How I Do It - MRI-ultrasound fusion prostate biopsy using the Fusion MR and Fusion Bx systems.

There is increasing evidence to support the use of multiparametric magnetic resonance imaging (MRI) in men at risk for clinically significant prostate cancer to help identify lesions and inform biopsy. Randomized, level 1 evidence demonstrates that men who are managed with MRI and MRI-ultrasound fusion targeted biopsy (MRF-TB) have more clinically significant prostate cancer and less clinically insignificant prostate cancer detected and avoid biopsy altogether more often than men who undergo systematic, whole-gland prostate biopsy (SPB). Furthermore, strategies that incorporate MRF-TB have lower rates of upgrading on radical prostatectomy compared to SPB. However, generalizing this data to wider practice is challenging because there is a learning curve for interpreting MRI and performing MRF-TB, and some of the fusion technologies are better than others. We describe our group's early experience with the Fusion MR and Fusion Bx systems (Focal Healthcare, Toronto, ON, Canada). These products are designed with elastic fusion technology that is user-friendly, intuitive and accurate. The Fusion MR contouring system is straightforward and allows for contouring with several MRI sequences simultaneously. The Fusion Bx biopsy system has a semi-robotic arm that accounts for prostate deformation and patient movement and allows for freehand-like access, which is a seamless transition from SPB for clinicians. There were 68 lesions targeted in the first 51 patients. The overall cancer detection rate was 22%/61%/83% for PI-RADS 3/4/5, respectively. The Gleason grade group 2 prostate cancer or higher rate was 6%/47%/75% for PI-RADS 3/4/5, respectively. There were no major complications in this cohort of patients. Limitations of this study include small number of patients and lack of formal follow up to rule out sepsis. Overall, the Fusion MR and Fusion Bx systems are accurate, straightforward and safe to use for MRF-TB. Early experience does not show any significant learning curve.

Diagnosis of prostate cancer: the implications and proper utilization of PSA and its variants; indications and use of MRI and biomarkers.

Prostate cancer screening remains highly controversial in medicine. The College of Family Physicians of Canada currently endorses positions that recommend against prostate-specific antigen (PSA) screening in men of all ages, while the Canadian Urological Association recommends shared and informed decision making for PSA screening in men 50-70 years old. Unfortunately, these opposing stances have left Family Physicians responsible for interpreting the appropriate course of action for their patients. Recent studies demonstrating an increase in incidence of metastatic prostate cancer have led to our support of the Canadian Urological Association recommendations. In an attempt to facilitate initial patient investigation, this article aims to outline current prostate cancer screening recommendations, as well as the various screening modalities available. The utility of PSA-based tests, serum and non-serum biomarkers, and multiparametric magnetic resonance imaging is discussed and evaluated.

Oncologic and Functional Outcomes of Partial Gland Ablation with High Intensity Focused Ultrasound for Localized Prostate Cancer.

PURPOSE: We assessed the outcomes of high intensity focused ultrasound as primary treatment of localized prostate cancer in a retrospective series. This represents one of the largest published series of patients at intermediate and high risk. MATERIALS AND METHODS: We performed a retrospective multicenter analysis of patients who underwent partial gland ablation between January 2013 and September 2017. Patients with biopsy proven localized disease and limited multifocality based on magnetic resonance imaging who preferred minimally invasive outpatient therapy were treated with the Sonablate® 500 system. Oncologic and functional outcomes were analyzed as well as risk factors for recurrence. RESULTS: A total of 166 procedures were performed in 150 patients. Grade Group 2 or greater was present in 89% of cases. Mean ± SD followup was 24.3 ± 14.4 months. Mean prostate specific antigen decreased 65% from 7.9 ± 6.8 ng/ml to a nadir of 2.7 ± 3.1 ng/ml. Confirmatory biopsies were performed in 87 patients (52%) at high risk for recurrence. Clinically significant cancer (Grade Group 2 or greater) was detected in 37 cases (42%). Patients with a higher number of positive cores, a medial tumor location or higher prostate specific antigen had a higher probability of recurrence. Salvage treatment was done in 37 patients (24.6%), including 16 repeat partial gland ablation procedures. CONCLUSIONS: Partial gland ablation with high intensity focused ultrasound therapy was safe and it had a minimal impact on functional outcomes. Local recurrence and/or failure occurred in 42% of patients at high risk for recurrence. Medially located tumors were associated with a higher failure rate. Serious complications were rare. Whole gland treatment was avoided in 81% of patients.

