Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).

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

Official Title
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Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).

Conditions
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Urologic Diseases

Intervention / Treatment
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* Procedure: Rezum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects of ≥ 18 years of age. Primary diagnosis of Benign Prostate Hypertrophy (BPH). Candidate for Rezūm therapy as per clinical decision of Investigator. Willing and able to accurately complete the required 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 |
| --- | --- |
| Rezum procedure<br> | Procedure: Rezum<br>* Rezum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum flow rate (Q-max) | Maximum flow rate (Q-max) | Baseline | 
| Change of Maximum flow rate (Q-max) | Change of Maximum flow rate (Q-max) | 1 month after surgery | 
| Change of Maximum flow rate (Q-max) | Change of Maximum flow rate (Q-max) | 3 months after surgery | 
| Change of Maximum flow rate (Q-max) | Change of Maximum flow rate (Q-max) | 6 months after surgery | 
| Change of Maximum flow rate (Q-max) | Change of Maximum flow rate (Q-max) | 12 months after surgery | 
| Change of Maximum flow rate (Q-max) | Change of Maximum flow rate (Q-max) | 24 months after surgery | 
| Change of Maximum flow rate (Q-max) | Change of Maximum flow rate (Q-max) | 36 months after surgery | 
| Post-Void Residual (PVR) volume | Post-Void Residual (PVR) volume | Baseline | 
| Change of Post-Void Residual (PVR) volume | Change of Post-Void Residual (PVR) volume | 1 month after surgery | 
| Change of Post-Void Residual (PVR) volume | Change of Post-Void Residual (PVR) volume | 3 months after surgery | 
| Change of Post-Void Residual (PVR) volume | Change of Post-Void Residual (PVR) volume | 6 months after surgery | 
| Change of Post-Void Residual (PVR) volume | Change of Post-Void Residual (PVR) volume | 12 months after surgery | 
| Change of Post-Void Residual (PVR) volume | Change of Post-Void Residual (PVR) volume | 24 months after surgery | 
| Change of Post-Void Residual (PVR) volume | Change of Post-Void Residual (PVR) volume | 36 months after surgery | 
| Prostate Volume measured by transrectal ultrasound (TRUS) | Prostate Volume measured by transrectal ultrasound (TRUS) | Baseline | 
| Change of Prostate Volume measured by transrectal ultrasound (TRUS) | Change of Prostate Volume measured by transrectal ultrasound (TRUS) | 12 months after surgery | 
| Questionnaire | IPSS | Baseline | 
| Change of Questionnaire | Change of IPSS score | 1 month after surgery | 
| Change of Questionnaire | Change of IPSS score | 3 months after surgery | 
| Change of Questionnaire | Change of IPSS score | 6 months after surgery | 
| Change of Questionnaire | Change of IPSS score | 12 months after surgery | 
| Change of Questionnaire | Change of IPSS score | 24 months after surgery | 
| Change of Questionnaire | Change of IPSS score | 36 months after surgery | 
| Adverse Events | Adverse Events | Baseline | 
| Change of Adverse Events | Change of Adverse Events | 1 month after surgery | 
| Change of Adverse Events | Change of Adverse Events | 3 months after surgery | 
| Change of Adverse Events | Change of Adverse Events | 6 months after surgery | 
| Change of Adverse Events | Change of Adverse Events | 12 months after surgery | 
| Change of Adverse Events | Change of Adverse Events | 24 months after surgery | 
| Change of Adverse Events | Change of 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