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.

Systematic review and meta-analysis of urinary incontinence prevalence and population estimates.

INTRODUCTION: Incontinence impacts the quality-of-life of people suffering from the disease. However, there is limited information on the prevalence of incontinence due to the stigma, lack of awareness, and underdiagnosis. OBJECTIVE: This study aims to conduct a systematic review and meta-analysis of overactive bladder (OAB) and nonobstructive urinary retention (NOUR). METHODS: The authors conducted a systematic review following the PRISMA guidelines using Embase, MEDLINE, and PubMed databases to identify the relevant publications in the English language. Two reviewers independently assessed the articles and extracted the data. Review papers were assessed for content and references. A meta-analysis of proportions was conducted using the RStudio software. To address the age heterogeneity, a subanalysis was conducted. Pooled data were overlayed on the Canadian population and a sample of 10 populous countries to estimate the number of people suffering from incontinence. RESULTS: Twenty-eight and eight articles were selected for OAB and NOUR, respectively. The pooled prevalence of OAB in men and women was 12% (95% CI: 9%-16%) and 15% (95% CI: 12%-18%), respectively. The estimated prevalence of NOUR was 15.6%-26.1% of men over 60 and 9.3%-20% of women over 60. The subanalysis pooled prevalence of OAB in men and women was 11% (95% CI: 8%-15%) and 12% (95% CI: 9%-16%), respectively. We estimated that 1.4-2.5 million women and 1.3-2.2 million men suffer from OAB in Canada. CONCLUSION: Urinary incontinence is an under-reported and underdiagnosed prevalent condition that requires appropriate treatment to improve a patient's quality-of-life.

Real-world onabotulinumtoxinA treatment patterns in patients with overactive bladder.

PURPOSE: Utilization patterns of third-line onabotulinumtoxinA for overactive bladder (OAB) symptoms-including discontinuation and use of other therapeutic options during or after treatment-are not well understood. This retrospective analysis of administrative claims was designed to characterize the unmet need for OAB treatment. MATERIALS AND METHODS: A retrospective claims analysis of Optum's deidentified Clinformatics® Data Mart Database (2009-2021) was performed among patients with diagnosis of OAB newly starting onabotulinumtoxinA injection (2015-2017). Study measures were evaluated during an 18-month pretreatment baseline and over a minimum of 36 months of follow-up. These included number of injections, days between injections, other measures of onabotulinumtoxinA utilization, use of second-line pharmacologic treatments, use of device and surgical treatment options, and complications. RESULTS: Of 2505 eligible patients, 535 (21.4%; 66.8 ± 13.3 y, 87.3% females) continued onabotulinumtoxinA throughout the study. The remaining 1970 (78.6%; 71.4 ± 11.6 y, 79.1% females) were considered discontinuers. Of continuers, 57% received ≥5 treatments. Of discontinuers, 84% received ≤2 treatments. Anticholinergics and ß3-adrenoceptor agonist medication use declined in all patients from baseline to follow-up; however, the absolute reduction in the proportion with any medication fill was similar across continuers versus discontinuers (21% vs. 18%, p < 0.0001). Sacral neuromodulation was initiated by 15/535 (3%) of continuers and 137/1970 (7%) of discontinuers (p < 0.0001). No patients initiated percutaneous tibial neuromodulation. CONCLUSIONS: Early discontinuation of onabotulinumtoxinA therapy for OAB is common and most discontinuers do not receive alternative treatments. Providers have the opportunity to educate OAB patients with un- or undertreated symptoms regarding alternative options.

AI for BPH Surgical Decision-Making: Cost Effectiveness and Outcomes.

PURPOSE OF REVIEW: Benign prostatic hyperplasia (BPH) is prevalent in nearly 70% of men over the age of 60, leading to significant clinical challenges due to varying symptom presentations and treatment responses. The decision to undergo surgical intervention is not straightforward; the American Urological Association recommends consideration of surgical treatment after inadequate or failed response to medical therapy. This review explores the role of artificial intelligence (AI), including machine learning and deep learning models, in enhancing the decision-making processes for BPH management. RECENT FINDINGS: AI applications in this space include analysis of non-invasive imaging modalities, such as multiparametric Magnetic Resonance Imaging (MRI) and Ultrasound, which enhance diagnostic precision. AI models also concatenate serum biomarkers and histopathological analysis to distinguish BPH from prostate cancer (PC), offering high accuracy rates. Furthermore, AI aids in predicting patient outcomes post-treatment, supporting personalized medicine, and optimizing therapeutic strategies. AI has demonstrated potential in differentiating BPH from PC through advanced imaging and predictive models, improving diagnostic accuracy, and reducing the need for invasive procedures. Despite promising advancements, challenges remain in integrating AI into clinical workflows, establishing standard evaluation metrics, and achieving cost-effectiveness. Here, we underscore the potential of AI to improve patient outcomes, streamline BPH management, and reduce healthcare costs, especially with continued research and development in this transformative field.

