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

NCT04801381 | Active Not Recruiting

• 1 other identifier: URO-202001
• Study Type: interventional
• Target: 202
• Locations: 2 countries
• Sites: 5

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).

Conditions

BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Keywords

Aquablation therapy; Laserenucleation; HoLEP; ThuLEP

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint

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

  3 months after index procedure

• 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.

  Through 3 months after index procedure

Secondary Outcomes (9)

• Change in IPSS

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

• Change in IIEF 5/SHIM

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

• Change in MSHQ-EjD-SF

  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

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

Study Arms (2)

Aquablation therapy

ACTIVE COMPARATOR

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

Transurethral laser enucleation

ACTIVE COMPARATOR

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

Procedure: Transurethral laser enucleation

Interventions

Aquablation therapy PROCEDURE

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

Aquablation therapy

Transurethral laser enucleation PROCEDURE

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).

Transurethral laser enucleation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bonn: lead
• PROCEPT BioRobotics: collaborator

Study Sites (5)

Department of Urology, University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

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

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Department of Urology, University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Frimley Health NHS Foundation Trust

London, United Kingdom

Location

Guy's and St. Thomas' Hospital

London, United Kingdom

Location

Study Officials

• Manuel Ritter, Univ.-Prof. Dr. med.

  Department of Urology, University of Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med. Manuel Ritter

Model Details: randomized and non-randomized trial

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 17, 2021
• Study Start: December 16, 2020
• Primary Completion: January 16, 2025
• Study Completion (Estimated): October 1, 2029
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); GB (2)