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

June 14, 2023 updated by: PROCEPT BioRobotics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • New Zealand
      • Tauranga, New Zealand, 3112
        • Tauranga Urology Research Ltd.
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Treatment Center
    • Surrey
      • Frimley, Surrey, United Kingdom, GU16 7UJ
        • Frimley Park Hospital
    • Wales
      • Bridgend, Wales, United Kingdom, CF31 1RQ
        • Princess of Wales Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Urology Centers of Alabama
    • California
      • La Mesa, California, United States, 91942
        • San Diego Clinical Trials
      • Los Angeles, California, United States, 90089
        • University of Southern California, Institute of Urology
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Urology Associates, P.C.
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Adult & Pediatric Urology P.C.
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine
    • Texas
      • Dallas, Texas, United States, 75390-9110
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Houston Metro Urology
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont College of Medicine
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
AQUABEAM System
Device: AQUABEAM System
The AQUABEAM system, a personalized image-guided tissue removal system, utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue.
Active Comparator: Active Comparator
Transurethral Resection of the Prostate (TURP)
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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. Results are presented as a percentage rounded to the whole number.
Three months post-treatment
Change 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.
Six months post-treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Long-term Effectiveness as Measured by International Prostate Symptom Score (IPSS) at 60 Months
Time Frame: 60 months following original surgical intervention
Change score of International Prostate Symptom Score (IPSS) at 60 months as compared to baseline. Score range is from 0 to 35, with a low score associated with more favorable outcomes. Change score is calculated from two time points as the value at the 60 months point minus the value at the baseline.
60 months following original surgical intervention
International Prostate Symptom Score (IPSS) at 60 Months
Time Frame: 60 months following original surgical intervention
International Prostate Symptom Score (IPSS) at 60 months. Score range is from 0 to 35, with a low score associated with more favorable outcomes.
60 months following original surgical intervention
International Prostate Symptom Score Quality of Life (IPSS-QoL) at 60 Months
Time Frame: 60 months following original surgical intervention
International Prostate Symptom Score Quality of Life (IPSS-QoL) sub-score. Score range is from 0 to 6, with a low score associated with more favorable outcomes.
60 months following original surgical intervention
Change in Maximum Urinary Flow Rate (Qmax) at 60 Months From Baseline
Time Frame: 60 months following original surgical intervention
Change in Uroflowmetry measurement of voided urine (in milliliters) per unit of time (in seconds) at 60 Months from Baseline. Change score is calculated from two time points as the value at the 60 months point minus the value at the baseline.
60 months following original surgical intervention
Change in Post-void Residual (PVR) at 60 Months From Baseline
Time Frame: 60 months following original surgical intervention
Change in Post-void residual (PVR) urine test at 60 Months from Baseline. Change score is calculated from two time points as the value at the 60 months point minus the value at the baseline.
60 months following original surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PROCEPT BioRobotics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Gilling, M.D., Urology BOP
  • Principal Investigator: Claus Roehrborn, M.D., UT Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TP0038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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