Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: We present final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor therapy (Rezum™) for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 197 subjects >50 years of age with International Prostate Symptom Score ≥13, maximum flow rate ≤15 ml/second and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the control arm of 61 subjects, a subset of 53 subjects requalified and after 3 months received treatment as part of the crossover group and were also followed for 5 years. The total number of vapor treatments to each lobe of the prostate was determined by length of prostatic urethra and included middle lobe treatment per physician discretion. RESULTS: Significant improvement of lower urinary tract symptoms was observed at <3 months post-thermal therapy, remaining durable through 5 years in the treatment group (International Prostate Symptom Score reduced 48%, quality of life increased 45%, maximum flow rate improved 44%, Benign Prostatic Hyperplasia Impact Index decreased 48%). Surgical re-treatment rate was 4.4% with no reports of device or procedure related sexual dysfunction or sustained de novo erectile dysfunction. Results within the crossover group were similar through 5 years. CONCLUSIONS: Minimally invasive treatment with water vapor thermal therapy provides significant and durable symptom relief as well as flow rate improvements through 5 years, with low surgical re-treatment rates and without impacting sexual function. It is a versatile therapy, providing successful treatment to obstructive lateral and middle lobes.

Cost Comparison of Benign Prostatic Hyperplasia Treatment Options.

PURPOSE OF REVIEW: To provide an economic context within which to consider treatment options for benign prostatic hyperplasia (BPH). To this end, this review provides a comparison of the costs of combination medical therapy, operative treatment, and office-based therapies for BPH from a payer perspective. RECENT FINDINGS: Analysis of Medicare charges from the authors' institution, as well as local retail costs of medication, demonstrated a wide range in costs of commonly used BPH treatments. In this study, interventions for BPH reached cost equivalence with combination medical therapy within 6 months to 8 years. A myriad of options for managing men with symptomatic BPH exist. It is prudent not only to consider surgeon preference and patient-specific factors when selecting a treatment but also to understand the economic impact different BPH therapies confer.

Costs of Managing Benign Prostatic Hyperplasia in the Office and Operating Room.

PURPOSE OF REVIEW: To review the costs associated with benign prostatic hyperplasia (BPH) management. Specifically, to compare the costs of medical therapy, office-based procedures, and surgical management from a payer perspective. RECENT FINDINGS: The American Urological Association released updated guidelines in 2018 for the surgical management of BPH. Over recent years, analyses investigating the cost-effectiveness of the modalities included in these guidelines have been completed. These show relatively newer, minimally-invasive office-based therapies can provide cost-effective alternatives to medical therapy. Likewise, surgical therapies provide a cost-effective means of BPH management, if performed well with low complication rates. However, comparisons of these studies are limited by the biases they contain. Minimally-invasive office-based therapies and well performed surgical therapies for BPH can achieve cost equivalence to combination medical therapy within a few years. Factors such as age, gland size, patient compliance, and surgeon skill should be considered when personalizing treatment recommendations for each patient.

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.

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.

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.

Identification of the variables associated with pain during transrectal ultrasonography-guided prostate biopsy in the era of periprostatic nerve block: the role of transrectal probe configuration.

OBJECTIVE: To identify the different factors that are associated with pain perceived during transrectal ultrasonography (TRUS)-guided prostate biopsy (PBx), with special focus on the role of transrectal probe configuration. PATIENTS AND METHODS: We analysed prospective data on 1114 patients undergoing TRUS-guided PBx at our institute from January 2007 to August 2010. Patients completed questionnaires based on a 10-point visual analogue pain scale related to the consecutive steps of PBx: probe insertion, application of periprostatic nerve block (PPNB) and the obtaining of PBx cores. The variables of interest were age, prostate volume, DRE findings, number of previous biopsies, probe type and the number of retrieved cores. All variables were correlated to pain scores using multivariate regression analysis. RESULTS: At the probe insertion step, end-fire probes were more painful than side-fire probes. The Siemens G50 with metal, short plastic and long plastic needle guides (Siemens, Munich, Germany) had higher pain scores than the B&K probe (Bruel & Kjaer Medical, Copenhagen, Denmark; P = 0.09, 0.008 and 0.003, respectively). For pain at the PPNB application step, all G50(TM) guide subtypes and the Sonoline Prima probe (Siemens) had higher pain scores than the B&K probe, but this only reached statistical significance for the G50(TM) probe with short plastic guide (P = 0.03). On obtaining PBx cores, all G50(TM) subtypes had higher pain scores when compared with the B&K probe (P = 0.59, 0.38 and 0.69, respectively). CONCLUSIONS: The probe design and needle guide affect pain during each step of TRUS-guided PBx. Both the B&K and Sonoline Prima probes caused less pain when compared with the G50(TM) probe, regardless of needle guide.

