Purpose: We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia.Materials and Methods: A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2: 1 to thermal therapy with the Rezum (R) System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months control subjects could requalify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy end point was a change in severity of symptom scores.Results: Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months and provided a sustained 51% reduction from baseline at 24 months (p < 0.0001). This produced a 5 and 8-point or greater score decrease in 84% and 74% of subjects, respectively, at 24 months. Crossover subject symptoms, flow rate and quality of life measures were markedly improved after thermal therapy compared to after the control procedure (p = 0.024 to < 0.0001). No de novo erectile dysfunction was reported.Conclusions: Convective radiofrequency water vapor thermal therapy is a minimally invasive office or outpatient procedure that provides early effective symptom relief that remains durable for 2 years and is applicable to the median lobe.

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy II1 Apr 2017PD56-11 DEVELOPMENT OF CONVECTIVE WATER VAPOR ENERGY FOR TREATING LOCALIZED PROSTATE CANCER: FIRST-IN-MAN EARLY CLINICAL EXPERIENCES. Christopher Dixon, Ramon Rodriguez Lay, Cesar Cabanas, Edwin Rijo, and Thayne Larson Christopher DixonChristopher Dixon More articles by this author , Ramon Rodriguez LayRamon Rodriguez Lay More articles by this author , Cesar CabanasCesar Cabanas More articles by this author , Edwin RijoEdwin Rijo More articles by this author , and Thayne LarsonThayne Larson More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2600AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Earlier work has confirmed the unique thermodynamic properties of phase-change convective radiofrequency (RF) ablation using water vapor (steam) to conform to the anatomical zones of the prostate. The objective of this study was to assess in vivo treatment of prostate cancer and the early clinical effects using convective RF water vapor. METHODS A total of 20 patients have been treated at 2 centers using the Reviv System and 6 have completed 6 month follow up biopsy. All patients had clinically localized prostate cancer as determined by biopsy, DRE, PSA and prostate MRI (non mp3). Treatment was performed using a urethral cooling catheter and a transperineal, ultrasound guided approach for needle placement and water vapor delivery. Several doses of thermal energy were tested depending on prostate size. Follow-up monitoring included serial, gadolinium enhanced MRIs performed pre-procedure and at 1 week, 1, 3, and 6 months post-procedure and a surveillance biopsy at 6 months post-procedure. Standard AE reporting was used to evaluate clinical outcomes. RESULTS 20 patients have been treated. 11 patients underwent hemiablation, 6 whole gland ablation (3 staged), 2 unilateral PZ treatment and 1 hemiablation with contralateral PZ ablation. Serial MRIs confirmed tissue ablation in all patients. Ablation was seen to the prostatic apex, capsular boundaries and the anterior zones of the prostate. Six-month surveillance biopsies have been completed on 6 patients. Four had completely negative biopsies for cancer and two had positive biopsies that were in untreated zones. Catheterization and adverse events will be reviewed. There has been no incontinence, bladder neck contractures or rectal injuries. CONCLUSIONS The zonal anatomy of the prostate is ideal for phase change convective RF ablation using water vapor. The thermodynamics and physical principles validated by MRI indicate that effective ablation can be safely delivered anywhere in the prostate including the apex, capsular margins and anterior prostate. Partial, focal, zonal or whole gland ablation can be performed. These early and limited data confirm that effective tissue ablation to all areas of the prostate is feasible using convective thermal water vapor. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e1120 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Christopher Dixon More articles by this author Ramon Rodriguez Lay More articles by this author Cesar Cabanas More articles by this author Edwin Rijo More articles by this author Thayne Larson More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology III1 Apr 2017PD23-10 CONVECTIVE RADIOFREQUENCY THERMAL THERAPY: DURABLE TWO-YEAR OUTCOMES OF A RANDOMIZED CONTROLLED AND PROSPECTIVE CROSSOVER STUDY TO RELIEVE LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA Claus Roehrborn, Steven Gange, Marc Gittelman, Kenneth Goldberg, Kalpesh Patel, Neal Shore, Richard Levin, Michael Rousseau, J. Randolf Beahrs, Jed Kaminetsky, Barrett