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 Treatment for Benign Prostate Hyperplasia: Current Standardized Procedure.

The following video Atlas summary reviews all technical elements of the standardized setup, robotic execution, aquablation procedure, and hemostasis for efficient rapid benign prostate hyperplasia treatment.

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.

Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH.

INTRODUCTION: To determine if Aquablation therapy can maintain long term effectiveness in treating men with moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with a baseline prostate volume between 30 and 80 mL at 5 years compared to TURP. MATERIALS AND METHODS: In a double-blinded, multicenter prospective randomized controlled trial, 181 patients with moderate to severe LUTS secondary to BPH underwent TURP or Aquablation. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent Grade 1 or Grade 2 or higher operative complications at 3 months. The assessments included IPSS, Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF) and uroflow (Qmax). The patients were followed for 5 years. RESULTS: The primary safety endpoint was successfully achieved at 3 months where the Aquablation group had a lower event rate than TURP (26% vs. 42%, p = .0149 for superiority). Procedure-related ejaculatory dysfunction was lower for Aquablation (7% vs. 25%, p = .0004). The primary efficacy endpoint was successfully achieved at 6 months, where the mean IPSS decreased from baseline by 16.9 points for Aquablation and 15.1 points for TURP; the mean difference in change score at 6 months was 1.8 points larger for Aquablation (p < .0001 for non-inferiority, p = .1346 for superiority). At 5 years, IPSS scores improved by 15.1 points in the Aquablation group and 13.2 points in TURP (p = .2764). However, for men with larger prostates (≥ 50 mL), IPSS reduction was 3.5 points greater across all follow up visits in the Aquablation group compared to the TURP group (p = .0123). Improvement in peak urinary flow rate was 125% and 89% compared to baseline for Aquablation and TURP, respectively. The risk of patients needing a secondary BPH therapy, defined as needing BPH medication or surgical intervention, up to 5 years due to recurrent LUTS was 51% less in the Aquablation arm compared to the TURP arm. CONCLUSIONS: The improvement in net health outcomes from Aquablation therapy outweigh those offered by a TURP when considering the efficacy benefit along with the lower risk of needing a secondary BPH therapy and avoiding retrograde ejaculation. Following Aquablation therapy, symptom reduction and uroflow improvement at 5 years have shown to be durable and consistent across all years of follow up compared to TURP. Larger prostates (≥ 50 mL) demonstrated a larger safety and efficacy benefit for Aquablation over TURP.

Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial.

INTRODUCTION: To compare 3-year efficacy and safety after prostate resection with Aquablation therapy or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostate hyperplasia (BPH). MATERIALS AND METHODS: One hundred and eighty-one patients assigned to either Aquablation therapy or TURP were followed for 3 years postoperatively. Patients and follow up assessors were blinded to treatment. Assessments included International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire (MSHQ-EjD), International Index of Erectile Function (IIEF) and uroflow. RESULTS: Over 3 years of treatment, improvements in IPSS scores were statistically similar across groups. Mean 3-year improvements were 14.4 and 13.9 points in the Aquablation and TURP groups, respectively (difference of 0.6 points, 95% CI -3.3-2.2, p = .6848). Similarly, 3-year improvements in Qmax were 11.6 and 8.2 cc/sec (difference of 3.3 [95% CI -0.5-7.1] cc/sec, p = .0848). At 3 years, PSA was reduced significantly in both groups by 0.9 and 1.1 ng/mL, respectively; the reduction was similar across groups (p = .5983). There were no surgical retreatments for BPH beyond 20 months for either Aquablation or TURP. CONCLUSIONS: Three-year BPH symptom reduction and urinary flow rate improvement were similar after TURP and Aquablation therapy. No subjects required surgical retreatment beyond 20 months postoperatively. (ClinicalTrials.gov number, NCT02505919).

Prostatic hydroablation (Aquablation): A new effective ultrasound guided robotic waterjet ablative surgery for treatment of benign prostatic hyperplasia.

