Emerging drugs for the treatment of benign prostatic hyperplasia: a 2023 update.

INTRODUCTION: Benign prostatic hyperplasia (BPH) is a condition that affects over 50% of men as they enter their fifth decade of life, often leading to lower urinary tract symptoms (LUTS). Primary treatment options include alpha blockers, 5-alpha reductase inhibitors, and phosphodiesterase-5 inhibitors. However, these medications can have some side effects, and there is a noticeable dearth of information addressing the long-term use of these medications. Thus, the exploration of all treatment modalities helps ensure patients receive personalized and effective care. Consequently, the primary objective of this review is to identify potential emerging medications for the treatment of BPH. AREAS COVERED: We conducted an extensive review of articles discussing pharmacotherapy for BPH spanning the last 15 years. Our information gathering process involved Scopus, PubMed-MEDLINE, Cochrane, Wiley Online Library Google Scholar, ClinicalTrials.gov, and the PharmaProjects database. This approach ensures that readers gain an in-depth knowledge of the existing therapeutic agents as well as promising avenues for managing BPH. EXPERT OPINION: BPH treatment targets a patient's specific constellation of symptoms. Therefore, a broad knowledge base encompassing various treatment options is paramount in ensuring optimal treatment. Looking forward, the emphasis on personalization promises to reshape the landscape of BPH treatment and improve patient outcomes.

Feasibility assessment of catheter-free water vapor thermal therapy for treatment of benign prostatic hyperplasia.

PURPOSE: To investigate safety and feasibility of performing water vapor thermal therapy (WVTT; Rezum, Boston Scientific, Marlborough, MA, USA) without postoperative catheterization among men with benign prostatic hyperplasia. METHODS: This is a prospective, single arm, unblinded pilot study of 20 consecutive male patients ages 40-80 who underwent WVTT at a single academic institution. All patients underwent 1 injection per lobe at the point of maximal obstruction based on visualization. Primary outcome was evaluation of voiding parameters, symptom scores, and need for catheterization at 3 day, 1, 3, and 6 month follow up compared to baseline visit 30 days prior to surgery. RESULTS: Mean age was 65 years (range 55-75). Mean prostate volume and PVR were 43 cc (range 30-68) and 89 cc, with 30% (n = 6) having median lobes. Patients received 2-3 treatments based on presence of bilobar versus trilobar hyperplasia. One patient (55 cc prostate, no median lobe) required catheterization for acute urinary retention on postoperative day 2. No patients required antibiotics for urinary tract infection or inpatient readmission within 30 days. Qmax significantly increased from 6 mL/s to 8, 13, 12, and 14 at 3 days, 1, 3, and 6 months (p < 0.05). IPSS decreased from 17 preoperatively to 10, 6, 7, and 8 (p < 0.05). No significant differences were noted in PVR, IIEF, MSHQ-EjD, or SF-12. CONCLUSIONS: In well-selected men, catheter-free WVTT is feasible and improved voiding parameters and symptom scores. No changes in sexual function, infectious complications, or readmission were noted. Only 1 patient (5%) required postoperative catheterization within 30 days.

Comparing prostatic artery embolization to surgical and minimally invasive procedures for the treatment of benign prostatic hyperplasia: a systematic review and meta-analysis.

