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not currently included in the 2015 UAB symptomatic
definition These classic LUTS are consistent with a
weak bladder contraction and are in accordance with
symptoms associated with DU in the literature The
current study also corroborated recent findings by Gammie
et al which associated a feeling of incomplete
emptying, absent, or reduced sensation and a variety of
bowel issues to DU patients. A postvoid residual of >30 ml
(median: 199 ml) was present in the majority of partici-
pants, and a large proportion of patients were currently or
had historically self-catheterised and/or had urinary tract
infections, as well as some who had experienced acute
retention episodes.
Previous research supports the findings that there can be
a broad impact on patient’s lives associated with LUTS
. The requirement to plan ahead around the location
of toilets, disruption to sleep, embarrassment in certain
situations, and consequent effect on social life, self-esteem,
and confidence are supported by other qualitative studies in
male and female patients with LUTS Many of the
patients with UAB experienced similar levels of impact but
others felt they were able to manage their symptoms to
minimise the impact on their lives.
The current study provides a robust evidence base on
which to base the development of a PRO instrument to
evaluate interventions for UAB. A number of symptoms,
signs, and areas of impact were identified that may provide
sensitive indicators of improvement or deterioration in UAB
following treatment. [18_TD$DIFF]There are [19_TD$DIFF]also challenges to the
development of a specific UAB PRO measure. Some of the
commonly reported symptoms may have multiple aetiol-
ogies, such as pain or nocturia, which may be a consequence
of other health or behavioural factors unrelated to lower
urinary tract dysfunction The overlap of the
reported symptoms in patients with coexisting OAB or
bladder outlet obstruction is already recognised and
will be investigated further in later quantitative PRO
measure validation studies.
A strength of this study is that all patients were clinically
verified to have a primary diagnosis of DU by PFS. In
addition, those with coexisting urological conditions were
included to ensure the relevance of the PRO measure to the
whole spectrum of DU patients. The study is not intended to
produce representative epidemiological data but to elicit
the overall patient experience of UAB. The further elucida-
tion of symptom prevalence and bother will be possible
later in the PRO measure development process. This study
also cannot be used to link UAB to urodynamic DU. Further
interviews with patients from the USA and Japan are
scheduled in order to explore potential differences in how
patients from other cultures and ethnicities describe UAB
symptoms.
5. Conclusions
The current study describes the progress in our under-
standing of how the clinical diagnosis of DU manifests as
symptoms, by a thorough exploration of the lived experi-
ence of patients. This knowledge supports the development
of a PROmeasure for the outcome assessment of UAB for use
in trials, research, and clinical practice and is valuable to the
further development of the definition of UAB.
Author contributions: Alan D. Uren had full access to all the data in the
study and takes responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Cotterill, Abrams, Hakimi.
Acquisition of data: Uren, Cotterill.
Analysis and interpretation of data: Uren, Cotterill, Klaver, Bongaerts,
Hakimi, Abrams.
Drafting of the manuscript: Uren.
Critical revision of the manuscript for important intellectual content: Uren,
Cotterill, Harding, Hillary, Chapple, Klaver, Bongaerts, Hakimi, Abrams.
Statistical analysis: None.
Obtaining funding: Cotterill, Abrams.
Administrative, technical, or material support: None.
Supervision: Cotterill.
Other: None.
Financial disclosures: Alan D. Uren certifies that all conflicts of interest,
including specific financial interests and relationships and affiliations
relevant to the subject matter or materials discussed in the manuscript
(eg, employment/affiliation, grants or funding, consultancies, honoraria,
stock ownership or options, expert testimony, royalties, or patents filed,
received, or pending), are the following: Uren, Abrams, Cotterill are
supported by a grant from Astellas; Klaver, Bongaerts, Hakimi are
employees of Astellas Pharma Europe; Abrams reports personal fees
from Astellas, Pfizer, Ferring, Ipsen, and Sun Pharma; Cotterill reports
personal fees from Procter and Gamble; Chapple reports personal fees
from Allergan, Astellas, Medtronic, Recordati; Harding reports personal
fees fromAstellas, Pfizer, Ferring, Allergan, Medtronic, American Medical
Systems, Pierre Fabre Pharmaceuticals.
Funding/Support and role of the sponsor: Astellas Pharma Europe
assisted with the design and conduct of the study, analysis, preparation,
review, and approval of the manuscript.
Acknowledgments: The authors would like to thank the participating
patients of Southmead Hospital, North Bristol NHS Trust for their valued
contributions. The authors are also grateful to Christopher Thomas,
research assistant, and the administrative team for their input to
conducting and transcribing the patient interviews. This work was
funded by Astellas Pharma Europe B.V. who also contributed to the
design of the study, preparation, and review of the manuscript.
Appendix A. Supplementary data
Supplementary data associated with this article can be
found, in the online version, at doi:10.1016/j.eur-
uro.2017.03.045.
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