Princeton IV consensus guidelines: PDE5 inhibitors and cardiac health.

BACKGROUND: In 1999, 1 year after the approval of the first oral phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), the first Princeton Consensus Conference was held to address the clinical management of men with ED who also had cardiovascular disease. These issues were readdressed in the second and third conferences. In the 13 years since the last Princeton Consensus Conference, the experience with PDE5 inhibitors is more robust, and recent new data have emerged regarding not only safety and drug-drug interactions, but also a potential cardioprotective effect of these drugs. AIM: In March 2023, an interdisciplinary group of scientists and practitioners met for the fourth Princeton Consensus Guidelines at the Huntington Medical Research Institutes in Pasadena, California, to readdress the cardiovascular workup of men presenting with ED as well as the approach to treatment of ED in men with known cardiovascular disease. METHOD: A series of lectures from experts in the field followed by Delphi-type discussions were developed to reach consensus. OUTCOMES: Consensus was reached regarding a number of issues related to erectile dysfunction and the interaction with cardiovascular health and phosphodiesterase-5 inhibitors. RESULTS: An algorithm based on recent recommendations of the American College of Cardiology and American Heart Association, including the use of computed tomography coronary artery calcium scoring, was integrated into the evaluation of men presenting with ED. Additionally, the issue of nitrate use was further considered in an algorithm regarding the treatment of ED patients with coronary artery disease. Other topics included the psychological effect of ED and the benefits of treating it; the mechanism of action of the PDE5 inhibitors; drug-drug interactions; optimizing use of a PDE5 inhibitors; rare adverse events; potential cardiovascular benefits observed in recent retrospective studies; adulteration of dietary supplements with PDE5 inhibitors; the pros and cons of over-the-counter PDE5 inhibitors; non-PDE5 inhibitor therapy for ED including restorative therapies such as stem cells, platelet-rich plasma, and shock therapy; other non-PDE5 inhibitor therapies, including injection therapy and penile prostheses; the issue of safety and effectiveness of PDE5 inhibitors in women; and recommendations for future studies in the field of sexual dysfunction and PDE5 inhibitor use were discussed. CLINICAL IMPLICATIONS: Algorithms and tables were developed to help guide the clinician in dealing with the interaction of ED and cardiovascular risk and disease. STRENGTHS AND LIMITATIONS: Strengths include the expertise of the participants and consensus recommendations. Limitations included that participants were from the United States only for this particular meeting. CONCLUSION: The issue of the intersection between cardiovascular health and sexual health remains an important topic with new studies suggesting the cardiovascular safety of PDE5 inhibitors.

A comprehensive analysis of clinical, quality of life, and cost-effectiveness outcomes of key treatment options for benign prostatic hyperplasia.

Treatment options for men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) have variable efficacy, safety, and retreatment profiles, contributing to variations in patient quality of life and healthcare costs. This study examined the long-term cost-effectiveness of generic combination therapy (CT), prostatic urethral lift (PUL), water vapor thermal therapy (WVTT), photoselective vaporization of the prostate (PVP), and transurethral resection of the prostate (TURP) for the treatment of BPH. A systematic literature review was performed to identify clinical trials of CT, PUL, WVTT, PVP, and TURP that reported change in International Prostate Symptom Score (IPSS) for men with BPH and a prostate volume ≤80 cm3. A random-effects network meta-analysis was used to account for the differences in patient baseline clinical characteristics between trials. An Excel-based Markov model was developed with a cohort of males with a mean age of 63 and an average IPSS of 22 to assess the cost-effectiveness of these treatment options at 1 and 5 years from a US Medicare perspective. Procedural and adverse event (AE)-related costs were based on 2021 Medicare reimbursement rates. Total Medicare costs at 5 years were highest for PUL ($9,580), followed by generic CT ($8,223), TURP ($6,328), PVP ($6,152), and WVTT ($2,655). The total cost of PUL was driven by procedural ($7,258) and retreatment ($1,168) costs. At 5 years, CT and PUL were associated with fewer quality-adjusted life years (QALYs) than WVTT, PVP, and TURP. Compared to WVTT, the incremental cost-effectiveness ratios (ICERs) for both TURP and PVP were above a willingness-to-pay threshold of $50,000/QALY (TURP: $64,409/QALY; PVP: $87,483/QALY). This study provides long-term cost-effectiveness evidence for several common treatment options for men with BPH. WVTT is an effective and economically viable treatment in resource-constrained environments.

Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management.

PURPOSE: Benign prostatic hyperplasia (BPH) is a histologic diagnosis describing proliferation of smooth muscle and epithelial cells within the prostatic transition zone. The prevalence and severity of lower urinary tract symptoms (LUTS) in aging men are progressive and impact the health and welfare of society. This revised Guideline provides a useful reference on effective evidence-based management of male LUTS/BPH. See the accompanying algorithm for a summary of the procedures detailed in the Guideline (figures 1 and 2[Figure: see text][Figure: see text]). MATERIALS AND METHODS: The Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, Cochrane Library, and AHRQ databases to identify eligible English language studies published between January 2008 and April 2019, then updated through December 2020. Search terms included Medical Subject Headings (MeSH) and keywords for pharmacological therapies, drug classes, and terms related to LUTS or BPH. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, information is provided as Clinical Principles and Expert Opinions (table 1[Table: see text]). RESULTS: Nineteen guideline statements pertinent to evaluation, work-up, and medical management were developed. Appropriate levels of evidence and supporting text were created to direct both primary care and urologic providers towards streamlined and suitable practices. CONCLUSIONS: The work up and medical management of BPH requires attention to individual patient characteristics, while also respecting common principles. Clinicians should adhere to recommendations and familiarize themselves with standards of BPH management.

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.

The New American Urological Association Benign Prostatic Hyperplasia Clinical Guidelines: 2019 Update.

PURPOSE OF REVIEW: The goal of this paper was to analyze the efficacy of the current modalities available to surgically treat lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). RECENT FINDINGS: There have been significant surgical advancements for the treatment of BPH, including an increasing development and utilization of minimally invasive surgical techniques (MISTs). These procedures have varying outcomes that are critical to understand. In addition, MISTs have important adverse effects, though have minimized effects on sexual function when compared to more invasive surgical techniques. It is important for all urologists to be familiar with the surgical techniques available to treat BPH and the updated American Urological Association (AUA) Guidelines. Further studies evaluating efficacy, safety, and sexual functioning will help guide care in the future and evolve practice.

Surgical Reintervention Rate after Prostatic Urethral Lift: Systematic Review and Meta-Analysis Involving over 2,000 Patients.

PURPOSE: The surgical reintervention rate after prostatic urethral lift is not well characterized but has been estimated at 2% to 3% per year. We performed a systematic review and meta-analysis to determine the surgical reintervention rate after prostatic urethral lift. MATERIALS AND METHODS: We systematically searched MEDLINE®, Embase® and the Cochrane Central Register of Controlled Trials for studies of men treated with prostatic urethral lift reporting at least 1 year of maximum followup data. We performed a random effects meta-analysis to estimate the annual rate of surgical reintervention after prostatic urethral lift, including those performed for lower urinary tract symptoms or involving device explant, additions or replacement. The robustness of the meta-analysis conclusions was evaluated in a one-study removed analysis and heterogeneity was investigated with a subgroup analysis. RESULTS: In 11 studies (2,016 patients) 153 surgical reinterventions were performed, among which transurethral resection of the prostate/laser (51.0%), repeat prostatic urethral lift (32.7%) and device explant (19.6%) were most common. The annual rate of surgical reintervention was 6.0% per year (95% CI 3.0-8.9). These results were not significantly influenced by any single study. The annual rate of surgical intervention was significantly influenced by the mean duration of patient followup. Surgical reintervention rates were 4.3% per year in studies with 1 year or less mean followup, 10.7% per year in studies with more than 1 year to 3 years mean followup and 5.8% per year in a single study with more than 3 years mean followup (p=0.04). CONCLUSIONS: The surgical reintervention rate with prostatic urethral lift is 6.0% per year and is higher in studies with longer followup durations.

A novel metric for treatment durability in clinical trials of minimally invasive treatments for benign prostatic hyperplasia.

