EURURO Vol. 73 No. 1

E15 148

Letter to the Editor
Reply to Bora Lee and Jae Heon Kim's Letter to the Editor
re: Alan D. Uren, Nikki Cotterill, Christopher Harding,
et al. Qualitative Exploration of the Patient Experience
of Underactive Bladder. Eur Urol 2017;72:402–7
We thank the authors for their letter on our article and
provide the following clarifications in response. A patient-
reported outcome (PRO) measure was not used as part of
the methodology in this study. Indeed, PRO measure
development requires a lengthy validation process, of
which this was the initial phase. The findings support the
development of a new PRO measure for the assessment of
the signs, symptoms, and impact of underactive bladder
(UAB).
The study used qualitative methodology to explore the
experience of UAB from a patient perspective using semi-
structured interviews, guided by an interview schedule.
Patients were encouraged to talk in an open-ended manner
about their experiences, using prompts from the interview
schedule to “guide” discussion. A well-designed interview
guide is important in order to help avoid possible
interviewer bias or unintentional influence of the re-
searcher on the type of responses from the subject.
Exploratory qualitative interviews are particularly useful
to explore around a topic for which little may be
understood, as is the case with UAB. Direct patient input
using qualitative research methodology is important for
the demonstration of content validity when developing a
new instrument
Although the underlying aetiology of the presenting
detrusor underactivity (DU) in the sample was not
assessed, neurological patients were excluded. However,
as UAB was the symptom complex under investigation, it
was not necessary to ascertain the underlying aetiology of
the DU at this stage. Indeed, there is a lack of evidence for
the symptomatic presentation of its various aetiological
origins, which requires further study. We took the
pragmatic decision to categorise our sample by those
with DU only and those with DU and coexisting condi-
tions. This allowed the notable reporting of incontinence
to be mainly associated with the inclusion of the group
with those who demonstrated DU and coexisting detrusor
overactivity or stress urinary incontinence during urody-
namic assessment. The complex underling aetiology of
nocturia was discussed as being problematic; we agree it
is uncertain to what extent nocturia can be attributed to
the presence of DU.
As an initial qualitative study, the intention was not to
produce representative epidemiological data, but to identify
the patient-relevant symptoms and impacts. Responsive-
ness and other psychometric properties of the develop-
mental PRO measure, including further elucidation of
symptom prevalence and bother, will be possible later in
the PRO measure validation process.
Conflicts of interest: Alan D. Uren, Paul Abrams, and Nikki Cotterill are
supported by a grant from Astellas. Monique Klaver, Dominique
Bongaerts, and Zalmai Hakimi are employees of Astellas Pharma
Europe. Paul Abrams has received personal fees from Astellas, Pfizer,
Ferring, Ipsen, and Sun Pharma. Nikki Cotterill has received personal
fees from Procter and Gamble. Christopher Chapple has received
personal fees from Allergan, Astellas, Medtronic, and Recordati.
Christopher Harding has received personal fees from Astellas, Pfizer,
Ferring, Allergan, Medtronic, American Medical Systems, and Pierre
Fabre Pharmaceuticals.
References
[1] Uren AD, Cotterill N, Harding C, et al. Qualitative exploration of
the patient experience of underactive bladder. Eur Urol 2017;72:
402–7. .
[2] Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity— establish-
ing and reporting the evidence in newly developed patient-
reported outcomes (PRO) instruments for medical product evalua-
tion: ISPOR PRO Good Research Practices Task Force Report: part 1 —
eliciting concepts for a new PRO instrument. Value Health
2011;14:967–77. .
[3]
.
Alan D. Urena,*
Nikki Cotterilla
Christopher Hardingb
Christopher Hillaryc
Christopher Chapplec
Monique Klaverd
Dominique Bongaertsd
ava ilable at
journal homepage:
DOIs of original articles: .
0302-2838/© 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.