Gravas Stavros, Laguna Pilar, Ehrnebo Mats, Wagrell Lennart, Mattiasson Anders, de la Rosette Jean J M C H
Diagnostic and Therapeutic Center of Athens Hygeia Agia Paraskevi, Athens, Greece.
J Urol. 2005 Sep;174(3):1002-6; discussion 1006. doi: 10.1097/01.ju.0000169266.20149.29.
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.
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.
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).
Combined experience from our pooled analysis indicates that PLFT challenges TURP in terms of efficacy and safety after 1 year of followup.