Cowen, Christopher Cantrill, Lance Mynderse, James Ulchaker, Thayne Larson, Christopher Dixon, and Kevin McVary Claus RoehrbornClaus Roehrborn More articles by this author , Steven GangeSteven Gange More articles by this author , Marc GittelmanMarc Gittelman More articles by this author , Kenneth GoldbergKenneth Goldberg More articles by this author , Kalpesh PatelKalpesh Patel More articles by this author , Neal ShoreNeal Shore More articles by this author , Richard LevinRichard Levin More articles by this author , Michael RousseauMichael Rousseau More articles by this author , J. Randolf BeahrsJ. Randolf Beahrs More articles by this author , Jed KaminetskyJed Kaminetsky More articles by this author , Barrett CowenBarrett Cowen More articles by this author , Christopher CantrillChristopher Cantrill More articles by this author , Lance MynderseLance Mynderse More articles by this author , James UlchakerJames Ulchaker More articles by this author , Thayne LarsonThayne Larson More articles by this author , Christopher DixonChristopher Dixon More articles by this author , and Kevin McVaryKevin McVary More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1074AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We report 2-year outcomes of a randomized controlled trial (RCT) plus 1-year results of a crossover trial after treatment with convective radiofrequency (RF) water vapor thermal therapy (Rezum System) for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). RF energy generates wet thermal energy in the form of water vapor that convectively disperses through tissue interstices, remaining confined within prostate zones to achieve rapid ablation of obstructive tissue. METHODS Men ≥ 50 years old with International Prostate Symptom Score (IPSS) ≥13, maximum flow rate (Qmax) ≤ 15 ml/s and prostate volume 30-80 cc were randomized 2:1 to RF thermal therapy with the Rezum System and control. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months, control subjects were requalified for the crossover study. The primary endpoint compared IPSS reduction at 3 months and evaluations continued to 24 months RESULTS Mean IPSS was reduced by 50% after RF thermal therapy (-11.2) vs. 20% (-4.3) for control at 3 months (p<0.0001); relief of LUTS remained durable with 51% improvements at 2 years (p<0.0001). The ≥5 (moderate) or ≥8 point (marked) IPSS decreases occurred in 84% and 74% of men through 24 months, respectively; 75% of these had severe LUTS (IPSS ≥19). Qmax increased 68% (6.2 ml/s) at 3 months vs. no change in controls (p <0.0001) and remained significantly improved at 2 years. Crossover subjects (n=53) had IPSS, Qmax and quality of life markedly improved after RF thermal therapy vs. prior control procedure (p <0.024 - <0.0001). Median lobe treatments were performed in 58 of 188 (31%) subjects in both studies; those with and without median lobe ablation achieved similarly reduced IPSS and improved Qmax. Sexual function assessments with the International Index of Erectile Function and Male Sexual Health Questionnaire remained stable. No de novo erectile dysfunction was reported. CONCLUSIONS Convective RF thermal therapy is a minimally invasive office or outpatient procedure requiring minimal anesthesia to achieve early, clinically meaningful LUTS relief and improved flow rate that remain durable for at least 2 years. Therapy is applicable to all obstructed prostate zones including median lobe. Patients experience minimal side effects. Rezum therapy conserves sexual function and presents an attractive alternative for men exploring a nonsurgical option for moderate to severe LUTS/BPH. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e450-e451 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Claus Roehrborn More articles by this author Steven Gange More articles by this author Marc Gittelman More articles by this author Kenneth Goldberg More articles by this author Kalpesh Patel More articles by this author Neal Shore More articles by this author Richard Levin More articles by this author Michael Rousseau More articles by this author J. Randolf Beahrs More articles by this author Jed Kaminetsky More articles by this author Barrett Cowen More articles by this author Christopher Cantrill More articles by this author Lance Mynderse More articles by this author James Ulchaker More articles by this author Thayne Larson More articles by this author Christopher Dixon More articles by this author Kevin McVary More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

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 (Q(max)) <= 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 Rezum 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 Rezum 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.

