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

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

Cell-kill modeling of microwave thermotherapy for treatment of benign prostatic hyperplasia.

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Cell-kill modeling of microwave thermotherapy for treatment of benign prostatic hyperplasia

We investigated whether cell-kill modelling could be used as a mean for predicting the outcome of microwave thermotherapy for benign prostate hyperplasia (BPH). The two models--Henriques' damage integral and Jung's compartment model--were implemented in a computer program. Real treatment data for 22 patients with BPH who were in chronic retention were used as input, including measured intraprostatic temperatures and microwave power. To test if modelling gives results that are consistent with actual observations, comparison with transrectal ultrasound (TRUS) measurements of the prostate volume before and after treatment was made. The sensitivity of the computer model for variations in the heat cytotoxicity and the temperature probe location in the adenoma was also tested. The average TRUS volume reduction 3 months after treatment was 26 cc, whereas the corresponding cell kill calculation was 27 cc. The computer model appears to be rather insensitive to minor uncertainties in heat sensitivity and location of the intraprostatic reference temperature sensors. Cell-kill modelling appears to give results that are consistent with actual observations. The coagulated tissue volume is calculated in real time during the treatment, thereby providing an immediate prediction of the treatment outcome. By using cell-kill modelling, the endpoint of a treatment can be set individually; e.g., when a certain volume reduction has been achieve

Efficacy and Safety of Rezum System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

OBJECTIVES: To assess 1 year efficacy and safety data from pilot trials of the Rezum System water vapor to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: A total of 65 men with symptoms of moderate to severe BPH were enrolled in pilot studies at centers in the Dominican Republic, the Czech Republic, and Sweden. Each patient was treated with transurethral delivery of sterile water vapor (steam). International Prostate Symptom Score (IPSS), peak urinary flow (Qmax), quality of life (QoL), post void residual (PVR), International Index of Erectile Function (IIEF) and prostate-specific antigen (PSA) were evaluated at 1 week and 1, 3, 6 and 12 months post-treatment. Safety was also assessed. RESULTS: Statistically significant clinical improvements at 1, 3, 6, and 12 months were reported for IPSS (decreased by 6.8, 13.4 13.1, and 12.5 points, respectively) and Qmax (increased by 2.0, 4.7, 4.3, and 4.6 ml/sec, respectively). At 12 months, these results equated to a 56% improvement in IPSS (

Evaluation of microwave thermotherapy with histopathology, magnetic resonance imaging and temperature mapping

Purpose: Interstitial temperature mapping was used to determine the heat field within the prostate by the Coretherm. (ProstaLund, Lund, Sweden) transurethral microwave thermotherapy device. Gadolinium. enhanced magnetic resonance imaging (MRI) and histopathology were used to determine the extent and pattern of coagulation necrosis following treatment. The cell kill assessment feature of the device was compared with MRI and histopathology. Materials and Methods: A total of 12 patients were treated, including 5 with adenocarcinoma of the prostate and 7 with benign prostatic hyperplasia. Temperature sensors were inserted from the perineum. to map the temperature distribution. The 5 patients with adenocarcinoma underwent prostatectomy and subsequent histopathology 3 to 6 weeks after treatment. MRI and cell kill calculations were performed in all patients. Results: Therapeutic temperatures were found in a bowl-like shape with a wide circumference of highest temperatures at the base of the prostate, and decreasing temperature and circumference toward the apex. Tissue necrosis assessed by histopathology, MRI and cell kill calculations overlapped reasonably well in shape and size. Histopathology showed that the prostatic urethra was destroyed by treatment. Conclusions: Coretherm microwave treatment causes significant tissue necrosis of the prostate, bladder neck and urethral mucosa. The cell kill calculation provides an on-line estimate of the amount of necrosis caused during treatment

Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia

Christopher M Dixon,1 Edwin Rijo Cedano,2 Dalibor Pacik,3 V&iacute;tězslav Vit,3 Gabriel Varga,3 Lennart Wagrell,4 Thayne R Larson,5 Lance A Mynderse6 1Department of Urology, Phelps Memorial Hospital, Sleepy Hollow, New York, NY, USA; 2Department of Urology, Clinical Canela, La Romana, Dominican Republic; 3Department of Urology, Brno University Hospital, Brno, Czech Republic; 4Urologcentrum, Stockholm, Sweden; 5Institute of Medical Research, Scottsdale, AZ, 6Department of Urology, Mayo Clinic, Rochester, MN,&nbsp;USA Objective: The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations.Patients and methods: Men aged &ge;45 years with an International Prostate Symptom Score &ge;13, a maximum urinary flow rate (Qmax) &le;15 mL/s, and prostate volume 20&ndash;120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months. Results: LUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen. Conclusion: The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years. Keywords: benign prostatic hyperplasia, lower urinary tract symptoms, convective RF, water vapor thermal therapy, minimally invasive&nbsp

Feedback microwave thermotherapy versus TURP for clinical BPH - A randomized controlled multicenter study

Objectives. To compare the outcome of a microwave thermotherapy feedback system that is based on intraprostatic temperature measurement during treatment (ProstaLund Feedback Treatment or PLFT) with transurethral resection of the prostate (TURP) for clinical benign prostatic hyperplasia (BPH) in a randomized controlled multicenter study. The safety of the two methods was also investigated. Methods. The study was performed at 10 centers in Scandinavia and the United States. A total of 154 patients with clinical BPH were randomized to PLFT or TURP (ratio 2:1); 133 of them completed the study and were evaluated at the end of the study 12 months after treatment. Outcome measures included the International Prostate Symptom Score (IPSS), urinary flow, detrusor pressure at maximal urinary flow (Qmax), prostate volume, and adverse events. Patients were seen at 3, 6, and 12 months. Responders were defined according to a combination of IPSS and Qmax: IPSS 7 or less, or a minimal 50% gain, and/or Qmax 15 mL/s or greater or a minimal 50% gain. Results. No significant differences in outcome at 12 months were found between PLFT and TURP for IPSS, Qmax, or detrusor pressure. The prostate volume measured with transrectal ultrasonography was reduced by 30% after PLFT and 51% after TURP. Serious adverse events related to the given treatment were reported in 2% after PLFT and in 17% after TURP. Mild and moderate adverse events were more common in the PLFT group. With the criteria mentioned above, 82% and 86% of the patients were characterized as responders after 12 months in the PLFT and TURP groups, respectively. The post-treatment catheter time was 3 days in the TURP group and 14 days in the PLFT group. Conclusions. The outcome of microwave thermotherapy with intraprostatic temperature monitoring was comparable with that seen after TURP in this study. From both a simplicity and safety point of view, PLFT appears to have an advantage. Taken together, our findings make us conclude that: within a 1-year perspective microwave thermotherapy with PLFT is an attractive alternative to TURP in the treatment of BPH