, in the event
`of a wetting accident
`
`Table 1. Selected Quotations Related to Quality-of-Life Issues
`
`Feelings
`I ”I have lost control over my bodily functions, and I resent it.”
`I ’’I'm just wet, and I feel like a child."
`I "You're scared to stand next to people. You're afraid the urine smell is there.”
`I ”There are times when I just sit and cry because I get so frustrated with it."
`Activities
`I "I no longer plan activities, unless I know I will have access to a restroom.”
`I ’’I keep sending my resumes out, and I keep thinking I'm gonna blow the
`interview because I have to go to the bathroom.”
`I ”My boss asked people if I was doing drugs in the bathroom.”
`I ’’I was a big runner and tennis player. That's difficult to do any more."
`
`a hermit.”
`
`Relationships
`I "This problem overshadows my sex life."
`I ’’I don't want to be away from my house. My son says, ‘You're becoming
`
`Source: Adapted and reprinted with permission from Brown IS, Subak LL, Gras
`J, et al. Urge incontinence: The patient's perspective. 1 Women's Health
`l998;7:1263-1269.
`
`- Wearing dark, often baggy clothing
`to hide wet spots andfor conceal
`adult diapers
`- Sitting on the aisle at the theater
`and on planes to have easier
`access to the bathroom
`
`- Sitting closest to the door for easi-
`er access to the bathroom.
`
`Quality-of-Life Issues Affecting
`Women
`
`In a series of focus groups composed
`of women of diverse ages and racial
`and ethnic backgrounds who suffered
`from urge incontinence, it was shown
`that
`the effects of incontinence on
`
`quality of life correlated with frequen-
`cy, nocturia, and pad uses‘ It was also
`shown that 24% of respondents wor-
`ried about bathroom availability, 14%
`about loss of control, 11% about anxi-
`ety, and 10% about sleep disturbances.
`Compared with older women (270
`years), those younger than 70 years of
`age were more likely to report feelings
`of unattractiveness and low self-esteem
`
`(12% vs 2%; P < 0.007), as well as
`adverse effects on dating and sexual
`activity (45% vs 0%; P < 0.02). Table 1
`lists several comments of the focus
`
`group participants.
`In a study conducted by Lam and
`colleagues,“ the reduction in social
`contacts and activities in 511 women
`
`(30 to 59 years of age) with stress,
`urge, mixed, or nonspecific urinary
`incontinence was evaluated using a
`study—specific questionnaire. Across
`all types of incontinence, 99 women
`(19.4%) reported avoiding at least 1
`social activity, and 32 women (6.3%)
`avoided more than 1 type of social
`activity. Five women (1%) abstained
`from work, 14 (2.7%) from visiting
`friends, 18 (3.5%) from going to the
`movies, 80 (15.7%) from sports, and
`16 (3.1%)
`from shopping. Although
`urinary incontinence does not appear
`to be a socially disabling condition, it
`may have a substantial impact on the
`everyday lives of women.
`According to research presented by
`Roe and colleagues,’ those who suffer
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`---QUALITY or LIFE
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`from urinary incontinence are more
`likely to need assistance with their
`activities of daily living. When com-
`pared with those respondents who
`were continent, people suffering from
`incontinence were significantly more
`likely to need help with cooking,
`housework, shopping, or their laundry.
`It was also shown that respondents
`who were incontinent were significant-
`ly more likely to need help with per-
`sonal care, such as dressing, feeding,
`bathing, or going to the toilet,
`than
`respondents who were continent.
`In a questionnaire surveying the
`prevalence of urinary incontinence
`and its influence on quality of life, it
`was shown that women with urinary
`incontinence reported a poorer quality
`of
`life compared with continent
`women (P < 0.01).” “(omen with urge
`incontinence and women with mixed
`
`incontinence reported a poorer quality
`of life than women with stress inconti-
`
`nence (P < 005). Only 6% of the
`women surveyed had sought medical
`attention for urinary incontinence.
`
`Quality-of-Life Issues Affecting Men
`There are few studies that address
`
`the impact of incontinence on quality
`of life in men. According to Lenderking
`and colleagues,” incontinence causes
`greater impairment in physical func-
`tioning in men than in women. In a
`self-assessment questionnaire address-
`ing quality of life in 50 men (mean age,
`67 years),
`it was shown that 26% of
`men with moderate-to-severe inconti-
`
`nence had severely limited their phys-
`ical activities.”
