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

• Sponsor: PROCEPT BioRobotics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02505919
• Collaborator: (none)
• Enrollment: 184
• Locations: 17
• Arms: 2
• Actual Duration (Months): 48.9
• Patients Per Site: 10.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 184 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: Nov 21, 2015
• Actual Primary Completion Date: Jul 14, 2017
• Actual Study Completion Date: Dec 19, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability) [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. Score of IPSS Questionnaire Between Baseline and 6 Months [Six months post-treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology Centers of Alabama	Birmingham	Alabama	United States	35209
2	San Diego Clinical Trials	La Mesa	California	United States	91942
3	University of Southern California, Institute of Urology	Los Angeles	California	United States	90089
4	Urology Associates, P.C.	Englewood	Colorado	United States	80113
5	Adult & Pediatric Urology P.C.	Omaha	Nebraska	United States	68114
6	Albany Medical College	Albany	New York	United States	12208
7	Weill Cornell Medical College	New York	New York	United States	10065
8	Wake Forest School of Medicine	Winston-Salem	North Carolina	United States	27157
9	UT Southwestern Medical Center	Dallas	Texas	United States	75390-9110
10	Houston Metro Urology	Houston	Texas	United States	77030
11	University of Vermont College of Medicine	Burlington	Vermont	United States	05401
12	Virginia Urology	Richmond	Virginia	United States	23235
13	Royal Melbourne Hospital	Melbourne	Victoria	Australia	3050
14	Tauranga Urology Research Ltd.	Tauranga		New Zealand	3112
15	Frimley Park Hospital	Frimley	Surrey	United Kingdom	GU16 7UJ
16	Princess of Wales Hospital	Bridgend	Wales	United Kingdom	CF31 1RQ
17	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

Study Documents (Full-Text)

• Study Protocol - Apr 12, 2016
• Statistical Analysis Plan - Sep 23, 2016

More Information

Publications

None provided.

• Responsible Party: PROCEPT BioRobotics
• ClinicalTrials.gov Identifier: NCT02505919
• Other Study ID Numbers: TP0038
• First Posted: Jul 22, 2015
• Last Update Posted: Apr 8, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by PROCEPT BioRobotics: Lower Urinary Tract Symptoms (LUTS)
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

Participant Flow

Arm/Group Title	Treatment	Control
Arm/Group Description	AQUABEAM System 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.	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)
Period Title: Treatment
STARTED	117	67
COMPLETED	116	65
NOT COMPLETED	1	2
Period Title: Treatment
STARTED	116	65
COMPLETED	116	65
NOT COMPLETED	0	0
Period Title: Treatment
STARTED	116	65
COMPLETED	116	65
NOT COMPLETED	0	0
Period Title: Treatment
STARTED	116	65
COMPLETED	116	65
NOT COMPLETED	0	0
Period Title: Treatment
STARTED	116	65
COMPLETED	116	63
NOT COMPLETED	0	2
Period Title: Treatment
STARTED	116	63
COMPLETED	115	61
NOT COMPLETED	1	2
Period Title: Treatment
STARTED	115	61
COMPLETED	112	60
NOT COMPLETED	3	1
Period Title: Treatment
STARTED	112	60
COMPLETED	97	55
NOT COMPLETED	15	5

Baseline Characteristics

Arm/Group Title	Treatment	Comparator	Total
Arm/Group Description	Aquablation Procedure Utilizing AQUABEAM system: To utilize 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.	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)	Total of all reporting groups
Overall Participants	117	67	184
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.0 (7.3)	65.8 (7.2)	65.9 (7.3)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	117 100%	67 100%	184 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 2.6%	3 4.5%	6 3.3%
Not Hispanic or Latino	114 97.4%	64 95.5%	178 96.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	3 2.6%	2 3%	5 2.7%
Hispanic	2 1.7%	3 4.5%	5 2.7%
Black	2 1.7%	2 3%	4 2.2%
White	109 93.2%	59 88.1%	168 91.3%
Other	1 0.9%	0 0%	1 0.5%
Not Available	0 0%	1 1.5%	1 0.5%
Region of Enrollment (Count of Participants)
New Zealand	11 9.4%	9 13.4%	20 10.9%
United States	61 52.1%	32 47.8%	93 50.5%
United Kingdom	32 27.4%	18 26.9%	50 27.2%
Australia	13 11.1%	8 11.9%	21 11.4%
Transrectal Ultrasound (TRUS) Prostate Size (mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL]	54.1 (16.2)	51.8 (13.8)	53.4 (15.4)
International Prostate Symptom Score (IPSS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	22.9 (6.0)	22.2 (6.1)	22.6 (6.1)

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)
Description	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.
Time Frame	Three months post-treatment

Outcome Measure Data

Analysis Population Description

At the 3 month follow-up period, 2 of the enrolled AQUABEAM subjects and 3 of the enrolled TURP subjects did not attend the office visit.