Introduction: Clinical trial manuscripts commonly report results of individual endpoints. However, durability of a medical treatment may be difficult to determine when evaluating endpoint outcomes individually. We reviewed pivotal trial manuscripts of two minimally invasive benign prostatic hyperplasia (BPH) treatments and estimated the rate of treatment durability using a composite, symptom-centric metric.Methods: Data were derived from published pivotal trial reports of two minimally invasive BPH treatments - water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL). We estimated the risk of medical or surgical retreatment using life-table methods, and the number of patients achieving the minimal clinically important difference (MCID) for the International Prostate Symptom Score (IPSS) using z-score methods. Treatment durability was defined as a MCID on the IPSS at the 4-year follow-up visit while free from medical or surgical retreatment.Results: Comparing WVTT to PUL, the rate of medical or surgical retreatment was 10.6% vs. 31.8%, the IPSS MCID was achieved in 82.2% vs. 79.5%, and treatment durability rates were 71.8% vs. 51.7%.Conclusions: Utilization of a composite treatment durability metric derived from endpoints commonly reported in the BPH literature may allow patients and their providers to make better informed treatment decisions.

Water vapor thermal therapy to alleviate catheter-dependent urinary retention secondary to benign prostatic hyperplasia.

BACKGROUND: Water vapor thermal therapy utilizes convectively delivered thermal energy to target ablation of obstructive prostatic tissue. We report results of this thermal therapy for relief of nonneurogenic complete urinary retention associated with BPH. PATIENTS AND METHODS: We conducted a retrospective analysis of 38 catheter-dependent men with complete urinary retention consecutively enrolled in a registry in two centers: median age 75.5 years and multiple comorbidities, median prostate volume 58.5 cc (23-153), median 2 failed trials without catheter (TWOCs), and median catheter dependency 3 months (0.3-35). The Rezum™ System thermal therapy procedure was performed in an ambulatory surgery center with conscious sedation or an office procedure room with a modified periprostatic block. Water vapor injections were customized to the configuration of the hyperplastic gland, including median lobe and/or enlarged central zone. RESULTS: Of the 38 treated patients, one was lost to follow-up and 26 of 37 (70.3%) voided spontaneously (mean of 1.6 ± 0.8 TWOCs) and were catheter free a median of 26 days (range 4-65) after the procedure; 18 of these 26 (69%) patients discontinued BPH medications. No significant differences in age, prostate volume, number of water vapor injections, or presence of the median lobe were associated with predicting a successful treatment outcome. Duration of follow-up for 20 catheter-free patients was a median of 475 days or 15.8 months (140-804 days); six patients were followed a median of 31.5 days (0-60). Adverse events were infrequent, mild, and resolved quickly including dysuria in five patients (13%), gross hematuria in four (10.5%), and UTIs in two (2.6%) with indwelling catheters. CONCLUSIONS: Water vapor thermal therapy may provide an effective and safe alternative to surgical treatment in this group of catheter-dependent patients in complete urinary retention.

Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study.

OBJECTIVE: To report 4-year outcomes of the randomized controlled trial of water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS: Total 188 subjects; 135 men ≥50years old, International Prostate Symptom Score ≥ 13, maximum flow rate (Qmax) ≤15 mL/s and prostate volume 30 to 80 cc treated with Rezum System thermal therapy were followed 4 years; subset of 53 men who requalified for crossover from control to active treatment were followed 3years. RESULTS: Lower urinary tract symptoms were significantly improved within ≤3 months after thermal therapy and remained consistently durable (International Prostate Symptom Score 47%, quality of life 43%, Qmax 50%, Benign Prostatic Hyperplasia Impact Index 52%) throughout 4years (P <.0001); outcomes were similarly sustained in crossover subjects at 3years. Surgical retreatment rate was 4.4% over 4years. No disturbances in sexual function were reported. CONCLUSION: The minimally invasive thermal therapy provides effective symptom relief and improved quality of life that remains durable for over 4years. It is applicable to all prostate zones with procedures performed under local anesthesia in an office setting.

Is Sexual Function Better Preserved After Water Vapor Thermal Therapy or Medical Therapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia?

