Active — Not RecruitingNot Applicable

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

Germany, United Kingdom202 participantsStarted 2020-12-16

Plain-language 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).

Who can participate

Age range45 Years – 80 Years

SexMALE

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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

What they're measuring

Primary Efficacy Endpoint

Timeframe: 3 months after index procedure

Primary Safety Endpoint

Timeframe: Through 3 months after index procedure

Trial details

NCT IDNCT04801381

SponsorUniversity of Bonn

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-16

View on ClinicalTrials.gov More BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms trials