Update on AUA guideline on the management of benign prostatic hyperplasia.

PURPOSE: To revise the 2003 version of the American Urological Association's (AUA) Guideline on the management of benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: From MEDLINE® searches of English language publications (January 1999 through February 2008) using relevant MeSH terms, articles concerning the management of the index patient, a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms (LUTS) were identified. Qualitative analysis of the evidence was performed. Selected studies were stratified by design, comparator, follow-up interval, and intensity of intervention, and meta-analyses (quantitative synthesis) of outcomes of randomized controlled trials were planned. Guideline statements were drafted by an appointed expert Panel based on the evidence. RESULTS: The studies varied as to patient selection; randomization; blinding mechanism; run-in periods; patient demographics, comorbidities, prostate characteristics and symptoms; drug doses; other intervention characteristics; comparators; rigor and intervals of follow-up; trial duration and timing; suspected lack of applicability to current US practice; and techniques of outcomes measurement. These variations affected the quality of the evidence reviewed making formal meta-analysis impractical or futile. Instead, the Panel and extractors reviewed the data in a systematic fashion and without statistical rigor. Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases. Guideline statements concerning pharmacotherapies, watchful waiting, surgical options and minimally invasive procedures were either updated or newly drafted, peer reviewed and approved by AUA Board of Directors. CONCLUSIONS: New pharmacotherapies and technologies have emerged which have impacted treatment algorithms. The management of LUTS/BPH continues to evolve.

Comparative Effectiveness of Transurethral Prostate Procedures at Enabling Urologic Medication Discontinuation: A Retrospective Analysis.

OBJECTIVE: To test the hypothesis that transurethral prostate procedures (TUPPs) eliminating tissue result in greater medication discontinuation and lower de novo initiation rates than procedures inducing tissue necrosis. METHODS: Retrospective review of all men undergoing first time TUPPs at a large tertiary center from 2001 to 2016 was completed. Procedure type and urologic medication use before, 3-12 months after, and greater than 12 months after TUPP were analyzed with simple open prostatectomy as a comparator. Tissue-eliminating TUPPs included transurethral resection of the prostate and laser prostatectomy. Tissue-necrosing procedures included microwave therapy (transurethral microwave therapy) and radiofrequency ablation (transurethral needle ablation), which were grouped in analyses. Medication types were 5-alpha reductase inhibitors (5ARI), alpha blockers, anticholinergics, and beta-3 agonists (B3A). RESULTS: A total 5150 TUPPs were analyzed. Preoperative medication use significantly varied across TUPPs for 5ARI (P <.01), alpha-blockers (P .01), and anticholinergics (P .047), but not B3A (P .476). Transurethral resection of the prostate and laser prostatectomy were associated with significantly higher medication discontinuation rates and lower resumption and initiation rates compared to tissue-necrosing procedures. Relative to TUPPs, simple prostatectomy had significantly higher medication discontinuation, as well as the lowest resumption and initiation rates. CONCLUSION: Tissue-eliminating benign prostatic hyperplasia procedures were associated with better medication discontinuation, resumption, and de novo initiation rates compared to tissue-necrosing benign prostatic hyperplasia procedures.

Cost-effectiveness analysis of six therapies for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.

OBJECTIVE: To conduct a cost-effectiveness analysis from payers' perspectives of six treatments for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and to examine positioning of these modalities in the marketplace for the best use of health care funds and quality-of-life benefits for patients. METHODS: The economic analysis was conducted with a Markov model to compare combination prescription drug therapy (ComboRx), minimally invasive therapies (MITs) including convective radiofrequency (RF) water vapor thermal therapy (Rezum®), conductive RF thermal therapy (Prostiva®), and prostatic urethral lift (UroLift®), and invasive surgical procedures including photovaporization of the prostate (Greenlight® PVP) and transurethral resection of the prostate (TURP). Effects assessed with International Prostate Symptom Score, adverse events, and re-treatment rates were estimated from medical literature; treatments effects were modeled using a common baseline score. Starting with each therapy, patients' transitions to more intensive therapies when symptoms returned were simulated in 6-month cycles over 2 years. Incremental cost-effectiveness ratios (ICERs) were calculated for pairs of treatments; uncertainty in ICERs was estimated with probabilistic sensitivity analyses. RESULTS: ComboRx was least effective and provided one-third of the symptom relief achieved with MITs. UroLift was similar in effectiveness to Prostiva and Rezum but costs more than twice as much. The cheaper MITs were ~$900 more expensive than the cost of ComboRx generic drugs over 2 years. TURP and PVP provided slightly greater relief of LUTS than MITs at approximately twice the cost over 2 years; typically, they are reserved for treatment of more severe LUTS. CONCLUSION: The analysis evaluated the costs and symptom relief of six treatment options in the continuum of care from a common baseline of LUTS severity. Identification of treatments for LUTS/BPH that demonstrate cost-effectiveness and provide appreciable symptom relief is paramount as reimbursement for patient care moves from volume-based services to value-based services.

