WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia
NCT ID: NCT04801381
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
202 participants
INTERVENTIONAL
2020-12-16
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aquablation therapy
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).
Aquablation therapy
Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA
Transurethral laser enucleation
Transurethral laser enucleation of the prostate using thulium laser (ThuLEP) or holmium laser (HoLEP).
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).
Interventions
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Aquablation therapy
Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA
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).
Eligibility Criteria
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Inclusion Criteria
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
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).
11. Contraindications for general and spinal anaesthesia
12. 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
13. Subject is unwilling to accept a blood transfusion if required
14. Subject is not able to give consent
15. Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
16. Simultaneously participation in another clinical trial in the field of urology
17. Known or persistent abuse of medication, drugs or alcohol
45 Years
80 Years
MALE
No
Sponsors
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PROCEPT BioRobotics
INDUSTRY
University of Bonn
OTHER
Responsible Party
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Manuel Ritter
Univ.-Prof. Dr. med. Manuel Ritter
Principal Investigators
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Manuel Ritter, Univ.-Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, University of Bonn
Locations
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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
Countries
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Other Identifiers
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URO-202001
Identifier Type: -
Identifier Source: org_study_id
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