CLINICAL OBSTETRICS AND GYNECOLOGY
`Volume 45, Number 1, 173–181
`© 2002, Lippincott Williams & Wilkins, Inc.
`
`The Overactive
`Bladder: Prevalence
`and Effects on Quality
`of Life
`
`G. WILLY DAVILA, MD and MINDA NEIMARK, MD
`Department of Gynecology, Section of Urogynecology and
`Reconstructive Pelvic Surgery, Cleveland Clinic, Ft. Lauderdale,
`Florida
`
`The term overactive bladder (OAB) has
`been popularized during the past 5 years as a
`condition that encompasses a wide range of
`irritative bladder filling and storage symp-
`toms. It includes the symptoms of urinary
`frequency, urgency, and urge incontinence,
`singly or in combination. Urgency is a
`strong desire to void accompanied by a fear
`of leakage or fear of pain. Frequency repre-
`sents the need to urinate on an abnormally
`frequent basis (more than eight times per
`day or more than two times per night [noc-
`turia]). Urge incontinence refers to the
`symptom of urine loss preceded by a strong
`sense of urgency. The appropriate term to
`describe this storage-phase disorder de-
`pends on whether the diagnosis is made
`clinically or cystometrically. The loss of
`urine secondary to a spontaneous or pro-
`voked involuntary detrusor contraction
`shown on a cystometrogram has been
`
`Correspondence: G. Willy Davila, MD, 2950 Cleveland
`Clinic Blvd., Weston, FL 33331. E-mail: davilag@
`ccf.org.
`
`termed detrusor instability or unstable blad-
`der by the International Continence Society
`(ICS). If uninhibited detrusor contractions
`are due to an identified neurologic etiology,
`such as multiple sclerosis or Parkinson’s
`disease, the term detrusor hyperreflexia is
`used. The accepted cystometric require-
`ments for a diagnosis of detrusor instability
`are uninhibited detrusor contractions with
`an amplitude of more than 15 cm H2O, or a
`true detrusor pressure rise of less than 15 cm
`H2O associated with urgency or urge incon-
`tinence.1
`Other terms that are clinically useful but
`have not been specifically defined by the
`ICS are motor urge incontinence and sen-
`sory urge incontinence. Motor urge inconti-
`nence is urine leakage associated with uro-
`dynamically demonstrated detrusor instabil-
`ity. Sensory urgency refers to symptoms of
`urgency without evidence of uninhibited de-
`trusor contractions on urodynamics.2 Al-
`though OAB and detrusor instability have
`different definitions, they are frequently
`used interchangeably by clinicians when de-
`
`CLINICAL OBSTETRICS AND GYNECOLOGY
`
`/
`
`VOLUME 45
`
`/
`
`NUMBER 1
`
`/
`
`MARCH 2002
`
`Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
`
`173
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`174
`
`DAVILA AND NEIMARK
`
`scribing urine loss associated with urgency.
`Because the literature reflects this inter-
`change of terms, for the sake of this chapter
`the terms are also used liberally.
`Detrusor hyperactivity with impaired
`contractility (DHIC) is a disorder involving
`cystometric diagnosis of detrusor instability
`in association with large residual volumes.
`A more complex form of bladder overactiv-
`ity, DHIC is unique to an elderly population.
`It has been shown to be the second most fre-
`quent cause of urinary incontinence in insti-
`tutionalized elderly patients.3 These patients
`tend to have the same symptoms as patients
`with detrusor instability, in addition to re-
`ports of incomplete bladder emptying, hesi-
`tancy, and straining to void. The etiology of
`the impaired contractility in these patients is
`unclear.4 A series of papers that set out to
`describe the pathophysiology of DHIC
`showed that widespread degeneration of
`axons and muscle cells inhibits normal blad-
`der contraction, resulting in a large re-
`sidual.5 Abnormal deposition of connective
`tissue and collagen within the bladder wall is
`thought to result from the chronic bladder
`overactivity, adversely impacting bladder
`contractility. Patients thought to have DHIC
`should undergo a pressure voiding study in
`addition to a cystometrogram if urodynamic
`testing is performed.
