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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02505919




Registration number
NCT02505919
Ethics application status
Date submitted
21/07/2015
Date registered
22/07/2015
Date last updated
8/04/2020

Titles & IDs
Public title
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)
Scientific title
A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS
Secondary ID [1] 0 0
TP0038
Universal Trial Number (UTN)
Trial acronym
WATER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia (BPH) 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - AQUABEAM System
Treatment: Surgery - Transurethral Resection of the Prostate (TURP)

Experimental: Treatment - AQUABEAM System

Active Comparator: Control - Transurethral Resection of the Prostate (TURP)


Treatment: Devices: 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.

Treatment: Surgery: 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)
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Three months post-treatment
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Six months post-treatment

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
80 Years
Gender
Males
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/12/2019
Sample size
Target
Accrual to date
Final
184
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Vermont
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
New Zealand
State/province [10] 0 0
Tauranga
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Surrey
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Wales
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
PROCEPT BioRobotics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02505919
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Gilling, M.D.
Address 0 0
Urology BOP
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications