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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

Gravas, S; Laguna, P; Ehrnebo, M; Wagrell, L; Mattiasson, Anders LU and de la Rosette, JJMCH (2005) In Journal of Urology 174(3). p.1002-1006
Abstract
Purpose: We compared ProstaLund Feedback Treatment(R) (PLFT(R)) to transurethral prostate resection (TURP) in terms of efficacy and safety in a pooled analysis of 3 clinical studies with 1-year followup. Materials and Methods: Overall raw data on 183 patients with PLFT(R) 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(R) and TURP groups, respectively. One-sided 95% CI analysis showed the noninferiority of PLFT(R) vs TURP for this variable. Mean... (More)
Purpose: We compared ProstaLund Feedback Treatment(R) (PLFT(R)) to transurethral prostate resection (TURP) in terms of efficacy and safety in a pooled analysis of 3 clinical studies with 1-year followup. Materials and Methods: Overall raw data on 183 patients with PLFT(R) 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(R) and TURP groups, respectively. One-sided 95% CI analysis showed the noninferiority of PLFT(R) vs TURP for this variable. Mean International Prostate Symptom Score was significantly decreased in the PLFT(R) 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(R) was within the noninferiority definition compared with that of TURP. The bother score decrease in the PLFT(R) 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(R) 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(R) 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(R) (p = 0.035). Conclusions: Combined experience from our pooled analysis indicates that PLFT(R) challenges TURP in terms of efficacy and safety after 1 year of followup. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
prostate, transurethral resection of prostate, prostatic hyperplasia
in
Journal of Urology
volume
174
issue
3
pages
1002 - 1006
publisher
Lippincott Williams & Wilkins
external identifiers
  • wos:000231274700054
  • pmid:16094023
  • scopus:23744511267
ISSN
1527-3792
DOI
10.1097/01.ju.0000169266.20149.29
language
English
LU publication?
yes
id
6a361e27-741c-42dd-b6e0-3cf66c6cb1ad (old id 226687)
date added to LUP
2007-08-24 13:31:08
date last changed
2017-07-09 04:21:57
@article{6a361e27-741c-42dd-b6e0-3cf66c6cb1ad,
  abstract     = {Purpose: We compared ProstaLund Feedback Treatment(R) (PLFT(R)) to transurethral prostate resection (TURP) in terms of efficacy and safety in a pooled analysis of 3 clinical studies with 1-year followup. Materials and Methods: Overall raw data on 183 patients with PLFT(R) 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(R) and TURP groups, respectively. One-sided 95% CI analysis showed the noninferiority of PLFT(R) vs TURP for this variable. Mean International Prostate Symptom Score was significantly decreased in the PLFT(R) 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(R) was within the noninferiority definition compared with that of TURP. The bother score decrease in the PLFT(R) 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(R) 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(R) 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 &lt;0.000001). Serious adverse events with causality occurred in 15.4% of patients with TURP compared with 6.0% in those with PLFT(R) (p = 0.035). Conclusions: Combined experience from our pooled analysis indicates that PLFT(R) challenges TURP in terms of efficacy and safety after 1 year of followup.},
  author       = {Gravas, S and Laguna, P and Ehrnebo, M and Wagrell, L and Mattiasson, Anders and de la Rosette, JJMCH},
  issn         = {1527-3792},
  keyword      = {prostate,transurethral resection of prostate,prostatic hyperplasia},
  language     = {eng},
  number       = {3},
  pages        = {1002--1006},
  publisher    = {Lippincott Williams & Wilkins},
  series       = {Journal of Urology},
  title        = {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},
  url          = {http://dx.doi.org/10.1097/01.ju.0000169266.20149.29},
  volume       = {174},
  year         = {2005},
}