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

N/ARecruitingNCT05201131

Can-Am HIFU Inc.50 enrolled

Overview

To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Urologic Diseases

Interventions

RezumPROCEDURE

Rezum

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dean Elterman

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Maximum flow rate (Q-max)

Time frame: Baseline

Change of Maximum flow rate (Q-max)

Time frame: 1 month after surgery

Change of Maximum flow rate (Q-max)

Time frame: 3 months after surgery

Change of Maximum flow rate (Q-max)

Time frame: 6 months after surgery

Change of Maximum flow rate (Q-max)

Time frame: 12 months after surgery

Change of Maximum flow rate (Q-max)

Time frame: 24 months after surgery

Change of Maximum flow rate (Q-max)

Time frame: 36 months after surgery

Post-Void Residual (PVR) volume

Time frame: Baseline

Change of Post-Void Residual (PVR) volume

Time frame: 1 month after surgery

Change of Post-Void Residual (PVR) volume

Central Contacts

Iris Chan

CONTACT

416-603-5800 iris.chan2@uhn.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Change of Post-Void Residual (PVR) volume

Time frame: 3 months after surgery

Change of Post-Void Residual (PVR) volume

Time frame: 6 months after surgery

Change of Post-Void Residual (PVR) volume

Time frame: 12 months after surgery

Change of Post-Void Residual (PVR) volume

Time frame: 24 months after surgery

Change of Post-Void Residual (PVR) volume

Time frame: 36 months after surgery

Prostate Volume measured by transrectal ultrasound (TRUS)

Time frame: Baseline

Change of Prostate Volume measured by transrectal ultrasound (TRUS)

Time frame: 12 months after surgery

Questionnaire

IPSS

Time frame: Baseline

Change of Questionnaire

Change of IPSS score

Time frame: 1 month after surgery

Change of Questionnaire

Change of IPSS score

Time frame: 3 months after surgery

Change of Questionnaire

Change of IPSS score

Time frame: 6 months after surgery

Change of Questionnaire

Change of IPSS score

Time frame: 12 months after surgery

Change of Questionnaire

Change of IPSS score

Time frame: 24 months after surgery

Change of Questionnaire

Change of IPSS score

Time frame: 36 months after surgery

Adverse Events

Time frame: Baseline

Change of Adverse Events

Time frame: 1 month after surgery

Change of Adverse Events

Time frame: 3 months after surgery

Change of Adverse Events

Time frame: 6 months after surgery

Change of Adverse Events

Time frame: 12 months after surgery

Change of Adverse Events

Time frame: 24 months after surgery

Change of Adverse Events

Time frame: 36 months after surgery