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

Last updated: February 3, 2025
Sponsor: University of Bonn
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Enuresis

Interstitial Cystitis

Prostate Disorders

Treatment

Aquablation therapy

Transurethral laser enucleation

Clinical Study ID

NCT04801381
URO-202001
  • Ages 45-80
  • Male

Study 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).

Eligibility Criteria

Inclusion

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 (BenignProstatic 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 andcomplete all required visits

  7. Written informed consent

Exclusion

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. urinarydiversion, 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 lifecircumstances to be problematic for the conduct of the study and the completion ofthe 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

Study Design

Total Participants: 202
Treatment Group(s): 2
Primary Treatment: Aquablation therapy
Phase:
Study Start date:
December 16, 2020
Estimated Completion Date:
October 31, 2029

Study 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).

Connect with a study center

  • Department of Urology, University Hospital Freiburg

    Freiburg, Baden-Württemberg 79106
    Germany

    Site Not Available

  • Klinik für Urologie, Universitätsklinikum Freiburg

    Freiburg, Baden-Württemberg 79106
    Germany

    Active - Recruiting

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

    Bochum, NRW 44791
    Germany

    Site Not Available

  • Department of Urology, University Hospital Bonn

    Bonn, NRW 53127
    Germany

    Site Not Available

  • Department of Urology, University of Bonn

    Bonn, NRW 53127
    Germany

    Active - Recruiting

  • Department of Urologie, Asklepios Westklinikum Hamburg

    Hamburg, 22559
    Germany

    Site Not Available

  • Frimley Health NHS Foundation Trust

    London,
    United Kingdom

    Site Not Available

  • Guy's and St. Thomas' Hospital

    London,
    United Kingdom

    Site Not Available

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