`There have been several points of debate
`throughout the years regarding what criteria
`are required to fulfill the diagnosis of detru-
`sor instability. Among the key issues is how
`the contractions are documented—during
`mechanical retrograde filling or physiologi-
`cally during ambulatory urodynamics. This
`is a crucial differentiation, because office
`urodynamics carry a significant false-
`negative rate (up to 50%) in diagnosing de-
`trusor instability. Ambulatory urodynamics
`may help identify detrusor instability in ap-
`proximately 50% of patients diagnosed with
`sensory urgency during an office cystomet-
`rogram.6 There has also been debate over
`whether low-compliance bladder demon-
`strated during a cystometrogram should be
`categorized as a type of detrusor instability.7
`
`Epidemiology
`Because of the variety of reported symptoms
`and recent modifications in applied termi-
`nology, there has been a wide range in the
`reported prevalence and incidence of OAB.
`A recent review of 48 epidemiologic studies
`concluded that the large discrepancy be-
`tween the results was largely due to a lack of
`conformity with regard to the definitions
`used when describing voiding symptoms in-
`cluding incontinence, survey methods used,
`and validation of results.7 In addition, be-
`cause urinary incontinence is most fre-
`quently an underreported, embarrassing
`condition, OAB prevalence and incidence
`rates are known to underestimate the actual
`numbers.
`Urinary incontinence imposes a large fi-
`nancial burden on the individual patient as
`well as to society as a whole. In 1995, ex-
`penses totaled $26.3 billion, or $3,565 per
`individual aged 65 and older with urinary in-
`continence.8
`
`Prevalence
`Prevalence (the total number of cases at a
`certain point in time) estimates are influ-
`enced by the definition of urinary inconti-
`nence used in the particular study as well as
`the methodology used for collecting data
`from patients regarding incontinence. The
`prevalence range for urinary incontinence is
`4.5% to 53% in women and 1.6% to 24% in
`men. In a recent survey, the estimated preva-
`lence of urinary incontinence in community-
`dwelling females was 40%.9 Unlike stress
`incontinence, where symptoms tend to cor-
`relate with the final diagnosis, the variability
`in OAB symptoms from individual to indi-
`vidual reduces the accuracy of population
`surveys.
`
`AGE-RELATED DIFFERENCES
`It is well documented that the prevalence of
`OAB increases with age. In a survey that
`analyzed more than 2,000 patients, detrusor
`instability was observed in 27% of patients
`
`Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1008, p. 174
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`Overactive Bladder: Prevalence and Quality of Life
`
`175
`
`younger than 65 and 38% of patients older
`than 65.10 The rate of urge incontinence
`identified in personal interviews among the
`elderly by questions regarding loss associ-
`ated with urgency is approximately
`5–20%.11 The prevalence of detrusor insta-
`bility in incontinent nursing home patients
`has been shown to be 61%, with half of these
`patients having impaired contractility
`(DHIC).3 Irritative bladder symptoms in
`nursing home patients include detrusor in-
`stability (31%), DHIC (30%), sensory ur-
`gency (1%), and mixed incontinence (4%),
`for a total prevalence of 65%.
`
`GENDER DIFFERENCES
`Almost all studies that investigate differ-
`ences between the sexes find that the preva-
`lence of urinary incontinence is at least 1.5
`to 2 times higher among women. Because of
`the differences in incontinence pathophysi-
`ology between men and women, there is a
`different distribution of incontinence types
`(Fig. 1). Stress incontinence is more pre-
`dominant than urge incontinence in women.
`Stress-related incontinence is reported to oc-
`cur in 49% of women, compared with a 22%
`incidence of urge incontinence. In men,
`overactive bladder is more common than
`stress incontinence (73% vs. 8%).12
`
`RACIAL DIFFERENCES
`There is little information regarding the
`prevalence of urge incontinence in different
`
`Females
`
`racial groups. It is difficult to compare the
`data from country to country because of the
`lack of standardization of diagnostic criteria
`when evaluating adults with urinary incon-
`tinence. In a study of 200 women, 56% of
`black women reported symptoms of urge in-
`continence compared with 28% of white
`women.13 A recent study by Mattox and
`Bhatia14 evaluated the prevalence of incon-
`tinence among white and Hispanic women
`with similar age, gravity, and parity who had
`undergone urodynamic evaluation. The
`prevalence of urge incontinence was 18% in
`the white population and 9% in the Hispanic
`population.
`
`OBESITY
`Obesity and increased body mass index have
`been shown to be commonly associated with
`stress as well as urge incontinence. In
`women with more than 20% over the aver-
`age weight for height for their age, 24% had
`detrusor instability.15
`Urethral instability, a poorly understood
`condition, is characterized by wide fluctua-
`tions in urethral pressure resulting in symp-
`toms of urgency, frequency, and possibly
`incontinence. An association with uninhib-
`ited bladder contractions has been found in
`approximately 42% of women with urethral
`instability.16 This tends to occur in young
`adult women with a history of perineal
`trauma such as bicycle riders and horseback
`riders.
`
`Stress
`incontinence
`49%
`
`Mixed
`incontinence
`19%
`
`Mixed
`incontinence
`29% ■
`
`Urge
`incontinence
`22%
`
`Males
`
`Stress
`incontinence
`9%
`
`Urge
`incontinence
`73%
`
`FIG. 1. Gender differences and incontinence types.
`
`Copyright 0 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1008, p. 175
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`

`

`synergia. The incidence of bladder dysfunc-
`tion in Parkinson’s ranges from 40% to
`70%, the majority being due to detrusor hy-
`perreflexia.16
`Cardozo et al19 reported the incidence of
`detrusor instability after surgery for stress
`urinary incontinence to be 15–30%.
`Spontaneous remission of OAB requires
`complex examination of the same study
`population over long periods of time. Some
`investigators believe that spontaneous re-
`mission should in fact be included as part of
`the natural course of urinary incontinence,
`whether it is accredited to behavior modifi-
`cation by the patient or medical interven-
`tion.17
`Various risk factors have been identified
`through epidemiologic research to be asso-
`ciated with the development of OAB symp-
`toms. Many conditions may mimic OAB
`symptoms and not necessarily cause urge in-
`continence (Table 1).
`
`TABLE 1. Conditions That Mimic
`Overactive Bladder
`
`Local
`Cystitis
`Estrogen deficiency
`Hypnotic drugs
`Bowel problems
`Bladder tumors
`Pelvic mass
`Radiation cystitis
`Interstial cystitis
`Neurologic
`Parkinson’s
`Multiple sclerosis
`Cognitive impairment
`Stroke
`Paraplegia
`Impaired mobility
`Medical
`Diabetes mellitus
`Diabetes insipidus
`Congestive heart failure
`Diuretics
`Environmental
`Caffeine
`Alcohol
`Tobacco
`Poor toilet habits
`Pyschosocial
`Limited activity
`
`176
`
`DAVILA AND NEIMARK
`
`INCIDENCE, NATURAL HISTORY,
`SPONTANEOUS REMISSION
`The natural history of OAB, including age of
`onset, actual incidence rates, occurrence of
`spontaneous remission, and associated risk
`factors for progression, is poorly under-
`stood.
`Incidence is defined as the number of new
`cases over a certain period of time. There is
`limited reliable information available to de-
`scribe incidence because of factors such as
`dropouts by migration, noncompliance, or
`death. The incidence of urge incontinence
`tends to increase with age, as do most of the
`underlying causes. Elving et al17 reported an
`increase in the incidence of urinary inconti-
`nence between the ages of 45 and 59 years.
