Aims
of
study
The
ICSmale
questionnaire
was
developed
to
assess
symptom
occurrence
and
bothersomeness
among
men
with
lower
urinary
tract
symptoms
(LUTS)
related
to
benign
prostatic
enlargement
(BPE).
It
has
been
shown
to
be
valid,
reliable
and
responsive
to
change,1,2 but
the
requirement
to
analyse
each
question
separately
has
made
it
an
unwieldy
measure.
The
aims
of
this
work
were
(a)
to
produce
a
simple
and
concise
scoring
system
that
omitted
duplicate
or
redundant
items
and
took
into
account
sensitivity
to
change
and
degree
of
problem
caused
by
LUTS,
and
(b)
to
test
the
internal
and
external
validity,
reliability
and
responsiveness
of
the
scoring
system.
Methods
Two
data
sets
were
used:
1.
Data
from
the
CLasP
randomised
controlled
trial
comparing
TURP,
non-contact
laser
therapy
and
conservative
management
(CM
-
monitoring
with
no
active
intervention)
in
340
men
with
uncomplicated
BPE3 were used to devise the scoring
system.
Parallel
analyses
were
undertaken
to
identify
redundant
items
and
underlying
dimensions.
Sensitivity
to
degree
of
problem
caused
and
sensitivity
to
change
were
examined
for
each
item,
and
factor
analysis
and
Cronbach’s
alpha
coefficients
were
employed
to
investigate
groupings
of
baseline
symptoms
that
could
be
combined
in
a
score. Redundant and insensitive items were omitted from the final factor
analysis.
The
internal
validity
of
the
scoring
system
was
investigated
in
terms
of
comparisons
of
the
distributions
of
scores
at
baseline
and
follow-up
in
each
of
the
treatment
groups
using
regression
models.
Correlations
between
ICSmale and I-PSS scores were computed.
2.
Data
from
the
317
men
followed
up
in
Phase
II
of
the
ICS-‘BPH’
study
of
men
with
LUTS
were
used
to
examine
the
external
validity
of
the
scoring
system.
ICSmale scores were investigated using regression models to compare patient
groups
according
to
treatment
received
–
TURP,
minimally
invasive
therapies,
drug
therapies
and
watchful
waiting.
All patients completed
the
23-item
developmental
version
of
the
ICSmale questionnaire at baseline and follow up (mean 8 months after
randomisation
in
CLasP,
16
months
in
ICS-‘BPH’
study).
Results
Devising
the
score:
Five
items
were
found
not
to
be
sensitive
to
the
degree
of
problem
caused,
not
to
change
following
active
treatment,
and
not
to
load
highly
in
the
initial
factor
analysis:
bladder
pain,
sitting
to
urinate,
always
had
a
weak stream, repeated urination, dysuria
and
acute
retention.
These
items
were
omitted
from
further
analyses. Duplicate items were found for reduced stream,
hesitancy
and
dribbling
and
were
also
dropped. 13 symptoms were entered into the final factor
analysis,
with
11
producing
two
clear
factors
with
scores
obtainable
by
simple
addition:
(a) Voiding symptoms
(ICSmaleVS):
hesitancy,
straining
to
continue,
reduced
stream,
intermittency
and
incomplete
emptying
(loadings
>0.49,
alpha
0.76;
minimum
0,
maximum
20)
(b) Incontinence (ICSmaleIS): urge, stress, miscellaneous and
nocturnal
incontinence,
urgency
and
post-micturition
dribble
(loadings
>0.50,
alpha
0.78;
minimum
0,
maximum
24)
The remaining items,
frequency
and
nocturia,
were
highly
problematic
and
sensitive
to
change,
but
did
not
load
into
either
factor
and
have
a
weak
correlation
with
each
other
(-0.21).
Internal validity of score: Missing data were
minimal.
ICSmaleVS
and
ICSmaleIS changed little in those randomised
to
CM.
ICSmaleVS
was
able
to
detect
significant
improvements
following
laser
therapy
and
TURP
compared
with
CM
(p<0.0001).
ICSmaleIS
was
also
able
to
detect
these
differences
(p<0.0001),
although
to
a
slightly
lesser
degree.
Correlations
were
highest
between
the
ICSmaleVS
and
the
I-PSS
(0.68),
and
somewhat
lower
between
ICSmaleIS
and
I-PSS
(0.36)
and
ICSmaleVS
and
ICSmaleIS
(0.24).
External validity of score: Again, ICSmaleVS was clearly able to distinguish between the treatment groups
in
the
ICS-’BPH’
study
(p<0.0001).
Those
who
received
TURP
exhibited
greater
improvements
than
those
receiving
miniminally
invasive
therapies,
and
these
in
turn
showed
greater
improvements
than
those
receiving
drug
therapies. Patients in the watchful waiting groups changed minimally. The pattern was similar for ICSmaleIS, but to a lesser degree (p<0.0012).
Frequency and nocturia: Individually and within a combined score, frequency and nocturia
were
able
to
indicate
significant
differences
between
the
treatment
groups.
When
included
in
the
other
scores,
however,
they
reduced
the
sensitivity
of
the
scores.
Conclusion
This work marks
the
completion
of
the
development
of
the
ICSmale
questionnaire.
The
final
version
(ICSmaleSF) is concise and consists of two
simply
scored
sub-scales
for
voiding
and
incontinence
(five
and
six
items
respectively),
with
the
separate
consideration
of
the
symptoms
frequency
and
nocturia.
For
completeness,
the
single
item
’interference
with
life’
may
also
be
added
from
ICSQoL to allow the separate assessment of impact on everyday life.
The
final
questionnaire
is
easy
to
complete,
results
in
minimal
missing
data,
produces
valid
and
reliable
data,
and
is
responsive
to
change.
In
addition,
it
now
provides
a
simple,
flexible
and
clinically
relevant
tool
for
research
and
clinical
practice.
We
hope
that
it
will
become
the
tool
of
choice
for
the
comprehensive
evaluation
of
men
with
LUTS.
References:
1.
The
psychometric
validity
and
reliability
of
the
ICSmale questionnaire. BJU, 1996; 77: 554-562.
2.
The
responsiveness
of
the
ICSmale
questionnaire
to
outcome:
evidence
from
the
ICS-'BPH'
study. BJUI,
1999;
83:
243-48.
3.
A
randomised
trial
comparing
TURP,
laser
therapy
and
conservative
management
in
men
with
symptoms
associated
with
benign
prostatic
enlargement:
the
CLasP
study. J Urol in press.