BACKGROUND: To summarize current evidence to report a comparative systematic review and meta-analysis of prostatic artery embolization (PAE) with transurethral resection of the prostate (TURP) and open simple prostatectomy (OSP) for the treatment of benign prostatic hyperplasia (BPH). METHODS: A systematic literature search was performed to identify studies published from inception until August 2021. The search terms used were (prostate embolization OR prostatic embolization) AND (prostatic hyperplasia OR prostatic obstruction) as well as the abbreviations of PAE and BPH. Risk of bias was assessed using the Cochrane Risk of Bias tool for randomized controlled trials (RCTs) and the Risk of Bias in Non-randomized Studies-of Interventions (ROBINS-I) tool for observational studies. Random-effects meta-analysis was performed using Revman 5.4. RESULTS: Seven studies were included with 810 patients: five RCTs and one observational study compared PAE with TURP, and one observational study compared PAE with OSP. The included studies had considerable risk of bias concerns. TURP and OSP were associated with more statistically significant improvements in urodynamic measures and BPH symptoms compared to PAE. However, PAE seems to significantly improve erectile dysfunction compared to OSP and improve other outcome measures compared to TURP, although not significantly. PAE appeared to reduce adverse events and report more minor complications compared with TURP and OSP, but it is unclear whether PAE is more effective in the long-term. CONCLUSION: PAE is an emerging treatment option for patients with symptomatic BPH who cannot undergo surgery or have undergone failed medical therapy. Overall, PAE groups reported fewer adverse events. Future ongoing and longer-term studies are needed to provide better insight into the benefit of PAE compared to other treatment options.

Use of the Schelin Catheter for transurethral intraprostatic anesthesia prior to Rezum treatment.

Minimally invasive surgery techniques (MIST) have become newly adopted in urological care.  Given this, new analgesic techniques are important in optimizing patient outcomes and resource management. Rezum treatment (RT) for BPH has emerged as a new MIST with excellent patient outcomes, including improving quality of life (QoL) and International Prostate Symptom Scores (IPSSs), while also preserving sexual function.  Currently, the standard analgesic approach for RT involves a peri-prostatic nerve block (PNB) using a transrectal ultrasound (TRUS) or systemic sedation anesthesia.  The TRUS approach is invasive, uncomfortable, and holds a risk of infection.  Additionally, alternative methods such as, inhaled methoxyflurane (Penthrox), nitric oxide, general anesthesia, as well as intravenous (IV) sedation pose safety risks or mandate the presence of an anesthesiology team.  Transurethral intraprostatic anesthesia (TUIA) using the Schelin Catheter (ProstaLund, Lund, Sweden) (SC) provides a new, non-invasive, and efficient technique for out-patient, office based Rezum procedures.  Through local administration of an analgesic around the prostate base, the SC has been shown to reduce pain, procedure times, and bleeding during MISTs.  Herein, we evaluated the analgesic efficacy of TUIA via the SC in a cohort of 10 patients undergoing in-patient RT for BPH.

Aquablation Therapy in Large Prostates (80-150 mL) for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Final WATER II 5-Year Clinical Trial Results.

PURPOSE: We report 5-year safety and efficacy outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia and large-volume prostate glands. MATERIALS AND METHODS: A total of 101 men with moderate to severe benign prostatic hyperplasia symptoms and prostate volumes between 80 and 150 mL underwent a robotic-assisted Aquablation procedure in a prospective multicenter international trial (NCT03123250). Herein we report the final 5-year results. RESULTS: The study successfully met its safety and efficacy performance goal, which was based upon transurethral resection of the prostate outcomes typically done in smaller prostates, at 3 months. Mean prostate volume was 107 mL (range 80-150) at baseline. Patient symptoms showed a significant improvement where the mean (SD) International Prostate Symptom Score of 22.6 (6.4) at baseline to 6.8 (4.6) at 5 years, resulting in a change score of 15.9 (7.7, P < .001). Uroflowmetry measurements also demonstrated improvement where the mean maximum urinary flow rate increased from 8.6 (SD 3.4) to 17.1 (9.8) mL/s at 5 years, resulting in a change score of 9.2 (11.1) mL/s at 5 years (P < .001). A regression analysis evaluating change in PSA as a function of baseline PSA across all time points out to 5 years resulted in a 50% reduction. A prespecified subgroup analysis using a baseline prostate volume cutoff of 100 mL showed no difference in efficacy outcomes through 5 years. Freedom from a secondary benign prostatic hyperplasia procedure at 5 years was 96.3% based on Kaplan-Meier. CONCLUSIONS: At 5-years of prospective follow-up, the Aquablation procedure was shown to be safe with durable efficacy and low rates of retreatment in men with large prostates (80-150 mL).

