f
`
`ELSEVIER
`
`DEFINITION AND EPIDEMIOLOGY OF
`OVERACTIVE BLADDER
`
`ALAN J. WEIN AND ERIC S. ROVNER
`
`ABSTRACT
`The Standardisation Subcommittee of the International Continence Society (ICS) now recognizes overactive
`bladder (OAB) as a “symptom syndrome suggestive of lower urinary tract dysfunction.” It is specifically
`defined as “urgency, with or without urge incontinence, usually with frequency and nocturia.” The ICS
`definition was not formulated until January 2001 and was not formally approved until September 2001.
`Therefore, collection and discussion of the epidemiologic characteristics of OAB are somewhat hampered by
`the different definitions of this condition used by different investigators. Most communications that ap-
`peared before 2000 more often described characteristics of incontinence rather than OAB, and the esti-
`mates of OAB prevalence within those studies varied significantly. Until recently, little definite epidemiologic
`information was available on the prevalence and comorbidities of OAB. An important challenge in treating
`OAB is to increase awareness of this significant problem worldwide and to impress on other specialists and
`primary care physicians the importance of identifying this clinical problem and managing it in a way that will
`maximize quality-of-life improvement while minimizing morbidity. UROLOGY 60 (Suppl 5A): 7–12, 2002.
`© 2002, Elsevier Science Inc.
`
`Overactive bladder (OAB) is now classified as a
`
`symptom syndrome suggestive of lower uri-
`nary tract dysfunction by the International Conti-
`nence Society (ICS).1 A standardization subcom-
`mittee was formed because of increasing debate
`and discussion about various aspects of terminol-
`ogy and was announced at the ICS meeting in
`1999. Sessions were held at the ICS annual meeting
`in August 2000 and at a 2-day committee meeting
`in London in January 2001. The latter resulted in a
`formalized approved draft, which was then pre-
`sented to the ICS membership via the ICS Web
`site2 and at the ICS meeting in September 2001.
`Minor changes were made at that point, and the
`document was formalized after an additional
`2-month posting on the Web site. Specifically,
`OAB is now defined as denoting urgency with or
`without urge incontinence, usually with frequency
`and nocturia.
`
`From the Division of Urology, University of Pennsylvania School
`of Medicine, Philadelphia, Pennsylvania, USA; Division of Urol-
`ogy, University of Pennsylvania Health System, Philadelphia,
`Pennsylvania, USA; and Continence and Pelvic Health Center,
`University of Pennsylvania Health System, Philadelphia, Penn-
`sylvania, USA.
`Reprint requests: Alan J. Wein, MD, University of Pennsylva-
`nia Health System, Division of Urology, First Floor Rhoads Pa-
`villon, 3400 Spruce Street, Philadelphia, Pennsylvania 19104.
`E-mail: larmerr@uphs.upenn.edu
`
`In the document, OAB is referred to as the over-
`active bladder syndrome. Synonyms include urge
`syndrome and urgency-frequency syndrome. This
`particular section of the lexicon revision is intro-
`duced by the following quotation:
`Syndromes describe constellations, or varying
`combinations of symptoms, but cannot be used
`for precise diagnosis. The use of the word syn-
`drome can only be justified if there is at least one
`other symptom in addition to the symptom used
`to describe the syndrome. In scientific communi-
`cations the incidence of individual symptoms
`within the syndrome should be stated, in addition
`to the number of
`individuals with the syn-
`drome. . . . The syndromes described are func-
`tional abnormalities for which a precise cause has
`not been defined. It is presumed that routine as-
`sessment (history taking, physical examination,
`and other appropriate investigations) has ex-
`cluded obvious local pathologies, such as those
`that are infective, neoplastic, metabolic, or hor-
`monal in nature.
