Convective Water Vapor Energy Research Articles

Convective Water Vapor Energy Ablation (Rezum®) Versus Prostatic Urethral Lift (Urolift®): A 2-Year Prospective Study.

Introduction: To compare the clinical outcomes and complication rates of convective water vapor energy ablation (Rezum®) and prostatic urethral lift (Urolift®). To identify predictive factors for treatment failures in both treatments. Materials & Methods: Prospective clinico-epidemiological data of patients who underwent Urolift® or Rezum® in a single institution for benign prostatic hyperplasia (BPH) was collected. The choice of intervention depended on the preference of the patients after patient-centric discussions. Results: From October 2019 to October 2022, 86 patients underwent Rezum®, and 62 patients underwent Urolift®. Rezum® involved a longer indwelling catheter duration (12.38 ± 5.548 vs 1.39 ± 3.010 days, p < 0.001) compared with Urolift®. Rezum® was associated with more complications compared with Urolift® (36 [41.9%] vs 10 [16.1%] cases, p < 0.001). Rezum® had more cases of hematuria (17 [19.8%] vs 4 [6.5%] cases [p = 0.022]) and urinary tract infections (27 [31.4%] vs 3 [4.8%] cases, p < 0.001) compared with Urolift®. There were no significant differences in Clavien-Dindo Grade 3-5 complications between the interventions. Urolift® was associated with higher reoperation rates (5 [8.1%] vs 0 [0%] cases, p = 0.010) compared Rezum®. Rezum® had higher anticholinergic usage rates compared with Urolift® post-operation (22 [25.6%] vs 8 [12.9%] cases, p = 0.024). Both interventions showed improvement in the International Prostate Symptom Score (IPSS), quality of life score, and peak velocity flow over the 2 years with no significant difference between the two. Based on receiver operating characteristic curve, preoperation IPSS ≥16 had 95.7% sensitivity and 38.4% specificity to predict the probability of treatment failures after the interventions. Conclusions: There was no difference in clinical outcomes of patients who underwent Rezum® and Urolift®. However, patients who had undergone Rezum® faced more minor complications and more required anti-cholinergic medications. Lastly, physicians should note that patients with IPSS ≥16 would unlikely benefit from either intervention.

Benign Prostatic Hyperplasia Surgery: A Snapshot of Trends, Costs, and Surgical Retreatment Rates in the USA

BackgroundAn increasing number of novel surgical treatments (NSTs) for benign prostatic hyperplasia (BPH) have been proposed over time to achieve similar functional outcomes to, but better perioperative and sexual outcomes than traditional procedures. ObjectiveTo assess the trends in the utilization and costs of BPH surgical procedures over the past decade, and to analyze the need for surgical retreatment after each procedure. Design, setting, and participantsA retrospective observational population-based analysis was conducted using the PearlDiver Mariner (PearlDiver Technologies, Colorado Springs, CO, USA) database, including all-payer nationally available claims records collected from 2011 to 2022. Outcome measurements and statistical analysisThe number and type of BPH surgical procedures per year, costs associated with each BPH surgical treatment, incidence of BPH surgical retreatment rate, and time to BPH surgical retreatment were assessed. Negative binomial regression and Cochran-Armitage test were used for the temporal trend analysis. A multivariable logistic regression analysis evaluated the predictors of BPH surgical retreatment. Results and limitationsIn the study period, 274 808 patients received surgical treatment for BPH. The most common procedure was transurethral resection of the prostate (TURP; 71.7%). The overall utilization of BPH surgical treatment increased over the study period. Traditional surgery remained most performed for the entire period (87.8%), but a statistically significantly rising trend of NSTs was recorded. The mean reimbursements paid per procedure was 1.43 times higher (p < 0.001) for NSTs than for traditional procedures. The surgical retreatment rate was 9.4%. The mean time to surgical retreatment was 25.3 mo, with 85.5% of cases re-treated within 5 yr. At the multivariable analysis, transurethral incision of the prostate, photoselective vaporization of the prostate, prostatic urethral lift, convective water vapor energy, and prostatic artery embolization had a significantly greater likelihood of surgical retreatment than TURP. Holmium/thulium laser enucleation of the prostate (HoLEP/ThuLEP), open simple prostatectomy (SP), and laparoscopic/robot-assisted SP were associated with a lower probability of resurgery than TURP, but a similar probability between these procedures. Retrospective design and a lack of relevant clinical data were the main limitations. ConclusionsOver the past decade, there has been a progressive increase in the adoption of NSTs. The rate of surgical retreatment appears <10%, with patients undergoing SP and HoLEP/ThuLEP experiencing a statistically significantly lower probability of surgical retreatment. Patient summaryWe investigated the trends, costs, and surgical retreatments of benign prostatic hyperplasia surgery. Transurethral resection of the prostate remains the most common procedure. Novel surgical treatments are associated with an upward trend, despite appearing more expensive overall. Retreatment is necessary in <10% of patients and generally within 5 yr.

