Transurethral Vapor Ablation in Patients with Intermediate-Risk Localized Prostate Cancer.

Purpose: We report results of a prospective, multicenter single-arm study of transurethral vapor ablation (TUVA) of prostate tissue in patients with unilateral, intermediate-risk, localized prostate cancer (PCa). Materials and Methods: Men ≥45 years of age with biopsy-confirmed unilateral Gleason grade group 2 (GGG2) adenocarcinoma of the prostate, prostate volume of 20-80 cc, and prostate-specific antigen (PSA) ≤15 ng/mL were enrolled. Cystoscopy and transrectal ultrasound (TRUS) guidance were used to deliver ∼103°C water vapor to prostate zones for unilateral hemigland ablation, including destruction of cancers detected by multiparametric MRI (mpMRI) and confirmed by biopsy. The primary outcomes were device-related serious adverse events (SAEs). At 7 days and 6 months postprocedure, the ablation extent was assessed by mpMRI; MRI/TRUS fusion biopsies were completed at 6 months. Quality of life (QOL) was assessed with validated questionnaires. Results: All subjects underwent a single hemigland TUVA procedure. No SAEs occurred. Grade 2 procedure-related AEs included transient urinary retention (n = 4) and erectile (n = 1) or ejaculatory dysfunction (n = 1). At 7 days, mpMRI revealed complete ablation of 14/17 (82%) visible lesions. At 6 months, biopsies showed no Gleason pattern ≥4 or ≥GGG2 cancer on the treated side of prostates in 13/15 (87%) subjects. Ten of 15 (67%) subjects were biopsy negative. Of the 5 biopsy-negative subjects, 2 had one core each of 3 + 4 disease and 3 had one core each of 3 + 3 disease with ≤5% involvement. Median prostate volume was reduced by 40.7% and PSA by 58%. Extensive QOL assessments showed, on average, no appreciable negative effects of treatment. Conclusions: Initial evidence suggests that TUVA is safe in men with intermediate-risk PCa. Preliminary results demonstrate the absence of ≥GGG2 disease on the treated side in 87% of men and a favorable QOL profile.

Rapid growth of a large penile median raphe cyst.

A 57-year-old male presented to the emergency department due to sudden growth of a penile mass. On physical exam, the mass was located on the ventral surface of the penis at the level of the corona and measured 7cm × 4cm x 3.5cm. Ultrasound suggested that it was cystic in nature. The mass was surgically removed, and final pathology revealed a median raphe cyst.

Rezum for retention-retrospective review of water vaporization therapy in the management of urinary retention in men with benign prostatic hyperplasia.

OBJECTIVE: Rezum vapor ablation is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation. Although Rezum is currently indicated for use in men with prostate sizes ≥30 and ≤80 ml, it is unclear how effective Rezum is for men in urinary retention. We sought to determine whether Rezum is effective in the treatment of catheter-dependent urinary retention secondary to BPH. METHODS: A retrospective chart review was conducted on consecutive patients who presented for urinary retention and subsequently treated with Rezum. We evaluated procedural details and examined variables pre- and post-Rezum (at 6 months) including International Prostate Symptom Score (IPSS), IPSS quality of life (IPSS-QOL), maximum flow (Qmax ), post void residual volume (PVR), prostate specific antigen, rate of retention, and use of alpha blockers and 5-alpha reductase inhibitor (5ARI). RESULTS: Of the 49 patients included in this study, median age of was 73 years, median prostate volume was 73cc (Interquartile range [IQR]: 50, 103) and a median lobe was present in 80% of patients. All patients were in urinary retention before treatment with a median PVR of 900 ml (IQR: 566, 1146). Following Rezum, IPSS (17 pre-Rezum, 4 post-Rezum) and IPSS-QOL (4 pre-Rezum, 1 post-Rezum) both improved at 6 months (p < 0.01). Qmax increased from 3 to 6 ml/s (p = 0.03) and PVR decreased from 900 to 78 ml (p < 0.01). Only 17/38 patients taking alpha-blockers and 7/15 patients on 5ARIs continued therapy at 6 months following Rezum (p < 0.01). Of the 49 patients treated, 10 (20.4%) remained in catheter dependent urinary retention following the procedure, and 6 remained in retention at 6 months (12.2%) even after further surgical therapies for BPH (p < 0.01). CONCLUSION: Rezum is a safe and effective therapy for treating catheter dependent urinary retention in patients with BPH, including those with median lobes. As a minimally invasive therapy, it is a promising option in patient, particularly those who are not suitable for prolonged anesthesia.

Convective Thermal Therapy: Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.

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® 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.

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 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.

Urolift: a New Face of Minimally Invasive Surgical Technique for Benign Prostatic Hyperplasia?