Reflex UroVysion testing of bladder cancer surveillance patients with equivocal or negative urine cytology: a prospective study with focus on the natural history of anticipatory positive findings.

A proportion of patients under surveillance for recurrent bladder carcinoma with no immediate evidence of bladder tumor recurrence have positive multitarget fluorescence in situ hybridization (FISH; UroVysion, Vysis, Downers Grove, IL) results. The course of these "anticipatory positive" cases and the time to bladder tumor recurrence remains unknown. We followed up 250 patients with urine cytologic results, concurrent multitarget FISH, and cystoscopic examination for recurrent urothelial carcinoma. Of 81 cases (32.4%) with FISH-positive results, tumor recurrence developed in 60 (74.0%). Of 169 (67.6%) FISH-negative cases, recurrent urothelial carcinoma developed in 22 (13.0%). Of 211 patients (84.4%) with negative cystoscopic examination results, 56 (26.5%) had positive FISH results, and in 35 (62.5%) of these patients, recurrent urothelial carcinoma developed. Approximately 27% of patients under bladder carcinoma surveillance without immediate evidence of tumor recurrence will have a positive FISH result, defining the anticipatory positive subset. In about 65% of this anticipatory positive group, recurrent bladder urothelial carcinoma developed within 29 months.

The Impact of Documentation on Medicare and Medicaid Reimbursement of Subspecialty Urology in the Era of Health Care Reform.

INTRODUCTION: As health care reform is ongoing, reimbursement will continually be increasingly scrutinized and decreased despite growing numbers of patients with comorbid medical conditions. This study determined the impact of inpatient comorbidity documentation on hospital reimbursement in a female pelvic medicine and reconstructive surgery group. METHODS: Departmental financial records from 2011 to 2012 were reviewed. All admissions by 4 female pelvic medicine and reconstructive surgeons at a tertiary referral center were collected. All DRG (Diagnosis Related Group) codes of pathological conditions specific to males, stones and nonsubspecialty issues were excluded from analysis. Using CMS (Centers for Medicare and Medicaid Services) reimbursement rates the effects of documenting and coding comorbidities or complications were determined. Geographic multipliers were excluded. The study objective was to determine the impact of inpatient documentation on hospital reimbursement from a urological subspecialty group. RESULTS: Each of 4 surgeons admitted an average of 29 inpatients per year of whom 29% had a comorbidity or complication documented. Mean reimbursement was $3,486 greater for cases with versus without a coded comorbidity or complication. This resulted in an additional $31,374 of reimbursement annually per surgeon or $125,496 for the group. CONCLUSIONS: Documenting comorbidities and complications in urology patients appropriately results in a substantial increase in reimbursement. Care should be taken by urologists to accurately note comorbid medical conditions. This is especially crucial as health care reform continues and growing numbers of patients present with chronic disease while reimbursement is further scrutinized and decreased.

Prophylactic tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: final report of a double-blind placebo-controlled randomized study.

