Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)
NCT ID: NCT02505919
Last Updated: 2023-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
184 participants
INTERVENTIONAL
2015-10-30
2021-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
AQUABEAM System
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
Transurethral Resection of the Prostate (TURP)
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)
Interventions
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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.
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)
Eligibility Criteria
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Inclusion Criteria
* Age from 45 to 80 years.
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.
* 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.
45 Years
80 Years
MALE
No
Sponsors
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PROCEPT BioRobotics
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Gilling, M.D.
Role: PRINCIPAL_INVESTIGATOR
Urology BOP
Claus Roehrborn, M.D.
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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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
University of Vermont College of Medicine
Burlington, Vermont, United States
Virginia Urology
Richmond, Virginia, United States
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Tauranga Urology Research Ltd.
Tauranga, , New Zealand
Frimley Park Hospital
Frimley, Surrey, United Kingdom
Princess of Wales Hospital
Bridgend, Wales, United Kingdom
Addenbrooke's Treatment Center
Cambridge, , United Kingdom
Countries
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References
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Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation(R) vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. J Urol. 2018 May;199(5):1252-1261. doi: 10.1016/j.juro.2017.12.065. Epub 2018 Jan 31.
Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Roehrborn C. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes. Urology. 2019 Mar;125:169-173. doi: 10.1016/j.urology.2018.12.002. Epub 2018 Dec 12.
Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. Adv Ther. 2019 Jun;36(6):1326-1336. doi: 10.1007/s12325-019-00952-3. Epub 2019 Apr 26.
Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial. Can J Urol. 2020 Feb;27(1):10072-10079.
Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Kaufman RP Jr, Badlani G, Plante M, Desai M, Doumanian L, Te AE, Roehrborn CG. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022 Feb;29(1):10960-10968.
Pimentel MA, Yassaie O, Gilling P. Urodynamic Outcomes After Aquablation. Urology. 2019 Apr;126:165-170. doi: 10.1016/j.urology.2019.01.020. Epub 2019 Feb 2.
Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc). Adv Ther. 2018 Jun;35(6):832-838. doi: 10.1007/s12325-018-0722-0. Epub 2018 Jun 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TP0038
Identifier Type: -
Identifier Source: org_study_id
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