Ablative minimally invasive surgical therapies for benign prostatic hyperplasia: A review of Aquablation, Rezum, and transperineal laser prostate ablation.

Benign prostatic hyperplasia (BPH) is one of the most common diseases affecting men and can present with bothersome lower urinary tract symptoms (LUTS). Historically, transurethral resection of the prostate (TURP) has been considered the gold standard in the treatment of LUTS due to BPH. However, TURP and other traditional options for the surgical management of LUTS secondary to BPH are associated with high rates of sexual dysfunction. In the past decade, several novel technologies, including Aquablation therapy, convective water vapor therapy (Rezum), and transperineal prostate laser ablation (TPLA), have demonstrated promising evidence to be safe and effective while preserving sexual function. In this review, we discuss three ablative minimally invasive surgeries: Aquablation, Rezum, and TPLA. We review their techniques, safety, as well as perioperative and functional outcomes. We go into further detail regarding sexual function after these ablative minimally invasive surgical therapies. Aquablation is a surgeon-guided, robot-executed, heat-free ablative waterjet procedure with sustained functional outcomes at 5 years while having no effect on sexual activity. Rezum is an innovative office-based, minimally invasive surgical option for BPH that delivers convective water vapor energy into prostate adenoma to ablate obstructing tissue. Rezum leads to significant improvements in Qmax, IPSS while preserving sexual function. TPLA is another office-based technology which uses a diode laser source to produce thermoablation. It leads to improvement in Qmax, IPSS, and QoL while preserving ejaculatory function. Overall, ablative minimally invasive surgical therapies have demonstrated excellent safety and efficacy profiles while preserving sexual function. These modalities should be discussed with patients to ensure informed and shared decision-making. Ablative minimally invasive surgical therapies may be particularly interesting to patients who value the preservation of their sexual function.

Preliminary results of a national multicenter study on the treatment of LUTS secondary to benign prostatic hyperplasia using the Rezūm® steam system

Introduction and objectiveRezūm® system is a minimally invasive transurethral therapy that uses convective water vapor energy to ablate prostatic tissue. The objective is to report 1-year functional and security outcomes obtained by using this technique in real clinical practice. Material and methodsProspective study conducted in 5 Spanish hospitals for the treatment of LUTS secondary to BPH using the Rezūm® system. Patients with prostatic medium lobe (ML) and urethral catheter carriers were also included. Pre- and post-operative data were collected using IPSS, IIEF-5 and QoL questionnaires, flowmetry and post-void residual volume. Complications and retreatment rate at one-year follow-up were also reported. Results137 patients, including 64 with ML and 10 patients with urinary retention were treated. Median prostate volume was 50 cm3 (15−131). At 3 months follow-up, significant improvement was observed in IPSS (−6.37 points), Qmax (+4.95 mL/s) and QoL (−1.29); and was maintained until 12 months: −10.78 points, +4.62 mL/s and −2.73 respectively (p < 0.001). No significant changes were observed in the sexual sphere. All complications were mild (≤ Clavien II). Retreatment rate at one year was 4%. ConclusionShort-term results of this technique are promising, showing improvement in terms of functional outcomes, with no impact on the sexual sphere or complications. Longer term follow-up should include treatment durability and comparison to standard BPH treatments.

