Does the imprecise definition of overactive bladder serve commercial rather than patient interests?
- SourceAvailable from: Kari A O Tikkinen[Show abstract] [Hide abstract]
ABSTRACT: No study has compared the bothersomeness of all lower urinary tract symptoms (LUTS) using a population-based sample of adults. Despite this lack of evidence, investigators have often cited their LUTS of interest as the "most bothersome" or "one of the most bothersome." To compare the population- and individual-level burden of LUTS in men and women. In this population-based cross-sectional study, questionnaires were mailed to 6000 individuals (18-79 yr of age) randomly identified from the Finnish Population Register. The validated Danish Prostatic Symptom Score questionnaire was used for assessment of bother of 12 different LUTS. The age-standardized prevalence of at least moderate bother was calculated for each symptom (population-level burden). Among symptomatic individuals, the proportion of affected individuals with at least moderate bother was calculated for each symptom (individual-level bother). A total of 3727 individuals (62.4%) participated (53.7% female). The LUTS with the greatest population-level burden were urgency (7.9% with at least moderate bother), stress urinary incontinence (SUI) (6.5%), nocturia (6.0%), postmicturition dribble (5.8%), and urgency urinary incontinence (UUI) (5.0%). Burden from incontinence symptoms was higher in women than men, and the opposite was true for voiding and postmicturition symptoms. At the individual level, UUI was the most bothersome for both genders. Although the response proportion was high, approximately a third did not participate. Both men and women with UUI report moderate or major bother more frequently than individuals with other LUTS. At the population level, the most prevalent bothersome symptoms are urgency, SUI, and nocturia. Urinary urgency was the most common troubling symptom in a large population-based study; however, for individuals, urgency incontinence was the most likely to be rated as bothersome.European Urology 01/2014; · 10.48 Impact Factor
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ABSTRACT: Objective: Assess and categorise the available prevalence data on coexistent LUTS and ED in the general population and among individuals consulting a healthcare provider for any reason or when seeking treatment for LUTS and/or ED. Methods: Literature search of English-language articles published during the last 15 years. Results: Of 23 relevant studies identified, 12 used both the International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF) as assessment tools and 11 used alternative approaches. In studies using both IPSS and IIEF, overall prevalence of coexistent LUTS/ED of any severity was not assessable for men in the general population, but rates ranged from 14-37% based on alternative assessments. In the general male population, 13-29% had moderate to severe LUTS and 8-35% had moderate to severe ED. In studies using both IPSS and IIEF, overall prevalence of coexistent LUTS and ED of any severity was 71-80% among men seeking treatment for LUTS, and 74% based on alternative assessments. Among men who sought treatment for either condition, 67-100% had moderate to severe LUTS and 43-59% had moderate to severe ED. Coexistence of LUTS and ED increased with age, ranging from 59-86% among men aged 40s to 60s in primary care to 79-100% in treatment-seeking men with LUTS aged 50s to 70s. Impact on QoL varied, but health-related QoL was generally worse in treatment-seeking men compared with men in the general population. Conclusions: Although less than one-third of middle-aged and older men in the general population have coexisting LUTS and ED, most men seeking treatment for either LUTS or ED have both conditions. Symptom severity and impact on QoL in each condition increase when LUTS and ED coexist.International Journal of Clinical Practice 10/2012; · 2.43 Impact Factor
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ABSTRACT: Objectives The overactive bladder syndrome (OAB) is a highly prevalent and bothersome symptom complex. We review contemporary reports to provide an update of the key aspects of its pathogenesis and the therapeutic approaches. Methods The PUBMED database was searched for relevant publications in the period from 1 January 1985 to 1 May 2013, using the keywords ‘overactive bladder’, ‘anti-muscarinics’, ‘β-3 agonists’, ‘intravesical botulinum toxin’, ‘tibial nerve stimulation and ‘sacral neuromodulation’. Results In all, 33 articles were selected for this review. OAB is very common, affecting 10–20% of the population. It is often bothersome and frequently affects the quality of life. The current definition of OAB remains a source of controversy. Anti-muscarinic agents remain the mainstay of pharmacotherapy. The new β-3 agonists have some efficacy whilst avoiding anti-cholinergic effects, and so might benefit patients who are unable to tolerate anti-muscarinic agents. Intravesical botulinum toxin is recommended for patients in whom oral pharmacotherapy fails, although the optimal parameters in terms of dosing, number of injections and injection site are yet to be fully established. Sacral neuromodulation is another option that has a good response in about half of patients. Conclusions OAB remains an incompletely understood problem that presents a significant management challenge. A range of therapeutic options is now available for clinicians managing this problem.Arab Journal of Urology. 01/2013; 11(4):313–318.