Prostatic artery embolization compared to transurethral resection of the prostate and prostatic urethral lift: a real-world population-based study.

BACKGROUND: There are growing interests for minimally invasive surgical techniques (MISTs) for the treatment of benign prostatic hyperplasia (BPH)-associated lower urinary tract symptoms (LUTS). Prostatic artery embolization (PAE) uses selective angioembolization of prostatic arteries, thereby reducing size to improve LUTS/BPH. However, real-world data comparing surgical outcomes between MISTs and tissue resective techniques are lacking. We assessed the differences in surgical outcomes between PAE, transurethral resection of the prostate (TURP), and prostatic urethral lift (PUL) in a real-world population for LUTS/BPH. METHODS: We present an observational population-based study of 12,902 men with BPH in New York State who received PAE, TURP, and PUL in outpatient and ambulatory surgery settings from 2014 to 2018. For short-term outcomes, we report 30-day and 90-day risks of readmission to inpatient and emergency room (ER) with/without complications and compared them across groups using χ2 tests and mixed-effect logistic regressions. For long-term outcomes, we report surgical retreatment and stricture rates using Kaplan-Meier failure curves and compared them using Log rank tests and Cox regression models. RESULTS: Of 12 902 men, 335 had PAE, 11,205 had TURP, and 1362 had PUL. PAE patients had the highest 30-day (19.9%) and 90-day (35.6%) risks of readmission to inpatient or ER (p < 0.01). Non-specific abdominal pain was the main diagnosis associated with 30-day and 90-day readmissions to inpatient or ER after PAE (14.3% and 26.8%, respectively). After 2 years of follow-up, PAE patients had the highest retreatment rate of 28.5% (95%CI 23.7-34.2%) compared to TURP (3.4% (95%CI 3.1-3.8%)) and PUL (8.5% (95%CI 5.6-12.9%)) (p < 0.001). CONCLUSION: In a real-world population, PAE was associated with the most frequent 30-day and 90-day readmission to inpatient or ER and the highest retreatment rate among all surgical techniques even when controlled for individual patient comorbidities and surgical volume.

A scoping review of office-based prostatic stents: past, present, and future of true minimally invasive treatment of benign prostatic hyperplasia.

PURPOSE: To conduct a scoping review of the existing literature and recent developments on prostatic stents for the treatment of benign prostatic hyperplasia (BPH). METHODS: A comprehensive search was performed on Embase, MEDLINE, and Web of Science to identify English literature on prostatic stents for the treatment of BPH. Additional studies and upcoming devices were identified through grey literature search and expert consultation. Study characteristics and stent information were extracted and tabulated narratively. RESULTS: Of the 1171 search results, 64 studies were included in this review. iTiND was the prostatic stent with the most long-term evidence. iTiND is a safe and effective minimally invasive treatment for BPH that preserves sexual function. Adverse events are mild and transitory. Emerging stents (e.g. Zenflow, Butterfly, Urocross, and Exime) had 7/64 eligible studies, where no studies had long-term follow-up. These newer stents show promising results for quality of life and BPH symptom management; however, long-term monitoring and head-to-head comparisons are needed. CONCLUSION: Over the last 50 years, prostatic stents have evolved and demonstrated improved clinical efficacy. iTiND provides a safe and effective outpatient treatment of LUTS secondary to BPH preserving erectile and ejaculatory function. Emerging prostatic stents are a promising, effective, and safe intervention in well-selected patients interested in its benefits.

Safety and efficacy of GreenLight PVP in octogenarians: evaluation of the Global GreenLight Group database.