`The document adds that these symptom combina-
`tions are suggestive of detrusor overactivity (de-
`fined as urodynamically demonstrable involuntary
`bladder contractions) but can exist because of
`other forms of urethrovesical dysfunction. The
`document again restates that these terms can be
`used only if there is no proven infection or other
`obvious pathology. The document implies that
`
`© 2002, ELSEVIER SCIENCE INC.
`ALL RIGHTS RESERVED
`
`0090-4295/02/$22.00
`PII S0090-4295(02)01784-3 7
`
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`Ex. 1009, p. 7
`
`

`

`OAB is an empirical diagnosis that can be used as
`the basis for initial management, after assessing the
`individual’s lower urinary tract symptoms, physi-
`cal findings, urinalysis, and other indicated inves-
`tigations. The definitions and descriptions were
`meant to restate or update those presented in pre-
`vious ICS Standardization of Terminology reports
`(see bibliography in the article by Abrams et al.1).
`
`PAST DEFINITION
`It is interesting that, although much argument
`was engendered by the use of the term OAB, this
`term was never actually defined or described by the
`ICS in any prior terminology reports. Overactive
`detrusor function (generally shortened to overactive
`detrusor) does appear,1 and this term is defined as a
`condition characterized by involuntary detrusor
`contractions during the filling phase of cystometry,
`which may be spontaneous or provoked. Overac-
`tive detrusor function was then divided into detru-
`sor hyperreflexia (caused by neurologic disease)
`and unstable detrusor (caused by a nonneurogenic
`cause), with the latter term used interchangeably
`with the term idiopathic detrusor instability. OAB
`was used interchangeably with overactive detrusor
`function and overactive detrusor, although it
`seems clear that this was never the intent of the ICS
`standardization and terminology committees.
`Thus, overactive detrusor function and the terms
`that, correctly or incorrectly, have been used as sub-
`stitutes (overactive detrusor, detrusor overactivity,
`and OAB) are all originally urodynamic-based terms
`and, strictly speaking, describe abnormalities of de-
`trusor function during filling cystometry. Thus, a
`urodynamic study was required to make a definitive
`diagnosis. Abrams and Wein3,4 and others recognized
`the difficulty of using a frequently used term that
`could be defined only on the basis of a relatively com-
`plicated study. They feel that many patients could be
`treated initially with reversible conservative therapy
`after a minimal evaluation, and primary care physi-
`cians could and should become more involved in the
`initial management of such patients. They further
`supported the view that the OAB, a very patient- and
`physician-friendly term, is capable of being used as a
`diagnosis based on symptoms and was sufficient for
`the initiation of management in many cases. They
`proposed preserving detrusor overactivity or overac-
`tive detrusor as a urodynamic-based definition that
`describes a particular type of detrusor dysfunction
`during filling cystometry. Spirited discussions on ter-
`minology occurred after Abrams and Wein3 chaired a
`consensus conference entitled “The Overactive Blad-
`der: From Basic Science to Clinical Management.”
`Further correspondence on this subject followed,5 fi-
`nally resulting in the formalization of OAB as a rec-
`ognized symptom complex.
`
`Artibani,6 Wein,7 and others have pointed out
`some of the problems in using only a urodynamic-
`based definition for OAB: (1) cystometry is an in-
`vasive test that requires administration and evalu-
`ation by skilled and trained specialists; (2) because
`of the high worldwide prevalence of OAB, it is nei-
`ther necessary nor economically feasible for all pa-
`tients to be evaluated initially by specialists using
`cystometry; (3) the sensitivity in detecting invol-
`untary detrusor contractions in patients with OAB
`symptoms varies with the type of study done, with
`up to 60% to 80% of patients who are “negative” on
`routine supine cystometry demonstrating involun-
`tary bladder contractions on either provocative
`cystometry or ambulatory urodynamics; (4) ⬎60%
`of healthy volunteers show involuntary detrusor
`contractions during ambulatory urodynamics; and
`(5) most traces on cystometry that show low com-
`pliance change into phasic involuntary detrusor
`contractions when long-term ambulatory monitor-
`ing is performed.
