Urologic Diseases
Conditions
Keywords
benigh prostate hypertrophy
Brief summary
To document the clinical outcome of Aquablation therapy for BPH patient in Canadian cohort.
Detailed description
Patients will be followed up for 3 years as standard of care.
Interventions
PROCEDUREAquablation
Aquablation
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
* Primary diagnosis of Benign Prostate Hypertrophy (BPH) * Male subjects of ≥ 18 years of age * Candidate for Aquablation therapy as per clinical decision of Investigator * Willing and able to accurately complete 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 |
|---|---|---|
| Maximum flow rate (Q-max) | Baseline | Standard of care |
| Post-Void Residual (PVR) volume | Baseline | Standard of care |
| Prostate Volume | Baseline | Standard of care |
| Questionnaires | Baseline | IPSS |
| Adverse Events | Baseline | Adverse Events |
Countries
Canada
Contacts
Primary ContactDean Elterman
Outcome results
None listed