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).

Aquablation for benign prostatic hyperplasia in large prostates (80-150 cc): 2-year results.

INTRODUCTION: To report 2-year safety and effectiveness of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume 80-150 cc prostates. MATERIALS AND METHODS: Between September-December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volumes of 80-150 cc underwent an ultrasound-guided robotically executed Aquablation procedure in a prospective multicenter international clinical trial (WATER II). Baseline, procedural and follow up parameters were recorded at baseline and scheduled postoperative visits. Herein we report 2-year safety and efficacy for this cohort. RESULTS: Mean prostate volume was 107 cc (range 80-150 cc). Mean IPSS improved from 23.2 at baseline to 5.8 at 2 years (17-point improvement, p < .0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 2 years (p < .0001). Maximum urinary flow increased from 8.7 to 18.2 cc/sec. Two subjects underwent a repeat procedure for BPH symptoms over the 2-year follow up period. By 2 years or study exit, all but 2 of 74 subjects stopped taking alpha blockers. Similarly, all but 4 of 32 subjects stopped taking 5α-reductase inhibitors. CONCLUSIONS: Two-year prospective multicenter follow up demonstrated that the Aquablation procedure is safe and effective in the treatment of men with LUTS due to BPH and prostates 80-150 cc with durable treatment efficacy, acceptable safety profile and a low retreatment rate. ClinicalTrials.gov number, NCT03123250.

Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial.

OBJECTIVE: To present 6-month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL. METHODS: Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA. RESULTS: The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien-Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien-Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post-void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction. CONCLUSIONS: Aquablation is safe and effective in treating men with larger prostates (80-150 mL), without significant increase in procedure or resection time.

WATER II (80-150 mL) procedural outcomes.

OBJECTIVES: To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large-volume benign prostatic hyperplasia (BPH). METHODS: Between September and December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volume of 80-150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra-operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee. RESULTS: The mean (range) prostate volume was 107 (80-150) mL. The mean (range) operating time was 37 (15-97) min and aquablation resection time was 8 (3-15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa (n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien-Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri-operative transfusions. CONCLUSIONS: Aquablation is feasible and safe in treating men with men with large prostates (80-150 mL). The 6-month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250).

An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device.

Purpose: To document the effect of the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel) on sexual function from a multicenter, randomized, single-blinded, sham-controlled trial. Materials and Methods: Men were randomized 2:1 between iTind and sham procedure arms. The iTind was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 3, and 12 months postoperatively using the Sexual Health Inventory for Men (SHIM) and International Index of Erectile Function (IIEF). Unblinding occurred at 3 months. Results: We studied 185 men with a mean age of 61.1 ± 6.5 years. There was no difference in SHIM or total IIEF between iTind and sham at 3 months or in the iTind arm at 12 months compared with baseline. Men in the iTind arm without erectile dysfunction at baseline showed an improvement in total IIEF score of +6.07 ± 21.17 points (p = 0.034) at 12 months, in addition to an improvement in ejaculatory function. SHIM scores remained unchanged in all groups, regardless of age, prostate volume, or baseline erectile function. Conclusion: No changes were observed in sexual and ejaculatory function of patients with iTind regardless of a man's age, prostate volume, and baseline sexual function. Clinicaltrials.gov: NCT02506465.

Current State of Advanced Practice Providers in Urological Practice.

INTRODUCTION: This document provides an update to the 2015 consensus statement with new content on inpatient utilization, procedural data, and compensation. The full document is available on the American Urological Association (AUA) website (https://www.auanet.org/guidelines/guidelines/current-state-of-advanced-practice-providers-in-urologic-practice). This document was created by an ad-hoc group of urological providers formed by the AUA board of directors. METHODS: A workforce shortage of 65,000 physicians is projected by the year 2025. In 2018, there were 3.89 urologists per capita, which is amongst the most severe specialty shortages. Urology has the second oldest surgical subspecialty workforce with an average age of 52.5 years. According to the 2018 census, 72.5% of urologists used an advanced practice provider (APP) in their practice, and APPs accounted for 41% of a medical doctor/doctor of osteopathy full-time equivalent. The AUA endorses the use of APPs in the care of patients through a formally defined, supervised role with a board certified urologist under the auspices of applicable state law. This physician-led, team-based approach provides the highest quality urological care. RESULTS: Urologists work with APPs frequently, but many may not know the most efficient way to incorporate them into their practice. This document examines APP integration from a regulatory and practice management approach, as well as provides information on inpatient utilization, procedural data, and compensation. CONCLUSIONS: This document supports the AUA's policy statement that in a team-based approach with a board certified urologist in a supervisory role, APPs contribute to the care of the patient with genitourinary disease and, therefore, encourages the proper use of APPs.