`These considerations and others prompted the
`ICS Standardisation Subcommittee to change other
`items in the ICS lexicon (Table I). Detrusor hyper-
`reflexia and detrusor instability were eliminated in
`favor of neurogenic detrusor overactivity and idio-
`pathic detrusor overactivity. These former 2 terms
`had both been used generically before the first ICS
`report in 1976. The most recent subcommittee
`thought that because there was no real logic or
`intuitive meaning to these terms, they should be
`abandoned in favor of others that were more de-
`scriptive and readily understood. Additionally, as
`most experienced clinicians have come to recog-
`nize, the extent of neurologic examination and in-
`vestigation varies in clinical and research practice,
`and it is likely that the proportion of patients in the
`neurogenic versus the idiopathic overactivity
`group would increase if a more complete neuro-
`logic assessment were performed. Motor urgency
`and sensory urgency have been completely elimi-
`nated, and no terms have replaced them.
`
`EPIDEMIOLOGY: PREVALENCE
`Little definite epidemiologic information was
`available on the prevalence of OAB until very re-
`cently. Nearly all epidemiologic studies in this area
`have focused on urinary incontinence. The prevail-
`ing method for estimating the prevalence of OAB
`seems to have been to take the prevalence of uri-
`nary urge incontinence (including mixed inconti-
`nence) and multiply by 3, estimating that approx-
`imately 33% of patients with OAB had urinary urge
`incontinence. The remaining patients did not,
`complaining only of urgency, generally with fre-
`quency and nocturia.8,9 The median prevalence of
`incontinence in women has been reported as vary-
`
`8
`
`UROLOGY 60 (Supplement 5A), November 2002
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`
`

`

`TABLE I.
`Eliminated Term
`Detrusor hyperreflexia
`Detrusor instability
`Motor urgency
`Sensory urgency
`Motor urge
`incontinence
`Reflex incontinence
`
`International Continence Society terms
`Replacement Term
`Neurogenic detrusor overactivity
`Idiopathic detrusor overactivity
`None
`None
`Detrusor overactivity incontinence
`with urgency
`Detrusor overactivity incontinence
`without sensation
`
`TABLE II. Prevalence of overactive bladder symptoms in the
`study by Milsom et al.9
`
`Symptom
`Frequency alone
`Urgency alone
`Urge incontinence alone
`Frequency and urgency
`Urgency and incontinence
`Frequency, urgency, and incontinence
`
`Prevalence
`(%)
`4.5
`1.5
`1
`7
`4.5
`3.5
`
`ing from 14% to 40.5% (using the ICS definition, it
`is 23.5%); in men, it varied from 4.6% to 15%. In
`women, urge and mixed incontinence accounted
`for a median relative share of 51% of cases, whereas
`in men, the combined total was 92%.8
`
`A POPULATION-BASED PREVALENCE STUDY
`Milsom et al.10 reported on a study performed by
`the Svenska Institutet for Opinionsundersokingar
`(SIFO)/Gallup Network in France, Germany, Italy,
`Spain, Sweden, and the United Kingdom. This
`study used a telephone questionnaire involving a
`2-stage screening procedure, which first identified
`individuals with bladder control problems and
`then characterized the nature of the urinary condi-
`tion. The first step specifically excluded individu-
`als whose only complaint was urinary tract infec-
`tion.
`Symptoms
`attributable
`to OAB were
`identified by positive response to specific ques-
`tions on frequency, urgency, and urge inconti-
`nence. Frequency caused by OAB was arbitrarily
`defined as ⬎8 micturitions in 24 hours. For noctu-
`ria, the working definition was having to get up ⱖ2
`times a night to urinate. Respondents could have
`⬎1 OAB symptom, but they were classified only
`once as having OAB. Positive responses that were
`suggestive only of stress incontinence, prostatic
`obstruction, or the occurrence of urinary tract in-
`fection resulted in exclusion from further investi-
`gation. Respondents who were ⱖ40 years of age
`with OAB only or mixed symptoms were included.