Oncologic and Functional Outcomes of Partial Gland Ablation with High Intensity Focused Ultrasound for Localized Prostate Cancer.

PURPOSE: We assessed the outcomes of high intensity focused ultrasound as primary treatment of localized prostate cancer in a retrospective series. This represents one of the largest published series of patients at intermediate and high risk. MATERIALS AND METHODS: We performed a retrospective multicenter analysis of patients who underwent partial gland ablation between January 2013 and September 2017. Patients with biopsy proven localized disease and limited multifocality based on magnetic resonance imaging who preferred minimally invasive outpatient therapy were treated with the Sonablate® 500 system. Oncologic and functional outcomes were analyzed as well as risk factors for recurrence. RESULTS: A total of 166 procedures were performed in 150 patients. Grade Group 2 or greater was present in 89% of cases. Mean ± SD followup was 24.3 ± 14.4 months. Mean prostate specific antigen decreased 65% from 7.9 ± 6.8 ng/ml to a nadir of 2.7 ± 3.1 ng/ml. Confirmatory biopsies were performed in 87 patients (52%) at high risk for recurrence. Clinically significant cancer (Grade Group 2 or greater) was detected in 37 cases (42%). Patients with a higher number of positive cores, a medial tumor location or higher prostate specific antigen had a higher probability of recurrence. Salvage treatment was done in 37 patients (24.6%), including 16 repeat partial gland ablation procedures. CONCLUSIONS: Partial gland ablation with high intensity focused ultrasound therapy was safe and it had a minimal impact on functional outcomes. Local recurrence and/or failure occurred in 42% of patients at high risk for recurrence. Medially located tumors were associated with a higher failure rate. Serious complications were rare. Whole gland treatment was avoided in 81% of patients.

High Intensity Focused Ultrasound for Radiorecurrent Prostate Cancer: A North American Clinical Trial.

PURPOSE: We determined the safety and efficacy of whole gland high intensity focused ultrasound in men with radiorecurrent prostate cancer. MATERIALS AND METHODS: A total of 100 men with clinically localized recurrent prostate cancer at least 2 years after external beam radiation therapy underwent whole gland high intensity focused ultrasound in an open label trial from 2009 to 2012. Treatments were performed at 16 sites, including 14 in the United States and 2 in Canada. The primary end point was the combination of a prostate specific antigen nadir of 0.5 ng/ml or less and negative biopsy at 12 months. Validated questionnaires were administered to monitor changes in urinary and sexual function. RESULTS: Of the 100 treated men, in whom mean age was 70 years (range 53 to 83), 78 completed the 12-month biopsy, which was negative in 63 (81%). Mean prostate specific antigen was 4.9 ng/ml (range 0.4 to 14) and the median Gleason score was 7. The 1-year end point of a prostate specific antigen nadir of 0.5 ng/ml or less plus negative biopsy was achieved in 50 men. During post-trial followup mean prostate specific antigen at 2 years was 1.1 ng/ml (range 0.1 to 17) in 33 patients. Adverse events developed in 91 men through 12 months, which were CTCAE grade 1 in 67, grade 2 in 80 and grade 3 in 20. Treatment related grade 3 adverse events included rectal fistulas in 5 men, which required surgery in 3, osteitis pubis in 3 and hematuria requiring intervention in 3. Treatment related grade 3 adverse events developed early in the trial and appeared related to operator experience. There were no life threatening adverse events or treatment related deaths. CONCLUSIONS: Whole gland high intensity focused ultrasound appears reasonably safe and effective to treat radiorecurrent prostate cancer. The rate of complications, which are potentially severe, was acceptable, especially considering the advanced, refractory nature of the disease and the limited treatment options.

Association between natural killer cell activity and prostate cancer: a pilot study.