`
`In a random sample that included
`1883 men (230 years of age), the con-
`sequences of incontinence were exam-
`ined,
`in addition to its prevalence.”
`Thirty-six percent of
`incontinent
`respondents believed that the disorder
`had affected their lifestyle a great deal
`or fair amount, and only 2.3% believed
`there had been no effect. Only 30% to
`45% of the respondents felt very confi-
`dent in major activities of social life;
`however, activities were curtailed to a
`
`greater degree in men and the elderly
`compared with women and younger
`individuals. The general activity re-
`strictions imposed by incontinence
`included drinking less when going out
`(35%), making a conscious effort
`to
`locate a public restroom (33%), going
`out less (15%), and restricting certain
`activities, such as lifting (10%).
`
`Seeking Medical Attention
`The Special Committee on Aging in
`the United States has identified uri-
`
`nary incontinence as one of the top 4
`important health-related quality-of-
`life problems affecting senior citizens
`(others include Alzheimer’s disease,
`loss of vision, and osteoporosis and
`fractures). Nevertheless, many suffer-
`ers have a misconception that urinary
`incontinence is an effect of aging,
`which has a negative impact on their
`decision to seek treatment.” In a sur-
`
`vey conducted to examine the occur-
`rence, attitudes, and knowledge about
`urinary incontinence among women
`55 years of age and older, respondents
`were not likely to seek help if they
`perceived urinary incontinence to be
`an inevitable outcome of advancing
`age and believed that no beneficial
`therapies were available.
`Instead,
`they were more likely to try to adjust
`their
`lifestyles
`to
`compensate.
`Although attempts to compensate for
`mild urinary incontinence may have
`little impact on lifestyle, quality of life
`and general health may be impaired
`when an individual
`limits
`social
`and/or recreational activities because
`
`of more severe urinary incontinence.
`As a result of this study,” it has
`been suggested that education on
`lower urinary tract health be provided
`to both the general public and to
`healthcare providers. Public educa-
`tion should focus on the fact that the
`
`occurrence of frequency, urgency,
`and urge incontinence is not a normal
`part of aging and that effective treat-
`ment methods
`are
`available.
`
`Furthermore, healthcare providers
`should be taught how to make basic
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`SYMPOSIUM PROCEEDINGS
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`continence assessments and informed
`
`of the available treatment options.
`In its role as an advocacy group for
`those with incontinence, the National
`Association for Continence (NAFC),
`reported results of a member survey.“
`There was a 1.9% rate of return from
`
`detailed questionnaires mailed to
`98,000 subscribers. Most respondents
`were covered by health insurance
`(Medicare, 61.3%; managed care orga-
`nizations, 25%; Medicaid, 5.7%; no
`insurance, 2.4%). Consumer satisfac-
`tion with treatment of incontinence
`
`was very low, with 64% reporting that
`they were not satisfied with treatment.
`Dissatisfaction corresponded to over-
`all general health and type of inconti-
`nence, with those who had good
`health or less severe incontinence
`
`tending to be more satisfied with treat-
`ment outcomes. Those with stress or
`mixed incontinence were more satis-
`fied with treatment than those with
`
`urge incontinence. It was shown that
`younger respondents (36 to 45 years
`of age) were as dissatisfied and unhap-
`py with their treatment outcomes
`those 65 years of age and older.”
`The majority of respondents (51%)
`rated conservative and behavioral
`
`treatment, such as pelvic muscle
`exercises, bladder retraining, and diet
`modification, as being most helpful;
`
`Figure 2. Consumer Response to Outcome of Therapies
`(Behavioral and Pharmacotherapeutic) for Urinary Incontinence
`
` Cured
`
`E] Worse
`
`5ource:Verdel| L ed. Consumer Focus "99:/"1 Survey. Spartanburg, South Carolina:
`National Association for Continence; 1999. Reprinted with permission from the
`National Association for Continence and the Alliance for Aging Research.
`
`I lm proved
`
`43%
`
`No change
`
`respondents observed no
`43% of
`change in outcome from their most
`helpful treatment; and only 3% report-
`ed being cured (Figure 2). These fig-
`ures probably underrepresent
`the
`actual percentage of patients who
`benefit from treatment because those
`
`who elected to participate in the
`NAFC and respond to the survey are
`likely to be those who remained
`incontinent. Nevertheless, this survey
`indicates that there is a gap in the
`expectations patients have of current
`therapies and suggests that improved
`communications are needed regard-
`ing treatment options and anticipated
`outcomes between patients
`and
`healthcare providers.
