Purpose: The International Continence Society (ICS) ICSmale questionnaire w
as devised to provide a thorough evaluation of the occurrence and bothersom
eness of lower urinary tract symptoms and their impact on the lives of men
with benign prostatic disease. This report completes the developmental work
on the questionnaire, producing the concise short form instrument, ICSmale
SF, with a valid, reliable and scientifically justified scoring system.
Materials and Methods: Two data sets were used. The short form version of t
he questionnaire was devised and initially evaluated using data on men with
uncomplicated lower urinary tract symptoms who were involved in the CLasP
randomized controlled trial comparing laser therapy with transurethral pros
tatic resection and conservative management or monitoring without active in
tervention. External validation of the scoring system was undertaken using
data from phase II of the ICS benign prostatic hyperplasia (BPH) study, an
observational study of outcome in men with lower urinary tract symptoms rel
ated to benign prostatic enlargement. All patients completed the developmen
tal version of the ICSmale questionnaire. Parallel analysis on the CLasP da
ta set identified items that were responsive to change or highly problemati
c, allowing other redundant and overlapping items to be eliminated. Factor
analysis and Cronbach's alpha coefficients were used to examine the cluster
ing of items. Regression models were used to investigate the validity of fo
llowup scores within and across treatment groups in the CLasP and ICS/BPH s
tudies.
Results: The questionnaire, which originally comprised 22 items, was shorte
ned to 11 items in the 2 distinct factors of voiding (ICSmaleVS) and incont
inence (ICSmaleIS) symptoms. Cronbach's cr coefficients were high at 0.76 f
or ICSmaleVS and 0.78 for ICSmaleIS. A simple additive score was calculated
by adding the 5 items in ICSmaleVS and 6 in ICSmaleIS. ICSmaleVS and ICSma
leIS detected expected improvement in the laser therapy and transurethral p
rostatic resection groups, and stability in the conservative management gro
up within CLasP. Similarly each subscore but particularly ICSmaleVS was sen
sitive to differences in the outcome of the range of treatments in the ICS/
BPH study. While frequency and nocturia were highly problematic and sensiti
ve to change individually, they did not load into the other main factors or
correlate with each other. It is suggested that these symptoms should be e
valuated separately with the additional inclusion of a single item measure
of the impact of lower urinary tract symptoms on daily life.
Conclusions: The ICSmaleSF represents a comprehensive, concise, valid and r
eliable instrument for evaluating men with lower urinary tract symptoms. Un
like other questionnaires in the field it contains subscores for the domain
s of voiding and incontinent symptoms as well as the separate consideration
of frequency, nocturia and impact on daily life. We hope that it will beco
me the tool of choice for the comprehensive evaluation of treatment of men
with lower urinary tract symptoms associated with benign prostatic disease.