INTRODUCTION: Natural killer (NK) cells play a significant role in tumor cell immunosurveillance. The association between the activity of NK cells and prostate cancer has previously been demonstrated using conventional research-based tests. MATERIALS AND METHODS: The aim of the present pilot study was to study the association between NK cell activity (NKA) and prostate cancer using a simple blood test. Subjects that had previously been selected for prostate biopsy underwent a blood test for NKA using an in vitro diagnostic device (IVDD) (NK Vue, ATGen Canada Inc., Laval, QC, Canada) prior to biopsy. RESULTS: Of the 43 subjects sent for prostate biopsy, 22 were found to have prostate cancer. The test performance of the NKA IVDD, assessed using receiver operating characteristics, showed an area under the curve of 75%, a sensitivity of 57%, a specificity of 91%, a positive predictive value of 86% and a negative predictive value of 69%, with an odds ratio of 13.33. Using a cut off of 200 pg/mL for NKA, the absolute risk of having prostate cancer with NKA values below this level was found to be 86%. CONCLUSIONS: This pilot study showed that subjects with low values of NKA were more likely to have a positive outcome at prostate biopsy.

The practical update for family physicians in the diagnosis and management of overactive bladder and lower urinary tract symptoms.

OBJECTIVE: To provide family physicians with an up-to-date, practical overview of the diagnosis and management of overactive bladder (OAB) alone or with bladder outlet obstruction. MAIN MESSAGE: OAB is urinary urgency with or without incontinence, often accompanied by frequency and nocturia, in the absence of urinary tract infection and can affect both men and women. Men often have co-existing OAB associated with bladder outlet obstruction, and benign prostatic hyperplasia. OAB can interfere with sleep, social activities, and sexual encounters, and it increases the risk of falls. CONCLUSION: Many patients with OAB seek initial evaluation and treatment from their family physicians. Optimal management of OAB by family physicians will improve patients' quality of life. More severe cases or 'red flags' uncovered while making the diagnosis, might warrant referral to a urologist.

Improving prostate cancer care collaboratively - a multidisciplinary, formal, consensus-based approach.

INTRODUCTION: There are numerous standard treatment options for men diagnosed with localized prostate cancer. Multidisciplinary consultation before decision-making is a consensus- and quality-based objective in Ontario. With the goals of working together more collaboratively and to provide higher quality information for patients at the time of decision-making, a prostate cancer community partnership consensus (PCPC) panel was formed among six partnering centers in the Greater Toronto Area. MATERIALS AND METHODS: Five iterative meetings were held among 40 prostate cancer specialists (32 urologists and 8 radiation oncologists) who participate in multidisciplinary clinics. The meetings defined the goals of the partnership as well as the topics and questions the group would address together. Answers to these questions were developed by formal consensus: >= 75% of participants had to agree with wording based on secret ballots to achieve consensus. RESULTS: All six groups wanted to participate to improve patient care/decision-making. Forty-one questions addressing 30 issues were derived from the literature and the group's collective experience. These issues were cross-tabbed against five management options: active surveillance, radical prostatectomy, low dose rate brachytherapy, high dose rate brachytherapy boost and external beam radiation. Answers common to all modalities were coalesced. Eighty-six issues were subjected to formal consensus. After three rounds of secret ballots, consensus was achieved for the answers to all issues. CONCLUSIONS: A formal consensus-based partnership between urology and radiation oncology to support newly diagnosed prostate cancer patients was feasible and resulted in a patient information guide which may improve decision-making.

Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study.

INTRODUCTION: To report the five year results of a prospective, multi-center, randomized, blinded sham control trial of the Prostatic Urethral Lift (PUL) in men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: At 19 centers in North America and Australia, 206 subjects ≥ 50 years old with International Prostate Symptom Score (IPSS ) > 12, peak flow rate (Qmax) ≤ 12 mL/s, and prostate volume 30 cc-80 cc were randomized 2:1 to the PUL procedure or blinded sham control. In PUL permanent UroLift implants are placed to hold open the lateral lobes of the prostate to reduce urinary obstruction. After randomized comparison at 3 months and the only opportunity to add more PUL implants, PUL patients were followed to 5 years. LUTS severity (IPSS), quality of life (QOL), BPH Impact Index (BPHII), Qmax, sexual function, and adverse events were assessed throughout follow up. RESULTS: IPSS improvement after PUL was 88% greater than that of sham at 3 months. LUTS and QOL were significantly improved by 2 weeks with return to preoperative physical activity within 8.6 days. Improvement in IPSS, QOL, BPHII, and Qmax were durable through 5 years with improvements of 36%, 50%, 52%, and 44% respectively. No difference was seen between Intent to Treat and Per Protocol populations. Surgical retreatment was 13.6% over 5 years. Adverse events were mild to moderate and transient. Sexual function was stable over 5 years with no de novo, sustained erectile or ejaculatory dysfunction. CONCLUSIONS: PUL offers rapid improvement in symptoms, QOL and flow rate that is durable to 5 years. These improvements were achieved with minimal use of a postoperative urinary catheter, rapid return to normal, and preservation of both erectile and ejaculatory function. Symptom improvement was commensurate with patient satisfaction. PUL offers a minimally invasive option in the treatment of LUTS due to BPH.

