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

Not Applicable

Recruiting

• Conditions: BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
• Interventions: Procedure: Aquablation therapy; Procedure: Transurethral laser enucleation

• Registration Number: NCT04801381
• Lead Sponsor: University of Bonn

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 prostatic hyperplasia with large prostates (80-180ml).

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 Timeline

• Study Start: 2020-12-16
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11
• Primary Completion: 2023-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aquablation therapy	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).
Transurethral laser enucleation	Transurethral laser enucleation	Transurethral laser enucleation of the prostate using thulium laser (ThuLEP) or holmium laser (HoLEP).

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	Through 3 months after index procedure	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.
Primary Efficacy Endpoint	3 months after index procedure	Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Klinik für Urologie, Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany

Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte; 🇩🇪 Bochum, NRW, Germany

Department of Urology, University of Bonn; 🇩🇪 Bonn, NRW, Germany