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.

Single-port transvesical versus open simple prostatectomy: a perioperative comparative study.

OBJECTIVE: To compare the initial perioperative outcomes of single-port transvesical simple prostatectomy (SP RASP) patients to those of open simple prostatectomy (OSP). PATIENTS AND METHODS: Perioperative data from 42 consecutive patients with BPH who underwent SP RASP were prospectively reviewed. Similarly, data from forty-three consecutive patients who underwent the standard OSP, were retrospectively collected. Through direct suprapubic bladder access, prostatic enucleation was performed using the prostatic capsule as a landmark. Then a complete vesicourethral mucosal advancement flap was accomplished. OSP was performed according to the standard approach. Demographics, Intra- and perioperative data were analyzed and assessed with a descriptive analysis. RESULTS AND LIMITATIONS: Baseline characteristics were comparable between the two groups, except for the preoperative median post-void residual volume, which was higher in the OSP group (p = 0.004). The SP RASP group had less intraoperative estimated blood loss (p < 0.001), no need for continuous bladder irrigation (p < 0.001), and less in-hospital opioid use (p < 0.001). Patients in the SP RASP group were discharged on postoperative day zero, compared to a median of 2 days for OSP (p < 0.001). The median Foley catheter duration was 7 days for SP RASP, compared to a median of 10 days for OSP (p < 0.001). SP RASP group had fewer postoperative complications, however, this did not reach statistical significance. CONCLUSION: SP RASP is an alternative approach in treating surgical BPH. It may offer patients less morbidity in comparison to OSP.

125I Interstitial brachytherapy with or without androgen deprivation therapy among unfavorable-intermediate and high-risk prostate cancer.

PURPOSE/OBJECTIVE(S): To determine if patients with unfavorable intermediate-risk (UIR), high-risk (HR), or very high-risk (VHR) prostate cancer (PCa) treated with 125I interstitial brachytherapy benefit from androgen deprivation therapy (ADT). MATERIALS/METHODS: We reviewed our institutional database of patients with UIR, HR, or VHR PCa, per 2018 NCCN risk classification, treated with definitive 125I interstitial brachytherapy with or without ADT from 1998-2017. Outcomes including biochemical failure (bF), distant metastases (DM), and overall survival (OS) were analyzed with the Kaplan-Meier method and Cox proportional hazards regression. PCa-specific mortality (PCSM) was analyzed with Fine-Gray competing-risk regression. RESULTS: Of 1033 patients, 262 (25%) received ADT and 771 (75%) did not. Median ADT duration was 6 months. By risk group, 764 (74%) patients were UIR, 219 (21%) HR, and 50 (5%) VHR. ADT was more frequently given to HR (50%) and VHR (56%) patients compared to UIR (16%; p<0.001), to older patients (p<0.001), corresponding with increasing PSA (p<0.001) and Grade Group (p<0.001). Median follow-up was 4.9 years (0.3-17.6 years). On multivariable analysis accounting for risk group, age, and year of treatment, ADT was not associated with bF, DM, PCSM, or OS (p≥0.05 each). CONCLUSION: Among patients with UIR, HR, and VHR PCa, the addition of ADT to 125I interstitial brachytherapy was not associated with improved outcomes, and no subgroup demonstrated benefit. Our findings do not support the use of ADT in combination with 125I interstitial brachytherapy. Prospective studies are required to elucidate the role of ADT for patients with UIR, HR, and VHR PCa treated with prostate brachytherapy.

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.

Single-port transvesical enucleation of the prostate: a clinical report of 34 cases.

