NCT02505919

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 were measured at 3 and 6 months, respectively, and subjects were followed out to 5 years to collect long-term clinical data.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
4 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2017

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

April 8, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

July 21, 2015

Results QC Date

March 13, 2020

Last Update Submit

June 14, 2023

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Lower Urinary Tract Symptoms (LUTS)

Outcome Measures

Primary Outcomes (2)

  • 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. Results are presented as a percentage rounded to the whole number.

    Three months post-treatment

  • Change 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.

    Six months post-treatment

Other Outcomes (5)

  • Long-term Effectiveness as Measured by International Prostate Symptom Score (IPSS) at 60 Months

    60 months following original surgical intervention

  • International Prostate Symptom Score (IPSS) at 60 Months

    60 months following original surgical intervention

  • International Prostate Symptom Score Quality of Life (IPSS-QoL) at 60 Months

    60 months following original surgical intervention

  • +2 more other outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

AQUABEAM System

Device: AQUABEAM System

Active Comparator

ACTIVE COMPARATOR

Transurethral Resection of the Prostate (TURP)

Procedure: Transurethral Resection of the Prostate (TURP)

Interventions

AQUABEAM SystemDEVICE

The AQUABEAM system, a personalized image-guided tissue removal system, utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue.

Treatment
Transurethral Resection of the Prostate (TURP)PROCEDURE

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)

Active Comparator

Eligibility Criteria

Age45 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
  • Age from 45 to 80 years.

You may not qualify if:

  • Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit.
  • 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.
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Urology Centers of Alabama

Birmingham, Alabama, 35209, United States

Location

San Diego Clinical Trials

La Mesa, California, 91942, United States

Location

University of Southern California, Institute of Urology

Los Angeles, California, 90089, United States

Location

Urology Associates, P.C.

Englewood, Colorado, 80113, United States

Location

Adult & Pediatric Urology P.C.

Omaha, Nebraska, 68114, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9110, United States

Location

Houston Metro Urology

Houston, Texas, 77030, United States

Location

University of Vermont College of Medicine

Burlington, Vermont, 05401, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Tauranga Urology Research Ltd.

Tauranga, 3112, New Zealand

Location

Frimley Park Hospital

Frimley, Surrey, GU16 7UJ, United Kingdom

Location

Princess of Wales Hospital

Bridgend, Wales, CF31 1RQ, United Kingdom

Location

Addenbrooke's Treatment Center

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (7)

  • 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. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation(R) vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. J Urol. 2018 May;199(5):1252-1261. doi: 10.1016/j.juro.2017.12.065. Epub 2018 Jan 31.

    PMID: 29360529BACKGROUND

  • 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.

    PMID: 30552937BACKGROUND

  • 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.

    PMID: 31028614BACKGROUND

  • 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.

    PMID: 32065861BACKGROUND

  • Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Kaufman RP Jr, Badlani G, Plante M, Desai M, Doumanian L, Te AE, Roehrborn CG. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022 Feb;29(1):10960-10968.

    PMID: 35150215BACKGROUND

  • 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.

    PMID: 30721737DERIVED

  • 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.

    PMID: 29873008DERIVED

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Angela Lee
Organization
PROCEPT BioRobotics Corporation
a.lee@procept-biorobotics.com
6502327215

Study Officials

  • Peter Gilling, M.D.

    Urology BOP

    PRINCIPAL INVESTIGATOR

  • Claus Roehrborn, M.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
All study subjects and the study site follow-up team are blinded to the assigned treatment until the year 3 follow-up.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 22, 2015

Study Start

October 30, 2015

Primary Completion

July 14, 2017

Study Completion

December 16, 2021

Last Updated

July 3, 2023

Results First Posted

April 8, 2020

Record last verified: 2023-06

Locations

US(12)AU(1)GB(3)NZ(1)