`For urge incontinence, the incidence in-
`creased from 0.08% to 0.2% (Fig. 2). Moller
`et al18 reviewed the prevalence of lower uri-
`nary tract symptoms in a Danish population;
`irritative symptoms had a prevalence of 29%
`and an incidence of 10%, and spontaneous
`remission occurred in 28%.
`Patients with neurologic lesions (multiple
`sclerosis, Parkinson’s disease, stroke, de-
`mentia) are at high risk of manifesting blad-
`der dysfunction at some point during their
`disease. In fact, 20–30% of patients with
`multiple sclerosis and Parkinson’s have ini-
`tial complaints of bladder dysfunction be-
`fore the diagnosis of their disease. The risk
`of developing bladder dysfunction is ap-
`proximately 90%, whether it is due to detru-
`sor hyperreflexia or detrusor sphincter dys-
`
`CD Wass
`0 Urge incontinence
`
`043
`
`4.5 -
`
`I 4.5-
`
`v.
`
`ai
`
`
`-0 O
`'a 03
`
`6 02
`O
`
`0.1 -
`
`a
`
`Incidence of urge and stress inconti-
`FIG. 2.
`nence increases with age.
`
`Copyright 0 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1008, p. 176
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`Overactive Bladder: Prevalence and Quality of Life
`
`177
`
`Severity Assessment and
`Quality of Life
`Overactive bladder represents a distinct en-
`tity within the realm of lower urinary tract
`disorders because of the unique difficulty in
`assessing severity and individual impact.
`Unlike stress incontinence sufferers, who
`may be able to prevent incontinence by
`avoiding incontinence-causing physical ac-
`tivities, adults with OAB must cope with the
`unpredictability of urgency symptoms and
`urine loss. Traditionally used incontinence
`severity assessment tools such as bladder
`diaries and pad testing are not effective
`when evaluating a patient with OAB be-
`cause of the great variability in symptoms
`and precipitating events.
`Patients with OAB use a variety of behav-
`ioral modification and coping skills to re-
`duce the impact of their symptoms. These
`include toilet-seeking, restriction of fluid in-
`take, dietary restrictions, limitation of physi-
`cal activity, and in severe cases limitation of
`social activities. A pervasive cycle of anxi-
`ety and distress regarding possible urine loss
`and embarrassment, and worsening urgency
`because of the internalized distress, fre-
`quently leads to a great psychological bur-
`den and various degrees of social isolation.
`This phenomenon is consistent with a well-
`known Chinese proverb: “The bladder is the
`window to the soul.”
`Quality of life (QOL) assessment instru-
`ments are frequently used in the evaluation
`of the individual impact of various medical
`conditions. In conditions where life prolon-
`gation is not a goal of therapy and accurate
`response assessment tools are lacking, QOL
`impact measurement is imperative.20 Uri-
`nary incontinence is particularly well suited
`for the use of QOL instruments because the
`impacts are greatly individually determined.
`QOL tools are either generic or condition-
`specific. Generic QOL questionnaires pro-
`vide a profile of an individual’s QOL cover-
`ing several health concepts and are typically
`divided into physical, psychological, and so-
`cial domains. Disease-specific question-
`
`naires, a newer concept in QOL analysis, are
`targeted at a specific facet of the patient’s
`health.
`The most commonly used generic QOL
`tool is the MOS Short Form 36 (SF-36). In
`Europe, the EuroQOL EQ-5D has been used
`as an index that is particularly useful in cost-
`utility analysis. Because of their lack of
`specificity, generic instruments rarely pro-
`vide enough information to measure a
`change in the condition’s impact brought
`about by therapy.21
`The impact of OAB has been evaluated
`using the SF-36 in various studies. It was
`shown to have a significant impact on five
`of the eight domains of the SF-36 (physi-
`cal functioning, social functioning, physi-
`cal role functioning, vitality, and emotional
`role functioning).22 In a study comparing
`therapy with oral oxybutynin, tolterodine,
`and placebo in adults with OAB, no signifi-
`cant differences were noted after 12 weeks
`or 12 months among groups when SF-36 re-
`sults were analyzed.23 However, analysis of
`simultaneously collected data using a dis-
`ease-specific QOL instrument, the King’s
`Health Questionnaire (KHQ), showed that
`both treatment groups had significant im-
`provements in QOL beginning at 10 weeks.