INTRODUCTION: Bothersome lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) are increasingly common amongst ageing men leading to poor quality of life. Surgical treatment options targeted at the obstructing prostate are often required to relief the bladder outlet obstruction, following failure or discontinuation of medical therapies. Transurethral resection of the prostate (TURP) has been the mainstay and gold standard for benign prostate surgery for last few decades. Currently with technological advancements, numerous minimally invasive surgical therapies have been employed to provide effective symptom relief while minimalizing morbidities and preserving sexual function. Prostatic hydroablation (Aquablation) is a new technique which involves high velocity water jets used in non-thermal ablation of the obstructing prostatic tissue robotically delivered by a transurethral cystoscopic handpiece and guided by real time transrectal ultrasound imaging. Recent trials have shown that aquablation is safe and effective in the treatment of symptomatic BPH while maintaining sexual preservation. METHOD: Aquablation using the Aquabeam system (PROCEPT BioRobotics, Redwood Shores, CA, USA) combines the precision of autonomous robotic execution in delivering high velocity waterjets via a cystoscopic handpiece with accurate anatomical prostatic mapping using real time transrectal ultrasound imaging. The initial part of the surgery involves careful treatment planning tailored to the prostatic anatomy with preservation of important landmarks nearby, then, high velocity waterjet streams are delivered to ablate the obstructing prostatic tissue without use of any heat. Following the ablation and removal of handpiece, a routine cystoscopic bladder washout is performed and haemostasis achieved with balloon tamponade from a 3 way catheter placed under tension empolying a custom designed catheter tensioning device. RESULTS: Initial studies involving a few case series and a phase II trial demonstrated the safety and effectiveness of aquablation in treatment of symptomatic BPH. Subsequently, a large multicentre international prospective randomised blinded clinical trial (WATER) was conducted to assess the efficacy of aquablation versus TURP. Results from this pivotal trial showed non-inferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. WATER II study was then conducted to assess the safety and feasibility from a multicentre prospective study of aquablation in the treatment of symptomatic large-volume BPH. The results from this study showed that aquablation is feasible and safe in treating men with men with large prostates (80-150 mL). CONCLUSION: The current landscape of BPH surgical treatment should be individualized with a shared decision- making process based on prostatic anatomy and clinical parameters combined with patient's preferences to select the ideal treatment option for each patient. Aquablation is one such option that involves a robotically delivered hydroablation technique based on individualised real time ultrasonic prostatic mapping that can offer safe and effective treatment for symptomatic BPH while minimising sexual dysfunction. Larger trials with longer follow up data will be required to further validate the long term effectiveness of aquablation.

