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

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ClinicalTrials.gov Identifier: NCT02505919
Recruitment Status : Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
PROCEPT BioRobotics

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia (BPH) Device: AQUABEAM System Procedure: Transurethral Resection of the Prostate (TURP) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
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
Official Title: A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS
Actual Study Start Date : November 21, 2015
Actual Primary Completion Date : July 14, 2017
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
AQUABEAM System
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.

Active Comparator: Control
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)




Primary Outcome Measures :
  1. Safety: Adverse Events Comparisons using Clavien-Dindo Grading System [ 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.

  2. Efficacy: Comparisons of IPSS [ Time Frame: Six months post-treatment ]
    The primary effectiveness endpoint is the IPSS change score from baseline to 6 months.



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 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:

  • 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 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.
  • 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 (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.
  • 31. Subject is unwilling to accept a transfusion should one be required.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505919


Locations
United States, Alabama
Urology Centers of Alabama
Birmingham, Alabama, United States, 35209
United States, California
University of Southern California, Institute of Urology
Los Angeles, California, United States, 90089
San Diego Clinical Trials
San Diego, California, United States, 92120
United States, Colorado
Urology Associates, P.C.
Englewood, Colorado, United States, 80113
United States, Nebraska
Adult & Pediatric Urology P.C.
Omaha, Nebraska, United States, 68114
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9110
Houston Metro Urology
Houston, Texas, United States, 77030
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05401
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
New Zealand
Urology BOP
Tauranga, New Zealand, 3112
United Kingdom
Frimley Park Hospital
Frimley, Surrey, United Kingdom, GU16 7UJ
Princess of Wales Hospital
Bridgend, Wales, United Kingdom, CF31 1RQ
Addenbrooke's Treatment Center
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
PROCEPT BioRobotics
Investigators
Principal Investigator: Peter Gilling, M.D. Urology BOP
Principal Investigator: Claus Roehrborn, M.D. UT Southwestern Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PROCEPT BioRobotics
ClinicalTrials.gov Identifier: NCT02505919     History of Changes
Other Study ID Numbers: TP0038
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Keywords provided by PROCEPT BioRobotics:
Lower Urinary Tract Symptoms (LUTS)

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male