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I1 Apr 2016PD21-04 TREATMENT OF LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA WITH CONVECTIVE WATER VAPOR ENERGY ABLATION: PRESERVED ERECTILE AND EJACULATORY FUNCTION Kevin McVary, Steven Gange, Marc Gittelman, Kenneth Goldberg, Kalpesh Patel, Neal Shore, Richard Levin, Michael Rousseau, J. Randolf Beahrs, Jed Kaminetsky, Barrett Cowan, Christopher Cantrill, Lance Mynderse, James Ulchaker, Thayne Larson, Christopher Dixon, and Claus Roehrborn Kevin McVaryKevin McVary More articles by this author , Steven GangeSteven Gange More articles by this author , Marc GittelmanMarc Gittelman More articles by this author , Kenneth GoldbergKenneth Goldberg More articles by this author , Kalpesh PatelKalpesh Patel More articles by this author , Neal ShoreNeal Shore More articles by this author , Richard LevinRichard Levin More articles by this author , Michael RousseauMichael Rousseau More articles by this author , J. Randolf BeahrsJ. Randolf Beahrs More articles by this author , Jed KaminetskyJed Kaminetsky More articles by this author , Barrett CowanBarrett Cowan More articles by this author , Christopher CantrillChristopher Cantrill More articles by this author , Lance MynderseLance Mynderse More articles by this author , James UlchakerJames Ulchaker More articles by this author , Thayne LarsonThayne Larson More articles by this author , Christopher DixonChristopher Dixon More articles by this author , and Claus RoehrbornClaus Roehrborn More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1471AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To report the prospective analysis of sexual function evaluated in a randomized controlled study of transurethral prostate convective water vapor thermal energy (Rezum System) to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). RF-generated wet thermal energy (water vapor), dispersed by convection can be targeted to defined prostate zones including the median lobe to achieve rapid tissue ablation. METHODS Men ≥50 years old with IPSS ≥ 13, Qmax ≤15 ml/s, prostates of 30-80 cc were stratified by International Prostate Symptom Score (IPSS) severity and randomized 2:1 to thermal therapy with the Rezum System and control. The control procedure was rigid cystoscopy with mimicked active treatment sounds. A wash-out period was required for all daily use of drugs for LUTS and/or erectile dysfunction (ED). The blinded group was compared at 3 months and treatment group evaluated over 1 year for LUTS with IPSS, flow rate (Qmax) and sexual function with the International Index of Erectile Function (IIEF-EF) and the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). RESULTS 197 men were randomized. LUTS improved 11 points in the active group (N=136) at 3 months vs. 4.3 points for control group (N=61), p<0.0001. In men with severe LUTS (IPSS >19), 85% achieved ≥ 30% reduction in symptoms. Qmax increased 68% (6.2 ml/s) at 3 months vs. no change in controls (p <0.0001). These improvements were sustained in 96% of treated subjects who completed their 1-year follow-up (p<0.0001). At study entry, 52% of treatment subjects had a history of erectile dysfunction (ED) and 26% had decreased-stoppage ejaculation. Only sexually active men (91/136) 67% were included in the sexual function analyses. In these, the IIEF-EF baseline mean was 17.2 (30 max score) and the MSHQ-EjD mean was 7.8 (15 max). There were no clinically meaningful negative changes in scores over 12 months. Modest decreases in ejaculatory volume occurred in 6 men (4.4%), anejaculation in 4 men (2.9%). No de novo ED was reported. CONCLUSIONS Conservation of sexual function is a fundamental QOL issue for men contemplating a nonsurgical treatment options for LUTS/ BPH. Convective water vapor thermal energy therapy is a minimally invasive treatment that provides rapid and durable LUTS improvements and no clinically significant changes in erectile and ejaculatory function. The thermal energy treatment was developed for in-office use and shown to be applicable to treatment of all prostate zones including median lobes. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e457-e458 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Kevin McVary More articles by this author Steven Gange More articles by this author Marc Gittelman More articles by this author Kenneth Goldberg More articles by this author Kalpesh Patel More articles by this author Neal Shore More articles by this author Richard Levin More articles by this author Michael Rousseau More articles by this author J. Randolf Beahrs More articles by this author Jed Kaminetsky More articles by this author Barrett Cowan More articles by this author Christopher Cantrill More articles by this author Lance Mynderse More articles by this author James Ulchaker More articles by this author Thayne Larson More articles by this author Christopher Dixon More articles by this author Claus Roehrborn More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