Resultados preliminares de un trabajo multicéntrico a nivel nacional para el tratamiento de STUI secundario a hiperplasia benigna de próstata mediante el sistema con vapor de agua Rezūm®

Introduction and objectiveRezūm® system is a minimally invasive transurethral therapy that uses convective water vapor energy to ablate prostatic tissue. The objective is to report 1-year functional and security outcomes obtained by using this technique in real clinical practice. Material and methodsProspective study conducted in 5 Spanish hospitals for the treatment of LUTS secondary to BPH using the Rezūm® system. Patients with prostatic medium lobe (ML) and urethral catheter carriers were also included. Pre- and post-operative data were collected using IPSS, IIEF-5 and QoL questionnaires, flowmetry and post-void residual volume. Complications and retreatment rate at one-year follow-up were also reported. Results137 patients, including 64 with ML and 10 patients with urinary retention were treated. Median prostate volume was 50cm3 (15-131). At 3 months follow-up, significant improvement was observed in IPSS (−6,37 points), Qmax (+4,95mL/s) and QoL (−1,29); and was maintained until 12 months: −10,78 points,+4,62mL/s and −2,73 respectively (p<0.001). No significant changes were observed in the sexual sphere. All complications were mild (≤Clavien II). Retreatment rate at one year was 4%. ConclusionShort-term results of this technique are promising, showing improvement in terms of functional outcomes, with no impact on the sexual sphere or complications. Longer term follow-up should include treatment durability and comparison to standard BPH treatments.

PD23-01 BENIGN PROSTATIC HYPERPLASIA (BPH) SURGICAL VOLUME DURING THE COVID-19 PANDEMIC AT A SINGLE INSTITUTION

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology IV (PD23)1 Sep 2021PD23-01 BENIGN PROSTATIC HYPERPLASIA (BPH) SURGICAL VOLUME DURING THE COVID-19 PANDEMIC AT A SINGLE INSTITUTION Thaiphi H. Luu, Natalia Hernandez, Ricardo R. Gonzalez, and Ricardo R. Gonzalez Thaiphi H. LuuThaiphi H. Luu More articles by this author , Natalia HernandezNatalia Hernandez More articles by this author , Ricardo R. GonzalezRicardo R. Gonzalez More articles by this author , and Ricardo R. GonzalezRicardo R. Gonzalez More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002016.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Conserving hospital resources during the COVID-19 pandemic has involved restricting nonessential care, especially when hospital capacity, staff and protective equipment was limited. Triage was required to assess severity of illness and need for intervention, particularly affecting the volume of elective procedures to treat BPH. We examined trends in BPH procedures in the office and hospital during surges in the pandemic. METHODS: We compiled monthly volumes for BPH procedures using CPT codes from March 2020 to January 2021 by full time faculty at a single 2541 bed hospital system. Prostatic transurethral resection, laser vaporization, laser enucleation, aquablation, and robotic assisted simple prostatectomy were performed in the hospital and categorized together as “BPH surgery.” In-office prostatic urethral lift (PUL) and convective water vapor energy (WAVE) were categorized as “MIST.” Percent change in case volume was calculated based on the previous 12-month average. Ureteroscopy and stent cases (“URS/stent”) were used as a control as they were more likely to be urgent. “Surges” during the pandemic were defined by county-specific metrics including hospitalization and COVID-19 positivity rates. RESULTS: During the pandemic, there was a modest decrease in BPH procedures with 582 cases, compared to 665 cases in the prior year. During the surges in 3/2020-4/2020, 7/2020, and 1/2021, the BPH surgery volume changed by -82.1%, -16.5%, and -47.5%, respectively. The MIST volume changed by -83.7%, +30.2%, and -7.7%, respectively. URS/stent cases decreased to a lesser degree than BPH procedures during the pandemic. CONCLUSIONS: During the COVID-19 pandemic, there was a slight decrease in the ability to perform surgery for BPH relative to stone cases. The trend was an adaptive response with pause in BPH surgeries during surges and an ensuing rebound. Office-based MIST procedures PUL and WAVE have been less affected compared to BPH surgeries in the hospital setting, likely resulting in conservation of hospital resources during surges. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e420-e420 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Thaiphi H. Luu More articles by this author Natalia Hernandez More articles by this author Ricardo R. Gonzalez More articles by this author Ricardo R. Gonzalez More articles by this author Expand All Advertisement PDF downloadLoading ...

