Seeking evidence that cell kill guided thermotherapy gives results not inferior to those of transurethral prostate resection: results of a pooled analysis of 3 studies of feedback transurethral microwave thermotherapy.
OBJECTIVE
We compared ProstaLund Feedback Treatment (PLFT) to transurethral prostate resection (TURP) in terms of efficacy and safety in a pooled analysis of 3 clinical studies with 1-year followup.


METHODS
Overall raw data on 183 patients with PLFT and 65 with TURP were pooled. All studies had identical inclusion criteria, and the efficacy and safety of the method were evaluated using the International Prostate Symptom Score, maximum urine flow (Qmax), responder rate, bother score, prostate volume reduction and adverse events.


RESULTS
The response rate was 85.3% and 85.9% in the PLFT and TURP groups, respectively. One-sided 95% CI analysis showed the noninferiority of PLFT vs TURP for this variable. Mean International Prostate Symptom Score was significantly decreased in the PLFT and TURP groups after 12 months (from 20.9 to 6.4 and 20.7 to 7.1, respectively). The 1-sided upper 95% CI of PLFT was within the noninferiority definition compared with that of TURP. The bother score decrease in the PLFT and TURP groups was not significant different (70.9% and 64.0%, respectively). An increase in Qmax from 7.7 to 16.1 ml per second 12 months after PLFT was noted, while the improvement in Qmax in the TURP group was higher (from 7.5 to 18.6 ml per second). The 1-sided lower 95% CI was close (0.76) but it did not attain the predetermined level of noninferiority (0.80). Mean transurethral ultrasound determined volume 12 months after PLFT and TURP was reduced by 32.8% and 58.1%, respectively. A significant correlation between the transurethral ultrasound determined prostate volume reduction and estimated cell kill was found (r = 0.456, p <0.000001). Serious adverse events with causality occurred in 15.4% of patients with TURP compared with 6.0% in those with PLFT (p = 0.035).


CONCLUSIONS
Combined experience from our pooled analysis indicates that PLFT challenges TURP in terms of efficacy and safety after 1 year of followup.
Gravas
Stavros
S
Diagnostic and Therapeutic Center of Athens Hygeia Agia Paraskevi, Athens, Greece. sgravas2002@yahoo.com
Laguna
Pilar
P
Ehrnebo
Mats
M
Wagrell
Lennart
L
Mattiasson
Anders
A
de la Rosette
Jean J M C H
JJ
D000368:Aged; D016923:Cell Death / Q000502:physiology*; D018849:Controlled Clinical Trials as Topic; D019160:Endosonography; D006801:Humans; D008297:Male; D015201:Meta-Analysis as Topic; D008875:Middle Aged; D009336:Necrosis; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data; D011467:Prostate / Q000473:pathology; D011470:Prostatic Hyperplasia / Q000000981:diagnostic imaging / Q000601:surgery*; D020728:Transurethral Resection of Prostate / Q000379:methods* / Q000706:statistics & numerical data