Lennart Wagrell

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.

Rezūm System Water Vapor Treatment for Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: Validation of Convective Thermal Energy Transfer and Characterization With Magnetic Resonance Imaging and 3-Dimensional Renderings.

OBJECTIVE To evaluate by magnetic resonance imaging the physical effects of convective thermal energy transfer with water vapor as a means of treating lower urinary tract symptoms due to benign prostatic hyperplasia. METHODS Sixty-five men with lower urinary tract symptoms were treated with the Rezūm System by transurethral intraprostatic injection of water vapor. A group of 45 of these men consented to undergo a series of gadolinium-enhanced magnetic resonance imagings of the prostate after treatment to monitor the size and location of ablative lesions, their time course of resolution, and the corresponding change in prostate tissue volume. Visualization was conducted at 1 week, 1, 3, and 6 months after treatment. RESULTS Outcomes were available for 44 patients. Convective thermal lesions were limited to the transition zone and correlated with targeted treatment locations. At 1 week after treatment, the mean volume of ablative lesions was 8.2 cm(3) (0.5-24.0 cm(3)). At 6 months, whole prostate volume was reduced by a mean of 28.9% and transition zone volume by 38.0% as compared with baseline 1-week images. At 3 and 6 months after treatment, the lesion volumes had reduced by 91.5% and 95.1%, respectively. Lesions remained within the targeted treatment zone without compromising integrity of the bladder, rectum, or striated urinary sphincter. CONCLUSION This imaging study confirms the delivery of convective water vapor technology to create thermal lesions in the prostate tissue. Lesions generated underwent near complete resolution by 3 and 6 months after treatment with a concomitant one-third reduction in overall prostate and transition zone volumes.

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

OBJECTIVE To assess 1-year efficacy and safety data from pilot trials of the Rezūm System water vapor to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIALS AND 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), postvoid residual, International Index of Erectile Function, and prostate-specific antigen 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 (P <.001) and an 87% improvement in Qmax (P <.001). QoL also improved at 12 months with a 61% improvement. Sexual function was maintained. Most of the adverse events (AEs) were related to endoscopic instrumentation and were of short duration. One case of urinary retention was classified as a procedure/device-related serious AE. CONCLUSION The Rezūm System provides effective relief of LUTS associated with BPH at 1 year. The procedure is safe with an acceptable side effect profile.

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

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 ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Qmax) ≤15 mL/s, and prostate volume 20–120 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.

MP27-20 CONVECTIVE RADIOFREQUENCY WATER VAPOR ENERGY PROSTATE ABLATION (REZUM®) EFFECTIVELY TREATS URINARY RETENTION

INTRODUCTION AND OBJECTIVES: New minimally invasive surgical therapies (MIST) for lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) such as prostatic urethral lift and convective radiofrequency water vapor energy prostate ablation (WaVE) have shown promising intermediate-term results in improving voiding symptoms. However, the initial trials excluded men in urinary retention; thus the ability of these new technologies to achieve catheter independence has not been evaluated. This study investigated outcomes of patients with urinary retention at baseline treated with WaVE. METHODS: Patients in urinary retention who underwent WaVE were retrospectively identified. Urinary retention was defined as dependence on an indwelling catheter or performance of clean intermittent catheterization (CIC) for bladder emptying. Age, duration of catheter dependence, prostate size, baseline IPSS and PVR, and number of treatments per procedure were recorded. For subjects with successful trials without catheter (TWOC), time to catheter independence and post-procedure PVR and IPSS were recorded. Baseline characteristics between subjects with successful TWOC and unsuccessful TWOC were compared using Mann Whitney U test and T-test for continuous variables and Chi-square test and Fisher0s exact test for non-continuous variables. RESULTS: 30 patients were identified with urinary retention who underwent WaVE. 22 subjects had an indwelling catheter, 8 subjects performed clean intermittent catheterization (CIC). Mean age was 76 years. Relevant baseline measures included (mean): duration of catheter dependence (6.9mo), prostate size (64.3 ml), PVR (538 mL), and number of treatments per procedure (6.4). 28/30 subjects had middle lobe treatment (1 treatment per procedure). 23 of 30 subjects (77%) achieved successful TWOC post-procedure. Mean time to catheter independence was 29 days post-procedure with mean post-procedure PVR 84 mL and post-procedure IPSS 9. There were no differences between subjects with or without successful TWOC in age, duration of catheter dependence, prostate size, baseline PVR, baseline IPSS, number of treatments per procedure, or treatment of median lobe. CONCLUSIONS: WaVE can effectively treat patients with urinary retention and successfully render patients catheter independent, including patients with a median lobe. Longer-term follow up is necessary to evaluate the durability of this technology.