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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Intervention / Treatment
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* Procedure: Aquablation therapy
* Procedure: Transurethral laser enucleation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 45 - 80 years International Prostate Symptom Score (IPSS) ≥ 8 Prostate size (measurement by transrectal ultrasound): 80 - 180 mL Subject has diagnosis of LUTS (Lower urinary tract symptoms) due to BPH (Benign Prostatic Hyperplasia) Patient is mentally capable and willing to sign a study-specific consent form Subjects with the ability to follow study instructions and likely to attend and complete all required visits Written informed consent Exclusion Criteria: Body mass index ≥ 42 Suspected or history of prostate cancer Suspected or history of bladder cancer Bladder stone Indwelling catheter for more than 3 months before baseline Active urinary tract infection History of urethral stricture or bladder neck stenosis Damage of the external urethral sphincter Previous prostate surgery or history of lower urinary tract surgery (e.g. urinary diversion, artificial sphincter or penile prosthesis) Use of anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except ASS 100mg/d). Contraindications for general and spinal anaesthesia 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 Subject is unwilling to accept a blood transfusion if required Subject is not able to give consent Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial Simultaneously participation in another clinical trial in the field of urology Known or persistent abuse of medication, drugs or alcohol

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized and non-randomized trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aquablation therapy, Laserenucleation, HoLEP, ThuLEP