`The interviewed population totaled 16,776 sub-
`jects. Approximately 19% of all respondents re-
`
`ported current bladder symptoms, but, overall,
`16.6% of total respondents, 15.6% of men, and
`17.4% of women reported symptoms suggestive of
`OAB. Responses by country varied somewhat,
`without explanation. The prevalence of OAB of
`men and women in Spain was 20% and 24%, re-
`spectively, whereas the prevalence in France was
`11% and 13%, respectively. In all, 79% of these
`patients had had their symptoms for ⱖ1 year, and
`49% had had them for ⬎3 years. Of those subjects
`with bladder symptoms, frequency was the most
`commonly reported symptom (85%), followed by
`urgency (54%) and urge incontinence (36%). The
`presence of individual symptoms occurring alone
`was small, as was the prevalence of respondents
`with all symptoms of OAB (Table II). The preva-
`lence of OAB and of all 3 symptoms increased with
`advancing age. This trend was apparent in both
`men and women. For men and women, respec-
`tively, prevalence percentages were as follows:
`3.4% and 8.7% for those 40 to 44 years old, 9.8%
`and 11.9% for those 50 to 54 years old, 18.9% and
`16.9% for those 60 to 64 years, 22.3% and 22.1%
`for those 70 to 74 years, and 41.9% and 31.3% for
`those ⱖ75 years of age.
`
`THE NATIONAL OVERACTIVE BLADDER EVALUATION
`PROGRAM
`Stewart et al.11 have been conducting the Na-
`tional Overactive Bladder Evaluation (NOBLE)
`Program to provide a clinically valid research def-
`inition of OAB, to establish estimates of its overall
`prevalence and the individual burden of illness,
`
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`

`

`and to explore differences between OAB popula-
`tions (i.e., those who are incontinent and those
`who are dry). A computer-assisted telephone inter-
`view was developed to estimate variation and prev-
`alence of OAB by demographic and other factors.
`This was assessed for reliability and clinical valid-
`ity. Clinical validity was assessed by comparison
`with a clinician’s diagnosis. The sensitivity and
`specificity of the computer-assisted telephone inter-
`view for OAB were 61% and 91%, respectively. The
`validated US national telephone survey involved
`5204 adults ⱖ18 years of age who were representa-
`tive of the noninstitutionalized US population with
`respect to sex, age, and geographic region. OAB dry
`was defined as ⱖ4 episodes of urgency in the previ-
`ous 4 weeks with either frequency ⬎8 more times per
`day or the use of ⱖ1 coping behaviors to control
`bladder function. OAB wet included the same criteria
`as OAB dry with, in addition, ⱖ3 episodes of urinary
`incontinence in the past 4 weeks that were clearly not
`episodes of stress incontinence. The overall preva-
`lence of OAB was reported as 16.9% in women and
`16.2% in men, increasing with age. The overall prev-
`alence of OAB dry and OAB wet in women was 7.6%
`and 9.3%, respectively, whereas in men it was 13.6%
`and 2.6%, respectively. In the United States, these
`figures would translate to 33.3 million adults with
`OAB, 12.2 million of whom had incontinence and
`21.2 million of whom did not. Interestingly, preva-
`lence by age increased by approximately the same
`slope in both men and women. The prevalence of
`OAB dry seemed to level off in men at about the age of
`60 years and in women at about the age of 50 years.
`The prevalence of OAB wet was quite low in men
`(3%) until the age of about 60 years, and this number
`increased to approximately 8% at the age of ⱖ65
`years, whereas for women, the prevalence increased
`from approximately 12% at the age of 60 years to
`approximately 20% at the age of ⱖ65 years.
