Pros-Eight transurethral radiofrequency thermotherapy for benign prostatic hyperplasia: preliminary clinical results.
BACKGROUND
We have developed a new transurethral thermotherapy device using 8MHz radiofrequency (RF) for the treatment of patients with symptomatic benign prostatic hyperplasia (BPH). We report the safety and effectiveness of the initial clinical experience with this device.


METHODS
Sixty patients with symptomatic BPH were subjected to a single 1-hour treatment under local anesthesia. The treatment device uses extracorporeal RF capacitive heating in combination with radiative heating and conductive cooling of the urethra.


RESULTS
In the 49 patients evaluable at 3 months, the mean International Prostate Symptom Score decreased from 17.8 to 13.1 (P < 0.0001) and the Quality of Life score decreased from 4.4 to 3.4 (P < 0.0005). Maximum flow rate increased from 8.1 to 9.7 mL/s (P < 0.05) at 3 months. Overall effectiveness by Homma's response criteria was as follows; excellent 4.1%, good 10.2%, fair 38.8% and poor 46.9%. Side effects were minimal. Gross hematuria was seen in 3 patients and erosion of the external urethral meatus was seen in 2 patients, but none had urinary retention.


CONCLUSIONS
In this initial clinical trial, transurethral RF thermotherapy was safe and resulted in modest symptomatic improvement. Further investigations for optimizing the treatment protocol seem warranted.
Yoshida
O
O
Department of Urology, Kyoto University, Faculty of Medicine, Japan.
Terai
A
A
Shichiri
Y
Y
Okada
Y
Y
Ishitoya
S
S
Okubo
K
K
Suzuki
Y
Y
Arai
Y
Y
D000368:Aged; D000369:Aged, 80 and over; D005500:Follow-Up Studies; D006801:Humans; D006979:Hyperthermia, Induced / Q000295:instrumentation / Q000379:methods; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011470:Prostatic Hyperplasia / Q000000981:diagnostic imaging / Q000628:therapy*; D000078702:Radiofrequency Therapy; D016896:Treatment Outcome; D014463:Ultrasonography; D014521:Urethra