OBJECTIVE: To present our experience with single-port transvesical enucleation of the prostate (STEP) in 34 patients with large-volume benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: We performed STEP in 34 patients with large volume (>60 g) BPH (mean age 69 years, body mass index 26 kg/m(2), and American Society of Anesthesiology class 2). The mean prostate volume estimated by transrectal ultrasonography was 102.5 mL and the mean baseline prostate-specific antigen level was 6.7 ng/mL. A novel single-port device was inserted percutaneously into the bladder through a 2-3 cm incision in the suprapubic skin crease. After establishing pneumovesicum, the prostate adenoma was enucleated transvesically using standard laparoscopic instruments, and the adenoma was extracted in pieces through the port. Digital assistance expedited enucleation of the apical adenoma in 19 (55%) cases. RESULTS: Transvesical enucleation was completed in all 34 cases; the mean operative duration was 116 min, and the estimated blood loss was 460 mL. There was one death from postoperative bleeding from uncontrolled coagulopathy in a Jehovah's Witness who refused a transfusion of blood and blood products. There were three complications during STEP (one death, one bowel injury and one haemorrhage) and five afterwards (four bleeding, one epididymo-orchitis). Open conversion was necessary in two patients for complications, and extension of the skin incision by 1-2 cm was necessary in two to expedite apical digital enucleation. The mean hospital stay was 3 days and mean analogue pain score at discharge was 2. All 33 patients (excluding the patient who died) were voiding spontaneously at a maximum follow-up of 8 months, with a mean American Urologic Association symptom score of 3, a maximum urinary flow rate of 44 mL/s, and a postvoid residual of 30 mL at the latest follow-up. No patient developed urinary incontinence. CONCLUSIONS: STEP is an effective treatment option for selected patients with large-volume obstructive BPH. Under pneumovesicum using laparoscopic visualization, the entire adenoma can be effectively enucleated and expeditiously extracted through the novel single port. Comparison of the STEP procedure with other open and transurethral techniques will determine its place in the surgical treatment of large-volume BPH.

Validation of the NCCN prostate cancer favorable- and unfavorable-intermediate risk groups among men treated with I-125 low dose rate brachytherapy monotherapy.

PURPOSE: To validate the 2019 NCCN subgroups of favorable- and unfavorable-intermediate risk (IR) prostate cancer among patients treated with brachytherapy, who are underrepresented in the studies used to develop the 2019 NCCN classification. METHODS: We included all 2,705 men treated with I-125 LDR brachytherapy monotherapy at a single institution, and who could be classified into the 2019 NCCN risk groups. Biochemical failure and distant metastasis rates were calculated using cumulative incidence analysis. RESULTS: Of 1,510 IR patients, 756 (50%) were favorable-IR, and 754 (50%) were unfavorable-IR. Median follow up was 48 months (range, 3-214). As compared to favorable-IR, the unfavorable-IR group was associated with significantly higher rates of biochemical failure (HR, 2.87; 95% CI, 2.00-4.10; p < 0.001) and distant metastasis (HR, 3.14; 95% CI, 1.78-5.50, p < 0.001). For favorable-IR vs. unfavorable-IR groups, 5-year estimates of biochemical failure were 4.3% (95% CI, 2.6-6.1%) vs. 17.0% (95% CI, 13.6-20.5%; p < 0.001), and for distant metastasis were 1.6% (95% CI, 0.5-2.6%) vs. 5.4% (95% CI, 3.3-7.4%; p < 0.001), respectively. Patients with one unfavorable-intermediate risk factor (unfavorable-IRF; HR, 2.27; 95% CI, 1.54-3.36; p < 0.001) and 2-3 unfavorable-IRFs (HR, 4.42; 95% CI, 2.89-6.76; p < 0.001) had higher biochemical failure rates; similar findings were observed for distant metastasis (1 unfavorable-IRF: HR, 2.46; 95% CI, 1.34-4.53, p = 0.004; 2-3 unfavorable-IRFs: HR, 4.76; 95% CI, 2.49-9.10, p < 0.001). CONCLUSIONS: These findings validate the prognostic utility of the 2019 NCCN favorable-IR and unfavorable-IR prostate cancer subgroups among men treated with brachytherapy. Androgen deprivation was not beneficial in any subgroup. Alternative treatment intensification strategies for unfavorable-IR patients are warranted.

