Clinical trial NCT02505919: Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)
Official title: A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Lower Urinary Tract Symptoms (LUTS)
Lead sponsor: PROCEPT BioRobotics
Sponsor class: INDUSTRY
First posted: 2015-07-22
Enrollment: 184
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 were measured at 3 and 6 months, respectively, and subjects were followed out to 5 years to collect long-term clinical data.


Eligibility 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 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.

Primary outcomes:
measure: Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)
timeFrame: Three months post-treatment
measure: Change Score of IPSS Questionnaire Between Baseline and 6 Months
timeFrame: Six months post-treatment
Secondary outcomes:
Other outcomes:
measure: Long-term Effectiveness as Measured by International Prostate Symptom Score (IPSS) at 60 Months
timeFrame: 60 months following original surgical intervention
measure: International Prostate Symptom Score (IPSS) at 60 Months
timeFrame: 60 months following original surgical intervention
measure: International Prostate Symptom Score Quality of Life (IPSS-QoL) at 60 Months
timeFrame: 60 months following original surgical intervention
measure: Change in Maximum Urinary Flow Rate (Qmax) at 60 Months From Baseline
timeFrame: 60 months following original surgical intervention
measure: Change in Post-void Residual (PVR) at 60 Months From Baseline
timeFrame: 60 months following original surgical intervention
Locations:
city: Birmingham
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: La Mesa
country: United States
facility: San Diego Clinical Trials
state: California
city: Los Angeles
country: United States
facility: University of Southern California, Institute of Urology
state: California
city: Englewood
country: United States
facility: Urology Associates, P.C.
state: Colorado
city: Omaha
country: United States
facility: Adult & Pediatric Urology P.C.
state: Nebraska
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research Ltd.
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
state: Surrey
city: Bridgend
country: United Kingdom
facility: Princess of Wales Hospital
state: Wales
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Treatment Center
Study officials:
affiliation: Urology BOP
name: Peter Gilling, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern Medical Center
name: Claus Roehrborn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.