Medium-Term Real-World Outcomes of Minimally Invasive Surgical Therapies for Benign Prostatic Hyperplasia: Water Vapor Thermal Therapy (Rezum) vs Prostatic Urethral Lift (UroLift) in a High-Volume Urban Academic Center.

Purpose: Water vapor thermal therapy (WVTT, i.e., Rezum®) and prostatic urethral lift (PUL, i.e., Urolift®) are minimally invasive surgical therapy (MIST) options for benign prostatic hyperplasia (BPH). Few studies have directly compared the two procedures. We examined the clinical characteristics and postoperative outcomes of patients undergoing WVTT and PUL at our high-volume urban academic center. Methods: We reviewed our institutional MIST database to identify patients with prostate sizes ≥30 and ≤80 cc who underwent WVTT or PUL for treatment of BPH between January 2017 and September 2021. Pre- and postoperative outcomes, including retreatment rates, American Urological Association symptom score (AUA-SS), maximum flow (Qmax), postvoid residual (PVR), medication usage, trial of void success rates, catheterization requirements, and postoperative complications within 90 days were extracted and compared between procedures. Results: Three hundred seven patients received WVTT and 110 patients received PUL with average follow-up times of 11.3 and 12.8 months, respectively. WVTT patients showed significant improvements in AUA-SS, Qmax, and PVR, whereas PUL patients showed improvements in only AUA-SS and Qmax. Both WVTT and PUL patients with longitudinal follow-up demonstrated improvements in AUA-SS, Qmax, and PVR. Postoperatively, alpha-blocker utilization was significantly decreased following both WVTT and PUL (WVTT: 73.9%-46.6%, PUL: 76.4%-38.2%, both p < 0.001). Compared to patients receiving PUL, WVTT patients more frequently reported postoperative dysuria (22.8% vs 8.3%, p = 0.001) and nonclot-related retention (18.9% vs 7.3%, p = 0.005); PUL patients more frequently experienced postoperative clot retention (7.3% vs 2.6%, p = 0.027). There were no differences in rates of postoperative bladder spasm, trial of void success, urinary tract infections, or emergency department visits. Postoperative erectile dysfunction and retrograde ejaculation were rare and occurred at similar rates. Conclusion: In the real-world setting, WVTT and PUL have similar medium-term efficacy in improving symptoms and decreasing medication utilization for patients with BPH. Differences in postoperative complication profiles should inform patient counseling.

Aquablation therapy in large prostates (80-150 cc) for lower urinary tract symptoms due to benign prostatic hyperplasia: WATER II 3-year trial results.

Objective: The objective of this study is to determine if Aquablation therapy can maintain its effectiveness in treating men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with large-volume (80-150 cc) prostates at 3 years. Subjects and Methods: One hundred one men with moderate-to-severe BPH symptoms and prostate volumes between 80 and 150 cc were enrolled in a prospective, nonrandomized, multicenter, international clinical trial in late 2017. Baseline, procedural, and follow-up parameters were recorded at baseline and scheduled postoperative visits. IPSS, Qmax, and treatment failure are reported at 3 years. Results: The mean prostate volume was 107 cc (range 80-150). Mean IPSS improved from 23.2 at baseline to 6.5 at 3 years (16.3-point improvement, p < 0.0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 3 years (improvement of 3.4 points, p < 0.0001). Maximum urinary flow increased from 8.7 to 18.5 cc/s. At 3 year follow-up, 6% of treated patients needed BPH medication and an additional 3% required surgical retreatment for LUTS. Conclusions: Three-year follow-up demonstrates a sustained symptom reduction response along with low irreversible complications to Aquablation in men with LUTS due to BPH and prostates of 80-150 cc. Current treatment options available for men with prostates of this size have similar efficacy outcomes but are burdened with high rates of irreversible complications. There are now numerous clinical studies with Aquablation used in various prostates sizes, and it should be offered as an option to men with LUTS due to BPH.

The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial.

