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Modified Water Vapor Thermal Therapy in Management of Patients With Large-volume Benign Prostatic Hyperplasia
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Summary
Water vapor thermal therapy (Rezum) is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation. Although Rezum is currently indicated for use in men with prostate sizes ≥30 and ≤80 ml, the guidelines offer no recommendation with regards to Rezum therapy for those with large-volume glands.
Official title: Modified Water Vapor Thermal Therapy (REZUM) in Management of Patients With Large-volume Benign Prostatic Hyperplasia
Key Details
Gender
MALE
Age Range
45 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2024-09
Completion Date
2027-09
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Rezum
The Rezum System is designed to treat patients with urinary symptoms associated with BPH. The Rezum System utilizes radiofrequency current to generate thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate in controlled 9-second doses. The vapor injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue, and the stored thermal energy is released, denaturing the cell membranes and causing cell death.
Locations (1)
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China