INTRODUCTION AND OBJECTIVES: Minimally invasive conductive ablative therapy options for LUTS secondary to BPH have traditionally demonstrated inconsistent efficacy outcomes both shortand long-term.Convective water vapor therapy has demonstrated an improvement in LUTS with minimal side effects at 1 year.The objective of this analysis was to evaluate the two-year effectiveness of convective WAVE ablation in treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia.METHODS: A total of 65 men with symptoms of moderate to severe BPH were enrolled in pilot studies at centers in the Dominican Republic (n¼20), the Czech Republic (n¼18), and Sweden (n¼27).Each patient was treated with transurethral delivery of RF-generated thermal water vapor using the Rezum System.International Prostate Symptom Score (IPSS), peak urinary flow (Qmax), quality of life (QoL), post void residual (PVR) and International Index of Erectile Function (IIEF) were evaluated at 1 week and 1, 3, 6, 12 and 24 months posttreatment.RESULTS: Statistically significant clinical improvements at 1, 3, 6, 12 and 24 months were reported for IPSS (decreased by 7.2, 13.4, 13.1, 12.5 and 12.1 points, respectively) and Qmax (increased by 2.3, 4.7, 4.3, 4.6 and 3.9 mL/sec, respectively).At 24 months, these results equated to a 55% improvement in IPSS (P

Purpose: This report reveals the results of a multicenter, randomized, controlled study using transurethral prostate convective water vapor thermal energy to treat lower urinary tract symptoms associated with benign prostatic hyperplasia.Materials and Methods: Men 50 years old or older with an International Prostate Symptom Score of 13 or greater, maximum flow rate of 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 between thermal therapy with the Rezum (R) System and control. Thermal water vapor was injected into the transition zone and median lobe as needed. The control procedure was rigid cystoscopy with simulated active treatment sounds. The primary end point compared International Prostate Symptom Score reduction at 3 months. Treatment subjects were followed for 12 months.Results: There were 197 men randomized ( active 136, control 61). Thermal therapy and control International Prostate Symptom Score was reduced by 11.2 +/- 7.6 and 4.3 +/- 6.9 respectively (p <0.0001). Treatment subject baseline International Prostate Symptom Score of 22 decreased at 2 weeks (18.6, p=0.0006) and by 50% or greater at 3, 6 and 12 months, p <0.0001. The peak flow rate increased by 6.2 ml per second at 3 months and was sustained throughout 12 months (p <0.0001). No de novo erectile dysfunction was reported. Adverse events were mild to moderate and resolved quickly.Conclusions: Convective water vapor thermal therapy provides rapid and durable improvements in benign prostatic hyperplasia symptoms and preserves erectile and ejaculatory function. Treatment can be delivered in an office or hospital setting using oral pain medication and is applicable to all prostate zones including the median lobe.