Does the Imprecise Definition of Overactive Bladder Serve
Commercial Rather than Patient Interests?
Kari A.O. Tikkinena,b,*, Anssi Auvinenc
aDepartment of Urology, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland;
Biostatistics, McMaster University, Hamilton, ON, Canada;cSchool of Health Sciences, University of Tampere, Tampere, Finland
bDepartment of Clinical Epidemiology and
The tendency has always been strong to believe that
whatever received a name must be an entity or being,
having an independent existence of its own. And if no
real entity answering to the name could be found, men
did not for that reason suppose that none existed, but
imagined that it was something peculiarly abstruse and
mysterious. —John Stuart Mill
Over the last decade, physicians and the general public
have increasingly used the term overactive bladder (OAB) in
referring to the complex of urinary storage symptoms
previously known as irritable bladder or unstable bladder.
The term first appeared in the literature in 1989 , but its
popularity increased dramatically when it was highlighted
in an industry-sponsored symposium in 1997 . The
pharmaceutical industry quickly adopted this simple but
exhaustivesymptom terminologyandused itsuccessfullyto
expand the indications for medications. Whereas previous
drugs had been licensed for urodynamically confirmed
bladder instability, in 1998, the US Food and Drug
Administration approved tolterodine for the treatment of
‘‘symptoms of overactive bladder.’’ Multimillion-dollar
advertising in some countries) followed.
The International Continence Society introduced the
current standardized definition of OAB in 2002. According
to this definition , OAB syndrome refers to urinary
urgency, with or without urge incontinence, usually with
increased daytime frequency and nocturia. Although
patient report of symptoms is all that is required for
diagnosis, the standardization report harks back to previous
operational definitions, rooted in pathophysiology, propos-
ing that OAB syndrome is ‘‘suggestive of urodynamically
demonstrable detrusor overactivity, but can be due to other
forms of urethro-vesical dysfunction’’ and that the term
‘‘can be used if there is no proven infection or other obvious
Despite the complex scientific terminology, the formu-
lation is hampered by the lack of specificity including
terms such as ‘‘usually’’ and ‘‘with or without’’ as well as
undefined ‘‘other obvious pathology.’’ The definition is
problematic in that it oversimplifies multifactorial symp-
toms, implying that OAB is an independent clinical
entity with uniform treatment options. Unfortunately, the
symptoms of OAB do not constitute such a coherent
constellation [4–6]. The underlying causes of the compo-
nents of OAB are not well understood [5,6], and the
available treatments, whether for urgency, urge inconti-
nence, frequency, or nocturia, are effective for only a
minority of affected patients .
For pharmaceutical companies, OAB has undeniably
proved lucrative—the proverbial ‘‘goose that laid the golden
egg.’’ We continue to see the marketing of a range of
anticholinergic medications for treatment of ‘‘the symp-
toms of overactive bladder.’’ As in other areas of medicine
, buoyed up by growing sales, pharmaceutical companies
have recruited opinion leaders to promote their treatments
for OAB and to align research efforts with commercial
interests. OAB publications have proliferated rapidly over
the past decade (Fig. 1). The association between commer-
cial funding and positive outcomes for randomized drug
trials is well recognized . A systematic review of the
sources of funding for the recent literature revealed that for
OAB, industry funding has extended beyond randomized
trials: Most epidemiologic studies are indeed funded by
pharmaceutical and device companies (Fig. 2) . A
EUROPEAN UROL OG Y 61 (2 012) 746–748
available at www.sciencedirect.com
journal homepage: www.europeanurology.com
* Corresponding author.
E-mail address: firstname.lastname@example.org (Kari A.O. Tikkinen).
0302-2838/$ – see back matter # 2012 Published by Elsevier B.V. on behalf of European Association of Urology.doi:10.1016/j.eururo.2011.12.013
majority of randomized controlled trials, epidemiologic
studies, and systematic reviews have included authors with
financial conflicts of interest (Fig. 3).
