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.

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).

Surgical treatment for BPH refractory to medication: robotic water jet ablation vs. TURP functional outcomes from two FDA clinical trials.

INTRODUCTION: A common indication for benign prostate hyperplasia (BPH) therapies is failure to improve with medical therapy. However, pivotal Federal Drug Administration (FDA) registered randomized clinical trials (RCTs) for minimally invasive surgical therapies (MISTs) are designed to be compared to either sham or placebo while off medical therapy at baseline, and as an alternative to medical therapy. There are few if any RCTs reporting the MISTS efficacy in patients with true medical therapy failure. We report on the efficacy of robotic water jet ablation therapy (RWT) and TURP in patients who have failed to improve with medical therapy. MATERIALS AND METHODS: Data was obtained from the WATER and WATER II clinical trials. Both clinical trials did not implement a drug washout period. Only patients with reported BPH medical therapy such as alpha-blockers (AB) and 5-alpha-reductase inhibitors (5-ARIs) usage were included. Functional outcomes as post-void residual volume (PVR), peak urinary flow rate (Qmax), internal prostate symptom score (IPSS), and quality of life score (QoL) were analyzed. RESULTS: AB and/or 5-ARIs usage at baseline were reported in 146 and 39 patients who underwent RWT (prostate sizes up to 150 cc) and transurethral resection of the prostate (TURP, prostate sizes up to 80 cc) respectively. Baseline median (IQR) IPSS, QoL, Qmax and PVR were 24 (18,28), 5 (4,5), 8.9 (6.4,11.5), and 95 (36,172), respectively. Functional outcomes did not statistically differ between Aquablation and TURP at baseline and at 36-month. In cohort of true medical failure, both RWT and TURP demonstrated group statistical improvements in PVR, Qmax, IPSS, and QoL at 36-month compared to baseline. CONCLUSIONS: RWT and TURP are effective BPH therapy in patients who truly failed medical therapy, and RWT demonstrated this in a much broader prostate size range.

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.

Aquablation Outcomes in Men With LUTS Due to BPH Following Single Versus Multi-pass Treatments.

OBJECTIVE: To determine whether existing data support the use of multiple passes in Aquablation for LUTS due to BPH. METHODS: Data were obtained from 2sources. The WATER trial (NCT02505919) is a prospective, multicenter, double-blind, randomized controlled trial of Aquablation vs TURP in prostate volumes of 30 - 80 ml. The WATER II trial (NCT03123250) is a prospective single-arm multicenter trial of Aquablation in prostate volumes of 80-150ml. The number of passes was determined by the procedural data collected and the video recordings of all study cases. RESULTS: In total, 127 Aquablation subjects underwent a single pass, 90 underwent multiple passes (80 had 2passes and 10 underwent 3passes), and 65 underwent TURP (in WATER only). Men undergoing 2or more passes with Aquablation had larger prostates but few differences in other baseline parameters, including prostate size range. Compared to a single pass, the use of 2or more passes during Aquablation resulted in lower IPSS scores (by ∼4 points, P = .0002) and lower IPSS QoL scores (by ∼0.7 points, P = .0096) at the later timepoints of 24 and 36 months. Similarly, 36-month Qmax values were higher (by ∼5 ml/sec, P = .0220) in those with 2or more passes than in those with 1pass. There was no statistically significant difference in ejaculatory dysfunction between groups. CONCLUSION: Independent of prostate volume, a multiple treatment pass protocol led to improved voiding outcomes and IPSS improvement.

WATER vs WATER II 3-Year Update: Comparing Aquablation Therapy for Benign Prostatic Hyperplasia in 30-80 cc and 80-150 cc Prostates.

OBJECTIVE: To compare the outcomes of Aquablation for small-to-moderate (30-80cc) prostates with the outcomes for large (80-150 cc) prostates at 3-year follow up. METHODS: WATER is a prospective, double-blind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and TURP in the treatment of LUTS/BPH in men 45-80 year with a prostate of 30cc-80cc. WATER II is a prospective, multicenter, single-arm international clinical trial of Aquablation in men with a prostate of 80cc-150cc. We compare 36-mo outcomes amongst 116 WATER and 101 WATER II study subjects undergoing Aquablation. RESULTS: International Prostate Symptom Score (IPSS) scores improved from 22.9 and 23.2 at baseline in WATER and WATER II, respectively, to 8.0 and 6.5 at 36-month, with 36-mo reductions of 14.4 and 16.3 points, respectively (P = .247). At baseline, urinary flow rate (Qmax) was 9.4 and 8.7 cc/sec in WATER and WATER II, improving to 20.6 and 18.5 cc/sec, respectively (P = .552) at 36-mo. Improvements in both IPSS and Qmax were immediate and sustained throughout follow-up. At 3 year, 98% and 94% of treated patients were BPH medication-free in WATER and WATER II, respectively (P = .038). At 3yr, 96% and 97% of treated patients were free from surgical retreatment in WATER and WATER II, respectively (P = .613). CONCLUSIONS: Three-year follow-up demonstrates that Aquablation therapy leads to sustained outcomes, few irreversible complications, and low retreatment rates for the treatment of LUTS/BPH independently of prostate volume.

I Can't Get No Satisfaction: Patient-reported Outcomes After Different Treatment Options for Lower Urinary Tract Symptoms.