Rezum water vapour therapy: promising early outcomes from the first UK series.

The management of symptomatic BPH is evolving and there is now an expanding portfolio of minimally invasive surgical therapies (MIST). These provide an attractive option for men looking for meaningful improvement in urinary symptoms whilst avoiding the risks of adverse effects, particularly with regards to maintaining sexual function.

TT3 MEDICARE BUDGET IMPACT ANALYSIS OF CONVECTIVE WATER VAPOR ENERGY THERAPY COMPARED TO PROSTATIC URETHRAL LIFT FOR TREATMENT OF BENIGN PROSTATIC HYPERPLASIA

Benign prostatic hyperplasia (BPH) costs the US healthcare system over $1 billion annually. Convective water vapor energy therapy (WAVE; Rezum System) and prostatic urethral lift (PUL; UroLift System) are minimally invasive surgical treatment options for men with BPH experiencing moderate-to-severe lower urinary tract symptoms (LUTS). We estimated the budget impact to Medicare of WAVE versus PUL using long-term clinical outcomes.

EDITORIAL COMMENT

How important really is it for a man to preserve his antegrade ejaculation following a benign prostatic hyperplasia (BPH) procedure? How many men really care? These are 2 questions that have yet to be published on in our urologic peer reviewed literature. Prior to the advent of medical management for BPH this was a nonissue. The only treatments were open simple prostatectomy or transurethral resection of the prostate (TURP), both of which produced a very high rates of ejaculatory dysfunction and was just expected to occur for patients postprocedure. Once medical management became available, the preservation of ejaculatory function was significantly improved for BPH treatments, but some drugs still had a 30% dysfunction rate. 1 Kaplan S. Side effects of alpha-blocker use: retrograde ejaculation. Rev Urol. 2009; 11: 14-18 PubMed Google Scholar In the recent past, newer minimally invasive treatments have been developed which attempt to limit this dysfunction. The Rezum, Urolift, and Aquaablation systems all have published articles in our urologic peer reviewed literature that have very low rates of ejaculatory dysfunction. 2 McVary KT Gange SN Gittelman MC et al. Erectile and Ejaculatory Function Preserved with Convective Water Vapor Energy. Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study. J Sex Med. 2016; 13: 924-933 Abstract Full Text Full Text PDF PubMed Scopus (71) Google Scholar , 3 McVary KT Gange SN Shore ND et al. Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift. J Sex Med. 2014; 11: 279-287 Abstract Full Text Full Text PDF PubMed Scopus (76) Google Scholar , 4 Gilling P Kaplan Steven A. Gul Zeynup Te Alexis E. et al. Two-year outcomes after aquablation compared to TURP: efficacy and ejaculatory improvement sustained. Adv Ther. 2019; 36 (Jun): 1326-1336 Google Scholar

Novel Surgical Treatments for Benign Prostatic Enlargement

Transurethral resection of the prostate (TURP) has been the gold standard for the treatment of elderly men with lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). However, over the last few years, advances in surgical treatment have led to the development of other treatment modalities. These innovations include convective WAter Vapor Energy (WAVE; Rezum System), prostatic urethral lift (PUL; UroLift System), Prostate Artery Embolisation (PAE) and Aquablation (AQUABEAM System). This review provides an update on these current minimal invasive surgical treatments. The evidence of their safety, tolerability and efficacy in clinical practice is reviewed.