`
`lomplianee With Therapy
`Although behavioral
`therapy has
`been shown to be highly effective (80%
`cure rate) in patients with OAB,” non-
`compliance outside the clinical
`trial
`setting limits its long-term efficacy.
`Some patients will comply better with
`pharmacotherapy than behavioral
`modifications, unless they experience
`adverse effects or a complicated regi-
`men is prescribed. In addition, if the
`prescribed therapy comes from a spe-
`cialist and the patient receives long-
`tenn management
`from his or her
`primary care physician, acceptance of
`the plan of therapy by the primary care
`physician is another often overlooked
`factor
`that
`influences compliance.
`importantly,
`if patients perceive an
`improvement in their quality of life as
`a result of therapy, they are more like-
`ly to comply.
`Overactive bladder is a chronic
`
`condition that often requires long-
`term therapy.
`Ilowever,
`there is a
`lack of outcome data on the manage-
`ment of patients over extended peri-
`ods of
`time, as well as
`limited
`information on long-term compliance
`with therapy for OAB. Most compli-
`anee data con1e fron1 clinical trials,
`which do not provide an accurate
`assessment of adherence in the
`
`everyday world.
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`Oxybutynin is an effective agent for
`managing the symptoms of OAB; how-
`ever, dry mouth occurs in about 50% of
`patients, contributing to an overall dis-
`continuation rate up to 27% of patients
`in clinical
`trials.” A study of 348
`women with OAB from the United
`
`that compliance
`Kingdom suggests
`rates with oxybutynin in clinical prac-
`tice are even lower.” A total of 73.6% of
`
`women with a mean age of 50.7 years
`responded to a survey at 6 and 12
`months after referral to a specialist for
`urinary symptoms. Most patients
`(83.5%) had been prescribed oxybu—
`tynin. At 6 months, even though only
`5.5% of respondents reported complete
`resolution of all their urinary symp-
`toms, a dismal 18.2% remained on ther-
`apy. The occurrence of side effects was
`reported as the reason for discontinua-
`tion of therapy by 39.8% of women.
`Lack of efficacy did not seem to play a
`major role, because 71.9% of women
`considered drug therapy to be effective.
`A follow-up study was conducted to
`evaluate whether commencing oxybu-
`tynin therapy at a lower dose with
`written instructions
`for gradually
`increasing the dose would result
`in
`improved compliance ((J..I. Kelleher,
`unpublished data). Ninety-six women
`with OAB were randomly prescribed
`oxybutynin, 2.5 mg twice daily or 5 mg
`at bedtime, with instructions
`to
`increase the dose to 5 mg 3 times daily
`over 6 weeks. Of
`the 96 women
`
`enrolled, 66 responded to a question-
`naire 2 years later. Similar to the previ-
`ous study, a high percentage of women
`(66.7%) were no longer taking oxybu—
`tynin, of whom 63.6% had discontinued
`therapy after 2 months. Of those who
`stopped therapy, 43.2% reported that it
`was due to side effects. Thus,
`lower
`dosage and slow titration did not sub-
`stantially improve compliance.
`In clinical
`trials,
`tolterodine 2 mg
`twice daily has been demonstrated to
`have a lower rate of dry mouth and dis-
`continuation because of dry mouth
`than oxybutynin 5 mg 3 times daily,”"‘”
`which may result in improved compli-
`
`QUALITY or LIFE
`
`long—term studies are
`ance. Ilowever,
`needed to determine whether this
`
`improved tolerability results in better
`compliance.
`
`Evaluating Sexual Functioning
`It should be no surprise that incon-
`tinence or the fear of leaking urine
`would interfere with sexual function;
`however, studies evaluating the bur-
`den of OAB on sexual quality of life
`
`It should he no surprise that incontinence or
`the fear of leaking urine would interfere with
`sexual function; however, studies evaluating
`the burden of OAB on sexual quality of life
`are scarce.
`
`are scarce. Of the studies that have
`
`evaluated the impact of OAB on sexu-
`al functioning, only 1
`incorporated
`the use of validated questionnaires to
`determine quality-of-life measures.
`There are some problems with
`using general rather than condition-
`specific questionnaires, however. For
`example, \Veber and colleagues” com-
`pared sexual function in women with
`and without uterovaginal prolapse
`and urinary incontinence. Using mul-
`tivariate analysis, increasing age was
`the only significant factor predictive
`of poorer sexual function. The general
`questionnaire used in this study may
`not have been sensitive enough to
`detect differences in function in this
`
`specific population.
