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Transperineal Irreversible Electroporation for Benign Prostatic Hyperplasia
Sponsor: First Affiliated Hospital of Zhejiang University
Summary
This clinical trial focuses on men with benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate causes urinary problems. The goal is to test a non-thermal ablation technique called irreversible electroporation (IRE), delivered with a steep pulse therapy system, for treating BPH. The main questions it aims to answer are: 1. How many participants have improved urine flow 3 months after treatment? 2. How do urinary symptoms, quality of life, and prostate size change after treatment? 3. What side effects occur, and how serious are they? Participants will be asked to: * undergo the IRE procedure: needle electrodes are placed in the prostate through the perineum under ultrasound guidance, and short electric pulses ablate the enlarged tissue; * attend follow-up visits at 1 and 3 months after the procedure for urine flow tests, symptom questionnaires, and ultrasound measurements.
Official title: Prospective, Multicentre, Single-Arm Clinical Trial on the Safety and Effectiveness of Transperineal Irreversible Electroporation for the Ablation of Benign Prostatic Hyperplasia
Key Details
Gender
MALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2024-09-11
Completion Date
2027-05-29
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
Composite steep-pulse therapeutic device (CNP-III)
Electrodes are inserted percutaneously into the bilateral transition zones of the prostate via a transperineal approach under real-time transrectal ultrasound guidance with a biplane probe; freehand or perineal template placement is permitted by the protocol. A minimum distance of 0.5 cm is maintained from the urethra, the prostatic apex, and the rectum; needle spacing is 1.0-2.2 cm; the effective exposed electrode length is 1.5, 2.0, or 2.5 cm. Ablation is performed in the high-frequency or low-frequency mode, with ablation parameters adjusted according to the delivered current. The ablation range is assessed intraoperatively by contrast-enhanced ultrasound. Procedures are performed under general anaesthesia, neuraxial anaesthesia, or intravenous sedation combined with local anaesthesia. An indwelling urinary catheter is placed before the procedure.
Locations (10)
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Quanzhou First Hospital
Quanzhou, Fujian, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
Zhangzhou Hospital of Fujian Province
Zhangzhou, Fujian, China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Jiading District Central Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China