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

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

Study Overview

• Status: Recruiting
• Conditions: Urologic Diseases
• Intervention / Treatment: Procedure: Rezum

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Iris Chan; Phone Number: 5033 416-603-5800; Email: Iris.Chan2@uhn.ca
• Study Contact Backup: Name: Dean Elterman; Phone Number: 141660358005033; Email: dean.elterman@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Dean Elterman
      • Contact: Dean Elterman; Phone Number: 5033 4166035800; Email: dean.elterman@uhn.ca
      • Contact: Iris Chan; Phone Number: Elterman 4166035800; Email: dean.elterman@uhn.ca
      • Principal Investigator: Dean Elterman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

• Male subjects of ≥ 18 years of age.
• Primary diagnosis of Benign Prostate Hypertrophy (BPH).
• Candidate for or have already completed Rezūm therapy as per clinical decision of Investigator.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rezum procedure	Procedure: Rezum; Rezum

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Can-Am HIFU Inc.
• Investigators: Principal Investigator: Dean Elterman, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: November 27, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: benigh prostate hypertrophy
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Urologic Diseases
• Other Study ID Numbers: Rezum in BPH CAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No