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.

Outcomes of sacral neuromodulation in male patients with overactive bladder, chronic pelvic pain, and fecal incontinence.

INTRODUCTION: Despite the growing body of literature on sacral neuromodulation (SNM) outcomes, research focusing on male patients remains limited and often represented by small cohorts nested within a larger study of mostly women. Herein, we evaluated the outcomes of SNM in a male-only cohort with overactive bladder (OAB), fecal incontinence (FI), chronic bladder pain, and neurogenic lower urinary tract dysfunction (NLUTD). MATERIALS AND METHODS: This retrospective cohort study included 64 male patients who underwent SNM insertion between 2013 and 2021 at a high-volume tertiary center. Indications for SNM therapy included OAB, FI, chronic pelvic pain, and NLUTD. Descriptive statistics, Fisher's and t-test were used in analysis. RESULTS: The mean age was 57.7 ± 13.4 years, and the most frequent reason for SNM insertion was idiopathic OAB (72%), FI (16%), pelvic pain (11%), and NLUTD (11%). A majority (84%) of men received treatment prior to SNM insertion. 84% reported satisfaction and 92% symptom improvement within the first year, and these improvements persisted beyond 1 year in 73% of patients. Mean follow up was 52.7 ± 21.0 months. The complication rate was 23%, and the need for adjunct treatments was significantly reduced (73% to 27%, p < 0.001). Treatment outcomes did not differ significantly between various indications for SNM therapy or the presence of benign prostatic hyperplasia (BPH). CONCLUSION: SNM is an effective and safe procedure for male patients with neurogenic and non-neurogenic OAB, pelvic pain, and FI. Over 70% of patients experienced symptomatic improvement and remained satisfied in the mid to long term follow up. BPH does not seem to hinder treatment outcomes.

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.

Psychological Health of Surgeons in a Time of COVID-19: A Global Survey.

OBJECTIVE: To assess the degree of psychological impact among surgical providers during the COVID-19 pandemic. SUMMARY OF BACKGROUND DATA: The COVID-19 pandemic has extensively impacted global healthcare systems. We hypothesized that the degree of psychological impact would be higher for surgical providers deployed for COVID-19 work, certain surgical specialties, and for those who knew of someone diagnosed with, or who died, of COVID-19. METHODS: We conducted a global web-based survey to investigate the psychological impact of COVID-19. The primary outcomes were the depression anxiety stress scale-21 and Impact of Event Scale-Revised scores. RESULTS: A total of 4283 participants from 101 countries responded. 32.8%, 30.8%, 25.9%, and 24.0% screened positive for depression, anxiety, stress, and PTSD respectively. Respondents who knew someone who died of COVID-19 were more likely to screen positive for depression, anxiety, stress, and PTSD (OR 1.3, 1.6, 1.4, 1.7 respectively, all P < 0.05). Respondents who knew of someone diagnosed with COVID-19 were more likely to screen positive for depression, stress, and PTSD (OR 1.2, 1.2, and 1.3 respectively, all P < 0.05). Surgical specialties that operated in the head and neck region had higher psychological distress among its surgeons. Deployment for COVID- 19-related work was not associated with increased psychological distress. CONCLUSIONS: The COVID-19 pandemic may have a mental health legacy outlasting its course. The long-term impact of this ongoing traumatic event underscores the importance of longitudinal mental health care for healthcare personnel, with particular attention to those who know of someone diagnosed with, or who died of COVID-19.