`Other nonspecific questionnaires have
`been used for QOL analysis. The Sickness
`Impact Profile, when used to assess inconti-
`nent women, showed that women with blad-
`der filling symptoms had a more significant
`QOL impact.24 The impact was most
`marked in younger women. The main do-
`mains affected were sleep and rest, emo-
`tional behavior, mobility, social interaction,
`and recreational activities. The Nottingham
`Health Profile was applied to elderly women
`both with and without urinary incontinence.
`Those with incontinence recorded higher
`scores, with most impact noted in emotional
`disturbances and social isolation.25
`Disease-specific QOL instruments have
`been developed for the evaluation of lower
`urinary tract and OAB impact. Specificity
`and sensitivity in identifying bladder dys-
`function impact are higher because the ques-
`
`Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
`
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`Ex. 1008, p. 177
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`178
`
`DAVILA AND NEIMARK
`
`tions are directed at aspects of life typically
`affected by bladder problems. The Inconti-
`nence Impact Questionnaire (IIQ) was one
`of the first to be developed. The initial 30-
`item IIQ has recently been reduced to a more
`attractive 7-item questionnaire.26 Aspects of
`QOL identified by the IIQ include daily liv-
`ing activities, physical activities, social in-
`teractions, and self-perception. The short
`form has been validated relative to the long
`form, increasing clinical use of the IIQ-7.
`This QOL tool is complemented by use of
`the Urogenital Distress Inventory (UDI),
`which was designed to quantify the impact
`of stress symptoms, bladder filling, and ob-
`structive symptoms. The UDI was also
`shortened from a 19-item questionnaire to a
`6-item tool, which was validated relative to
`the long form. Although not popularized for
`widespread clinical use, the IIQ/UDI combi-
`nation is frequently used in clinical research
`studies.
`Other disease-specific QOL instruments
`include the KHQ and the York Incontinence
`Perception Scale (YIPS), the Incontinence
`QOL (IQOL), and the Bristol Female Lower
`Urinary Tract Symptoms (FLUTS) ques-
`tionnaires. The KHQ contains 30 items and
`has been validated.27 The YIPS assesses
`psychosocial adjustment to incontinence
`and includes eight items focusing on self-
`perception, lifestyle adaptations, and health
`QOL.28 The IQOL includes 28 items, in-
`cluding emotional adaptation to urinary in-
`continence.29 The FLUTS reports primarily
`bladder symptoms such as filling, voiding,
`and incontinence symptoms, including a
`“bother” factor. It is a rather comprehensive
`questionnaire including sexual health issues
`and daily and social activities and has been
`validated against pad tests and bladder dia-
`ries.30
`Regardless of the instrument used, OAB
`has been shown to have a more significant
`impact on QOL than stress incontinence.
`Improved understanding of the unique QOL
`impact of irritative bladder symptoms and
`OAB have led to the development of QOL
`instruments directed specifically at identify-
`
`ing the impact of OAB. The IIQ and UDI
`were used as a basis for QOL evaluation in
`women with OAB. Critical analyses using
`focus panels, literature review, and expert
`opinions were then used to develop OAB-
`specific tools, the Urge-IIQ and Urge-
`UDI.31 The Urge-IIQ is a 30-item question-
`naire that also includes domains relative to
`sexual function. The Urge-UDI has nine
`items. They were validated against the ge-
`neric SF-36. Clinical utility was shown in a
`multicenter, open-label, nonrandomized,
`single-arm clinical study evaluating the ef-
`fect of a once-a-day formulation of oral oxy-
`butynin (Ditropan XL). Adequate reliabil-
`ity, validity, and responsiveness to change
`were shown for the two urge-QOL tools dur-
`ing this study.32
`Because the effect of OAB on QOL has
`significant variability from individual to in-
`dividual, assessing a patient’s perspective
`and explanatory style may add to the ability
`of a QOL questionnaire to identify QOL im-
`pact. This premise was studied in a focus
`group approach in women with OAB.33 Pa-
`tient-defined aspects of QOL impact were
`more focused on coping with embarrass-
`ment and interference with lifestyle. Experts
`may focus more on OAB functional impact
`on the individual, whereas patients cite the
`impact of OAB on their emotional well-
`being and interference with activities. The
`top-listed items by patients were the need for
`pre-emptive strategies to avert urinary in-
`continence, lack of self-control, adaptation
`of daily routine, shame, fear of public em-
`barrassment, and lack of predictability
`(Table 2). Although these issues may seem
`obvious, they are not specifically identified
`or quantified in commonly used QOL instru-
`ments.
