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
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* Corresponding author.
E-mail address: email@example.com (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
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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