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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Control
Hide 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
Arm/Group Title Treatment Comparator Total
Hide 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
Hide 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.
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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%)    
Hide 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
Hide 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
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):
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