INTRODUCCIÓN: Los molestos síntomas del tracto urinario inferior secundarios a hiperplasia benigna de próstata son cada vez más frecuentes entre los varones, con el envejecimiento, y conllevan una pobre calidad de vida. Con frecuencia, son necesarias diferentes opciones de tratamiento quirúrgico dirigidas a la próstata obstructiva para mejorar la obstrucción del vaciado vesical. La resección transuretral de próstata ha sido el pilar y patrón de referencia de la cirugía de la próstata benigna durante las últimas décadas. Actualmente, con los avances tecnológicos, se han utilizado numerosos tratamientos quirúrgicos mínimamente invasivos para obtener un alivio sintomático y a la vez minimizar la morbilidad y conservar la función sexual. La hidroablación prostática (Aquablation) es una técnica nueva que implica utilizar chorros de agua de alta velocidad para la ablación no térmica del tejido prostático obstructivo administrados robóticamente mediante un cistoscopio y guiados por ecografía transrectal en tiempo real. Los ensayos clínicos recientes han mostrado que aquablation es seguro y efectivo en el tratameinto de la HBP sintomática, a la vez que mantiene la conservación de la potencia sexual. MÉTODOS: Aquablation utiliza el sistema Aquabeam (PROCEPT BioRobotics, Redwood Shores, CA, USA) y combina la precisión de la ejecución robotizada autónoma para aplicar chorros de agua de alta velocidad mediante un cistoscopio con el mapeo anatómico prostático preciso utilizando ecografía transrectal en tiempo real. La parte inicial de la cirugía implica una planificación cuidadosa ajustada a la anatomía prostática con conservación de las referencias anatómicas cercanas, y después, se aplican chorros de agua de alta velocidad para la ablación del tejido prostático obstructivo sin utilizar nada de calor. Después de la ablación y extracción de la vaina del cistoscopio se procede a un lavado vesical mediante cistoscopia de rutina y la hemostasia se consigue con taponamiento mediante balón utilizando una sonda de 3 vías colocado mediante tracción utilizando un aparato de tracción de diseñado a medida.RESULTADOS: Los estudios iniciales incluyendo unas pocas series y un ensayo clínico fase II demostraron la seguridad y efectividad de aquablation en el tratamiento de la HBP sintomática. Posteriormente, se llevó a cabo un estudio prospectivo, aleatorizado ciego, multicéntrico e internacional (WATER) para evaluar la eficacia de aquablation frente a RTUP. Los resultados de este ensayo clínico primordial mostraban una mejoría de los síntomas no inferior en comparación con la resección transuretral, pero con un riesgo de disfunción sexual menor. Después, se hizo el estudio WATER II para evaluar seguridad y factibilidad, en un ensayo prospectivo, multicéntrico de aquablation en el tratamiento de HBP sintomática con próstatas grandes. Los resultados de este estudio mostraron que aquablation es factible y seguro en el tratamiento de varones con próstatas grandes (80-150 mL).CONCLUSION: El panorama actual del tratamiento quirúrgico de la HBP debe ser individualizado, con un proceso de toma de decisiones compartido basado en la anatomía prostática y parámetros clínicos combinados con las preferencias del paciente para seleccionar el tratamiento ideal para cada paciente. Aquablation es una de las opciones que consiste en una técnica de hidroablación aplicada mediante robot, basándose en un mapeo prostático ecográfico en tiempo real, que puede ofrecer un tratamiento efectivo y seguro de la HBP sintomática minimizando la disfunción sexual. Serán necesarios ensayos clínicos más grandes, con seguimientos más largos, para validar aún más la efectividad de aquablation a largo plazo.

Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained.

INTRODUCTION: To compare 2-year safety and efficacy outcomes after Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostate hyperplasia (BPH). METHODS: One hundred eighty-one patients with BPH were assigned at random (2:1 ratio) to either Aquablation or TURP. Patients and follow-up assessors were blinded to treatment. Assessments included the International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function and uroflow. The focus of analysis was 2-year outcomes. RESULTS: At 2 years, IPSS scores improved by 14.7 points in the Aquablation group and 14.9 points in TURP (p = .8304, 95% CI for difference - 2.1 to 2.6 points). Two-year improvements in maximum flow rate (Qmax) were large in both groups at 11.2 and 8.6 cc/s for Aquablation and TURP, respectively (p = 0.1880, 95% CI for difference - 1.3 to 6.4). Sexual function as assessed by MSHQ was stable in the Aquablation group and decreased slightly in the TURP group. At 2 years, PSA was reduced significantly in both groups by 0.7 and 1.2 points, respectively; the reduction was similar across groups (p = 0.1816). Surgical retreatment rates after 12 months for Aquablation were 1.7% and 0% for TURP. Over 2 years, surgical BPH retreatment rates were 4.3% and 1.5% (p = 0.4219), respectively. CONCLUSION: Two-year efficacy outcomes after TURP and Aquablation were similar, and the rate of surgical retreatment was low and similar to TURP. TRIAL REGISTRATION: ClinicalTrials.gov no. NCT02505919. FUNDING: PROCEPT BioRobotics.

Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial.