INTRODUCTION: The present study analyzes the largest international GreenLight database, the Global GreenLight Group (GGG), to evaluate the functional and safety profile of GreenLight photoselective vaporization of the prostate (PVP) in octogenarians. METHODS: The GGG is a database comprised of patients that underwent GreenLight PVP from 2011 to 2019 performed by 8 experienced urologists at 7 international hospitals. Patients 80 years or older at the time of surgery were categorized as octogenarians. They were compared to a similar group of PVP patients below the age of 80. RESULTS: Among 3,648 patients, 586 men were above the age of 80. Compared to patients under the age of 80, octogenarians had larger prostates (76.0 vs 71.9 ml, p = 0.02) and a lower BMI (25.6 vs 26.7, p = 0.045). Operative time was not significantly longer in octogenarians. The improvement in functional outcomes between 80-year-old patients and control patients was not significantly different at one-year follow-up, with the exception of maximum urinary flow (Qmax) that favoured younger patients (10.3 vs 12.6 ml/s, p = 0.02). The odds of transfusion were greater for older patients [OR 8.2 (95% CI 3.6-18.9, p < 0.01)], but they were not at increased risk of hematuria. Octogenarians had higher readmission rates (23.0 vs 11.9%, p < 0.01). CONCLUSIONS: GreenLight PVP is a safe option in well-selected octogenarians in a cohort of patients treated by surgeons experienced with the technology. The odds of transfusion were higher in patients over 80, but the absolute risk remains low. The 30-day hospital readmission rate was higher in octogenarians.

Functional outcomes of GreenLight 180-W photoselective vaporization in patients with large (≥ 80 cc) prostates: an analysis of over 3000 men in the Global Greenlight Group (GGG) database.

INTRODUCTION: GreenLight photoselective vaporization of the prostate (PVP) has gained widespread adoption as an option to traditional transurethral resection of the prostate. Prior reports expressed concern with the use of PVP in large prostates. The aim of this study was to investigate the adjusted outcomes of GreenLight PVP in men with large (≥ 80 cc) vs. small prostates (< 80 cc). METHODS: Data were obtained from the Global Greenlight Group which pools data from 7 high volume centers. Men with established benign prostatic hyperplasia who underwent GreenLight PVP using the XPS-180 W system between 2011 and 2019 were eligible and assigned into two groups based on their prostate size (≥ 80 and < 80 cc). 11 functional and perioperative covariates were collected. Analyses were adjusted for patient age and presence of median lobe. RESULTS: 3426 men met the inclusion criteria. 34.6% (n = 1187) of patients had a large prostate size. Baseline age and prostate volume were significantly different between the groups. The magnitude of absolute improvement in unadjusted international prostate symptom score was significantly greater in the large (≥ 80 cc) prostate group at 12 months, with an absolute change of 19.17 points (95% CI 18.46-19.88; p < 0.01). There was also a significant drop in PVR at both 6- (p = 0.007) and 12 months (p = 0.005). There were no significant differences in transfusion (p = 0.42), hematuria (p = 0.80), or 30-day readmission rates (p = 0.28). CONCLUSIONS: Greenlight PVP is a safe and effective alternative for patients with prostate sizes ≥ 80 cc, with durable outcomes relatively independent from prostate size.

How I Do It: Penthrox in Urology.

Penthrox is a portable handheld inhaler that delivers a low dose of methoxyflurane - an anesthetic with analgesic effects, rapid onset of action, and a favorable side-effect profile. It has been widely used for acute pain management in Australia for the past 40 years. Currently, it is approved for use in over 55 countries, including Canada. Prospective randomized studies highlight Penthrox analgesic effectiveness and safety profile for emergency, prehospital and outpatient settings. In addition, the use of multimodal analgesia, specifically Penthrox, can play an important role in the analgesic management of urological procedures, such as prostatic biopsies and office-based minimally invasive surgical therapies. Herein readers will familiarize themselves with Penthrox, significant studies, and technique used for outpatient urological procedures.

How I Do It: Optilume BPH catheter system.