Mirabegron as Add-On Treatment to Solifenacin in Patients with Incontinent Overactive Bladder and an Inadequate Response to Solifenacin Monotherapy: Responder Analyses and Patient-Reported Outcomes from the BESIDE Study [corrected].

PURPOSE: We investigated improvements in overactive bladder and patient reported outcomes in patients with overactive bladder and refractory incontinence treated with mirabegron 50 mg plus solifenacin 5 mg vs solifenacin 5 or 10 mg. MATERIALS AND METHODS: Patients with overactive bladder who were incontinent despite 4 weeks of single-blind daily solifenacin 5 mg were randomized 1:1:1 to a double-blind daily combination of mirabegron 50 mg/solifenacin 5 mg, or solifenacin 5 or 10 mg for 12 weeks. The mirabegron dose was increased from 25 to 50 mg after week 4. Symptom bother, health related quality of life and patient perception of bladder condition were assessed by OAB-q (Overactive Bladder Questionnaire) and the PPBC (Patient Perception of Bladder Condition) questionnaire, respectively. Responder rates were based on a 50% reduction in daily incontinence, zero incontinence episodes and fewer than 8 micturitions per 24 hours with minimal important differences in OAB-q and PPBC. RESULTS: Overall 2,174 patients with a median age of 59 years were randomized, including 727 to the combination, 728 to solifenacin 5 mg and 719 to solifenacin 10 mg. Symptom bother, total health related quality of life and its subscales (coping, concern and social), and PPBC were significantly improved with combination vs solifenacin monotherapy (p <0.05). The odds of achieving clinically meaningful improvements in incontinence, micturition frequency, symptom bother, health related quality of life and PPBC were significantly higher for combination than solifenacin monotherapy. The odds of becoming continent was 47% and 28% higher for combination vs solifenacin 5 and 10 mg (OR 1.47, 95% CI 1.17-1.84, p = 0.001 and OR 1.28; 95% CI 1.02-1.61, p = 0.033, respectively). CONCLUSIONS: Significantly more patients on the combination achieved clinically meaningful improvements in incontinence and micturition frequency. Improvements were accompanied by similar improvements in PPBC, symptom bother and health related quality of life.

24-month durability after crossover to the prostatic urethral lift from randomised, blinded sham.

OBJECTIVE: To evaluate the 24-month effectiveness of the prostatic urethral lift (PUL) procedure in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) assessed through a crossover study. PATIENTS AND METHODS: In all, 53 patients underwent a sham procedure as part of the blinded, randomised L.I.F.T. (Luminal Improvement Following prostatic Tissue approximation for the treatment of LUTS secondary to BPH) study at 19 centres and elected to enrol in this crossover study. The crossover procedure involved placement of permanent implants (UroLift® system) into the prostatic lateral lobes. Patients were followed for 3 months after the sham procedure and then for 24 months after crossover to PUL, with assessments of urinary symptom relief, quality of life (QoL), urinary flow rate, sexual function, and adverse events. RESULTS: At 24 months after crossover to PUL, the International Prostate Symptom Score (IPSS), QoL, BPH Impact Index, and maximum urinary flow rate improved 36%, 40%, 54%, and 77% from baseline, respectively. Each IPSS parameter on average improved significantly from baseline (P < 0.005) and remained stable throughout follow-up. Symptom response after the sham procedure indicated initial improvement at 1 month with significant decay by 3 months. Adverse events were typically mild to moderate and patients returned rapidly to normal activity. Four patients (8%) required intervention with transurethral resection of the prostate and one patient required additional PUL implants within the 24-month period. There were no reported instances of de novo sustained erectile or ejaculatory dysfunction. CONCLUSIONS: The PUL procedure is associated with rapid symptom relief, increased urinary flow rate and QoL improvement that remain stable over 24 months. Morbidity is low and sexual function is preserved.

Nocturia: diagnosis and management for the primary care physicians.