`
`EPIDEMIOLOGY: QUALITY OF LIFE AND
`COMORBIDITIES
`In the study by Milsom et al.,10 65% of men and
`67% of women with OAB reported that their symp-
`toms had an effect on daily living, and 60% of those
`with symptoms found them bothersome enough to
`consult a medical practitioner. Frequency and ur-
`gency alone (59%) were almost as common as urge
`incontinence (66%) as reasons for seeking help. Of
`those who sought medical care, only 27% were re-
`ceiving medication for symptoms at the time of the
`interview. Of those who were not taking medication,
`27% had previously tried pharmacologic treatment,
`which failed. Of those who were not taking medica-
`tion and who had never tried drugs, 54% reported
`they were likely to discuss the problem with a physi-
`cian again and 46% were not. Of those who had tried
`
`drugs but in whom the drugs had failed, 65% re-
`ported they were likely to discuss the problem with a
`physician again and 35% were not.
`Liberman et al.12 assessed the impact of symp-
`toms of OAB on the quality of life in a community-
`based US sample population. The survey was con-
`ducted in 2 phases: (1) a cross-sectional household
`telephone survey was performed among an age-
`stratified sample of 4896 adults; and (2) a fol-
`low-up questionnaire was mailed to a subset of
`these respondents to assess their health-related
`quality of life (HRQOL). The Medical Outcomes
`Study Short-Form (SF)-20 was used. This mea-
`sures HRQOL during the past month in 6 domains:
`physical functioning, role functioning, social func-
`tioning, mental health, health perception, and
`bodily pain. Both groups, OAB wet and OAB dry,
`had significantly lower crude HRQOL scores than
`the control groups in every domain. This was true
`also after adjustment for confounders. Statistically
`significant differences were observed in 5 of the 6
`domains for the total OAB group, all 6 domains for
`the OAB wet group, and 3 of 6 domains for the OAB
`dry group. In the OAB dry group, after adjustment
`for confounders, individuals with symptoms of
`both frequency and urgency scored statistically
`significantly lower than did the controls in all 6
`HRQOL domains. There were numerical differ-
`ences for the frequency-only and urgency-only
`subgroups, but these did not reach statistical sig-
`nificance. Individuals reporting ⱖ11 micturitions
`per day did have statistically significant lower do-
`main-specific scores than those of controls in the
`areas of physical functioning, mental health, and
`bodily pain. The HRQOL scores for individuals
`with 9 to 10 micturitions per day were not signifi-
`cantly different from those of controls.
`In a study by Stewart et al.,11 illness impact was
`assessed by completed self-administered question-
`naires on quality of life, depression status, and
`sleep quality. Quality of life was assessed with the
`36-Item Short-Form (SF-36) Health Survey, a stan-
`dardized generic instrument that measures HRQOL
`in the previous month in 8 domains (physical func-
`tioning, role functioning, social functioning, mental
`health, vitality, health perception, emotional role,
`and bodily pain). Depression status was assessed by
`the Center for Epidemiologic Studies Depression
`Scale, which is a self-reported scale developed to
`identify depression-related symptoms. Sleep quality
`was assessed by the Medical Outcomes Sleep Scale, a
`12-item questionnaire that measures sleep distur-
`bance, insomnia, sleep quality and duration, and rest-
`fulness. After adjusting for differences in comorbid
`illnesses and other demographic factors, both men
`and women with OAB wet and OAB dry had clinically
`and significantly lower quality-of-life subscores,
`
`10
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`

`more depression-related symptoms, and a poorer
`quality of sleep.
