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WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia (WATER III)

Primary Purpose

BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Aquablation therapy

Transurethral laser enucleation

About this trial

This is an interventional treatment trial for BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms focused on measuring Aquablation therapy, Laserenucleation, HoLEP, ThuLEP

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Age: 45 - 80 years
International Prostate Symptom Score (IPSS) ≥ 8
Prostate size (measurement by transrectal ultrasound): 80 - 180 mL
Subject has diagnosis of LUTS (Lower urinary tract symptoms) due to BPH (Benign Prostatic Hyperplasia)
Patient is mentally capable and willing to sign a study-specific consent form
Subjects with the ability to follow study instructions and likely to attend and complete all required visits
Written informed consent

Exclusion Criteria:

Body mass index ≥ 42
Suspected or history of prostate cancer
Suspected or history of bladder cancer
Bladder stone
Indwelling catheter for more than 3 months before baseline
Active urinary tract infection
History of urethral stricture or bladder neck stenosis
Damage of the external urethral sphincter
Previous prostate surgery or history of lower urinary tract surgery (e.g. urinary diversion, artificial sphincter or penile prosthesis)
Use of anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except ASS 100mg/d).
Contraindications for general and spinal anaesthesia
The investigator considers a pre-existing condition or the subject's life circumstances to be problematic for the conduct of the study and the completion of the follow-up investigations
Subject is unwilling to accept a blood transfusion if required
Subject is not able to give consent
Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
Simultaneously participation in another clinical trial in the field of urology
Known or persistent abuse of medication, drugs or alcohol

Sites / Locations

Klinik für Urologie, Universitätsklinikum FreiburgRecruiting
Department of Urology, Augusta-Kranken-Anstalt, Bochum MitteRecruiting
Department of Urology, University of BonnRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Aquablation therapy

Transurethral laser enucleation

Arm Description

Aquablation therapy: Computer-assisted transurethral ablation of prostate tissue using a high-pressure water jet. Subsequent removal of residual ablated tissue at the bladder neck and haemostasis by transurethral electroresection (TUR).

Transurethral laser enucleation of the prostate using thulium laser (ThuLEP) or holmium laser (HoLEP).

Outcomes

Primary Outcome Measures

Primary Efficacy Endpoint

Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change

Primary Safety Endpoint

Primary safety endpoint is defined as the occurrence of an Adverse Event rated by the investigator as related or unrelated to the study procedure, classified as Clavien Dindo grade 2 or higher or any grade 1 event resulting in persistent disability, such as ejaculatory or erectile dysfunction or incontinence, as evidenced through 3 months after treatment.

Secondary Outcome Measures

Change in IPSS

Change in IPSS (International Prostate Symptom Score)

Change in IIEF 5/SHIM

Change in IIEF5/SHIM (International Index of Erectile Function)

Change in MSHQ-EjD-SF

Change in MSHQ-EjD-SF (Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form)

Change in Dysuria Questionnaire

Change in ICIQ-UI-SF

Change in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form)

Post void residual urine

Reduction of Post void residual urine

Qmax, Uroflowmetry

Changes of maximum flow rate (Qmax) measured by Uroflowmetry

Prostate volume reduction

Number of re-interventions

Number of re-interventions defined as need for additional tissue resection following the index procedure due to BPH.

Full Information

NCT ID

NCT04801381

First Posted

March 10, 2021

Last Updated

May 9, 2023

Sponsor

University of Bonn

Collaborators

PROCEPT BioRobotics

1. Study Identification

Unique Protocol Identification Number

NCT04801381

Brief Title

WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia

Acronym

WATER III

Official Title

WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80-180ml) in Benign Prostatic Hyperplasia

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 16, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Bonn

Collaborators

PROCEPT BioRobotics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Comparative analysis of efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) and transurethral laser enucleation as surgical therapy for benign prostatic hyperplasia with large prostates (80-180ml).

Detailed Description

Prospective randomized and non-randomized cohort, two-arm multicenter trial two arm multicenter trial to evaluate the efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) compared to transurethral laser enucleation - the current reference standard of minimal invasive therapy for benign prostatic hyperplasia in large prostates (80-180ml).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Keywords

Aquablation therapy, Laserenucleation, HoLEP, ThuLEP

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized and non-randomized trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aquablation therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Transurethral laser enucleation

Arm Type

Active Comparator

Arm Description

Transurethral laser enucleation of the prostate using thulium laser (ThuLEP) or holmium laser (HoLEP).