`In an effort to have a specific, vali-
`dated, and reliable questionnaire to
`evaluate sexual functioning in this
`population, Rogers and Kammerer
`have developed the Pelvic Organ
`Prolapse/Incontinence Sexual Ques-
`tionnaire (PISQE; R. Rogers, unpub-
`lished
`data). This
`questionnaire
`consists of 31 questions in 3 domains:
`behavioral-emotive, physical, and part-
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`ner related. The PISQ has been shown
`to have high internal consistency, test
`and retest reliability, and a good corre-
`lation with the Sexual History Form-12
`(SIIF-12), another questionnaire often
`used in urogynecologic research.
`In
`clinical studies, the PISQ has been able
`to distinguish between patients with
`and without sexual dysfunction (R.
`Rogers, unpublished data).
`The PISQ was applied to 139 sexu-
`ally active women. Patients provided
`information regarding pelvic organ
`prolapse or urinary incontinence; self-
`reports were not confirmed by physical
`examination. There were significant
`differences in PISQ scores among
`women with incontinence compared
`with those without
`incontinence.
`
`Specifically, although the desired fre-
`quency of
`intercourse was similar
`between patients with and without
`incontinence, the actual frequency of
`intercourse was
`significantly less
`among patients with incontinence
`than among those without
`inconti-
`nence. Patients with incontinence or
`
`prolapse reported having previous loss
`of urine with intercourse and restrict-
`
`ing sexual activity for fear of losing
`urine during it. Additionally, patients
`with incontinence reported significant-
`ly more dyspareunia and vaginal dry-
`ness,
`regardless
`of
`their use
`of
`hormone replacement
`therapy com-
`
`Table 2. Differences in Sexual Function
`
`UI/POP
`n = 83 (%)
`
`No UI/POP
`n = 56 (%)
`
`Vaginal dryness 96
`
`Frequency
`Desired (>monthly)
`Actual (>month|y)
`Loss of urine with sex
`
`Dyspareunia
`Restrict sexual activity
`
`71
`45
`42
`27
`70
`
`100
`95
`14
`24
`4
`46
`
`pared with patients without inconti-
`nenee or prolapse. These results sup-
`port a relationship between OAB and
`poor sexual functioning (Table 2).
`
`Assessing Quality of Life
`Evaluation of the severity of OAB
`normally involves a record of urinary
`symptom scores, a bladder diary, and,
`in select cases, objective urodynamic
`data. Although these are essential
`clinical measures, they provide little
`information regarding the impact on a
`patient’s life. Many other factors play
`a role in OAB, so it is important to
`include an evaluation of quality of life
`in clinical
`trials.
`In measuring the
`quality of life associated with OAB, it
`is vital to examine both severity and
`duration as well as to establish the
`
`correct diagnosis. In developing any
`definitive instrument to assess quality
`of life in both men and women, an in-
`depth interview with the patient
`should be conducted, with discussion
`of such areas as sleep, emotional, sex-
`ual, and social
`functioning. Within
`emotional
`functioning, self-esteem,
`anxiety over hygiene (ie, odor) and
`having incontinent episodes, sadness,
`health preoccupation, and helpless-
`ness all appear to be important issues
`for those who suffer from OAB.
`
`is
`it
`functioning,
`Within social
`essential to assess work less, socializ-
`ing, and activity avoidance. In addi-
`tion,
`the use of the word “bother”
`may be more appropriate than that of
`“problem” in quality-of-life evalua-
`tions, because patients may find
`symptoms bothersome but may not
`consider them problematic,
`in that
`they are not associated with serious
`illness or mortality.
`Quality of life can be measured
`objectively, and several instruments
`for such measurement have been
`
`developed, validated, and used exten-
`sively. Currently, there are 2 major
`types of quality-of-life questionnaires:
`generic and disease specific.
`Generic quality-of-life question-
`naires (eg, Medical Outcome Study
`
`Source: R. Rogers, unpublished observations.
`UI : urinary incontinence; POP : pelvic organ prolapse.
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`
`---QUALITY or LIFE
`
`Short Forms 36 and 20 [MOS SF-36,
`SF-20], European Quality of Life Scale
`[Euro-QOL], and Sickness
`Impact
`Profile) offer some advantages because
`tlley are reliable, validated,
`readily
`available, and useful
`in assessing a
`broad range of populations and ages in
`many
`different
`disease
`states.