`Kobelt13 reported that the results of the assess-
`ment of HRQOL with the SF-36 in a Swedish pop-
`ulation with established urge or mixed inconti-
`nence
`indicated
`that
`this
`cohort
`scored
`significantly lower in all domains than did the gen-
`eral Swedish population, matched for age and sex
`distribution. In addition, she reported that these
`results were, to some extent, confirmed using data
`from a clinical trial in the United States and Canada
`in which 2 treatments for urinary incontinence
`were compared with placebo. The SF-36 scores of
`the trial population at baseline were significantly
`lower than those of the healthy, age-matched pop-
`ulation in 6 of 8 domains. In 3 of these (social
`functioning, role limitations caused by emotional
`problems, and mental health), the scores were sig-
`nificantly correlated with micturitions and leaks at
`baseline, whereas the correlations with scores in
`the domains of vitality and general health were of
`borderline significance. Using some of the same
`data, Abrams et al.14 reported that patients with
`OAB were found to have a lower quality of life in
`the social and functional domains of the SF-36
`than did patients with diabetes. They pointed out
`that many patients with OAB tend to stop pursuing
`enjoyable social and physical activities, living with
`the condition in silence because they are too em-
`barrassed to talk about their condition or are un-
`aware that it can be treated. They list the most
`common reactions to the urinary incontinence
`component of OAB as embarrassment, frustration,
`anxiety, annoyance, depression, and fear of odor.
`Abrams et al.1 also enumerate the elaborate behav-
`iors (coping mechanisms) that many patients de-
`velop, which are aimed at hiding and managing
`such urine loss. They also cite the results of Kelle-
`her et al.15 who used the King’s Health Question-
`naire, a survey originally developed to evaluate
`quality of life in women with urinary incontinence.
`Using this survey, women with OAB and inconti-
`nence were reported to have significantly greater
`quality-of-life impairment compared with women
`with stress incontinence and normal urodynamic
`function. These last few reports emphasize a diffi-
`culty in assessing impairment of quality of life in
`patients with OAB: most of these surveys have been
`performed in patients with OAB wet, which must
`be acknowledged, because quality-of-life impair-
`ment in this group is most likely greater than in the
`OAB dry group. More recent studies have begun to
`overcome the deficit in data on quality of life as it
`applies to the total OAB population and its subdi-
`visions of OAB wet and OAB dry.
`Brown et al.16 provide an overview of the impact
`of OAB on other problems now known to coexist
`with this condition. They report that urinary in-
`
`continence is independently associated with falls
`and fractures among community-dwelling, elderly
`women in that women with weekly urge inconti-
`nence have a 26% greater risk of sustaining a fall
`and a 34% increased risk of fracture after adjusting
`for other causes. More frequent incontinence was
`associated with increased risk, and women with
`daily urge incontinence had increased risks of 35%
`and 45% of sustaining falls and fractures, respec-
`tively. These investigators believe that because pre-
`vious studies have demonstrated that urge incon-
`tinence has been associated with frequency/
`urgency and nocturia, OAB symptom, and not just
`urge incontinence, has the potential to increase the
`risk of falls and fractures among elderly women.
`They cite previous studies as identifying urinary
`tract infections and skin infections as factors that
`increase the cost of OAB and cite recent analyses
`that suggest a potential reduction in health care
`costs for patients receiving treatment for OAB. Af-
`ter the diagnosis of OAB, the number of services
`received for urinary tract infections and skin infec-
`tions decreased 40% and 60%, respectively, and
`was associated with potential cost savings in a
`small sampling from the 1996 to 1997 California
`Medicaid program. Regarding depression, Brown
`et al.16 cite data that suggest a strong association
`between depression and urge incontinence in a
`survey that used a Beck Depression Inventory.
`They cite the prevalence of depression as 60% in
`those with idiopathic urge incontinence, as 42% in
`patients with mixed incontinence, and as only 14%
`in patients with stress incontinence. Finally, al-
`though it seems intuitive that OAB would be asso-
`ciated with sleep disturbances, they caution that
`the extent to which OAB alone contributes to sleep
`disturbances remains unclear, because many indi-
`viduals, particularly elderly individuals, report
`sleep problems that are unrelated to the nocturia
`component of OAB.