Benign prostatic hyperplasia (BPH) is a common and progressive disease affecting aging men which has a significant impact on quality of life. The Optilume BPH Catheter System (Optilume BPH) is a prostatic dilation system that combines balloon dilation with a localized transfer of paclitaxel to maintain long term patency. Optilume BPH can be deployed using standard rigid cystoscopy without general anesthesia in an office setting. Prospective data indicate that Optilume BPH has favorable functional and sexual patient outcomes. Readers will familiarize themselves with Optilume BPH, significant historical studies and the technique for deploying Optilume BPH.

Peri-prostatic nerve block using Clarius EC7 HD3 handheld ultrasound guidance.

Transrectal ultrasound (TRUS) is a common modality used during urological procedures that require real-time visualization of the prostate, such as prostate biopsy and peri-prostatic nerve blocks (PNB) for surgical procedures. Current practice for TRUS-guided PNB requires use of costly, fixed, and non-portable ultrasound machinery that can often limit workflow. The Clarius endocavity EC7 probe, a digital, handheld and pocket-sized endocavity ultrasound (US) device, is an alternative, portable technology which was recently shown to accurately visualize and measure prostate dimensions and volume. Moreover, in recent years, there has been a renaissance of office-based treatments for minimally invasive surgical therapies (MIST) for the treatment of benign prostate hyperplasia (BPH). More specifically, the Rezum procedure has been demonstrated to offer men a short, outpatient therapy with excellent 5-year outcomes in durability and preservation of antegrade ejaculation. While other anesthetic techniques have been described for Rezum, including inhaled methoxyflurane (Penthrox), nitrous oxide, IV sedation and general anesthesia (which often mandate the presence of an anesthesiology team), US-guided local blocks offer the urologist an independent method for pain management. While most urologists may not have direct access to expensive, cart-based ultrasound systems, point of care ultrasound (POCUS) technology, such as Clarius (Vancouver, BC, Canada) and Butterfly (Butterfly Network, Inc, Guilford, CT, USA), can provide high-resolution imaging in combination with smart phone technology. Herein, we sought to describe the technique for using Clarius EC7 for TRUS-guided PNB and its use in urological application with the Rezum BPH procedure.

Age-stratified potency outcomes of bilateral nerve sparing robotic-assisted radical prostatectomy.

INTRODUCTION: This study aims to report age-stratified potency outcomes in men undergoing robot-assisted radical prostatectomy (RARP). MATERIALS AND METHODS: A retrospective review was performed on a database of 1737 patients who underwent RARP for localized prostate cancer between 2007 and 2019. Inclusion criteria consisted of patients undergoing bilateral nerve-sparing RARP. Exclusion criteria were preoperative Sexual Health Inventory for Men (SHIM) score < 17 and postoperative androgen deprivation therapy or radiotherapy. Patients were divided into four cohorts based on age: ≤ 54 years (group 1); 55-59 years (group 2); 60-64 years (group 3) and ≥ 65 years (group 4). Functional outcomes were measured up to 36 months. Kaplan-Meier analysis was performed to compare the time to recovery of potency stratified by age groups using log-rank testing. RESULTS: A total of 542 patients met the selection criteria. Potency rates were significantly different between groups. Groups 1 through 4 demonstrated potency recovery rates of 64.2%, 52.3%, 36.6% and 20.7% at 1-year follow up, respectively. After 3 years, groups 1 through 4 had potency rates of 77.9%, 67.0%, 50.5% and 35.0%, respectively. Recovery of potency was achieved at a median time after surgery of 199, 340 and 853 days for groups 1-3, respectively. The Cox proportional hazard model showed that older age, higher body mass index (BMI), and lower preoperative SHIM score were associated with significantly higher rates of impotence. CONCLUSION: This study shows that RARP has acceptable potency outcomes, regardless of age. However, patient factors, including older age and preoperative SHIM were significantly associated with poorer functional recovery. This data is valuable in prognostic evaluation and patient counseling.