`Ilowever,
`the problem with using
`generic questionnaires is that results
`are often insensitive to the specific
`condition measured and therefore fail
`
`to address many of the issues relevant
`to the disease. As a result disease-spe-
`cific instruments are more beneficial
`
`in evaluating the impact of a specific
`lower urinary tract symptom on quali-
`ty of life and are more sensitive than
`their generic counterparts in detecting
`changes as a result of treatment. The
`Incontinence Impact Questionnaire,
`the Urinary Distress Inventory,
`the
`York Incontinence Perception Scale,
`the Incontinence Quality of Life
`Index,
`and
`the King’s
`Ilealth
`Questionnaire (KIIQ) are several
`instruments that have been developed
`specifically for urinary incontinence.
`\Vith the exception of the KIIQ, the
`disadvantage in using a disease-specif-
`ic questionnaire to evaluate quality of
`life is that other health dimensions,
`including psychological aspects, are
`not assessed, and comparisons with
`other diseases cannot be made.
`
`The King's Health Questionnaire
`The KIIQ is a short, patient—com—
`pleted, condition-specific, validated
`quality-of-life and symptom-impact
`short-form questionnaire?" Symptom-
`impact and quality—of—life measures are
`divided and can be presented either as
`domain scores, total scores, or individ-
`ual scores across the questionnaire.
`The questionnaire has been shown to
`be sensitive and responsive to clinical
`changes in lower urinary tract symp-
`toms. Although the KIIQ was initially
`designed and validated for use among
`women, recent studies also have also
`proved it to be a valid and reliable
`instrument for evaluating quality of life
`
`in men with urinary incontinence.
`There is good correlation between the
`KIIQ and generic questionnaires,
`including the SF-36. There are 8 vali-
`dated cultural adaptations of the ques-
`tionnaire available in 26 languages,
`including German, Spanish, Swedish,
`Greek, Italian, and Japanese.
`The KIIQ was originally tested in
`293 women who were referred for
`
`evaluation of urinary incontinence?"
`The results of this analysis show that
`symptoms are significantly more
`bothersome in patients with OAB
`than in patients with stress inconti-
`nence. This may be the result, in part,
`of the greater predictability of leakage
`because of stress incontinence than
`
`urge incontinence, making adaptive
`measures more successful in women
`with stress incontinence. When com-
`
`bined-domain scores were evaluated,
`women with OAB also had significant-
`ly greater quality-of-life impairment
`compared with women with normal
`urodynamic function or women with
`stress incontinence (Figure .3).
`The KIIQ has also been used to
`assess responses to clinical changes in
`a recent naturalistic study comparing
`the effects of 10 weeks of tolterodine
`
`or oxybutynin therapy on OAB symp-
`toms in 378 patients (67% women)
`older than 50 years of age.“ A total of
`294 patients completed both generic
`instruments (SF-36 and the Euro-
`QoL) and the KIIQ until
`study
`completion. In a subset analysis per-
`formed by (l..l. Kelleher, mean scores
`for the KIIQ, corrected for comorbidi-
`ty, were
`significantly higher
`in
`younger women than in older women,
`with the higher scores indicating
`greater impairment. The less signifi-
`cant effect on quality of life in older
`women may be a result of adaptive
`changes they have made over time, or
`possibly it is because younger women
`have a more active lifestyle and thus
`perceive symptoms as more bother-
`some. Women who received either
`
`tolterodine or oxybutynin therapy
`during the study showed significant
`
`VOL. 6, NO. 11, SUI’.
`
`THE AMERICAN JOURNAL OF MANAGED CARE
`
`S587
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2063 - 0008
`
`

`
`SYMPOSIUM PROCEEDINGS
`
`improvements from baseline in all
`domains other than health percep-
`tions and interpersonal relationships.“
`Ilowever, effects on interpersonal
`relationships are difficult to evaluate
`with the KIIQ for 2 reasons: the num-
`ber of questions is limited, and ques-
`tions
`regarding
`interpersonal
`relationships exclude patients who
`are not having interpersonal relation-
`ships at study initiation. There was no
`significant difference in mean scores
`obtained from the SF-36 or the Euro-
`
`QOL questionnaire during the 10-
`week course of treatment; however,
`when it was measured with the KIIQ,
`quality of life improved significantly.
`
`Directions for Future Study
`Overactive bladder can result
`
`in
`
`social seclusion and psychological
`stress and limit the day-to-day activi-
`
`ties of those who suffer from it. There
`
`are currently many different types of
`questionnaires
`that
`healthcare
`providers can use to further their
`understanding of the impact of OAB
`on their patients’ day-to-day lives.