BACKGROUND: Men often experience deterioration of sexual function after the use of α-blockers and 5-α reductase inhibitors for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia. Thus, an alternative treatment with water vapor thermal therapy (Rezum System, Boston Scientific, Marlborough, MA, USA) which is an efficacious minimally invasive surgical treatment that preserves sexual function was examined. AIM: To compare sexual function over 3 years after continuous daily treatment with pharmaceutical agents in the Medical Therapy of Prostatic Symptoms (MTOPS) study vs a single thermal therapy procedure (Rezum study) in subjects with matched criteria for LUTS severity and prostate size. METHODS: We used sexual function data from sexually active cohorts in the MTOPS study (1,209) randomized to doxazosin, finasteride, combination drugs and placebo, and sexually active men who received thermal therapy (86). MTOPS study participants completed the Brief Male Sexual Function Inventory; men in the Rezum trial completed the International Index of Erectile Function and Male Sexual Health Questionnaire. MAIN OUTCOME MEASURE: Estimated mean changes from baseline for sexual function variables were compared using a linear mixed repeated measures model with fixed effects for treatment and follow-up visits. RESULTS: With continued daily drug use, men experienced significant worsening of sexual desire, erectile and ejaculatory function with finasteride and combination drug therapy, and reduced desire and erectile function with doxazosin. Thermal therapy was not associated with significant negative changes in sexual function throughout 3 years after treatment. CLINICAL IMPLICATIONS: Water vapor thermal therapy can result in greater LUTS improvements than either doxazosin or finasteride alone, whereas combination drug therapy may equal that of this Rezum procedure, but all drug therapies did have a significant negative impact on sexual function in contrast to the preservation of libido, erectile, and ejaculatory function after thermal therapy. STRENGTH & LIMITATIONS: The report includes high-quality data from 2 large randomized controlled trials in subjects with similar baseline inclusion criteria for LUTS severity and prostate size. It is the first longitudinal assessment of sexual function domains restricted to sexually active men treated with drugs or a single minimally invasive surgical treatment with the Rezum procedure. A limitation of the study is the use of 2 different, although validated sexual function inventories (Brief Male Sexual Function Inventory and International Index of Erectile Function). CONCLUSION: A single water vapor thermal therapy procedure for targeted prostate tissue ablation for LUTS/ benign prostatic hyperplasia had no deleterious effect on 4 sexual function domains compared with appreciable worsening of sexual function after long-term single or combination drug use. McVary KT, Rogers T, Mahon J, et al. Is Sexual Function Better Preserved After Water Vapor Thermal Therapy or Medical Therapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia? J Sex Med 2018;15:1728-1738.

Three-Year Treatment Outcomes of Water Vapor Thermal Therapy Compared to Doxazosin, Finasteride and Combination Drug Therapy in Men with Benign Prostatic Hyperplasia: Cohort Data from the MTOPS Trial.

PURPOSE: We evaluated the long-term outcomes of treatment of lower urinary tract symptoms due to benign prostatic hyperplasia to compare a 1-time water vapor thermal therapy procedure with daily medical therapy in cohorts from the MTOPS (Medical Therapy of Prostatic Symptoms) study. MATERIALS AND METHODS: Results in the treatment arm of a randomized, controlled trial of thermal therapy using the Rezum® System were compared to MTOPS subjects treated with doxazosin and/or finasteride. Evaluations were restricted to medical therapy subjects, representing 1,140 of the original 3,047 (37.4%), with a prostate volume of 30 to 80 cc and an International Prostate Symptom Score of 13 or greater to include men who met key criteria of the Rezum and MTOPS trials. Outcomes were compared during 3 years for symptom changes and clinical progression rates. RESULTS: Thermal therapy improved symptom scores by approximately 50% throughout 36 months (p <0.0001). Symptom improvement was greater than with either drug alone but similar to that of combination drugs (p ≤0.02 and 0.73, respectively). The peak flow rate improved 4 to 5 ml per second after thermal therapy and doxazosin while thermal therapy was superior to finasteride and combination drugs for 24 and 12 months (p <0.001 and <0.01, respectively). Observed rates of clinical progression during 3 years corroborate these outcomes with approximately 5 times greater progression for any medical therapy vs a single thermal therapy procedure. CONCLUSIONS: A single water vapor thermal therapy procedure provided effective and durable improvements in symptom scores with lower observed clinical progression rates compared to daily long-term use of pharmaceutical agents.

Three-Year Outcomes of the Prospective, Randomized Controlled Rezum System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.

