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Transperineal Irreversible Electroporation for Benign Prostatic Hyperplasia

Sponsor: First Affiliated Hospital of Zhejiang University • ClinicalTrials.gov ID: NCT06867315

Registry updated: 2026-10-14

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Description

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.

Interventions

Composite steep-pulse therapeutic device (CNP-III) (Device)
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.

Eligibility criteria

Inclusion Criteria: 1. patients with BPH diagnosed through digital rectal examination, B-mode ultrasound and urinary flow rate. 2. international prostate symptom score(IPSS)\>=12. 3. Maximum urinary flow rate between \>5ml/s and \<15ml/s with a minimum voided volume ≥ 150ml. 4. Age ≥ 50 years old. 5. Subjects are willing to participate and have signed the informed consent form. Exclusion Criteria: 1. Patients with acute or severe urinary tract infections. 2. Patients clinically diagnosed with prostate cancer. 3. Patients with neurogenic bladder or bladder dysfunction due to other factors. 4. Patients with urethral stricture. 5. Patients who have undergone previous prostatectomy (TURP), enucleation, or laser surgery. 6. Patients with implanted pacemakers or metal replacements in the pelvis or hip joints. 7. Patients who cannot tolerate general anesthesia or surgery due to severe systemic diseases, heart diseases, pulmonary insufficiency, failure of vital organs, or other reasons. 8. Patients in the trial group who have taken medications that can affect BPH symptoms within 3 months of postoperative follow-up. 9. Patients who have participated in other drug trials or medical device clinical trials within 3 months prior to enrollment. 10. Patients deemed unsuitable for participation in this clinical trial by the investigator.

Conditions

Benign Prostatic Hyperplasia

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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