OBJECTIVE: To test the hypothesis that benign prostatic hyperplasia (BPH) robotic surgery with aquablation would have a more pronounced benefit in certain patient subgroups, such as men with more challenging anatomies (e.g. large prostates, large middle lobes) and men with moderate BPH. METHODS: We conducted prespecified and post hoc exploratory subgroup analyses from a double-blind, multicentre prospective randomized controlled trial that compared transurethral resection of the prostate (TURP) using either standard electrocautery vs surgery using robotic waterjet (aquablation) to determine whether certain baseline factors predicted more marked responses after aquablation as compared with TURP. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade ≥2 surgical complications. RESULTS: For men with larger prostates (50-80 g), the mean IPSS reduction was four points greater after aquablation than after TURP (P = 0.001), a larger difference than the overall result (1.8 points; P = 0.135). Similarly, the primary safety endpoint difference (20% vs 46% [26% difference]; P = 0.008) was greater for men with large prostate compared with the overall result (26% vs 42% [16% difference]; P = 0.015). Postoperative anejaculation was also less common after aquablation compared with TURP in sexually active men with large prostates (2% vs 41%; P < 0.001) vs the overall results (10% vs 36%; P < 0.001). Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post-void residual urine volume. CONCLUSIONS: In men with moderate-to-severe lower urinary tract symptoms attributable to BPH and larger, more complex prostates, aquablation was associated with both superior symptom score improvements and a superior safety profile, with a significantly lower rate of postoperative anejaculation. The standardized, robotically executed, surgical approach with aquablation may overcome the increased outcome variability in more complex anatomy, resulting in superior symptom score reduction.

Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes.

OBJECTIVE: To report 1-year safety and efficacy outcomes after either Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) METHODS: This double-blinded, multicenter prospective randomized controlled trial assigned 181 patients with BPH-related moderate-to-severe lower urinary tract symptoms to either electrocautery-based prostate resection (TURP) or Aquablation. Efficacy endpoints included reduction in International Prostate Symptom Score and improvement in uroflow parameters. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher complications. RESULTS: BPH symptom score improvements were similar across groups with 12-month reduction of 15.1 points after TURP or Aquablation. In both groups, mean maximum urinary flow rates increased markedly postoperatively, with mean improvements of 10.3 cc/s for Aquablation versus 10.6 cc/s for TURP (P = .8632). At 1 year, Prostate-specific antigen (PSA) was reduced significantly (P < .01) in both groups by 1 point; the reduction was similar across groups (P = .9125). Surgical retreatment for BPH rates for TURP were 1.5% and Aquablation 2.6% within 1 year from the study procedure (P = not significant (NS)). The rate of late complications was low, with no procedure-related adverse events after month 6. CONCLUSION: The 1-year outcomes after TURP and Aquablation were similar and the rate of late procedure-related complications was low. (ClinicalTrials.gov number, NCT02505919).

WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia.

PURPOSE: We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. MATERIALS AND METHODS: In a double-blind, multicenter, prospective, randomized, controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwent transurethral prostate resection or Aquablation. The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months. The primary safety end point was the development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications. RESULTS: Mean total operative time was similar for Aquablation and transurethral prostate resection (33 vs 36 minutes, p = 0.2752) but resection time was lower for Aquablation (4 vs 27 minutes, p <0.0001). At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I-PSS improvements. The prespecified study noninferiority hypothesis was satisfied (p <0.0001). Of the patients who underwent Aquablation and transurethral prostate resection 26% and 42%, respectively, experienced a primary safety end point, which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority (p = 0.0149). Among sexually active men the rate of anejaculation was lower in those treated with Aquablation (10% vs 36%, p = 0.0003). CONCLUSIONS: Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. Larger prostates (50 to 80 ml) demonstrated a more pronounced superior safety and efficacy benefit. Longer term followup would help assess the clinical value of Aquablation.

Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study.

OBJECTIVES: To compare prostatic urethral lift (PUL) with transurethral resection of the prostate (TURP) with regard to symptoms, recovery experience, sexual function, continence, safety, quality of life, sleep and overall patient perception. PATIENTS AND METHODS: A total of 80 patients with lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH) were enrolled in a prospective, randomized, controlled, non-blinded study conducted at 10 European centres. The BPH6 responder endpoint assessed symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation and safety. Additional evaluations of patient perspective, quality of life and sleep were prospectively collected, analysed and presented for the first time. RESULTS: Significant improvements in International Prostate Symptom Score (IPSS), IPSS quality of life (QoL), BPH Impact Index (BPHII), and maximum urinary flow rate (Qmax ) were observed in both arms throughout the 2-year follow up. Change in IPSS and Qmax in the TURP arm were superior to the PUL arm. Improvements in IPSS QoL and BPHII score were not statistically different between the study arms. PUL resulted in superior quality of recovery, ejaculatory function preservation and performance on the composite BPH6 index. Ejaculatory function bother scores did not change significantly in either treatment arm. TURP significantly compromised continence function at 2 weeks and 3 months. Only PUL resulted in statistically significant improvement in sleep. CONCLUSION: PUL was compared to TURP in a randomised, controlled study which further characterized both modalities so that care providers and patients can better understand the net benefit when selecting a treatment option.