Arm/Group Title	Treatment	Comparator
Arm/Group Description	Aquablation Procedure Utilizing AQUABEAM system: To utilize 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.	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)
Measure Participants	114	62
Count of Participants [Participants]	29 24.8%	26 38.8%

2. Primary Outcome

Title	Score of IPSS Questionnaire Between Baseline and 6 Months
Description	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.
Time Frame	Six months post-treatment

Outcome Measure Data

Analysis Population Description

At the 6 month follow-up period, 2 of the enrolled AQUABEAM subjects and 1 of the enrolled TURP subjects did not complete the IPSS questionnaire.

Arm/Group Title	Treatment	Comparator
Arm/Group Description	Aquablation Procedure Utilizing AQUABEAM system: To utilize 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.	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)
Measure Participants	114	62
Mean (Standard Deviation) [score on a scale]	-16.9 (6.6)	-15.1 (7.9)

Adverse Events

Time Frame	3 years
Adverse Event Reporting Description	Hematuria which fall in the following categories are classified as an Adverse Event: Extended catheterization beyond 3 days Repeat catheterization beyond three days post treatment Extended Hospitalization - per hospital standard of care (Serious Adverse Event) Blood transfusion (Serious Adverse Event)
Arm/Group Title	Treatment		Control
Arm/Group Description	AQUABEAM System 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.		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)
All Cause Mortality
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/116 (3.4%)		1/65 (1.5%)
Serious Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/116 (21.6%)		12/65 (18.5%)
General disorders
Non-urologic	17/116 (14.7%)	23	6/65 (9.2%)	7
Renal and urinary disorders
Bladder neck contracture	2/116 (1.7%)	2	1/65 (1.5%)	1
Pain	0/116 (0%)	0	1/65 (1.5%)	1
Prostate cancer	0/116 (0%)	0	1/65 (1.5%)	1
Urinary retention	3/116 (2.6%)	3	1/65 (1.5%)	1
Urinary tract infection	2/116 (1.7%)	2	0/65 (0%)	0
Urinary tract stones	1/116 (0.9%)	1	1/65 (1.5%)	1
Urinary urgency/frequency/difficulty/leakage	4/116 (3.4%)	4	0/65 (0%)	0
Kidney	1/116 (0.9%)	1	0/65 (0%)	0
Surgical and medical procedures
Bleeding	2/116 (1.7%)	2	3/65 (4.6%)	4
Other (Not Including Serious) Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	95/116 (81.9%)		54/65 (83.1%)
General disorders
Non-urologic	69/116 (59.5%)	152	28/65 (43.1%)	63
Renal and urinary disorders
Bladder pain/spasm	7/116 (6%)	7	2/65 (3.1%)	2
Bleeding	19/116 (16.4%)	22	12/65 (18.5%)	12
Dysuria	18/116 (15.5%)	18	7/65 (10.8%)	7
Pain	7/116 (6%)	8	7/65 (10.8%)	8
Urethral stricture	3/116 (2.6%)	3	4/65 (6.2%)	4
Urinary retention	8/116 (6.9%)	9	3/65 (4.6%)	3
Urinary tract infection	14/116 (12.1%)	20	8/65 (12.3%)	12
Urinary urgency/frequency/difficulty/leakage	28/116 (24.1%)	43	20/65 (30.8%)	33
Reproductive system and breast disorders
Erectile dysfunction	4/116 (3.4%)	4	6/65 (9.2%)	6
Retrograde ejaculation	13/116 (11.2%)	13	21/65 (32.3%)	21

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If the Study is a Multi-centre Study, then the institution agrees that no Publication of the Study results may be made until Publication of the results of the Multi-centre Study or 2 years after Study Completion, whichever is sooner.