`Ilowever, there is a need to develop a
`short, concise questionnaire that can
`he used universally in clinical trials
`and studies. It also may be necessary
`to adapt a validated disease-specific
`questionnaire for use in specific
`patient groups.
`As Roe and colleagues? point out in
`their study, people from ethnic minor-
`ity groups are underrepresented;
`therefore, future research on preva-
`lence estimates of urinary inconti-
`nence should also target ethnic
`minorities, using stratified sampling
`techniques as well as questionnaires
`that contain appropriate language.
`
`Figure 3. Domain Scores of the King's Health Questionnaire by Urodynamic Diagnosis
`
`-0- Women with OAB (n = 80)
`
`-:l- Women with stress incontinence (n = 133)
`-I- Women with normal urodynamics (n = 14)
`
`Domain
`
`Score
`
`Source: Kelleher C], Cardozo LD, Khuller V, Salvatore S. A new questionnaire to assess the quality of life in urinary incontinent women. Br]
`Obstet Gynaecoi1997;104:1374-1379. Adapted with permission from C.J. Kelleher and the British journal of Obstetrics and Gynaecology.
`
`5588
`
`THE AMERICAN JOURNAL OF MANAGED CARE
`
`JULY 2000
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2063 - 0009
`
`

`
`In the National Overactive BLadder
`
`concentrated urine that leads to uri-
`
`---QUALITY or LIFE
`
`the
`Evaluation (NOBLE) Program,
`individual burden of OAB in the
`
`United States will be researched by
`estimating the population prevalence
`of OAB and its symptoms (urgency,
`frequency, and urge incontinence),
`assessing the extent
`to which OAB
`interferes with functioning, and deter-
`mining how OAB influences overall
`health. A longitudinal cohort also will
`be identified to measure the natural
`
`history of the disease. These results
`will be used as supportive information
`in future estimates of the economic
`
`burden of ()AB to society.
`In addition, results from the NOBLE
`Program will be used to develop a blad-
`der health questionnaire that can be
`used by primary care physicians to
`screen individuals with bladder health
`
`problems and to validate a computer-
`assisted telephone interview used to
`screen people with OAB symptoms.
`Furthermore,
`the development of a
`simple bladder health questionnaire
`will also provide patients with termi-
`nology for their symptoms and a better
`understanding of their condition, facil-
`itating open communication between
`patient and physician. The goal of the
`program is to allow patients to feel
`comfortable discussing OAB with their
`healthcare provider. An OAB-specific
`quality-of-life instrument is also being
`developed and validated.
`
`Conclusion
`
`Appreciation of the specific impact
`of OAB on the quality of life is critical
`to understanding the need for appro-
`priate health services. Many sufferers
`of OAB seek to manage their symp-
`toms by adjusting to the problem
`instead
`of
`seeking
`treatment.
`Although many elderly people with
`urinary incontinence initially may
`manage their condition with adaptive
`measures, medical attention is need-
`ed before it becomes troublesome; for
`example, severe restriction of fluid
`intake may lead to more serious con-
`sequences, such as dehydration or
`
`nary tract infections.
`It has been shown that approxi-
`mately half of all OAB sufferers would
`welcome some form of
`treatment;
`however, they are reluctant to seek
`help. Of those who discuss their
`symptoms with their primary care
`physicians, 30% do not receive treat-
`ment and 80% are not examined?
`
`Dismissing incontinence and its relat-
`ed symptoms not only has a negative
`impact on the quality of life of those
`who suffer, but it also puts a consider-
`able financial burden on society,
`resulting from a failure to properly
`diagnose and treat OAB.
`
`---REFERENCES---
`
`1. Milsom I. The prevalence of overactive
`bladder. Presented at the 14th Congress of
`the European Association of Gynecology and
`Obstetrics, September 1999, Grenada, Spain.
`2. Wein AJ, Rovner ES. The overactive blad-
`der: An overview for primary care health
`providers. Int} Fern’! 1999:4456-66.
`3. Kobelt-Nguyen G, Johanesson M,
`Mattiasson A, et al. Correlations between
`symptoms of urge incontinence and scores of
`a generic quality of life instrument (SF36)
`and health status measurements (Euro-Qol)
`and between changes in symptoms and QoL
`scores. Presented at the 27th Annual Meeting
`of the International Continence Society,
`September 23-26, 1997, Yokohama, Japan.
`Abstract.
`
`4.