In all symptom-based disorders there is a risk of defining
very mild or rare symptoms as abnormal [8,10], even if they
may represent normal physiologic variation. Once diag-
nosed, people tend to regard their symptoms as a disease
amenable to medical intervention. Defining minor symp-
interests of the pharmaceutical industry [8,10]. A recent
analysis by a collaboration of international authors  of a
widely cited industry-sponsored epidemiologic study 
concluded that in 2008, one in nine individuals in the world
had OAB, with direct annual costs of approximately s2
trillion . This implausible suggestion likely results from
biases exaggerating the magnitude of the problem:
Typically survey response proportions are low, time periods
for symptom occurrence are unclear, and case definitions
fail to distinguish between minor transient and truly
bothersome symptoms that merit investigation and treat-
Researchers and the medical community have a respon-
sibility to ensure that research activities align with and are
proportionate to global health importance (ie, to narrow
Fig. 1 – Publications across all journals indexed in Scopus, including the term overactive bladder, 1998–2010.
Fig. 2 – Reported funding sources for overactive bladder papers by subtype. Includes manuscripts of original research with term overactive bladder
between January 2007 and November 2011 that include funding statements and that were published in the five journals that publish the most overactive
bladder research (BJU International, European Urology, International Urogynecology Journal and Pelvic Floor Dysfunction, Neurourology and Urodynamics,
and The Journal of Urology).
RCT = randomized controlled trial.
E UR O P E A N U R OL O GY 61 ( 2 01 2) 7 4 6 – 7 4 8
rather than widen the 10/90 gap). This is particularly so for
urinary problems, which have high remission rates and are
amenable to watchful waiting. Labeling those patients with
mild and possibly transient symptoms as suffering from a
medical syndrome risks causing healthy people to consider
themselves sick and exposes them to needless drug side
effects when physicians offer drug treatment. The possibly
unnecessary prescription of medications also incurs ex-
pense for patients and for publicly funded health services
and could result in substantial opportunity costs, with more
cost-effective treatments remaining unfunded . We do
not suggest that OAB should be dismissed as a marketing
gimmick. Despite disagreements about prevalence, sub-
stantial numbers of people are affected by each of the
symptoms, and some experience distress sufficient to
restrict their daily lives . Our aim as researchers should
be to identify these people and find means to effectively
alleviate their condition while avoiding unnecessary inter-
The use of the current OAB concept has two deleterious
effects. First, encouraging a view of OAB as a uniform
understand the underlying causes of OAB symptoms.
Second, encouraging the view of symptoms, however mild,
as part of a medical syndrome risks overmedicalization.
Rather than lump together a heterogeneous group of
symptoms [13,14], we should investigate the individual
symptoms separately to understand their different risk
factors and varied underlying pathophysiology. Elsewhere,
the need to determine the varying causes of nocturia has
been convincingly argued  rather than reliance on a
‘‘one pill for every patient’’ philosophy. This wise counsel
could be equally applied to urgency, urge incontinence, and
frequency. Moving optimally toward a future of more
effective treatments is likely to entail relinquishing the
concept of an OAB syndrome.
Conflicts of interest: Dr. Tikkinen serves as a European Association of
Urology guideline panel member on the conservative treatment of non-
neurogenic male lower urinary tract symptoms and as an International
Consultation on Incontinence Epidemiology committee member.
Funding support: The work of Dr. Tikkinen was funded by unrestricted
grants from the Finnish Medical Foundation and the Finnish Cultural
Foundation. The fundingsources had noroleinthedesign and conduct of
the study; collection, management, analysis, and interpretation of the
data; and preparation, review, or approval of the manuscript. The
authors’ work was independent of the funders.
Acknowledgment statement: We thank Drs. Gordon H. Guyatt and Katy
Khoo for valuable comments on earlier versions of manuscript, Felix
Allen for assistance with information retrieval, and Virginia Mattila for
 Fall M, Ohlsson BL, Carlsson CA. The neurogenic overactive bladder.
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 Abrams P, Wein AJ. The overactive bladder: from basic science to
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ogy of lower urinary tract function: report from the Standardisation
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Fig. 3 – Reported conflicts of interest for authors of overactive bladder
papers by subtype. Includes manuscripts of original research with term
overactive bladder between January 2007 and November 2011 that
include conflict of interest statements and that were published in the
five journals that publish the most overactive bladder research (BJU
International, European Urology, International Urogynecology Journal
and Pelvic Floor Dysfunction, Neurourology and Urodynamics, and The
Journal of Urology).
RCT = randomized controlled trial.
EUROPEAN UROLOGY 61 (2012) 746–748