Recruiting NCT05201131
Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rezum.
- Who it may be relevant to
- Registry conditions: Urologic Diseases. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.
Interventions
- Procedure Rezum
Rezum
Primary outcome measures
- 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 [Time frame: 3 months after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Dean Elterman — Toronto
Identifiers
NCT: NCT05201131 · Rezum in BPH CAN