Minimally invasive techniques for the treatment of benign prostatic hyperplasia

Benign Prostatic Hyperplasia (BPH) occurs in up to 80% of men older than 70 years. The prevalence of BPH increases with age, from approximately 25% of men at 50 years of age to 50 to 90% of individuals in their 8th decade of life. Treatment options for lower urinary tract symptoms (LUTS) secondary to BPH have been long restricted to drug therapy and, after failure of the former, surgical treatment. However, prostate surgery is associated with risks such as bleeding, necessity of transfusion and ejaculatory dysfunction. Several novel and minimally invasive methods for treatment of BPH have arisen in the past years. Common to all of these techniques are a more favorable safety profile and varying rates of success and clinical improvement, however frequently inferior to standard surgical techniques. Patients who will benefit the most from these procedures are those who would not wish to undergo surgery, those at prohibitively high risk for surgery, and those wishing to avoid ejaculatory dysfunction secondary to trans-urethral resection of the prostate (TURP) or open resection. Mechanical devices such as Temporary implantable nitinol device and Urolift appear to provide satisfying results with a favorable safety profile. Persistence of improvement is still questionable since follow-up longer than 5 years is not available for these methods. Of note, these methods may be of limited performance for larger prostates, in special, Urolift for those with a large median lobe or a prostate larger than 100 grams. Similarly, novel techniques for tissue ablation, including convective water vapor energy, appear to offer promising and safe results, yet with limited follow-up. Prostate artery embolization (PAE) is another safe procedure and an option for patients who are not suited for surgery, with satisfying short and medium-term follow-up but unknown results at long-term.

The new kids on the block: prostatic urethral lift (Urolift) and convective water vapor energy ablation (Rezūm).

The main objective of novel minimally invasive treatment options is to provide relief of bothersome lower urinary tract symptoms (LUTS) equally effective to current standard techniques, but with a more favorable safety profile. Here we present the first clinical experience with the prostatic urethral lift (Urolift) and the convective water vapor energy ablation (Rezūm). Urolift offers rapid and durable relief of LUTS with complete preservation of sexual function. It is not as effective as the reference method transurethral resection of the prostate (TURP) in terms of symptom relief and urodynamic parameters, but it in selected patients with special interest in sexual activity and rapid recovery it may be an attractive option. The Rezūm system also offers rapid and safe relief of LUTS without compromising sexual function. But it targets all critical prostatic zones including an obstructive middle lobe. In selected patients with bothersome LUTS, who seek a minimally invasive procedure offering a fast return to daily activity and complete preservation of sexual function, Urolift is a good option. First 3-year clinical data on Rezūm demonstrated efficacy and safety in a prospective randomized, sham-controlled trial. It addresses all critical zones of benign prostatic obstruction including the middle lobe without compromising sexual function. Long-term data and the direct comparison with the reference method TURP are missing to define its role in the surgical spectrum of minimally invasive treatment options.

067 Convective Water Vapor Energy Ablation Effectively Treats Lower Urinary Tract Symptoms Due to Benign Prostatic Enlargement While Preserving Erectile and Ejaculatory Function: Results of a Multicenter, Randomized, Controlled Trial

067 Convective Water Vapor Energy Ablation Effectively Treats Lower Urinary Tract Symptoms Due to Benign Prostatic Enlargement While Preserving Erectile and Ejaculatory Function: Results of a Multicenter, Randomized, Controlled Trial

Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study.

Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction. 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. Men at 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 15 mL/s, and prostate volume of 30 to 80 cm(3) were randomized 2:1 between Rezūm System thermal therapy and control. Thermal water vapor (103°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. 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. 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 flow rate were significantly superior to controls at 3 months and throughout 1 year (P < .0001). 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.

Editorial Comment on “Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study”

Editorial Comment on “Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study”

Response and Rebuttal to Editorial Commentary on “Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study”

Thank you for the opportunity to respond to Dr Corona’s comments. Parsimoniously stated, lower urinary tract symptoms (LUTS) and the treatments impact sexual function. The challenge in advancing the medical and surgical care of men with LUTS is to maximize the impact on the bothersome symptoms while avoiding the undesirable effects on erectile and ejaculatory function. Excitingly, this new technology offers that possibility. Durability of the therapeutic response in men with LUTS and its impact is the next important issue and future reports will be forthcoming. We agree with Dr Corona that the need for comparative trials of the convective vapor technique with standard surgical approaches. These types of comparisons will undoubtedly be forthcoming, but clearly Dr Corona will agree that in any investigatory endeavor one must start at the beginning. This beginning was a success and lays the ground for confirmatory studies as well as those suggested above. Dr Corona wonders if the randomized controlled trial (RCT) accounted and controlled for the proper confounding variables impacting men with LUTS that we have previously published. To avoid the plague of self-citation we will not belabor these publications here. Concerning the possibility that these risk factors may confound the measurement of sexual function in this report, in our view the randomization process controls for these putative confounders unless one believes that the controls or the treatment groups are somehow unequally weighted in respective cohorts. Our analysis suggest that such bias do not exist. Contrary to cross-sectional and single cohort studies, one advantage of the blinded RCT design is the inherent protection against such unaccounted variables.

