Status:
ACTIVE_NOT_RECRUITING
WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia
Lead Sponsor:
University of Bonn
Collaborating Sponsors:
PROCEPT BioRobotics
Conditions:
BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Eligibility:
MALE
45-80 years
Phase:
NA
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 pro...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
- Simultaneously participation in another clinical trial in the field of urology
- Known or persistent abuse of medication, drugs or alcohol
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2029
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04801381
Start Date
December 16 2020
End Date
October 1 2029
Last Update
February 6 2025
Active Locations (5)
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1
Department of Urology, University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte
Bochum, North Rhine-Westphalia, Germany, 44791
3
Department of Urology, University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany, 53127
4
Frimley Health NHS Foundation Trust
London, United Kingdom