Modified Water Vapor Thermal Therapy in Management of Patients With Large-volume Benign Prostatic Hyperplasia

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• International Prostate Symptom Score (IPSS) change from baseline to 3 months. — from baseline to 3 months
  International prostate symptom score (IPSS) is a questionnaire used to indicate the severity of LUTS symptoms, There are 7 questions relating to different symptoms subjects be experiencing. 7 questions about patients' urinating include Incomplete emptying, Frequency, Intermittency, Urgency, Weak stream, Straining and Nocturia, every question have 0-5 scores according to Prostate Symptom, the higher score mean patient have more severe the symptoms. IPSS total score: the minimum score is 0 and maximum score are 35. IPSS total 0-7 scores are mild symptoms, IPSS total 8-19 scores are moderate symptoms and IPSS total 20-35 scores are severe symptoms. International Prostate Symptom Score (IPSS) scores were recorded at baseline to 3 months. The mean change in IPSS was calculated.

Trial sites (1)

More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China

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