`Because more women than men suffer
`from OAB, development of QOL question-
`naires has focused on quantifying primarily
`female issues. A few instruments have pro-
`vided insight into the impact of urinary in-
`continence in men. The ICSmale question-
`naire was used for assessment of bladder
`symptoms in men older than 40 years.34 Al-
`
`Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1008, p. 178
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`

`Overactive Bladder: Prevalence and Quality of Life
`
`179
`
`TABLE 2. Top 10 Incontinence-Related
`Quality of Life Items
`
`10. Urinary incontinence psychological, not
`physical problem
`9. Self-concept
`8. Resignation
`7. Loss of sleep
`6. Lack of predictability
`5. Fear of public embarrassment
`4. Shame
`3. Adaptation of daily routine
`2. Lack of self-control
`1. Need for pre-emptive strategies to avert urinary
`incontinence
`
`Data from DuBeau CE, Levy B, Mangione CM, Resnick NM.
`The impact of urge urinary incontinence on quality of life. J Am
`Geriatr Soc. 1998;46:683–692.
`
`though irritative symptoms such as urgency,
`frequency, and urge incontinence are not
`common in men, they were noted to have a
`higher QOL impact score.35 The KHQ has
`been evaluated in a correlation with the SF-
`36, which resulted in validation in men.23
`Many factors can hinder the assessment
`of QOL in patients with urinary inconti-
`nence. The QOL instrument used must have
`been validated in the population for which it
`is being used. Factors such as gender, age,
`culture, and language may reduce the reli-
`ability of a QOL tool. Preliminary work on
`an individual-specific QOL questionnaire
`has shown that identifying a specific activity
`adversely affected by incontinence can be
`helpful in determining impact and response
`to therapy.36
`Because OAB symptoms tend to be
`chronic and no therapies curative, even a
`highly sensitive instrument may not be able
`to detect an improvement in bladder func-
`tion. If OAB affects one aspect of QOL more
`significantly than others, that particular as-
`pect may not be specifically quantified be-
`fore and after therapy. Patients may have un-
`realistic expectations regarding therapy out-
`comes, long-term incontinence avoidance
`behaviors may persist despite improved
`bladder function, and patients may have un-
`recognized secondary gain benefits from
`their OAB symptoms.
`
`Summary
`Overactive bladder represents a health con-
`dition of increasing public and medical rec-
`ognition. Because of the wide variation in
`reported symptoms of OAB, accurate esti-
`mates of prevalence and incidence are diffi-
`cult to calculate. Specific causes of revers-
`ible OAB symptoms should be identified
`and treated accordingly. Because most cases
`of OAB are idiopathic, complete elimina-
`tion of symptoms and “cure” are not realistic
`for most patients. Assessing severity and re-
`sponse to therapy is challenging. Few OAB
`severity assessment tools are specific
`enough to be used in all patients. Newer
`urge-related QOL questionnaires are helpful
`in assessing the severity of the condition and
`response to therapy. As our understanding
`of the epidemiology of OAB and impact as-
`sessment increases, we shall be able to im-
`prove our current means of addressing this
`common medical problem.
`
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`Ex. 1008, p. 179
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