Clinical trial NCT05201131: Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
Official title: Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urologic Diseases
Keywords: benigh prostate hypertrophy
Lead sponsor: Can-Am HIFU Inc.
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum flow rate (Q-max)
timeFrame: Baseline
measure: Change of Maximum flow rate (Q-max)
timeFrame: 1 month after surgery
measure: Change of Maximum flow rate (Q-max)
timeFrame: 3 months after surgery
measure: Change of Maximum flow rate (Q-max)
timeFrame: 6 months after surgery
measure: Change of Maximum flow rate (Q-max)
timeFrame: 12 months after surgery
measure: Change of Maximum flow rate (Q-max)
timeFrame: 24 months after surgery
measure: Change of Maximum flow rate (Q-max)
timeFrame: 36 months after surgery
measure: Post-Void Residual (PVR) volume
timeFrame: Baseline
measure: Change of Post-Void Residual (PVR) volume
timeFrame: 1 month after surgery
measure: Change of Post-Void Residual (PVR) volume
timeFrame: 3 months after surgery
measure: Change of Post-Void Residual (PVR) volume
timeFrame: 6 months after surgery
measure: Change of Post-Void Residual (PVR) volume
timeFrame: 12 months after surgery
measure: Change of Post-Void Residual (PVR) volume
timeFrame: 24 months after surgery
measure: Change of Post-Void Residual (PVR) volume
timeFrame: 36 months after surgery
measure: Prostate Volume measured by transrectal ultrasound (TRUS)
timeFrame: Baseline
measure: Change of Prostate Volume measured by transrectal ultrasound (TRUS)
timeFrame: 12 months after surgery
measure: Questionnaire
timeFrame: Baseline
measure: Change of Questionnaire
timeFrame: 1 month after surgery
measure: Change of Questionnaire
timeFrame: 3 months after surgery
measure: Change of Questionnaire
timeFrame: 6 months after surgery
measure: Change of Questionnaire
timeFrame: 12 months after surgery
measure: Change of Questionnaire
timeFrame: 24 months after surgery
measure: Change of Questionnaire
timeFrame: 36 months after surgery
measure: Adverse Events
timeFrame: Baseline
measure: Change of Adverse Events
timeFrame: 1 month after surgery
measure: Change of Adverse Events
timeFrame: 3 months after surgery
measure: Change of Adverse Events
timeFrame: 6 months after surgery
measure: Change of Adverse Events
timeFrame: 12 months after surgery
measure: Change of Adverse Events
timeFrame: 24 months after surgery
measure: Change of Adverse Events
timeFrame: 36 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Dean Elterman
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Dean Elterman
role: PRINCIPAL_INVESTIGATOR
References: