Plenary: Next Frontier, Sunday

Plenary: Next Frontier

PNFLBA-03: Late-Breaking Abstract - The WATER Study Clinical Results – A Phase III blinded randomized parallel group trial of Aquablation vs. Transurethral Resection of the Prostate with Blinded Outcome Assessment for Moderate-to-Severe LUTS in men with Benign Prostatic Hyperplasia

Sunday, May 14
1:05 PM - 1:10 PM
Location: BCEC: Ballroom East

Presentation Authors: Claus Roehrborn*, Dallas, TX, Peter Gilling, Tauranga, New Zealand

Introduction and Objective
Prostate resection for patients with LUTS remains the gold standard for surgical treatment of BPH.
A prospective single-arm multicenter trial at 3 centers in Australia and New Zealand with 1-year follow-up on 21 men with a similar profile to WATER patients has been previously presented. The prostate volume dropped from 57 ml at baseline to 35 ml (P<0.0001), mean IPSS score improved from 23.0 at baseline to 6.8 at 12 months (P<0.0001), and maximum urinary flow increased from 8.7 mL/sec to 18.3 mL/sec (P<0.0001) in that study. There were no serious perioperative adverse events. No subject developed urinary incontinence and sexual function was preserved postoperatively.

We aimed to compare the safety and efficacy of prostate ablation using a high-pressure waterjet (A) vs. mono- or bipolar electrocautery resection (T).


Methods
In this randomized, blinded, multicenter phase III trial, men with moderate-to-severe LUTS related to BPH were assigned to transurethral resection of the prostate using either standard electrosurgery (TURP) or robotically-assisted waterjet ablation (Aquablation). The patients were blinded to treatment along with the outcome assessment and follow-up conducted by a surgeon different from the operating surgeon to assure blinded evaluation.

The trial has a co-primary safety and efficacy endpoint designed to show non-inferiority regarding efficacy. With a minimum enrollment of 177, the estimated power for safety was 99% and efficacy was 80%.

The primary safety endpoint was the occurrence of Clavien-Dindo Grade 1 (persistent ejaculatory dysfunction, erectile dysfunction, or urinary incontinence) or Grade 2 or higher operative complications at 3 months. The primary efficacy endpoint was the reduction IPSS score at 6 months.


Results
The geographic enrollment from the International and US sites was 91 and 93 subjects, respectively. The mean baseline IPSS score (T: 22.2 vs. A: 22.9, p=0.43), demographic profile (Table 1), and mean prostate volume (T: 52 mL vs. A: 54 mL, p=0.31) were similar in both arms. Mean operative time was equivalent between the two groups (T: 35.5 vs. A:32.8 minutes, p=0.28), but mean resection time was significantly lower in the Aquablation group (28 vs. 4 minutes, p<.0001). The relationship between resection time and prostate size was 8x larger in the TURP group versus Aquablation (0.32 vs. 0.04 min/mL). The length of hospital stay and subset by geography was similar for both arms, a mean of 1.4 days. At 3 months, Qmax significantly improved in both groups (T: 9.1 ± 2.7 to 20.1 ± 11.4 vs. A: 9.4 ± 3.0 to 20.9 ± 13.4, p=NS).


Conclusions
Preliminary analyses demonstrate equal efficacy of Aquablation vs TURP while ablation time was significantly shorter for aquablation.


Source of Funding
WATER was sponsored by PROCEPT BioRobotics. (NCT02505919).


Keywords
Benign prostatic hyperplasia, transurethral resection, lower urinary tract symptoms, robotic, Aquablation


Table 1


Claus G. Roehrborn, MD

UT Southwestern Medical Center

Brief Biographical Sketch

Claus G. Roehrborn, MD
Professor and Chairman, Department of Urology
University of Texas Southwestern Medical Center
Dallas, Texas

Claus G. Roehrborn, MD, was born and raised in West Germany. After attending medical school in Giessen, Germany, he began his residency in surgery and urology at the German Army Hospital in Giessen. In 1984, he came to Dallas, Texas, and continued his urology residency at The University of Texas Southwestern Medical Center at Dallas. After finishing his residency in 1989 he won an American Foundation of Urologic Disease Scholarship and worked for 2 years with Dr. Jean Wilson in the field of androgen regulation of prostate development and growth. In 1992, he joined the urology faculty at University of Texas Southwestern, where he currently is Professor and Chairman of the Department of Urology.

His clinical activities focus on benign and malignant prostate diseases and he has performed nearly 2,000 robotic prostatectomies and several thousand minimally invasive and surgical/laser treatments for BPH. He recently helped to develop the UTSW MRI TRUS fusion program and has performed approximately 500 of such procedures

Dr. Roehrborn’s research interests are in the areas of benign and malignant prostate diseases, including medical and minimally invasive therapies for BPH, and markers for prostate cancer. His basic, translational and clinical research has yielded over 450 peer-reviewed publications, more than 30 book chapters, and numerous other contributions to the literature.

Dr. Roehrborn has been the lead researcher for the 1994 Agency for Health Care Policy and Research (AHCPR) BPH Guidelines and has been involved in the American Urological Association (AUA) Guidelines efforts from their inception. He has chaired committees at the WHO-sponsored Consensus Conferences on BPH from 1994 through 2005, and is cochairman of the AUA BPH Guidelines Committee.



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Assets

PNFLBA-03: Late-Breaking Abstract - The WATER Study Clinical Results – A Phase III blinded randomized parallel group trial of Aquablation vs. Transurethral Resection of the Prostate with Blinded Outcome Assessment for Moderate-to-Severe LUTS in men with Benign Prostatic Hyperplasia



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