Assessment of energy density usage during 180W lithium triborate laser photoselective vaporization of the prostate for benign prostatic hyperplasia. Is there an optimum amount of kilo-Joules per gram of prostate?

OBJECTIVES: To assess the effect of energy density (kJ/mL) applied on adenoma during photoselective vaporization of the prostate (PVP) treatment for benign prostate hyperplasia (BPH) on functional outcomes, prostate-specific antigen (PSA) reduction and complications. PATIENTS AND METHODS: After exclusions, a total of 440 patients who underwent GreenLight (tm) laser XPS-180W lithium triborate PVP for the treatment of BPH were retrospectively reviewed. Data were collected from seven different international centres (Canada, USA, UK and France). Patients were stratified into four energy density groups (kJ/mL) according to intra-operative energy delivered and prostate volume as determined by preoperative transrectal ultrasonography (TRUS): group 1: <3 kJ/mL; group 2: 3-5 kJ/mL; group 3: 5-7 kJ/mL; and group 4: ≥7 kJ/mL. Energy density groups were chosen arbitrarily. PSA reduction and functional outcomes (International Prostate Symptom Score, quality of life, post-void residual urine volume, maximum urinary flow rate) were compared at 6, 12 and 24 months. Peri-operative complications and retreatment rates were also compared among the groups. RESULTS: The PSA reduction rates at 24 months after the procedure were 51, 61, 79 and 83% for the energy density groups <3, 3-5, 5-7 and ≥7 kJ/mL, respectively (P ≤ 0.01). This held true after accounting for baseline confounders. Energy density was not associated with higher complication rates, including haematuria, stricture formation, incontinence, refractory urinary retention, urinary tract infection and conversion to transurethral resection of the prostate. Functional outcomes at 2 years of follow-up were equivalent among the groups (P > 0.05 for all) and similar retreatment rates were observed (P = 0.36). CONCLUSION: Higher energy usage per cc of prostate was associated with a more significant reduction in PSA level (>50%) at 6, 12 and 24 months, suggesting increased vaporization of adenoma tissue; however, this did not translate into differences in functional outcomes at 2-year follow-up.

A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study.

BACKGROUND: The GOLIATH study is a 2-yr trial comparing transurethral resection of prostate (TURP) to photoselective vaporization with the GreenLight XPS Laser System (GL-XPS) for the treatment of benign prostatic obstruction (BPO). Noninferiority of GL-XPS to TURP was demonstrated based on a 6-mo follow-up from the study. OBJECTIVE: To determine whether treatment effects observed at 6 mo between GL-XPS and TURP was maintained at the 2-yr follow-up. DESIGN, SETTING, AND PARTICIPANTS: Prospective randomized controlled trial at 29 centers in nine European countries involving 281 patients with BPO. INTERVENTION: Photoselective vaporization using the 180-W GreenLight GL-XPS or conventional (monopolar or bipolar) TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the International Prostate Symptom Score for which a margin of three was used to evaluate the noninferiority of GL-XPS. Secondary outcomes included Qmax, prostate volume, prostate specific antigen, Overactive Bladder Questionnaire Short Form, International Consultation on Incontinence Questionnaire Short Form, occurrence of surgical retreatment, and freedom from complications. RESULTS AND LIMITATIONS: One hundred and thirty-six patients were treated using GL-XPS and 133 using TURP. Noninferiority of GL-XPS on International Prostate Symptom Score, Qmax, and freedom from complications was demonstrated at 6-mo and was sustained at 2-yr. The proportion of patients complication-free through 24-mo was 83.6% GL-XPS versus 78.9% TURP. Reductions in prostate volume and prostate specific antigen were similar in both arms and sustained over the course of the trial. Compared with the 1(st) yr of the study, very few adverse events or retreatments were reported in either arm. Treatment differences in the Overactive Bladder Questionnaire Short Form observed at 12-mo were not statistically significant at 24-mo. A limitation was that patients and treating physicians were not blinded to the therapy. CONCLUSIONS: Twenty-four-mo follow-up data demonstrated that GL-XPS provides a durable surgical option for the treatment of BPO that exhibits efficacy and safety outcomes similar to TURP. PATIENT SUMMARY: The long-term effectiveness and safety of GLP-XLS was similar to conventional TURP for the treatment of prostate enlargement.