An Outcomes Review of Minimally Invasive Transurethral Convective Water Vapor Energy (WAVE) Therapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

The Rezūm® System utilizing convective water vapor energy (WAVE™) has been proven to safely and effectively ablate obstructive tissue of the prostate, including the median lobe. Clinical trials have demonstrated rapid and significant relief of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) while improving quality of life scores. Moreover, durability of these beneficial results has been demonstrated through 12 months of follow-up. The most common side effects include dysuria, urgency, and hematuria, which are typically of short duration. Importantly, erectile and ejaculatory functions are preserved. This thermal therapy can be performed in an outpatient or office setting under oral sedation, prostate block, or conscious IV sedation.

Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

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. 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 Rezūm® 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. 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 12months (p<0.0001).No de novo erectile dysfunction was reported. Adverse events were mild to moderate and resolved quickly. 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.

PII-LBA1 USING THE THERMAL ENERGY OF CONVECTIVELY DELIVERED WATER VAPOR FOR THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA: THE REZUM II STUDY

You have accessJournal of UrologyPlenary Session II – Late Breaking Abstracts1 Apr 2015PII-LBA1 USING THE THERMAL ENERGY OF CONVECTIVELY DELIVERED WATER VAPOR FOR THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA: THE REZUM II STUDY Kevin McVary, Lance Mynderse, Steven Gange, Marc Gittelman, Kenneth Goldberg, Kalpesh Patel, Neal Shore, Richard Levin, Michael Rousseau, Randolf Beahrs, Jed Kaminetsky, Barrett Cowan, Christopher Cantrill, James Ulchaker, and Claus Roehrborn Kevin McVaryKevin McVary More articles by this author , Lance MynderseLance Mynderse 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 , Randolf BeahrsRandolf 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 , James UlchakerJames Ulchaker More articles by this author , and Claus RoehrbornClaus Roehrborn More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.03.081AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To report the results from the first multicenter, randomized, blinded study on the use of convective water vapor energy (WAVE) to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia. METHODS Men at least 50 years of age with International Prostate Symptom Score (IPSS) 13 or greater, a maximum flow rate of 15 ml/sec or less, and a prostate volume of 30-80cc were randomized 2:1 between treatment with the Rezum System and a control procedure. In the Rezum group, using a transurethral approach, convective water vapor energy was injected into the transition zone and median lobe, if present. The sham control consisted of a cystoscopy and robust mimicry of the active therapy. The primary endpoint was comparison of IPSS reduction at 3 months. The Rezum arm subjects were followed to 1 year and assessed for LUTS, Qmax, QoL and sexual function. RESULTS A total of 197 men were randomized (Rezum 136 vs. control 61). At 3 months, IPSS in the Rezum and control arms was reduced by 11.2±7.6 and 4.3±6.9, respectively (p<.0001), meeting the primary endpoint. At the time of this report, 40 subjects had completed their 1-year follow-up. Rezum subjects experienced IPSS reductions from a baseline of 22.0 to 18.6, 10.6, 9.8 and 10.7 at 2 weeks, 3 months, 6 months and 1 year, respectively (p<.0001). Rezum subjects with a baseline IPSS score ≥19 experienced a mean reduction of -5.3, -13.7, -14.2, and -13.8 at 2 weeks, 3 months, 6 months and 1 year, respectively. Qmax increased by 3.2, 6.2, 5.5 and 4.9 ml/sec at 4 weeks, 3 months, 6 months and 1 year, p<0.0001, respectively. A median lobe was treated in 22% (30/136) of subjects in Rezum arm. Adverse events were typically mild and transient. There was no reported occurrence of de novo erectile dysfunction. CONCLUSIONS Convective water vapor energy, delivered with the patient under local anesthesia in an office setting, provides rapid and sustained improvement in symptoms and flow, with minimal adverse events, while preserving erectile function. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e495 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kevin McVary More articles by this author Lance Mynderse 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 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 James Ulchaker More articles by this author Claus Roehrborn More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...