Effective clinical management of benign prostatic obstruction is determined by the ability to address lower urinary tract symptoms as measured via patient-reported outcomes (PROs). Minimally invasive surgical therapies (MISTs) offer better erectile or ejaculatory side effects and potentially faster recovery time in comparison to transurethral resection of the prostate (TURP). Premature excitement for MISTs derives from prospective sham-controlled trials with several years of follow-up data. Currently there is a lack of randomized controlled trials that directly compare MISTs to TURP and of a clearer definition of treatment failure. These types of studies are important in comparing efficacy between treatments. In head-to-head comparison, TURP yields the most robust improvement in PROs when compared to MISTs. At best, MISTs may achieve equivalent urological symptom-relief profiles to TURP; however, noninferiority assessments are needed. MISTs are potentially advantageous for their side-effect profiles and lower complication rates, but consistency in reporting these data is needed. PATIENT SUMMARY: We looked at the current data on patient-reported outcomes after each type of treatment for lower urinary tract symptoms. We found that the efficacy of these procedures is difficult to compare given the lack of direct studies comparing new options to the standard procedure. We can only conclude that the standard procedure, transurethral resection of the prostate, will provide the best relief of voiding symptoms as reported by patients.

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

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

The state of TURP through a historical lens.

In 1926 Maximilian Stern introduced a new instrument to treat obstructions at the vesical orifice and baptized it resectoscope. With reference to astonishing historical statements about the new instrument and surgical technique made by the pioneers and their critics we will value why transurethral resection of the prostate (TURP) remains the gold standard for most men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic enlargement. TURP is currently challenged by recently introduced new instruments and techniques claiming advantages over TURP. However, TURP offers an excellent balance between high efficacy in symptom relieve and low morbidity along with low costs and favorable long term outcome compared to other treatment options. We will outline these arguments demonstrating that even after a century has elapsed, since its introduction into the urologists armamentarium, TURP continues to stand the passage of time.

Rezum therapy for patients with large prostates (≥ 80 g): initial clinical experience and postoperative outcomes.

PURPOSE: Rezum is a minimally invasive surgery for benign prostatic hyperplasia. Current guidelines recommend Rezum for prostates < 80 cc, but little data exist describing outcomes in patients with prostates ≥ 80 cc. We compare outcomes after Rezum between men with small < 80 cc (SP) and large ≥ 80 cc prostates (LP). METHODS: Patients undergoing Rezum between Jan 2017-Feb 2020 were subdivided by prostate volume (< 80, ≥ 80 cc). Outcomes were documented pre- and postoperatively. Descriptive analyses of urodynamics data (Qmax, PVR), symptom scores (AUA-SS, SHIM), disease management (medications, catheterization, retreatments), and clinical outcomes were conducted. RESULTS: 36 (17.6%) men had prostates ≥ 80 cc (LP mean prostate size 106.8 cc). LP men had improved Qmax and PVR postoperatively; those with longitudinal follow-up exhibited improved Qmax, PVR, and AUA-SS. After one year, alpha-blocker usage decreased significantly (LP 94.44-61.11%, p = 0.001, SP 73.96-46.15%, p = 0.001); other medication usage and self-catheterization rates remained unchanged. Compared to SP patients, differences in passing trial void (LP 94.44%, SP 93.45%), postoperative UTI (LP 19.44%, SP 10.12%), ED visits (LP 22.22%, SP 17.86%), readmissions (LP 8.33%, SP 4.76%), and retreatment (LP 8.33%, SP 4.76%) were insignificant. However, mean days to foley removal (LP 9, SP 5.71, p = 0.003) and urosepsis rates (LP 5.56%, SP 0.00%, p = 0.002) differed. CONCLUSION: In select LP patients, Rezum provided short-term symptomatic relief and improved voiding function comparable to SP patients. Postoperatively, though alpha-blocker usage decreased significantly, use of other medications did not change, and nearly two-thirds of patients still needed alpha-blockade. Further efforts should explore the possibility of expanding Rezum's inclusion criteria.

Ejaculatory Hood-Sparing Photoselective Vaporization of the Prostate vs Bipolar Button Plasma Vaporization of the Prostate in the Surgical Management of Benign Prostatic Hyperplasia.

Introduction and Objectives: After transurethral prostatectomy, erectile dysfunction and ejaculatory dysfunction are significant concerns for patients. We compared ejaculatory hood-sparing technique in patients who underwent photoselective vaporization of the prostate using the GreenLight Laser (EjS-PVP) with the ejaculatory hood-sparing technique in patients who underwent bipolar button plasma vaporization of the prostate (EjS-BPVP) in the surgical management of benign prostatic hyperplasia (BPH). Materials and Methods: Twenty-seven patients were randomized to either undergo EjS-PVP or EjS-BPVP from August 2016 to March 2018. All of the patients were sexually active with antegrade ejaculation before prostatectomy. We evaluated International Prostate Symptom Score (IPSS), quality of life (QoL), peak flow rate (Qmax), postvoid residual volume (PVR), International Index of Erectile Function and ejaculatory function by the Male Sexual Health Questionnaire (MSHQ). Men were evaluated preoperatively and at 1, 3, and 6 months postoperatively. The primary outcome was ejaculation preservation measured as no change or preservation in antegrade ejaculate at the last follow-up visit by MSHQ (6 months). Results: Twenty-seven patients with a mean age of 65.6 ± 8.4 years underwent either EjS-BPVP or EjS-PVP (Table 1). There were no differences in baseline characteristics between the two groups. Improvements in IPSS, QoL, Qmax, and PVR were durable throughout the study period in both groups. There was no difference in outcomes between groups. Postoperatively, there was no change in ejaculatory function with EjS-BPVP utilizing either 180 W EjS-PVP or bipolar energy. The change in MSHQ Ejaculation Scale was -2.1 and -5.4 at 6 months in both arms. The 6-month ejaculatory preservation rate was 85% in the EjS-PVP group and 78% in the EjS-BPVP group. Conclusions: EjS GreenLight photoselective vaporization and bipolar plasma button vaporization is a safe and effective method for treating men with lower urinary tract symptoms secondary to BPH with maintenance of antegrade ejaculation.