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Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) | Clinical Trials | Clareo Health

COMPLETEDNA

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)

A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS

NCT02505919•PROCEPT BioRobotics

View on ClinicalTrials.gov

Summary

A prospective multicenter randomized blinded study comparing Aquablation of the prostate with the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The primary endpoints for safety and effectiveness were measured at 3 and 6 months, respectively, and subjects were followed out to 5 years to collect long-term clinical data.

Eligibility

Age

45 - 80 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
•Age from 45 to 80 years.

Exclusion Criteria

•Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit.
•Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured ≤ 30 days prior to the date of surgery.
•History of inadequate response, contraindication, or refusal to medical therapy.
•Body Mass Index (BMI) ≥ 42.
•History of prostate cancer or current/suspected bladder cancer.
•Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds.
•Subjects with a history of actively treated bladder cancer within the past two (2) years.
•Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size \>20% of full bladder size).
•Active infection, including urinary tract infection.
•Prostatitis treated with antibiotics within 1 year of enrollment.
+14 more criteria

Locations (17)

Urology Centers of Alabama

Birmingham, Alabama, United States

San Diego Clinical Trials

La Mesa, California, United States

University of Southern California, Institute of Urology

Los Angeles, California, United States

Urology Associates, P.C.

Englewood, Colorado, United States

Adult & Pediatric Urology P.C.

Omaha, Nebraska, United States

Albany Medical College

Albany, New York, United States

Weill Cornell Medical College

New York, New York, United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Houston Metro Urology

Houston, Texas, United States

Key Dates

Start Date

October 30, 2015

Primary Completion Date

July 14, 2017

Completion Date

December 16, 2021

Last Updated

July 3, 2023

Enrollment

184

ACTUAL participants

Conditions

Benign Prostatic Hyperplasia (BPH)

Interventions

AQUABEAM System

DEVICE

Transurethral Resection of the Prostate (TURP)

PROCEDURE

Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia

NCT07016620

Benign Prostatic Hyperplasia (BPH)

View study

RECRUITINGNA

Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging

NCT06817733

Benign Prostatic Hyperplasia (BPH)

View study

COMPLETEDNA

Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)

NCT02026908

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)

Inclusion Criteria

Exclusion Criteria

Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia

Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging

Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)

Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate

Study of Median Lobe Prostatic UroLift Procedure