The management of clinical benign prostatic hyperplasia (BPH) remains a common problem in daily urologic practice. Recently, a new minimally invasive procedure for BPH, the Urolift System, has been introduced. This article reviews the current literature discussing the technique, efficacy, adverse events, limitations, and possible concerns. The existing data which includes a 3-month, sham-controlled multicenter trial with a subsequent 3-year follow-up indicates significant improvements in the outcome measures in particular urinary symptoms. The adverse event profile and reoperation rates are acceptable. A particular benefit includes the lack of negative effects on erectile or ejaculatory function. The procedure can be performed with minimal anesthesia, but is limited to lateral lobe enlargement as it is unsuitable for median lobe or central zone obstruction. Another potential drawback is the placement of permanent implants into the prostatic urethra. The adoption of this procedure will ultimately be determined by multiple factors including ease of use, patient satisfaction, durability, and reimbursement.

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

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: 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 Rezum 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. 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 flow rate 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.

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.

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® 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.

Rezum 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 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.

Transurethral convective water vapor as a treatment for lower urinary tract symptomatology due to benign prostatic hyperplasia using the Rezum(®) system: evaluation of acute ablative capabilities in the human prostate.

BACKGROUND: The purpose of this study was to assess the acute ablative characteristics of transurethral convective water vapor (steam) using the Rezum(®) 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.

The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.

BACKGROUND: Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists (alpha-blockers) or 5alpha-reductase inhibitors. The long-term effect of these drugs, singly or combined, on the risk of clinical progression is unknown. METHODS: We conducted a long-term, double-blind trial (mean follow-up, 4.5 years) involving 3047 men to compare the effects of placebo, doxazosin, finasteride, and combination therapy on measures of the clinical progression of benign prostatic hyperplasia. RESULTS: The risk of overall clinical progression--defined as an increase above base line of at least 4 points in the American Urological Association symptom score, acute urinary retention, urinary incontinence, renal insufficiency, or recurrent urinary tract infection--was significantly reduced by doxazosin (39 percent risk reduction, P<0.001) and finasteride (34 percent risk reduction, P=0.002), as compared with placebo. The reduction in risk associated with combination therapy (66 percent for the comparison with placebo, P<0.001) was significantly greater than that associated with doxazosin (P<0.001) or finasteride (P<0.001) alone. The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy (P<0.001) and finasteride (P<0.001) but not by doxazosin. Doxazosin (P<0.001), finasteride (P=0.001), and combination therapy (P<0.001) each resulted in significant improvement in symptom scores, with combination therapy being superior to both doxazosin (P=0.006) and finasteride (P<0.001) alone. CONCLUSIONS: Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone. Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy.

Lower urinary tract symptoms in young men: videourodynamic findings and correlation with noninvasive measures.

PURPOSE: In a prospective manner we sought to determine the cause of lower urinary tract symptoms in young men and whether noninvasive testing and symptoms scores are useful in deciding which patients to evaluate with videourodynamics. MATERIALS AND METHODS: We evaluated 85 men 18 to 45 years old with lower urinary tract symptoms. Patients with a history of known neurological disease or urethral stricture were excluded from the study. Patients were evaluated with the American Urological Association (AUA) symptom index, noninvasive uroflowmetry post-void residual and videourodynamics, and classified by specific urodynamic diagnoses. Noninvasive uroflowmetry (normal versus abnormal), post-void residual and AUA symptom index (total, voiding and storage scores) were evaluated as predictors of urodynamic abnormalities. RESULTS: Mean patient age was 35.1 (range 18 to 45) and mean symptom duration was 53.8 months. Mean AUA scores were total 19.3, voiding 10.8 and storage 8.5. Videourodynamic diagnoses were primary bladder neck obstruction in 40 (47%) cases, dysfunctional voiding in 12 (14%), impaired contractility in 8 (9%), sensory urgency in 7 (8%), detrusor instability alone in 5 (6%), detrusor instability and impaired contractility in 1 (1%), external detrusor-sphincter dyssynergia in 1 (1%) and normal in 5 (6%). Of these patients, 9 could not void during urodynamics and in 6 (7%) no urodynamic diagnosis was made. Videourodynamics were not considered helpful in patients with a normal or nondiagnostic study or sensory urgency only (group 1) but were helpful or diagnostic in the remaining patients (group 2). Only 5 of 18 patients (28%) in group 1 had an abnormal uroflow compared to 56 of 67 (84%) in group 2 (p <0.0001). Mean post-void residual volumes were not different between the 2 groups (40.3 versus 40.0 ml.). Mean total and storage symptom scores were also not different between the 2 groups but voiding scores were significantly higher in group 2 (11.5 versus 8.3, p <0.03). CONCLUSIONS: Lower urinary tract symptoms in young men have a variety of underlying causes. Videourodynamics is an extremely helpful diagnostic test especially in men with abnormal uroflow and high voiding scores.