Litigation associated with 5-alpha-reductase-inhibitor use: A Canadian legal database review.

INTRODUCTION: 5α-reductase inhibitors (5ARI) are commonly prescribed medications. There is ongoing controversy about the adverse events of these medications. The aim of this study is to characterize lawsuits in Canada involving medical complications of 5ARIs use. MATERIALS AND METHODS: Legal cases were queried from CanLII. Cases were included if they involved a party taking a 5ARI who alleged an adverse event. Relevant full cases were retained, and pertinent characteristics were extracted with the help of a legal expert. RESULTS: Our deduplicated search yielded 67 unique legal documents from December 2013 to February 2019. Twelve of these documents met the inclusion criteria (representing 3 cases, considering each case had several hearings). The medical complaints filed by the plaintiffs were all related to medication side effects (n = 3, 100%). The plaintiffs were commonly patients themselves. Defendants were exclusively pharmaceutical companies. Persistent erectile dysfunction after stopping the medication was cited as a side effect in all complaints. The prescriptions were made for male pattern hair loss (n = 3, 100%) in all cases. All cases represent class actions brought by the plaintiffs, and they have been certified by their respective court. However, the cases are still ongoing. CONCLUSION: While 5ARI use has been linked to undesired sexual side effects, there have been few litigations on this issue in Canada. Persisting sexual dysfunction after stopping the medication is the only complaint presented in legal action. To date, no judgment against a physician or pharmaceutical company was identified. Cases are still ongoing.

The impact of 5-ARI on perioperative and functional outcomes of GreenLight PVP: an analysis of the Global GreenLight Group database.

INTRODUCTION: In this study, we sought to investigate the impact of 5-alpha reductase inhibitors (5-ARI) on the perioperative and functional outcomes of 180-Watt XPS GreenLight photovaporization of the prostate (PVP) using a large international database. MATERIALS AND METHODS: Data were obtained from the Global GreenLight Group (GGG) database, which includes eight high-volume, experienced surgeons from seven international centers.  All men with established benign prostatic hyperplasia (BPH) with known 5-ARI status who underwent GreenLight PVP using the XPS-180W system between 2011 and 2019 were eligible for the study.  Patients were assigned to two groups based on the preoperative use of 5-ARI.  Analyses were adjusted for patient age, prostate volume, and American Society of Anesthesia (ASA) score. RESULTS: We included 3,500 men, of which 1,246 (36%) had preoperative 5-ARI use.  Patients in both groups were similar with regards to age and prostate size.  On multivariable analysis, total operative time was slightly shorter (-3.26 min 95% CI: 1.20 - 5.32, p < 0.01) and required 35.6kJ less laser energy (95% CI: -48.0kJ - -23.3kJ, p < 0.01) for patients on 5ARI compared to those without 5-ARI.  However, no clinically significant difference was appreciated regarding postoperative transfusion rates [OR 0.048 (95% CI -0.82-0.91; p = 0.91)], hematuria rates [OR 0.96 (95% CI 0.72-1.3; p = 0.81)], 30-day readmission rates [OR 0.98 (95% CI 0.71-1.4; p = 0.90)], or overall functional outcomes. CONCLUSION: Our findings suggest that preoperative 5-ARI is not associated with any clinically significant different perioperative or functional outcomes for GreenLight PVP using the XPS-180W system.  There is no role for the initiation or discontinuation of 5-ARI prior to GreenLight PVP.

Aquablation versus TURP: 5-year outcomes of the WATER randomized clinical trial for prostate volumes 50-80 mL.