The Continuing Story of the Cost-Effectiveness of Photoselective Vaporization of the Prostate versus Transuretheral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Obstruction.

BACKGROUND: In 2008, a UK assessment of technologies for benign prostatic obstruction concluded negatively about photoselective vaporization of the prostate (PVP), and the 2010 National Institute for Health and Care Excellence guidance caused several UK institutions to abandon PVP. OBJECTIVE: To reassess the costs and effects of PVP versus transurethral resection of the prostate (TURP) on the basis of most recent data. METHODS: The same model was used as in 2008. Transition probabilities were estimated using a Bayesian approach updating the 2008 estimates with data from two meta-analyses and data from GOLIATH, the latest and largest trial comparing PVP with TURP. Utility estimates were from the 2008 assessment, and estimates of resource utilization and costs were updated. Effectiveness was measured in quality-adjusted life-years gained, and costs are in UK pounds. The balance between costs and effects was addressed by multivariate sensitivity analysis. RESULTS: If the 2010 National Institute for Health and Care Excellence analysis would have updated the cost-effectiveness analysis with figures from its own meta-analysis, it would have estimated the change in quality-adjusted life-years at -0.01 (95% confidence interval [CI] -0.05 to 0.01) instead of at -0.11 (95% CI -0.31 to -0.01) as in the 2008 analysis. The GOLIATH estimate of -0.01 (95% CI -0.07 to 0.02) strengthens the conclusion of near equivalence. Estimates of additional costs vary from £491 (£21-£1286) in 2008 to £111 (-£315 to £595) for 2010 and to £109 (-£204 to £504) for GOLIATH. PVP becomes cost saving if more than 32% can be carried out as a day case in the United Kingdom. CONCLUSIONS: The available evidence indicates that PVP can be a cost-effective alternative for TURP in a potentially broad group of patients.

Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study.

BACKGROUND: Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral lift (PUL) is a treatment option that may overcome these limitations. OBJECTIVE: To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, controlled trial at 10 European centers involving 80 men with BPH LUTS. INTERVENTION: PUL or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation, and safety. Noninferiority was evaluated using a one-sided lower 95% confidence limit for the difference between PUL and TURP performance. RESULTS AND LIMITATIONS: Preservation of ejaculation and quality of recovery were superior with PUL (p<0.01). Significant symptom relief was achieved in both treatment arms. The study demonstrated not only noninferiority but also superiority of PUL over TURP on the BPH6 endpoint. Study limitations were the small sample size and the inability to blind participants to enrollment arm. CONCLUSIONS: Assessment of individual BPH6 elements revealed that PUL was superior to TURP with respect to quality of recovery and preservation of ejaculatory function. PUL was superior to TURP according to the novel BPH6 responder endpoint, which needs to be validated in future studies. PATIENT SUMMARY: In this study, participants who underwent prostatic urethral lift responded significantly better than those who underwent transurethral resection of the prostate as therapy for benign prostatic hyperplasia with regard to important aspects of quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT01533038.

Photoselective Vaporization of the Prostate for Benign Prostatic Hyperplasia Using the 180 Watt System: Multicenter Study of the Impact of Prostate Size on Safety and Outcomes.

