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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505919
• Other study ID #: TP0038
• Status: Completed
• Phase: N/A
• Start date: October 30, 2015
• Est. completion date: December 16, 2021

Study information

• Verified date: June 2023
• Source: PROCEPT BioRobotics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 16, 2021
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

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)

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Melbourne	Victoria
New Zealand	Tauranga Urology Research Ltd.	Tauranga
United Kingdom	Princess of Wales Hospital	Bridgend	Wales
United Kingdom	Addenbrooke's Treatment Center	Cambridge
United Kingdom	Frimley Park Hospital	Frimley	Surrey
United States	Albany Medical College	Albany	New York
United States	Urology Centers of Alabama	Birmingham	Alabama
United States	University of Vermont College of Medicine	Burlington	Vermont
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Urology Associates, P.C.	Englewood	Colorado
United States	Houston Metro Urology	Houston	Texas
United States	San Diego Clinical Trials	La Mesa	California
United States	University of Southern California, Institute of Urology	Los Angeles	California
United States	Weill Cornell Medical College	New York	New York
United States	Adult & Pediatric Urology P.C.	Omaha	Nebraska
United States	Virginia Urology	Richmond	Virginia
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
PROCEPT BioRobotics

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  United Kingdom, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long-term Effectiveness as Measured by International Prostate Symptom Score (IPSS) at 60 Months	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
Other	International Prostate Symptom Score (IPSS) at 60 Months	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
Other	International Prostate Symptom Score Quality of Life (IPSS-QoL) at 60 Months	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
Other	Change in Maximum Urinary Flow Rate (Qmax) at 60 Months From Baseline	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
Other	Change in Post-void Residual (PVR) at 60 Months From Baseline	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
Primary	Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)	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
Primary	Change Score of IPSS Questionnaire Between Baseline and 6 Months	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