INTRODUCTION: To report the 5-year efficacy and safety of Aquablation compared with transurethral resection of the prostate for the management of lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with prostate volumes 50-80 mL. MATERIALS AND METHODS: In a large double-blinded, multicenter, and prospective randomized controlled trial, 96 randomized men with 50-80 mL prostates who underwent Aquablation or transurethral prostate resection were prospectively identified for subgroup analysis. Follow up was performed for up to 5 years. The primary efficacy endpoint was the reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo (CD) postoperative complications grade 1 persistent and grade 2 or higher at 3 months. RESULTS: Both groups had comparable baseline characteristics. Reduction in IPSS score was significantly higher in the Aquablation group across 5 years of follow up (-14.1 vs. -10.8, p = 0.02). The Aquablation group achieved a significantly lower rate of CD1P and CD2 or higher events at 3 months follow up (risk difference of -23.1%). Among recorded adverse events, de novo postoperative ejaculatory dysfunction was notably lower in Aquablation (risk difference of -21.9%), while the risk of bleeding remained similar after 6 months. The surgical and medical retreatment rate at 6 months was also lower in Aquablation (risk difference of -14.4%). CONCLUSIONS: In the 50-80 mL prostate volume subgroup, Aquablation yields superior long-term symptom relief and lower complication rates than standard transurethral resection, with notably lower rates of ejaculatory dysfunction. This further supports the adoption of Aquablation for men with medium-sized prostates.

Rezum therapy for ≥80-mL benign prostatic enlargement: a large, multicentre cohort study.

OBJECTIVE: To evaluate the efficacy and safety of Rezum therapy in benign prostatic hyperplasia (BPH) patients with prostates ≥80 mL. METHODS: A prospective registry was established at two high-volume Canadian centres. Patients had baseline medical history documented, and uroflowmetry and questionnaire results were recorded over 12 months. RESULTS: Eighty-three patients (median [interquartile range {IQR}] age 69.2 [63.2, 74.8] years) with a prostate size ≥80 mL were included. The median (IQR) prostate volume was 100.0 (88.5, 115.0) mL and 65% had a median lobe. Twenty-one patients had prior urinary retention. The median (IQR) number of injections was 13 (11, 15) and catheterization duration was 9 (7, 14) days. International Prostate Symptom Scores (IPSSs) improved by 24%, 57% and 59% at 1, 3 and 12 months, respectively (P < 0.001). IPSS Quality of Life (QoL) scores improved by 27%, 56% and 70% at these same timepoints (P < 0.001). Maximum urinary flow rate improved by 55% at 3 months (P = 0.002) and 59% at 12 months, and post-void residual urine volume improved by 58% at 3 months (P = 0.006). BPH Impact Index scores improved by 57% at 3 months and 71% at 12 months. International Index of Erectile Function-15 scores improved by 15% at 6 months, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction scores improved by 22.4% at 1 month. Three patients (3.6%) noted reduced/anejaculation. No events of Clavien-Dindo grade III or higher occurred. CONCLUSION: This study demonstrates, for the first time, the safety and efficacy of Rezum therapy in large glands >80 mL. IPSS improved by 59% and IPSS QoL score improved by 70% at 12 months. Objective maximum urinary flow measures improved at 12 months by 59%, while erectile and ejaculatory function remained preserved.

Real-world data comparing minimally invasive surgeries for benign prostatic hyperplasia.

