A randomized trial comparing transurethral resection of the prostate, laser therapy and conservative treatment of men with symptoms associated with benign prostatic enlargement: The CLasP study
Jl. Donovan et al., A randomized trial comparing transurethral resection of the prostate, laser therapy and conservative treatment of men with symptoms associated with benign prostatic enlargement: The CLasP study, J UROL, 164(1), 2000, pp. 65-70
Purpose: We evaluated the effectiveness of a new technology (noncontact las
er therapy) versus that of standard surgery (transurethral prostatic resect
ion) and conservative management for lower urinary tract symptoms associate
d with benign prostatic enlargement.
Materials and Methods: Men with uncomplicated lower urinary tract symptoms,
that is no acute or chronic urinary retention, were randomized to receive
laser therapy with a noncontact, side firing neodymium:YAG probe, standard
transurethral prostatic resection or conservative management, including mon
itoring without active intervention, in a large multicenter pragmatic rando
mized controlled trial called the CLasP study. Primary outcomes were Intern
ational Prostate Symptom Score (I-PSS), maximum urinary flow rate, a compos
ite measure of success based on I-PSS and maximum urinary flow rate categor
ies, I-PSS quality of life score and post-void residual urine volume. Secon
dary outcomes included treatment failure, hospital stay and major complicat
ions. Followup was 7.5 months after randomization. Intent to treat analysis
was done using analysis of covariance, proportional odds models and the Ne
wman-Keuls multiple comparisons procedure.
Results: Of symptomatic patients 117, 117 and 106 were randomized to receiv
e laser therapy, transurethral prostatic resection and conservative managem
ent, respectively. Baseline characteristics were similar. All primary outco
mes indicated that transurethral prostatic resection and laser therapy were
superior to conservative management, and resection was superior to laser t
herapy. As measured by combined improved symptoms and maximum urinary flow,
a successful outcome was achieved in 81%, 67% and 15% of men who underwent
transurethral prostatic resection, laser therapy and conservative manageme
nt, respectively. Hospital stay was significantly shorter and complications
fewer for laser therapy than for resection but catheters were in place sig
nificantly longer. Men treated conservatively did not have deterioration or
treatment failure.
Conclusions: Laser therapy and transurethral prostatic resection are effect
ive for decreasing lower urinary tract symptoms and post-void residual urin
e volume as well as improving quality of life and maximum urinary flow in t
he short term in men presenting with moderate to severe symptoms. Transuret
hral prostatic resection is superior to laser therapy in terms of effective
ness but some patients may elect laser therapy due to the shorter hospital
stay and lower risk of complications. Conservative management may be accept
able and safe in men with lower urinary tract symptoms since we observed no
marked deterioration in the short term.