NCT04801381

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: University of Bonn · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
PROCEDURE	Aquablation therapy	Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA
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).

Timeline

• Start date: 2020-12-16
• Primary completion: 2025-01-16
• Completion: 2029-10-01
• First posted: 2021-03-17
• Last updated: 2025-02-06

Locations

5 sites across 2 countries: Germany, United Kingdom