Objectives, We report the first experimental studies of focused extrac
orporeal pyrotherapy. Methods. focused extracorporeal pyrotherapy has
been used to treat superficial bladder tumors in a Phase II protocol i
n 25 patients. In 5 cases, for technical reasons, pyrotherapy was not
used. In 20 patients (10 under general anesthesia and 10 under spinal
anesthesia), the mean treated volume was 3 cm(3) with an average of 30
0 shots and a mean skin focused length of 90 mm. Treatment time was 44
minutes; hospital stay was 2 days. Postoperatively, two skin burns an
d one acute retention were observed. Results, Of 20 patients, 15 (75%)
had a normal urinary cytology bladder ultrasonography and cystoscopy
at 1 month. in 67% of patients with primary tumor, there was no recurr
ence at 1 year; 33% had recurrent tumors. No infiltrative tumor or met
astases have been observed during this follow-up (3 to 21 months). Con
clusions, These encouraging results show that ablation of superficial
bladder tumor is feasible, The technique must be improved to allow tre
atment of larger tumor volume in a shorter time.