OBJECTIVES: To assess the differences in surgical outcomes between the prostatic urethral lift (PUL) and previous thermal energy procedures for the treatment of benign prostatic hyperplasia (BPH). METHODS: We present an observational population-based study of 2694 men with BPH in New York State and California who received PUL, transurethral needle ablation (TUNA), or transurethral microwave therapy (TUMT) in outpatient and ambulatory surgery settings from 2005 to 2018. For these surgical procedures, short-term outcomes were reported and compared using a Chi-square test and mixed-effect logistic regressions. Long-term outcomes were described using Kaplan-Meier failure curves and compared using a Log-rank test and Cox regressions. RESULTS: A significant portion of PUL patients had a comorbidity count ≥ 2 (n = 838, 37.0%). PUL exhibited the lowest 30 day and 90-day inpatient or ER readmission rates among all surgical techniques except for 90-day ER readmission (p < 0.05). No differences were observed for 1- and 3-year risks of reoperation between PUL [5.5% (95% CI 4.4-6.8%) and 14.9% (95% CI 10.9-20.1%)], TUNA [7.4% (95% CI 5.0-10.9%) and 11.3% (95% CI 8.3-15.4%)] and TUMT [8.5% (95% CI 4.7-15.2%) and 15.3% (95% CI 9.5-24.0%)]. 1- and 3-year risks of stricture development for PUL were 0.2% (95% CI 0.0-0.7%) and 0.2% (95% CI 0.0-0.07%), respectively. CONCLUSION: In a patient population with chronic conditions, patients treated with PUL exhibited similar 30- and 90-day inpatient or ER readmission rates when compared to previous reports. However, 1- and 3-year reoperation risks for PUL closely resembled previous thermal energy surgical procedures.

Functional and surgical outcomes of Aquablation in elderly men.

PURPOSE: As benign prostatic hyperplasia (BPH) is an age-related process, growing interest in surgical management for elderly men has emerged. Recently, Aquablation was approved for treatment of BPH associated lower urinary tract symptoms (LUTS) and utilizes robotic ultrasound guided surgeon-controlled waterjet ablation. We assessed the differences in functional and surgical outcomes between elderly and young men undergoing Aquablation for BPH/LUTS. MATERIALS AND METHODS: We retrospectively assessed prospectively collected data from the WATER I (NCT02505919) and WATER II (NCT03123250) clinical trials reporting safety and efficacy of Aquablation in the treatment of LUTS/BPH in men 45-80 years with a prostate between 30 and 80 cc, and 80 cc and 150 cc, respectively. Men ≥ 65 years were defined as elderly and men < 65 years as young. RESULTS: Of 217 patients included, 83 (38.2%) were young and 134 (61.8%) were elderly. Mean age (SD) was 59.3 (± 3.4) years and 71.2 (± 4.2) years for young and elderly men, respectively. At 3 years of follow-up compared to baseline, elderly men showed similar reductions in total IPSS (7.68 points vs 7.12 points, p > 0.05) and similar increases in Qmax (20.6 mL/s vs 19.3 mL/s, p > 0.05) compared to young men. The ejaculatory dysfunction rate was similar for both cohorts (12.0% vs 9.7%, p > 0.05). Elderly men experienced similar annual retreatment rates compared to young men (1.5% vs 0.8% p > 0.05). CONCLUSIONS: Elderly men undergoing Aquablation have similar functional and surgical outcomes as young men. Elderly patient BPH surgical counseling should, therefore, consider Aquablation as a treatment option for LUTS/BPH.

Development of a North American coordinated registry network for surgical treatment of benign prostatic hyperplasia.

PURPOSE: To create a prospective, multicenter coordinated registry network (CRN) of robust "real world" data for benign prostatic hyperplasia (BPH) that links surgical practices to objective and subjective outcomes of patients who undergo surgery for the improvement in lower urinary tract symptoms (LUTS) secondary to BPH. METHODS: We gathered a group of BPH experts from various institutions to identify the minimum core data elements needed to assess BPH procedures. To achieve consensus on the data elements, we used a Delphi method adaptation, in which a series of surveys were answered by the expert panel individually and anonymously. Survey results were collected and analyzed. Questions for the following round were based on response analysis from the prior survey. This process was repeated until consensus was achieved. RESULTS: Participation rates in the first and second rounds were 100% and 90%, respectively. The expert panel reached consensus on 148 data elements out of the 182 proposed, capturing patient medical and surgical history, procedure, discharge, short- and long-term follow-up, device factors, surgery, and surgeon factors. CONCLUSION: We have successfully developed a set of core data elements to support the study of BPH surgical therapies by gathering an expert panel on BPH and using the Delphi method. These data elements influence provider decisions about treatment and include important outcomes related to efficacy and safety.