OBJECTIVE: To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Unblinding occurred at 3 months. RESULTS: A total of 175 men (mean age 61.1 ± 6.5) participated (118 iTind vs 57 sham). A total of 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, vs 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (P< .0001), a 3.52ml/s increase in peak urinary flow rate (P < .0001) and a 1.9-point reduction in quality of life (P < .0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred. CONCLUSION: Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.

Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results.

OBJECTIVE: To report 12-month safety and effectiveness outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume prostates. METHODS: One hundred and one men with moderate-to-severe BPH symptoms and prostate volumes of 80-150 cc underwent a robotic-assisted Aquablation procedure in a prospective multicenter international clinical trial. Functional and safety outcomes were assessed at 12 months postoperatively. RESULTS: Mean prostate volume was 107 cc (range 80-150). Mean operative time was 37 minutes and mean Aquablation resection time was 8 minutes. The average length of hospital stay following the procedure was 1.6 days. Mean International Prostate Symptom Score improved from 23.2 at baseline to 6.2 at 12 months (P <.0001). Mean International Prostate Symptom Score quality of life improved from 4.6 at baseline to 1.3 at 12-month follow-up (P <.0001). Significant improvements were seen in Qmax (12-month improvement of 12.5 cc/sec) and postvoid residual (drop of 171 cc in those with postvoid residual >100 at baseline). Antegrade ejaculation was maintained in 81% of sexually active men. No patient underwent a repeat procedure for BPH symptoms. There was a 2% de novo incontinence rate at 12 months, and 10 patients did require a transfusion postoperatively while 5 required take back fulgurations. At 12 months, prostate-specific antigen reduced from 7.1 ± 5.9 ng/mL at baseline to 4.4 ± 4.3 ng/mL. CONCLUSION: The Aquablation procedure is demonstrated to be safe and effective in treating men with large prostates (80-150 cc) after 1 year of follow-up, with an acceptable complication rate and without a significant increase in procedure or resection time compared to smaller sized glands. ClinicalTrials.gov number, NCT03123250.

Special Article: ICD-10: The Time is Now.

INTRODUCTION: The mandated conversion to ICD-10 is immediately on the horizon. METHODS: The history, rationale, costs and benefits of, and opposition to the new coding system are presented. RESULTS: Successful implementation requires a teamwork approach. Billing and coding systems that are in place must be thoroughly assessed. Conversion is expensive and a budget must be created. Training is a crucial part of moving forward and a test period is needed after training is complete. CONCLUSIONS: ICD-10 has arrived and adopting it is the only option.

Symptoms after removal of ureteral stents.

BACKGROUND AND PURPOSE: Urology practices frequently encounter individuals who experience various degrees of pain/discomfort after ureteral stent removal. These symptoms have been previously proved to greatly affect functionality, convalescence time, quality of life, and healthcare costs. The etiology is unclear, but the condition is often self-limiting. We counsel individuals on their risk of having post-ureteral stent removal pain based on anecdotal data. We sought to evaluate the incidence of post-ureteral stent removal pain and attempt to find the probable cause. PATIENTS AND METHODS: All individuals who had a ureteral stent placed and subsequently removed for various etiologies (between January 2012 and May 2013) were evaluated by filling a survey conducted by a member of the healthcare team 1 to 3 weeks after ureteral stent removal. Univariate and multivariate analysis were used to assess correlation between demographics, operative procedures, convalescent time, and post-ureteral stent removal symptoms. All statistical analyses were performed using SAS(®) software, and a P value of less than 0.05 was considered to indicate statistical significance. RESULTS: Of the 104 individuals in the final cohort, 64% had symptoms after stent removal (pain, hematuria, frequency, urgency, or fever), and among those with symptoms, 60% experienced pain/discomfort. On univariate analysis, stone basketing and indwelling stent discomfort correlated positively with pain after stent removal. On the other hand, the use of anticholinergics and a longer indwelling stent duration were associated with less pain after stent removal. On multivariate analysis, correlation with procedures involving basket extraction and indwelling stent discomfort maintained significance. CONCLUSION: Our series suggests that two of three individuals who undergo ureteral stent removal experience symptoms thereafter. Individuals undergoing stone basket extraction and those who experienced stent discomfort were more likely to have pain after stent removal. Anticholinergic use and stents indwelling for a longer time were associated with less pain after stent removal.