PURPOSE: To evaluate the effectiveness of prophylactic tamsulosin (Flomax) in reducing the urinary symptoms in patients undergoing 125I prostate implantation (PI) for prostate adenocarcinoma. METHODS AND MATERIALS: This is a single-institution, double-blind, placebo-controlled, randomized trial for patients undergoing PI for prostate adenocarcinoma comparing prophylactic tamsulosin versus placebo. Eligibility criteria included patients not taking tamsulosin or other alpha-blockers treated with PI. The patients were randomly assigned to either tamsulosin (0.8 mg, orally once a day) or matched placebo. All patients started the medication 4 days before PI and continued for 60 days. The American Urologic Association (AUA) symptom index questionnaire was used to assess urinary symptoms. The AUA questionnaire was administered before PI for a baseline score and weekly for 8 weeks after PI. Patients were taken off the study if they developed urinary retention, had intolerable urinary symptoms, or wished to discontinue with the trial. RESULTS: One hundred twenty-six patients were enrolled in this study from November 2001 to January 2003 (118 were evaluable: 58 in the tamsulosin arm and 60 in the placebo group). Pretreatment and treatment characteristics were comparably matched between the two groups. The urinary retention rate was 17% (10 patients) in the placebo group compared with 10% (6 patients) in the tamsulosin group (p = 0.3161). Eighty-eight percent (14 patients) of those who developed urinary retention experienced it within 2 weeks after the PI. Intolerable urinary symptoms were reported equally (10 patients in each group) with 70% occurring in the first 2 weeks after PI. There was a significant difference in mean AUA score in favor of tamsulosin at Week 5 after PI (p = 0.03). CONCLUSIONS: Prophylactic tamsulosin (0.8 mg/day) before prostate brachytherapy did not significantly affect urinary retention rates, but had a positive effect on urinary morbidity at Week 5 after PI.

Prospective evaluation of interstitial laser coagulation of the prostate: importance of surgical technique and patient selection.

PURPOSE: To evaluate the impact of improvements in surgical technique and patient selection on overall outcomes of interstitial laser coagulation (ILC) of the prostate and to describe our treatment algorithm. PATIENTS AND METHODS: During a 4-year period, 66 men with bothersome lower urinary-tract symptoms underwent ILC of the prostate using the Indigo 830e Diode Laser System (Ethicon Endo-Surgery). Patients were assessed preoperatively and followed prospectively. Parameters included American Urological Association Symptoms Index, Quality of Life Scale, Problems Due to Symptoms Score, postvoiding residual volume, maximum flow rate, number of treatment punctures, and adverse events. One-year follow-up data were compared with baseline data using the Wilcoxon signed rank test or Fisher's exact test. Patients were stratified into those treated during the first 2 years (group 1) and those treated in the latest 2 years (group 2), corresponding to changes in surgical technique and patient selection. RESULTS: Maximum flow rates improved by 47% and 85% in groups 1 and 2, respectively, at 12 months postoperatively compared with baseline (P = 0.04)l. The mean number of punctures differed significantly, with 6.4 in group 1 and 8.4 in group 2 (P = 0.03). Subjective measures were significantly improved from baseline in both groups and did not differ between groups. The incidence of adverse events was similar in the two groups. CONCLUSIONS: Improvements in surgical technique and patient selection described herein corresponded to significantly higher maximum flow rates without an increase in adverse events.

Prophylactic urethral stenting with Memokath® 028SW in prostate cancer patients undergoing prostate 125I seed implants: phase I/II study.

PURPOSE: To study the feasibility/toxicity of urethral stenting with the Memokath® 028SW stent in patients undergoing prostate implant (PI) for prostate adenocarcinoma. MATERIAL AND METHODS: An Investigational Device Exemption from the Food and Drug Administration (FDA) and institutional review board (IRB) approval were obtained. Twenty patients enrolled. Baseline American Urological Association (AUA) score was obtained prior to PI. Follow-up information was obtained with weekly phone calls for the first 12 weeks and biweekly calls for the next 12 weeks to assess toxicity and AUA score. Removal of the stent was planned at six months after PI, or earlier due to excessive toxicity/patient request. RESULTS: Median age was 66.5 years. The median prostate volume was 39 cc (range: 10-90). The median baseline AUA score was 7.5 (range: 1-21). Three patients required intermittent self-catheterization (ISC) within 3 days after PI. No patients required ISC beyond day 3 after PI. The median duration of ISC was 1 day (range: 1-2). AUA scores returned to baseline values 6 weeks after PI. The week 6 AUA score was 10 (range: 4-16). Seven patients (35%) underwent early removal because of patient preference. The reasons were: incontinence (n = 3), discomfort (n = 2), hematuria (n = 1), and obstructive symptoms (n = 1). The median time of stent removal in these patients was 13.9 weeks (range: 0.9-21.4). Thirteen patients (65%) had ISC and/or urinary catheterization post stent removal. Median time for ISC use was 10 days (range: 1-90). CONCLUSIONS: Urethral stenting with Memokath® in patients undergoing PI was feasible, but resulted in relatively high rate of urinary incontinence and discomfort. Given the adverse effects experienced by patients of this study, further studies should focus only on patients with highest risk of urinary obstruction from PI or those with obstruction needing ISC.