Trial document




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  DRKS00023668

Trial Description

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Title

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

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Trial Acronym

WATER III

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URL of the Trial

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Brief Summary in Lay Language

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).

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Brief Summary in Scientific Language

Prospective randomized controlled 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).

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00023668
  •   2020/11/24
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  •   yes
  •   Approved
  •   240/20, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Aquablation therapy (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA): 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).
  •   Transurethral laser enucleation of the prostate using thulium laser (ThuLEP) or holmium laser (HoLEP).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
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Primary Outcome

The trial includes both a primary efficacy and a primary safety endpoint.

Primary Efficacy Endpoint
The primary endpoint is defined as IPSS (International Prostate Symptom Score) change 3 months after surgery.

Primary Safety Endpoint
Primary safety endpoint is defined as the occurrence of an Adverse Event rated by the investigator as related or unrelated to the study procedure, classified as Clavien Dindo grade 2 or higher or any grade 1 event resulting in persistent disability, such as ejaculatory or erectile dysfunction or incontinence, as evidenced through 3 months after treatment.

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Secondary Outcome

1. Change in IPSS (International Prostate Symptom Score) (Visits 4-11, 1st-60th month)
2. Change in IIEF 5 (International Index of Erectile Function)
3. Change in MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form)(Visit 5-11, 3rd to 60th month)
4. Change in Dysuria Questionnaire (Visits 4-11, 1st-60th month)
5. Change in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) (Visits 4-11, 1st-60th month)
6. Reduction of Post void residual urine (Visits 3,5,6,7,9)
7. Changes Qmax (Uroflowmetry)(Visits 3,5,6,7,9)
8. Prostate volume reduction (comparison of visit 5 and visit 1)
9. Number of re-interventions: defined as need for additional tissue resection following the index procedure due to BPH.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2020/12/16
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   45   Years
  •   80   Years
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Additional 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 (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

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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. 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

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Addresses

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    • Klinik und Poliklinik für Urologie Universitätsklinikum Bonn
    • Mr.  Univ.-Prof. Dr. med.  Manuel  Ritter 
    • Venusberg Campus 1
    • 53127  Bonn
    • Germany
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    •   0228/28714180
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    • Klinik und Poliklinik für Urologie Universitätsklinikum Bonn
    • Mr.  Univ.-Prof. Dr. med.  Manuel  Ritter 
    • Venusberg Campus 1
    • 53127  Bonn
    • Germany
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    • Klinik und Poliklinik für Urologie Universitätsklinikum Bonn
    • Mr.  Dr. med.  Johannes  Stein 
    • Venusberg Campus 1
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • PROCEPT BioRobotics
    • 900 Island Dr Ste 210
    • 94065  CA, Redwood City
    • United States
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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