Primary care physicians commonly see men or women with nocturia (or nocturnal polyuria). Nocturia can have a dramatic impact on a patient's physical and emotional quality of life, including work performance or ability to function, because of the interrupted sleep patterns. It has also been determined that the most important sleep interval is the time from first falling asleep until first awakening. Nocturia is one of the most common and most bothersome symptoms of lower urinary tract symptoms (LUTS). In a man, LUTS is most commonly caused by benign prostatic obstruction (BPO) related to the enlargement of the prostate. In a woman, the most common cause of LUTS is overactive bladder (OAB). This article first explores the different causes and types of nocturia, then describes how to diagnose different types of nocturia (including use of frequency-volume charts), and last, discusses different approaches for managing nocturia (including the use of desmopressin), depending on the type and cause.

Testosterone deficiency syndrome: benefits, risks, and realities associated with testosterone replacement therapy.

Testosterone deficiency syndrome, which has sometimes been termed age-related or late-onset hypogonadism, is a syndrome characterized by both clinical manifestations as well as a biochemical deficiency of testosterone. This condition is associated with considerable morbidity and mortality, accounting for billions of dollars in health care costs. There is some evidence that suggests that restoring testosterone levels in these individuals may help to manage or delay progression of the associated morbidities. Furthermore, despite controversies in the literature and media, testosterone replacement has proven to be quite safe in most men with minimal if any adverse effects when dosing to achieve the eugonadal range. It is nevertheless very important for clinicians to be aware of the possible risks and contraindications of treatment to ensure proper patient selection and appropriate monitoring.

The primary care physician's role in the monitoring and management of the potential sequelae of the medical treatment of prostate cancer: early and late.

Significant progress has been made in the management of aggressive prostate cancer. The established old and new treatments have resulted in the significant delay in progression of disease, improvement of the quality of life, as well as the increase in the overall survival of men with advanced prostate cancer. However, these therapies carry with them possible adverse effects that primary care physicians are experienced in managing. Thus, there is an increasing need for the urologist to involve and partner closely with the primary care practitioner to prevent, identify and manage the potential side effects of these life-changing therapies.

Optimizing subcutaneous injection of the gonadotropin-releasing hormone receptor antagonist degarelix.

The gonadotropin-releasing hormone (GnRH) receptor antagonist degarelix has several unique characteristics compared to luteinizing hormone-releasing hormone (LHRH) analogs used in the management of prostate cancer. Notable differences of GnRH receptor antagonists include no flare reaction, and a more rapid suppression of testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH) and prostate-specific antigen (PSA) compared to LHRH analogs. Despite emerging evidence supporting the use of GnRH receptor antagonists over the more widely used LHRH analogs in the management of prostate cancer, physicians may be reluctant to prescribe degarelix. They may be concerned about patient complaints about injection-site reactions (ISRs). The subcutaneous injection of degarelix has been associated with a higher rate of ISRs compared with the intramuscular injections of LHRH analogs. This "How I Do It" article describes techniques and strategies that have been developed by physicians and nurses to reduce the discomfort associated with the subcutaneous delivery of degarelix.

Risks, benefits, and approaches to hormonal blockade in prostate cancer. Highlights from the European Association of Urology Meeting, March 20-24, 2015, Madrid, Spain.

Several abstracts presented at the 2015 European Association of Urology Meeting highlighted new developments in hormone therapy for prostate cancer management. One abstract described how the luteinizing hormone-releasing hormone (LHRH)/gonadotropin-releasing hormone (GnRH) agonist leuprolide, but not the LHRH/GnRH antagonist degarelix, induced plaque instability in a mouse model. A second abstract showed that in patients with a history of severe cardiovascular disease, degarelix was associated with fewer cardiovascular events than treatment with an LHRH agonist. A third abstract showed how primary androgen-deprivation therapy was linked with increased all-cause mortality in a US registry. A fourth abstract showed that in the ANAMEN study, cognitive performance was not significantly affected by 6 months of treatment with GnRH agonists. Last, a fifth abstract showed that low-dose prednisone, with or without abiraterone, was associated with an overall low incidence of corticosteroid-associated adverse events.

Medical therapy for benign prostatic hyperplasia: a review.

