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

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ClinicalTrials.gov Identifier: NCT02505919

Recruitment Status : Completed

First Posted : July 22, 2015

Results First Posted : April 8, 2020

Last Update Posted : April 8, 2020

Sponsor:

Information provided by (Responsible Party):

PROCEPT BioRobotics

Tracking Information

First Submitted Date ^ICMJE

July 21, 2015

First Posted Date ^ICMJE

July 22, 2015

Results First Submitted Date ^ICMJE

March 13, 2020

Results First Posted Date ^ICMJE

April 8, 2020

Last Update Posted Date

April 8, 2020

Actual Study Start Date ^ICMJE

November 21, 2015

Actual Primary Completion Date

July 14, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability) [ Time Frame: Three months post-treatment ]
The primary safety endpoint is the proportion of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment. Note that the Clavien-Dindo classification scheme is for grading postoperative complications not events that reflect lack of effective treatment.
Score of IPSS Questionnaire Between Baseline and 6 Months [ Time Frame: Six months post-treatment ]
The primary effectiveness endpoint is the IPSS change score from baseline to 6 months. International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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 will be measured at 3 and 6 months, respectively, and subjects will be followed out to 3 years to collect long-term clinical data.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

All study subjects are blinded to the assigned treatment until study exit. One of the investigational site teams is blinded to the randomization assignment as well.

Primary Purpose: Treatment

Condition ^ICMJE

Benign Prostatic Hyperplasia (BPH)

Intervention ^ICMJE

Device: AQUABEAM System
To utilizes proprietary heat-free high-pressure waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
Procedure: Transurethral Resection of the Prostate (TURP)
Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)

Study Arms ^ICMJE

Experimental: Treatment
AQUABEAM System

Intervention: Device: AQUABEAM System
Active Comparator: Control
Transurethral Resection of the Prostate (TURP)

Intervention: Procedure: Transurethral Resection of the Prostate (TURP)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

184

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

December 19, 2019

Actual Primary Completion Date

July 14, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.
Subject has medical record documentation of a prostate volume between 30mL and 80mL (inclusive) by transrectal ultrasound (TRUS). (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is between 30mL and 80mL, it may be used for the inclusion/exclusion criteria.)
Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit.
Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15mL/s. (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 125mL, and the Qmax is less than 15mL/s it may be used for the inclusion/exclusion criteria.)
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.

Exclusion Criteria:

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.
Ever been diagnosed with a urethral stricture, meatal stenosis, or bladder neck contracture.
Subject has damage to external urinary sphincter .
Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use.
Post-Void Residual (PVR) > 300 mL.
Urinary retention at time of enrollment or subject has been catheterized in the 14 days prior to the surgical procedure.
Subject has a history of intermittent self-catheterization.
Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
Subjects on anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d).
Any severe illness that would prevent complete study participation or confound study results.
Participants using systematic immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents (Nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than or equal to 100mg).
Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
Contraindication to general or spinal anesthesia.
Subject has any other disease or condition(s) that would interfere with completion of the study and follow up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes.
Subject is unwilling to accept a transfusion should one be required.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

Male

Ages ^ICMJE

45 Years to 80 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, New Zealand, United Kingdom, United States

Removed Location Countries

Germany

Administrative Information

NCT Number ^ICMJE

NCT02505919

Other Study ID Numbers ^ICMJE

TP0038

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

PROCEPT BioRobotics

Study Sponsor ^ICMJE

PROCEPT BioRobotics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Peter Gilling, M.D.	Urology BOP
Principal Investigator:	Claus Roehrborn, M.D.	UT Southwestern Medical Center

PRS Account

PROCEPT BioRobotics

Verification Date

April 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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