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: The Optilume BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The PINNACLE study is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and efficacy of Optilume BPH against a sham surgical procedure. MATERIALS AND METHODS: Eligible patients were men 50 years or older with symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g. Subjects were randomized 2:1 to receive treatment with Optilume BPH or a sham surgical procedure. Blinding was maintained for subjects in both arms and evaluating personnel through 1 year postprocedure. Follow-up assessments included the International Prostate Symptom Score, uroflowmetry, and other quality-of-life and sexual function assessments. RESULTS: A total of 148 men were randomized (100 active, 48 sham) at 18 centers in the U.S. and Canada. Subjects randomized to receive Optilume BPH saw a reduction in International Prostate Symptom Score of 11.5±7.8 points at 1 year posttreatment, as compared to a reduction of 8.0±8.3 points at 3 months in the sham arm. Flow rate was dramatically improved after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%). CONCLUSIONS: Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.

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).

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.

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.

Results from a global multicenter registry of 6193 patients to refine endoscopic anatomical enucleation of the prostate (REAP) by evaluating trends and outcomes and nuances of prostate enucleation in a real-world setting.

PURPOSE: To collect a multicentric, global database to assess current preferences and outcomes for endoscopic enucleation of the prostate (EEP). METHODS: Endourologists experienced in EEP from across the globe were invited to participate in the creation of this retrospective registry. Surgical procedures were performed between January 2020 and August 2022. INCLUSION CRITERIA: lower urinary tract symptoms not responding to or worsening despite medical therapy and absolute indication for surgery. EXCLUSION CRITERIA: prostate cancer, concomitant lower urinary tract surgery, previous prostate/urethral surgery, pelvic radiotherapy. RESULTS: Ten centers from 7 countries, involving 13 surgeons enrolled 6193 patients. Median age was 68 [62-74] years. 2326 (37.8%) patients had large prostates (> 80 cc). The most popular energy modality was the Holmium laser. The most common technique used for enucleation was the 2-lobe (48.8%). 86.2% of the procedures were performed under spinal anesthesia. Median operation time was 67 [50-95] minutes. Median postoperative catheter time was 2 [1, 3] days. Urinary tract infections were the most reported complications (4.7%) followed by acute urinary retention (4.1%). Post-operative bleeding needing additional intervention was reported in 0.9% of cases. 3 and 12-month follow-up visits showed improvement in symptoms and micturition parameters. Only 8 patients (1.4%) required redo surgery for residual adenoma. Stress urinary incontinence was reported in 53.9% of patients and after 3 months was found to persist in 16.2% of the cohort. CONCLUSION: Our database contributes real-world data to support EEP as a truly well-established global, safe minimally invasive intervention and provides insights for further research.

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.

Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6-month results from the global postmarket ELITE study.

AIMS: Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStimTM Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6-month follow-up. METHODS: Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG). Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB-q) at baseline and follow-up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device-, procedure-, or therapy-related adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB-q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline. RESULTS: Sixty-eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3- and 6-month follow-up visits, respectively. The OAB-q HRQL demonstrated a statistically significant improvement from baseline to 3-month follow-up with an average increase of 33 ± 24 points (n = 67, p < 0.001). The change was also observed at 6-months with an average increase of 31 ± 23 points (n = 65) compared to baseline. Eighty-two percent of subjects achieved the minimally important difference in HRQL score at 3- and 6-month, respectively, with a change of 10 points or greater. The majority of subjects reported that their bladder condition was better at 3-month (92.5%, 62/67) and 6-month (89%, 59/66) compared to before they were treated with SNM therapy delivered by the InterStim Micro system. For subjects with urgency urinary incontinence (UUI), the average change from baseline to follow-up in UUI episodes/day was -3.6 (95% CI: -4.7, -2.6; n = 62) at 3-month and -3.7 (95% CI: -4.7, -2.7; n = 61) at 6-month. Among subjects with urgency-frequency (UF), the average change from baseline to follow up in voids/day was -4.5 (95% CI: -6.3, -2.7; n = 52) at 3-months and -4.4 (95% CI: -6.0, -2.7; n = 52) at 6-month. The cumulative incidence of device-, procedure-, or therapy- related adverse events was 7.4% (5/68). Out of these five related adverse events, there was one serious adverse event (1.5%, implant site pain) at the time of database snapshot. CONCLUSIONS: These data confirm the safety and clinical performance of the InterStim Micro device for subjects with OAB by demonstrating a significant improvement in OAB-q HRQL score at 3-month. Similar improvements were observed at 6 months in addition to an incidence of adverse events that is comparable to previously reported rates for SNM.

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.