`
`ASSOCIATED COSTS
`In this area, as in many others, analyses of the
`economic implications of OAB, separate from in-
`continence, are essentially nonexistent. Wagner
`and Hu17 reported the total costs of urinary incon-
`tinence in the United States in 1995 to be
`$26,292,400,000. Of these, direct costs accounted
`for $25.6 billion and indirect costs for $700 mil-
`lion. It is imperative that a similar analysis be per-
`formed for patients with OAB, including those
`with OAB wet and OAB dry. Only by quantification
`of the total economic burden of OAB will the im-
`portance of the disease in society be established.
`Hu and Wagner18 believe that it is likely that the
`economic burden of OAB is significantly greater
`than that of urinary incontinence.
`
`UROLOGY 60 (Supplement 5A), November 2002
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`

`

`CONCLUSION
`
`OAB is a highly prevalent disorder that affects the
`lives of millions of people worldwide. The impor-
`tance of OAB as a term has been recognized by the
`ICS, which now incorporates this term in its lexicon
`as a symptom syndrome. Prevalence of OAB, as dis-
`tinct from urinary incontinence, is now the subject of
`some well-performed surveys, and, through these, we
`are beginning to be able to characterize the disorder
`in terms of various demographic features. Data on the
`effects on quality of life and the economic burden of
`OAB are still relatively scarce, and information on the
`effects of various treatments on these parameters is
`essentially nonexistent. All of these factors will be-
`come increasingly important as we try to increase
`awareness of this significant problem worldwide and
`try to impress on other specialists and primary care
`physicians the importance of identifying this clinical
`problem and managing it in a way that will maximize
`quality-of-life improvement while minimizing mor-
`bidity.
`
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`2001.
`
`DISCUSSION FOLLOWING DR. WEIN’S PRESENTATION
`
`David R. Staskin, MD (New York, NY): A patient comes to
`you reporting the following: (1) I have had urinary frequency
`all of my life; (2) I have never had an accident; (3) I have never
`lost any urine, no matter how bad the frequency is (as opposed
`to the woman who says I have had frequency and urgency.
`Every once in a while, I can’t make it to the toilet, and I leak
`urine).
`Would you use an afferent drug with this patient because this
`is a sensory condition, rather than using an efferent drug because
`this is a motor condition?
`Karl-Erik Andersson, MD, PhD (Lund, Sweden): We do
`not know how our drugs work, not even antimuscarinics. You
`cannot exclude the fact that antimuscarinics affect the sensory
`arm of the micturition reflex. Therefore, we are not really
`helped in our choice of drug by the basic physiology and
`pharmacology. The mechanism of action does not indicate
`whether the patient would respond to a certain drug better
`than to another drug. We have to determine that by clinical
`trials.
`Dr. Staskin: However, if you had the perfect sensory drug, it
`would inhibit both categories. When is a specific diagnosis
`
`needed, and when is it not needed? I think that you do not
`need a specific diagnosis to begin to treat people as long as you
`are going to treat them with behavioral modification. It is a
`symptom syndrome. Instead of urgency with frequency and
`nocturia, it is overactive bladder.
`Joseph G. Ouslander, MD (Atlanta, GA): I agree with what
`you said, given what we know now. It would make a difference
`if the definitional issues that you are talking about predicted
`response to specific treatments.
`Alan J. Wein, MD (Philadelphia, PA): I think that people
`who have higher degrees of awareness, concern, and the ability
`to stop the involuntary detrusor contractions once they start
`do much better with behavioral therapies than those who
`are totally unaware. I think there are many different kinds of
`treatments that do better in some categories than others. If we
`do not continue to make these subtle distinctions, we will
`treat everybody the same way, and we will not make inroads into
`how patients are different from each other. We also will not be
`able to determine why some patients are doing well and others
`are not.
`
`12
`
`UROLOGY 60 (Supplement 5A), November 2002
`
`Petitioner - Avation Medical, Inc.
`Ex. 1009, p. 12
`
`