Benign Prostatic Hyperplasia (BPH)WATERIINCT03123250

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

A study testing Aquablation in people with Benign Prostatic Hyperplasia (BPH), run by PROCEPT BioRobotics at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 80 years, men only
Conditions the study is for: Benign Prostatic Hyperplasia (BPH)
What is being tested?: Aquablation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 16 sitesin 2 countries
Study dates: 14 Aug 2017to 20 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male age 45-80 years.
Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
Subject has an IPSS score greater than or equal to 12.
Maximum urinary flow rate (Qmax) less than 15mL/s.
Serum creatinine < 2 mg/dL within 30 days of surgery.
History of inadequate or failed response, contraindication, or refusal to medical therapy.
Prostate size ≥ 80 mL and ≤ 150 mL as measured by TRUS.
Patient is mentally capable and willing to sign a study-specific informed consent form.

Who cannot join

BMI ≥ 42.
Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
Participants using systemic immune-suppressants including corticosteroids (except inhalants); unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) prior to treatment per standard or care except for low dose aspirin (e.g. less than or equal to 100mg).
Contraindication to both general and spinal anesthesia.
Any severe illness that would prevent complete study participation or confound study results.
History of prostate cancer or current/suspected bladder cancer. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds.

Show all 16Show fewer

History of actively treated bladder cancer within the past two (2) years.
Clinically significant bladder calculus or bladder diverticulum (e.g., pouch size >20% of full bladder size).
Active infection, including urinary tract infection or prostatitis.
Urinary catheter use daily for 90 or more days consecutively.
Previous urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
Ever been diagnosed with a clinically significant urethral stricture or meatal stenosis, or bladder neck contracture.
Known damage to external urinary sphincter.
Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent.
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.
Subject is unwilling to accept a transfusion should one be required.

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

United States13 sites

Albany Medical College
Albany, New York, 12208
University of Vermont
Burlington, Vermont, 05054
UT Southwestern Medical Center
Dallas, Texas, 75390-9110
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Tibor Rubin VA Medical Center
Long Beach, California, 90822
University of Southern California, Institute of Urology
Los Angeles, California, 90089
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Adult & Pediatrics Urology
Omaha, Nebraska, 68114
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Virginia Urology
Richmond, Virginia, 23235
San Diego Clinical Trials
San Diego, California, 92120
Urology of Virginia
Virginia Beach, Virginia, 23462
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

Canada3 sites

Université de Montréal
Montreal, Quebec, H2X 0A9
University of Toronto-University Health Network
Toronto, Ontario, M5G 1Z6
University of British Columbia
Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) with prostate volumes between 80 mL and 150 mL. The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. Treated subjects will be followed out to 60 months to collect long-term clinical data.

Conditions: Benign Prostatic Hyperplasia (BPH)
Being tested: Aquablation
Keywords: Lower Urinary Tract Symptoms (LUTS), AQUABEAM, Aquablation, Benign Prostatic Hyperplasia (BPH)
Medical subject headings: Prostatic Hyperplasia, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AquablationDevice
The procedure is performed with the AquaBeam System. It is designed to utilize a high-velocity sterile saline waterjet as the cutting medium, which is projected through a nozzle positioned within the prostatic urethra. The Aquablation procedure integrates real-time ultrasound imaging with a robotically executed surgeon guided high-velocity waterjet to resect prostate tissue.

Study groups in NCT03123250
Study group	Role	What they receive
Aquablation procedure	Experimental	Not described Receives: Device: Aquablation

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
The percentage 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.
Measured: 3 months post-treatment
Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline
The change in total IPSS score at 3 months as compared to baseline.
The objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia IPSS ranges from 0 to 35. A higher score indicates a worse outcome.
Measured: 3 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 201720 Dec 2022

First posted21 Apr 2017
Study start14 Aug 2017
Primary completion27 Mar 2018
Study completion20 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03123250
Sponsor's protocol ID: TP0124
Acronym: WATERII
Status last verified: Jun 2023
First submitted: 11 Apr 2017
Last updated: 28 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Bhojani N, Bidair M, Kramolowsky E, Desai M, Doumanian L, Zorn KC, Elterman D, Kaufman RP Jr, Eure G, Badlani G, Plante M, Uchio E, Gin G, Paterson R, So A, Roehrborn C, Motola J, Kaplan S, Humphreys M. Aquablation Therapy in Large Prostates (80-150 mL) for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Final WATER II 5-Year Clinical Trial Results. J Urol. 2023 Jul;210(1):143-153. doi: 10.1097/JU.0000000000003483. Epub 2023 Apr 28.
PubMed 37115632
Desai M, Bidair M, Zorn KC, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Roehrborn C, Kaplan S, Motola J, Bhojani N. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial. BJU Int. 2019 Aug;124(2):321-328. doi: 10.1111/bju.14703. Epub 2019 Mar 29.
PubMed 30734990
Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys MR, Roehrborn CG, Kaplan S, Motola J, Zorn KC. Aquablation for benign prostatic hyperplasia in large prostates (80-150 cc): 2-year results. Can J Urol. 2020 Apr;27(2):10147-10153.
PubMed 32333733
Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Roehrborn C, Kaplan S, Motola J, Zorn KC. WATER II (80-150 mL) procedural outcomes. BJU Int. 2019 Jan;123(1):106-112. doi: 10.1111/bju.14360. Epub 2018 Jun 10.
PubMed 29694702
Bhojani N, Bidair M, Zorn KC, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Kaplan S, Motola J, Desai M, Roehrborn C. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results. Urology. 2019 Jul;129:1-7. doi: 10.1016/j.urology.2019.04.029. Epub 2019 May 3.
PubMed 31059728
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.
PubMed 29873008

