Long-term pooled analysis of multicenter studies of cooled thermotherapy for benign prostatic hyperplasia results at three months through four years.
OBJECTIVE
To determine the long-term efficacy of cooled thermotherapy in the treatment of lower urinary tract symptoms of clinical benign prostatic hyperplasia.


METHODS
A total of 541 men underwent cooled thermotherapy treatment in six multicenter studies in the United States, England, and Canada. Both fixed and random effects models were used to pool the data across the six studies. The treatment response was measured as the difference between the urinary tract symptoms at baseline versus those at 3, 12, 24, 36, and 48 months after therapy. The treatment response included changes in the American Urological Association Symptom Score (AUA symptom score), peak urinary flow rate in milliliters per second (Qmax), and quality of life (QOL).


RESULTS
The baseline measures were comparable across the studies. At 3 months, the AUA symptom score had improved by a mean of 11.6 (55%), Qmax by a mean of 4.0 (51%), and QOL by a mean of 2.3 (53%). These changes persisted with only slight attenuation through 48 months (corresponding mean changes of 43%, 35%, and 50%). These changes were highly statistically significant (P <0.0001 to 0.01). An improvement of at least 25% was achieved for the AUA symptom score and QOL by more than 85% of men and by more than 65% of men for Qmax.


CONCLUSIONS
This pooled analysis of six multicenter studies of cooled thermotherapy, involving 541 men, found highly significant improvements in AUA symptom score, Qmax, and QOL. The results were highly consistent across the studies. The improvements reflected changes from baseline values of 45% to 50% for AUA symptom score and QOL and 35% to 40% for Qmax at a follow-up duration up to 48 months after therapy. The level of improvement for all three measures remained high at 48 months, indicating that the response is durable.
Trock
Bruce J
BJ
Division of Epidemiology, Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, Maryland 21287, USA.
Brotzman
Michelle
M
Utz
William J
WJ
Ugarte
Roland R
RR
Kaplan
Steven A
SA
Larson
Thayne R
TR
Blute
Michael L
ML
Roehrborn
Claus G
CG
Partin
Alan W
AW
D000368:Aged; D001831:Body Temperature; D002170:Canada; D003080:Cold Temperature; D003431:Cross-Cultural Comparison; D004739:England; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011470:Prostatic Hyperplasia / Q000175:diagnosis / Q000628:therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D020728:Transurethral Resection of Prostate / Q000379:methods*; D016896:Treatment Outcome; D014481:United States; D014563:Urodynamics / Q000502:physiology; D014867:Water / Q000008:administration & dosage
D014867:Water