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

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

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

NCT04801381•University of Bonn

View on ClinicalTrials.gov

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).

Eligibility

Age

45 - 80 years

Sex

MALE

Healthy Volunteers

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).
+7 more criteria

Locations (5)

Department of Urology, University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

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

Bochum, North Rhine-Westphalia, Germany

Department of Urology, University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Frimley Health NHS Foundation Trust

London, United Kingdom

Guy's and St. Thomas' Hospital

London, United Kingdom

Key Dates

Start Date

December 16, 2020

Primary Completion Date

January 16, 2025

Completion Date

October 1, 2029

Last Updated

February 6, 2025

Enrollment

202

ACTUAL participants

Conditions

BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Interventions

Aquablation therapy

PROCEDURE

Transurethral laser enucleation

PROCEDURE