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

February 3, 2025 updated by: Manuel Ritter, University of Bonn

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • Department of Urology, University Hospital Freiburg
    • NRW
      • Bochum, NRW, Germany, 44791
        • Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte
      • Bonn, NRW, Germany, 53127
        • Department of Urology, University Hospital Bonn
  • United Kingdom
      • London, United Kingdom
        • Guy's and St. Thomas' Hospital
      • London, United Kingdom
        • Frimley Health NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Body mass index ≥ 42
  2. Suspected or history of prostate cancer
  3. Suspected or history of bladder cancer
  4. Bladder stone
  5. Indwelling catheter for more than 3 months before baseline
  6. Active urinary tract infection
  7. History of urethral stricture or bladder neck stenosis
  8. Damage of the external urethral sphincter
  9. Previous prostate surgery or history of lower urinary tract surgery (e.g. urinary diversion, artificial sphincter or penile prosthesis)
  10. Use of anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except ASS 100mg/d).
  11. Contraindications for general and spinal anaesthesia
  12. 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
  13. Subject is unwilling to accept a blood transfusion if required
  14. Subject is not able to give consent
  15. Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
  16. Simultaneously participation in another clinical trial in the field of urology
  17. Known or persistent abuse of medication, drugs or alcohol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Aquablation therapy
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).
Procedure: Aquablation therapy
Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA
Active Comparator: Transurethral laser enucleation
Transurethral laser enucleation of the prostate using thulium laser (ThuLEP) or holmium laser (HoLEP).
Procedure: Transurethral laser enucleation
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Efficacy Endpoint
Time Frame: 3 months after index procedure
Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change
3 months after index procedure
Primary Safety Endpoint
Time Frame: Through 3 months after index procedure
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.
Through 3 months after index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in IPSS
Time Frame: 1,6,12,24,36,48 and 60 months after index procedure
Change in IPSS (International Prostate Symptom Score)
1,6,12,24,36,48 and 60 months after index procedure
Change in IIEF 5/SHIM
Time Frame: 3,6,12,24,36,48 and 60 months after index procedure
Change in IIEF5/SHIM (International Index of Erectile Function)
3,6,12,24,36,48 and 60 months after index procedure
Change in MSHQ-EjD-SF
Time Frame: 3,6,12,24,36,48 and 60 months after index procedure
Change in MSHQ-EjD-SF (Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form)
3,6,12,24,36,48 and 60 months after index procedure
Change in Dysuria Questionnaire
Time Frame: 1,3,6,12,24,36,48 and 60 months after index procedure
Change in Dysuria Questionnaire
1,3,6,12,24,36,48 and 60 months after index procedure
Change in ICIQ-UI-SF
Time Frame: 1,3,6,12, 24,36,48 and 60 months after index procedure
Change in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form)
1,3,6,12, 24,36,48 and 60 months after index procedure
Post void residual urine
Time Frame: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Reduction of Post void residual urine
day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Qmax, Uroflowmetry
Time Frame: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Changes of maximum flow rate (Qmax) measured by Uroflowmetry
day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Prostate volume reduction
Time Frame: comparison of Visit 5 (3 months) and visit 1 (baseline)
Prostate volume reduction
comparison of Visit 5 (3 months) and visit 1 (baseline)
Number of re-interventions
Time Frame: Through 60 months after index procedure
Number of re-interventions defined as need for additional tissue resection following the index procedure due to BPH.
Through 60 months after index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bonn

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PROCEPT BioRobotics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manuel Ritter, Univ.-Prof. Dr. med., Department of Urology, University of Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • URO-202001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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