INTRODUCTION: Benign prostatic hyperplasia (BPH) is a common disease that affects men as they age. Historically the treatment has been primarily surgical in nature, but over the past 25 years significant advances in medical therapy have been made, sparing some men from interventional procedures. MATERIALS AND METHODS: This article highlights the current state-of-the-art with respect to medical therapy for lower urinary tract symptoms secondary to BPH (BPH-LUTS) including a review of landmark studies and recent areas of research in the field. RESULTS: Alpha blockers are considered first line when treating BPH-LUTS in men with small prostates and 5-alpha reductase inhibitors (5-ARIs) are recommended in men with large symptomatic prostates. While, phosphodiesterase-5 (PDE-5) inhibitors are the mainstay of erectile dysfunction therapy, they also play a role in treating BPH-LUTS. If men have persistent irritative storage symptoms after first line BPH therapy then overactive bladder (OAB) medications can be added or substituted. Combination therapies can be used to provide short term symptom relief with long term disease management. CONCLUSIONS: Medical therapy remains the main treatment option for men suffering from BPH-LUTS. Numerous medical options are available that can be tailored to meet the individual's needs depending on their personal and prostate characteristics. An algorithmic approach, as we have defined within this article, can be a helpful guide to this decision-making process.

Alpha blocker monotherapy versus combination therapy with antimuscarinics in men with persistent LUTS refractory to alpha-adrenergic treatment: patterns of persistence.

INTRODUCTION: Patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) often present with voiding and storage symptoms, which may require combination therapy with an alpha blocker and an antimuscarinic (AM). This study compared treatment persistence in LUTS/BPH patients on alpha blocker monotherapy with those using combination alpha blocker and AM therapy (AB/AM). MATERIALS AND METHODS: Retrospective analysis of anonymized patient longitudinal prescription reimbursement claims data. All patients who had claims for any of four alpha blocker medications and six AM agents during an index period from April 1, 2011 to March 31, 2012 were included. For the combination therapy group, the effect of adherence with the AM medication on persistence to the alpha blocker was examined. RESULTS: Patients on AB/AM combination therapy remained on alpha blockers for longer than those on alpha blocker monotherapy (p = 0.04); 92.4% were persistent at 3 months versus 89.0%, and at 1 year 50.8% were persistent versus 49.6%, respectively. The highest number of days on therapy was reported for tamsulosin plus solifenacin. As confirmed by multivariate analysis, patients with the highest adherence to AM medication (= 80%) persisted on alpha blockers for longer than those with the lowest (< 50%) adherence (p < 0.05). CONCLUSIONS: Patients taking an AM in combination with an alpha blocker showed greater persistence with alpha blocker treatment over a 1 year period. When an AM is combined with an alpha blocker in patients with LUTS/BPH, the additional medication burden does not have a negative impact on persistence and may even improve it.

Three year results of the prostatic urethral L.I.F.T. study.

INTRODUCTION: To report the three year results of a multi-center, randomized, patient and outcome assessor blinded trial of the Prostatic Urethral Lift (PUL) in men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: At 19 centers in North America and Australia, 206 subjects = 50 years old with International Prostate Symptom Score (IPSS) ≥ 13, peak flow rate (Qmax) ≤ 12 mL/s, and prostate volume between 30 cc-80 cc were randomized 2:1 to the PUL procedure or sham control. PUL involved placing permanent UroLift implants into the lateral lobes of the prostate to enlarge the urethral lumen. After randomized comparison at 3 months, PUL patients were followed to 3 years. LUTS severity (IPSS), quality of life, Qmax, sexual function, and adverse events were assessed throughout follow up. RESULTS: The therapeutic effect of PUL regarding IPSS was 88% greater than sham at 3 months. Average improvements from baseline through 3 years were significant for total IPSS (41.1%), quality of life (48.8%), Qmax (53.1%), and individual IPSS symptoms. Symptomatic improvement was independent of prostate size. There were no de novo, sustained ejaculatory or erectile dysfunction events and all sexual function assessments showed average stability or improvement after PUL. Fifteen of the 140 patients originally randomized to PUL required surgical reintervention for treatment failure within the first 3 years. CONCLUSIONS: PUL offers rapid improvement in voiding and storage symptoms, quality of life and flow rate that is durable to 3 years. Patients demonstrated a level of symptom relief that is associated with significant patient satisfaction. PUL, a minimally invasive procedure, is very effective in treating bothersome LUTS secondary to benign prostatic obstruction (BPO) and is unique in its ability to preserve total sexual function while offering a rapid return to normal physical activities.