Introduction: Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction. Aim: To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions. Methods: Menat least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15mL/s, and prostate volume of 30 to 80 cm(3) were randomized 2: 1 between Rezum System thermal therapy and control. Thermal water vapor (103 degrees C) was injected into lateral and median lobes as required for treatment of benign prostatic hyperplasia. The control procedure entailed rigid cystoscopy with simulated active treatment sounds. Main Outcome Measures: Blinded group (active = 136, control = 61) comparison occurred at 3 months and the active arm was followed to 12 months for International Prostate Symptom Score, peak flow rate, and sexual function using the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. The minimal clinically important difference in erectile function perceived by subjects as beneficial was determined for each erectile function severity category. Subjects not sexually active were censored from sexual function analysis. Results: No treatment-or device-related de novo erectile dysfunction occurred after thermal therapy. International Index of Erectile Function and Male Sexual Health Questionnaire for Ejaculatory Function scores were not different from the control group at 3 months or from baseline at 1 year. Ejaculatory bother score improved 31% over baseline (P =.0011). Also, 32% of subjects achieved minimal clinically important differences in erectile function scores at 3 months, and 27% at 1 year, including those with moderate to severe erectile dysfunction. International Prostate Symptom Score and peak flowrate were significantly superior to controls at 3 months and throughout 1 year (P<.0001). Conclusion: Convective water vapor thermal therapy provides sustainable improvements for 12 months to lower urinary tract symptoms and urinary flow while preserving erectile and ejaculatory functions. Copyright (C) 2016, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

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 Rezum 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. (C)2015 Elsevier Inc.

Background: The purpose of this study was to assess the acute ablative characteristics of transurethral convective water vapor (steam) using the Rezum((R))system in men with benign prostatic hyperplasia through histologic and radiographic studies.Methods: Seven patients were treated with transurethral intraprostatic injections of sterile steam under endoscopic visualization followed by previously scheduled adenectomies. The extirpated adenomas were grossly examined followed by whole mount sectioning and staining with triphenyl-tetrazolium chloride (TTC) to evaluate thermal ablation. Histology was performed after hematoxylin and eosin staining on one prostate. After review of results from the first patient cohort, an additional 15 patients with clinical benign prostatic hyperplasia were treated followed by gadolinium-enhanced magnetic resonance imaging (MRI) at one week.Results: In the first patient cohort, gross examination of TTC-stained tissue showed thermal ablation in the transition zone. In addition, there was a distinct interface between viable and necrotic prostatic parenchyma. Histopathologic examination revealed TTC staining-outlined necrotic versus viable tissue. Gadolinium-enhanced MRIs in the cohort of 15 patients demonstrated lesion defects in all patients at 1 week post-procedure. Coalesced lesions were noted with a mean (+/- standard deviation) lesion volume of 9.6 +/- 8.5 cm(3). The largest lesion volume was 35.1 cm(3). Ablation using vapor was rapid and remained confined to the transition zone, consistent with the thermodynamic principles of convective thermal energy transfer.Conclusion: Thermal ablation was observed in all specimens. The resulting coalescing ablative lesions, as seen on MRI, were confined to the transition zone. These studies confirm the ablative capabilities of vapor, validate the thermodynamic principles of convective heating, and allow for further clinical studies.

OBJECTIVE 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).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 Rezum System provides effective relief of LUTS associated with BPH at 1 year. The procedure is safe with an acceptable side effect profile. (C) 2015 Elsevier Inc.

The Rezūm System™ is based on phase-change convective heat transfer with water vapor (steam) to ablate tissue. This is distinctly different than conductive heat transfer used by earlier devices such as radiofrequency or microwave systems. A summary of the early work is presented as well as a discussion of the important principles that make phase-change convective heating particularly useful in the prostate. Preliminary work suggests clinical promise for treating men with BPH and has led to a large scale trial to assess safety and efficacy of the procedure.