OBJECTIVE: To report 3-year outcomes of a prospective, multicenter, randomized, blinded control trial after treatment with convective radiofrequency (RF) water vapor thermal therapy for moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Fifteen centers enrolled and randomized 197 men ≥50 years old with International Prostate Symptom Score (IPSS) ≥13, maximum flow rate (Qmax) ≤15 mL/s, and prostate volume 30 to 80 cc to thermal therapy with Rezum System or control (2:1). Rigid cystoscopy with simulated active treatment sound effects served as the control procedure. Convective RF thermal energy was delivered into obstructive prostate tissue including the median lobe as needed. After randomized comparison at 3 months, thermal therapy subjects were followed annually for 3 years. RESULTS: Convective RF thermal therapy yielded IPSS improvement of 160% compared with control subjects at 3 months (P <.0001). Maximal symptom relief of at least 50% improvement in IPSS, quality of life, Qmax, and BPH Impact Index remained durable throughout 3 years (P <.0001). Subjects with a treated median lobe had similar responses. No late-related adverse events occurred, and no de novo erectile dysfunction was reported. The surgical retreatment rate was 4.4% over 3 years. CONCLUSION: The minimally invasive convective RF thermal therapy is an office or ambulatory outpatient procedure with minimal transient perioperative side effects. It provides early effective and durable relief of BPH symptoms with preservation of sexual function in subjects followed up for 3 years and is applicable to treatment of the median lobe and hyperplastic central zone tissue.

Male Lower Urinary Tract Symptoms and Cardiovascular Events: A Systematic Review and Meta-analysis.

CONTEXT: The correlation among metabolic syndrome, lower urinary tract symptoms (LUTS), and cardiovascular disease (CVD) is well established. In particular, CVD has been proposed as a potential risk factor for both LUTS progression and severity. OBJECTIVE: To evaluate whether LUTS severity can be considered as a significant risk factor of major adverse cardiac events (MACE) in the male population. EVIDENCE ACQUISITION: A systematic literature search was performed using PubMed, Google Scholar, and Scopus. The combination of the following keywords was adopted in a free-text strategy: benign prostatic hyperplasia (BPH) or lower urinary tract symptoms (LUTS) and cardiovascular, cardio, major adverse cardiac events, MACE, heart disease, heart, myocardial infarction, myocardial, infarction, stroke, ischemic events, ischemic, cardiac death, coronary syndrome. We included all cross-sectional and longitudinal trials enrolling men and comparing the prevalence or incidence of MACE in men with moderate to severe LUTS compared with those without LUTS or with mild LUTS. The studies in which only nocturia was evaluated were excluded from the analysis. EVIDENCE SYNTHESIS: Of 477 retrieved articles, 5 trials longitudinally reported the incidence of MACE in patients with moderate to severe LUTS in comparisons to those with mild or no LUTS and 10 studies reported the prevalence of history of MACE at enrollment. All were included in the present meta-analysis. Among cross-sectional studies, 38 218 patients and 2527 MACE were included in the meta-analysis. The mean age of enrolled patients was 62.2±8.0 yr. Presence of moderate to severe LUTS significantly increased the risk of reported history of MACE (p<0.001). Metaregression analyses showed that the risk of MACE was lower in older patients and higher in those with diabetes. The association between LUTS-related MACE and diabetes was confirmed in a multivariate regression model after adjusting for age (adjusted r=0.498; p<0.0001). Longitudinal trials included 25 494 patients and 2291 MACE. The mean age of enrolled patients was 52.5±5.5 yr, and mean follow-up was 86.8±22.1 mo. Presence of moderate to severe LUTS was associated with an increased incidence of MACE compared with the rest of the sample (odds ratio: 1.68; 95% confidence interval, 1.13-2.50; p=0.01). CONCLUSIONS: Men with moderate to severe LUTS seem to have an increased risk of MACE. A holistic approach in considering the morbidities of aging men should be strongly encouraged and represents an important role for the practicing urologist. PATIENT SUMMARY: We evaluated whether the severity of lower urinary tract symptoms could be considered as a significant risk factor for major adverse cardiac events (MACE) in the male population. We demonstrated that men with moderate to severe LUTS have an increased risk of MACE.

Saw Palmetto for Symptom Management During Radiation Therapy for Prostate Cancer.

CONTEXT: Lower urinary tract symptoms (LUTSs) affect 75%-80% of men undergoing radiation therapy (RT) for prostate cancer. OBJECTIVES: To determine the safety, maximum tolerated dose (MTD), and preliminary efficacy of Serenoa repens commonly known as saw palmetto (SP) for management of LUTS during RT for prostate cancer. METHODS: The dose finding phase used the time-to-event continual reassessment method to evaluate safety of three doses (320, 640, and 960 mg) of SP. Dose-limiting toxicities were assessed for 22 weeks using the Common Terminology Criteria for Adverse Events for nausea, gastritis, and anorexia. The exploratory randomized controlled trial phase assessed preliminary efficacy of the MTD against placebo. The primary outcome of LUTS was measured over 22 weeks using the International Prostate Symptom Score. Additional longitudinal assessments included quality of life measured with the Functional Assessment of Cancer Therapy-Prostate. RESULTS: The dose finding phase was completed by 27 men who reported no dose-limiting toxicities and with 20 participants at the MTD of 960 mg daily. The exploratory randomized controlled trial phase included 21 men, and no statistically significant differences in the International Prostate Symptom Score were observed. The prostate-specific concerns score of the Functional Assessment of Cancer Therapy-Prostate improved in the SP group (P = 0.03). Of 11 men in the placebo group, two received physician-prescribed medications to manage LUTS compared with none of the 10 men in the SP group. CONCLUSION: SP at 960 mg may be a safe herbal supplement, but its efficacy in managing LUTS during RT needs further investigation.