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Benign Prostatic Hyperplasia (BPH) trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
ClinicalTrials.gov ID: NCT03123250
Acronym / sponsor ID: WATERII / TP0124
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Lower Urinary Tract Symptoms (LUTS), AQUABEAM, Aquablation, Benign Prostatic Hyperplasia (BPH)
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: PROCEPT BioRoboticsIndustry (pharma, biotech, devices)
Study start: 14 Aug 2017 (actual)
Primary completion: 27 Mar 2018 (actual)
Study completion: 20 Dec 2022 (actual)
First posted: 21 Apr 2017 (actual)
Results: Posted 28 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Aquablation procedure	Experimental	Device: Aquablation

Who may qualify

Ages: 45 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male age 45-80 years.
Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
Subject has an IPSS score greater than or equal to 12.
Maximum urinary flow rate (Qmax) less than 15mL/s.
Serum creatinine < 2 mg/dL within 30 days of surgery.

Key exclusion criteria (16 listed)

BMI ≥ 42.
Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
Participants using systemic immune-suppressants including corticosteroids (except inhalants); unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) prior to treatment per standard or care except for low dose aspirin (e.g. less than or equal to 100mg).
Contraindication to both general and spinal anesthesia.
Any severe illness that would prevent complete study participation or confound study results.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AquablationThe procedure is performed with the AquaBeam System. It is designed to utilize a high-velocity sterile saline waterjet as the cutting medium, which is projected through a nozzle positioned within the prostatic urethra. The Aquablation procedure integrates real-time ultrasound imaging with a robotically executed surgeon guided high-velocity waterjet to resect prostate tissue.	Device	Aquablation procedure

Primary outcome

Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
Time frame: 3 months post-treatment
The percentage 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.
Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline
Time frame: 3 months post-treatment
The change in total IPSS score at 3 months as compared to baseline. The objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia IPSS ranges from 0 to 35. A higher score indicates a worse outcome.

Results and safety

Results posted to the registry on 28 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aquablation Procedure	101	101

Primary outcome: Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment

Time frame: 3 months post-treatment. Number. Unit: percentage

Measure	Aquablation Procedure n = 101
Value	45.5

Primary outcome: Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline

Time frame: 3 months post-treatment. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Aquablation Procedure n = 95
Value	-16.5 (-18.1 to -14.8)

Population analysed: The number of participants analyzed for this outcome measure consist of the participants who completed the IPSS questionnaire at 3 months post-treatment.

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aquablation Procedure	18 of 101 (17.8%)	82 of 101 (81.2%)	0 of 101

Limitations and caveats (from the sponsor): The main limitation is that the trial is a single-arm study with a pre-specified performance goal and not randomized against another treatment arm.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37115632Bhojani N, Bidair M, Kramolowsky E, Desai M, Doumanian L, Zorn KC, Elterman D, Kaufman RP Jr, Eure G, Badlani G, Plante M, Uchio E, Gin G, Paterson R, So A, Roehrborn C, Motola J, Kaplan S, Humphreys M. Aquablation Therapy in Large Prostates (80-150 mL) for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Final WATER II 5-Year Clinical Trial Results. J Urol. 2023 Jul;210(1):143-153. doi: 10.1097/JU.0000000000003483. Epub 2023 Apr 28.
Background: PubMed 30734990Desai M, Bidair M, Zorn KC, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Roehrborn C, Kaplan S, Motola J, Bhojani N. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial. BJU Int. 2019 Aug;124(2):321-328. doi: 10.1111/bju.14703. Epub 2019 Mar 29.
Background: PubMed 32333733Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys MR, Roehrborn CG, Kaplan S, Motola J, Zorn KC. Aquablation for benign prostatic hyperplasia in large prostates (80-150 cc): 2-year results. Can J Urol. 2020 Apr;27(2):10147-10153.
Background: PubMed 29694702Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Roehrborn C, Kaplan S, Motola J, Zorn KC. WATER II (80-150 mL) procedural outcomes. BJU Int. 2019 Jan;123(1):106-112. doi: 10.1111/bju.14360. Epub 2018 Jun 10.
Background: PubMed 31059728Bhojani N, Bidair M, Zorn KC, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Kaplan S, Motola J, Desai M, Roehrborn C. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results. Urology. 2019 Jul;129:1-7. doi: 10.1016/j.urology.2019.04.029. Epub 2019 May 3.
Derived from this study: PubMed 29873008Chughtai 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.
Individual participant dataSharing planned: Undecided

Related trials for Benign Prostatic Hyperplasia (BPH)

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aquablation in people with Benign Prostatic Hyperplasia (BPH), run by PROCEPT BioRobotics at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment (time frame: 3 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03123250, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.