Actively Recruiting
Study of Rezum Thermal Therapy for Men with Benign Prostate Enlargement in Canada
Led by Can-Am HIFU Inc. · Updated on 2022-01-21
50
Participants Needed
1
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are documenting the clinical outcomes of Rezum therapy for men diagnosed with benign prostatic hyperplasia BPH within a Canadian patient group. This observational study aims to understand how patients respond to this convective thermal treatment using the Rezum System and how it affects their urinary function and prostate health over time. The intervention involves the Rezum procedure, which is a thermal therapy designed to treat BPH. Participants receive the Rezum treatment, and their progress is monitored at multiple intervals after the procedure to assess changes in urinary flow, prostate size, and symptoms. Follow-up measurements occur at baseline and then at 1, 3, 6, 12, 24, and 36 months after surgery to track the therapys effects over an extended period. Participants will undergo various assessments including maximum urinary flow rate, post-void residual urine volume, prostate volume by ultrasound, and symptom questionnaires. Adverse events are also recorded at each time point to monitor safety. The study involves long-term follow-up for up to three years after treatment to gather comprehensive data on patient outcomes and therapy impact.
CONDITIONS
Brief Title
Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
Research Team
I
Iris Chan
D
Dean Elterman
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