The Association of Urologic Oncology Fellowship Training and Diagnostic Yield of Prostate Biopsy.

OBJECTIVE: To determine the relationship between urologic oncology fellowship training (UOFT) and diagnostic yield of prostate biopsy. METHODS: Retrospective review was conducted of patients who underwent prostate biopsy across the Cleveland Clinic between 2000 and 2018. Biopsies done by urologists with and without UOFT were detailed via descriptive statistics and appropriate (chi-square, Student t, Wilcoxon rank-sum) tests. Multivariate logistic regression was used to examine the association between UOFT and positive prostate biopsy, adjusting for relevant covariates. RESULTS: A total of 11,241 biopsies by 129 urologists had complete information available for review. Sixteen urologists (12.4%) had UOFT; 113 either completed a different fellowship or no fellowship. Those with UOFT were more likely to use MRI-guided biopsy (7.80% vs 3.05%, P <.0001), more likely to get a positive biopsy (41.25% vs 32.72%, P <.0001), and more likely to obtain an adequate number (by ≥12) of cores (90.25% vs 74.53%, P <.0001). UOFT remained a significant predictor of positivity when adjusting for patient age and race, PSA, 5-alpha-reductase-inhibitor use, year of biopsy, years in practice, and type of biopsy (MRI or transrectal ultrasound guided). UOFT also predicted higher-risk biopsy (Gleason sum ≥7), adjusting for the same variables, though this association lost significance when adjusting for adequacy of biopsy. The learning curve to achieve a higher percentage of positive biopsies was steeper for nonurologic oncology fellowship trained than for UOFT urologists. CONCLUSION: UOFT is associated with higher diagnostic yield on prostate biopsy, higher uptake of MRI-guided biopsy, and less steep learning curve. This may be due to patient selection, technique, or, as we demonstrate here, adherence to guidelines.

KTP laser nerve sparing radical prostatectomy: comparison of ultrasonic and cold scissor dissection on cavernous nerve function.

PURPOSE: Energy sources used during nerve sparing radical prostatectomy are known to compromise cavernous nerve function. Lasers offer the potential for accurate dissection while minimizing collateral injury to delicate neural structures. We evaluated cavernous nerve function following KTP laser dissection and compared outcomes to those of ultrasonic shears and cold scissor dissection. MATERIALS AND METHODS: Laparoscopic unilateral neurovascular bundle mobilization was performed in 36 survival dogs using a KTP laser, ultrasonic shears and an athermal technique with cold scissors and clips in 12 each. Peak intracavernous pressure upon cavernous nerve stimulation, expressed as a percent of mean arterial pressure, was measured acutely and at 1 month. Thermal spread from the KTP laser and ultrasonic shears was assessed histologically ex vivo in harvested peritoneum. RESULTS: Median peak intracavernous pressure as a percent of mean arterial pressure was similar immediately and 1 month after laser and athermal dissection, and significantly decreased after dissection with ultrasonic shears. Acute peak intracavernous pressure as a percent of mean arterial pressure was 53%, 96% and 98% for ultrasonic shears, laser and the athermal technique, respectively (laser vs athermal p = 0.51, ultrasonic shears vs laser p <0.001 and ultrasonic shears vs athermal p <0.001). Chronic peak intracavernous pressure as a percent of mean arterial pressure was 56%, 98% and 100% for ultrasonic shears, laser and the athermal technique, respectively (laser vs athermal p = 0.38, ultrasonic shears vs laser p = 0.016 and ultrasonic shears vs athermal p = 0.013). The median depth of acute laser injury was 600 microm compared to 1.2 mm for ultrasonic shear dissection and 450 microm crush injury due to the athermal technique. Thermography revealed less collateral thermal spread from the laser than from the ultrasonic shears (median greater than 60C thermal spread 1.07 vs 6.42 mm, p <0.01). CONCLUSIONS: The KTP laser was comparable to the athermal technique and superior to the ultrasonic shears for preserving cavernous nerve function.

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.