PURPOSE: We evaluated photoselective vaporization of the prostate using the GreenLight™ XPS™ 180 W system for benign prostatic hyperplasia treatment in a large multi-institutional cohort at 2 years. We particularly examined safety, outcomes and the re-treatment rate in larger prostates, defined as a prostate volume of 80 cc or greater, to assess the potential of photoselective vaporization of the prostate as a size independent procedure. MATERIALS AND METHODS: A total of 1,196 patients were treated at 6 international centers in Canada, the United States, France and England. All parameters were collected retrospectively, including complications, I-PSS, maximum urinary flow rate, post-void residual urine, prostate volume, prostate specific antigen and the endoscopic re-intervention rate. Subgroup stratified comparative analysis was performed according to preoperative prostate volume less than 80 vs 80 cc or greater on transrectal ultrasound. RESULTS: Median prostate size was 50 cc in 387 patients and 108 cc in 741 in the prostate volume groups less than 80 and 80 cc or greater, respectively. The rate of conversion to transurethral prostate resection was significantly higher in the 80 cc or greater group than in the less than 80 cc group (8.4% vs 0.6%, p <0.01). I-PSS, quality of life score, maximum urinary flow rate and post-void residual urine were significantly improved compared to baseline at 6, 12 and 24 months of followup without significant differences between the prostate size groups. The re-treatment rate at 2 years reported in 5 of 411 patients was associated with the delivery of decreased energy density (2.1 vs 4.4 kJ/cc) in the group without re-treatment. CONCLUSIONS: Photoselective vaporization of the prostate using the XPS 180 W system is safe and efficacious, providing durable improvement in functional outcomes at 2 years independent of prostate size when treated with sufficient energy.

A European multicenter randomized noninferiority trial comparing 180 W GreenLight XPS laser vaporization and transurethral resection of the prostate for the treatment of benign prostatic obstruction: 12-month results of the GOLIATH study.

PURPOSE: We present the 1-year results of the GOLIATH prospective randomized controlled trial comparing transurethral resection of the prostate to GreenLight XPS for the treatment of men with nonneurogenic lower urinary tract symptoms due to prostate enlargement. The updated results at 1 year show that transurethral resection of the prostate and GreenLight XPS remain equivalent, and confirm the therapeutic durability of both procedures. We also report 1-year followup data from several functional questionnaires (OABq-SF, ICIQ-SF and IIEF-5) and objective assessments. MATERIALS AND METHODS: A total of 291 patients were enrolled at 29 sites in 9 European countries. Patients were randomized 1:1 to undergo GreenLight XPS or transurethral resection of the prostate. The trial was designed to evaluate the hypothesis that GreenLight XPS is noninferior to transurethral resection of the prostate on the International Prostate Symptom Score at 6 months. Several objective parameters were assessed, including maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen, in addition to functional questionnaires and adverse events at each followup. RESULTS: Of the 291 enrolled patients 281 were randomized and 269 received treatment. Noninferiority of GreenLight XPS was maintained at 12 months. Maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen were not statistically different between the treatment arms at 12 months. The complication-free rate at 1 year was 84.6% after GreenLight XPS vs 80.5% after transurethral resection of the prostate. At 12 months 4 patients treated with GreenLight XPS and 4 who underwent transurethral resection of the prostate had unresolved urinary incontinence. CONCLUSIONS: Followup at 1 year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate. The complication-free rates and overall reintervention rates were comparable between the treatment groups.

