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

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

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).

Study Overview

• Status: Recruiting
• Conditions: BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
• Intervention / Treatment: Procedure: Aquablation therapy; Procedure: Transurethral laser enucleation

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, 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).

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johannes Stein, Dr. med.; Phone Number: 0049228/28714184; Email: johannes.stein@ukbonn.de

Study Locations

• Germany
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • Recruiting
      • Klinik für Urologie, Universitätsklinikum Freiburg
      • Contact: Christian Gratzke, Univ.Prof. Dr. med.
  • NRW
    • Bochum, NRW, Germany, 44791
      • Recruiting
      • Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte
      • Contact: Burkhard Ubrig, Prof. Dr. med.
      • Contact: Simon Gloger, Dr. med.; Phone Number: 0049234 5172651; Email: s.gloger@augusta-bochum.de
    • Bonn, NRW, Germany, 53127
      • Recruiting
      • Department of Urology, University of Bonn
      • Contact: Johannes Stein, Dr. med.; Phone Number: 0049228/28714184; Email: johannes.stein@ukbonn.de
      • Principal Investigator: Manuel Ritter, Univ.-Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: Aquablation therapy; Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA
Active Comparator: Transurethral laser enucleation; Transurethral laser enucleation of the prostate using thulium laser (ThuLEP) or holmium laser (HoLEP).	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint	Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change	3 months after index procedure
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.	Through 3 months after index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IPSS	Change in IPSS (International Prostate Symptom Score)	1,6,12,24,36,48 and 60 months after index procedure
Change in IIEF 5/SHIM	Change in IIEF5/SHIM (International Index of Erectile Function)	3,6,12,24,36,48 and 60 months after index procedure
Change in MSHQ-EjD-SF	Change in MSHQ-EjD-SF (Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form)	3,6,12,24,36,48 and 60 months after index procedure
Change in Dysuria Questionnaire	Change in Dysuria Questionnaire	1,3,6,12,24,36,48 and 60 months after index procedure
Change in ICIQ-UI-SF	Change in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form)	1,3,6,12, 24,36,48 and 60 months after index procedure
Post void residual urine	Reduction of Post void residual urine	day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Qmax, Uroflowmetry	Changes of maximum flow rate (Qmax) measured by Uroflowmetry	day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Prostate volume reduction	Prostate volume reduction	comparison of Visit 5 (3 months) and visit 1 (baseline)
Number of re-interventions	Number of re-interventions defined as need for additional tissue resection following the index procedure due to BPH.	Through 60 months after index procedure

Collaborators and Investigators

• Sponsor: University of Bonn
• Collaborators: PROCEPT BioRobotics
• Investigators: Principal Investigator: Manuel Ritter, Univ.-Prof. Dr. med., Department of Urology, University of Bonn

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: HoLEP; ThuLEP; Aquablation therapy; Laserenucleation
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: URO-202001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No