Aquablation in Benign Prostatic Hyperplasia in Canada

Study Overview
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Brief Summary
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To document the clinical outcome of Aquablation therapy for BPH patient in Canadian cohort.

Detailed Description
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Patients will be followed up for 3 years as standard of care.

Official Title
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Canadian Cohort of Aquablation, a Robotically Executed, Surgeon-guided, High-pressure Water Jet Ablation Therapy for Endoscopic Resection of Prostate Tissue, in Benign Prostatic Hyperplasia (BPH).

Conditions
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Urologic Diseases

Intervention / Treatment
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* Procedure: Aquablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of Benign Prostate Hypertrophy (BPH) Male subjects of ≥ 18 years of age Candidate for Aquablation therapy as per clinical decision of Investigator Willing and able to accurately complete questionnaires Willing and able to provide signed and dated informed consent Exclusion Criteria: Characteristics indicating a poor compliance with study protocol requirements. Disease or other health condition that is not suitable for this study. Unable or unwilling to provide signed informed consent.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aquablation<br> | Procedure: Aquablation<br>* Aquablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum flow rate (Q-max) | Standard of care | Baseline | 
| Post-Void Residual (PVR) volume | Standard of care | Baseline | 
| Maximum flow rate (Q-max) | Standard of care | 1 month after surgery | 
| Post-Void Residual (PVR) volume | Standard of care | 1 month after surgery | 
| Maximum flow rate (Q-max) | Standard of care | 3 months after surgery | 
| Post-Void Residual (PVR) volume | Standard of care | 3 months after surgery | 
| Maximum flow rate (Q-max) | Standard of care | 6 months after surgery | 
| Post-Void Residual (PVR) volume | Standard of care | 6 months after surgery | 
| Maximum flow rate (Q-max) | Standard of care | 12 months after surgery | 
| Post-Void Residual (PVR) volume | Standard of care | 12 months after surgery | 
| Maximum flow rate (Q-max) | Standard of care | 24 months after surgery | 
| Post-Void Residual (PVR) volume | Standard of care | 24 months after surgery | 
| Maximum flow rate (Q-max) | Standard of care | 36 months after surgery | 
| Post-Void Residual (PVR) volume | Standard of care | 36 months after surgery | 
| Prostate Volume | Standard of care | Baseline | 
| Prostate Volume | Standard of care | 12 months after surgery | 
| Questionnaires | IPSS | Baseline | 
| Questionnaires | IPSS | 1 month after surgery | 
| Questionnaires | IPSS | 3 months after surgery | 
| Questionnaires | IPSS | 6 months after surgery | 
| Questionnaires | IPSS | 12 months after surgery | 
| Questionnaires | IPSS | 24 months after surgery | 
| Questionnaires | IPSS | 36 months after surgery | 
| Adverse Events | Adverse Events | Baseline | 
| Adverse Events | Adverse Events | 1 day of Surgery | 
| Adverse Events | Adverse Events | 1 month after surgery | 
| Adverse Events | Adverse Events | 3 months after surgery | 
| Adverse Events | Adverse Events | 6 months after surgery | 
| Adverse Events | Adverse Events | 12 months after surgery | 
| Adverse Events | Adverse Events | 24 months after surgery | 
| Adverse Events | Adverse Events | 36 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benigh prostate hypertrophy