Effect of lycopene on androgen receptor and prostate-specific antigen velocity / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>There is increasing interest in the role of dietary factors in both the development and behaviour of prostate cancer. This study was carried out to evaluate the impact of the dietary factor lycopene on DNA synthesis, activity and expression of the androgen receptor gene element in prostate LnCaP cells and to report our pilot phase II study investigating its effect on prostate-specific antigen velocity over one year.</p><p><b>METHODS</b>LnCaP cells were grown with or without different concentrations of lycopene or tetrahydrofuran (THF solvent) added to the culture medium for 48 hours. DNA synthesis was measured by the incorporation of bromodeoxyuridine (Brdu) into DNA during a 4-hour pulse, followed by immunostaining and visualization of stained cells using fluorescence microscopy. A transient transfection of a plasmid DNA recombinant containing an androgen receptor element-luciferase (ARE-Luc) report gene into LnCaP cells was developed and the impact of different concentrations of lycopene on the androgen receptor element was reflected by quantitative analysis of the luciferase enzyme function. Expression of the androgen gene was also studied by Western blotting. The phase II pilot study patients (n=41) previously diagnosed with prostate cancer were enrolled and given lycopene supplement, 10 mg per day, and response was measured by observing changes in the plasma prostate-specific antigen (PSA) levels.</p><p><b>RESULTS</b>The addition of 0.5 micromol/L, 5 micromol/L, 10 micromol/L and 15 micromol/L of lycopene was shown to inhibit cell growth by 2.66%, 4.29%, 3.73% and 13.66%, respectively, compared with the THF solvent control samples (P=0.015). As compared with the RPMI1640 medium group, cell proliferation in the presence of 5 micromol/L, 10 micromol/L, and 15 micromol/L lycopene was inhibited by 8.12%, 6.33% and 12.00%, respectively (P=0.024). We showed for the first time that lycopene inhibited the activity of the androgen receptor gene element in a dose-related manner. Inhibition was seen in the transcription of the luciferase construct and confirmed by androgen receptor element expression assayed by Western blotting. Regression slopes of (log) PSA vs. time decreased in 26/37 (70%, 95%CI 53%-84%) of the patients after supplementation and in eight cases (21%) the post-treatment slope was negative. For these eight patients, the average fall in PSA was equivalent to 2% over 28 days (i.e. an average slope/d of -0.000713). The Wilcoxon rank-sum test showed an overall statistically significant decrease in slope (P=0.0007). Analysis of the PSA doubling time (pretreatment vs. posttreatment) showed a median increase after supplementation for 174 days; however, this was not statistically significant (P=0.18).</p><p><b>CONCLUSIONS</b>Lycopene as an antioxidant dietary factor could significantly inhibit DNA synthesis in a dose-dependent pattern; the result revealed lycopene might inhibit androgen receptor gene element activity and expression. Dietary lycopene may play an important role in prostate cancer cell proliferation and further supports a large randomized study into the role of lycopene supplementation in malignant prostate disease.</p>

Photoselective vaporization of the prostate with the potassium-titanyl-phosphate laser in men with prostates of >100 mL.

OBJECTIVES: To assess the efficacy of photoselective vaporization of the prostate (PVP) in men with prostates of >100 mL and causing bladder outlet obstruction (BOO), using the high-power 80 W potassium-titanyl-phosphate laser (GreenLight PV, Laserscope, San Jose, CA, USA), which offers rapid tissue ablation with minimal bleeding. PATIENTS AND METHODS: We assessed 54 consecutive patients with prostates of >100 mL (mean 135, SD 42, range 100-300) who had PVP between May 2003 and August 2005. Evaluations before PVP included urine flowmetry, the International Prostate Symptom Score (IPSS), a quality-of life (QoL) score, prostate-specific antigen (PSA) level, and prostate volume measured by transrectal ultrasonography (TRUS). RESULTS: The mean (SD, range) duration of PVP was 81.6 (22.9, 39-150) min, the mean energy used for PVP was 278 (60, 176-443) kJ and the mean duration of catheterization after PVP was 23.0 (17.1, 0-72) h. The mean (sd) maximum urinary flow rate improved from 8.0 (3.1) to 18.2 (8.1), 18.5 (9.2), 17.9 (7.8) and 19.3 (9.8) mL/s at 3, 6, 12 and 24 months, respectively. The IPSS and QoL scores showed similar improvements, and there was a statistically significant reduction in PSA level and prostate volume after PVP. There was no major complication and no patient had transurethral resection syndrome or a blood transfusion. CONCLUSIONS: The 80 W KTP laser PVP offers rapid tissue ablation in patients with BOO caused by a large prostate. The short- and medium-term outcomes show that this technique can be a viable alternative to open prostatectomy.