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

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ClinicalTrials.gov Identifier: NCT02505919

Recruitment Status : Completed

First Posted : July 22, 2015

Results First Posted : April 8, 2020

Last Update Posted : April 8, 2020

Sponsor:

Information provided by (Responsible Party):

PROCEPT BioRobotics

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition	Benign Prostatic Hyperplasia (BPH)
Interventions	Device: AQUABEAM System Procedure: Transurethral Resection of the Prostate (TURP)
Enrollment	184

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Treatment	Control
Arm/Group Description	AQUABEAM System ...	Transurethral Resection of the Pros...
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: 1 Week Follow-Up
Started	116	65
Completed	116	65
Not Completed	0	0
Period Title: 1 Month Follow-Up
Started	116	65
Completed	116	65
Not Completed	0	0
Period Title: 3 Months Follow-Up
Started	116	65
Completed	116	65
Not Completed	0	0
Period Title: 6 Months Follow-Up
Started	116	65
Completed	116	63
Not Completed	0	2
Period Title: 12 Months Follow-Up
Started	116	63
Completed	115	61
Not Completed	1	2
Period Title: 24 Months Follow-Up
Started	115	61
Completed	112	60
Not Completed	3	1
Period Title: 36 Months Follow-Up
Started	112	60
Completed	97	55
Not Completed	15	5

Baseline Characteristics

Arm/Group Title		Treatment	Comparator	Total
Arm/Group Description		Aquablation Procedure Utilizing AQU...	Transurethral Resection of the Pros...	Total of all reporting groups
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 Number of Baseline Participants		117	67	184
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	117 participants	67 participants	184 participants
		66.0 (7.3)	65.8 (7.2)	65.9 (7.3)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	117 participants	67 participants	184 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	117 100.0%	67 100.0%	184 100.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	117 participants	67 participants	184 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%	0 0.0%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	117 participants	67 participants	184 participants
Asian		3 2.6%	2 3.0%	5 2.7%
Hispanic		2 1.7%	3 4.5%	5 2.7%
Black		2 1.7%	2 3.0%	4 2.2%
White		109 93.2%	59 88.1%	168 91.3%
Other		1 0.9%	0 0.0%	1 0.5%
Not Available		0 0.0%	1 1.5%	1 0.5%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	117 participants	67 participants	184 participants
New Zealand		11	9	20
United States		61	32	93
United Kingdom		32	18	50
Australia		13	8	21
Transrectal Ultrasound (TRUS) Prostate Size Mean (Standard Deviation) Unit of measure: mL
	Number Analyzed	117 participants	67 participants	184 participants
		54.1 (16.2)	51.8 (13.8)	53.4 (15.4)
International Prostate Symptom Score (IPSS) ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	117 participants	67 participants	184 participants
		22.9 (6.0)	22.2 (6.1)	22.6 (6.1)
		[1] Measure Description: The International Prostate Symptom Score (IPSS) scale ranges from 0 to 35. A higher score indicates an unfavorable outcome.

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...
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 AQU...	Transurethral Resection of the Pros...
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)
Overall Number of Participants Analyzed	114	62
Measure Type: Count of Participants Unit of Measure: Participants
	29 25.4%	26 41.9%

2.Primary Outcome


Title	Score of IPSS Questionnaire Between Baseline and 6 Months
Description	The primary effectivenes...
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 AQU...	Transurethral Resection of the Pros...
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)
Overall Number of Participants Analyzed	114	62
Mean (Standard Deviation) Unit of Measure: 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 ...		Transurethral Resection of the Pros...
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 (%)		Affected / at Risk (%)
Total	4/116 (3.45%)		1/65 (1.54%)
Serious Adverse Events Serious Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/116 (21.55%)		12/65 (18.46%)
General disorders
Non-urologic ^†	17/116 (14.66%)	23	6/65 (9.23%)	7
Renal and urinary disorders
Bladder neck contracture ^†	2/116 (1.72%)	2	1/65 (1.54%)	1
Pain ^†	0/116 (0.00%)	0	1/65 (1.54%)	1
Prostate cancer ^†	0/116 (0.00%)	0	1/65 (1.54%)	1
Urinary retention ^†	3/116 (2.59%)	3	1/65 (1.54%)	1
Urinary tract infection ^†	2/116 (1.72%)	2	0/65 (0.00%)	0
Urinary tract stones ^†	1/116 (0.86%)	1	1/65 (1.54%)	1
Urinary urgency/frequency/difficulty/leakage ^†	4/116 (3.45%)	4	0/65 (0.00%)	0
Kidney ^†	1/116 (0.86%)	1	0/65 (0.00%)	0
Surgical and medical procedures
Bleeding ^†	2/116 (1.72%)	2	3/65 (4.62%)	4
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	95/116 (81.90%)		54/65 (83.08%)
General disorders
Non-urologic ^†	69/116 (59.48%)	152	28/65 (43.08%)	63
Renal and urinary disorders
Bladder pain/spasm ^†	7/116 (6.03%)	7	2/65 (3.08%)	2
Bleeding ^†	19/116 (16.38%)	22	12/65 (18.46%)	12
Dysuria ^†	18/116 (15.52%)	18	7/65 (10.77%)	7
Pain ^†	7/116 (6.03%)	8	7/65 (10.77%)	8
Urethral stricture ^†	3/116 (2.59%)	3	4/65 (6.15%)	4
Urinary retention ^†	8/116 (6.90%)	9	3/65 (4.62%)	3
Urinary tract infection ^†	14/116 (12.07%)	20	8/65 (12.31%)	12
Urinary urgency/frequency/difficulty/leakage ^†	28/116 (24.14%)	43	20/65 (30.77%)	33
Reproductive system and breast disorders
Erectile dysfunction ^†	4/116 (3.45%)	4	6/65 (9.23%)	6
Retrograde ejaculation ^†	13/116 (11.21%)	13	21/65 (32.31%)	21
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Angela Lee
Organization:	PROCEPT BioRobotics Corporation
Phone:	6502327215
EMail:	a.lee@procept-biorobotics.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 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.

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.

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.

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.

Layout table for additonal information

Responsible Party:	PROCEPT BioRobotics
ClinicalTrials.gov Identifier:	NCT02505919
Other Study ID Numbers:	TP0038
First Submitted:	July 21, 2015
First Posted:	July 22, 2015
Results First Submitted:	March 13, 2020
Results First Posted:	April 8, 2020
Last Update Posted:	April 8, 2020

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