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.

Counseling on sexual side effects from TURP.

INTRODUCTION: We designed a pilot study to measure preoperative sexual dysfunction risk counseling between sexual medicine experts (SME) and general urologists between monopolar/bipolar transuretheral resection of the prostate (TURP) and laser TURP (LT). MATERIALS AND METHODS: An emailed electronic survey was distributed to members of the North Central Section (NCS) of the American Urologic Association and the Sexual Medicine Society of North America (SMSNA). Overall, 260 (12.3%) completed the survey. Counseling for ejaculatory disorder (EjD), erectile dysfunction (ED), stricture formation and incontinence was assessed. Additional subset analysis between those SME's versus general urologist was done. RESULTS: Overall, 82% (224) identified as general urologists and 18% (49) as SME. Two-thirds were in private practice versus academic. Over 90% of all practitioners 'almost always' counsel about the possibility of EjD, with varied risk rate for LT. Overall, 62%(140) for monopolar TURP (MBT) and 60% (110) for LT 'almost always' counsel about ED. There was no statistical difference between groups counseling on incontinence, strictures, EjD or ED between SME and general urologists. CONCLUSIONS: Sexual side effects of treatment for LUTS/BPH are appreciated by urologists. Most practitioners counsel about EjD, however the incidence varies between MBT and LT. Practitioners counsel their patients on ED less often than EjD. Counseling rates are not improved with those specializing in sexual medicine independent of TURP technique.

Intake of caffeinated, carbonated, or citrus beverage types and development of lower urinary tract symptoms in men and women.

Evidence to substantiate recommendations for restriction of caffeinated or acidic beverages as self-management for lower urinary tract symptoms (LUTS) is limited. We examined longitudinal and acute associations between beverage intake and LUTS in the Boston Area Community Health (BACH) cohort (n = 4,144) between 2002 and 2010. Multivariable models tested associations between baseline intakes and progression of LUTS at 5-year follow-up, between follow-up intakes and International Prostate Symptom Scores at follow-up, and between 5-year intake changes and LUTS progression. Greater coffee or total caffeine intake at baseline increased the odds of LUTS progression in men (coffee: >2 cups/day vs. none, odds ratio = 2.09, 95% confidence interval: 1.29, 3.40, P-trend = 0.01; caffeine: P-trend < 0.001), particularly storage symptoms. Women who increased coffee intake by at least 2 servings/day during follow-up (compared with categories of decreased or unchanged intakes) had 64% higher odds of progression of urgency (P = 0.003). Women with recently increased soda intake, particularly caffeinated diet soda, had higher symptom scores, urgency, and LUTS progression. Citrus juice intake was associated with 50% lower odds of LUTS progression in men (P = 0.02). Findings support recommendations to limit caffeinated beverage intake for LUTS, and in men, they suggest benefits of citrus juice consumption. Further clinical research is warranted, particularly of the precise role of sodas containing artificial sweeteners in bladder sensations and urological function.

Clinically significant prostate cancer is rarely missed by ablative procedures of the prostate in men with prostate specific antigen less than 4 ng/ml.

PURPOSE: Laser vaporization of the prostate is widely used to treat lower urinary tract symptoms. It may decrease the hospital cost and morbidity associated with transurethral resection of the prostate. However, prostate cancer may go undetected because tissue is not taken at laser vaporization. To our knowledge the rate of clinically significant prostate cancer missed by laser vaporization has not been assessed to date. We determined the rate of clinically significant prostate cancer detected by transurethral resection of the prostate compared to the estimated number of cancers missed by laser vaporization. MATERIALS AND METHODS: A total of 74,505 men diagnosed with stage T1 prostate cancer between 2004 and 2006 were identified from the SEER (Surveillance, Epidemiology and End Results) program in the United States. The total number of laser vaporizations and transurethral resections were calculated based on Medicare claims for the same period. Clinically significant cancer was defined as that with a Gleason score of 7 or greater in men 40 to 75 years old. RESULTS: If prostate specific antigen screening were used uniformly (excluding men with prostate specific antigen greater than 4 ng/ml), only 1 of 382 transurethral resections of the prostate would identify clinically significant prostate cancer for a total of 390 in the American population in 3 years. Based on Medicare reported laser vaporization use a total of only 163 clinically significant cancers would be missed in more than 60,000 procedures. CONCLUSIONS: The incidence of T1a and T1b prostate cancer remains low and few patients have clinically significant prostate cancer. When prostate specific antigen screening is used, the number of clinically significant tumors missed by ablative procedures is low (average of 0.26% of all procedures) and can be identified by prostate specific antigen screening.

Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial.

PURPOSE: We recently reported an association between the bother and severity of lower urinary tract symptoms secondary to benign prostatic hyperplasia and the severity of sleep disturbance. However, few studies have examined whether alterations in the severity of urinary symptoms influence the degree of sleep problems over time. MATERIALS AND METHODS: The severity of lower urinary tract symptoms in men enrolled in CAMUS (Complementary and Alternative Medicine for Urological Symptoms), a clinical trial of saw palmetto (Serenoa repens), was evaluated using AUASI (American Urological Association symptom index) and quality of life scores. Sleep disturbance was evaluated by the Jenkins sleep scale at 0, 24, 48 and 72 weeks. Statistical analyses were used to assess the relationship(s) between changes in lower urinary tract symptoms and sleep disturbance. RESULTS: The baseline characteristics of the 339 men (172 placebo arm and 167 saw palmetto arm) enrolled in the CAMUS trial with assessment of sleep disturbance and urinary symptoms were similar. There were no differences between improvements in the severity of sleep disturbance or urinary symptoms between the 2 experimental arms. Combined analyses of the entire cohort revealed significant associations (p <0.001) between the AUASI score and sleep disturbance severity with time. Multivariate analyses demonstrated that improvements in lower urinary tract symptoms other than nocturia were the most significant predictors of improvements in sleep disturbance. Specific analyses adjusting for other baseline characteristics demonstrated that a 3-point improvement in AUASI score was associated with a 0.73-point improvement in the Jenkins sleep scale with time. CONCLUSIONS: Improvements in lower urinary tract symptoms correlate with changes in sleeping abilities with time in men with benign prostatic hyperplasia. While nocturia is significantly associated with sleep disturbance, other changes in overall lower urinary tract symptoms are better predictors of changes in sleep dysfunction.

Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.

CONTEXT: Saw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH); however, recent clinical trials have questioned their efficacy, at least at standard doses (320 mg/d). OBJECTIVE: To determine the effect of saw palmetto extract (Serenoa repens, from saw palmetto berries) at up to 3 times the standard dose on lower urinary tract symptoms attributed to BPH. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, multicenter, placebo-controlled randomized trial at 11 North American clinical sites conducted between June 5, 2008, and October 10, 2010, of 369 men aged 45 years or older, with a peak urinary flow rate of at least 4 mL/s, an American Urological Association Symptom Index (AUASI) score of between 8 and 24 at 2 screening visits, and no exclusions. INTERVENTIONS: One, 2, and then 3 doses (320 mg/d) of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks. MAIN OUTCOME MEASURES: Difference in AUASI score between baseline and 72 weeks. Secondary outcomes included measures of urinary bother, nocturia, peak uroflow, postvoid residual volume, prostate-specific antigen level, participants' global assessments, and indices of sexual function, continence, sleep quality, and prostatitis symptoms. RESULTS: Between baseline and 72 weeks, mean AUASI scores decreased from 14.42 to 12.22 points (-2.20 points; 95% CI, -3.04 to -1.36) [corrected]with saw palmetto extract and from 14.69 to 11.70 points (-2.99 points; 95% CI, -3.81 to -2.17) with placebo. The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo (upper bound of the 1-sided 95% CI most favorable to saw palmetto extract was 1.77 points, 1-sided P = .91). Saw palmetto extract was no more effective than placebo for any secondary outcome. No clearly attributable adverse effects were identified. CONCLUSION: Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00603304.