Objective To establish the short term clinical and urodynamic effect o
f transurethral microwave thermotherapy (TUMT) in men with symptomatic
uncomplicated benign prostatic hyperplasia (BPH) using a randomized c
ontrolled trial comparing the treatment with both 'placebo-like' and u
ntreated control groups. Patients and methods The study comprised 120
symptomatic patients with BPH who were candidates for transurethral re
section and TUMT, They were randomized to one of three groups: group 1
underwent a standard TUMT, group 2 underwent a simulated treatment id
entical to group 1 but with no emission of microwaves and group 3 rece
ived no treatment. The treatment of the first two groups was 'double-b
lind' and the heat experienced by the patients during treatment was si
mulated in both, Patients were assessed on entry to the study and 6 mo
nths after treatment using an identical protocol to measure the Americ
an Urological Association (AUA) symptom score, maximum urinary flow ra
te (Q(max)), post-void residual urine volume (PVR), minimum urethral o
pening pressure (p(muo)) and maximum detrusor pressure (p(det max)). R
esults In the untreated group there were no clinically or statisticall
y significant changes in the median AUA symptom score, Q(max), PVR, p(
muo) and p(det max). In group 1 the AUA score changed significantly, f
rom 19 to 9.5, but the Q(max), PVR, p(muo) and p(det max) did not. In
group 2, the AUA score also changed significantly, from 17.5 to 9.5, b
ut Q(max), PVR, p(muo) and p(det max) did not. Conclusion The untreate
d control group showed no clinically relevant deterioration or improve
ment. The standard and simulated TUMT groups showed little clinically
relevant improvement in 'objective' variables, while the clinically si
gnificant symptom improvement was of a similar magnitude in both group
s.