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II1 Apr 2014MP71-11 REZūM® SYSTEM WATER VAPOR TREATMENT FOR BENIGN PROSTATIC HYPERPLASIA: CHARACTERIZATION WITH MAGNETIC RESONANCE IMAGING AND 3D RENDERING Lance Mynderse, Dennis Hanson, Richard Robb, Edwin Rijo Cedano, Dalibor Pacik, Gabriel Varga, Thayne Larson, and Christopher Dixon Lance MynderseLance Mynderse More articles by this author , Dennis HansonDennis Hanson More articles by this author , Richard RobbRichard Robb More articles by this author , Edwin Rijo CedanoEdwin Rijo Cedano More articles by this author , Dalibor PacikDalibor Pacik More articles by this author , Gabriel VargaGabriel Varga More articles by this author , Thayne LarsonThayne Larson More articles by this author , and Christopher DixonChristopher Dixon More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2170AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Rezūm® System is a novel BPH transurethral therapy based on convective thermal energy transfer using water vapor (steam). The condensation of steam releases 540 calories of stored thermal energy / ml of H2O, releasing 208 calories of energy per 0.4 ml treatment, causing necrosis of the targeted areas. Historically, gadolinium-enhanced MRI has shown significant correlation with whole mount histopathology of the prostate following minimally invasive ablative therapies. The objectives were to validate the principle of phase-change convective thermal energy transfer to treat BPH patients, and assess the MRI detected lesion characteristics and prostate volume reduction. METHODS IRB approvals were obtained from 3 centers, and 65 men with BPH/LUTS enrolled in the pilot studies, 60 of which were consented for MRI review. One to 4 vapor injections / lobe, including the median lobe, if present, were delivered. Gadolinium-enhanced MRI’s were conducted at 1wk, 1, 3 and 6 mos to assess the location of the thermal lesions (TL) and perform volume measurements for total prostate (TPV), transition zone (TZV) and thermal lesions (TLV). MRI’s were analyzed and volumes computed via co-registered T2 and post-contrast T1 axial acquisitions using the Analyze® Image Visualization and Analysis System. RESULTS Thermal lesions were normally limited to the transition zone (TZ) and corresponded well to the targeted treatment locations. Mean TLV at 1 wk (n=54) was 8.9 cc (range 0.5-35.1cc) and decreased by 59% at 1 mo (n= 51) and by 92% at 3 mos (n=28) and 96% at 6 mos (n=27). Mean TZV at 1 wk (n=54) was 41.2cc (range 9.1-113cc) and decreased by 17.2% at 1 mo (n=51) and 26.2% at 3 mos (n=28) and 34% at 6 mos (n=28). Mean TPV at 1 wk (n=54) was 69.7cc (range 20-169cc) decreased by 13.6% at 1 mo (n= 51) and by 19.9% at 3 mos (n=28) and 27.3% at 6 mos (n=28). MRI analysis of the TL demonstrated an excellent anatomic safety profile. The MRIs of 2 patients demonstrated extra-prostatic TL at the bladder neck, likely from vapor delivered outside the TZ, visible at 1 wk and 1 mo, but totally resolved by 3 mos. No adverse clinical sequelae were evident in these patients. CONCLUSIONS The Rezūm® System creates significant thermal lesions. Prostate MRI studies: 1.) Validated the principle of convective heating to generate TL, 2.) Documented treated tissue volumes, 3.) Confirmed near complete resolution of imaged lesions by 6 mos, 4.) Demonstrated reduction in TPV from baseline supporting probable clinical benefit, and 5.) Confirmed a favorable safety profile of this technology. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e794 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Lance Mynderse More articles by this author Dennis Hanson More articles by this author Richard Robb More articles by this author Edwin Rijo Cedano More articles by this author Dalibor Pacik More articles by this author Gabriel Varga More articles by this author Thayne Larson More articles by this author Christopher Dixon More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Direct current (DC) ablation is a novel non-thermal technology that causes focused coagulative necrosis in the lateral lobes of the prostate to treat benign prostatic hyperplasia (BPH). The necrosis is caused by a zone of non-physiologic pH which is created in a predictable pattern around each electrode in which a direct current is applied during treatment. The objective of this study was to optimize treatment parameters and assess treatment tolerability using transurethral DC ablation as an office-based treatment for BPH.