Urologic Diseases
Conditions
Keywords
benigh prostate hypertrophy
Brief summary
To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.
Interventions
PROCEDURERezum
Rezum
Sponsors
Can-Am HIFU Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Volume measured by transrectal ultrasound (TRUS) | Baseline | Prostate Volume measured by transrectal ultrasound (TRUS) |
| Maximum flow rate (Q-max) | Baseline | Maximum flow rate (Q-max) |
| Change of Maximum flow rate (Q-max) | 1 month after surgery | Change of Maximum flow rate (Q-max) |
| Post-Void Residual (PVR) volume | Baseline | 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 Prostate Volume measured by transrectal ultrasound (TRUS) | 12 months after surgery | Change of Prostate Volume measured by transrectal ultrasound (TRUS) |
| Questionnaire | Baseline | IPSS |
| Change of Questionnaire | 1 month after surgery | Change of IPSS score |
| Adverse Events | Baseline | Adverse Events |
| Change of Adverse Events | 1 month after surgery | Change of Adverse Events |
Countries
Canada
Contacts
Primary ContactIris Chan
Backup ContactDean Elterman
Outcome results
None listed