Intervention Type

Procedure

Intervention Name(s)

Aquablation therapy

Intervention Description

Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA

Intervention Type

Procedure

Intervention Name(s)

Transurethral laser enucleation

Intervention Description

Transurethral laser enucleation is performed according to the standard established at the respective test center. Included laser techniques: Holmium laser (HoLEP) and Thulium laser (ThuLEP).

Primary Outcome Measure Information:

Title

Primary Efficacy Endpoint

Description

Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change

Time Frame

3 months after index procedure

Title

Primary Safety Endpoint

Description

Time Frame

Through 3 months after index procedure

Secondary Outcome Measure Information:

Title

Change in IPSS

Description

Change in IPSS (International Prostate Symptom Score)

Time Frame

1,6,12,24,36,48 and 60 months after index procedure

Title

Change in IIEF 5/SHIM

Description

Change in IIEF5/SHIM (International Index of Erectile Function)

Time Frame

3,6,12,24,36,48 and 60 months after index procedure

Title

Change in MSHQ-EjD-SF

Description

Change in MSHQ-EjD-SF (Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form)

Time Frame

3,6,12,24,36,48 and 60 months after index procedure

Title

Change in Dysuria Questionnaire

Description

Change in Dysuria Questionnaire

Time Frame

1,3,6,12,24,36,48 and 60 months after index procedure

Title

Change in ICIQ-UI-SF

Description

Change in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form)

Time Frame

1,3,6,12, 24,36,48 and 60 months after index procedure

Title

Post void residual urine

Description

Reduction of Post void residual urine

Time Frame

day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure

Title

Qmax, Uroflowmetry

Description

Changes of maximum flow rate (Qmax) measured by Uroflowmetry

Time Frame

day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure

Title

Prostate volume reduction

Description

Prostate volume reduction

Time Frame

comparison of Visit 5 (3 months) and visit 1 (baseline)

Title

Number of re-interventions

Description

Number of re-interventions defined as need for additional tissue resection following the index procedure due to BPH.

Time Frame

Through 60 months after index procedure

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 45 - 80 years International Prostate Symptom Score (IPSS) ≥ 8 Prostate size (measurement by transrectal ultrasound): 80 - 180 mL Subject has diagnosis of LUTS (Lower urinary tract symptoms) due to BPH (Benign Prostatic Hyperplasia) Patient is mentally capable and willing to sign a study-specific consent form Subjects with the ability to follow study instructions and likely to attend and complete all required visits Written informed consent Exclusion Criteria: Body mass index ≥ 42 Suspected or history of prostate cancer Suspected or history of bladder cancer Bladder stone Indwelling catheter for more than 3 months before baseline Active urinary tract infection History of urethral stricture or bladder neck stenosis Damage of the external urethral sphincter Previous prostate surgery or history of lower urinary tract surgery (e.g. urinary diversion, artificial sphincter or penile prosthesis) Use of anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except ASS 100mg/d). Contraindications for general and spinal anaesthesia The investigator considers a pre-existing condition or the subject's life circumstances to be problematic for the conduct of the study and the completion of the follow-up investigations Subject is unwilling to accept a blood transfusion if required Subject is not able to give consent Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial Simultaneously participation in another clinical trial in the field of urology Known or persistent abuse of medication, drugs or alcohol

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Johannes Stein, Dr. med.

Phone

0049228/28714184

johannes.stein@ukbonn.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manuel Ritter, Univ.-Prof. Dr. med.

Organizational Affiliation

Department of Urology, University of Bonn

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik für Urologie, Universitätsklinikum Freiburg

City

Freiburg

State/Province

Baden-Württemberg

ZIP/Postal Code

79106

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian Gratzke, Univ.Prof. Dr. med.

Facility Name

Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte

City

Bochum

State/Province

NRW

ZIP/Postal Code

44791

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Burkhard Ubrig, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Simon Gloger, Dr. med.

Phone

0049234 5172651

s.gloger@augusta-bochum.de

Facility Name

Department of Urology, University of Bonn

City

Bonn

State/Province

NRW

ZIP/Postal Code

53127

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Johannes Stein, Dr. med.

Phone

0049228/28714184

johannes.stein@ukbonn.de

First Name & Middle Initial & Last Name & Degree

Manuel Ritter, Univ.-Prof.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia

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